Complementary Medicines: What is the Truth? Mary L Hardy, MD. Wellness Works & Georgetown University, Masters Program in Integrative Medicine

Transcription

1 Complementary Medicines: What is the Truth? Mary L Hardy, MD Wellness Works & Georgetown University, Masters Program in Integrative Medicine

2 Evidence: In the Eye of the Beholder? Consumers Researchers Health Care Providers Regulators

3 Who Uses DS/ VMN? United States* Female White Middle aged or older Higher SES Higher Education Australia** Female Similar Age trend Similar Ed trend *van der Horst K & Siegrist M. Appetite 2001; 57: Dickinson A & MacKay D. Nutr J, 2014; 13:14. ** Koslow S. Consumer Fact Book, 2015.

4 Prevalence of Use of DS/VMS SURVEY YEARS PREVALENCE NHANES I % adults NHANES II % NHANES III % NHANES % NHANES % NHANES % Dickinson A & MacKay D. Nutr J, 2014; 13:14; Blendon RJ et al. JAMA Int Med 2013; 173(1): 74-6.Koslow S. Consumer Fact Book. Regular use 50% average Overall use 66% or higher AU- 70% use last year Use Increases with Age Female (43-75%) Men (36-66%) Use increases w/ chronic conditions AU- Similar effect

5 Most Commonly Used DS/VMS United States Australia Multi-vitamin Multivitamins Omega 3 Fish Oil Fish/Krill/Omega 3 Oil Calcium Calcium Vitamin D Glucosamine/ CoQ10 Vitamin C Vit B & C/ Energy Combo Vitamin B (Complex) Immunity Vitamin E Probiotics Glucosamine/ Chond* Stress & Sleep Products** *Dickinson A et al. J Am Coll Nutr 2014; 33(2): **Koslow S. Consumer Fact Book, 2015.

6 Health & Habits DS/ VMN Users Diet generally better Exercise more Less likely to smoke Less likely to drink sugary drinks Low or moderate alcohol Normal BMI Some chronic illnesses but not HTN or DM Dickenson A & MacKay D. Nutrition Journal :14; der Horst K & Siegrist M. Appetite 2011; 57:

7 Sources of DS Information Physician > 50% (not in all) Books & Magazines 35-50% Internet 20% East & 50% West Family & friends 30% Rozaga MR et al. BMC Complement Altern Med 2013:200. Published online 2013 Jul 30

8 Reasons for Use United States Overall health 33-58% Bone health 25-58% Nutrient gaps Prevent health problems Australia General health 61% Join health 21% Bone health 18% Boost immunity Energy Dickinson A & MacKay D. Nutr J, 2014; 13:14. ** Koslow S. Consumer Fact Book, 2015.

9 Other Common Reasons for Use Improve energy Prevent Maintain health More common in younger users Disease based uses more common in elderly Heart Eye Joint Bone Bailey RL. JAMA Int Med 2013, 173:

10 Evidence Based Medicine Risk Benefit Value Integrates the best external evidence with individual clinical expertise & patient choice. Sackett DL. Spine 1998; 23(10):

11 State of Research DS 2010 ODS Strategic Plan

12 Is An RCT All That There Is? Evidence needs vary with intention Efficacy vs Safety Totality of evidence should be considered

13 Factors Influencing Decision Making Pre-existing belief influences judgment of new health information. Consonant with other values (part healthy lifestyle) Belief that supplement act as insurance Influenced by media Stronger value on health Perceived susceptibility to disease Chang D et al. J Health Psych 2011, 17(5): Conner M et al. J Nutr 2003, 133 (6): 1978s-82s

14 Potency of Belief by Users Beliefs in DS/MV are strong, durable & affect behavior Elderly cohort: 50% felt no difference but continued to use supplement Only 25% would change use after negative efficacy study (similar result reported 12 years earlier) Less likely to report ADE Wold RS et al. J Nutr Health Aging 2007, 11(1):3-7; Blendon RJ et al. JAMA Int Med 2013, 173 (1): 74-6; Blendon RJ et al. Arch Int Med 2001, 161: ; Walji R et al. BMC Compl Alt Med 2010, 10:8; Barnes J et al. Br J Clin Pharmacol 1998, 45(59):

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17 Consumer Information & Behavior Information regarding non-approval by FDA (disclaimer statement) no change rating of efficacy or safety. Mandatory disclaimers unaware of them or no effect on perceptions of product. Point of sale communication campaign 27% aware of message Of these 11% more info 10% changed behavior Dodge T et al. J Health Commun 2011, 16(3): ; Kesselheim AS et al. Health Aff (Millwood) 2015, 34(3): ; Perlman A et al. Health Commun 2013, 28:

18 How Consumers Hear Science News

19 Public Attitude Towards Science 80% interested in new scientific discoveries 40% internet as main source info Difficulty with basic issues in experimental drug trial design Lay scientific beliefs influential Natural = safe Better safe than sorry

20 Publication Bias General & CAM Generally a bias towards positive studies- perhaps especially in CAM journals. Not all privately conducted studies are published General problem in medical literature Studies published European journals significantly more likely to be positive (76% vs 50% p<0.0001) Studies originating outside US significantly more likely to be positive Schmidt K et al. BMJ 2001, 323: 1071; Sood A et al. J Clin Epi 2007, 60:

21 Publication Bias Supplements Journals increased pharmaceutical ads Fewer DS articles More articles concluding DS unsafe Safety issues discussed least often in CT or cohort than in editorials or reviews Kemper K & Hood K. BMC Compl Alt Med 2008, 8:11

22 Patients Participate in Research

23 Evidence for Use: Nutritional Shortfall NHANES % took MVI > 9 Nutrient shortfalls (food) in this population Vitamin A 35% Vitamin C 31% Vitamin D 74% Vitamin E 67% Calcium 39% Magnesium 46% Similar results NHANES Wallace T et al. J Am Coll Nutr 2014, 33(2): ; Bailey R et al. J Acad Nutr Diet 2012, 112:

24 Evidence for Use General Wellbeing RDBPCT 50 men 8 wks MVI formula Reduction in depression anxiety & improvement alertness & functioning Qualitative end RDBPCT 114 men & women; 16 wks MVI Increased energy level, Enhanced mood Harris E et al. Hum Psychopharmacol 2011, 26(8): 560-7; Sarris J et al. Nutr J 2012, 11:110

25 Prevent Health Problems Osteoporosis & Bone Fractures Translating from Observational Studies to RCT s- problems Vitamin Paradox Under reporting of PHS II

26 Vitamin & Risk of Cancer RCT s Study Subjects (N) Follow Up Yrs Intervention RR of Ca (HR Ca Mort) Linxian 29, F/U BC, VE, Se, Combo SuViMax 13, VC, VE, BC, Zn, Se 0.87 ( ) (HR 0.95( )) 0.69 ( ) Men only CARET 18,314 4 BC, Retinol 1.28 ( ) p=0.02 SELECT 35, VE, Se 1.02 ( ) Women s AO FA CV Study 5, FA, B6, B ( ) ATBC 29, BC, AT, Combo 1.16 (1.02-1,33) Lung BC alone PHS II 14, MMMVI 0.92 ( ) Greenwald P et al. Am J Clin Nutr (suppl) 314S-7S

27 Story Of Misapplication of Science Using DNA Barcoding Products found to be fraudulent Not Containing Herbs on Label

28 Public Health Action: Ephedra When Non-Causal Data was Enough Shekelle P, Hardy M et al. JAMA 2003, 289: Efficacy & safety RCT for efficacy RCT, CR for safety Probable cause CR identified Not causal- Case controlled trial Public health action taken anyway

29 St John s Wort: Finally Getting it Right

30 Where to Now? Research going forward Correct design for the most useful question Explore consumer attitude towards scientific information Educational opportunities Health care providers Consumers Proactive actions to avoid defensive posture

31 SUMMARY & QUESTIONS THANK YOU FOR YOUR ATTENTION!