Complementary and Alternative Medicine

1. Complementary and Alternative Medicine

2. World Health Organization Defines CAM as a “broad set of health care practices that are not part of that country's own tradition and are not integrated into the dominant health care system” The US National Center for Complementary and Alternative Medicine (NCCAM), defines CAM as "a group of diverse medical and health care systems, practices, and products, which are not generally part of conventional medicine" INTRODUCTION • CAM Definitions

3. Women are the largest consumers of healthcare PREVALENCE • Prevalence of CAM use world wide is increasing with studies showing 23% to 65% (Low Dog 2009, Fugh-berman & Kronenberg 2003) (Fisher, Ward 1994, Ernst 2000) Europe 40% (Barnes et al. 2007) 54% of women USA 20% to 48% (Ernst, White 2000, Thomas, Nicholl & Coleman 2001) UK 68.9% 56%-88% of women (Charlie et al.2007) (Artus, Croft & Lewis 2007, McDonough, Devine & Baxter 2007 ) Australia

4. Recommendations regarding six aspects of CAM evidence information research training regulation National Health Service (NHS) provision The House of Lords Select Committee (http://www.publications.parliament.uk/pa/ld199900/ldselect/ldsctech/123/12301.htm)

5. Categories of complementary and alternative medicine (CAM) disciplines

6. What’s the situation in Scotland? • How many patients use CAM? • What do they use? • Why do they use CAM?

7. Survey Population Approximately 1000 patients • Respiratory Clinic 239 patients • General Medical Clinic 250 patients • Breast Clinic 453 patients

8. Personal Health Score 1 as bad as - 5 as good as

9. Prescribed Medicines • Range 0-30 • 0-1 11% • 2-4 35% • 5-6 21% • 10 6% • 15 2% • 30 0.5%

10. CAM Use • GIM/Resp 65% • Breast Clinic 69.5% • On average 67% use CAM

11. Number of CAMs Used Range 0-17 different types • 45% 1-2 • 14% 3-4 • 1% 17 • 71% Vitamins and Mineral Products

12. CAM Used

13. CAMS • Meditation 3% • Nutritional medicines 2% • Osteopathy 3% • Reflexology 3.5% • Reiki 4.3% • Relax and visual 3% • Spiritual healing 1%

14. What Herbals • Cod liver/fish oil 40-61% • Cranberry 16-26% • Echinacea 11-20% • Evening primrose 8-19% • Glucosamine 8-32% • Grapefruit 7% • Garlic 7%

15. HERBALS • Peppermint 6% • Eucalyptus 5% • Ginger 5% • Chammomile 5% • Lactobacillus 5% • Aloe 4% • Gingko 3% • St John’s Wort 2%

17. Who uses? • Females • Family use • Spouse use • Friend use • University education

18. Beliefs • CAMs are safer than prescribed medicines • 26% disagreed • 54% uncertain • 11% agree • Combination of CAMs and prescribed medicine is better than either alone. • 22% disagree • 30% agreed • Patients should only use CAMs recommended by medical professionals • 27% disagreed

19. Beliefs • CAMS are more effective than prescribed • 3% agreed • 43% disagreed • CAMS are cheaper than prescribed • 40% disagreed • 8% agreed • CAMS can interfere with prescribed meds • 38% agreed • 60% disagreed

20. Beliefs • CAMs can cause side effects • 39% agreed • 4% disagreed • CAMS should be available through the NHS • 65% agreed

21. Danger! Danger! • Herbals • Vitamins and Minerals • Homeopathy

22. The problem... • Ask the doctor. “Since having a heart attack, I have been taking lisinopril, Zocor, Plavix, aspirin, a multivitamin, fish oil, calcium, vitamin D, coenzyme Q(10), chia oil, B-50 complex, grape seed extract, Nu-Zymes, Natural Energy supplement, Super C22 and astragalus.” “I am thinking of taking a brain booster called Procera AVH.” Will it interfere with my heart medications? Harv Heart Lett. 2009 Jun;19(10):8

23. Herbals/Botanicals • Used by 40-50% of patients • Contain chemicals with serious and often unknown physiological effects • Almost a third of patients with breast cancer take herbs containing phytoestrogens. • Soya, evening primrose, flax seed, chamomile, garlic, black cohosh and red clover • SAFE??

24. Herb-Drug Interactions are Common • General Practice 4% • In the breast cancer study 40% of patients prescribed adjuvant endocrine therapy also used herbal CAM therapies. • 119 possible herb-drug interactions • (55 with tamoxifen, 66 with anastrazole, 6 with letrozole and 2 with exemestane).

25. The supplements most commonly implicated were soya, cranberry, echinacea, glucosamine, grapefruit and garlic Are they taking an informed risk??

26. What’s the Truth About Herbals? The double blind randomised controlled study is king

27. Glucosamine • Arthritis • Available on prescription • 1955 articles • 18 randomised placebo controlled trials • Evidence base poor • Possibly some benefit

28. Evening Primrose • Mastalgia • Menopausal Symptoms • Atopic dermatitis • Oseporosis • 237 Articles • 26 Trials • No good evidence of benefit • Some evidence for use in dermatitis

29. Echinacea • Enhance immune system prevent infection • 744 articles • 49 Trials • Positive benefit in small studies • No benefit in large studies • Trials suggests possible benefit for oral hygiene and anal warts

30. Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. • For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea.

31. Cranberry • Prevention of Urinary Tract Infections • Antioxidant • Dementia • 571 articles • 76 trials • All recent studies negative • Drug interactions

32. Grapefruit • Protection against heart disease • Protection against cancer • 1034 articles • 0 randomised placebo controlled trials • No good evidence of benefit • Increased risk of breast cancer • Numerous drug interactions

33. St John’s Wort • Depression • Smoking cessation • Menopause No evidence of benefit • ADHD/ OCD • 1917 articles • Positive evidence for depression • Numerous drug interactions

34. Conclusions • CAM use is common • Herbals are used by a large number of patients and the public • Little high quality evidence if any of benefit • Increasing evidence of harm for some herbals

35. Vitamins and Minerals • Who uses vitamins ?? • 70% of our population

37. Background • Oxidative stress may play a role in the pathogenesis of cancer and cardiovascular disease, the leading causes of death in middle and high-income countries (Sies 1985; Poulsen 1998; Halliwell 1999). • Diet provides numerous vitamins and trace elements that are essential for good health. • Observational studies have reported a significant positive association between higher intake of fruits and vegetables and reduced risk of chronic diseases • (Block 1992; Ames 1993; Willcox 2004).

38. Are Antioxidants good for you?Who uses any of these? • Vitamin A • β carotene • Vitamin C • Vitamin E • Selenium • A combination of the above

39. Mortality in Randomized Trials of Antioxidant Supplements for Primary & Secondary Prevention Vitamin A 16% (10-24%) β carotene 7% (2-11%) Vitamin C no sig effect Vitamin E 4% (1-7%) Selenium no sig effect 47 low-bias trials with 180,938 participants Bjelakovic G et al., JAMA 2007;297:842-857

40. Mortality in Randomized Trials of Antioxidant Supplements for Primary & Secondary Prevention Vitamin A 16% (10-24%) β carotene 7% (2-11%) Vitamin C no sig effect Vitamin E 4% (1-7%) Selenium no sig effect 47 low-bias trials with 180,938 participants Bjelakovic G et al., JAMA 2007;297:842-857

41. Mortality in Randomized Trials of Antioxidant Supplements for Primary & Secondary Prevention of Heart Disease Vitamin A 16% (10-24%) β carotene 7% (2-11%) Vitamin E 4% (1-7%) 47 low-bias trials with 180,938 participants Bjelakovic G et al., JAMA 2007;297:842-857

42. Updated Meta-analysis: 78 RCTs • 296,707 participants (19 to 39,876 per trial) : • 26 trials - 215,900 healthy. • 52 trials - 80,807 with various chronic stable diseases. • Mean age - 63 y (range 18 - 103 y); 46%women. • Design: 46 parallel-group, 30 factorial, 2 cross-over. • All antioxidants administered orally alone or in combination with vitamins/ minerals, or other interventions. • Duration: 28 days to 12 years (mean 3y; median 2y). Bjelakovic G, et al., Cochrane Database Syst Rev. 2012 Mar 14

43. 56 trials with low risk of bias • 244,056 participants • 18,833 dead/146,320 (12.9%) versus • 10,320 dead/97,736 (10.6%); • RR 1.04, 95% CI 1.01 to 1.07 Supplements significantly increased mortality Bjelakovic G, et al., Cochrane Database Syst Rev. 2012 Mar 14

44. Mortality in Randomized Trials of Antioxidant Supplements for Primary & Secondary Prevention Vitamin A 7%(-3 to 18%) β carotene 5% (1 to 9%) Vitamin C 2%(-2 to 7%) Vitamin E 3% (0-5%) Selenium -3% (-9 to 3%) 56 trials with low risk of bias with 244,056 participants Bjelakovic G, et al., Cochrane Database Syst Rev. 2012 Mar 14

45. What about vitamin D supplements?

46. Vit D and Mortality • Overall, vitamin D decreased mortality • (RR 0.97, 95% CI: 0.94 to 1.00) • 50 trials; median duration 2 years • n=94,148, mean age 74, • 79% women – mainly in institutions + dependent care • All due to vitamin D3 (median daily dose 800 IU) • (RR 0.94, 95% CI: 0.91 to 0.98) • NNT 161 Bjelakovic G et al., Cochrane Database Syst Rev. 2011 Jul 6;(7):CD007470.

47. Vit D3 + Calcium? • Vitamin D3 administered singly: No statistically significant effect on mortality (RR 0.91, 95% CI 0.82 to 1.02, P = 0.10). • Vitamin D3 combined with calcium: Significantly decreased mortality (RR 0.95, 95%CI 0.91 to 0.99, P = 0.02)

48. Dose of vitamin D3 • <800 IU daily significantly ↓ mortality (RR 0.92, 95% CI 0.87 to 0.97, P = 0.005) • A dose of vitamin D3 ≥ 800 IU a day had no significant effect on mortality (RR 0.96, 95% CI 0.92 to 1.01, P = 0.13, I2 = 0%).

49. However

50. Calcium supplements ± vitamin D increase risk of cardiovascular events RCTs contributing trial-level data (n=11,921): Bolland M et al., BMJ 2010;341:c3691