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Complementary Medicine: Where Is the Evidence?

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Complementary Medicine: Where Is the Evidence? Applied Evidence N EW R ESEARCH F INDINGS T HAT A RE C HANGING C LINICAL P RACTICE Complementary medicine: Where is the evidence? Edzard Ernst, MD, PhD, FRCP (Edin.) Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK Practice recommendations omplementary or alternative medicine has moved from the fringe of health care ■ Herbal medicines have been submitted to Ctoward its center; recent figures show systematic reviews more frequently than that in Germany, for instance, no less than any other complementary therapy, and three quarters of the general population use at it is here where the most positive evidence least 1 complementary therapy.1 In the United can be found. States, the equivalent figures have increased ■ There is not much research into potential from 33% in 1990 to 42% in 1997.2 serious risks of complementary medicine. Virtually all survey data agree that those Possible risks range from the toxicity most fascinated with complementary medicine of herbs to vertebral artery dissection are predominantly female, affluent, middle- or nerve damage after chiropractic aged, and well-educated. Seventy-eight percent manipulation. of all Medicaid programs provide coverage of at least 1 form of complementary medicine.3 ■ Currently the Cochrane Library contains At the same time, critics of complementary 34 systematic reviews of complementary medicine often insist there is no good evidence medicine: 20 of herbal medicines, 7 of to support these therapies,4,5 and that it is a acupuncture, 3 of homeopathy, 2 of waste of resources and a misuse of science to manual therapies, and 2 of other forms. try establishing an evidence base for therapies that are essentially nonscientific, irrational, and implausible fads.6 But is this really true? ■ RESEARCH IN COMPLEMENTARY MEDICINE Correspondence: Complementary Medicine, Peninsula Medical Over the last 30 years, the level of original School, Universities of Exeter and Plymouth, 25 Victoria Park Road, Exeter EX2 4NT, United Kingdom. E-mail: research activity in complementary medicine [email protected]. has increased considerably.7 The best quality of 630 AUGUST 2003 / VOL 52, NO 8 · The Journal of Family Practice COMPLEMENTARY MEDICINE AppliTABLE Cochrane reviews in complementary medicine with (tentatively) positive results First author (primary studies)* Therapy Indication Reservations* Furlan (8) Massage Low back pain More studies required, some trials of poor quality Green (4) Acupuncture Lateral elbow pain More studies required, most trials of poor quality Linde (7) Acupuncture Asthma Evidence only positive for peak expiratory flow rate, effect size small Linde (27) St John’s wort Depression Some trials of poor quality, (Hypericum perforatum)† few equivalence studies Little (11) Various herbal Rheumatoid arthritis More studies required, medicines some trials of poor quality Little (5) Various herbal Osteoarthritis More studies required, medicines some trials of poor quality Melchart (26) Acupuncture Headache Evidence positive only for migraine headaches, effect size small Pittler (7) Kava (Piper methysticum)† Anxiety Concern over safety Pittler (13) Horse chestnut Chronic venous Scarcity of long-term studies (Aesculus hippocastanum)† insufficiency Pittler (4) Feverfew Migraine prevention More studies required, (Tanacetum parthenium)† effect size small Pittler (2) Globe artichoke Hypercholesterolemia More studies required effect (Cynara scolymus)† size small Vickers (7) Oscillococcinum Influenza More studies required, effect size small Wilt (21) Saw palmetto Benign prostate Effect size moderate, (Serenoa repens)† hypertrophy scarcity of long-term studies Wilt (18) African prune Benign prostate Scarcity of long-term studies (Pygeum africanum)† hypertrophy Wilt (4) Cernilton† Benign prostate More studies required, hypertrophy scarcity of long-term trials Wilt (4) Beta-sitosterols† Benign prostate More studies required, hypertrophy scarcity of long-term trials All data extracted from The Cochrane Library, 2003. “More studies required” means that volume of data was small; “trials of poor quality” means that the average quality of the evidence was lowered by flawed studies; “effect size” describes the difference in clinical response to active and control treatment. *As expressed by authors of respective review. †Plant-based treatments. AUGUST 2003 / VOL 52, NO 8 · The Journal of Family Practice 631 COMPLEMENTARY MEDICINE Herbal medicines are submitted (a full list is available from the author), and for more systematic reviews and most were not in the Cochrane format. have the most positive evidence Linde and Willich have analyzed selected systematic reviews of acupuncture, homeo- pathy, and herbal medicine, and have shown evidence for or against the effectiveness of that their methodological approach differed any therapy is usually provided by Cochrane considerably.14 reviews.8,9 ■ METHODS OF REVIEWING Cochrane reviews COMPLEMENTARY MEDICINE Currently the Cochrane Library contains 34 The conclusions of these methodologically systematic reviews and 35 protocols of com- diverse articles were still surprisingly plementary medicine10 (depending on what one consistent.15 Some maintain that complementa- considers complementary/alternative and what ry medicine cannot be evidence-based in the mainstream, this figure might vary margin- conventional sense of the word16; that “softer” ally). Twenty of the reviews are of herbal types of evidence need to be taken into medicines, 7 of acupuncture, 3 of homeopathy, consideration as well17; that placebo effects 2 of manual therapies, and 2 of other forms of must not be dismissed as nonbeneficial18; that comple-mentary medicine. Twelve reviews the healing encounter includes significant include a meta-analytic approach. factors that may never be quantifiable19; that The 34 reviews comprise a total of 286 “the scientific method cannot measure hope, clinical, mostly randomized and often placebo- divine intervention, or the power of belief.”20 controlled, double-blind studies. In 1999, the And, obviously, research in complementary Cochrane Library listed more than 4000 medicine “must consider social, cultural, controlled trials of complementary medicine political, and economic contexts.”21 and a further 4000 awaited assessment.11 The debate about what constitutes the best The single largest Cochrane review of research methods for complementary medicine complementary medicine is a meta-analysis has been going on for decades. There are no of randomized clinical trials of St John’s wort simple answers except that, like in any type of for depression, based on 27 primary studies scientific inquiry, there are no intrinsically with a total of 2291 patients.12 Seven of good or bad methods, only good and bad the 34 Cochrane reviews are “negative”—ie, matches between the research question posed do not suggest a positive clinical effect of the and the methodology employed.22 intervention under evaluation. Eleven are Herbal medicines have been submitted to entirely inconclusive and 16 draw at least systematic reviews more frequently than any tentatively positive conclusions (Table). Given other complementary therapy, and it is in this the dire funding situation for research in area where most of the positive evidence can complementary medicine,13 this evidence base be found (also outside Cochrane reviews).23 is remarkable. The medical conditions treated with comple- mentary medicine are often chronic benign Other reviews diseases for which existing conventional The Cochrane database may be the best but treatments fail to offer a cure or a risk-free certainly is not the only source of systematic reduction of symptoms (Table). Given the pop- reviews of complementary medicine. My unit ularity of complementary medicine and the has published about 100 systematic reviews economic importance of these conditions, it 632 AUGUST 2003 / VOL 52, NO 8 · The Journal of Family Practice COMPLEMENTARY MEDICINE seems ill-conceived to argue against further Trials of complementary medicines 6 research in this area. pose problems—how do you Firm conclusions of the Cochrane (or other) placebo-control a study of massage? reviews of complementary medicine are often hampered by the paucity of primary studies; 10 of the 16 reviews in Table are based on medicine, for instance, tend to advise their fewer than 10 primary studies. The average clients against employing important medical methodological quality of the primary data is in interventions.28 At present there are no reliable some but by no means all disappointing.24–26 incident figures regarding serious adverse effects of complementary medicine,5,23,27 render- Problems in testing ing this area perhaps the most urgent topic for complementary medicine further research. There is little doubt that rigorous trials of complementary medicine can pose formidable ■ MOVING FORWARD problems.22 What, for instance, is an adequate At a time when healthcare systems universally placebo for a study of massage therapy, and are strapped for money, the decision whether how should one blind patients in such a trial? to integrate complementary medicine into rou- The biggest obstacle to good research is tine medicine will undoubtedly be influenced perhaps the notorious lack of research funding by economic considerations. Virtually all in this area, which is all the more acute research on this issue is inconclusive or flawed because costs can be particularly high for or both.29 We therefore cannot be sure whether trials of time-intensive
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