Pain and Supplements: How to Incorporate the Guidelines Robert A. Bonakdar, MD FAAFP Director of Pain Management Scripps Center for Integrative Medicine
Assistant Clinical Professor University of California, San Diego, School of Medicine
Disclosure • Research Support – Johnson and Johnson
• Consultant – Mcneil Consumer Health – Quadrant Healthcomm
Learning Objectives • Recognize why its important to discuss dietary supplements (4 P’s) • Describe the prevalence and patterns of use • Review Guidelines that endorse Clinically Tested Dietary Supplements • Describe how to apply point of care tools to improve discussion and coordination of care
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Journal of the AMERICAN DIETETIC ASSOCIATION, 2010 doi: 10.1016/j.jada.2010.07.024
Dietary Supplements - Why bother? 4 P’s CAM discussion • Protect • Promote • Permit • Participate Jonas, W.B., Chez, R.A. Complementary & alternative medicine. In Current Diagnosis & Treatment in Family Medicine. South-Paul, JE, Matheny, SC and Lewis, EL (Eds). New York: McGraw-Hill 2007; pp.549-557.
Where NOT to get your Information •
KEY Trends– Dietary Supplements 1. 2. 3. 4. 5.
HOW often are patients using DS WHAT DS they are using and WHY? WHICH patients are using DS? HOW they are using DS? WHO are they discussing DS with?
The New Pharmacy
Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec10;(12):1-23.
NHANES* Trends NHANES
Male
Female TOTAL
I (1971–1974)
28%
38%
23%
II (1976–1980)
32%
43%
35%
III (1988–1994)
35%
43%
40%
1999-2000
47%
57%
52%
2003–2006
44%
53%
49%
Note: Use increases with age *National Health and Nutiritonal Education Survey J. Nutr. 141: 261–266, 2011. Am J Epidemiol 2004;160:339–349
Other Supplement Surveys • The US Food and Drug Administration sponsored Health and Diet Survey National – 73% of US adults were found to use supplements
• Dietary Supplement Use Within a Multiethnic Population – 83% of men and 73% of women J Am Diet Assoc. 2006 Dec;106(12):1966-74. J Am Diet Assoc. 2011;111:1065-1072.
Bottom-line on use • “About one-half of the U.S. population and 70% of adults > 70 y.o. use dietary supplements…”
J. Nutr. 141: 261–266, 2011.
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KEY Trends– Dietary Supplements 1. 2. 3. 4. 5.
HOW often are patients using DS WHAT DS they are using and WHY? WHICH patients are using DS? HOW they are using DS? WHO are they discussing DS with?
Top Non-Herbals 2011 1. 2. 3. 4. 5. 6. 7. 8.
ESSENTIAL FATTY ACID GLUCOSAMINE & CHONDROITINS PROBIOTIC/ACIDOPHILUS COENZYME Q10 MELATONIN AMINO ACID LUTEIN SAM-E
Source: Nutrition Business Journal 2012
Demographics of the DS Utilizer • Education level: Higher • Health condition: Varies / Dichotomy – Lower BMI / Chronic – Higher physical activity / End-Stage
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Sex: ~ Slightly to much greater use F > M Race: ~ Higher in certain ethnic group “Holistic Health View” “Active Coping Behavior” Am J Clin Nutr 2007;85(suppl):277S–9S. /Journal of Nutrition. 2001;131:1339S-1343S Why Patients Use Alternative Medicine: Results of a National Study. Astin JAMA, 1998 Patterns of alternative medicine use by cancer patients. Med J Aust. 1996;165:545-548.
Begbie SD et a
HOW Are Supplements Being Used? • Sub-optimal: – Confusion – Low Disclosure – Low Discussion – Minimal participatory decision making
Can Patients Read Labels? • Knowledge of dietary supplement label • “misconceptions regarding the term "natural," … product claims, and testing for product safety existed among participants. • Supplement users need additional education about supplement claims . . .to make informed health care choices.” Patient Educ Couns. 2004 Mar;52(3):291-6.
Supplement Stare
Can We Help Patients? • Analysis of 256 PCP visits at UCSF • Despite differential knowledge about CAM treatments, physicians helped patients assess the risks and benefits of CAM treatments and made recommendations based on patient preferences • PRACTICE IMPLICATIONS: • Providers do not have to possess extensive knowledge about … CAM to have meaningful discussions with patients and to give patients a framework for evaluating CAM treatment Koenig CJ, Ho EY, Yadegar V, Tarn DM. Negotiating complementary and alternative medicine use in primary use.care visits with older patients. Patient Educ Couns. 2012 Apr 5.
A Framework for Approaching the Patient: HERBAL Mnemonic Hear Educate and Evaluate Record Be aware Agree to Discuss Learn Re-evaluate
Bonakdar R. The H.E.R.B.A.L. Guide: Dietary Supplement Resources for the Clinician. Lippincott 2010.
How to Practically Communicate and Coordinate Dietary Supplements
1. Assume all patients are using Supplements 2. Hear the patient out: Create an open environment for discussion & use face to face questioning
Complete The Care
All In The Asking • A traditional H & P including medication questions yields a 5% CAM use • Direct questioning reveals > 40% use • 30.5% reported use of DS on a standard medical questionnaire as part of an H&P • During a more intensive survey, 61% of the same patients reported use of supplements
Metz J et al. Cancer Patients use unconventionsl medical therapies far more frequently than starndard history and physical examination suggests. Proc Am Soc Clini Oncol 19:602a, 2000 (absr 2368)..
Practical Communication and Coordination of Dietary Supplements 1. Assume all patients are using Supplements 2. Hear: Create an open environment for discussion with face to face questioning 3. Educate and Evaluate in time-effective ways to increase informed choices
Educate on Good Resources
http://www.nal.usda.gov/fnic/pubs/bibs/gen/dietarysupplementsconsumers.pdf
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Office of Dietary Supplements http://ods.od.nih.gov
Educate – Key Details On Use • How to use: – “You need to use this for 3-4 months before we would expect to see benefit” – Timing of supplementation – Formulation/Brand and Dosage
• Why you are using: – Glucosamine example: Joint space preservation
Educate – When to expect benefit, example: Riboflavin
Finding Evidence • http://dietary-supplements.info.nih.gov – NIH Office of Dietary Supplements • www.nlm.nih.gov/nccam/ camonpubmed.html
– CAM on PubMed
• www.naturaldatabase.com – An objective, subscriber funded database of supplement information / interactions
• WWW.CTDSD.com – Clinically Tested Dietary Supplement Database
PubMed Dietary Supplement Subset •
http://ods.od.nih.gov/Research/PubMed_Dietary_Supplement_Subset.aspx
Searching • Natural Medicines Comprehensive Database • www.naturaldatabase.com
• Natural Standard • www.naturalstandard.com
• Dynamed – http://ebscohost.com/dynamed
All AAFP recognized source of Evidence-Based Information
Finding a Reliable Brand • Consumer Lab – www.consumerlab.com
• NSF www.nsf.org • USP www.uspverified.org – Dietary Supplement Verification Program
• “Prescription” brands • Clinical Trial brands
Educate: WHAT to use FORMULATION IS CRITICAL Well made brand (safety seals) “Prescription Brand” Clinically Tested Brand May be the difference between whether a supplement is going to be beneficial or not
Prescription Brands • Brands which are recognized as prescription medications in other countries but which are categorized as dietary supplements in the US • Examples – SAMe – Glucosamine sulfate
www.CTDSD.com
Clinically Tested • Supplements which has been evaluated for efficacy and monitored for safety in controlled trials – Clinically Tested Dietary Supplement Database – WWW.CTDSD.com
Educate and Evaluate • Examples: – Protect – – Promote – Butterbur in Migraine – Permit – Omega-3 in spinal pain – Permit – SAMe and Omega-3s in refractory OA / depression *Assumes focus on supplements and that other treatments (diet, meds, activity, etc) have been reviewed
Clinical Scenario - Promote • Female patient with ongoing migraines and difficulty tolerating numerous previous preventatives • “What else can I try?” – Natural Database – ODS / Pubmed Supplement subset – CTDSD.com
ďƒŞ
Headache. 2003 Jan;43(1):76-8.
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Butterbur (Petasites hybridus root) • Constituents – Sesquiterpene – Petasin – Isopetasin – Volatile oils – Flavonoids – Tannins – Pyrrolizidine alkaloids*
• Activity • Antispasmodic effects on smooth muscle • leukotriene & histamine synthesis • Used traditionally for allergy disorders
Butterbur - not all are created equally • Wild butterbur may have liver toxicity which has not been noted with prescription brand • Not all butterbur brands been evaluated for safety or efficacy in migraine • Most all + trials on butterbur (petasites) in migraine done on Petadolex brand • From a safety and efficacy standpoint important to use clinically tested brands and not assume that what’s on the shelf matches. Headache. 2003 Jan;43(1):76-8.
Butterbur (Petadolex)
Lipton RB, Gobel H, Einhaupl KM, et al. Petasites hybridus root (butterbur) is an effective preventive treatment for migraine. Neurology 2004;63(12):2240–2244.
Feverfew Studies • 3 (+): Reduced severity, duration, and frequency ( ~ 24%) of migraine headaches.1-3 (employed dried, powdered leaves). • 1 (-): study which used an alcohol extract4 • Cochrane: “Results from these trials were mixed and did not convincingly establish that feverfew is efficacious for preventing migraine.”5 1. Johnson ES. Br Med J 1985;291:569–73. 2. Murphy JJ, Lancet 1988;2:189–92. 3. . Palevitch D, Phytother Res 1997;11:508–11. 4. De Weerdt CJ, Phytomed 1996;3:225–30.5. 5. Cochrane Database Syst Rev. 2004;(1):CD002286.
Stable extract reproducibly manufactured with supercritical CO2 from feverfew
• Appeared to be effective in subgroup of patients with >4 migraines per month
Cephalalgia 2002; 22:523–532. Cephalalgia 2005; 25:1031–1041.
Clinically Tested for Migraine Supplement
Formula Name
Avail Manuf. in US?
Butterbur petasites hybridus Feverfew
Tanacetum parthemium
Petadolex Mig-99
Webber Webber Schape r& Br端mm er
Daily Adult Dose
Daily Ped. Dose
LOE/Stud Freq ies
BID/TI Yes 150 mg 100 mg D Level I Yes
WWW.CTDSD.com
6.25 mg TID
TID
Level II
Clinical Scenario - Permit • Patient with discogenic back pain • Also has elevated triglycerides and history of prior MI currently on a statin • “Should I take a fish oil supplement, I’ve heard it may (not) help?”
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• “Insufficient evidence…” • Editorial: • Among 14 RCTs included in the metaanalysis, most were very small short-term studies and were not designed to evaluate CVD end points. Arch Intern Med. 2012;172(9):686-694.
• Among 1,050 patients with prior myocardial infarction (MI), the incidence of MCE in the EPA group (15.0%) was significantly lower than that in the control group (20.1%, adjusted hazard ratio =0.73, 95%CI 0.54–0.98, P=0.033, NNT =19).
Japan EPA Lipid Intervention Study (JELIS) • N = 18,645 with cholesterol (70% women) • Received statin or statin + EPA (1.8 g/d) • At 5-years, EPA reduced major adverse CV events by an additional 19%
Is it available? Avail Supplement Formula Name Manuf. in US? Omega-3
Daily Adult Dose
LOE/Stu Freq dies
Mochida EPA (ethyl Pharma icosapentate) (Japan) NO 1800 mg QD Level II
WWW.CTDSD.com
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• 250 patients on NSAIDs for lumbar and/or cervical spine pain • Omega-3 essential fatty acids (EPA and DHA), 2.4 gms for 2 weeks then 1.2 gms thereafter: ProEPA by Nordic Naturals • 59% were able to d/c NSAIDs
Not a perfect situation • Science is not perfect • Brand availability not perfect • Permit: – Discuss approaches including dietary approaches and available similar brands (predominantly EPA) which he may use handout provided
Is it available? Avail Supplement Formula Name Manuf. in US? Omega-3
Omega-3
Daily Adult Dose
LOE/Stu Freq dies
Mochida EPA (ethyl Pharma icosapentate) (Japan) NO 1800 mg QD Level II 2 caps: Pro-EPA
Nordic Naturals
WWW.CTDSD.com
900 mg EPA / Yes 200 mg DHA BID
Level II
Practical Communication and Coordination of Dietary Supplements 1. Assume all patients are using Supplements 2. Hear: Create an open environment for discussion 3. Educate and Evaluate in time-effective ways 4. Record
If its not written down…. • Geriatrics Study: – Only 35% of all self-reported supplements were documented in the charts.
• Mayo Clinic Interaction Study: – Use of dietary supplements was documented in only 26% of the medical records.
• Recording in the clinic chart one of the easiest ways to prevent interactions… J Gerontol A Biol Sci Med Sci. 2002 Apr;57(4):M223-7 The American Journal of Medicine (2008) 121, 207-211 .
Practical Communication and Coordination of Dietary Supplements
1. Assume all patients are using Supplements 2. Hear: Create an open environment for discussion 3. Educate and Evaluate in time-effective ways 4. Record 5. Be Aware for Reactions / Interactions a. Know the common culprits b. Have quick reference guides c. Point of Care Confirmation
Scenario • Patient with history of arthritis and depression with suboptimal response to current anti-depressant: • “I have heard that St. Johns Wort may help?”
• N=1818 Mayo Clinic; 39.6% using supplements • In total, 107 interactions with potential clinical significance were identified • No patient had serious harm from the possible interactions during the study period
The American Journal of Medicine (2008) 121, 207-211
HDI • 5 DS accounted for 68% of the potential interactions (garlic, valerian, kava, ginkgo, SJW) • 4 classes of RX accounted for 94% of the potential interactions (antithrombotics, sedatives, antidepressants, antidiabetic agents) • A small number of Rx medications and DS accounted for most of the interactions. The actual potential for harm was low… • This information likely will help educate patients and physicians about these potential interactions.
Confirming Interactions • Ex: www.naturaldatabase.com
http://reference.medscape.com/druginteractionchecker http://www.drugs.com/drug_interactions.html
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http://ods.od.nih.gov/Research/PubMed_Dietary_Supplement_Subset.aspx
• Level 1 evidence to support light therapy in seasonal MDD and St. John's wort in mild to moderate MDD. • also some evidence for the use of exercise, yoga and sleep deprivation, as well as for omega-3 fatty acids and SAM-e. • Some CAM treatments have evidence of benefit in MDD. However, problems with standardization and safety concerns may limit their applicability in clinical practice.
• The combination therapy demonstrated significantly greater improvement in HAMD scores over time (P = 0.008) beginning at week 4 (P = 0.014) (versus citalopram + placebo) J Clin Psychopharmacol. 2012 February; 32(1): 61–64.
• 6-week, RDBPC trial of SAMe 800 mg BID • The HAM–D response and remission rates were higher for those receiving SAMe (36.1% & 25.8%, respectively) than placebo (17.6% &11.7%, • The NNT for response and remission was 6 and 7 respectively. • Adverse events similar for placebo & SAMe Am J Psychiatry 2010; 167:942–948
SAMe Conclusion • Review of 11 studies: • “SAMe appears to be as effective as NSAIDs in reducing pain and improving limitations in patients with OA, without the adverse effects often associated with NSAIDS”
Soeken K et al. Safety and Efficacy of SAMe for Osteoarthritis. J of Fam Pract. 2002. 51(5). 425-30.
Clinically Tested Supplements for Depression Augmentation Supplement
SAMe Omega-3
Formula Name
Manuf.
SAMe Complete
Pharmavite
Pro-EPA
Nordic Naturals
WWW.CTDSD.com
Avail Daily Adult in US? Dose
Yes Yes
800 mg 2 caps:
LOE/Studi Freq es
BID Level II
900 mg EPA / 200 mg DHA BID
Level II
What about Glucosamine /Chondroitin in this patient? •
http://www.rheumatology.org/practice/clinical/guidelines/osteoarthritis.asp
NICE Guidelines
www.nice.org.uk/CG059
A Review of the Guidelines
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• 18. Treatment with glucosamine and/or chondroitin sulphate may provide symptomatic benefit in patients with knee OA. If no response is apparent within 6 months treatment should be discontinued. • 19. In patients with symptomatic knee OA glucosamine sulphate and chondroitin sulphate may have structure-modifying effects …
EULAR Knee OA Recommend. •
http://www.eular.org/
Why The Difference? • Longer history of use • Availability of prescription versions • Longer research track record with available formulations • Look at benefits beyond short-term: – Joint preservation
• 8 primary trials of > 12 mo. duration showed evidence of statistically significant improvements in joint space loss, pain and function for glucosamine sulphate • In 2 studies of glucosamine sulphate, the need for knee arthroplasty was reduced from 14.5% to 6.3% at 8 years' follow-up. Health Technology Assessment 2009; Vol. 13: No. 52 DOI: 10.3310/hta13520
Arthritis Rheum. 2009 Feb;60(2):524-33.
Clinically Tested Supplements for Osteoarthritis Supplement
Formula Name
Glucosamine Sulphate Dona Chrondroitin 4 & 6 Sulphate Condrosulf
Manuf.
Avail Daily Adult in US? Dose
LOE/Studi Freq es
Rotta
Yes
1500mg
QD
Level I
IBSA
No
800 mg
QD
Level I
WWW.CTDSD.com
Practical Communication and Coordination of Dietary Supplements
1. Assume all patients are using Supplements 2. Hear: Create an open environment for discussion 3. Educate and Evaluate in time-effective ways 4. Record 5. Be Aware for Reactions / Interactions 6. Agree to Discuss
Agree to Discuss • As soon as the clinic interaction is over, there may be a desire to re-consider supplement choices: – New Information/research (Good and Bad) – Condition / Reasons for Supplementation Changes
• Create an avenue for ongoing discussion: – – – –
Nurse Dietician Pharmacist Other Healthcare providers . . .
Put new information in perspective • Patient: An informed media filter – How reliable is this information, does it agree with other information I have read/discussed? – How hyped is the report? (Office of DS guides)
• Provider: – Have reliable office handouts or internet links regarding the most common questions: • “Regarding the recent study on _____” • “Regarding the recent report of interactions. . ”
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http://ods.od.nih.gov/
Practical Communication and Coordination of Dietary Supplements
1. Assume all patients are using Supplements 2. Hear: Create an open environment for discussion 3. Educate and Evaluate 4. Record 5. Be Aware for Reactions / Interactions 6. Agree to Discuss 7. Learn
Learning • Find sources that come to you that: • Keep you updated / alerted on – Research – Details (Brands / Formulations) – Interactions – Regulations / Recalls
Ongoing Learning • Newsletters from reputable sources – Office of Dietary Supplements – NCCAM – HerbalGram American Botanical Council Web site: http://www.herbalgram.org
• Conferences – American College of Nutrition • http://www.americancollegeofnutrition.org
– Natural Supplements an Evidence Based Update • http://www.scripps.org/events/natural-supplements-anevidence-based-update
Practical Communication and Coordination of Dietary Supplements 1. 2. 3. 4. 5. 6. 7. 8.
Assume all patients are using Supplements Hear: Create an open environment for discussion Educate and Evaluate Record Be Aware for Reactions / Interactions Agree to Discuss Learn Re-evaluate
r e-evalute periodically - TIPS • Set up a feasible time-frame to re-evaluate supplementation • Have patient monitor symptoms during trial • Don’t expect too much too fast – Supplements may take several months to have expected effect
• Monitor pros/cons of ongoing therapy – Is it a keeper? avoid stockpiling
Summary: A Framework for Approaching the Patient Hear Educate and Evaluate Record Be aware Agree to Discuss Learn Re-evaluate
Bonakdar R. The H.E.R.B.A.L. Guide: Dietary Supplement Resources for the Clinician. Lippincott 2010.
Conclusions – DS • DS used by a majority of our pain patients while communication and coordination is not optimal • Our patients need and desire our input to help guide their choices in this arena • Time effective strategies are available to to improve discussion and evidence-based incorporation of dietary supplement
Pain and Supplements: How to Incorporate the Guidelines Robert A. Bonakdar, MD FAAFP Director of Pain Management Scripps Center for Integrative Medicine
Assistant Clinical Professor University of California, San Diego, School of Medicine