The
Natural
Therapist
EDITION 36 NO. 2 | WINTER 2021
ISSN 1031 6965
Winter 2021
The Official Journal of THE AUSTRALIAN NATURAL THERAPISTS ASSOCIATION
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TARGETING OPTIMAL HEALTH
Contents Edition 36 No. 2
|
Winter 2021
From the Chair 4
Executive Officer Report
ANTA News
5 ANTA News 20 Winter Breakfast Ideas by Rachel Knight
7
12
Clinical Records - What Should go into Them?
Common Sources of Error in Clinical Trial Literature - Part 1: Introduction to Statistical Methodology
Isaac Enbom, National Remedial Therapy Branch Chair and ANTA Director, explains the importance of keeping current and informative clinical records of your clients.
24
The Growing Clinical Research of Withania Kerry Bone explores the herb Withania
somnifera and how it affects people differently.
In this series, Tony Reid explains the common sources of error in clinical trial literature.
30
40
45
Relevance of Ayurveda for Preventative Health and Chronic and NonCommunicable Diseases
Clinical Efficacy of a Blend of Five Medicinal Herbs for Osteoarthritis Management
Heart Shock Treatment Strategies
Neerja Ahuja explores the trends of chronic
George Thouas explores the clinical efficacy of
and non-communicable diseases and the role
a blend of medicinal herbs and how they can
that Ayurveda plays.
help with the management of osteoarthritis.
EDITION 36 NUMBER 2 – WINTER 2021
Kaitlin Edin explores trauma and how it’s explained within Chinese Medicine.
ISSN 1031 6965
ANTA BRANCH CHAIRPERSONS
The
Natural Therapist
The Natural Therapist is published by the Australian Natural Therapists Association (ANTA) for natural therapy practitioners. The opinions and views expressed by the contributors and advertisers are not necessarily the opinions and views of ANTA. Every effort is taken to ensure accuracy and ANTA accepts no responsibility for omissions, errors or inaccuracies. ANTA relies on contributors and advertisers to make sure material provided for The Natural Therapist complies with the Australian Consumer Law under the Competition and Consumer Act 2010. ANTA accepts no responsibility for breaches of the Australian Consumer Law by contributors or advertisers. Material in The Natural Therapist is subject to copyright and may not be reproduced in any form without the permission of ANTA and its contributors.
Elizabeth Greenwood • National President • Director of ANTA • National Western Herbal Medicine Branch Chair • ICNM Ambassador • CPE/Seminar Chair • Registration Chair • Website & Media Chair • ANTAB Committee Member • ANRANT Committee Member
Kaitlin Edin • Director of ANTA • National Acupuncture Branch Chair • ANTAB Committee Member • ANRANT Committee Member
Warren Maginn • National Vice-President • Director of ANTA • National Nutrition Branch Chair • TGA Chair • Ethics Panel Chair • ANTAB Committee Member • ANRANT Committee Member
Mark Shoring • Director of ANTA • National Multi-Modality Branch Chair • ANTAB Committee Member • ANRANT Committee Member
Shaun Brewster • National Treasurer • Director of ANTA • National Myotherapy Branch Chair • ANTAB Chair • ANRANT Committee Member • Health Fund Chair Ananda Mahony • Director of ANTA • National Naturopathy Branch Chair
Isaac Enbom • Director of ANTA • National Remedial Therapy Branch Chair • ANTAB Committee Member • ANRANT Committee Member
Tino D’Angelo • Director of ANTA • National Chinese Herbal Medicine Branch Chair
The
Natural Therapist
Marketing & Production Tasha Kemsley Circulation Enquiries 1800 817 577
Editorial & Advertising Enquiries thenaturaltherapist@anta.com.au Membership Enquiries info@anta.com.au
Tony Reid • Traditional Chinese Medicine Industry Advisor Jim Olds • Executive Officer • Company Secretary • Business Plan Chair • ANRANT Chair
ANTA NATIONAL ADMINISTRATION OFFICE T: 1800 817 577 | F: (07) 5409 8200 E: info@anta.com.au P: PO BOX 657 MAROOCHYDORE QLD 4558 W: www.anta.com.au
ANTA Executive Welcome Winter 2021
From the Chair
The aftermath of the COVID-19 restrictions have been interesting in relation to the way a State Government appears to be omitting all natural, remedial and myotherapists as small business operators who should benefit from the small business support packages being rolled out to similar and many quite obscure, sole trader and small businesses in Victoria. Following this puzzling scenario, ANTA has joined the Council of Small Business Organisations Australia (COSBOA) which is the national peak body, exclusively representing the interests of small businesses Australia-wide. It is obvious that all ANTA Members operate small businesses either as sole traders or other combinations of partners in small business operations across the country. With representation through COSBOA, we intend to bring the needs of all ANTA Members to the attention of State and Federal politicians via the critical mass COSBOA has carriage over for this very purpose.
We have also represented ANTA Members through collaboration with four major Associations to bring the plight of small business operators to the attention of the Victorian Government in particular, as well as all State and Territory Governments to establish a uniform category for unregistered health workers. This issue is causing feelings of confusion and isolation for natural therapists and has now become a moving feast at each new crisis. Natural and manual therapists have seemingly morphed into a different category of health worker at each new event. As a result of the initiatives to bring change, we are now seeing consistency in action across five substantial professional Associations to become a cohesive group, developing strategies to benefit all our respective Members. This is good news for health practitioners from all Associations. We have maintained our points of difference, but not at the expense of the suite of benefits to our respective Members. The collaborating Associations are carrying this significant critical mass of manual and natural therapists to lobby State and Federal Governments to achieve a consistent level of recognition as health service providers to the Australian public. While the now National Cabinet has legislated a National Code of Conduct, which is a negative licencing instrument, yet to be adopted by all State and Territory Governments, the health service providers it regulates are yet to be recognised with consistency from State to State.
Winter 2021
For example, in NSW we are “unregistered health practitioners”, in Victoria we are “general health practitioners”, South Australia, Northern Territory, the Australian Capital Territory and Queensland we are entitled “Health Care Workers” for the purpose of regulation under this Code. Western Australia have yet to adopt any iteration of this “National” Code. Tasmania have the Tasmanian Code of Practice for Health Care Workers. The majority then, appear to agree we should be known as “Health Care Workers”. It is no great leap to understand how we slipped from one category to another at each crisis over the last year or so when calls for plans to operate clinics were drawn up by each State’s Health Department. The Code, a regulatory instrument is enforceable through each State’s Office of the Health Ombudsman within the State and Territories’ Health Care Complaints Commissions, or equivalent. These State and Territory regulators continue to struggle for consistency with a title for this category of health care worker that have existed since before ANTA was established as a professional Association to promote and protect Natural Therapists in 1955. These same regulators, known as the COAG Ministers at that time, stated in 2016, “they did not have an appetite to receive another submission for statutory registration to bring all ‘Health Care Workers’ under one uniform national regulatory body”. One might wonder who they believe is funding their respective existences as elected officers and who voted them into office? In conclusion, your ANTA National Council, and your National Administration Office staff are working diligently within a collective to bring your needs to the attention of State, Territory and Australian Governments through collaboration and representation at a level never-before achieved at a national level. We trust we have the confidence of you, our Members, to represent your position in this way.
PAGE 4 | WINTER 2021 | THE NATURAL THERAPIST VOL36 NO.2
Regards
Jim Olds
ANTA Fellow ANTA Executive Officer & Company Secretary BHSc MST, BHSc Comp Med, GC Higher Ed, MSC, Dip Nut, Dip RM, Dip TCMRM
ANTA News Winter 2021
ANTA News
The Process of Receiving Health Fund Provider Numbers ANTA recommends that members who are accredited in modalities that are recognised by the private health funds should read the following information to understand the process for obtaining a provider number. It has come to our attention that many members think that they will receive their new provider number almost immediately after providing ANTA with new clinic details. • Ensure that before you advise ANTA of your clinic address details that you are fully compliant. This means that the following must be up-to-date: ANTA membership fees, Professional Indemnity/Public Liability insurance, First Aid qualification, Police Check/Working With Children check, 20 annual CPE points from the previous calendar year. Specific details of these requirements are found in your membership portal, and if any of these requirements have expired you should see a red flag alert on the left-hand side of your profile page. • Advise ANTA of your clinic address via your membership portal, using the applicable form. ANTA will not accept address changes by email or phone. • Once ANTA receives your clinic details via your membership portal, please allow 1-2 working days for ANTA staff to enter the information into your profile. • If any of the compliance requirements have not been met, we will contact you to have them rectified before we will enter your clinic details into your profile. • When your clinic details have been entered into your profile, they are forwarded to the relevant health funds on their next scheduled lists. You can check ANTA’s Health Fund Reporting Dates calendar which is under the Health Fund Notifications tab on our homepage. It can take 2-3 weeks from the beginning of each month for all health funds to be sent lists. • Once your clinic details have been forwarded to a health fund on a scheduled report, please understand that ANTA has no control over how long it takes the health fund to process the list. • Check the following documents (available in your membership portal) for information regarding provider numbers from all health funds: Health Fund Provider Numbers, Health Fund List, Health Fund Contact List, and ARHG Instructions. • Medibank and Bupa are the only health funds that return provider numbers to ANTA. Therefore, once they have been returned to ANTA they will be emailed to you. • Before you contact ANTA via email or phone to ask questions about provider numbers, please ensure that you have read the abovementioned health fund information documents. Members often contact our Administration Office when the answer to their question is in these documents. ANTA would also like to point out that if you cease practising in a clinic, you must advise ANTA immediately via your membership portal as we are obliged to notify the health funds on their next scheduled lists.
Therapist Spotlight, ANTA’s New Podcast Therapist Spotlight is ANTA’s new initiative in which we aim to interview Members from our ANTA community to highlight the abilities and gifts they bring to the world of Natural Health. The launch of this project has two aims: to showcase how diverse and skilled our natural health community is to the public and educate on how valuable Natural Health is to the public health landscape, and two; we want to allow the breadth of ANTA therapists to be able to see and interact with each other, for growing our networking capabilities and strengthening our society. If you would like to be involved, please email an introduction of yourself to therapistspotlight@anta.com.au, we would love to hear from you! Therapist Spotlight is streaming now on all major podcast platforms and YouTube, search @TherapistSpotlight now! THE NATURAL THERAPIST VOL36 NO.2 | WINTER 2021 | PAGE 5
We’re all better for working together Sometimes, there’s a lot that can be learned from nature. Luckily, there are few things more Australian than coming together when times are tough. And over the past year, communities across Australia are doing what they can to help each other through some challenging times. That’s why Guild Insurance and ANTA have come together to help Australian natural therapists not only today, but well into the future. Visit guildinsurance.com.au/ANTA now to find out how we’re working towards a better tomorrow for you, and your practice.
1800 810 213 guildinsurance.com.au Better through experience.
Insurance issued by Guild Insurance Limited ABN 55 004 538 863, AFS Licence No. 233791 and subject to terms, conditions and exclusions. Guild Insurance supports ANTA through the payment of referral fees. Please refer to the policy wording and policy schedule for details. For more information call 1800 810 213 NAT147261 ANTA FP Ad 042021
ANTA Member Article Winter 2021
Isaac Enbom
National Remedial Therapy Branch Chair ANTA Director
Clinical Records What Should go into Them? Client records – what is actually required? This is a common question our National Administration Office receives from many Members. It is also the most common reason Members lose their provider status when audited by Health Funds – their client records do not show sufficient information. Good record keeping is formally covered as part of our formal education but for whatever reason, we often find that our Members client files are lacking the detail and information that is expected from a legal document.
Client Files– What are They?
Client files, clinical records, treatment notes: whatever term you use, the client file pertains to the documented account of a client’s personal health information, presenting condition and treatment in paper or electronic form. These are legal documents and therefore must be recorded in blue or black ink (if recorded by hand), must be stored in chronological order, must be written in English and must be stored securely and confidentially in accordance with the Act (Privacy Act (1988)) and your relevant state-based legislation. This means they are kept
confidential (to be shared only with the client or at the client’s discretion) and be stored securely (under lock and key) on the clinic premises.
Components of ‘Clinical Records’:
• The client file is a term used for all information stored under, or is attached to, a single client name or other identifier. The ‘file’ will contain personal information as well as all of the information relating to the assessment and treatment of that individual. It will include all relevant client details such as name, address, contact information, relevant medical history and evidence of informed consent. It is expected that this ‘file’ is kept up to date and held indefinitely. • The ‘individual treatment records’ includes information about each consultation. This information must be recorded at the time of the appointment or reasonably practicable thereafter. The following information must be recorded for each and every client consultation: ◊ Details of consultation: Such as date and
THE NATURAL THERAPIST VOL36 NO.2 | WINTER 2021 | PAGE 7
ANTA Member Article Winter 2021
time, therapist identifying details, purpose of treatment/presenting condition including symptoms and any other relevant information such as a history of other treatment/s relevant to the complaint and any concurrent medical/ therapeutic treatment. ◊ Details of physical assessment: This may vary depending on modality but must clearly indicate the need for treatment. These are also used to form the baseline to measure progress or condition improvement. Examples may include Range of Motion (ROM) testing for manual therapists and/or other specific diagnostic measures relevant to the modality; for example pulse or tongue assessment for Chinese Medicine. ◊ Treatment plan: This should include details such as client goals/beliefs, intended treatment and treatment strategy. This may be planned over a single session or over a period of time. ◊ Evidence of informed consent: This may be written, verbal or implied but must be documented in relation to the treatment plan listed above. ◊ Treatment provided: This should be specific and include details such as region/ muscle/structure treated, modalities used (manual therapies) or medicine/s used, dosage, prescription period and prescription ingredients (ingestive therapies). ◊ Evaluation of treatment: Or otherwise termed ‘reassessment’ will include a measureable effectiveness of the treatment applied. Generally, this section will hold equivalent detail as to the initial physical assessment relevant to the modality.
◊ Condition-based recommendations: This may include lifestyle advice, corrective exercise, referrals and any other relevant communication with or about the client/ patient. It is the practitioner’s responsibility to maintain good clinical records. There is no right or wrong way to document these but we must be mindful of the critical information to be contained. All information must be legible and easy to understand from a third party perspective. It is also worth noting that Health Funds will audit Members from time to time and insufficient detail is often a reason for provider status to be suspended or removed. Your health records are also considered a legal document and may be subpoenaed in a court of law. This point is an important one – asking yourself a simple question following your notes “would this make sense to another practitioner?” can sometimes help in identifying what key information should be included or is missing. The ANTA Board of Directors have put together an easy-to-read resource, the ‘Guide to Clinical Record Keeping’ which is available through the ANTA Member Centre to assist our Members in maintaining good clinical records. Our insurance partner Guild Insurance, also has a number of documents and publications available which detail some of the above mentioned components.
For references log into your ANTA Member Centre > The Natural Therapist > Journal Articles
PAGE 8 | WINTER 2021 | THE NATURAL THERAPIST VOL36 NO.2
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Risk factors for lactose intolerance
Lactose intolerance can affect people of all ages – from premmie babies to the elderly. However, it is most prevalent in babies with immature digestive systems, certain ethnic races such as Asians (95% prevalence) and people of Mediterranean origin (65%), and the elderly.
Is it safe to use Lacteeze long term?
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Lacteeze tablets contain natural lactase enzymes. Simply take 1 – 2 tablets just before consuming dairy to increase the levels of enzymes in the body. Lacteeze tablets are available in a range of strengths and flavours and are suitable for all ages. Lacteeze Drops contain a different form of lactase enzyme so they work differently to the tablets. The Drops are added to liquid dairy products such as milk, breastmilk, infant formula, cream or evaporated milk to reduce the lactose content before consumption. Lacteeze Infant Drops are suitable for babies with colic associated with lactose intolerance, and are clinically proven to reduce crying time in these babies by at least 45%. THE NATURAL THERAPIST VOL36 NO.2 | WINTER 2021 | PAGE 9
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ANTA Member Article Winter 2021
Tony Reid
M.Ac (Acupuncture) M.TCM (Traditional Chinese Medicine)
Common Sources of Error in Clinical Trial Literature Part 1: Introduction to Statistical Methodology Introduction
Since the early 1960’s statistical studies in medicine have moved from being a newly introduced innovation to the most acceptable way to verify medical theories and practices. However, the critical limitations of this methodology are often ignored and this, along with poor handling of appropriate statistical methods, has resulted in many false positive and non-replicable results in clinical research to date.
History and Development
Statistical studies have played an increasingly important role within medicine since the 1960’s through the pioneering work of Hill, based on methodology developed by Fisher in the 1930’s. These types of studies underpinned advances in diagnosis and treatment during the 1970’s. Unfortunately, the derailing influence of vested interests soon became increasingly apparent – beginning in the 1980’s and extending to the present day. In the 1990’s the medical profession adopted a system for ranking clinical studies and other sources of medical knowledge, including the development and implementation of methodologies to reduce bias in medical research. This initiative was spearheaded by a group of Canadian epidemiologists, headed by Sacket. Thus was born what is now termed Evidence Based Medicine (EBM) and Evidence Based Practice (EBP). Concurrently, since the mid 1990’s the Consolidated Standards of Reporting Trials (CONSORT) group (focused on clinical trials) and the Preferred Reporting Items for Systematic and Meta-Analyses (PRISMA) group (focused on systematic reviews and meta-analyses of trials) have periodically issued statements in an effort to develop and disseminate international standards for transparent reporting of medical research.
Guidelines for assessing clinical trials have been developed and refined since the 1960’s. Currently accepted models include the Jadad scale, Physiotherapy Evidence Database scale (PEDro), Cochrane Collaboration’s risk of bias tool, etc1. These, together with the CONSORT and PRISMA statements mentioned above, have been widely published, with the aim of improving and standardising both the design and reporting of clinical trials. They have been incorporated into university curriculums and are generally accepted within the medical profession, However, at the time of writing there are still many clinical trials and reports of trials that either fall short of these standards or introduce new and unacknowledged sources of error.
How to Read an Academic Paper
When you read an academic paper in which other works are cited, these other works are either research studies, review papers, official clinical guidelines or pages from an authoritative textbook. The purpose behind including citations is twofold. Firstly, to provide a source from which to verify the facts that are being used in the discussion. Secondly, some references may direct readers to an article or a chapter in a book, in which there is a more comprehensive and detailed discussion of issues that have only been mentioned quite briefly. Therefore, an important part of reading an academic paper is to include at least a cursory glance at the references and then, if necessary, to access a particular source, either to check the facts, or to gain a deeper understanding of the issues involved by reading what others have to say on the subject. You should not always accept a fact or a viewpoint simply because a reference has been cited. The following discussion aims to illustrate why this process of additional scrutiny is absolutely necessary.
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ANTA Member Article Winter 2021
Peer Review Failings: Abstracts are Often Unreliable
You may have presumed that the process of scrutinising source material has already been done for us, through peer review. You may even argue that the whole purpose of reading a review paper on a certain topic, which may be based on a hundred or more original studies and related material, is to get an idea of the most recent advances in a particular area without having to go through all of these other papers. The inconvenient truth is that the process, in which qualified experts read and critically evaluate a paper before publication, is subject to a considerably greater degree of inconsistency and error than we would expect from normal human error. A survey conducted in 1999, found that up to 68% of abstracts in papers from medical journals are either false or misleading, and the situation remained quite poor over the following ten years2,3. With the subsequent publication the CONSORT statements in 2001 and then in 2010, which included guidelines for proper reporting of abstracts, it is hoped that the situation may have improved somewhat4. However, this appears to be unlikely5. The ‘abstract’ is a short summary of findings at the beginning of a paper that is freely accessible when you do an online search for scientific papers on a particular subject. While many academic papers are available free of charge, most are not, and journals may charge $30-50 USD for access to a complete paper. This can add up quite quickly when you are searching for information on a particular topic! It is not surprising, therefore that the abstract is the most frequently read portion of scientific papers available on PubMed6. The purpose of the abstract is to provide a concise and accurate summary of the paper, highlighting the main content, the purpose of the research, the relevance or importance of the work, as well as the main outcomes together with sufficient supporting data7. Unfortunately, quite a large number of them are inaccurate or misleading, in spite of peer review. There are several reasons for this2,3,5: • ‘Publication bias’: This leads to pressure on researchers to come up with something positive, as negative trials tend not to be published • Vested interests: Sometimes those conducting a study have a vested interest in the drug or treatment protocol appearing to be more effective and safer than it really is. At present most clinical trials on drug treatments are funded by pharmaceutical companies
• Poor understanding: Of statistics by researchers and reviewers • Sloppy reporting: Which may have been ignored because of a reported positive outcome Please, take a moment to let this fact sink in… The peer review process is deeply flawed, and you cannot fully place your trust in the information gained from the abstract of an academic paper. And this is just the beginning. The situation only gets worse when we examine the other parts of an academic paper, specifically papers within the clinical trial literature8.
Poor Handling of Statistical Methodology in Medical Research
In a recent review, which discusses the widespread poor handling of statistical methodology in medical research literature, we find the bold, but comforting, statement: ‘the most important thing clinicians should know about statistics, are not formulas but basic concepts’. Additionally, the author proposes that the best way for medical researchers to avoid the common statistical pitfalls is to design and analyse their studies in consultation with a qualified statistician9. The implication here is that medical researchers, who may have only studied a single unit of medical statistics as undergraduates, should not attempt to apply statistical science in their research but leave it to the experts. In the same way that a physician will refer patients to a surgeon when there is a surgical problem, a specialist statistician should be given charge of this component of a medical study. Otherwise problems can, and frequently do, arise. The following section explores some of the main problem areas that are raised in this review9. However, we must first clearly understand the nature and scope of statistical studies: what they can do and what they can’t do10,11.
Statistical Studies do not Provide Proof
Statistical studies are not designed to provide proof; this is the domain of mathematics and logic. A statistical study on a medical treatment provides information about a specific relationship, i.e. the strength of association between an intervention and the outcomes that have been observed. Such studies are only able to demonstrate association, but not causation. Acceptable proof of causation in medicine is obtained through a complex series of steps that include and go beyond the statistical demonstration of a strong association12,13. Moreover, in any statistical study, because of the limited sample size (i.e. the number of subjects within a clinical trial) compared with the total population with a particular condition, the results will always carry some degree
THE NATURAL THERAPIST VOL36 NO.2 | WINTER 2021 | PAGE 13
ANTA Member Article Winter 2021
of uncertainty. This is the reason why a clinical trial is usually repeated several times, in different locations and with different members of the population of interest before the results are accepted into mainstream practice. The critical point is this: statistical studies aim to minimise uncertainty and to minimise inaccuracy; however, they do not, and cannot, entirely remove them. Thus, the results of a clinical trial are never entirely true nor, for that matter, entirely false; even though experts in the field may imply the contrary8. The best that can be provided by a statistical study is a likely range of values (or measurements) together with a measure of the degree of uncertainty associated with this range. At best, if the studies are carried out properly, we can be reasonably confident that the outcomes we will see in our clinic are likely to be somewhere within this range. Thus, while inaccuracies and uncertainties are always part of a statistical study, the aim is to minimise them. And this is very much a work in progress.
Figure 1. Normal Distribution - The BellShaped Curve
Note that: µ = the average or mean value, generally referred to simply as ‘the mean’ σ = the standard deviation (SD) • Approximately 68% of values in the distribution are within one SD of the mean, i.e. they lie between one SD above or one SD below the mean value • Approximately 95% of values in the distribution are within two SD of the mean • Approximately 99% of values in the distribution are within three SD of the mean
Normal Distribution
The most fundamental concept in statistical studies of populations is the ‘normal distribution’
curve. If we take a measure of some characteristic (e.g. height) in every member of a particular population (e.g. adult males), and if we plot the resulting measurements on a graph with number of people on the vertical (left hand) axis and height measurement on the horizontal (bottom) axis, the results will conform to the pattern of distribution in Figure 1: The Normal Distribution. In general, we will find that the measured values (height) will cluster around a ‘mean’ (the average height) and be distributed in such a way that approximately 95% of the population have a height that is within two ‘standard deviations’ (SD) of the mean (i.e. within the range of two SD below the mean and two SD above the mean). The value of the standard deviation is calculated mathematically from the data that have been collected. In this example our measurements and analysis are highly accurate because we have, theoretically, measured every member within the population and there is no uncertainty because we have measured everyone. Our degree of accuracy is only limited by the accuracy of our measuring instruments.
Critical Assumptions
What if we don’t have the resources or the time to measure everyone and are only able to measure a small portion of this population. How accurate would our figures be when applied back to the entire population of interest? Here we have the basic ‘leap of faith’. At this point statistical science rests on the assumption that we can quantify both the range of measurements and the degree of uncertainty, based on data obtained from a small portion of the total population. However, this is only an assumption, which may or may not be true. Imagine a situation where we only measured the heights of the adult males in a nursing home, or alternatively, in an elite basketball team. The average height and the range of normal height would likely be quite different in each situation; and neither would be representative of the entire population. This is an example of what are known as ‘confounding factors’, which have a measurable effect on the results that are being collected. This is the nature of statistics: given a certain assumption, which generally cannot be proven to be true, the application of a specific statistical test will provide a measure of the strength of the relationship between two or more variables (e.g. the outcome of a particular treatment used on a certain population with a particular disorder). The other important assumption in clinical trials is
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ANTA Member Article Winter 2021
that the participants taking the active treatment are evenly matched with those who are taking the placebo. Factors such as age, severity of the illness and psychological state may profoundly influence a patient’s response to an intervention. Sometimes important differences between the two groups may go unrecognised. Therefore, in a clinical study, no matter how well designed or carefully analysed, there is always a chance, albeit a small one, that the conclusions are not applicable to the population of interest. One or more of our assumptions, conscious or not, may have been erroneous. So, while every effort may have been made to ensure accuracy and reliability in a clinical trial, there always exists the finite possibility that there are hidden errors and that the results will not apply in a real-life clinical setting. Never-the-less, we must also say that a carefully designed clinical trial, analysed correctly and reported transparently will provide valuable and useful information most of the time, and that statistics do have a rightful place in our clinical decision making. Our goal is to discover the best ways to evaluate this kind of information.
Mean and Standard Deviation
results.
Confidence Intervals: Two Additional BellShaped Curves
The discussion in the above paragraph illustrates the fact that any study dealing with a limited number of subjects will generate a mean that is likely to be different from the true mean of the whole population of interest – remembering that the mean is the average, around which the actual measured values will be clustered, both above and below. This degree of uncertainty can also be quantified and is provided in clinical studies by the ‘confidence interval’ (CI), which represents the range within which the true mean for entire population is likely to occur. Thus, a more realistic interpretation of results in a clinical study would be visually represented by adding two additional bell-shaped curves, one to the left and one to the right of the one in Figure 1. One of our new bell-shaped curves will be centred on the lowest value of the CI and the other on highest value. This idea has important consequences for real-life clinical application of clinical trial results.
Probability and Statistical Significance
Returning to our example of height measurements in adult males. If you were to examine only one member of this population, his height could be anywhere between the lowest measure and the highest measure, so your ability to predict his height is at its lowest point. In addition, we are unable to make a judgement about whether his height is normal or abnormal. These types of judgement are the basis for some of the essential statistical concepts: our intuitive idea of ‘normal’ in this case means, in statistical terms, that a person’s height is close to the mean (average) height, and ‘abnormal’ signifies that the person is an outlier, outside of the majority. Statistical science quantifies this: ‘normal’ height = the range of height measurements clustered around the mean (i.e. within the range of plus or minus two standard deviations), and ‘abnormal’ height would be any measurement that is outside of this 95% range. The more people you examine, the more likely you are to find that most of the heights fall into a range that gets closer and closer to the population mean. That is to say that the range of values, within which 95% of the heights fall, becomes closer and closer to the two SD range on either side of the mean of the entire population. Conversely, the fewer people that are examined, the further away from the normal range (i.e. the less accurate) your results will become. Therefore, we need to find a practical compromise, i.e. a minimum number of subjects that will provide meaningful
The other important axiom in statistical studies has to do with the application of probability theory. The logic behind this process may be illustrated with a simple example: how to calculate the probability (denoted by the symbol ‘p’) that a coin tossed five times will come down with the same side up each time. The first toss determines which side you are looking for; and in the four subsequent tosses the probability of getting this particular side (say, heads) is one in two (i.e. 0.5 or 50%) for each toss. To calculate the probability of four more tosses showing heads we multiply these probabilities together: 0.5 x 0.5 x 0.5 x 0.5 (=0.065). This gives us a probability of 6.5% (p=0.065). The precision of the maths belies the fact that we are not dealing with anything concrete here. This calculation seems to imply that if we were to repeat the example 200 times, we would find 13 sequences of five with identical faces (or 6.5 in 100). Unfortunately, this is not correct, and we are unlikely to get exactly 13 sequences of 5 identical throws in this experiment. What this p value really means is that if we repeated the experiment (200 lots of 5 throws) many times, the average number of times we get 5 identical faces will get closer and closer to 13, the more times we repeat the experiment. Additionally, the results will match a normal distribution pattern more and more closely the more times the experiment is repeated. Therefore, the best we can say is that p is likely to be within a
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particular range, e.g. 5–8 (if we calculated that the standard deviation was 1.5 in the above example). Please note that this gives a range of likely values rather than a fixed definite value. To return to our original example, after the five identical tosses, we might be suspicious that this coin is biased, but as p is not less that 0.05 (the generally accepted cut-off for significance) we may accept that the coin could indeed be normal. However, if we get another head on the sixth throw (p=0.03125) then we can start to become suspicious – that is, if we are strictly following the standard statistical paradigm. Personally, I would be examining the coin very closely after the fourth head, especially if I had been betting on tails! This illustrates several important points about the application of statistics in research. In clinical studies, the level of statistical significance is generally set at 5% (p<0.05). We, or rather the statisticians, can calculate the probability that the difference between the results in the two study groups is due to random chance. When this probability, p, is less than 5% (expressed as p<0.05) we say that the results are statistically significant. This cut-off point for significance is much like an ‘industry standard’. The widespread acceptance of this standard makes it easier to apply for funding, get your paper published in a journal, and get approval from your peers. But we need to remember that this is not an expression of objective truth, nor a demonstration of proof (and these are common misinterpretations); a study could just as well use 10% or 1% (p<0.1 and p<0.01 respectively); it depends on whether or not the benefits or risks are major or trivial. If there is a major risk involved in a treatment (i.e. severe and disabling side effects) we may be willing to accept a greater degree of uncertainty when assessing this risk. Let us now extend our example of five coin-tosses into a clinical trial. We are suspicious that our original coin is biased in some way so that it favours heads. We must find another coin that is normal in every way and compare the results when we do five tosses in a row, repeated, say, 200 times. The new coin represents the placebo group and the original coin, the treatment group. We want to see if the results we get with the first coin are different from those with the standardised new coin. If at the end of the trial we had close to 13 lots of same face throws with the normal coin, that is to be expected and are confident that this coin is normal. If we also ended up with a similar result for the original coin, then we can also be quite certain that this coin is
not biased. Here is where things get interesting. If we get a different result with our original coin, what amount of difference should be deemed significant? Statisticians have methods to calculate the probability that the difference in results between the two groups have occurred by chance only, and this is given as a number between zero and one. As the number gets closer and closer to zero the difference is less and less likely to have occurred by chance. The cut-off point is generally accepted as 0.05, which signifies that the results would only be expected to occur five times in a hundred. All too often this process is used inappropriately. In a clinical trial where the placebo group has very few positive responders and the treatment group has a majority of positive responders, the results are obvious, and we do not need the statistical analysis to tell us whether or not the treatment works. However, when the placebo group has around 40% of subjects responding (measured as remission or significant improvement), and the active treatment group does marginally better, as in most published trials on antidepressants14,15 then the finding of a ‘statistically significant’ difference between the two groups may be misleading. Apart from avoiding the issue of clinical significance (i.e. whether or not we can expect to see real benefits to patients in the clinic), attention is diverted away from issues that need to be examined more closely, such as the validity of the diagnosis and the normal course of the illness.
Application of Statistics within Clinical Trials
Clinical studies deal with the likelihood that a particular health outcome will occur within a given population when a particular therapeutic intervention is applied. There will always be some degree of uncertainty, but by applying statistical analysis we endeavour to minimise this uncertainly to acceptable levels. There are three important variables in this process, each having a critical influence on the others: the size of the effect (that we are hoping to achieve or avoid), the size of our sample (i.e. the number of participants in a trial) and the cut-off point that we choose for deciding whether or not the relationship is significant. Therefore, statistical studies are not objective; preconceived ideas (a.k.a. biases) are incorporated into them in the form of assumptions that are used to set the statistical parameters. These assumptions are derived from decisions that have been made at the critical steps in designing the study, based on the researchers’ values, ideas about an illness and about what level of risk or benefit is deemed to be acceptable or desirable.
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Now, what exactly are we testing in a clinical trial? The common misconception is that we are attempting to quantify a treatment’s effects – therapeutic and/or adverse. Unfortunately, this is not what clinical trial results are telling us – even though, according to the principles of EBM, clinicians are entitled to make such an inference, using their knowledge and experience, along with advice from peers and mentors, when considering how to incorporate the results of a trial into their practice16,17. The term, ‘statistical significance’ as used in clinical trials, refers to the process used to establish that the results obtained by the treatment (a.k.a. the ‘active intervention’) were not likely to be due to the effects of random chance. Essentially, when trial results are characterised by a low p value (i.e. below the 5% or other nominated cut-off point for significance), this is telling us that we have sufficient evidence to reject the ‘null hypothesis’; the proposition that the intervention is doing nothing and that the observed differences between the two study groups are due to random chance. When we are able to reject the null hypothesis, it means that the real effects of the intervention (i.e. the difference between the effects seen in the active treatment group and the placebo groups) do not lie within the same range as those that would occur due to random factors. We are more than 95% sure of it; but, of course, we could also be wrong – and there is less than a 5% chance of that. This is what the ‘evidence’ gained from a clinical trial is telling us: it is highly likely that the active treatment is not doing nothing.
Null Hypothesis Significance Testing
Why are clinical trials conducted in this way? Historically, clinical trial methodology was developed from the methods used in epidemiology, where the most practical way to test for a significant factor in a disease outbreak is to first analyse the data to see whether or not the factor under consideration has effects that are not simply due to chance. Obviously, there are an almost unlimited number of factors at play within any given scenario, and therefore it is more likely that an incorrect one could be chosen. Hence the need for an efficient, lowcost method that doesn’t require large resources while you do repeated tests to find something that may actually be having an influence (or rather ‘not having no influence’) on the outbreak, spread and the severity of the disease being studied. Moreover, this methodology is most suitable for assessing scenarios in which there are a number of different factors (a.k.a. ‘variables’) at play, some of which may only be having a small, but significant effect. Thus,
epidemiological methods are designed to detect variables with different degrees of influence, ranging from quite small to quite large. In this way, an epidemiological study begins with the proposal, or ‘hypothesis’ that a particular factor is having no influence on a disease – the null hypothesis. Then data is collected and analysed in order to accept or reject the null hypothesis. This is where the p value comes in, and this process is referred to as ‘null hypothesis significance testing’ (NHST). When applying this methodology to assess the effects of a single medicinal intervention on the course of a disease, there are many changes that need to be made to the original epidemiological methods. Thus, clinical trial methodology in particular, as well as EBM as a whole, are still very much works in progress – and there are many critical areas where improvement is warranted. In clinical trials, when the p value is given, it is generally implied (unless stated otherwise) that the standard p<0.05 is taken to be statistically significant. When p is less than 0.05, this is equivalent to saying that if there were no real difference between the outcomes in the two groups being studied (i.e. the active treatment group and the placebo group), the outcomes obtained in this trial would only occur very rarely in the population of interest. Therefore this particular trial result most likely represents the sort of result you would see in the majority of this population. In practice, there are ways to calculate the minimum number of subjects in a trial so that the results will, in fact, be meaningful. Thus, when the p value is less than 0.05, and we can reject the null hypothesis, we are confident that there must be some sort of association between the administration of the treatment and the measured outcomes and that this finding applies to the whole of the population of interest. Put in another way, the results allow us to be reasonably sure that the intervention is not doing nothing within the study group and that it will also not do nothing when applied within the population of interest.
Ground Zero: The Placebo Group
In a trial that compares an active treatment with a placebo, when the p value is less than 0.05 the difference between the effects of the two interventions being compared (e.g. between active and placebo, or between two different active treatments) is deemed not to be due to random chance and that the treatment is not doing nothing. The placebo arm of the study provides the
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reference level that defines what ‘doing nothing’ means in measurable terms. It is important to bear this in mind, as one study comparing herbal and pharmaceutical treatments for depression makes the extraordinary statement, when reporting on the failure of the active treatment to surpass the placebo: ‘These findings were clearly due to the consistently high placebo response rate on all outcome measures’ 18. This line of reasoning contains two major flaws. One is that, by definition, the placebo response rate is ground zero: the response rate in the placebo group represents the zero setting that is to be used in order to accurately measure the results (if any) of the active treatment. This means that whatever response is found in the placebo group, the only way it can be legitimately used is to subtract it from the response of the active treatment group, in order to get a measurement of the true response to the active treatment. The second important error (which the above researchers also commit) is that clinical trial protocol demands that you ignore the response within a particular group, i.e. the difference between the measures taken at the beginning of the trial and those taken at the end of the trial within a particular group. The outcome measures only become meaningful when a comparison is made between the active treatment group and the placebo group at the end of the trial, subtracting the latter results from the former. Otherwise, when both the active treatment group and the placebo group both improve (e.g. in a self-limiting disease, in which patients will tend to get better without any treatment), you can get a false impression of efficacy if you only look at the results in the treatment group.
Confounding Factors
A critical assumption in NHST, which is virtually impossible to prove, is that we have accounted for all of the possible confounding factors, so that the study groups are equally matched, or ‘controlled’. Important confounding factors include age, gender, severity of illness, duration of illness, previous treatments (and how long since stopping them before entering the trial), current medications, socio-economic factors, education level, patient expectations, attitudes to the illness (e.g. perceived benefits from being ill), and the validity of the diagnosis, i.e. do the subjects all have the same disease? In addition, the potential biases of the researchers are removed through randomisation and blinding, so that assignment of participants to the study groups is done by a computer-
generated random system, and none of the people who administer the treatments and measure the outcomes know to which group a participant belongs19,20. As a previous US Secretary of Defense once explained: ‘There are known knowns. There are things we know we know. We also know there are known unknowns. That is to say, we know there are some things we do not know. But there are also unknown unknowns, the ones we don’t know we don’t know’. And there’s the rub: in spite of careful assessment of potential confounding factors in a clinical trial, in which every effort has been made to ensure that these factors are evenly matched between groups, it is always possible that some other yet to be discovered factors have played a decisive role in the trial outcomes19,20. Another reason to be cautious about accepting the results of a single clinical trial. Thus, another critical aspect of NHST in clinical trials, and one that is often neglected, is that when the p value is below the nominated cut off point for statistical significance (usually 0.05), it means that the active treatment is not doing nothing or that there are unknown or unacknowledged confounding factors at work, influencing the trial results. A well-reported clinical trial should discuss how potential confounding factors were prevented from influencing the trial outcomes, together with a brief discussion of other possible confounders. Unfortunately, sometimes researchers fail to do this and sometimes there are unknown factors at play. Another important issue with confounding factors is that clinical trials, randomised and controlled as they aim to be, are a step removed from real life clinical scenarios, in which individual patients, who may, indeed, come to us at random, are in no way ‘controlled’. Each one comes complete with a unique set of confounding factors. This fact represents a considerable barrier to the application of a generalised ‘significant’ result from a clinical trial to an individualised clinical encounter. In Part 2, we examine in detail the common sources of error in contemporary clinical research and a simple check-list is provided for use in the assessment of a clinical trial report.
For references log into your ANTA Member Centre > The Natural Therapist > Journal Articles
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SUNHERBAL.COM
1300 797 668
ANTA Member Recipes Winter 2021
Winter Weekend Breakfast Ideas Rachel Knight is a Chef and Naturopath based in Melbourne. Her passion for food as medicine has led her to a career in educating the importance of good nutrition and how to maintain a healthy balanced diet. She currently teaches primary students the fundamentals of cooking and how to utilise fresh produce from the school garden through the Stephanie Alexander Program. She also works are a Head Chef, Food Editor and Stylist for Nativa and the Sugar Free Living Magazine.
Gluten Free Crumpets
Categories Vegan
Dairy-Free
Gluten-Free
Breakfast
Recipe Data Serves
12
Prep
1 hour 40 minutes
Cook / Chill
10 minutes
Nutrition Carbohydrates
Protein
Fats
Energy (kJ)
Calories
Serving size
22.5g
1.6g
4.1g
566kJ
135
54g
Ingredients
• 400ml Almond Milk, warmed to room temperature • ¾ tbsp Coconut Sugar • 1 tbsp Yeast • 300g Gluten Free Self-Rising Flour • ½ tsp Salt • ½ tsp Bicarbonate of Soda • Oil, for frying • Honey to serve
Method
1. Combine the almond milk, coconut sugar and yeast in a bowl. Set aside in a warm area for 10 minutes or until it starts to form bubbles on the surface. 2. In a separate bowl combine the flour, bicarbonate of soda and salt. Add the frothy milk mixture and whisk until the batter is smooth. 3. Leave to prove, covered in a warm area for around 90 minutes. You will know it has proved when air bubbles form on the surface of the batter. 4. Once the batter has proved, heat a frying pan over medium heat with 1 tablespoon of oil. Place greased egg rings into the frying pan. 5. Spoon 2 tablespoons of the batter into each ring and cook for 3-5 minutes. Bubbles will form on the top of the crumpet. 6. The top of the crumpet should be fairly dry before you
flip it over. Once turned over cook for a further 1-2 minutes. 7. Remove from the pan, serve hot with honey or toppings of choice.
Tips:
• Make the crumpets ahead of time and reheat in the toaster. • Grease the egg rings beforehand to prevent the batter from sticking to the ring. • Nutritional information is per crumpet without honey.
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ANTA Member Recipes Winter 2021
Mini Bagels
Categories Gluten-Free
Recipe Data Serves
20
Prep
1 hour 35 minutes
Cook / Chill
25 minutes
Nutrition Carbohydrates
Protein
Fats
Energy (kJ)
Calories
Serving size
26.9g
1g
5.4g
678kJ
61
75g
Ingredients
water and honey to the boil, reduce the heat to a simmer. 8. Drop bagels in 2 at a time and boil for 1 minute. Using a slotted spoon, remove from the water and place back onto the lined tray. Repeat with the remianing bagels. Set aside for 5 minutes to cool. 9. In a small bowl combine the egg white and water. Brush over the bagels and top with your choice of seeds. 10. Place in the oven for 20 minutes; increase the heat to 220°C and bake for a further 5 minutes. 11. Leave to cool on the baking tray.
The Poaching Liquid: • 750ml Water (3 cups) • 3 tbsp Honey or Maple Syrup
Tips:
• 2 tbsp Coconut Sugar • 560ml Warm Water (2 ¼ cups) • 1 tbsp Yeast • 560g Gluten Free Plain Flour (4 cups) plus extra for kneading • ½ tsp Xanthan Gum • 3 tbsp Psyllium Husk • 2 tsp Gluten Free Baking Powder • 1 tsp Salt • 1 tsp Apple Cider Vinegar • 125g Butter, melted (½ cup)
Bagel Toppings: • 1 Egg White lightly whisked • 1 tbsp Water • Sesame seeds, Poppy seeds, Nigella seeds
Method
1. In a bowl combine the yeast, 1 tablespoon of coconut sugar and the warm water. Cover and place in a warm area until frothy (around 5-10 minutes). 2. In a stand mixer, using the dough hook attachment place the flour, xanthan gum, the remaining coconut sugar, psyllium husk, baking powder and salt. Add the yeast mixture and on a low-speed and beat for 2 minutes. 3. Add the melted butter and apple cider vinegar, beat on a medium speed for 4 minutes. The dough will still be quite sticky. 4. Transfer the dough to a heatproof bowl, cover and place in a warm area for 20 minutes. 5. Tip the dough onto the clean surface, if it is still sticky add more flour. You should be able to divide and roll the dough into 20 small balls without it sticking to your hands. 6. Line a baking tray with baking paper. Press your finger through each ball to make a hole and place onto the prepared tray. Cover and set aside in a warm area for 10 minutes. 7. Preheat the oven to 200°C. In a small pot bring the
• Filling Suggestions ◊ Smashed avocado, feta and pumpkin seeds ◊ Slamon, cream cheese and rocket ◊ Peanut butter, banana and chia seeds. • Nutritional information is per bagel with sesame seeds and without toppings. • If there are no warm areas in your house, set your oven to 40°C and place the covered bowl in the oven to prove.
THE NATURAL THERAPIST VOL36 NO.2 | WINTER 2021 | PAGE 21
Outmanoeuvring Infections with Olive Leaf
By Ian Breakspear MHerbMed(USyd) ND DBM CertPhyto Since at least the early 1800’s olive leaf (Olea europaea) has been used to treat fevers1 and again became popular in the late 1900’s after the role of oleuropein in the defence of the olive tree against microbial attack was elucidated2. Clinical trials have demonstrated the value of olive leaf extract (OLE) in reducing the number of sick days in high school athletes3, positively influencing cardiovascular risk factors4,5, and improving insulin sensitivity in overweight middleaged men6. A number of in vitro investigations have demonstrated the antiviral activity of OLE and its constituents, and it is postulated that OLE may block viral entry into cells, enhance macrophage activity, and in some cases inhibit viral replication1. However, the oleuropein content of the OLE appears to be key to this activity7. My recently published research has demonstrated that many practitioner-only liquid olive leaf extracts contain quite low concentrations of oleuropein, and none of the practitioner OLE’s assessed declared oleuropein concentration on the label8. Whilst clinical research has utilised OLE containing 100mg of oleuropein per daily dosage3, my research demonstrated that none of the tested practitioner-only extracts achieved even half this amount at their maximum daily dosage8. So what should you look for in a practitioner-only olive leaf extract? Firstly, my research indicated that extracts made from fresh leaves as opposed to dry leaves tended to have far greater levels of oleuropein, and on average a slightly higher total biophenol level8. So, look for extracts made from fresh leaves. Secondly, look for a practitioner liquid OLE which makes a clear statement as to its oleuropein concentration, so that you can adjust your dosages to be consistent with the various clinical trials. Finally, like all herbal medicines, it pays to know the source. Complete traceability from tree to bottle is important in ensuring quality and enables the practitioner to have greater confidence in the medicines they are using. For references log into your ANTA Member Centre > The Natural Therapist > Journal Articles
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Professor Kerry Bone is now live on Facebook @profkerrybone Follow for the latest in natural medicine science and research, plus be the first to find out about Kerry’s upcoming activities, events and book launches.
Each week I’ll be sharing exclusive content to this page, including segments such as Q&A with Kerry, Practitioner Tips and my favourite segment, Grumpy Old Herbalist.
Key features of Kerry’s Facebook page include: The latest in science and research Kerry answering the questions you’ve always wanted to ask The best of Kerry’s Practitioner Tips Kerry’s monthly segment on correcting herbal injustices Keeping up to date with Kerry’s latest activities and events
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ANTA Member Article Winter 2021
Kerry Bone
Founder and Director of Research at MediHerb Principal of Australian College of Phytotherapy Adjunct Professor of New York Chiropractic College
The Growing Clinical Reach of Withania When considering the impact of herbal prescribing, there is probably no area more important in modern times than facilitating an optimal stress response with adaptogenic herbs. One of our best adaptogenic herbs comes from India, where its tonic effects have been recognised for thousands of years. This is of course the root of Withania somnifera. But even in ancient texts this wonderful plant was known to have other related benefits, especially as a male tonic, for anti-ageing and to boost body strength. Based on modern research we can add other assets for Withania, especially in brain health. Grasping these relevant and evidence-based insights into how Ashwagandha can not only optimise and conserve our stress response, but also help with sleep, anxiety, cognition and male fertility (to name a few) will further support your patients’ health and well-being, and underpin your success as clinicians. As noted above, Withania somnifera is an important herb from the Ayurvedic medical system used for the treatment of debility, emaciation, impotence and premature ageing. Not surprisingly, it has
been dubbed the ‘Indian ginseng’. Its Indian name, Ashwagandha, is said to refer to the ‘smell and strength of a horse’ and possibly alludes to its reputed aphrodisiac properties, although it could also relate to the smell of the root. Pharmacological research on Withania has stressed its anti-tumour, neuroprotective, antiaddictive and adaptogenic actions, reinforcing its comparison with Asian ginseng (Panax ginseng). However, Withania occupies an important place in the herbal materia medica because, while it is not as potent as ginseng, it lacks the potential stimulating effects of the latter. In fact, it has a mild sedative action as indicated by its specific name ‘somnifera’. It is therefore, ideally suited to the treatment of overactive but debilitated patients, in whom ginseng might tend to aggravate the overstimulation. Before this century there were few clinical trials on Withania, but this has changed dramatically in recent times, with now around 30 trials published in peer review journals. Some of the key findings from these trials, which greatly extend the clinical reach of this important herb, are reviewed below.
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Effects on Stressed People
In earlier research, Withania (1g/day) was administered to trainee mountaineers over 29 days in an uncontrolled trial that included a 5200m altitude gain through trekking, and 6 days training at that height, including a climb to 6400m and subsequent descent. Psychological and physiological parameters were tested at various altitudes. Withania improved sleep patterns, responsiveness, alertness and state of awareness, together with physical capabilities1. In an eight week double-blind, placebo-controlled, randomised clinical trial (DBPCRT) in 50 people under chronic stress, Withania (600mg/day extract) significantly reduced perceived stress, food craving, serum cortisol and body weight2. In a 60-day DBPCRT, the stress-relieving and pharmacological activities of a Withania extract (240mg/day) were investigated in 60 stressed, healthy adults3. All participants completed the trial with no adverse events reported. In comparison with the placebo, Withania treatment was associated with a statistically significant reduction in the Hamilton anxiety scale (p=0.040) (see below for more trials on anxiety). Withania intake was also associated with greater reductions in morning cortisol (p<0.001), and DHEA-S (p=0.004) compared with the placebo. Testosterone levels increased in men (p=0.038) but not women (p=0.989) over time, although this change was not statistically significant compared with the placebo (p=0.158). In another eight week DBPCRT (n=60), significant reductions in perceived stress were observed for Withania extract at intakes of 250mg/day (p<0.05) and 600mg/day (p<0.001); serum cortisol levels reduced with both treatment groups and there were significant improvements in sleep quality from taking the herb (see more on sleep below)4.
normal. Interestingly, serum luteinizing hormone (LH) and testosterone increased in all subgroups (p<0.01) while a fall in follicle-stimulating hormone (FSH) and prolactin (p<0.01) was most marked in the subgroup with low sperm count. In the other trial, 60 apparently infertile men with normal sperm parameters received the above dose of Withania for three months6. The men were again classified into three subgroups: 20 heavy smokers, 20 under psychological stress and 20 with infertility of unknown aetiology. Compared with baseline, significant improvements were noted for sperm liquefaction and concentration in all three subgroups (p<0.01 to p<0.05). Semen volume was not changed in any subgroup and sperm motility improved only in the smokers and stressed men. Morning (8am) and afternoon (4pm) serum cortisol levels were significantly lower in all subgroups following Withania treatment (results were quite marked for the afternoon readings, with 36% to 48% reductions, indicating less stress on the body). Antioxidant parameters in semen were generally improved. LH and testosterone were significantly higher in all subgroups and FSH and prolactin were lower (except for prolactin in the subgroup with unknown aetiology).
Exercise and Anabolic Effects
In an eight week DBPCRT in 57 men starting resistance training, Withania (600mg/day extract) caused significant improvements in muscle strength and size, and testosterone7. Specifically, the men had significantly greater increases in muscle strength on the bench-press exercise (placebo: 26.4kg vs. Withania: 46.0kg; p=0.001) and the leg-extension
Male Tonic and Fertility Activity
Early research (two open label clinical trials from the same research group in India) suggested that Withania might exert beneficial effects in male fertility. The first trial investigated the impact of Withania (5g/day of root powder in milk) for three months in 75 infertile men5. The trial assigned three subgroups: 25 men with relatively normal semen profile (although much poorer than a control group), 25 with low sperm concentration and 25 men with low sperm motility. The herbal treatment resulted in significant increases from baseline for sperm motility and concentration in all three subgroups (p<0.01), although values were still substantially lower than THE NATURAL THERAPIST VOL36 NO.2 | WINTER 2021 | PAGE 25
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exercise (9.8kg vs. 14.5kg; p=0.04), and significantly greater muscle size increase at the arms (5.3cm(2) vs 8.6cm(2); p=0.01) and chest (1.4cm vs. 3.3cm; p<0.001). From a DBPCRT in active young men (n=38) over 12 weeks: compared to placebo, Withania (500mg/ day dried extract) improved upper and lower-body strength, supported a favourable distribution of body mass, and was well tolerated clinically in men doing resistance training8. No other between-group differences were found for body composition, visual analogue scales for recovery and affect, or systemic haemodynamics. However, only the Withania group experienced statistically significant improvements from baseline in average squat power, peak bench press power, 7.5km time trial performance, and perceived recovery scores. Meta-analysis (four clinical trials) of the effect of Withania on maximum oxygen consumption (VO2max) in men and women performing exercise found a significant enhancement in both healthy adults and athletes (p=0.04)9. VO2max, also known as maximal oxygen uptake, is the measure of the maximum amount of oxygen a person can utilise during intense exercise. It commonly used to assess aerobic endurance.
Anxiety
A 2014 systematic review located five clinical trials10. All trials gave positive results in anxiety and used varying methods of assessment (against placebo
mainly). The authors concluded Withania improved anxiety and stress in all studies undertaken to date. Results from a recent trial found that Withania (1g/day of a dried extract) is a safe and effective adjunctive therapy to with selective serotonin reuptake inhibitors (SSRIs) in generalised anxiety disorder, conferring a benefit over and above the drug therapy11.
Sleep
Several recent RCTs provide evidence that the ‘somnifera’ in Withania’s botanical name is well chosen. Positive trials for sleep improvement have been recorded in healthy volunteers12, insomnia patients13 and the elderly14. One DBPCRT was conducted over eight weeks in a mixed cohort of 80 healthy volunteers and insomnia patients15. There were significant improvements with Withania treatment (600mg/day dried extract) in sleep onset latency (p=0.013), anxiety (p<0.05), mental alertness (p<0.01) and sleep quality (p<0.05) for the insomnia patients. Further analysis confirmed that sleep onset latency (p<0.0001) and sleep efficiency (p<0.0001) were the most improved parameters.
Cognition
Most adaptogenic herbs have been shown to benefit cognition in clinical trials. The data for Withania is now accumulating for this important application: two recent RCTs evaluated its clinical efficacy for improving memory and cognitive
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functioning in adults with mild cognitive impairment (MCI). A pilot trial over eight weeks (n=50) demonstrated significant improvements (compared with the placebo) in immediate and general memory, executive function, sustained attention and information-processing speed16. In a second small crossover RCT (n=15), Withania combined (surprisingly) with Andrographis improved cognitive performance in a test for attention and concentration after four weeks, which was positively correlated with electroencephalogram (EEG) changes17.
Thyroid Function
In an eight week prospective DBPCRT in 50 people with subclinical hypothyroidism and elevated serum thyroid stimulating hormone (TSH) levels (4.5-10μIU/L), Withania root dried extract (600mg/ day) improved serum TSH (p<0.001), T3 (p=0.0031), and T4 (p=0.0096) levels significantly, compared to the placebo18. Only one person taking Withania reported mild and temporary adverse effects, compared to three in the placebo group.
Adverse Liver Effects?
With the increasing use and scrutiny of medicinal plants comes the increased possibility of finding rare, unexpected adverse reactions. However, it is important that such reports are carefully analysed and backed up by other studies before definitive conclusions are formed. Recently, five cases have emerged from Iceland connecting drug-induced liver injury (DILI) to the use of Withania19. In all cases the damage was reversible with discontinuation of the herb and resulted in no permanent liver injury. The report has been criticised for its incompleteness and a lack of plausibility20. At this stage it is important to watch out for a similar potential reaction in patients, but there is no cause for alarm. Ironically, there are laboratory experiments demonstrating Withania protects against liver damage21.
For references log into your ANTA Member Centre > The Natural Therapist > Journal Articles
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Neerja Ahuja
Advanced Diploma in Ayurveda Diploma in Human Values Principle Consultant at Ayurveda Awareness Centre
Relevance of Ayurveda for Preventative Health and Chronic and Non-Communicable Diseases
Trends of Chronic and Non-Communicable Diseases
From the last few decades, there has been a global concern on raising trends of chronic and noncommunicable diseases (NCD), an epidemic of lifestyle related diseases like diabetes, obesity, heart diseases, typically a result of stress, improper diet and irregular or sedentary lifestyle. These NCDs are lifestyle disorders that can be prevented by lifestyle modification. The healthcare burden in developing countries is mainly from noncommunicable diseases, and the prevention of such disease is the solution for it.
Some Numbers for Non-Communicable Diseases and Chronic Conditions
According to the health statistics of the World Health Organisation (WHO), among 57 million global deaths in 2008, 63% were due to NCD like cardiovascular, cancers, respiratory diseases, etc. Chronic conditions are a substantial global, national, and individual health issue, contributing to both premature mortality and morbidity. Globally, they are leading causes of disease burden, responsible for around 70% of deaths worldwide (WHO 2017a). NCD are prone to kill more people than communicable diseases worldwide. For NCD and chronic health issues, lifestyle disorder is a major factor.
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Economic Effects of Non-Communicable Diseases
prevention of such diseases.
The economic consequences of NCD are huge, because of the combined burden of health care costs and lost economic productivity due to illness and premature deaths. A study commissioned by the World Economic Forum concluded that the World would sustain a cumulative output loss of a. $47 trillion between 2011 and 2030 because of NCD and mental illness, b. about $30 trillion of which will be attributable to cardiovascular diseases, cancers, chronic pulmonary diseases, and diabetes. NCDs are also a major cause of huge health expenditure among the uninsured people
Figure 1: Burdon of Communicable and NonCommunicable Diseases a) Globally and in b) Australia
A growing body of scientific evidence has shown that lifestyle intervention is an essential element in treatment of chronic disease that can be as effective as medication, but without risks and undesirable side effects. Lifestyle interventions may include diet, exercise, stress management, and de-addiction, for both treatment and management of diseases. Modern medicine is starting to appreciate the role of dietary factors in the pathogenesis, progress, and outcome of disease.
Role of Ayurveda as Preventative Health System for Chronic and Non-Communicable Disease Disorders
The WHO considers Ayurveda as the oldest holistic health care. The factors contributing to lifestyle diseases typically include a. irregular food habits, b. sedentary work, and c. stress Ayurvedic lifestyle supports physical, mental as well as social health. These lead to improvement in disease process, disease symptoms and improvement in the quality of life, helping in the prevention and management of diseases.
Non-Communicable Disease Risk Factors
Factors that contribute to the development of NCDs, typically include: a. tobacco use, b. excessive alcohol consumption, c. poor diet, and d. lack of physical activity Measurable risk factors for the incidence of NCDs, include: a. high blood pressure, b. hypercholesterolemia, and c. obesity
Prevention of Chronic and NonCommunicable Disease Disorders by Lifestyle Modification From a Western medicine perspective, plenty of research has been initiated for establishing the of role of lifestyle modification in the management of NCD disorders, but very little has been done to establish role of lifestyle intervention in the
Healthy living style mentioned in Ayurveda is in the form of daily, and seasonal routines, good food habits and appropriate physical exercise.
Disease Process According to Ayurveda
According to Ayurveda, before any disease manifests, warning signs of upcoming diseases can be traced by the occurrence of few of the premonitory sign or symptoms of that particular disease. For example, patients moving towards disorders of deranged fat metabolism (Meda Dhatu vikruti) may present with the symptoms of lethargy, heaviness in the body, indigestion and unsatisfactory bowel habits. If these people are screened for blood tests for lipid profile or plasma glucose level, the reports may indicate abnormal lipid profile or prediabetic state. For example, the flare-up of episodes of allergic conditions such as allergic asthma, allergic rhinitis, urticarial rashes, and eczema is strongly associated with inappropriate diet and lifestyle such as
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incompatible diet along with sedentary lifestyle. For such individuals, implementing of modified lifestyle can help to bring down the severity of conditions. Regular detox and rejuvenation (Panchakarma) procedures along with immune modulatory medicines (Rasayana) may prevent recurrences of the symptoms. Working on the prevention level may stop or slow down the progression of the disease and avoid the complications. Ayurveda has great contribution in treatment of diseases as well as prevention of diseases.
Focus of Ayurveda in Attaining and Maintaining Health and Wellbeing
To promote good physical, mental, and social quality of life, Ayurveda focuses on a. prevention of disease from root cause; the root cause includes inappropriate food and lifestyle habits that have a direct impact on your health, this happens due to “mistake of the intellect” (pragya aparadha). b. managing any disease by avoiding its cause as the first line of defence. With internal and external medication or treatments being of secondary significance. c. maintaining a healthy lifestyle, through the following Four Pillars of Ayurveda: 1. AHARA (life supporting diet), emphasises need for a healthy, nourishing diet. 2. VIHARA (life supporting activities), appropriate recreational activities to relax body and mind, this includes relaxation, maintaining stillness of action-speech-thoughts, (e.g. meditation) and group activities (e.g. sports) where one can lose the sense of individuality and get present to community. 3. ACHARA (lifestyle), the importance of healthy daily routines and activities such as exercise and recommends yoga asana and pranayama on a regular basis, as they support cardiorespiratory health, other than physical and mental strength. 4. VICHARA (thought processes), the right thoughts and right attitude towards life is essential for wellbeing, a balanced state of mind is achieved by following the human values, moral restraints, and ethical observances (yama-niyama of yoga for sattwic state of mind).
AHARA (Life Supporting Diet)
Modern medicine is starting to appreciate the role
of dietary factors in the pathogenesis, progress, and outcome of disease. Nutritional, biochemical, and metabolic aspects of diet play an important role in maintaining health. Ahara means life supporting diet. Ayurveda gives importance to not just what you eat, but also how you eat and when you eat. Every bite you put in your mouth counts for your wellbeing.
Some quotes • “Let food be your medicine, and let medicine be your food” • “Without proper diet, medicine is of no use” • “With proper diet, medicine is of no need” • “Annam Brahma—means the food is Brahman (Lord of creation)” • “As the food so the mind, As the mind so the Man” According to Ayurveda, our food is categorised into three kinds: 1. Sattwic Sattwic diet brings peace and equanimity in the mind and sense of wellness, and is prepared and served with love and affection.
Sattwic food is simple food and chosen to give nourishment at the mind-body level, giving energy to the body and keeps the mind stable. This food type typically includes milk (organic, bio-dynamic in today’s time) and milk products, fresh fruits, dry fruits, seasonal vegetables cooked and eaten fresh, unrefined cereals, pulses, spices like ginger, pepper, turmeric, cumin, honey, jaggery, ghee, and vegetable oil. 2. Rajasic Rajasic food creates an agitated and restless state of mind. These foods include meats, especially red meats, garlic, onion, unseasonal vegetables, hot and sour foods. 3. Tamasic Tamasic food creates a lethargic state of mind. This includes food, which is old, left over or cooked over a long period. All refined, processed, artificial flavoured foods, deep-frozen foods, deep-fried foods, liquor, tobacco, drugs are typically included here. In Ahara, Ayurveda has described the properties of different foods, starting from daily food such as grains, pulses, and cereals to various other foods such as milk, buttermilk, ghee, water and so on. It gives definite rules about do’s and don’ts of healthy eating.
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Ayurveda not only addresses what food is best for an individual, but also how food is best eaten and how it is best combined. Appropriate food choices, taken in the best possible way, will help prevent most digestive problems. This will also help in preventing more serious diseases in the deeper tissues and organs of the body.
Vihara includes pattern of social relations, appropriate use of five senses, entertainment, and dressing sense. A lifestyle is a characteristic bundle of behaviours that makes sense to both others and self, in a given time and place, including social relations, “food” from our five senses, entertainment and dress.
A good balanced diet and its appropriate modifications recommended by an Ayurveda Practitioner, can support in many ways as: 1. Prevent disease by restricting the pathogenesis of many diseases 2. Interfere in the disease process, helping in resolving it early 3. Adjunct to reverse the adverse effects of common medicines, and may work synergistically with medicines to cure the disease 4. Preventing many serious systemic diseases caused by poor lifestyle 5. Preventing aggravations and relapses of the disease 6. Preventing co-morbidities
For example, according to Ayurveda, diabetes mellitus (Prameha) is caused by inappropriate diet and lifestyle (mithya ahara vihara) such as sedentary lifestyle, excessive sleep, laziness, excessive intake of yoghurt, excessive milk products, intake of food substances which are cold, unctuous, sweet, fatty and liquid, and all other kapha promoting substances.
VIHARA (Life Supporting Activities)
Vihara means recreation. Stress is a common factor in many diseases. Everybody is stressed but the reasons for stress can vary. Recreation, relaxation and enjoying family time rejuvenates the body and mind. It is a kind of anti-depressant. In Vihara, Ayurveda speaks about certain things that are to be undertaken and some of the things which are to be avoided. E.g. Ayurveda always mentioned that ‘Vyayama’ i.e. exercise, is to be carried out daily, but appropriate to one’s mind body type (prakruti), age and strength. Very heavy, disproportionate workouts/exercises may be harmful to the individual. Vihara also gives hints and do’s and don’ts regarding sleeping patterns, behaviour, habits, and routines. Spending some time in activities which you enjoy clears the mind, relieves depression and anxiety, elevates mood, and gives a feeling of wellbeing. Active creative hobbies like gardening, painting, playing musical instruments engage all sensory organs and release stored emotions and recharge the mind. Playing sports is another way of relaxing body and mind. Relaxation is an extremely important aspect of a well-balanced personality. It is important for our body, emotions, and our nervous system. Regular exercise and relaxation keep you fit and help in prevention of disease.
Mostly sedentary life, wrong kind of foods, incompatible diet, excessive intake of food (ati matra sevana) leads to diabetes mellitus (Prameha). So, any person who wants to prevent diabetes mellitus, must practice a healthy way of living by following daily routines (dinacharya), seasonal routines (rutucharya), by consumption of healthy food (hita ahara) whose intake leads to maintenance of the three doshas in balanced state (sama avastha) so that a person can avoid any kind of disease. As per Ayurveda, preventing a disease before its onset is done by following healthy food and lifestyle (hita ahara and vihara). For a healthy body and mind, we need to discourage the harmful lifestyle and encourage lifestyle that supports life.
ACHARA (Lifestyle)
Achara stresses on the mode of lifestyle which needs correction so that any existing disease will not reappear later and if there is no disease, lifestyle works at preventative level. Ayurveda stresses the importance of healthy activities such as exercise and recommend asanas according to individual mindbody type, and pranayama. How often is it that your day goes not according to your plans and you get hassled with too much work in the day? Our mental health and being are dependent on better routines (achara). Regularity and sincerity are two major components of a good routine. One of the best examples of following a routine is the sun - It rises and sets daily according to its plan, without any excuse. We live according to its rhythms. Imagine if there was no routine of a sun rise!
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Table 1: Modern Research Finding on the Contemporary Ayurvedic Lifestyle Recommendation Sleep
Ayurveda Recommendation
Modern Medicine Research
Not sleeping at night is harmful for life. It brings vata aggravation and deranges the digestive fire.
2007 study lea by the International Agency for Research on Cancer (IARC) showed that shift work has been associated with cancer.
Wakefulness in night causes disturbance in activities of digestive enzymes which leads to indigestion.
For shift workers, daytime sleep: a. disturbs the daily activities of digestive enzyme b. sets in Shift Work Sleep Disorder (SWSD) which requires medications with lifestyle changes c. leads to diseases like diabetes mellitus, cancer etc.
Exercise
Exercise leads to increase in metabolism, supplies oxygen to cells leading to improved: a. stamina b. strength, and c. digestion
1. Aerobic exercise activates hypothalamuspituitary-adrenal (HPA) axis and increase number, function, and movement of lymphoid cells 2. Moderate exercise stimulates gastric emptying and increases secretions of gastric juice which leads to rapid and healthy digestion 3. Lack of exercise/ sedentary lifestyle leads to delayed gastric emptying It has been proved that exercise has a role in the treatment of diabetes mellitus and obesity.
Oil Massage
Abhyanga (oil massage) stimulates calmness and de-stress the nervous system to maintain a good health.
According to modern researchers, oil massages increase skin blood flow diverting blood from muscle following 12 minutes of massage which helps in lactate clearance and recovers body from fatigue due to accumulation of lactate in muscles after prolonged exercise.
Natural Urges
Suppression of natural urges like cough, belching, urge to fart, urge to sneeze, urge to sleep (there are 13 kinds described) has been contraindicated by ayurvedic text as it is a direct cause of many diseases.
Research has proved that voluntary suppression of defecation delays gastric emptying, and retention of urge of urination causes significant increase in the level of blood pressure, pulse rate, and respiratory rate.
Irregularity of Food Irregular food quantity and at irregular times, aggravates all three doshas and deranges the ‘digestive fire’. Warm Foods
Nowadays, due to irregular jobs or business schedules people take meals at irregular times and irregular quantity. Irregular time of food intake disrupts the normal digestive patterns.
Intake of warm foods (Ushna ahara) has been By heating food, our bodies have less work to do in advised especially when digestion is weak. It helps digesting the food, increasing the number of calories with digestion. Regular intake of cold foods results in available for us to absorb. indigestion.
It works to plan your day in advance. Incorporate all necessary task for self, work, food, recreation, and sleep. The solutions to many of our difficulties in life lie in setting out right habits and right routines.
you are”. If you think you are weak, you will be weak. If you think you are strong, you will be strong. Managing your thought process is crucial for wellness.
VICHARA (Thought Processes)
Good thought processes can be added in daily life by things like, reading good books, reading scriptures, being in company of good people, books, podcasts, blogs, reciting certain mantras, recollecting good experiences, and thinking positive in all situations.
Mind has been described and said to be as restless as a ‘drunken monkey bitten by a scorpion’. In Vichara, Ayurveda stresses upon the “right thoughts” for de-stressing of the mind, modes of relaxation and how to solve the solvable problems and how to live harmoniously with the non-solvable issues. Our mental health is dependent on how we think. Our thoughts are food for our mind. Buddha says, “Based on your thinking you become the person
Right thoughts and right attitude towards life is vital for wellbeing. A balanced state of mind is obtained by following the human values, moral restraints, and ethical observances (yama-niyama of yoga).
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Some quotes • Vichara is about uncluttering your mind. It is about living with a peaceful mind. It is about experiencing your human potential that becomes possible at a whole new level when you clear your mental tensions! • Do you know your busy mind creates more physical tensions in your body than with what you do physically? • “As the mind, so the man” • “Your body opens up more when your mind opens up!” • “Nothing tightens the spine like the tangled mind!” Vichara is also a process of exploring inward, to uncover the tight spots in your mind and emotions, and to untangle them compassionately and effectively. Vichara can help steady your emotions and your mind.
An Ayurvedic therapist is focused on raising the awareness of the patient for better health through Vihara and is concerned about social healthy relationships, work, and spiritual growth in addition to the current disease. This can be done through: • Stress management (through enhancing Sattwa) • Restful sleep • A daily balancing routine (Proper Dinacharya) • Mind - body integration (enhancing Sattwa) • Herbal supplementation Ayurveda, the “Science of Life”, promotes a lifestyle that is in harmony with nature. It is used to treat a variety of illnesses including depression, digestive, and chronic disorders. Below are some examples of how to follow an Ayurvedic lifestyle. Specific programs are usually set for individuals as well, in addition to these:
Some Practical Examples of Managing Vichara
As you dissolve your old and negative thinking patterns and mental and emotional blocks, you will experience clarity in your mind to access the inner answers, opening your mind to new possibilities.
Some Practical Ayurvedic Daily Lifestyle Routines Recommended for Good Health
Ayurvedic Focus on Prevention to Restore Client’s Optimal Health
1. Avoid suppression of natural urges and forcibly creating artificial urges when body does not want to eliminate something (e.g. in bulimia) 2. Eliminate the body’s waste products in morning to avoid illness 3. Exercise early in the morning and an oil massage regularly delays aging 4. Wash your face & eyes with water 5. Do “Detox” according to season e.g. in winter, put oil in your nostrils to clear sinuses 6. Try to wake up between the hours of 4a.m. and 6a.m., have an early and light dinner between 6p.m. and 8p.m. and go to sleep early by 10p.m. 7. Take therapeutic nutrition (diet based on Ahara principles of Ayurveda) and Rasayana (Rejuvenative substances) 8. Work at mind, and body level through psychological, occupational, and medicine components (Aushadha) 9. Eat breakfast as per Ahara recommendations for your body type 10. Try to get gainful employment that works for your mind-body type (prakruti)
We create our own life and that is why we train or not train our mind continuously. A negative mind can create any disease. A negative mind cannot be trained; it must be quietened first.
So, we need to stop thinking and increase our energy levels. One way of doing it is putting our mind on something positive and steady it, rather than allowing it to waver. If our mind is disturbed and wavering, we can put our focus on some work or activity that we enjoy, for example • We can work with hands in the garden • Do Asanas or focus on the breath • Take a few deep breaths • Eat something fresh • Play with a child Watch our thoughts and the most important is to think right, even if people around us are triggering something negative in us. How can we work on right thoughts? Whenever one feels that mind is going towards negativity, one can opt to join the company of like-minded people, if possible, and focus on: • Discussing good thoughts • Read good literature • Watch your breath • Memorise a poem • Sing a song, and • Write All the above help the mind to go in a new direction. It becomes one pointed. Stopping the mind from wavering is not easy. But making it one pointed is easier.
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Conclusion
Lifestyle management plays a significant role in maintaining health, recovering from illness or surgery. Ayurveda gives us daily and seasonal routine to be followed to not only preserve and maintain health and achieve long life but also to be creative and productive, fulfilling our own potential. If we want to be healthy then we need to take care of these “4 Pillars of Health.” When one is established in these four areas of Ahara, Vihara, Achara and Vichara, then good physical, mental, emotional, and spiritual health is possible.
In summary, we can use the ancient “Science of Life”, Ayurveda, to enhance wellness, fulfil our own potential as human being, and reduce the economic burden of NCD and chronic illnesses management, as well as work on preventative health. Ayurveda is not just the science of past, but also of the future, in helping to live longer and healthier, adding years to life and life to our years.
For references log into your ANTA Member Centre > The Natural Therapist > Journal Articles
Neerja Ahuja - Advanced Diploma in Ayurveda, Diploma of Human Values, Trained Yoga teacher, M.A. (Maths Statistics), Graduate Diploma (Computing), is a Principle Consultant at
Ayurveda Awareness Centre (AAC, www.ayurveda-awareness.com.au) and started the first Ayurveda Registered Training Organisation in Australia, offering qualifications up to Advanced Diploma level. Neerja consults clients for diet, lifestyle routines for physical, mental and emotional hygiene, offering Ayurvedic detoxification and de-stressing treatments. Her online courses have been taken up by students in 135 countries. She runs workshops, seminars and courses in Ayurveda both inhouse and for other organisations. She runs a one year course “ Foundation Training in Clinical Ayurveda and Self Care” (FTCASC) for other practitioners, and runs online LIVE “Self Care with Ayurveda” for anyone interested in their own health and wellbeing.
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George Thouas, PhD
Head of Research & Development Max Biocare Pty Ltd
Clinical Efficacy of a Blend of Five Medicinal Herbs for Osteoarthritis Management
Introduction
Osteoarthritis (OA) is a persistent cause of physical disability and compromised quality of life, especially among the elderly, and affects around 7% of the global population1. OA joint pain and discomfort is also intensified by changes in air pressure and temperature2, which explains why sufferers commonly dread the winter months. Traditional paradigms employing herbal extracts, typically as blends, have been dispensed for rheumatism, non-specific arthritides and joint pain for hundreds of years in Eastern and Western cultures3, with more than 30 known herbal species that have been evaluated in clinical trials4. To this end, it has been concluded that even small effects may be clinically meaningful and that health professionals should not be discouraged from using herbal medicines4. This article highlights the outcomes of a recently published clinical intervention involving a combination herbal formula in osteoarthritis sufferers.
Study Design
A single-arm, open label trial was conducted across eight osteopathy clinics in Poland during 20195, with outcomes featuring in the journal Advances in Orthopedics this month. The study involved 137 subjects with grade 0-2 osteoarthritis (mean age of 60 years, range 40-88; male: 32%; female: 68%, with mostly right knee dominant OA). The investigational product was a combination herbal formula comprising of Curcuma longa (turmeric) curcuminoid-phospholipid complex (500mg, standardised to 100mg curcuminoids, equivalent to dried Curcuma longa rhizome (16.5g)); combined with extracts equivalent to dried Boswellia serrata gum oleoresin (500mg); Harpagophytum procumbens (Devil’s claw) tuber (500mg); Apium graveolens (celery) seed (500mg) and Zingiber officinale rhizome (165mg). Subjects were given 2 tablets/day, supplementary to standard-ofcare pain medications, for 36 weeks, with a total of 107 subjects completing the course. Primary efficacy measures included endurance responses
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Figure 1:
Figure 3:
Figure 1. Increase in distance covered during a 6-minute walking challenge (p=0.0002 for each time point vs baseline) during intervention with the blend of five herbal formula.
Figure 3. WOMAC clinical pain, stiffness and mobility (global) scores, assessed after the walking challenge at weeks 12, 24, 36 (p<0.001 vs baseline for each time point) during intervention with the blend of five herbal formula.
Figure 2:
Figure 2. Improvement in knee flexibility during intervention with the blend of five herbal formula, as indicated by heel-thigh distance. For supine distances, p=0.045, p=0.001 and p=0.021 for weeks 12, 24 and 36. For prone distances, p=0.002 for weeks 24 and 36, vs baseline).
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Figure 4:
pain medications at all three time points, which by the end of the study represented an almost 50% reduction. Furthermore, more than 90% of participants reported being satisfied with the product by the end of the supplementation period.
Implications of the Study
Figure 4. Intervention with the blend of five formula resulted in a significant decrease in the use of standard pain medication (p<0.05 by week 36).
to a 6-minute walking test challenge, along with qualitative pain and mobility evaluations, quantitation of knee flexibility, and changes in the usage of standard medications.
Study Outcomes
From week 12-36, a progressive increase in distance covered during the 6-minute walking test was observed, which equated to an overall increase of 26.0m by the end of treatment (p<0.001 for each time point vs baseline) (Figure 1). This improvement in endurance corresponded with modest, but statistically significant improvements in knee flexibility, including decreases in heel-to-thigh distances in both supine (by up to 4.6%, p=0.001) and prone (by up to 0.45%, p=0.002) positions (Figure 2). According to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index employed for all subjects at all time points, significant decreases in knee pain, stiffness and mobility were reported throughout the intervention, aggregating to a global improvement of 58% (p<0.001) by week 36 (Figure 3). In association with these trends was a decrease in the use of standard
Curcuma longa rhizome
Boswellia serrata
The outcomes of this trial confirm that the botanical formula under evaluation was successful in assisting with the management of joint pain and mobility problems experienced by suffers of mild knee OA, as a complementary therapy taken alongside standard pain relief medication. They also confirm that individual botanicals retain their efficacy when used in combination. For example, the present observations were consistent with findings of reduced pain and improved quality of life observations of previous clinical evaluations involving the same curcuminoid-phytosome complex, at a similar level and over a similar time frame (three months)6. Similarly, the other herbal ingredients have each shown individual efficacy in pain management in other studies4, in particular Boswellia and Devil’s Claw. While the present study was an uncontrolled, single-arm study, it remains relevant to current herbal medicine practices, whereby their efficacy in mobility is largely based on individual patient responses before and after administration, over a controlled time frame and possibly involving additional therapies.
Conclusion
This study highlights that defined extracts of phytomedicines have quantifiable efficacy and provide further support for herbal medicines as alternatives to standard medications for osteoarthritis, and potentially other joint conditions.
For references log into your ANTA Member Centre > The Natural Therapist > Journal Articles
Harpagophytum procumbens
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Apium graveolens
Zingiber officinale rhizome
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Eggshell membrane: a novel nutraceutical for joint and skin health Wendy McLean BHSc(Nat), BAdvSc(Hons), PhD
Eggshell membrane, a natural ingredient obtained from the inner membrane that covers the shell of an egg, is a rich source of amino acids and substrates required for joint and connective tissue health. Eggshell membrane contains collagen (type I, V, and X), glycosaminoglycans (GAGs), glucosamine, lysozyme and proteins such as elastin.1 The main GAG in eggshell membrane is hyaluronic acid, which has a unique capacity to bind and retain water molecules, thus contributing to skin hydration, and joint viscosity and elasticity.2 Extracts from eggshell membrane have been studied for their ability to support healthy skin aging and joint health, including alleviating joint pain and stiffness associated with osteoarthritis.
Mechanisms of action As well as containing constituents necessary for joint repair and connective tissue health, eggshell membrane contains a synergy of natural compounds that have anti-inflammatory,3,4 immunomodulatory5,6 and chondroprotective actions.6 In animal arthritis models, eggshell membrane has been shown to possess direct cartilage-protective or -preserving effects.7 These cartilage-protective or -preserving effects were associated with reduced inflammatory cytokines (IL-1β and IL-6) and cartilage-degrading enzymes (matrix metalloproteinases) in serum and decreased markers of inflammation (high-sensitivity CRP and nitric oxide).7 Human clinical studies also demonstrate the chondroprotective effects of eggshell membrane.6,8 In healthy postmenopausal women, supplementation with eggshell membrane reduced exercise-induced cartilage turnover and joint pain and stiffness.6,8 Of note, in the study by Ruff et al. (2018) eggshell membrane not only prevented an increase in the cartilage degradation biomarker C-terminal crosslinked telopeptide of type II collagen (CTX-II) but reduced urinary CTX-II below baseline levels, indicating a substantial benefit to joint cartilage integrity.6
Clinical applications - osteoarthritis Eggshell membrane has demonstrated safety and efficacy in multiple human clinical trials, for relieving joint pain and stiffness in individuals with osteoarthritis.9-15 Collectively the published human clinical studies have demonstrated rapid treatment responses in osteoarthritis patients, with reductions in pain and stiffness within four to 10 days, with continuing results over 30–60 days. Furthermore, eggshell membrane studies have shown safety and efficacy in healthy exercising populations, as well as in osteoarthritis populations.6,8
Clinical applications – skin health Several human clinical trials have demonstrated beneficial effects of eggshell membrane supplementation for improving the health and appearance of skin by improving firmness, elasticity,16,17 and skin barrier function.17,18 A recent 60-day study of healthy adults (45 to 75 years) showed a 25% increase in skin elasticity, 51% improvement in skin firmness and a 33% decline in skin fatigue after 60 days of eggshell membrane intake.17
Clinical summary Eggshell membrane has no known drug interactions, or serious side effects such as those associated with conventional treatments prescribed for joint pain and arthritis, such as NSAIDs. It is a safe and effective therapy for reducing joint pain and stiffness, preventing joint damage and improving skin health, firmness and elasticity. For further clinical support, see BioMedica’s technical sheet ‘Supporting connective tissue health with collagen builders’ at biomedica.com.au References available on request
BioMedica Nutraceuticals P 1300 884 702 | www.biomedica.com.au
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Kaitlin Edin
Acupuncturist | Eastern Herbal Medicine Chinese Medicine Practitioner National Acupuncture Branch Chair - ANTA
Heart Shock Treatment Strategies In the first article of this two-part series, I introduced a more nuanced understanding of the heart, revisioning how it works, developing the deeper awareness of its relationship to the blood, as seen through the Eastern medical lens. I identified the kinds of shocks that are brought to bear, and how the shape of those familial, cultural, gendered and national experiences is writ upon the personal. As we remember, Trauma or Heart Shock (as the Eastern medics call it), affects both the heart as the residence of the Shen and the kidneys as the treasure trove of the Jing, in both an organ and meridian sense, separately and together. With complementarities one does not exist without the other, but for the purposes of differentiation, we can say that without Jing there is no body, and without Shen there is no animation. This relationship between the Kidney and the Heart is the expression in and of the physical body; the earthly vessel of manifestation (Jing) and the sacred, divine, pure spark of heaven (Shen). Through the developing relationship between these states of being: the Shaoyin; articulated through the meridians and time; as development from embryo to elder, is the sovereign human being. It should be noted here, that as practitioners, in order to listen with open hearted connection, our own Shaoyin needs to be functioning well. The correspondences tell us that the kidneys open to
the ears, the heart to the tongue. Deep and active listening finds the ears open and the tongue held. When we hear the narratives that patients bring us and do not underestimate the relief, release and healing that active and conscious listening can provide, we deepen the Shaoyin reserves of both ourselves and those we treat. The combination of the wisdom and the spirit, that is the healthy Shaoyin connection, provides recognition with acceptance of what is being, or has been, suffered. The Taiyang meridians, the yang aspect of the Shaoyin (if you like), represented by the Bladder and the Small Intestine, are the meridians symbolic of dynamic movement and invigoration (yang water; the churn of surf) and integration (yang fire; the burning away of the impurities). They move at the surface of wei qi level, as the instinctual and reactive aspect of the energy body. It is an energy or dynamic that is a step beyond or before our conscious mind and body - lightning fast, sensitive and reactive to life’s flux. It might be considered in translation (from East to West) as the nervous system. It is here in the Taiyang that our bodily responses to the external world are most obvious. Physical cold will make us shiver, emotional coldness might make the hairs on the back of the neck arise which really is a different kind of shiver. Both are instinctive responses in that zone of the senses. Heightened awareness within the Taiyang might be observed
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through a strong or keen sense of smell, sensitivity to loud noises, responsiveness to the lightest touch. It is here we might find a patient or oneself ‘highly sensitive’, and where we might encounter those that find the skin-penetrating ‘pins’ of the acupuncturist’s trade ‘uncomfortable’ or even ‘scary’. It is an interesting point of reflection to consider our own response to ‘sensitivity’. How much do we accept another’s sensitive nature as gift or curse, not only for them but for us. What does it demand of us in our approach to them? Does it require us to slow down and have more patience? Does it require that we become more sensitive, and when we do does pain arise in ourselves? One of the reasons why I love the Meridian Therapy strategies so much is simply because philosophically there is a validating awareness of what it means to be a sensitive person. Too often being sensitive is considered troublesome, or the person derided as hyperbolic or immature. When we recognise and accept as practitioners the tenderness and strain of the human body and heart in pain, we are able to deepen our skills and soften our approach. It becomes less about treatment as a technical application (and us as having the answer) and more about how the technique begins to inform us and the patient of their inherent sensitivities.
The Gentle Embrace of Meridian Therapy Acupuncture Strategies
One of the most beautiful, elegant and powerful treatment strategies I have learned in my years of graduate skills training is the Dr Manaka Cord Treatment for Whiplash. I have found it a remarkable treatment for post trauma states, whether it be actual or emotional whiplash. And I thank Sensei Paul Movsessian, a master practitioner of Meridian Therapy and Toyohari, who has transmitted to me with generosity, much of the healing arts of Dr Manaka and Meridian Therapy more generally. I use it often as a first treatment to gauge a person’s receptiveness. I use it when there has been any kind of fall or accident. I use it when a person feels they are disconnected or haven’t ended up where they wanted to go in life. I use it when there has been expressed trauma of any kind, especially anything that has threatened, or seems, to have ‘derailed’ the person. And these days after 10 years of regularly applying this treatment in clinic I am no longer surprised how many people “don’t feel anything during the treatment” and then get up off the table and get a bit wobbly, as if their legs - the structural supports of their spine - have been recalibrated
without them knowing. This notion of “not feeling anything” in itself is fascinating, as though if we don’t feel it, then it’s not quite real. It certainly opens up the mind to the idea that there are levels of stimulation that the body doesn’t feel through the nervous system, but which might be having an impact anyway.
Ion Pumping Cords and the X-Signal System
A cord treatment refers to a treatment using ion pumping cords (IPC). “An IPC is essentially a copper wire or silver chain with a germanium or silicone diode in it. This allows a unidirectional flow of bioelectrical current through the wire, creating part of a circuit. Theoretically attaching the positive and negative clips of an ion cord to two needles inserted shallowly will create a polarity between the two needles and bioelectrical and ionic currents will begin to flow inside the body” 1. The currents are minute, too small to stimulate the nervous system so the favoured explanation of the mechanism is “... a flow through the wire of a negative charge from the red to black clip and positive charge from the black to red clip. There is also some evidence to suggest that ‘part of the mechanism of the IPC involves the production of minute electrical currents in the wire from the transduction of external fields’ 1. More on this when we come to the clinical guidelines for the use of polarity devices. Underpinning the use of the IPC is “the theory of the X-signal system as the biological system that lies at the heart of acupuncture and moxibustion theory and practice can be stated as follows: There is a primitive signal (information) system in the body that has embryological roots, but is masked by the more advanced and complex control (regulation) systems. Thus, the original signal system is hard to find or see. This primitive system is able to detect and discriminate internal and external changes and plays a role in regulating the body by transmitting this information. This system serves as the modus operandi of acupuncture... we cannot explain it with neurophysiology because it manifests and is manipulated clinically with minute stimuli or influences that cannot be clearly said to affect the nervous system... It appears to operate at a more primitive and deeper level than many of the flows of biological information - neural, hormonal, biochemical...” 1. The IPC treatments as generally used within Dr Manaka’s protocols and are applied to the eight
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extraordinary meridians, although they can also be used symptomatically with main meridian point combinations. According to the modern Classical acupuncture scholar and clinician Ann Cecil-Sterman, when the IPC are applied to the eight extraordinary vessel channels (which are usually reserved to treat at the yuan qi level) they will treat at the level of the wei qi2. This means that we can treat using the eight extraordinary vessels, access their structural and symbolic relevance in ways that don’t disturb what the Classists rightly consider the deeper yuan levels of the body. We may still affect the yuan qi, but through the wei qi. We can speak to the Shaoyin through the Taiyang. The conversation we are engaging in with the body is less threatening because it is less direct.
Polarity Devices
IPC are a polarity device that come in a pair of cords. Other devices that can be used interchangeably for testing and treatment include zinc and copper plates, North and South faced magnets, and electrostatic adsorbers. (All of these tools can be found in Australia through the various industry suppliers, although Helio Supply has a consistent and extensive range of meridian therapy tools). The many polarity devices have their own particular uses and can be used interchangeably, however for the Whiplash Treatment mentioned below, there is no substitute.
The Rationale for Polarity and Treatment Considerations Using the Ion Pumping Cords
Bilateral Approach - The Rationale
There is often no rationale for doing treatments bilaterally as many in the Si Yuan or Tung Method traditions will attest. The Meridian Therapy traditions tend not to treat bilaterally as a matter of course and there are only a few treatments even within the Dr Manaka Protocols that require bilateral application. It should be stated again here that the IPC treatments are quite different to the standard acupuncture treatments applied within different diagnostic systems. The bilateral nature of this treatment is important. If we remember that the stimuli directed at the body with this kind of treatment is very small and the idea with the treatment is not to overly engage the nervous system, then the bilateral nature of this treatment strategy is to ensure that the ‘information’ is equal on both sides. The nature of the stimuli at work in these kinds of treatments is theorised to be related to how the embryo maintains structural symmetry in utero.
Dr Manaka’s Whiplash Treatment
Dr Manaka’s Whiplash Treatment can be applied using acupuncture needles or silver spike points (SSP). The SSP are taped onto the body and rest upon the skin. The acupuncture needles are inserted obliquely and once inserted are then taped in place to secure them. I find the SSP, which are noninsertive, quicker and easier in clinic and just as effective.
As acupuncturists we hardly need any rationale for how polarity might assist us in treatment. It is at the heart of our philosophical approach (yin/ yang) to life, and the body in situ. We use polarity when we define and delineate the body into the yin and yang of upper and lower, left and right, back and front. Dr Richard Tan’s masterful approach developed into the Si Yuan Balance Method, with its efficient and elegant truss structures, incorporates these relational polarities, together with the system polarities expressed in the Chinese clock, and other yin/yang systems. Dr Manaka’s approach is the octahedral model, isophasality and topology. Even if we don’t label it polarity medicine, the diagnostic framework of acupuncture medicine is always giving us this tension and balance within treatments. The clinical advantage to having a more nuanced and granular way of working with yin yang, in particular with polarity devices such as the IPC, the plates or the adsorbers, “is the greater control gained over the therapeutic effects” 1.
What you will need:
• 2 x IPC sets (4 cords) • 8 SSP + white tape 1” • OR 0.18 x 40mm needles Acuglide Pro (Japanese handled needle) + White tape ½”
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If you are going to use acupuncture needles you must do the following:
• Use Japanese metal handle needles. The handles are solid metal and this allows application to be done properly. The Chinese and Korean style needles are not appropriate and are generally not of a high enough quality of stainless steel. • The needle must be inserted at an oblique angle at the points and only inserted about 2-3mm into the skin. Due to the gauge of the needles used, insertion must be done with a guide tube. • Once inserted, the needles must then be taped using the ½” white tape. • The tape must be cut and not torn into acceptable lengths. • The needle shaft should be taped first along the length of the needle, to about ⅔ of the way along the shaft, then a piece of tape placed at the top of the needle across the handle. See photo.
to SI3 and BL62 bilaterally, then SJ5 and GB41 bilaterally. • Attach the red clip of one IP cord to SI3 and the black clip to BL62 on the right-hand side. • Repeat on the left-hand side. • Then attach the black clip to SJ5 on the righthand side and the red clip on the GB41. • Repeat on the left-hand side. • All four IPC should be attached to the clips or needles. • No cords should be crossing the body. • The cords should be running along the sides of the body. • The right hand is attached to the right foot at two places. The left hand is attached to the left foot at two places. Allow the person to rest comfortably for about 20 minutes.
Do not needle any other point, apply moxa or essential oils while this cord treatment (Whiplash Treatment) is ‘ongoing’ In particular, you must never needle above the Dai Mai (umbilicus) when cords are attached. It tends to make the person feel nauseated. After 20 minutes, remove the IPC as well as all the needles or the SSP. The needles will require putting in the sharps container, the SSP can be put in a small bowl of alcohol or rubbed down with alcohol swabs to clean for reuse.
Silver Spike Points
If you are using the SSP which in many ways are easier to apply, use the 1” tape, push the stem of the spike through the tape and tape the spike to the body, ensuring that the point of the spike is resting on the acupuncture point.
Application
• Apply the SSP or the taped acupuncture needles
Turn the patient over to lie on their front (if this is possible). Now you are going to apply one round of needle head moxa to BL19, BL22, BL27, BL28 which are the back shu points of the GB, SJ, SI, BL respectively. If you haven’t been trained to do needle head moxa properly, you will need to modify the treatment a little by using a heat lamp over the needled points instead and allow the patient to rest for about 15-20
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minutes. Please check the lamp does not get too hot. If you have been trained in how to apply needle head moxa properly, you will be using metal Japanese handled needles of 0.22 x 40mm or 0.22 x 50mm at BL19, BL22, BL27 and BL28 bilaterally. If you are able to use the smoky wakakusa (sweet grass) moxa punk then you can do all the points together, because while this will be warm it will not be too hot or last very long. If you are only able to use the Ondan smokeless moxa caps, or baskets depending on your preference, then you will need to apply the moxa in stages. This is because the smokeless moxa is much warmer and goes for longer. Do the Back Shu of the GB and SJ points first, then do the SI and BL points. Once the moxa has finished, remove the moxa ash and the needles from the back shu points and allow the patient to carefully and slowly turn over to their back and rest for a moment before getting them to their feet. Ensure the patient gets up carefully and advise them to take it very easy for the next day or two. They need to feel their feet on the ground before they stand up from this treatment, so please ensure you have a little time to allow your patient to “get grounded”.
Considerations
SI3 and BL62 are the Master and Couple points of the Du mai and Yang Qiao mai when used in combination they activate these two extraordinary vessels. However, they are also Small intestine and Bladder channel points and will to a degree engage the Taiyang system. These channels structurally affect the back. SJ5 and GB14 are the Master and Couple points of the Dai mai and the Yang Qiao mai when used in combination they access these two extraordinary vessels. As we know the Qiao mai channels emerge from and engage with the Du mai, so have an effect on the spine. The Dai mai or belt channel runs the width of the body and is said to pull all the channels together. It has an effect on the pelvic basin and the area around the umbilicus. It has a way of binding the vertical structures together. The points to access the eight extraordinary channels though are also engaging the Shaoyang system. The Shaoyang relationship is important for the structural aspects of the side body, by its
relationships to the fascial planes and the health of the interstitial aspect of the soft tissue.
Modifications to Aspects of Treatment
If your patient is too sensitive then do one needle and moxa on alternating sides of the body (either left or right BL19, then the opposite side BL22, then opposite BL27 and opposite BI28). Or you just do the needle head moxa on the SI and BL back shu points. If you are needling only and using a heat lamp instead of moxa, you can use 0.16 x 30mm or 0.16 x 40mm on the points. Body acupuncture is better done with finer needles after cord treatments. If your patient can not lie on their front, then lie them on the side and apply needles without the moxa. Apply a heat lamp if you have it. If you haven’t been trained to apply head moxa do not wing it. There are other just as beneficial ways to complete the treatment. Moxa is a specialty technique and requires care in application and removal. If you would like to be trained in how to apply needle head and chinetsukyu moxa techniques, then Paul Movsessian has online modules that you can do through China Books. It should be stated in case of any confusion, this is not an electro-machine protocol. The charge we are working with is from the body’s own field and much smaller than the currents introduced to the body with electro. You can not use this treatment with electro-machine currents.
Summary
In being able to apply a very gentle and respectful treatment to the Heart in shock, we are able to begin a better conversation with the body. It sets up and develops a level of trust in the therapeutic alliance that is both somatic and philosophical. In being sensitive to treatment we recalibrate our own skin and find how our own perceptions are either developing or perhaps no longer serving us. When we listen with the inherited and gained wisdom of our own Shaoyin this is then engaged in the hands and we deepen our skills within the practice of the medicine.
For references log into your ANTA Member Centre > The Natural Therapist > Journal Articles
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