Gastroenterology Today Summer 2017

Volume 27 No. 2

Summer 2017

Gastroenterology Today In this issue The growth of Endoscopy insourcing Deciding whether or not to recommend a (Se) supplement Investigating the efficacy of the low FODMAP diet

Gastroenterology insourcing experts supporting clinical demand and capacity Driving change through highly innovative and flexible working practices

Offering rapid mobilisation with consultant-led specialist teams

Delivering significant cost and operational efficiencies in both outpatients and day surgery

Developing long term and sustainable partnerships

Inside: Dr Matthew Banks, 18 Week Support Gastroenterology Clinical Director on driving high quality weekend endoscopy services.

CONTENTS

CONTENTS 5

EDITORS COMMENT

6

FEATURE T he Growth of Endoscopy Insourcing

8

Deciding whether or not to recommend a (Se) supplement

Gastroenterology insourcing experts clinical 12 supporting AUDIT Investigating the efficacy of the low FODMAP diet demand and capacity 14

NEWS

Driving change through highly innovative and flexible working practices

Offering rapid mobilisation

Delivering significant cost and operational efficiencies in both outpatients and day surgery

Developing long term and

32

35

with consultant-led BSG POSTERS specialist teams

COMPANYsustainable NEWSpartnerships

Inside: Dr Matthew Banks, 18 Week Support Gastroenterology Clinical Director on driving high quality weekend endoscopy services.

COVER STORY

Insourcing endoscopy services: Rethink your working day (and weekend) Due to an ageing population, the success of The Bowel Cancer Screening Program, and increasing patient awareness of cancer risk, the NHS will need to perform 44% more endoscopies by 2020 than it is currently doing. 1 This means an extra 750,000 procedures per year. Therefore, resolving the need for proficient endoscopy clinical staff and diagnostic capacity is critical for the earlier diagnosis and treatment of cancer.

Many Trusts have already expanded their Gastroenterology services towards a 7-day working week to improve service delivery. Furthermore, more Trusts are turning to insourcing services, rather than outsourcing services, to manage their increasing clinical endoscopy needs at cost-effective rates. This insourcing solution offers several benefits over outsourcing.

For example, by using any spare assets or capacity within a Trust, during the evenings and weekends, insourcing allows for a high volume of patients to be seen in a relatively short space of time. This can help a Trust clear endoscopy backlogs, and meet an increase in demand for gastroenterology services.

In addition, because insourcing may be delivered below the national tariff, any savings can be passed directly on to the Trust. 18 Week Support brings in its own external clinical and management expertise to work alongside a Trust’s own clinical and operational teams. This approach offers the added bonus of creating a shared learning experience and boosting staff morale – another major NHS concern, and one which is inherently tied to performance.

Insourcing also enables the Trust to retain overall control over the delivery of endoscopy and gastroenterology services. By seeing patients within a hospital’s own setting, the Trust can monitor the safety and success of these services. For more information about 18 Week Support insourcing contact: +44 (0)203-869-8790 or http://18weeksupport.com/contact/.

Health Services Management Centre at the University of Birmingham and the Strategy Unit at NHS Midlands and Lancashire Commissioning Support Unit (2015) Scoping the Future: An evaluation of endoscopy capacity across the NHS in England. Cancer Research UK https://www.cancerresearchuk.org/sites/ default/files/scoping_the_future_-_final.pd. Accessed 31/03/17.

This issue edited by: Dr N Inayet BSc. MBBS MRCP(GIM) MRCP(Gastroenterology) c/o Media Publishing Company Media House 48 High Street SWANLEY, Kent BR8 8BQ ADVERTISING & CIRCULATION: Media Publishing Company Media House, 48 High Street SWANLEY, Kent, BR8 8BQ Tel: 01322 660434 Fax: 01322 666539 E: info@mediapublishingcompany.com www.MediaPublishingCompany.com PUBLISHING DATES: February, June and October.

COPYRIGHT: Media Publishing Company Media House 48 High Street SWANLEY, Kent, BR8 8BQ PUBLISHERS STATEMENT: The views and opinions expressed in this issue are not necessarily those of the Publisher, the Editors or Media Publishing Company.

Next Issue Autumn 2017 Subscription Information – Summer 2017 Gastroenterology Today is a tri-annual publication currently sent free of charge to all senior qualified Gastroenterologists in the United Kingdom. It is also available by subscription to other interested individuals and institutions.

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GASTROENTEROLOGY TODAY - SUMMER 2017

As an established insourcing company, 18 Week Support provides consultant led clinical teams to work directly within a Trust – in collaboration with existing in-house teams. With its rigorous clinical and safety standards, 18 Week Support aims to match or exceed the services supplied by Trusts to their own patients.

Gastroenterology Today

1

3

Are your patients taking the right dose?

✓ Monitor: Think about the dose of Creon® your patients are taking and review their symptoms regularly.

✓ Dosing: If the treatment is not successful, consider For the titrating up their dose. treatment of pancreatic ✓ Reduce pill burden: If patients are still symptomatic or exocrine require more than 100,000 lipase units per meal, consider insufficiency titrating up to a higher strength using Creon® 40,000.

Creon Micro Pancreatin 60.12 mg Gastro-resistant Granules, Creon 10000 Capsules, Creon 25000 Capsules, Creon 40000 Capsules: PRESCRIBING INFORMATION

Presentation: Creon Micro: Gastro-resistant granules of pancreatin, containing in 100mg: 5,000 PhEur units of lipase; 3,600 PhEur units of amylase; 200 PhEur units of protease.

Creon 10000: Each capsule contains pancreatin equivalent to: 10,000 PhEur units of lipase; 8,000 PhEur units of amylase; 600 PhEur units of protease.

Creon 25000: Each capsule contains pancreatin equivalent to: 25,000 PhEur units of lipase; 18,000 PhEur units of amylase; 1,000 PhEur units of protease.

Creon 40000: Each capsule contains pancreatin equivalent to: 40,000 PhEur units of lipase; 25,000 PhEur units of amylase; 1,600 PhEur units of protease.

Indication: Pancreatic exocrine insufficiency.

Dosage and Administration: Creon Micro: Initially 100mg (5000 lipase units) taken with each feed or meal or immediately after. The required quantity of granules should be dispensed using the measuring scoop provided which holds 100mg. In young infants, mix with a small amount of (undiluted) apple juice and give from a spoon directly before the feed. In weaned infants, mix with acidic liquids or soft foods (e.g. undiluted apple juice or apple puree) and take directly before the meal without chewing. Alternatively, mix the granules with a small amount of milk on a spoon and administer to the infant immediately. The granules should not be added to the baby’s bottle.

Creon 10000, 25000 and 40000: Initially one or two capsules during or immediately after meals, then adjust according to response. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice.

Job code:CRE-2017-0109 Date of preparation: April 2017

Creon Micro, 10000, 25000 and 40000: Dose increases, if required, should be added slowly with careful monitoring of response and symptomatology. Maximum daily dosage of Creon Micro should not exceed 10,000 units lipase/kg/day. Ensure adequate hydration. If the granules are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth. Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see below).

Contraindications, Warnings etc: Hypersensitivity to pancreatin of porcine origin or any excipients.

Fibrosing colonopathy has been reported in CF patients taking high dose pancreatin preparations. As a precaution, medically assess unusual or changes in abdominal symptoms, especially for doses above 10000 units of lipase/kg/day.

Pregnancy and Lactation: There is inadequate evidence of safety in use during pregnancy.

Pancreatic enzymes can be used during breast-feeding.

Ability to Drive and Operate Machinery: No or negligible influence on ability.

Side Effects: Most commonly, gastrointestinal disorders.

Common: nausea, vomiting, constipation, diarrhoea and abdominal distension. Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower

incidences compared to placebo were reported for abdominal pain (very common, ≥1/10).

Uncommon: rash.

Frequency unknown: Hypersensitivity (anaphylaxis), pruritus and urticaria, strictures of the ileo-caecum and large bowel (fibrosing colonopathy). See SPC for further information.

Interactions: no studies performed.

Name and Address of Marketing Authorisation Holder: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL PL No: Creon Micro: PL 46302/0031, Creon 10000: PL 46302/0028, Creon 25000: PL 46302/0029, Creon 40000: PL 46302/0030 Basic NHS price: Creon Micro (20g): £31.50, Creon 10000 (100 capsules): £12.93, Creon 25000 (100 capsules): £28.25, Creon 40000 (100 capsules): £47.55 Legal Category: Creon Micro and Creon 10000: P, Creon 25000 and Creon 40000: POM Further information is available in the UK from: BGP Products Ltd., Building Q1, Quantum House, 60 Norden Road, Maidenhead, SL6 4AY Date of Last Revision: 29/03/2017 Adverse events should be reported.Reporting forms and infomation can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Mylan by phone 0800 121 8267 or email ukpharmacovigilance@mylan.com.

EDITORS COMMENT

EDITORS COMMENT NHS and cybersecurity Recently the National health service faced many days of chaos when hackers demanding a ransom, infiltrated the computer systems of up to 40 NHS sites and blocked access to vital patient records with a “ransomware “attack. This resulted in delay in care provision as appointments and operations had to be cancelled and at some acute sites ambulances had to be diverted. This was later found to be part of a larger worldwide attack which experts in online security called the ‘the biggest ransomware attack in history’. This attack behaved like a pandemic spreading quickly with some reports in media suggesting more than 57,000 incidents of infection in over 99 countries. NHS bosses declared it a major incident and had to request the help of GCHQ’s national cyber security centre to fight this attack.

In the wake of this attack, NHS systems have been found to be particularly vulnerable to such attacks as most of the trusts are using out-dated and unsupported systems with little or no security against such attacks. On this occasion, there was no evidence that confidential patient data had been accessed but it is impossible to say whether the hackers had the ability to do so if they wished.

The exposure of these vulnerabilities is obviously very alarming for everyone concerned bringing NHS digitising and its cybersecurity under the spotlight. The ambitious National Programme for Information Technology (NPfIT) for secondary care, was launched in 2002 but shut down in 2011 as it failed to achieve its goals. Parts of the NHS IT services have reportedly been outsourced to private contractors since 2002 under the “Delivering 21st Century IT Support for the NHS” (DoH,2002) and lack of up to date technology has been blamed on under-funding.

Encouragingly however, the Treasury has allocated £4.2 billion last year to support the digitising of NHS. In the hope to tackle this with the correct approach from the first step, the National Advisory Group on Health Information Technology in England published an independent report (Making IT work: harnessing the power of health information technology to improve care in England) in September 2016 which suggests several recommendations taking into account the lessons learned from the failure of NPfIT. Although the recommendations do not specifically address the issue of cybersecurity, one would hope that the recent crisis would bring this sensitive area to the forefront with allocation of ample resources to deal with this. It is not too hard to imagine that the next successful cyber-attack on the NHS could be even larger in scale and could cost us dearly not only financially but more importantly could potentially compromise patient care.

Dr N Inayet, Research Fellow, St George’s Hospital London BSc. MBBS MRCP(GIM) MRCP(Gastroenterology) Editor

GASTROENTEROLOGY TODAY - SUMMER 2017

“The exposure of these vulnerabilities is obviously very alarming for everyone concerned bringing NHS digitising and its cybersecurity under the spotlight.”

5

FEATURE

THE GROWTH OF ENDOSCOPY INSOURCING

Researched and written by Dr Iqbal Khan, MBChB, BSc, PhD FRCP, Consultant Gastroenterologist (Endoscopy Lead at Northampton General Hospital, UK); Medical Advisor and Caldicott Guardian to Medinet.

Why is there a need for insourcing?

As a trainee, fifteen to twenty years ago, I recall patients who often had to wait many months and sometimes over a year for their endoscopy procedure. There was little or no focus on the quality of the procedure. (1-2) It was acceptable for patients to have an incomplete procedure and anecdotally there were consultants with caecal intubation rates of 50%. It was also a time with little focus on endoscopy training, which was largely experiential. The state of affairs was confirmed by the National Confidential Enquiry into patient outcomes and death, following endoscopic procedures. (3) Fortunately, since that time there has been an evolution in gastrointestinal endoscopy across the UK, and now we are performing many more complex procedures at a much higher quality with better outcomes for patients. (4, 5) Much of the safety and quality change was driven by the Joint Advisory Group for gastrointestinal endoscopy (JAG) through their well-organized programmes such as the National Endoscopy training programme (JETS) and the Global Rating Scale (GRS). This work has led to an improvement in all endoscopy practice and the performance of the practitioners (both as endoscopists and nurse assistants).

GASTROENTEROLOGY TODAY - SUMMER 2017

6

However, over the years a number of factors have placed an unprecedented burden on endoscopy units and the current demand is disproportionate to the capacity to deliver endoscopy activity.

Some of these factors are demographic such as an ageing and expanding population. No doubt the quality improvements will have also contributed by setting aside dedicated training lists and slowing endoscopy procedures to enhance endoscopic views and quality, but the situation is much more complex than this.

National policy has introduced the Bowel Cancer Screening Programme and more recently Bowelscope. There have been multiple government campaigns to ‘be clear on cancer’ leading to a higher patient expectation and demand for procedures. The National Institute for Health and Care Excellence (NICE) lowered their recommended threshold for the referral of patients suggestive of cancer to a 2-week wait pathway. Moreover, the last decade has seen a growth in timeconsuming, complex therapeutic procedures such as Endoscopic Mucosal Resection (EMR), Endoscopic surgical dissection (ESD), complex hepatobiliary procedures during ERCP, and the growth of EUS as a cancer staging tool. Further pressure has been placed on the service by the introduction of many more formal gastrointestinal

(GI) bleed service rotas. (6) The future vision of the British Society of Gastroenterology (BSG) to set up an Endoscopy Quality Improvement Programme could put further strain on the endoscopy services, but it could also serve as an opportunity to change services to make them easier to deliver over the next decade without compromising safety and quality.

These pressures are really felt by individual endoscopy units and Trusts as there is the potential to receive fines for missing targets and lose JAG accreditation. This usually happens when patients can expect to wait more than six weeks for their diagnostic endoscopic test. Hence endoscopy units have to increase their capacity and maintain their quality and positive patient experiences. However, this now has to be delivered in this time of austerity, where the National Health Service (NHS) as a whole is expected to make 2% efficiency savings per year. (7)

Strategies to increase endoscopy capacity Perhaps the most obvious strategy is to ensure that we reduce the waste in the system. (8) Examples include patients who have inadequate bowel preparations or fail to attend appointments. To mitigate this, patients should be educated, ideally with a nurse pre-assessment and by reminding patients to attend by telephone or text. Units with poor bowel preparation problems should switch to better quality preparations and consider the use of split dose bowel preparation. This involves taking laxatives on the day before and on the day of the procedure.

A unit can ensure that its staff and facilities are used as efficiently as possible. Patient turnaround times are crucial to this and ideally all endoscopy rooms should be used throughout the week, and where necessary to maintain waiting list targets, they should also be utilized in the evenings and the weekends. In recent times, there has been an interest in managing the workload through non-medical (usually nurse) endoscopists.

When these measures fail, the workload can be outsourced or insourced. Outsourcing involves sending patients offsite to an external endoscopy provider, which is often a private hospital in the vicinity.

It is important that JAG accredited units only outsource to other JAG accredited units. Insourcing involves bringing in experienced practitioners (endoscopists, nurses and decontamination staff) into the units own space to optimize its capacity. The overall control of this work, including quality monitoring remains under the scrutiny of the Endoscopy Unit and its governance structure.

FEATURE Endoscopy insourcing, a personal experience

Insourcing of endoscopy services is one possible solution to the problem and one that ensures Trusts maximize their own capacity and aspire to deliver a 7-day service.

It is a cold Friday evening in 2010 and I am busy rushing to the airport to catch a plane to Scotland. I am excited, but also slightly apprehensive at the prospect of going over to another part of the UK to deliver a lot of endoscopy over the course of the weekend. The flight was bumpy, but the weekend went really well. The endoscopy equipment was familiar to me and I quickly adapted to the reporting tool. The patients welcomed the timeliness of their procedure and the local staff assisting were very friendly. Most of the patients were reassured with normal procedures but some had pathology such as inflammatory bowel disease and cancer which could be dealt with quickly.

It is fundamentally important that all insourcing activity is closely monitored to ensure clinical and information governance is in not compromised. Patient safety as well as satisfaction should always be core to the service provided.

Over the subsequent seven years, I have visited many hospitals all over the UK and developed a real understanding of the insourcing model and how it contributes to an efficient endoscopy service at the national level. Table 1 shows the volume of endoscopic work carried out by Medinet over those years and well illustrates the growth of insourcing over the period. The experienced garnered has not only enhanced my own practice as an endoscopist, but has also given me the confidence to clinically lead an endoscopy unit to maximum efficiency.

The success of the insourcing model is multifactorial, but largely reflects two factors. Primarily, there is an ever expanding demand for endoscopy services to be delivered local to the patient with an often limited capacity to deliver. Secondly, it enables endoscopy units to deliver additional capacity, but without losing control of their patients to an external provider. The Trust is able to monitor the additional activity to ensure safety, confidentiality and continuity of care and where appropriate early discharge.

The opportunity to sit within Medinet’s governance committee has given me the confidence that the insourcing model is a safe and viable option to deliver endoscopy.

Conclusions The last two decades have seen and incredible transformation in the delivery of endoscopy services across the UK, however, with increasing demands and no significant increase in capacity or resources, there is a possibility that this work could be undone. The endoscopy community should use every opportunity to ensure that this does not happen.

Year

Procedures undertaken Colons

Gastros

Flexis

Total

2010/11

503

507

96

1,106

2011/12

6,306

4,046

1,824

12,176

2012/13

8,661

6,443

2,295

17,399

2013/14

7,687

6,649

1,816

16,152

2014/15

11,540

9,367

2,879

23,786

2015/16

15,805

15,287

4,025

35,117

2016/17

16,083

14,756

4,158

34,997

Total*

66,585

57,055

17,093

140,733

*up to and including March 2017

References 1. Bowles CJA, Leicester R, Romaya C, et al. A prospective study of colonoscopy practice in the UK today: are we adequately prepared for the national colorectal cancer screening tomorrow? Gut 2004; 453:277-83.

2. Valori R. Quality improvements in endoscopy in England. Tech Gastrointest Endosc 2012; 14:64-72.

3. Cullinane M , Gray A, Hargreaves C, et al. Scoping our practice: The 2004 report on the National Confidential enquiry into patient outcomes ad death. 2004. Http://www.ncepod.org.uk/ pdf/2004/04sum.pdf 4. Lee TJ, Rutter MD, Blanks RG et al. Colonoscopy quality measures: experience for the NHS Bowel Cancer Screening Programme, Gut 2012; 61:1050-7.

5. Gavin DR, Valori RM, Anderson JT et al. The national colonoscopy audit: a nationwide assessment of the quality and safety of colonoscopy in the UK. Gut 2013; 62:242-9.

6. NCEiPOaD (NCEPOD). Time to get control? A review of the care received by patients who have a severe gastrointestinal haemorrhage. 2015.

7. NHS. The five year forward view. 2014. https://www.england.nhs.uk/ wp-content/uploads/2014/10/5yfv-web.pdf 8. Seward S, Lumley S. Endoscopy provision: meeting the challenges. Frontline Gastroenterology 2017; 8(2): 90-93.

GASTROENTEROLOGY TODAY - SUMMER 2017

It is important that doctors and nurses who provide insourcing activity are experienced, highly skilled and versatile and there needs to be stringent control of both clinical and information governance. To ensure best practice there should be a dual control of all insourcing activity. This should happen through the Trusts own endoscopy governance structure and an additional layer of governance through the organization delivering the service. It is essential that there are good lines of communication between the two organizations and every opportunity is used for clinical and operational learning. Patient satisfaction should be at the heart of the whole process.

Table 1. Insourced endoscopy procedures carried out by Medinet

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FEATURE

WHAT ARE THE CLINICAL CONSIDERATIONS WHEN DECIDING WHETHER OR NOT TO RECOMMEND A SELENIUM (SE) SUPPLEMENT TO A PATIENT, AND WHAT IS THE EVIDENCE FOR ANY SUCH RECOMMENDATION Michael Quinlan, Registered Nutritionist

Evidence of U-shape relationship between Se status, health and disease The clinical decision regarding whether or not to recommend Se supplementation to a patient should be based on the scientific evidence (e.g. from cancer trials) that shows a U-shape relationship between Se status, health and disease

(1 - 4)

.

when baseline status is low / suboptimal and not when baseline status is already optimal or even high

consider dietary options of increasing intake/status such as the use of functional foods or Se-rich foods (e.g. high-Se mushrooms).

Age of patient – (evidence of particular risk of low intake among elderly) Evidence shows elderly persons have increased risk of low Se intake

Evidence only supports recommending supplementation with Se (1 - 6)

will most likely be low/ suboptimal. If so, the clinician could also

.

(5, 8)

. Brain function and immune function often declines with

age. Considerable evidence exists to show that good Se status supports good immune function and good brain function/cognition (1, 9, 10)

.

If our patient is female and of childbearing age it may be worth

Patient’s selenium (Se) intake/status key factors to be considered:

asking if she has any pregnancy plans as Se is very important during pregnancy and lactation

(1, 5, 6)

.

Sex – male/female Location - where the patient has/ is/ will be living

Males have slightly higher requirements than females

(1, 5)

There is great variety in Se intake in different parts of the world (e.g.

is important to protect male fertility and sperm health

(1)

(US – high, Europe - low, Eastern Europe – very low, China –mix of

also important during pregnancy and poor status is linked to

low and high)

(1, 5, 7)

. Se levels in foods, especially plant foods, are

miscarriage, pre-term birth and pre-eclampsia

(1, 5, 6)

. Se

. Se is

.

dependent on the amount of Se plants can get from the soil they are grown in and this varies wildly from region to region. Locations where plants can only obtain low levels of Se from soil (e.g. much of UK) are associated with population deficiency

(5, 7)

. Se from

animal sources is not impacted by location to the same degree as plants and fodder

(1, 6)

.

GASTROENTEROLOGY TODAY - SUMMER 2017

of deficiency caused by location (e.g. importing Se-rich grains into the UK)

. So, assuming our patient is living in the UK then low

availability from local plant foods is relevant and he/she will have to consume animal sources (meat, seafood, dairy) and/or imported Se-rich plant sources

(1, 5 - 7)

.

(e.g. Keshan disease (KD), Kashin-Beck disease, viral virulence, preeclampsia, disease of the thyroid, cancers, cognitive decline and Parkinson’s disease

(1, 5, 6, 11)

. Evidence shows that

supplementing with Se will address low status and in turn reduce associated disease risks

(1, 5, 6)

.

Evidence also links high Se status with increased risk of skin

Patient’s habitual diet –

and prostate cancer and Type 2 diabetes mellitus (T2DM)

People in the UK get most of their Se from meat, poultry and

The aim here would be to reduce intake/status and certainly not

seafood

(1, 5)

. Not surprisingly vegans, vegetarians/ non-meat

eaters in low Se locations such as the UK can find it challenging to meet their Se intake requirements from diet alone

(5)

(1, 5, 6)

.

to compound matters by boosting status further by giving Se supplements.

. As well as

avoiding meat sources vegetarians are prone to consuming high

Impact of disease – inflammatory response, acute-phase

amounts of phytate-containing plant foods which can decrease Se

response, oxidative stress

bioavailability.

If the patient has been or is dealing with disease then the disease state itself may impact on Se status (i.e. may increase the demand

If the patient’s habitual dietary intake is deficient then Se status

8

Disease Evidence associates low Se status with risk of various diseases

Importing plant foods from Se-rich locations can limit the impact (1, 5 - 7)

State of health of patient

for Se intake)

(1, 5, 6)

.

FEATURE Immune health

Table 1

Low Se status is associated with impaired immune function and studies show that supplementing with Se can boost immune function (persons supplemented with Se were better able to clear viral

U-shape correlation between Se intake/status, health and disease

infections) (1, 5, 6).

Left hand arm of U

Middle of U

Right hand arm of U

Viral virulence / increased related complications

• Baseline Se intake = deficient

• Baseline Se intake = sufficient

• Baseline Se intake = excessive

• Baseline Se status = low

• Baseline Se status = optimal

• Baseline Se status = high

negative associations (1, 5).

• High risk of disease and poor health

• Low risk of disease and poor health

• High risk of disease and poor health

Fertility and reproductive health

Recommend Se supplement

Don’t recommend Se supplement to patient

Don’t recommend Se supplement to patient

Low Se status is associated with increased susceptibility to viral virulence and to increased complications and more difficulty clearing viral infections (e.g. influenza, HIV/AIDS) (1, 5, 6). Evidence highlights benefits in correcting low status by supplementation to reduce such

Low Se status is linked to poor male fertility and sperm health and to problems for women in pregnancy (e.g. miscarriages, pre-term births and pre-eclampsia) (1). Evidence highlights benefits in correcting low status by supplementation to reduce such negative associations (5, 6).

Cognitive health

References 1. Rayman MP (2012). Selenium and human health. Lancet.

379(9822):1256-68.

Observational studies link low Se status with poor brain health/ cognition (1, 5). Good Se status is associated with reduced cognitive decline.

2. Rayman MP. (2008) Food-chain selenium and human health: emphasis on intake. Br J Nutr 100: 254–68.

Physical signs

3. Duffi eld-Lillico AJ, Reid ME, Turnbull BW, et al. (2002) Baseline characteristics and the eff ect of selenium supplementation on cancer incidence in a randomized clinical trial: a summary report of the Nutritional Prevention of Cancer Trial. Cancer Epidemiol Biomarkers Prev 11: 630-39.

Alopecia, garlic breath, dermatitis, breaking nails and selenosis are all associated with excessive intake/ high status (1, 5, 6). Our patient should be checked for any such signs. Low Se status could be indicated by an enlarged thyroid gland (i.e. goitre).

4. Lippman SM, Klein EA, Goodman PJ, et al. (2009) Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA 301: 39–51.

Other family members’ health status If a family member has any history of any health issues linked to Se then this could prove useful (e.g. certain genetic polymorphism

5. Patient. Author Current version: Dr Jan Sambrook. Selenium [Internet];[cited 1st May 2016]. Updated: 02/02/2016. Available from http://patient.info/pdf/1699.pdf#

indicate benefits from increased Se) (1).

Laboratory testing to confirm baseline status This is especially important if dietary analysis indicates deficient intake (5).

Testing whole blood will provide a good long-term measure of Se status.

Smoking/ socio-economic status Smoking and poor economic-status are both linked to low Se status .

(5)

dose, form Supplements can be a fast reliable and flexible means of adjusting and monitoring Se intake/ status. If existing intake/status is low then a significantly high Se supplement will be required to increase status to optimum levels. The clinician should base their decision on dosing and form of Se to use, on best possible evidence (1 – 2, 12).

In conclusion – clinical decision The clinician should be aware of the evidence base that describes a U-shaped relationship between Se intake/ status, health and disease. The clinician should consider all patient details with regard to the factors that influence Se intake/status. A recommendation to supplement is only supported by evidence if the patient’s existing baseline status is low/ suboptimal, as per table 1.

7. Johnson CC, Fordyce FM, Rayman MP. (2010) Symposium on ‘Geographical and geological influences on nutrition’: factors controlling the distribution of selenium in the environment and their impact on health and nutrition. Proc Nutr Soc 69: 119–32.

8. Bates CJ, Thane CW, Prentice A, et al; (2002) Selenium status and its correlates in a British national diet and nutrition survey: people aged 65 years and over. J Trace Elem Med Biol. 16(1):1-8.

9. Shahar A, Patel KV, Semba RD, et al. (2010) Plasma selenium is positively related to performance in neurological tasks assessing coordination and motor speed. Mov Disord 25: 1909–15.

10. Gao S, Jin Y, Hall KS, et al. (2007) Selenium level and cognitive function in rural elderly Chinese. Am J Epidemiol 165: 955– 65 11. Lee EH, Myung SK, Jeon YJ., (2011) Effects of selenium supplements on cancer prevention: meta-analysis of randomized controlled trials. Nutr Cancer. 2011 Nov; 63(8):1185-95.

12. Yiming Xia, Kristina E Hill., (2005) Effectiveness of selenium supplements in a low-selenium area of China1–3 829Am J Clin Nutr 81:829–34.

GASTROENTEROLOGY TODAY - SUMMER 2017

Supplements - ease of implementation/ clinical monitoring,

6. National Institutes of Health (NIH) Office of Dietary Supplements Selenium-Health Professional [Internet]; [cited 1st May 2016].

Updated February 11, 2016. Available from: https://ods.od.nih.gov/ factsheets/Selenium-HealthProfessional/

9

Lighten their load

Iron doesn’t need to be hea v y

Feraccru is an oral ferric iron, an alternative treatment for iron deficiency anaemia in adults with inflammatory bowel disease, who failed on oral ferrous products.

Lighten their load; the AEGIS study demonstrated a significant 2.25 g/dL increase in Hb at Week 12 and a safety profile comparable to placebo.1,2 Prescribing information for Feraccru 30mg hard capsules Please refer to Summary of Product Characteristics before prescribing.

Presentation: A red hard capsule. Each capsule contains 30 mg iron (as ferric maltol). Indications: Feraccru is indicated in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD). Dosage and Administration: Adults: Feraccru should be taken orally. The whole capsule should be taken on an empty stomach (with half a glass of water). The recommended dose is one capsule twice daily, in the morning and evening. The absorption of iron is reduced when Feraccru is taken with food. Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks treatment is required.

The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests. The Elderly: No dose adjustment is necessary. Children: The safety and efficacy of Feraccru in children (17 years and under) has not yet been established. No data are available.

Patients with hepatic or renal impairment: No clinical data is available in this patient population. Contra-Indications: Known hypersensitivity to the active substance or to any of the excipients; Haemochromatosis and other iron overload syndromes; Patients receiving repeated blood transfusions. Warnings And Precautions: Feraccru should not be used in

patients with inflammatory bowel disease (IBD) flare or in IBD patients with haemoglobin (Hb) levels <9.5g/dL. Iron preparations in excess may cause toxicity especially among children and so Feraccru must not be administered to children. Take special care when used with other dietary and/or iron salt supplementation. Before starting treatment, iron deficiency anaemia (IDA) diagnosis should be made based on blood tests; it is important to exclude underlying causes of anaemia other than iron deficiency (e.g. gastric erosion, colonic carcinoma). Feraccru contains lactose and so patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine. This product also contains Allura Red AC (E129) and Sunset Yellow FCF (E110); these may cause allergic reactions. Interactions: Food has been shown to inhibit uptake of Feraccru and so Feraccru should be taken on an empty stomach. Avoid concomitant administration of Feraccru and IV iron, dimercaprol, chloramphenicol and methyldopa. Feraccru should be given at least 2 to 3 hours apart from: penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) moxifloxacin, mycophenolate, norfloxacin, ofloxacin, tetracyclines, calcium and magnesium salts e.g. magnesium trisilicate. Pregnancy and Lactation: There are no data from the use of Feraccru in pregnant women. As a precautionary measure, it

Hb, haemoglobin.

References: 1. Gasche C, et al. Inflamm Bowel Dis 2015;21:579-588. 2. Schmidt C, et al. Aliment Pharmacol Ther 2016;44:259-270.

Date of preparation: March 2017. Job code: PP-FER-UK-0072.

is preferable to avoid the use of Feraccru during pregnancy. Ferric maltol is not available systemically and is therefore unlikely to pass into the mother’s milk. No clinical studies are available to date. As a precautionary measure, it is preferable to avoid the use of Feraccru during breast-feeding.

Undesirable Effects: Common side effects: Abdominal pain, flatulence, constipation, abdominal discomfort/distension, nausea and diarrhoea.

Marketing Authorisation Number: EU/1/15/1075/001 Marketing Authorisation Holder: Shield TX (UK) Ltd, Gateshead Quays, NE8 3DF, UK. Price: £47.60 Legal Category: POM. Date of Preparation: June 2016 For more details contact: Shield TX (UK) Ltd Gateshead Quays NE8 3DF, UK. 0191 511 8500.

Adverse events should be reported.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Shield TX (UK) Ltd Tel. 0207 186 8500 Fax 0191 511 8501 e-mail drugsafety@shieldtx.com

ADVERTORIAL

Feraccru® (ferric maltol): an oral iron alternative for adults with IBD and iron-deficiency anaemia Introduction Iron-deficiency anaemia (IDA) is a common complication of inflammatory bowel disease (IBD), affecting at least 50% of patients as a result of blood loss, malabsorption and chronic inflammation.1–3 Anaemia affects patients’ overall health, resulting in increased clinic visits and hospitalisation, and substantially impairs their quality of life.4,5 Unchecked, IDA can result in debilitating physical and cognitive dysfunction.6

IDA management recommendations The British Society of Gastroenterology (BSG) and the European Crohn’s and Colitis Organisation (ECCO) recommend iron supplementation in all IBD patients with IDA.7,8 Treatment goals are to achieve haemoglobin (Hb) levels of ≥12.0 g/dl in women and ≥13.0 g/dl in men.8 The BSG recommends oral iron first line to achieve treatment goals in a simple and economical manner; therapy should be continued for 3 months after IDA has been corrected so that iron stores are replenished.

Intravenous formulations are recommended for patients who are intolerant or have insufficient response to oral iron.7 ECCO recommends oral iron for patients with mild anaemia, whose disease is clinically inactive and who have not been previously intolerant to oral iron. IV iron is recommended if any of the following apply: clinically active IBD, previous intolerance to oral iron, Hb <10 g/dl, or need for erythropoiesisstimulating agents.8

intestinal mucosa in complex form, allowing efficient absorption of elemental ferric iron.13,14 Feraccru is given as one 30 mg capsule twice daily, morning and evening, on an empty stomach with water.12 (Figure 1)

Feraccru clinical trial evidence The AEGIS clinical trial programme involved patients with remitting or mildly active ulcerative colitis or Crohn’s disease who had mild or moderate IDA and who had failed oral ferrous products principally due to poor GI tolerability.15,16 Patients were randomised to receive Feraccru (n=64) or placebo (n=64) for 12 weeks, after which all patients could continue on Feraccru for 52 weeks (maximum treatment duration 64 weeks). Of the 97 patients who entered the extension phase, 74% were able to complete 64 weeks of treatment.16 By week 12, Feraccru significantly improved mean Hb concentration by 2.25 g/dl vs placebo (P<0.0001; Figure 2), and 66% of Feraccrutreated patients achieved Hb normalisation (median time to normalisation <2 months).15 IBD flares were less frequent with Feraccru (2%) than with placebo (8%).15 Feraccru had an adverse-event profile comparable to that of placebo.15,16 The proportion of patients with gastrointestinal adverse events was similar in the two groups: 38% on Feraccru vs. 40% on placebo.15 Feraccru had no negative impact on patients’ quality of life.15,16

Shield Therapeutics: Feraccru Ad Bleed: 3 mm Supply as hi-res PDF Job no: 01243 Size: 297 x 210 mm

Journal: Gastro Today

Feraccru contains a stable complex of ferric iron (Fe3+) with maltol,11,12 which reaches the

Fe3+

Iron transporter mechanism causes ferric maltol to dissociate on uptake from gastrointestinal tract

Unabsorbed ferric maltol is excreted intact in faeces

Iron transporter mechanism Fe2+

Iron uptake from ferric maltol is saturable, avoiding the potential for iron overload

Fe3+

Most iron enters the liver and bone marrow via transferrin

Ferric iron remains tightly bound with maltol until it is absorbed, minimising free-radical production.

Maltol is rapidly absorbed by diffusion and eliminated in urine as glucuronide.

Conclusion IDA is a common but treatable complication of IBD. Therefore, all IBD patients should be screened for IDA and offered appropriate treatment. If patients are not able to tolerate standard oral ferrous iron, an alternative oral iron supplementation can now be offered.

Feraccru is an oral ferric (Fe3+) option for adults with IDA in IBD following failure of previous oral ferrous agents, offering efficient iron absorption, comparable tolerability to placebo, and proven efficacy.

Figure 2. Feraccru achieves significant improvements in haemoglobin vs. placebo within 12 weeks, and sustains haemoglobin levels for up to 64 weeks15,16

Oral iron options

16

RCT

OLE

P<0.0001

15 Hb concentrtion (g/dl)

To date most oral iron products have used a ferrous iron formulation (Fe2+). However, only 10% of ingested ferrous iron is absorbed.6 Most of the dose ends up in the distal bowel, where it generates reactive oxygen species, exacerbating gut inflammation.9 Oral ferrous iron is associated with adverse events in at least 50% of patients,10 over 30% of patients discontinue treatment early,10 and over 70% are dissatisfied with treatment tolerability or effectiveness.4 An alternative treatment option is therefore needed that retains the convenience of oral administration while being well absorbed and well tolerated.

Figure 1. Ferric maltol reduces exposure of free iron in the intestines, limiting the potential for gastrointestinal toxicity11–14

14 13 12 11

Switch patients changed to Feraccru from placebo after Week 12

10

Continued patients Switched patients

9 0 Continued Switch

4

8

12

(n=64) (n=59) (n=59) (n=58) (n=64) (n=61) (n=56) (n=53)

16

20

24 28 32 36 40 44 Time since randomisation (weeks) (n=43) (n=41)

(n=41) (n=36)

48 (n=40) (n=37)

52

56

60

64 (n=35) (n=36)

Absolute haemoglobin concentrations over time in patients receiving Feraccru or placebo for 12 weeks, followed

by Feraccru for up to 52 weeks in the AEGIS clinical trial programme

References: 1. Stein J et al. Nat Rev Gastroenterol Hepatol 2010;7:599–610. 2. Bergamaschi G et al. Haematologica 2010;95:199–205. 3. Bager P et al. Scand J Gastroenterol 2013;48:1286–1293.

4. Danese S et al. Eur J Gastroenterol Hepatol 2014;26:1385–1391. 5. Koutroubakis IE, et al. Clin Gastroenterol Hepatol 2015;13:1760-1766. 6. Allocca M et al. Curr Drug Targets 2014;15:1011–1019.

7. Goddard AF et al. Gut 2011;60:1309–1316. 8. Dignass AU et al. J Crohns Colitis 2015;9:211–212. 9. Erichson K et al. Scand J Gastroenterol 2003;38:543–548. 10. Lugg S et al. J Cohns Colitis 2014;8:876– 880. 11. Bokemeyer B. Drug Discov Today 2015;20:1037–1039. 12. Feraccru. Summary of Product Characteristics. Shield. December 2016. 13. Barrand MA et al. Br J Pharmacol 1991;102:723–729.

14. Barrand MA, Callingham BA. Br J Pharmacol 1991;102:408–414. 15. Gasche C et al. Inflamm Bowel Dis 2015;21:579–588. 16. Schmidt C et al. Aliment Pharmacol Ther 2016;44:259–270.

See opposite for prescribing information. Date of preparation: April 2017. PP-FER-UK-0081

AUDIT

AN AUDIT INVESTIGATING THE EFFICACY OF THE LOW FODMAP DIET IN IMPROVING SYMPTOMS IN PATIENTS WITH IBS AT LEWISHAM HOSPITAL Katie Sanders April 2016 Background: Evidence suggests that the consumption of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) may result in symptoms in some patients with irritable bowel syndrome (IBS). The low FODMAP diet is an emerging dietary treatment for IBS. The low FODMAP (Fermentable Oligo-, Di-, Monosaccharides and Polyols) diet is a diet low in fermentable carbohydrates. These types of carbohydrate are rapidly fermented by bacteria and can have osmotic effects on the bowel leading to functional gastrointestinal (GI) symptoms in sensitive individuals, including: bloating, flatulence and diarrhoea (1).

Evidence suggests that a reduction in high FODMAP foods leads to an improvement in GI symptoms (2, 3). The aim of this audit was to determine whether the low FODMAP diet was effective in improving symptoms within the first 4-8 weeks.

Method: All patients with IBS who were referred for a low FODMAP diet and attended a dietetic outpatient consultation for dietary management of their symptoms were included in the audit. Patients were asked to score their symptoms subjectively as either none, mild, moderate, or severe, at their initial assessment and at subsequent follow-up appointments. The symptoms patients were asked about were abdominal pain, bloating, wind/flatulence, belching, abdominal gurgling, urgency to open bowels, incomplete evacuation, nausea, heartburn, acid regurgitation, tiredness, and overall symptoms. Patients were also asked at their initial and follow up appointments if they had satisfactory relief of their gut symptoms.

Results: 43 patients were included in this audit. 29 were female, 14 were male, and the average age was 40 years old. Table 1 and Figure 2 both show that 86% of patients reported an overall improvement in their symptoms following the low FODMAP diet, for 12 % there appeared to be no difference and 2% there was a worsening in their overall symptoms. There were a greater number of patients reporting improvements in abdominal pain, bloating, flatulence, belching and stomach gurgling than the other symptoms.

GASTROENTEROLOGY TODAY - SUMMER 2017

12

% improved

% no difference

% worse

Abdominal pain

86

14

0

Bloating

77

21

2

Flatulence

79

19

2

Belching

67

33

0

Stomach gurgling

84

16

0

Urgency to open bowels

60

40

0

Incomplete evacuation

53

42

5

Nausea

37

60

2

Heartburn

42

56

2

Acid regurgitation

26

72

2

Tiredness

60

37

2

Overall improvement

86

12

2

Table 1: % of patients whose symptoms improved / no difference / worsened on the low FODMAP diet.

When patients were asked if they had satisfactory relief of their symptoms, 91% reported â&#x20AC;&#x153;Yesâ&#x20AC;?, as shown in Figure 1.

Figure 1. Graph to show the % of patients reporting satisfactory improvement in their symptoms following the low FODMAP diet.

% of paMents reporMng saMsfactory improvement in symptoms 100 90 80 70 60 50 40 30 20 10 0

91

9 yes

no

Initial appt

Classification following the low FODMAP diet

c

1

c

n

10

n=8 c=2

d

7

n=6 d=1

n,c

4

n=2 c=1 c,n=2

n,c,d

6

n=3 c,n=3

n,d

9

n=5 n,d=1 n,c=2 d=1

Total number of patients

37

BSC classification

Table 2. Stool type using the Bristol stool chart (BSC) classification at the initial appointment and following the low FODMAP diet. In the table above c = type 1 and 2 stools (indicating constipation), n =type 3 and 4 stools (indicating normal/ideal), and d = type 5,6,7 stools (indicating tendency towards diarrhoea). A number of patients reported mixed classifications, for example n, c = type 1-4 stools.

Table 2 shows 1 patient reported constipation and following the low FODMAP diet still reported constipation. 10 patients reported normal (type 3-4) stools and following the low FODMAP diet 8 remained the same but 2 patients became more constipated. 7 patients reported diarrhoea at their initial appointment and following the low FODMAP diet 6 of these patients had normal stools and 1 remained to report a tendency

AUDIT

Figure 2. Graph to show the % change in patient reported symptoms following the low FODMAP diet. towards diarrhoea. 4 patients reported a mixture of type 1-4 stools at their initial appointment and following the low FODMAP diet, 2 patients reported normal stools,1 patient constipation and 1 patient normal and constipation. 6 patients reported alternating diarrhoea and constipation indicated by type 1-7 stools and following the low FODMAP diet 3 of these patients reported normal stools and 3 normal and constipation. 9 patients reported type 3-7 stools at their initial appointment and following the low FODMAP diet, 5 patients then reported normal stools (type 3-4), 1 normal and diarrhoea (type 3-7), 2 patients normal and constipation (type 1-4) and 1 patient diarrhoea (type 5-7).

% of patients

Type 3-4 stools (n) only

Initial appt

After low FODMAP diet

27

65

Table3. % of patients who reported type 3-4 stools only at initial appointment and after the low FODMAP diet.

Patients also reported a change in how frequently their bowels opened following the low FODMAP diet as shown in Table 4.

Reduced frequency of BO

51

No difference

49

Increased frequency BO

0

Table 4. Change in frequency of bowels opening (BO) following the low FODMAP diet.

Conclusion: The results showed that the low FODMAP diet improved functional GI symptoms in 86% of IBS patients and 91% of patients reported a satisfactory relief in their symptoms at their follow up appointment. The biggest improvements were for symptoms of abdominal pain, bloating, belching, and flatulence. The low FODMAP diet also reduced stool frequency in 51% of patients and changed stool consistency with more patients (65%) having type 3-4 stools following the low FODMAP diet. The low FODMAP diet has shown to be effective in the management and overall symptom improvement in IBS patients.

References: 1. Gibson PR, Shepherd SJ. Food choice as a key management strategy for functional gastrointestinal symptoms. Am J Gastroenterol. 2012;107(5):657–66 2. Halmos EP, Power VA, Shepherd SJ et al. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology.

2014;146(1):67-75 3. Barrett JS, Gearry RB, Muir, JG et al. Dietary poorly absorbed, short chain cabohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther 2010;31:874–82

GASTROENTEROLOGY TODAY - SUMMER 2017

The low FODMAP diet appeared to change stool type and out of 22 patients who reported diarrhoea as part of their symptoms, only 3 patients reported diarrhoea following the low FODMAP diet. 11 patients reported constipation as part of their symptoms at their initial appointment and following the low FODMAP diet only 7 still reported constipation. 4 patients however who didn’t report constipation at their initial appointment reported constipation following the low FODMAP diet. 65% of patients reported type 3-4 stools only following the low FODMAP diet compared with 27% at the initial appointment.

% of patients

13

NEWS Mild to moderate ulcerative colitis patients not being managed adequately in primary care • One third receiving less than the recommended dose of maintenance therapy (1) • Nearly half needing ‘extra’ therapy including steroids (1) • Nearly one in three struggling with multiple dosing regimens (1) • An effective once daily alternative, which reduced disease activity in more than 50% of patients, hospital visits by 86% and days off work by 69% (4) is ‘rarely’ prescribed (1) • Cost to NHS due to avoidable GP and Hospital visits. (1,4) An independent study (1) has demonstrated that many patients with ulcerative colitis (UC), are not being managed adequately in primary care, resulting in increased disease activity, extra medication, GP and hospital visits, time off work and cost to the NHS. The study, conducted by a team of independent clinical pharmacists, (2) was carried out across 31 GP Practices within the South Worcestershire Clinical Commissioning Group and looked at 158 UC patients over a six month period. One third of the 158 patients reviewed were found to be receiving less than the recommended dose of maintenance therapy, 45% of patients needed to be prescribed other therapies and 29% were struggling to adhere to multiple dosing regimens whilst an effective once-daily alternative was available but only prescribed to 1% of patients. The study also recorded hospital and GP visits and time off work over the previous six months.

GASTROENTEROLOGY TODAY - SUMMER 2017

14

‘The majority of UC patients have distal disease, for which the recommended long term (maintenance) therapy is a rectal mesalazine to best reach the site of the inflammation,’ explains Dr Riadh Jazrawi, Medical Director at Dr Falk Pharma who supported the study.

‘However, it is well known that patients dislike using rectal therapy, but oral tablet therapies may require multiple dosing. Once Daily Salofalk Granules (SAG), taken orally, delivers mesalazine throughout the colon and provides a high concentration of mesalazine to target areas in the distal area.’ (3).

At the end of the first review, 59 of the patients were switched to oral Once Daily Salofalk

Granules (SAG) for the second study (4). After six months, 30 felt better (51%) compared to 3 patients (3%) who stayed on their current mesalazine therapy, and only 3 (5%) had undergone hospital interventions compared to 12 patients (12.1%) who stayed on their existing mesalazine therapy.

According to the Walmsley disease activity index, (5) 50.8% of patients who changed to SAG experienced a reduction in disease activity compared to 13.1% in the group who stayed on current mesalazine therapy.

In addition, the study found that the group who changed to SAG experienced 69% fewer days off work, 44.5% fewer GP visits, 86% less hospital visits and needed 50% fewer steroid courses than before the switch. Overall, the costs savings in terms of drug costs alone (not including hospital admissions), were estimated to be around £27,500.

‘This review demonstrates that there is something we can do to make a real improvement in the lives of people who suffer from UC,’ explains Dr David Farmer, GP and Clinical Lead, NHS South Worcs CCG. ‘The first stage showed that a relatively small amount of money could be saved by switching to once a day SAG and we had evidence too that patients felt better on a once a day therapy. On the revisits however, six months on, the results were much more significant all round and in the case of patient outcomes they were really quite stunning. Both patient groups received education on their treatment, but of those who switched, about half felt better and there was no difference in those staying on their current therapy. They tended to stay stable.

‘GP and hospital visits were down – in the case of hospital visits by nearly 87% which is an emphatic result - as was the decrease in days off work.

Given that the significant difference between the two groups was their medication change, then it is highly suggestive that these results were due to the medication rather than anything else.’

These findings supported those from a previous pilot study (6) carried out across seven GP practices in Leicestershire which also found that changing patients with UC to once daily SAG improved outcomes and reduced costs in primary and secondary care.

The pilot was later approved by NICE as a case study for their prestigious QIPP Programme (Quality, Innovation, Productivity and Prevention)(7).

‘Although the results are very positive in terms of patient improvement, these reviews clearly demonstrate that UC patients are not getting a good deal in primary care,’ says Dr Jazrawi.

‘Patients who do not want to use rectal therapy are often not being treated effectively. One third are being under dosed with oral therapies and nearly two thirds are being asked to take their tablets more than once a day which makes adherence more difficult for them.

‘Hardly any – just 1% - are receiving a therapy which can be taken orally, just once a day and which delivers mesalazine directly to the affective area of the colon.’

‘Given its positive affect on the lives of those who were in the review, I believe this programme should at least be considered

by GP’s and possibly GP pharmacists as something to offer their UC patients even in a less detailed form,’ agrees Dr Farmer.

‘It would certainly carry a small cost to the GP but in the long term, as the review demonstrates, it would save them money in the form of less GP visits, hospital referrals etc and overall improved quality of life. Most importantly it is likely to reduce disease activity in the patient, a disease which impacts in just about every area of the patient’s life.’

References 1. Link to poster submission Is Ulcerative Colitis Managed Adequately in Primary Care? https://drfalkhub.com/ files/2914/7645/8081/Is_UC_managed_ adequately_in_Primary_Care.pdf 2. Medical Management Solutions, Ravenstone, Leicestershire UK 3. Alimentary Pharmacology and Therapeutics 2003; 17: 1163–1169.

4. Link to poster submission Maintenance Therapy with SAG Improves Long Term Management of UC Patients in Primary Care https://drfalkhub.com/files/9814/7645/8121/ Maintenance_therapy_with_Salofalk_ Granules_improves_long_term_ management_of_UC_patients_in_PC.pdf 5. Walmsley et al Gut 1998;43;29-32 6. Prasher H. Savania P and Jazrawi RP. Changing Patients with Ulcerative Colitis to Once Daily Mesalazine Improves Outcomes and Reduces Costs in Primary and Secondary Care. Presented at the 8th ECCO Congress, February 2013, Vienna, Austria.

7. www.nice.org.uk/savingsandproductivityandl ocalpracticeresource?ci=http%3A%2F%2Fa rms.evidence.nhs.uk%2Fresources%2FQIPP %2F1039017%3Fniceorg%3Dtrue NB Salofalk Granules is coded DrF15/048

NEWS Autoimmune hepatitis

Crohn’s disease

Collagenous colitis

Getting on with

their lives By getting on with

their steroid The only budesonide with three indications Efficacy localised at the site of the disease1-4 Limiting the risk of systemic side effects2-4

GASTROENTEROLOGY TODAY - SUMMER 2017

Prescribing Information (Please refer to full SPC before prescribing) Presentation: Budenofalk® gastro-resistant granules, each sachet contains 9mg budesonide, Budenofalk® gastro-resistant capsules, each containing 3mg budesonide. Indications: Induction of remission of mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Induction of remission of active collagenous colitis. Autoimmune hepatitis (capsules only). Dosage: Adults: For Crohn’s disease and collagenous colitis: one sachet or three capsules daily with liquid half an hour before food, without chewing or crushing, or one capsule three times daily. Limit treatment to 8 weeks, then withdraw gradually. For autoimmune hepatitis: one capsule three times daily. Possibly combine with azathioprine. Maintenance of remission: one capsule twice daily. Revert to 3 capsules daily if transaminases ALAT and/or ASAT elevate again. Treat until remission is achieved or 24 months. Children: Not recommended; safety and efficacy not established. Contra-indications: hypersensitivity to any constituent. Hepatic cirrhosis. Warnings/Precautions: Change from other steroids may result in symptoms due to reduced systemic steroids. Use with caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts or family history of glaucoma or diabetes or any condition in which glucocorticosteroids may have undesirable effects. Not appropriate for upper GI Crohn’s or extraintestinal symptoms. Long term, high dose use may result in glucocorticosteroid systemic effects. Infection: suppression of the inflammatory response and immune function increases susceptibility to infections and their severity. Clinical presentation of infections may be atypical and presentation of serious infections may be masked. Chickenpox and herpes zoster are of particular concern. Passive immunisation needed within 10 days in exposed non-immune patients taking systemic glucocorticosteroids. Urgent specialist care required on confirmed chickenpox. Give normal immunoglobulin immediately after measles exposure. Do not give live vaccines to those with chronic glucocorticosteroid use.

Antibody response to other vaccines may be diminished. With severe liver function disorders: increased systemic bioavailability. Suppression of the HPA axis and reduced stress response: supplementary systemic glucocorticoid treatment may be needed. Avoid concomitant treatment with CYP3A4 inhibitors. Do not use in patients with galactose or fructose intolerance, glucose – galactose malabsorption, sucrase – isomaltase insufficiency or Lapp lactase deficiency or congenital lactase deficiency. In autoimmune hepatitis evaluate transaminase levels every 2 weeks for the first month and then every 3 months. Interactions: Beware concomitant administration of cardiac glycosides and saluretics. CYP3A4 inhibitors: avoid concomitant administration. CYP3A4 inducers: may reduce systemic and local exposure, necessitating dose adjustment of budesonide. CYP3A4 substrates: may compete with budesonide increasing plasma concentrations depending on relative affinities. Small, non-significant effect of cimetidine on budesonide kinetic effects. Oestrogens/

Budesonide, the Dr Falk way

oral contraceptives may elevate plasma concentrations and enhance corticosteroid effects. Steroid-binding compounds and antacids may reduce budesonide efficacy; administer at least 2 hours apart. Because adrenal function may be supressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Use in pregnancy and lactation: Avoid use in pregnancy unless essential. Do not breastfeed during Budenofalk treatment. Undesirable effects: Cushing’s syndrome, growth retardation in children, glaucoma, cataracts, dyspepsia, constipation, gastric or duodenal ulcers, pancreatitis, increase in risk of infections, muscle and joint pain and weakness and twitching, osteoporosis, osteonecrosis, headache, pseudotumor cerebri (including papilloedema) in adolescents, depression, irritability and euphoria, psychomotor hyperactivity, anxiety, aggression, allergic exanthema, petechiae, ecchymosis, contact dermatitis, delayed wound healing, increased risk of thrombosis, vasculitis (after withdrawal from long-term treatment), fatigue, malaise. Side effects characteristic of systemic glucocorticosteroid therapy may occur. Exacerbation or reappearance of extraintestinal manifestations when switching from systemically acting glucocorticosteroids may occur. Frequency is likely to be lower than with equivalent dosage of prednisolone. Legal category: POM. Costs: UK NHS: 60 sachets £135; 100 capsules £75.05. Ireland (PtW): 60 sachets: €152.15; 100 capsules: €78.96. Licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Licence numbers: (granules) PL08637/0020 (UK) PA573/2/3 (IE) (capsules) PL08637/0002 (UK) PA573/2/1 (IE).

Prepared: October 2016.

Further information available on request.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov. uk/yellowcard (UK residents) or at https://www.hpra.ie/homepage/about-us/report-an-issue/humanadverse-reaction-form (residents of the Republic of Ireland). Adverse events should also be reported to Dr Falk Pharma UK Ltd. References: 1.Bar-Meir S et al. Gastroenterol 1998; 115(4): 835-40. 2. De Cassan C et al. Dig Des 2012; 30(4): 368-75.

3. Czaja AJ. Dig Dis Sci 2012; 57(8): 1996-2010. 4. Miehlke S et al. Gastroenterol 2002; 123(4): 978-84.

Dr F17/052 Date of preparation: March 2017

15

NEWS Oesophageal cancer: Loss of muscle mass represents a significant risk to survival Published in Medical News Today www.medicalnewstoday.com Oesophageal cancer patients who suffer loss of muscle mass (sarcopenia) during neoadjuvant therapy (chemotherapy prior to surgery) survive, on average, 32 months less than patients with no sarcopenia. This is the central finding of a recent study conducted at the Comprehensive Cancer Center (CCC) of MedUni Vienna and Vienna General Hospital.

rapidly over the past few years. The number

The results show that patients who suffered

of cases in men has risen sixfold and has

sarcopenia (loss of muscle mass below a

quadrupled in women, men being more likely

defined threshold) at any time during treatment

to develop this type of cancer than women.

had a poorer prognosis for survival: on average, their period of survival was 32 months shorter

Apart from smoking and high alcohol

than that of patients who were not diagnosed

consumption, risk factors for oesophageal

with sarcopenia. Sarcopenia was therefore

cancer also include gastro-oesophageal

identified as an independent risk factor.

reflux disease and the resulting cell changes in the lower part of the oesophagus (Barrett

Says Matthias Paireder, Department of Surgery

metaplasia). The standard treatment for

(Head: Michael Gnant) of MedUni Vienna

patients in which the tumour is advanced but

and Vienna General Hospital, member of

not yet metastasised, is to give chemotherapy

the CCC-GET and lead author of the study:

or a combination of chemotherapy and

“Sarcopenia is not necessarily a side effect

radiotherapy prior to surgery (multimodal

of chemotherapy. Many patients were already

therapy). In local carcinomas that are not

sarcopenic before the treatment and there

advanced, surgery is the treatment of choice.

was no significant progression of sarcopenia during treatment. The reasons for this loss of

The study has recently been published in the

Nutrition and exercise affect chances of

general muscle mass are poor nutrition and

European Journal of Cancer Surgery.

survival

lack of exercise.”

In their study, experts in stomach and Oesophageal cancer is the eighth commonest

oesophageal cancer from the Comprehensive

New study planned

type of cancer and sixth commonest cause

Cancer Center of MedUni Vienna and Vienna

In a new study, the team headed up by

of death from cancer in Austria. According to

General Hospital (CCC GET-Unit, Head:

Paireder and Schoppmann will investigate

“Statistik Austria”, approximately 420 people

Sebastian Schoppmann) investigated to what

whether a programme that includes nutritional

develop this type of cancer every year. This

extent sarcopenia and body composition

advice and physical training could significantly

means that oesophageal cancer is a rare form

changed during multimodal therapy and whether

increase long-term survival for oesophageal

of cancer but the number of cases has grown

this has any influence upon long-term survival.

cancer patients.

We don’t want people to die of embarrassment.

GASTROENTEROLOGY TODAY - SUMMER 2017

16

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We want every patient, that undergoes a procedure to be ensured, that the physician is trained in a simulated environment, to minimise discomfort to the patient.

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www.surgicalscience.com

NEWS Irritable Bowel Syndrome: diagnosis, treatment and management

other factors, which are known triggers of

or prescribed according to the predominant

disease. All patients should be asked about

symptoms, and in some cases a combination

‘Red Flags’ (see Figure 1) and if present, these

of drugs may be required.

should precipitate a referral to secondary care.

A patient presenting with new symptoms of IBS should undergo basic investigations, including

By Dr Simon Smale, Gastroenterologist and Medical Adviser to The IBS Network

full blood count, C reactive protein or other inflammatory marker for Inflammatory Bowel Disease and antibody testing for Coeliac Disease. In those with diarrhea predominance

Introduction According to NICE , Irritable Bowel Syndrome 1

(IBS) is estimated to affect between 10 – 20% of the UK population at any one time, equating to around 12 million people.

bile salt malabsorption should be considered.

Faecal calprotectin is a heat stable neutrophil granule protein, which is found in elevated levels in the stools of patients with active inflammatory

IBS causes a significant burden on the NHS, costing £200m annually in the UK.

2

National

and international guidance stresses the importance of making a positive diagnosis based on symptom assessment and appropriate investigation. Despite this recent data has shown that a third of people had

gastrointestinal disease. In patients under 60 years old without Red Flag symptoms referred to secondary care a normal faecal calprotectin has a negative predictive value of 0.964 for excluding symptomatic organic intestinal disease.v It is therefore increasingly used as a non-invasive means of excluding organic disease in patients thought likely to have IBS.

to visit their GP at least five times before diagnosis, with 44% of sufferers reporting

Figure 1 Red Flag symptoms

delayed diagnosis and treatment of the condition has impacted their quality of life.

3

Understanding IBS symptoms

‘Red Flag’ symptoms: The following symptoms are warning signs for a person to be referred to their GP:

IBS is a chronic disorder of gastrointestinal function with no well-defined structural or biochemical cause.4 It is a chronic, sometimes debilitating condition that can disrupt many people’s personal and working lives. The causes are thought to be multi-factorial. Psychological stress, gastrointestinal infection, diet and changes

• Rectal bleeding. Although in many cases rectal bleeding is caused by haemorrhoids, which often develop in people with IBS, regular loss of blood from the rectum should never be ignored.

• Persistent fever and malaise.

have a role in precipitating symptoms.

• An unexplained change in bowel habit persisting for more than six weeks, in an individual over 50 years old.

of constipation, diarrhoea, abdominal pain and

• Family history of bowel or ovarian cancer.

bloating. Over time, patients often move from

• Iron Deficiency Anaemia.

being constipation predominant to diarrhoea

Lifestyle impact on IBS Understanding physical activity levels and the psychological status of a patient with IBS is important. Emotional context can influence IBS symptoms, even in the absence of psychiatric disease. Physical activity also has a significant impact on bowel function.

Treating IBS

often complain of tiredness and fatigue.

There are a wide variety of treatments

Approximately 15% of patients who develop

available to relieve symptoms of IBS, however

IBS have other functional disease, such as

because of the multi-factorial nature of the

fibromyalgia, interstitial cystitis.

pathogenesis no single treatment is universally effective. Whilst placebo responses are high,

Early diagnosis of IBS

most studies would suggest that drug effects

With wide variations in symptoms from person

account for improvement in only 15-20%

to person, and the fact that other conditions

of patients. Helping people with IBS make

can masquerade as IBS, diagnosis is often

improvements to diet and lifestyle is key to

challenging. Where possible, clinicians are

long-term management. The IBS Network aims

encouraged to make a positive diagnosis of

to promote greater education awareness and

IBS without resorting to complex and invasive

understanding of Irritable Bowel Syndrome and

procedures. All patients should undergo a

provides useful signposts for many patients

thorough symptom assessment documenting

in this regard (www.theibsnetwork.org).

the key features and exploring lifestyle and

Medical treatments should be recommended

National Collaborating Centre for Nursing and Supportive Care (2008) Irritable bowel syndrome in adults: diagnosis and management of irritable bowel syndrome in primary care. National Institute for Health and Care Excellence. https://www.nice.org.uk/guidance/cg61/resources/irritable-bowelsyndrome-in-adults-diagnosis-and-management-975562917829 2 Canavan C, West J and Card T, (2014) Review article, The economic impact of IBS. Alimentary Pharmacology and Therapeutics 40 (9) 1023-34.

3 Based on research conducted by Vital Research and Statistics on behalf of IBS Screen that sampled 1,000 IBS or IBD sufferers who have been

Providing advice on managing stress and anxiety whether through adapting work/ life balance and talking or complementary therapies can be useful (see https://www. theibsnetwork.org/stress/).

Self-management IBS is a complex, long-standing illness which clinicians often find challenging to diagnose because of the fear that IBS is masking a second disease. Failure to make a positive diagnosis can increase the likelihood of repeated visits to GPs and other medical practitioners and can cause psychological distress. Once someone is diagnosed with IBS, and encouraged to gain a better understanding of the potential triggers, whether linked to diet, lifestyle, stress or other factors, and knowing treatments, therapies and changes to make – they can often take control of their own illness through long-term self-management.

For more information and support on managing IBS symptoms, visit www.theibsnetwork.org

diagnosed. All research collated between 16/12/2016 and 30/12/2016, http://www.ibsscreen.co.uk NICE guidelines, https://cks.nice.org.uk/irritable-bowel-syndrome#!diagnosissub:2/-494656 High negative predictive value of a normal faecal calprotectin in patients with symptomatic intestinal disease. James Turvill. Frontline Gastroenterology. http://dx.doi.org/10.1136/flgastro-2011-100011

4 5

GASTROENTEROLOGY TODAY - SUMMER 2017

predominant and visa versa. Sufferers

1

Encouraging the use of a food diary will help show any patterns (such as irregular eating) where symptoms may be worse. If people are struggling to make changes or are using exclusion diets they should be referred to a Registered Dietitian.

• Unintentional or unexplained weight loss.

in the gut micro-biome have all been postulated to

Symptoms can include one or a combination

Dietary changes People with IBS usually find that eating can trigger their symptoms, but it’s often difficult to identify what component, if any, of the meal may be responsible. It may be the act of eating, the context of the meal, or just eating in a rush that is upsetting the gut. For others, certain food and drink may exacerbate their symptoms, such as fizzy drinks, dairy, gluten, fatty foods, onions, garlic, and some fruits, perhaps containing FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols).

See the British Dietetic Association food fact sheet (https://www.bda.uk.com/foodfacts/ IBSfoodfacts.pdf) and recommendations on The IBS Network website for additional diet advice (https://www.theibsnetwork.org/diet ).

17

NEWS New indicators to aid Crohn’s disease diagnosis and treatment

Diagnostics for Digestive Health

Published in Medical News Today - www.medicalnewstoday.com The diagnosis, understanding and management of Crohn’s disease may have just received a helping hand from a joint ASU Biodesign Institute and Mayo Clinic study aimed at developing a better blood test for the disease.

MEET THE EXPERTS AT BSG 2017 STAND NO. 64

The study, led by Biodesign scientists Josh LaBaer and Ji Qiu, along with gastroenterologists Shabana Pasha and Jonathan Leighton from Mayo Clinic Arizona, successfully identified several molecules, called biomarkers, that were unique indicators found only in patients with Crohn’s disease.

20-22 JUNE MANCHESTER

“If we are going to truly alter the natural history of Crohn’s disease and help people, we needed to develop a new test for early,

■

■

■

accurate diagnosis, as well as administrating appropriate therapy,”

Faecal Immunochemical Testing

The latest developments for Bowel Screening or Symptomatic Assessment

said Josh LaBaer, the Biodesign Institute’s interim executive director.

“We are particularly excited about the links between the immune

Calprotectin Testing

Point of Care Quantum Blue® fCAL and Remote Patient Management Solutions with IBDoc®

response against self proteins and Crohn’s disease, as this may give physicians a new avenue to explore both the potential cause and treatments,” said LaBaer, who leads a team of 100-plus interdisciplinary scientists as director of the Virginia G. Piper Center

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diabetes to improve patient outcomes.

The medical cause of Crohn’s disease remains a mystery with no simple medical explanation or cure. But in the course of the disease, the body’s own immune system is somehow triggered to attack the gut.

Knowing this, LaBaer and Qiu advanced a new approach, immunoproteomics, to broadly sift through the entire repertoire of immune system proteins in the blood and identify early bell

GASTROENTEROLOGY TODAY - SUMMER 2017

weathers of Crohn’s disease, the most common inflammatory bowel disease.

Crohn’s currently afflicts about 3 out of 1,000 people in the U.S., and for some unknown reason, the incidence is also on the rise.

Crohn’s is often associated with chronic, debilitating stomach pain, diarrhea, and other symptoms that may come and go. One in five people will have to be hospitalized each year, and surgery may eventually be required for the most severely afflicted. Inflammation is often a sign that the immune system has been triggered.

Crohn’s diagnosis can be very difficult, and involves either expensive medical imaging from MRIs, invasive biopsies, or

Tel: +44 (0)23 8048 3000 | Web: www.alphalabs.co.uk

cataloging the symptoms. Physicians’ primary course of action is to help relieve patient’s suffering from chronic gut pain and symptoms through anti-inflammatory drugs.

18Gastro-Today_Half-Ad_Jun17_03May17.indd 1

03/05/2017 14:29:50

Life feels good when Crohn’s is under control

NEWS

1,2

For the induction of remission in adults with mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon3

Budesonide 9mg daily is recommended by the BSG for isolated ileocaecal disease with moderate disease activity4 grapefruit juice may increase systemic exposure and should be avoided.

Patients with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take Entocort CR. Monitor height of children who use prolonged glucocorticoid therapy for risk of growth suppression. Interactions: Concomitant colestyramine may reduce Entocort CR uptake. Concomitant oestrogen and contraceptive steroids may increase effects. CYP3A4 inhibitors may increase systemic exposure. CYP3A4 inducers may reduce systemic exposure. May cause low values in ACTH stimulation test. Fertility, pregnancy and lactation: Only to be used during pregnancy when the potential benefits to the mother outweigh the risks for the foetus. May be used during breast feeding. Adverse reactions: Common: Cushingoid features, hypokalaemia, behavioural changes such as nervousness, insomnia, mood swings and depression, blurred vision, palpitations, dyspepsia, skin reactions (urticaria, exanthema), muscle cramps, menstrual disorders. Uncommon: anxiety, tremor, psychomotor activity. Rare: aggression, glaucoma, cataract, ecchymosis. Very rare: Anaphylactic reaction, growth retardation. Prescribers should consult the summary of product characteristics in relation to other adverse reactions. Marketing Authorisation Numbers, Package Quantities and basic NHS price: PL 45329/0003. Packs of 100 capsules: £84.15. Legal category: POM. Marketing Authorisation Holder: Tillotts Pharma GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany. Date of preparation of PI: March 2017

Adverse events should be reported.

Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to Tillotts Pharma UK Ltd. Tel: 01522 813500.

GASTROENTEROLOGY TODAY - SUMMER 2017

ENTOCORT CR 3mg Capsules (budesonide) - Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing Information Presentation: Hard gelatin capsules for oral administration with an opaque, light grey body and an opaque, pink cap marked CIR 3mg in black radial print. Contains 3mg budesonide. Indications: The induction of remission in patients with mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon. Dosage and administration: Adults: 9mg once daily in the morning for up to eight weeks. Full effect achieved in 2-4 weeks. When treatment is to be discontinued, dose should normally be reduced in final 2-4 weeks.

Paediatric population: Not recommended. Older people: No special dose adjustment recommended. Swallow whole with water. Do not chew. Contraindications: Hypersensitivity to the active substance or any of the excipients. Warnings and Precautions: Side effects typical of corticosteroids may occur. Systemic effects may include glaucoma and when prescribed at high doses for prolonged periods, Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density and cataract. Caution in patients with infection, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts or with a family history of diabetes or glaucoma. Particular care in patients with existing or previous history of severe affective disorders in them or their first degree relatives. Caution when transferring from glucocorticoid of high systemic effect to Entocort CR. Chicken pox and measles may have a more serious course in patients on oral steroids.

They may also suppress the HPA axis and reduce the stress response.

Reduced liver function may increase systemic exposure. When treatment is discontinued, reduce dose over last 2-4 weeks. Concomitant use of CYP3A inhibitors, such as ketoconazole and cobicistat-containing products, is expected to increase the risk of systemic side effects and should be avoided unless the benefits outweigh the risks. Excessive

References: 1. Greenberg GR et al. N Engl J Med 1994; 331: 836-841.

2. Rezaie A et al. Cochrane Database Syst Rev 2015; 6: CD000296.

3. Entocort® CR 3mg Capsules – Summary of Product Characteristics.

4. Mowat C et al. Gut 2011; 60: 571-607.

Date of preparation: April 2017. UK/EN/0002/0915(1)a(3).

19

NEWS Content has been organised with the help

Charity launches new information website to help those affected by Crohn’s Disease and Ulcerative Colitis

of patients and healthcare professionals and signposts to other websites and charities, social media and bloggers such as So Bad Ass –by Sam Cleasby who shares her experiences of managing Ulcerative Colitis and living with a stoma, among other bloggers and opinion formers.

The ‘Crohn’s and Colitis Companion’ is a new, website developed by

Mitesh Gandhi, Digital Manager at Crohn’s

patient support charity, Crohn’s and

and Colitis UK said;

Colitis UK[1]. The website streamlines relevant and helpful information about

“Being diagnosed with IBD is daunting and

Inflammatory Bowel Disease (IBD)² and

knowing where to find the right information

provides links to reliable and trustworthy

can be overwhelming, therefore we wanted

sources.

to design a mobile site that would simplify the many resources into one easy to

There is a wealth of information online

navigate place. It is not only for people

about Crohn’s Disease and Ulcerative

recently diagnosed with IBD but can

Colitis – sometimes a vast quantity for

support people managing their condition

the user to tackle and with discrepancies around accuracy. The Crohn’s and Colitis

long-term. The Companion is evolving and

Companion assists the user in navigating a

we want people to review and suggest new

large variety of information by allowing them

content through the easy feedback function

to view common topics, such as managing

found on each page.”

symptoms and how to live with IBD long term.

www.crohnsandcolitis.org.uk/companion

Seeking Subjects for ELAD Clinical Trial Assessing Survival in Subjects Diagnosed with Acute Alcoholic Hepatitis ®

VTL-308 Clinical Trial Overview: www.AAHStudy.com VTL-308: A Phase 3, Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation (AILD)

GASTROENTEROLOGY TODAY - SUMMER 2017

20

“Being diagnosed with IBD is daunting and knowing where to find the right information can be overwhelming, therefore we wanted to design a mobile site that would simplify the many resources into one easy to navigate place.”

Current Enrolling sites in the UK/IRE AINTREE

Dr. Cyril Sieberhagen Aintree University Hospital NHS Foundation Trust Lower Lane Liverpool L9 7AL

BIRMINGHAM

DONCASTER

Dr. Joanna Sayer Doncaster and Bassetlaw Hospitals NHS Foundation Trust Doncaster Royal Infirmary Armthorpe Road Doncaster DN2 5LT

Dr. Ahmed Elsharkawy University Hospitals Birmingham NHS Foundation Trust Heritage Building (Queen Elizabeth Hospital) Queen Elizabeth Medical Centre Birmingham B15 2TH

The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.

DUNDEE

GLASGOW

Key Eligibility Criteria*: • Age 18 to <50 • MELD score <30 • Bilirubin ≥16 mg/dL (273.6 μmol/L) • Maddrey score ≥32 • INR ≤2.5 • Association (6 weeks or less) of alcohol use • Serum Creatinine <1.3 mg/dL (115.04 μmol/L) and hospital admission for this episode of AILD

LONDON

LONDON

NOTTINGHAM

DUBLIN

*Although subjects may meet the criteria above, they may not qualify for VTL-308. Please visit www.clinicaltrials.gov for full inclusion/exclusion criteria and for more information about participation.

For more information please contact Michael Stephens, Senior Director, Clinical Operations at clinicaltrials@vitaltherapies.com or +44 (0) 7702 575656 ELAD® is an investigational extracorporeal, human hepatic cell-based liver treatment designed to improve survival of subjects with liver failure by providing hepatic support continuously for up to five days.

Sponsor: Vital Therapies, Inc. The ELAD System has not been demonstrated to be safe or effective for any indication and is not available for sale in the United States or any other country. CAUTION: Investigational Product. Limited by United States law to investigational use.

www.aahstudy.com or www.clinicaltrials.gov NCT#02612428

VITAL THERAPIES, INCORPORATED 00 1 858 673 6840 | www.vitaltherapies.com Copyright ©2008-2017 Vital Therapies, Inc. All rights reserved.

AD-000002-0617 v09

Professor John Dillon Ninewells Hospital and Medical School Dundee, DDI 9SY Dr. Janet Dearden Barts Health NHS Trust Grahame Hayton Unit Ambrose King Centre Royal London Hospital Whitechapel Road London E1 1BB

Dr. Stephen Ryder Nottingham Digestive Diseases Centre Nottingham University Hospitals NHS Trust and the University of Nottingham Queens Medical Centre Derby Road Nottingham NG7 2UH

Dr. Stephen Barclay Glasgow Royal Infirmary 84 Castle St Glasgow G4 0SF Professor Rajiv Jalan Institute of Liver and Digestive Health Upper Third Floor, UCL Medical School Royal Free Hosptial Rowland Hill Street London NW3 2PF Dr. Ross MacNicholas St. Vincent’s University Hospital Elm Park Dublin 4 Ireland

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21

NEWS Acid Reflux in Infants: Causes, Symptoms, and Treatment Written by Hannah Nichols. Reviewed by Alana Biggers, MD, MPH Last reviewed: Fri 3 February 2017 Published in Medical News Today www.medicalnewstoday.com Most infants “spit up” milk as part of their daily activities. The action of spitting up milk is known as reflux or gastroesophageal reflux.

Reflux is perfectly normal, common in infants, and is rarely serious.

Gastroesophageal reflux (GER) happens when the contents of the stomach wash back into the baby’s food pipe. It is defined as reflux without trouble, and usually resolves itself.

Sometimes, a more severe and long-lasting form of gastroesophageal reflux called gastroesophageal reflux disease (GERD) can cause infant reflux.

Causes of reflux and GERD in infants There is a muscle at the lower end of the food pipe called the lower esophageal sphincter.

This muscle relaxes to let food into the stomach and contracts to stop food and acid passing back up into the food pipe.

If the muscle does not entirely close, liquid flows back into the food pipe from the stomach. This sequence occurs in all people, but it happens more frequently in infants under the age of 1 year.

Sometimes reflux in infants might be caused by a more serious condition, such as: • Food intolerance • Eosinophilic esophagitis, a buildup of a type of white blood cell that inflames or injures the tissue of the esophagus • Pyloric stenosis, an infant condition that blocks food from flowing into the small intestine • GERD

GER sometimes goes unnoticed, as the liquid remains in the lower food pipe, or the liquid is regurgitated and vomited.

Risk factors Most risk factors for infant GER are unavoidable and include:

Reflux, or regurgitation, is common in infants and peaks between 3-4 months of age. Some infants regurgitate at least once a day, while some regurgitate with most feeds.

• Temporary relaxation of lower esophageal sphincter after feeding • Frequent large-volume feedings • Short food pipe • Laying down

Regurgitation rates decline as the muscle that controls the flow of food matures, usually by the time an infant is 18 months old.

The following conditions raise the risk of experiencing infant GERD:

Although more common in adults, GER can develop into gastroesophageal reflux disease (GERD). This condition may cause more troublesome symptoms and complications.

Symptoms include slow weight gain, irritability, unexplained crying, and sleep disturbances.

GERD requires treatment to avoid tissue damage to the lining of the food pipe.

• Hiatal hernia • Neurodevelopmental disorders • Cystic fibrosis • Epilepsy • Congenital food pipe disorders • Asthma • Premature birth • Obesity • Parent history of reflux

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NEWS Symptoms GER is uncomplicated, and infants with this type of reflux are often called “happy spitters.”

Infants with GER may sometimes experience frequent vomiting, irritability, prolonged or refused feeding, or back arching.

Infants with GER have: • Normal weight gain • Little difficulty with feedings • No significant respiratory symptoms • No neurobehavioral symptoms However, in contrast, symptoms of GERD in infants include: • Poor weight gain, weight loss, and failure to thrive • Feeding refusal or lengthy feedings • Irritability after eating • Difficulty swallowing or pain when swallowing • Frequent vomiting • Stomach pain, chest pain, and pain in other abdominal areas • Long-term coughing, wheezing, or hoarseness • Asthma • Recurring laryngitis, pneumonia, sinusitis, or inflammation of the middle ear Infants are unable to say where something hurts, but they may show signs of distress, excessive crying episodes, sleep disturbances, and decreased appetite.

If an infant presents symptoms of GERD, it is important to get advice from a doctor or pediatrician as other, more severe, conditions share some of the symptoms of reflux in infants.

Diagnosis of reflux in infants Diagnostic tests are not typically used for diagnosing GER or GERD. Diagnostic tests have not been found to be any more reliable than a doctor asking questions and carrying out a physical examination.

Doctors tend to use diagnostic testing if symptoms do not improve, no weight gain is observed, and lung problems are present.

Methods of testing might include ultrasound, blood and urine tests, esophageal pH and impedance monitoring, X-rays, and upper endoscopy and biopsy.

Treatments Most cases of regurgitation or reflux resolve within the baby’s first year and require no treatment.

Lifestyle changes Reflux is less frequent and less severe in breastfed babies.

• Reducing feeding volumes in overfed infants • Feeding smaller amounts more frequently • Adding thickening agents (1 teaspoon rice cereal per ounce of formula) • Trying antiregurgitant formulas • Trying hypoallergenic formulas for infants allergic to cow’s milk protein • Interrupting feedings to burp the baby regularly In breastfed babies, removing immunogenic foods, such as cow’s milk and eggs, from the mother’s diet may improve symptoms.

Laying a baby tummy-side down or left side down while awake and after feedings is linked with fewer episodes of infant reflux. However, while asleep, infants are recommended to sleep on their back to reduce the risk of sudden infant death syndrome.

Keeping infants upright for at least 30 minutes following feeds and elevating crib and diaper-changing tables by 30 degrees may also help prevent symptoms of reflux.

Medications Medications are not recommended for children with uncomplicated reflux. Reflux medications can have complications, such as preventing absorption of iron and calcium in infants and increasing the likelihood of developing particular respiratory and intestinal infections.

acid production in the stomach and can help heal the lining of the food pipe. H2 blockers are usually used for short-term or on-demand relief and PPIs are often used for long-term GERD treatment.

Surgery Surgical procedures for infant GERD may only be considered in severe cases. If medications are unsuccessful or there are serious complications, surgery may be an option.

Do infants outgrow reflux?

Infants tend to outgrow regurgitation as the lower esophageal sphincter strengthens.

Most cases GER will disappear by 18 months of age of earlier.

However, around 2-7 percent of parents of children between the ages of 3-9 years report that their child experiences heartburn, upper abdominal pain, or regurgitation. Around 5-8 percent of teenagers describe the same symptoms.

GERD declines until 12 years of age and then peaks between 16-17 years old. GERD tends to be more common in teenage girls than boys.

GER occurs more often in childhood and GERD occurs more often in adulthood.

advancing science, linking people

If feeding and positional changes do not improve GERD, and the infant still has problems with feeding, sleeping, and growth, a doctor may recommend medications to decrease the amount of acid in the infant’s stomach.

Medications that might be prescribed include H2 blockers and proton pump inhibitors (PPIs).

These medications ease symptoms of GERD by lowering

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If the baby is growing as expected, appears healthy, and seems content, no further testing is required.

The following changes may help improve infant reflux in formula-fed babies:

23

17.05.17 11:31

NEWS UK survey shows many patients with ulcerative colitis find it difficult to keep their disease under control on conventional therapies

colon (large bowel), and is one of the two most

Low expectations, high despondency

common forms of inflammatory bowel disease

Patient expectations of effective intervention

- the other is Crohn’s disease. The research

when experiencing a flare are often low,

was commissioned and funded by MSD

with a fifth of patients taking no action as

with the co-operation of Crohn’s and Colitis

they feel ‘nothing can be done’ for their

UK, who provided a link to the survey via its

symptoms.1 Of all those surveyed, 41%

website and social media channels.

are reluctant to report flare-ups to their doctor, and 59% of all patients believe

A third of those with moderate to severe UC

their doctor is more satisfied that their UC

Three-quarters of those who describe their

reported experiencing five or more flare-ups

is under control than they are, suggesting

disease as moderate to severe say their

over the past 12 months.1 Symptoms during

a significant degree of resignation and

disease is ‘poorly controlled’, with a third

flare-ups negatively affect patients’ quality of

despondency that prevents people with UC

having had five or more flares over the past

life, and include frequent bowel movements,

seeking help.1 However, of those who did

year.

blood in stools, high temperature, stomach

see a healthcare professional when having

pains and fatigue.1

a flare nearly half (42%) were positive,

HODDESDON, 16th February 2017

stating they had a satisfactory experience,

– New research shows that nearly three-

Dr Charlie Murray, Clinical Director of

were offered good support and that their

quarters of patients with moderate to severe

Gastroenterology at the Royal Free Hospital,

IBD nurse was easily contactable.

ulcerative colitis (UC) taking conventional

London, says: “Despite advances in therapy

treatments describe their disease as ‘poorly

and a better understanding of disease, these

controlled’ (continuous or regular experience

results demonstrate that we need to do better

of symptoms that negatively affect quality

in managing ulcerative colitis and that we

of life), with half saying they are somewhat

should always be aiming for full symptom

or completely dissatisfied with their current

relief.”

professional, the survey found they are more likely to speak to an IBD nurse than a consultant – 51% would speak to an IBD nurse and 29% would visit their consultant. 1

medication; only 1% were completely satisfied with their current treatment.1 Ulcerative colitis

The online survey considered the level of

is a chronic disease, causing inflammation and

disease control, satisfaction with treatment and

ulceration of the inner lining of the rectum and

impact on quality of life among 345 adults with ulcerative colitis who were biologic-naïve, non-colectomised and currently taking conventional therapies. As this research was not accompanied

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assessment, there are limitations on drawing conclusions from patients’ feedback. Of the 345 respondents, 162 (47%) described moderate (symptoms are bothersome) or severe (symptoms interfere with normal activities). Just under half (48%) of all respondents were were aged 40–54 and 10% were aged 24

Specialising in Gastroenterology

quarters (75%) were female.

24 8782 Gastropharm Ad 88x123,5.indd 1

When patients do contact a healthcare

03/04/2017 14:08

A proportion of patients would not seek advice from a healthcare professional at all – 28% take steroids during a flare, and 16% look for help and information online.1 About ulcerative colitis2 Ulcerative colitis a common form of inflammatory bowel disease affecting approximately 146,000 people in the UK. Ulcerative colitis is often diagnosed in young adults between the ages of 15 and 25, but can affect children and older adults as well. It is a condition that causes chronic inflammation and ulceration of the inner lining of the rectum and colon (the large bowel). In UC, tiny ulcers develop on the surface of the lining and these may bleed and produce pus. Symptoms typically include diarrhoea, fatigue, weight loss, abdominal pain and anaemia. When medications do not control the disease, surgery may be considered as an option to remove the affected colon (colectomy).

References 1. MSD Data on File. Survey of patients with ulcerative colitis. October 2016.

GAST-1201227-0000 2. Crohn’s and Colitis UK. What is Ulcerative Colitis? Available at: www. crohnsandcolitis.org.uk/aboutinflammatory-bowel-disease/ulcerativecolitis. Last accessed January 2016

NEWS effective and cost effective interventions

replacements to improve clinical outcomes

Targeted prevention of cardiovascular and digestive disorders may have the greatest effect on reducing the risk of death following joint replacement, new study finds

offered to patients with osteoarthritis. The

for the benefit of patients, clinicians and

chance of dying following joint replacement

industry. As part of its programme of work

remains very low and has halved during

the registry carries out in-depth studies to

the time the NJR has been collecting data,

support decision-making in regard to patient

although older patients and males have

safety, standards in quality of care and

higher death rates.

overall effectiveness of joint replacement

understand what clinical decisions and

Concluding on the study’s findings,

A study of nearly 720,000 hip and knee

strategies could be taken to even further

NJR medical director, Mr Martyn Porter,

reduce the risk of death and enhance a

commented:

replacement patients has shown that clinicians should be aware of a patient’s potential for post-operative complications

surgery.

“This study has been carried out to better

patient’s outcome following joint replacement.

“We shouldn’t lose sight that joint replacement “We expected cardiovascular related

surgery offers significant benefits – getting

cardiovascular and respiratory risks.

diseases to be the greatest cause of

patients back to their chosen lifestyle sooner,

death in the immediate post-operative

free from pain and with improved mobility.

The National Joint Registry for England,

period following joint replacement surgery.

relating to the digestive system as well as

Wales, Northern Ireland and the Isle of Man (NJR) has carried out an in-depth study to better understand the causes of death following hip and knee replacement. The findings reinforce existing research which highlights complications relating to the heart are the most common cause of death soon after a hip or knee replacement, and one of the most common causes up to 10

Ischaemic heart disease accounted for

“Undergoing surgery will ultimately cause a

around 30 per cent of deaths for both hip

short-term increase in the risk of death, but

and knee replacement patients within 90

this returns to a normal level between 30- and

days. Further strategies could be introduced

90-days post-operation. These findings are

to target this and may lead to a reduced risk.

important and should enable clinicians and patients to consider the balance between

“However, the increased risk of digestive

the short-term increased risks at the time of

system related deaths was unexpected.

a hip or knee joint replacement operation

Clinicians need to be aware of this and ScheBo_GastroToday_Jan_2017 17:18 benefits.” compared12/01/2017 to the longer-term

years after. However, using the NJR’s large

anticipate problems

dataset, researchers have found that there is

such as intestinal

also a marked increase in digestive disease

bleeds, obstructions

related death in the 90 days following hip

and perforations.

and knee replacement which needs clinical

Patients identified

consideration.

with these potential problems or being at

Professor Ashley Blom, from the University

risk of them before

of Bristol who led the team which undertook

their operation may

the study on behalf of the NJR, is calling

require additional

upon clinicians working in the area of joint

preventative

replacement to consider the study’s findings

strategies and a

to further reduce the risk of death and

more rigorous post-

enhance a patient’s outcome post-operation.

operative monitoring and care plan.

5 April 2017), examined the causes and

“Tackling both

number of deaths of hip and knee joint

cardiovascular

replacement patients between 2003 to

and digestive

2012 compared with those expected from

disorders should

the general population. The research

not only increase

team were able to study 56,568 deaths

life expectancy but

following 717,025 hip and knee replacement

enhance the cost-

procedures for osteoarthritis over the nine

effectiveness of joint

year period.

replacement.”

Commenting on the reason for the study

Established in 2002,

and its findings, Professor Blom said:

the NJR monitors the performance of hip,

“It is important to remember that joint

knee, ankle, elbow

replacement is one of the most highly

and shoulder joint

GASTROENTEROLOGY TODAY - SUMMER 2017

The study, published today (Wednesday

25

NEWS

Here to support you, to support your patients with exclusive enteral nutrition

“Pleasant vanilla flavour” 1

GASTROENTEROLOGY TODAY - SUMMER 2017

To find out more information on Modulen® IBD: Call: 00800 6887 48 46 Visit: www.nestlehealthscience.co.uk

References: 1. Results from a focus goup help at ESPGHAN 2016 - data on file. All of the flavouring options listed were tested by seven healthcare professionals at a round table discussion. This was a selection of Dietitians, an IBD nurse and a paediatric consultant, who manage a case load of Crohn’s disease patients For healthcare professional use only

Health Science produces a range of foods for special medical purposes for use under medical supervision used with patients requiring either an oral nutritional supplement 26Nestlé or a sole source of nutrition. ® Reg. Trademark of Société des Produits Nestlé S.A.

NEWS New risk tool to help UK GPs decide if patients under 50 have a serious bowel condition Published in Medical News Today www.medicalnewstoday.com The University of Exeter, in partnership with Bowel Cancer UK Never Too Young campaign, Durham University and North Tees and Hartlepool NHS Foundation Trust, publishes in the British Journal of General Practice a new research and risk assessment tool. Funded by the Department of Health, this tool aims to support GPs to identify the symptoms of a serious bowel condition for patients aged under-50. This research comes ahead of Bowel Cancer Awareness Month in April.

The assessment tool will calculate the risk of a serious bowel condition allowing the GP to decide whether a patient needs further tests. This is the first of its kind for younger people and aims to speed up the diagnosis of patients under 50 who often experience significant delays.

Lower gastrointestinal (GI) symptoms are common and in younger people are often attributed to nonserious conditions, like Irritable bowel syndrome (IBS). But we know there are more than 2,500 new diagnoses of bowel cancer every year in under 50s in the UK and approximately 13,000 people are diagnosed with inflammatory bowel disease, many of these also under the age of 50.

Symptoms of these conditions account for one in 12 GP appointments, but given that most of these symptoms won’t be caused by bowel cancer, it can be difficult for GPs to distinguish between those patients with non-serious conditions, such as IBS, and serious conditions, like bowel cancer and inflammatory bowel disease.

Using data from the well-established Clinical Practice Research Datalink (CPRD), a high quality national database representative of the UK as a whole, the researchers assessed the frequency of symptoms in people with a serious bowel condition, and used this to calculate the positive predictive value (PPV) of bowel cancer or inflammatory bowel disease.

Using symptoms, a physical examination and blood test results, the tool calculates the PPV of a serious disease with a percentage, as well as suggesting next steps:

• Risk level <1%: The GP should monitor the patient’s progress, but at this stage no further tests are needed.

• Risk level 1-3%: The GP should recommend the patient for a faecal calprotectin test to help rule out a non-serious condition like Irritable bowel syndrome (IBS).

• Risk level >3%: The GP should refer the patient for an urgent colonoscopy or refer the patient to a specialist for further assessment.

The tool recommends that patients with a risk threshold of 3% or more should have further urgent investigation, an action which is in line with NICE referral guidelines for suspected cancer and the NICE Quality Standard for inflammatory bowel disease.

Willie Hamilton, Professor of Primary Care Diagnostics at the University of Exeter Medical School, who led the research says: “The risk assessment tool should be used as a reminder to GPs to consider the likelihood of an individual patient having a serious bowel condition given the symptom or combination of symptoms they present with. The tool does not replace clinical judgement but provides more information to base a referral decision.”

GASTROENTEROLOGY TODAY - SUMMER 2017

27

NEWS

A simple solution to the complex symptoms of IBS-C1,5

Constella® is a first-in-class, once-daily, continuous treatment.1,2 Constella® normalises bowel function, providing sustained relief from the pain, bloating and constipation associated with IBS-C.1,3,4 Constella® is generally well tolerated and has an established safety profile.1 One convenient treatment, multiple symptoms relieved.1,3,4

GASTROENTEROLOGY TODAY - SUMMER 2017

28

PRESCRIBING INFORMATION (Please consult the Summary of Product Characteristics (SmPC) before prescribing.)

Constella® 290 micrograms hard capsules Linaclotide Active Ingredient: contains 290 micrograms of linaclotide.

Indication: Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.

Dosage and Administration: The recommended dose is one capsule (290 micrograms) once daily. The capsule should be taken 30 minutes before a meal. Physicians should periodically assess the need for continued treatment. Consult SmPC for further information.

Contraindications, Warnings, etc: Contraindications: Hypersensitivity to linaclotide or to any of the excipients or known or suspected mechanical gastrointestinal obstruction. Warnings & Precautions: Use once a diagnosis of moderate to severe IBS-C is established. Patients should be aware of the possible occurrence of diarrhoea and lower gastrointestinal bleeding during treatment. Should prolonged (more than 1 week) or severe diarrhoea occur and/or lower gastrointestinal bleeding occur during treatment, a medical physician should be contacted and temporary discontinuation of linaclotide until diarrhoea episode is resolved may be considered. Exercise caution in patients prone to a disturbance of water or electrolyte balance such as elderly, patients with CV diseases, diabetes, hypertension; and electrolyte control should be considered. Not recommended in patients with chronic

inflammatory conditions of the intestinal tract, such as Crohn’s disease and ulcerative colitis. Elderly: Special attention should be given to these patients and the treatment benefit-risk ratio should be carefully and periodically assessed. Children: Not recommended. Interactions: The efficacy of medicinal products absorbed in the intestinal tract with a narrow therapeutic index such as levothyroxine and oral contraceptives may be reduced. The use of an additional contraceptive method is recommended. Concomitant treatment with proton pump inhibitors, laxatives or NSAIDs may increase the risk of diarrhoea. Pregnancy and lactation: It is preferable to avoid the use during pregnancy. Use during breast-feeding is not recommended. Animal studies indicate that there is no effect on male or female fertility. Ability to drive and use machines: None known. Adverse Effects: These are ranked under heading of frequency using the following convention: very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). Very common: diarrhoea.

Common: gastroenteritis viral, abdominal pain, flatulence, abdominal distension, dizziness. Uncommon: faecal incontinence, defecation urgency, lower gastrointestinal haemorrhage including haemorrhoidal haemorrhage and rectal haemorrhage, nausea, vomiting, hypokalaemia, dehydration, decreased appetite, orthostatic hypotension, blood bicarbonate decreased.

Consult SmPC in relation to other side-effects.

Legal Category: POM Marketing Authorisation Number(s): 28 – EU/1/12/801/002 NHS Cost: (excluding VAT) £37.56 – Carton containing HDPE bottle containing 28 capsules.

UK/0839/2016d – January 2017

Constella® is recommended in the NICE CG61 guidelines5

Marketing Authorisation Holder: Allergan Pharmaceuticals International Limited, Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland.

Further information is available from: Allergan Ltd, Marlow International, The Parkway, Marlow, Buckinghamshire, SL7 1YL, UK. Email: uk_medinfo@allergan.com Tele: 01628 494 026.

Date of Revision: 08/06/2016 Item code: UK/0461/2016

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Allergan Ltd. UK_MedInfo@Allergan.com or 01628 494 026 References: 1. Constella® Summary of Product Characteristics. 2. Sood R, Ford AC. Ther Adv Chronic Dis 2013; 4(6): 268–276. 3. Quigley EM, et al. Aliment Pharmacol Ther 2013; 37(1): 49–61. 4. Chey WD, et al. Am J Gastroenterol 2012; 107: 1702–1712. 5. National Institute of Health and Clinical Excellence. Clinical Guideline 61. Published February 2008. Updated February 2015. Available at: https://www.nice.org.uk/guidance/cg61 [Accessed October 2016].

NEWS Study indicates promising new approach to prevent and treat cholesterol gallstones Published in Medical News Today www.medicalnewstoday.com According to current estimates, 20 to 25 million Americans have or will develop gallstones, representing almost 15% of adults. Although only a small percentage of individuals with gallstones develop symptoms, more than 700,000 individuals annually undergo surgical gallbladder removal and many more take medications to

Gallbladders from the non-CAR-stimulant

Liu, Jiangying Kuang, Jing Shen, Shiyun Pu,

treated mice were filled with gallstones

Lei Chen, Hong Li, Tong Wu, Rui Li, Yanping

composed of bile with aggregated

Li, Wei Jiang, Zhiyong Zhang, Jinhan He,

cholesterol crystals. The CAR-stimulant-

The American Journal of Pathology, doi:

treated mice showed transparent bile

10.1016/j.ajpath.2016.12.013, published

free of cholesterol precipitates. After two

online 7 March 2017.

weeks of the lithogenic diet, the walls of the gallbladders of control mice showed evidence of inflammation, which was not noticeable in the treated group.

CAR stimulation also produced related benefits, including enhanced conversion of cholesterol into bile acids and elevation of bile acid re-absorption. “Collectively, it appears that CAR plays an important role in maintaining the homeostasis of cholesterol,

Breath test could help detect stomach and oesophageal cancers Published in Medical News Today www.medicalnewstoday.com A test that measures the levels of five

bile acids, and triglyceride levels,”

chemicals in the breath has shown

commented Dr. He. “Whether CAR could

promising results for the detection of

be a novel target in preventing or treating

cancers of the oesophagus and stomach

cholesterol gallstone disease in humans

in a large patient trial presented at the

remains to be further determined.”

European Cancer Congress 2017.

Gallstones are most commonly formed when

Together, stomach and oesophageal cancer

the liver and small intestine.

excess cholesterol in the bile precipitates

account for around 1.4 million new cancer

as solid crystals, which then aggregate

diagnoses each year worldwide 1. Both

“CGD is one of the most common

and fuse into stones. More common in

tend to be diagnosed late, because the

gastroenterological disorders and the

women, formation of gallstones has been

symptoms are ambiguous, meaning the

incidence rate is increasing because of

attributed to high-caloric diets, type 2

five-year survival rate for these two types of

improved standard of living, a chronic high-

diabetes mellitus, metabolic syndrome,

cancer is only 15%.

cholesterol diet, and over-nutrition. Our study

disorders of lipid metabolism, and obesity.

indicated that the constitutive androstane

Although most individuals with gallstones

receptor (CAR) plays an important role in

remain asymptomatic, about one fifth

maintaining the homeostasis of cholesterol

complain of discomfort and experience

and triglyceride levels and its activation may

recurrent painful episodes; complications

represent a new approach for treating CGD,”

such as pancreatitis or cholecystitis

explained lead investigator Jinhan He, PhD,

are possible. Currently, removal of the

of the Department of Pharmacy, West China

gallbladder is the surgical treatment for

Hospital of Sichuan University, Chengdu,

gallstones, although surgery is limited by

Suchuan (China).

its invasive nature (even those performed

manage the condition or undergo stonedissolving procedures. A new study in The American Journal of Pathology reports on a promising new approach to prevent and treat cholesterol gallstone disease (CGD) that reduces the biliary output of cholesterol via activation of receptors present in tissues of

laparoscopically), risk of side effects, and high cost. Gallstones may also be treated

composition of the gallbladder and hepatic

non-surgically (e.g. oral dissolution with

bile for anti-lithogenesis (formation of

ursodeoxycholate or lithotripsy) but these

stones) effects. Researchers compared mice

approaches have their own drawbacks. For

that were injected weekly for two weeks with

instance, oral dissolution is appropriate

a medication that stimulates CAR activity

for only a small proportion of symptomatic

to others that were administered control

patients, may take a long time to work, and

injections. All mice were fed with either a

has a recurrence rate of more than 50%.

standard diet or a high-cholesterol/high fat

Limitations for lithotripsy include stone

(lithogenic) diet that induced gallstones.

recurrence, incomplete ductal clearance,

patients, showed that the test could diagnose cancer with an overall accuracy of 85%.

Dr Sheraz Markar, an NIHR Clinical Trials Fellow from Imperial College London, under the supervision of Professor George Hanna, told the Congress: “At present the only way to diagnose oesophageal cancer or stomach cancer is with endoscopy. This method is expensive, invasive and has some risk of complications.

“A breath test could be used as a noninvasive, first-line test to reduce the number of unnecessary endoscopies. In the longer term this could also mean earlier diagnosis and treatment, and better survival.”

and a small risk of serious adverse effects

The trial was based on the results of

The scientists found that 94.7% of the non-

(such as biliary pancreatitis and liver

previous research that suggested differences

CAR-stimulant injected mice developed

hematoma).

in the levels of specific chemicals (butyric, pentanoic and hexanoic acids, butanal, and

gallstones compared to 33.3% of CARstimulant-injected mice when fed the

Article: Activation of Constitutive Androstane

decanal) between patients with stomach or

lithogenic diet. Microscopic inspection

Receptor Prevents Cholesterol Gallstone

oesophageal cancer and patients with upper

of tissue showed striking differences.

Formation, Shihai Cheng, Min Zou, Qinhui

gastrointestinal symptoms without cancer.

>>>

GASTROENTEROLOGY TODAY - SUMMER 2017

Activation of CAR alters the biochemical

The new research, involving more than 300

29

NEWS it’s been an incredible comfort to have the

The new research aimed to test whether this ‘chemical signature’ that seemed to typify cancer could be the basis of a diagnostic test.

In the new study, the research team collected breath samples from 335 people at St Mary’s Hospital, Imperial College Healthcare NHS Trust; University College London Hospital; and the Royal Marsden Hospital, London. Of these, 163 had been diagnosed with stomach or oesophageal cancer and 172 showed no evidence of cancer when they had an endoscopy.

All the samples were analysed with a technique called selected ion flow-tube mass spectrometry, which is able to accurately measure small amounts of different chemicals in mixtures of gases such as breath.

Researchers measured the levels of the five chemicals in each sample to see which ones matched to the ‘chemical signature’ that indicated cancer.

The results showed that the test was 85% accurate overall, with a sensitivity of 80%

Epic challenge will provide valuable support to people with Crohn’s and Colitis Derek McEwan, founder of the Catherine McEwan foundation¹ and Trustee of Crohn’s and Colitis UK² raised an incredible £100,000 last year when he undertook the Arch 2 Arc challenge³, with friend and Ambassador of Glasgow Children’s Hospital Charity, Barry Cook.

The phenomenal challenge involved running, cycling and swimming from London to Paris. The money raised was shared between Crohn’s and Colitis UK, Glasgow Children’s Hospital Charity and

Derek McEwan said; “Arch2Arc was the challenge of a lifetime.

We trained almost every day for a year to get in shape for the six-day challenge and it changed our lives. Not only Barry and I, but our families too. To raise over £100,000 made the effort very worthwhile indeed, especially when we could support Crohns & Colitis UK which is a cause very close to our hearts.”

Barry Cook added; “I am delighted that Derek and I are able to

the MS Society.

support the Crohn’s and Colitis UK helpline

The donation to Crohn’s and Colitis UK will

these services are as my daughter was

make a significant contribution towards providing essential support and information to people affected by Inflammatory Bowel Disease (IBD), through the running of the helpline services. The Crohn’s and Colitis UK helpline helps people to understand more about IBD, diagnosis and treatment options,

services initiative – I know how important diagnosed with Ulcerative Colitis at the age of five years old - having that support and information is crucial and can be a lifeline for many who suffer from IBD and their families.”

Sarah Porch Director of Support Services from Crohn’s and Colitis UK said;

and a specificity of 81%. This means that

provides information to help people live well

not only was the breath test good at picking

with the conditions as well as being there to

“As the leading UK charity in the battle

up those who had cancer (sensitivity), it was

listen if someone needs to talk.

against Crohn’s Disease and Ulcerative Colitis, we rely massively on the support of

also good at correctly identifying who did not People with IBD can experience painful,

fundraisers such as Derek to ensure we can

unrelenting symptoms, which can cause

provide our vital services to people living

Dr Markar said: “Because cancer cells are

huge embarrassment and have a negative

with IBD in the UK. The money raised from

different to healthy ones, they produce a

impact on their quality of life. The personal

incredible challenges like this help us reach

different mixture of chemicals. This study

nature of the symptoms can cause people

more people with essential information,

suggests that we may be able detect these

to conceal their illness, as they are reluctant

emotional and financial support and go

differences and use a breath test to indicate

to talk about their condition, especially at

towards achieving a better quality of life for

which patients are likely to have cancer of

school or work, leaving them to feel isolated

those with the conditions. Crohn’s Disease

the oesophagus and stomach, and which

and depressed. Crohn’s and Colitis UK’s

and Ulcerative Colitis can be stressful

do not. However, these findings must be

helpline, delivered by phone, email and on-

and isolating. They are not always easy

validated in a larger sample of patients

line, provides a lifeline for people affected

conditions to live with – and many suffer in

before the test could be used in the clinic.”

by IBD. The information and support service

silence - that’s where we come in, to provide

will reach over 12,000 this year and this

information and support to those who need

number is growing year on year.

our help.”

One caller said;

To find out more information on how Crohn’s

have cancer (specificity).

GASTROENTEROLOGY TODAY - SUMMER 2017

30

charity’s help.”

Over the next three years, the researchers will continue with a larger trial, using the test with patients who are being given an

and Colitis UK can help you visit http://

endoscopy for gastrointestinal symptoms but not yet diagnosed with cancer. This will

“I was diagnosed a month ago as I needed

email.precise.uk/c/eJwNjUFuwyAURE9jlgg-

assess the ability of the test to pick up cases

support, so I phoned Crohn’s and Colitis

GOMFi6RRpG7bE2D4DqgOIMCy2tMX

within a group that is likely to contain only a

UK helpline. I wasn’t sure if it would help.

aTSzeNIbb1A6dDuJBhhfmBg9AwhO-

small percentage of cancers.

but I was so grateful to the gentleman I

aL1SoFrAMpuj-f947FMkpWKLjak5w8Jh

spoke to that day - at the beginning of the

rltt7u2TAkPqLhgXCq9rsgkbNxycrfdhe_

The team is also working on breath tests for

phone call I was so upset I was finding it

4h2aWihwm9F7aJG4TPEeu66Ku5pCaTd7lI_

other types of cancer, such as colorectal and

difficult to talk, but by the end of the call, I

bYaK6vIR-0naXk2kk1Me15XL_

pancreatic, which could be used as first-line

felt much brighter. Both the Information and

RR1vO7YgtxPRy-V1s-qVjSTdfeKBt-

tests in general practice surgeries.

the emotional support services are amazing;

OmHHWbF1T8OL0QW

NEWS

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GASTROENTEROLOGY TODAY - SUMMER 2017

FAST

31

POSTERS

COMPARISON OF TRANSIENT ELASTOGRAPHY, TH ASSESSMENT FOR THE PRESEN

W. On, R. Angelescu, A. Abelidis, B. Gurun

Department of Gastroenterology, Macclesfield Dis

INTRODUCTION

RESULTS

• Transient elastography (TE) has well established role in assessment of liver fibrosis in patients with chronic liver disease.

• Portal hypertension (PH) is a surrogate marker of liver fibrosis, which lead to development of varices.

• Currently used predictors of liver fibrosis and PH include radiological findings of splenomegaly and biochemical/haematological markers: AST/platelet ratio, FIB4 score and thrombocytopenia.

• A significant proportion (20-50%) of cirrhotic patients develop oesophageal varices over time.

• Macclesfield hospital is a regional TE (FibroScan®, Echosens) centre serving population of above 1 mil since 2010.

• 2,643 patients underwent TE during June 2010 and January 2016.

AIM AND METHODS

GASTROENTEROLOGY TODAY - SUMMER 2017

32

• Our aim was to establish more accurate way of using TE data in conjunction with radiological and haematological findings to predict presence of oesophageal varices.

• Data of 2643 patients undergoing TE was analysed together with oesophago-gastro-duodenoscopy (OGD), abdominal ultrasound scan (USS) and biochemical and haematological findings.

• A cut-off value of liver stiffness measurement (LSM) of >11.5 kPa was used to identify patients with liver cirrhosis.

• Preliminary calculations allow us to adopt a LSM cutoff value of >25 kPa as a predictive value of associated presence of oesophageal varices.

• Thrombocytopenia was defined as a platelet (PLT) count of <150 x 109/L from our laboratory system (Labcentre).

• Splenomegaly was defined by bipolar length of > 13cm on USS. • Presence of oesophageal varices was verified by OGD findings within 1 year of TE. • Data was obtained from our hospital’s patient records and database.

• LSM of >11.5 kPa was recorded in 372 patients.

• 157 patients with LSM >11.5 kPa underwent a OGD within 1 year of TE. • The aetiologies of liver cirrhosis in our cohort group of patients were as follow: Aetiology

No. of patients (%)

Alcoholic Liver Disease Non Alcoholic Fatty Liver Disease

85 (54%) 26 (17%)

Chronic Hepatitis C Primary Biliary Cirrhosis

10 (6%) 5 (3%)

Haemochromatosis Autoimmune Hepatitis Chronic Hepatitis B Budd Chiari Syndrome

3 (2%) 2 (1%) 1 (1%) 1 (1%)

Mixed aetiology Unspecified

3 (2%) 21 (13%)

• Oesophageal varices were identified in 26% (41/157) of cirrhotic patients.

Prevalence of oesophageal varices (n=157)

VARICES 26%

NO VARICES 74%

POSTERS

HROMBOCYTOPENIA AND SPLENOMEGALY IN RISK NCE OF OESOPHAGEAL VARICES

ng, R. Saravanan, G. Berrisford, K. Koss

strict General Hospital, Cheshire, United Kingdom

CONCLUSIONS

ANALYSIS • 56% (88/157) of cirrhotic patients had a LSM of >25 kPa. • 38% (60/157) of cirrhotic patients had splenomegaly on radiological imaging.

• 45% (70/157) of thrombocytopenia.

cirrhotic

patients

had

• 18% (29/157) of cirrhotic patients had a triad of LSM of >25kPa, splenomegaly and thrombocytopenia.

• 83% (34/41) of cirrhotic patients with oesophageal varices had a LSM of >25 kPa. • The sensitivity and specificity of TE, TE+/thrombocytopenia+/-splenomegaly in predicting presence of oesophageal varices are outlined below: Specificity

LSM >25 kPa

83%

53%

Thrombocytopenia

59%

60%

Splenomegaly

61%

70%

LSM >25 kPa AND thrombocytopenia

45%

85%

LSM >25 kPa AND thrombocytopenia AND splenomegaly

31%

94%

LSM >25 kPa OR thrombocytopenia

95%

20%

LSM >25 kPa OR thrombocytopenia OR splenomegaly

97%

14%

• Forty six cirrhotic patients (26%) had LSM <25 kPa with normal PLT and normal spleen size on USS. Only 1 patient (2%) in that group (TE = 16.7 kPa) had borderline oesophageal varices.

• A LSM cut-off value of >25 kPa or thrombocytopenia or splenomegaly offered best sensitivity of 97% in predicting presence of oesophageal varices.

• There was a trend of increasing prevalence of oesophageal varices and incidence of oesophageal bleeding with higher values of LSM (up to 75 kPa).

• Only a small proportion of patients with LSM of <25kPA had oesophageal varices.

• Patients with LSM<25kPa, normal PLT and normal spleen size on USS are unlikely to have evidence of significant oesophageal varices.

• We recommend that cirrhotic patients with LSM > 25kPa should be prioritised for surveillance OGD.

GASTROENTEROLOGY TODAY - SUMMER 2017

Sensitivity

• In our cohort study, we observed that LSM of >25kPa offers better sensitivity in predicting presence of oesophageal varices than splenomegaly and thrombocytopenia.

33

POSTERS

Gastroenterology Patient Clinical Management Systems CIMS is the supplier of InfoFlex patient clinical management systems covering all areas of Gastroenterology including Endoscopy Reporting, IBD, hepatology and cancer. It is a single integrated solution covering eReferrals, Waiting Lists, Triage, Scheduling, Procedure Reporting and National Reporting and Data Submissions to NED/JAG. CIMS is the supplier of the National IBD Registry and IBD Patient Management System (PMS).        

GASTROENTEROLOGY TODAY - SUMMER 2017

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Pathway Management of Referral to Discharge - eReferrals, Waiting Lists, Triage & Scheduling covering all areas of gastroenterology Reporting and Image Capture across the full range of Endoscopy Procedures National JAG and NED requirements Mobile Devices for clinicians, patients, and access across the community High capability for local configuration Integration with other Trust systems – HL7, XML, ITK, Inter-Trust Messaging Audit and research CIMS’ help desk provides high quality support

COMPANY NEWS

AVENSYS UK LTD – THE TECHNICAL SUPPORT EXPERTS COMMITTED TO EXTENDING THE LIFE OF YOUR ENDOSCOPES Every hospital must be served by the highest standards of medical equipment engineering and support services.

All equipment must be safe to use and above all accurate in the information it provides. Clinical staff have to be confident that any clinical decisions that are based upon the use of such equipment are 100% reliable, safeguarding patient safety. These are the exacting standards that Avensys delivers.

Endo360 – Maximum Service, Minimum Investment Endo360 is a proactive approach to reducing the frequency and severity of endoscope repairs, helping hospitals to identify and manage costs more effectively. The programme was designed in collaboration with clinicians to improve endoscope performance, minimise expensive repairs, extend the life of existing equipment and increase staff awareness and confidence. It also ensures that critical medical equipment is inspected and calibrated on a routine basis by dedicated

Avensys is a name recognised in hospitals throughout the country

experts based at the Avensys endoscope workshop.

as a trusted supplier of biomedical equipment engineering service solutions. From single all-encompassing repair and asset

Avensys understands that different hospitals have different requirements,

management packages to technical training courses, everything

and a “one size fits all” approach does not meet client needs. In

Avensys offers is designed to take worry and responsibility away

response to this, Avensys has developed four different levels of support,

from hospitals, leaving them free to focus on patient care.

each structured to provide a different level of service, but adhering to the same underlying commitment to delivering a comprehensive and

The New Avensys Endoscope Workshop

cost-effective solution for endoscopes that have been deemed by the manufacturer as being at the end of their life, but are still fit for purpose.

Centrally located in the Midlands, the dedicated Avensys British endoscope workshop provides a specialist repair and maintenance

Whichever level customers choose, they receive:

service for rigid and flexible endoscopes and all associated equipment, regardless of age or manufacturer. All work is carried out by skilled technicians using state of the art equipment and repair components specially engineered to improve equipment longevity.

• Cover on all flexible endoscopes regardless of make, model, manufacturer and age • Bi-annual maintenance visits • Online staff training

The workshop’s location means it is well placed for a rapid turnaround on all repairs, ensuring essential equipment is returned

Endo360 Bronze is an ideal entry level, providing a “pay as you go”

to endoscopy departments as quickly as possible. Offering

mend and repair management programme that allows clients to only

outstanding service and value, the Avensys workshop provides the

pay for the work needed, rather than being tied into an expensive

most extensive repair capability in the industry, delivered from an

ongoing contract.

ideally situated base.

Endo360 Silver provides a fixed annual service budget, detailed An Efficient Use of Resources

service reports, and loan equipment support.

The endoscope maintenance and repair service from Avensys

Endo360 Gold gives a fixed monthly service budget with a 100% credit

helps hospitals to meet both cost and environmental challenges by

at year end for under-utilisation. It avoids monthly swings in repair costs

ensuring an efficient use of resources. Instead of having to replace

while also eliminating the risk of overpaying for repair services.

workshop to be given a new lease of life quickly and efficiently. In

Endo360 Platinum is the top level of cover, allowing a fixed annual

this way, endoscopy departments get the most from their investment

service budget. All repairs are covered, including accidental damage.

in expensive equipment with less waste, less unnecessary expenditure, and the assurance that endoscopes will be available

At Avensys, we focus on more than “just repairing your equipment”.

and ready for use when needed.

Our focus is to meet and exceed the service and information needs of our customers. In our specialised business there is no room for error, no

Flexible Solutions to Endoscope Maintenance and Repair

time for mistakes, and no reason for anything less than perfection. With extensively trained endoscope technicians and attentive management,

Endoscopic surgery is becoming increasingly common. However,

we are committed to providing you with the finest in instrument repair.

endoscopes are very costly and fragile, and prone to damage during use or cleaning. Ongoing repair contracts can be expensive and

For more information, please contact:

inefficient, but Avensys has developed a cost-effective solution,

Avensys UK Ltd

delivered by the endoscope workshop, designed to support

Tel: 01562 745 858

endoscopy units by helping them to get the maximum life out of

Email: info@avensysmedical.co.uk

endoscopes without unnecessary spending – Endo360.

Web: www.avensysmedical.co.uk

GASTROENTEROLOGY TODAY - SUMMER 2017

ageing endoscopes, they can be sent to the centrally located

35

COMPANY NEWS

PANCREATIC CANCER AND BACTERIA Author: Dr. Ashton J Harper MBBS, BSc, MRCS (Head of Medical Affairs for Protexin Human Healthcare) Introduction: Pancreatic cancer ranks fourth for most common cause of cancer death

(Di Cerbo et al. 2016). Good dental hygiene in combination with oral

despite having a comparatively low incidence (Yadav & Lowenfels

probiotic adjuncts may therefore prove important in reducing at least

2013). Late recognition and resistance to treatment add heavily to the

one of the associated risk factors in PC.

poor prognosis and, with predictions of a rise in pancreatic diseases in the future, there is a present necessity to improve our understanding

Metabolic disease, bacteria and pancreatic cancer:

of modifiable risk factors, develop better screening methods, and enhance treatment for established disease. Smoking is the single

Obesity and type II diabetes are pandemic and both associated with

greatest risk factor contributing to pancreatic cancer; however diet and

an increased risk of pancreatic cancer. Insulin resistance has been

genetics are also implicated (Schwabe 2014). One relatively new area

shown to be causally related to PC and anti-diabetic drugs such as

of consideration is the role bacteria play in causation of this disease,

sulfonylureas and GLP-1 agonists may also increase the risk of PC

both directly and indirectly, and how microbiota manipulation may help

(Singhal et al. 2016). Lactic acid probiotic bacteria have demonstrated

in prevention and treatment (Singhal et al. 2016). This article will explore

anti-obesity an anti-diabetic effects in animal studies. Mechanisms

the mechanisms and evidence that link bacteria to pancreatic cancer.

explored include increased insulin sensitivity, increased adiponectin production (glucose regulation and fatty acid oxidation), increased

Helicobacter and pancreatic cancer:

skeletal muscle glucose transport (GLUT)4 mRNA expression as well as decreased pro-inflammatory cytokines. Promising results in human

Helicobacter species have been implicated not only in gastric

probiotic trials include reduced LDL cholesterol, improved insulin

carcinoma but also biliary tract cancer, hepatocellular carcinoma,

resistance and reduction in body weight (Singhal et al. 2016).

and pancreatic cancer (PC) (Nilsson et al. 2006). In one study Helicobacter DNA was discovered in 75% of exocrine PC and 60%

Carciongens, barrier function and the role of probiotics in

of chronic pancreatitis (established risk factor for PC), whereas in

pancreatic cancer:

benign pancreatic samples it was undetectable(Nilsson et al. 2006).

The most convincing pathomechanism here is chronic inflammation,

Bacterial inactivation of carcinogens:

a key feature of gastric, colonic and hepatobiliary tract cancers.

GASTROENTEROLOGY TODAY - SUMMER 2017

36

Bacterial components such as lipopolysaccharides (LPS), a membrane

Diet is known to play a substantial role in pancreatic carcinogenesis and

constituent of gram negative bacteria (e.g. – Helicobacter species),

remains an important focus for research. Compounds with tumorigenic

peptidoglycans and DNA motifs are capable of inducing inflammation

potential may result from ingesting meat that has been cooked at

through various immune pathways (Nilsson 2006). Chronic inflammation

high temperatures. Probiotic lactic acid bacteria have been shown to

is associated with DNA damage, cell proliferation and an inactivation

remove or metabolise such carcinogens thus reducing the risk of cancer

of tumour suppressor genes that may result in malignancy (Elinav et

(Singhal et al. 2016). Furthermore, promising in-vitro studies have

al. 2013). Furthermore, the treatment of H. pylori involves triple therapy

demonstrated that probiotics may be able to reduce the bio-availability

and, although this has a generally good success rate, repeated courses

of carcinogenic compounds from fungi (mycotoxins) and toxic heavy

of antibiotics, specifically penicillins, may promote cancer formation

metals (Singhal et al. 2016).

(Boursi et al. 2015).

Probiotics and mucosal barrier function: The oral microbiome and pancreatic cancer: A high fat diet in mice was shown to increase plasma levels of LPS leading The microbial residents of the oral cavity are shifted in periodontal

to low-grade inflammation associated with obesity and diabetes; a situation

disease compared to a healthy state. Periodontal disease encompasses

the authors termed ‘metabolic endotoxaemia’ (Cani et al. 2007). This

a spectrum of inflammatory states that affect both the soft and hard

observation is supported by an epidemiological study in humans in which

structures of the mouth and is an independent risk factor associated

healthy patients fed on a fat-enriched diet were characterized by a higher

with PC. Researchers have taken advantage of microbial deviations

fasting endotoxemia (Cani et al. 2007). Metabolic endotoxaemia may

here by using bacterial RNA from saliva as biomarkers (96.4% sensitivity

well play a part in the association between inflammation and cancer. Of

and 82.1% specificity) in discriminating between PC and healthy

great promise is the finding that probiotic therapy for 4 weeks decreased

controls (Farrell 2012). Lactobacillus, an oral commensal and commonly

metabolic endotoxemia and adipose tissue inflammation by improving

used probiotic species, is capable of reducing gum inflammation and

multiple facets of intestinal mucosal barrier function (see table 1) in obese

suppressing pathogenic bacteria associated with periodontal disease

and diabetic mice (Cani & Van Hul 2015).

COMPANY NEWS Table 1. Probiotic mechanisms promoting homeostatic barrier function Probiotic effect

Mechanism

SCFA production

Activate receptors that trigger secretion of glucagon-like peptide (GLP-1 and GLP-2). These exhibit an array of metabolic, proliferative and cytoprotective actions (Cani & Van Hul 2015)

Stimulate mucosal defence system

Promote mucin production and stimulate secretion of antimicrobial peptides such as regenerating isletderived 3-gamma (RegIIIg) (Cani & Van Hul 2015)

Competitive exclusion of pathogens

Competition for nutrients and competition for adhesion at the intestinal mucosa. Probiotic bacteria have been shown to reduce faecal putrefactive microorganisms (e.g. coliforms) that synthesise putative carcinogens in the colon (Chong 2014)

Stimulate IgA secretion

Secretory immunoglobulin A (IgA) mediates the mucosal immune system, which provides the first line of defence against inhaled and ingested pathogenic bacteria and viruses (Kikuchi et al. 2015)

Probiotics as chemotherapy adjuncts: There are at least 4 ways in which probiotics may be of benefit for cancer patients undergoing chemotherapy: 1. Prevent chemotherapy induced diarrhoea • Gastrointestinal mucositis affects approximately 50% of all cancer patients and a number of human probiotic trials have shown a significant reduction in the incidence of this complication (Touchefeu et al. 2014).

2. Reduce chemotherapy related cachexia (Ertz-Archambault et al. 2017) • Cachexia affects up to 80% of PC patients and is associated with reduced survival and progressive disease.

• Lactobacilli species are consistently reduced in mouse models of cachexia.

• A symbiotic product including lactobacilli species has been found to improve survival of leukaemic mice with cachexia.

3. Improving response to chemotherapeutic agents • Disruption of the microbiota by antibiotics has been shown to impair the response of tumours to immunotherapy and platinum chemotherapy in mice (Lida et al. 2013).

4. Augment immune response to tumour cells • In a mouse model of melanoma Bifidobacteria was found to augment the immune response to tumour cells (Ertz-Archambault et al. 2017).

Conclusion: A surprising number of studies reveal that the association between bacteria and pancreatic cancer risk is undeniable. Encouraging existing research offers a range of possibilities for probiotic therapy including treatment of associated diseases, bolstering defences against inflammation, nullifying carcinogens and reducing the side effects of chemotherapy. This field certainly requires further studies to confirm and validate specific bacterial treatments; however the future at least seems promising.

Boursi, B. et al., 2015. Recurrent antibiotic exposure may promote cancer formation-Another step in understanding the role of the human microbiota? European Journal of Cancer, 51(17), pp.2655–2664.

Available at: http://dx.doi.org/10.1016/j.ejca.2015.08.015.

Cani, P.D. et al., 2007. Metabolic Endotoxemia Initiates Obesity and Insulin Resistance. Diabetes, 56(July), pp.1761–1772.

Cani, P.D. & Van Hul, M., 2015. Novel opportunities for nextgeneration probiotics targeting metabolic syndrome. Current opinion in biotechnology, 32, pp.21–7. Available at: http://www.scopus.com/ inward/record.url?eid=2-s2.0-84910614571&partnerID=tZOtx3y1.

Di Cerbo, A. et al., 2016. Mechanisms and therapeutic effectiveness of lactobacilli. Journal of Clinical Pathology, 69(3), pp.187–203. Available at: http://jcp.bmj.com/lookup/doi/10.1136/jclinpath-2015-202976.

Chong, E.S.L., 2014. A potential role of probiotics in colorectal cancer prevention: review of possible mechanisms of action. World journal of microbiology & biotechnology, 30(2), pp.351–74. Available at: http:// www.ncbi.nlm.nih.gov/pubmed/24068536.

Elinav, E. et al., 2013. Inflammation-induced cancer: crosstalk between tumours, immune cells and microorganisms. Nature Reviews Cancer, 13(11), pp.759–771. Available at: http://www.nature.com/ doifinder/10.1038/nrc3611.

Engelbrektson, A. et al., 2009. Probiotics to minimize the disruption of faecal microbiota in healthy subjects undergoing antibiotic therapy.

Journal of medical microbiology, 58(Pt 5), pp.663–670.

Ertz-Archambault, N., Keim, P. & Von Hoff, D., 2017. Microbiome and pancreatic cancer: A comprehensive topic review of literature. World Journal of Gastroenterology, 23(10), pp.1899–1908.

Farrell, J., 2012. Variations of oral microbiota are associated with pancreatic diseases including pancreatic cancer. Gut, 61(4), pp.582–588.

Kikuchi, Y. et al., 2015. In vivo dose response and in vitro mechanistic analysis of enhanced immunoglobulin A production by Lactobacillus plantarum AYA. , 34(3), pp.53–58.

Lida, N. et al., 2013. Commensal Bacteria Control Cancer Response to Therapy by Modulating the Tumor Microenvironment. Science, 342(1), pp.967–970.

Mcfarland, L. V, 2014. Use of probiotics to correct dysbiosis of normal microbiota following disease or disruptive events : a systematic review.

BMJ, 4:e005047.

Nilsson, H.O. et al., 2006. Helicobacter species ribosomal DNA in the pancreas, stomach and duodenum of pancreatic cancer patients. World Journal of Gastroenterology, 12(18), pp.3038–3043.

Schwabe, R., 2014. The microbiome and cancer. Nature Reviews Cancer, 13(11), pp.800–812.

Singhal, B., Mukherjee, A. & Srivastav, S., 2016. Role of Probiotics in Pancreatic Cancer Prevention: The Prospects and Challenges.

Advances in Bioscience and Biotechnology, 7(11), pp.468–500.

Available at: http://www.scirp.org/journal/PaperDownload. aspx?DOI=10.4236/abb.2016.711045.

Touchefeu, Y. et al., 2014. Systematic review: The role of the gut microbiota in chemotherapy- or radiation-induced gastrointestinal mucositis - Current evidence and potential clinical applications.

Alimentary Pharmacology and Therapeutics, 40(5), pp.409–421.

Yadav, D. & Lowenfels, A., 2013. The Epidemiology of Pancreatitis and Pancreatic Cancer. Gastroenterology, 144(6), pp.1252–1261.

GASTROENTEROLOGY TODAY - SUMMER 2017

• Probiotics have demonstrated ability in stabilising the baseline microbiota community (Engelbrektson et al. 2009) and to correct dysbiosis following iatrogenic insult with antibiotics (Mcfarland 2014) thus helping to foster an intact commensal microbiota required for optimal cancer therapy response.

Bibliography:

37

Focus Focus on on FIT FIT Focus on FIT

FOCUS ON FIT

Focus on FIT

ATale Tale Two Settings Two Settings AATale ofofof Two Settings by Professor Callum G. Fraser, Professor Fraser, A Tale ofCallum Two Settings by by Professor Callum G. G. Fraser,

Centre for Research into Cancer Prevention Centre Research into Cancer Prevention Centre forfor Research Cancer Prevention by Professor Callum into G. Fraser, and Screening, University Dundee, and Screening, University of of Dundee, and Screening, University of Dundee, Centre for Research into Cancer Prevention Ninewells Hospital and Medical School, Dundee Ninewells Hospital Medical School, Dundee Ninewells Hospital andand Medical School, Dundee and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee Faecal Faecal Faecal Immunochemical Tests Immunochemical Tests Immunochemical Tests used Faecal (FIT)(FIT) are are nownow used (FIT) arefor now used asymptomatic Immunochemical Tests for asymptomatic for asymptomatic (FIT)population-based arepopulation-based now used population-based bowel (cancer) for asymptomatic bowel (cancer) bowel (cancer) screening population-based screening andand alsoalso screening and assessment also for bowel for (cancer) the the assessment for the assessment of patients presenting with lower screening and also of patients presenting with lower of patients presenting with lower abdominal symptoms, particularly for the assessment abdominal symptoms, particularly in in abdominal symptoms, particularly in primary care. with of patients presenting lower primary care. primary care. abdominal symptoms, particularly in primary care. provide investigation FIT FIT provide oneone investigation thatthat FIT provide one investigation that is of significant value in these is of significant value in these twotwo is of significant valueclinical in these two These different settings.

FIT provide one investigation that These veryvery different clinical settings. very different clinical settings.

These applications have different target is ofapplications significant value in these two have different target applications have different target populations, aims, faecal haemoglobin verypopulations, different clinical settings.

These aims, faecal haemoglobin populations, aims, faecal haemoglobin cut-offs, interpretation of results, applications have different of target cut-offs, interpretation results, cut-offs, interpretation of results, benefits, potential harms, additional populations, aims, faecal haemoglobin potential harms, additional benefits, potential harms, improvements additional benefits, potential possible cut-offs, interpretation of results, potential improvements andand possible potential improvements and possible strategies for the future. potential harms, additional benefits, strategies for the future. strategies for the future. potential improvements and possible strategies the future. isfor important these different It isItimportant thatthat these different It is important that theseappreciated different as this test aspects of FIT aspects of FIT are are appreciated as this test aspectsrolls of FIT are appreciated as this test across the UK major It is rolls important that these outout across the UKdifferent andand the the major rolls outadvantages across the of UKincreasing and the major aspects of FIT are as screening this test advantages of appreciated increasing screening advantages of increasing screening to which rollsuptake outuptake across the helping UK and thedecide major andand helping to decide which uptake patients and helping to decide which care presenting in primary advantages increasing patients of presenting in screening primary care patientswould presenting inmost primary care benefit from colonoscopy uptake andbenefit helping to decide which would most from colonoscopy would benefit most from colonoscopy gained. in primary care patients presenting are are gained. are gained. would benefit most from colonoscopy are The gained.

The adjacent table clarifies adjacent table clarifies the the The adjacent table clarifies the attributes. attributes. attributes.

The adjacent table clarifies the attributes.

GASTROENTEROLOGY TODAY - SUMMER 2017

38

Characteristic Characteristic Characteristic Characteristic Target Target Target Population Population Population Target Population

AimAim Aim Aim

Purpose Purpose Purpose Purpose Faecal Faecal Faecal Haemoglobin Haemoglobin Haemoglobin Cut-off Faecal Cut-off Cut-off Concentration Haemoglobin Concentration Concentration Used Cut-offUsed Used Concentration Used Interpretation Interpretation of of Interpretation of Results Results Results Interpretation of Results

Potential Harms Potential Harms Potential Harms Potential Harms

••• ••• ••• •••

more FindFind outout more at at Find out more at www.alphalabs.co.uk/FIT www.alphalabs.co.uk/FIT www.alphalabs.co.uk/FIT Find out more at www.alphalabs.co.uk/FIT

✓ ✓ ✓ ✓

Additional Additional AdditionalBenefits Benefits Benefits Additional Benefits Potential Potential Potential Improvements Improvements Improvements Potential Improvements

COMPANY NEWS

Distinguishing FIT in Screening from FIT in Assessment of the Symptomatic FIT in the Symptomatic

Asymptomatic individuals eligible to participate in structured screening programmes, which differ from nation to nation in the UK, being 60-74 years in England, Wales and Northern Ireland, and 50-74 years in Scotland along with those older individuals who choose to “opt-in”.

Patients of any age who present in primary care with lower abdominal symptoms such as rectal bleeding, a change in bowel habit to constipation or diarrhoea, unexplained weight loss, anaemia, abdominal pain, and abdominal or rectal mass.

In addition, some patients seen at certain secondary care clinics such as gastroenterology, will benefit.

To select those participants in screening programmes who have no symptoms, but are at highest risk of colorectal neoplasia – cancer and higher-risk (advanced) adenoma.

To identify those patients who are most unlikely to have significant colorectal disease and would not benefit from referral for colonoscopy, saving resources and shortening waiting times, as well as identifying those who have significant colorectal disease and would benefit.

Rule in neoplasia.

Rule out significant colorectal disease (cancer + higher-risk adenoma + Inflammatory Bowel Disease).

Rule in significant colorectal disease.

High – especially in colonoscopy constrained countries.

Selected to give the screening programme performance characteristics desired, such as the positivity rate with which the available colonoscopy resource could cope.

Low – 10 µg Hb/g faeces is widely recommended.

Selected to ensure that patients with “negative” results, most unlikely to have significant colorectal disease, do not necessarily get early referral for colonoscopy. And, if “positive”, stimulates early referral to secondary care for further investigation.

A “positive” result means that a risk of significant colorectal disease is present and further investigation is warranted. A “negative” result means the participant should be invited again at the set screening interval, currently two years in the UK.

If the result is “negative”, there is considerable reassurance that significant colorectal disease is not present. A “detectable” faecal haemoglobin means that the patient warrants further investigation.

Not all colorectal neoplasia is detected – interval cancer proportions are high when high faecal haemoglobin cutoffs are applied. Thus, a “negative” result does not mean that colorectal neoplasia is absent and participants receive information on lifestyle and symptoms.

There is a “reassurance” effect of a “negative” result.

Moreover, a “positive” result does not mean that colorectal neoplasia is present, but the participant will undergo an invasive and potentially harmful investigation.

FIT in assessment of the symptomatic is not perfect and some colorectal disease will be missed if a “negative” result is used as guidance for no referral.

Most cancers are detected, but a slightly greater proportion of higher-risk adenoma and inflammatory bowel diseases are not detected. Thus, patients with “negative” results could be given reassurance, but possible alternatives such as watching and waiting, referral to secondary care clinics, or a repeat FIT might be warranted, particularly if symptoms persist.

Not only cancer detected but also some higher-risk adenoma, sometimes precursors of cancer, and Inflammatory Bowel Disease.

Not only possibility of significant colorectal disease being “excluded”, but cancer, higher-risk adenoma, sometimes precursors of cancer, and Inflammatory Bowel Disease detected.

As FIT screening progresses and as the available colonoscopy resource expands, implementation of lower cut-offs over time would increase detection of cancer and even more higher-risk adenoma.

Investigation of more analytically sensitive methods for detection of faecal haemoglobin, since many patients have undetectable faecal haemoglobin with current methodology.

Use of FIT result in combination with other variables such as blood haemoglobin.

GASTROENTEROLOGY TODAY - SUMMER 2017

FIT in Screening

39

Helicobacter Test INFAI ® The most used 13C-urea breath test for the diagnosis of Hp-infection worldwide

• more than 4.5 million INFAI tests performed in Europe • approved for children from the ages of 3 to 11 • special INFAI test for patients with dyspepsia taking PPIs • cost-effective CliniPac Basic version for hospital use INFAI Institute for Biomedical Analysis & NMR Imaging, INFAI UK Ltd Innovation Centre, University Science Park, University Road, Heslington, YORK YO10 5DG, UK Phone +44 1904 435 228 - Fax +44 1904 435 229 - mail: info@infai.co.uk - Visit us at www.infai.com