E Ernst* MD PhD FRCP FRCPEd

*Complementary Medicine
Peninsula Medical School
Universities of Exeter & Plymouth
25 Victoria Park Road
Exeter EX2 4NT UK

Email: Edzard.Ernst@pms.ac.uk

Tel: +44 (0)1392 424989

Fax: +44 (0)1392 427562

 

Our unit was created 10 years ago with the remit to conduct rigorous research into complementary medicine. As straightforward as this task may seem, it turned out to be not a small order indeed. First, complementary medicine is a huge and highly diverse area (Table 1). Second, applying science to it is fraught with logistical obstacles, methodological problems and ‘ideological’ complications. At the time, there was little agreement other than one: the task was both timely and important. The general population was (and is) in the middle of a romance with all things alternative, and no university chair did (or does) exist in the UK to carry out this ‘mission impossible’.

The research agenda

The first step was to define the most important research question and work out a research strategy. The choice of potential research question seemed endless:

• Who uses complementary medicine?
• For what health problems?
• What types of complementary medicine are particularly popular?
• Why do people use complementary medicine?
• What are patients’ expectations?
• What are patients’ experiences?
• What are doctors’ attitudes?
• What are other countries’ experiences?

etc, etc, etc

 

Considering that complementary medicine is woefully under-researched, I felt that these questions were interesting but not as burning as the following two:

• Does complementary medicine work?
• Is complementary medicine safe?

These two issues dominated our research agenda in the years to come. The strategy for making progress was largely determined by them. The most reliable path to conclusive answers was to conduct clinical trials of specific complementary therapies for defined conditions and to produce state of the art reviews of clinical data already published.

Methodological and ‘ideological’ problems

Our strategy remained not without critics. In essence their argument was that reductionist science is not applicable to holistic healthcare. This is clearly not the place to go into the technical details of this debate, but I am as convinced as ever that the scientific evaluation of complementary medicine is both feasible and necessary.

But this is not the same as denying that complementary medicine has numerous characteristics which sets it apart from orthodox medicine and which require thoughtful attention when planning research. Such idiosyncrasies usually can be accounted for within the rules of scientific research. To put it bluntly, there is no ‘alternative science’ and no alternative to science when one aims at finding the truth. Not trying to answer our two main questions means, in my view, failing our patients who have a right to know whether these treatments do more good than harm. Conducting ‘softer’ research, e.g. surveys to show how many patients are satisfied with aromatherapy, healing, etc, would not convince the sceptics and thus generate no progress.

Logistical obstacles

Research is never easy and usually encounters a myriad of problems. By far the most cumbersome obstacle turned out to be the lack of sufficient research funds. All medical researchers suffer from shortage of funds, but in complementary medicine the problem has entirely different dimensions. For instance, the proportion of the medical research budget dedicated by the NHS to this area is 0.08% and the corresponding figure for UK medical charities is 0.05%. Consider that about a third of the UK population uses complementary medicine and that currently even the most fundamental questions remain unanswered, and the enormity of under-funding becomes evident.

 

Progress

Despite these predicaments, considerable progress has been made. Evidently this is not the place to give a comprehensive account of our results. Interested readers can obtain a full report entitled ‘The Evidence So Far’ at a cost price by emailing (edzard.ernst@pms.ac.uk).

The two areas where we have been most active are acupuncture and herbal medicine. Some of our more noteworthy findings include establishing that acupuncture is a safe procedure when administered by well-trained healthcare professionals. To generate this certainty, we had to carry out the then largest prospective studies in the 3000 year history of acupuncture. Serious adverse effects (e.g. puncturing the heart), even fatalities, have been reported after acupuncture but they are extreme rarities. Mild, transient side-effects, we can now state with confidence, occur in about 7% of all patients. Similarly we have conducted systematic research into the safety of many herbal medicines. They concluded that the following remedies are not usually associated with serious risks: Aloe vera, Artichoke, Asian ginseng, Black cohosh, Chaste tree, Cranberry, Feverfew, Garlic, Ginger , Ginkgo, Green tea, Hawthorn, Horse chestnut, Peppermint, Red clover, Siberian ginseng, St. John’s wort, Valerian

Asserting safety is important, but what about efficacy? We have shown beyond reasonable doubt that acupuncture/acupressure works for:

Back pain

Dental pain

Nausea and vomiting.

Contrary to what many believe, acupuncture is not a panacea. According to our results, it is, for instance, not more effective than a placebo for smoking cessation or weight loss, both indications for which it is popular. And for most other conditions we currently cannot be sure. Essentially this means that we need more and better research.

The results of our research into the efficacy of herbal medicine are much more complex. Obviously each remedy has to be judged on its own merit, and generalisations are not possible. Table 2 is an attempt to summarise the evidence to date.

 

Future challenges

Few areas of medicine are as much in the public eye as is complementary medicine. During the last 10 years, I found this to be a mixed blessing. On the one hand, publicity can facilitate raising the much-needed funds. On the other hand, this high visibility renders interference from outside a strong possibility. Only a fool would reject true expert advice but the advice I am talking about is often from ‘self-appointed experts’. Thus it is frequently ill-conceived, misleading, driven by various self-interests and unscientific. Add political correctness to all this and you have a powerful but unappetising cocktail which can turn into a significant obstruction to effective research. It was Bert Brecht who once wrote, “the opposite of good is not bad but good intentions”. The challenge for complementary medicine research will be to channel such public interest constructively.

Complementary medicine research must be as scientifically sound as any other research and, at the same time, it should thoughtfully account for the many idiosyncrasies of this field. Scientifically sound means, amongst other things, that investigations should:

• minimise bias
• be reproducible
• seek to establish causal relationships where possible.

The challenge, in my view, is to conduct research in such a way that it even convinces critics.

We also should be clear about the best strategy for making progress. ‘Integrated medicine’ has fast become the new buzz word in complementary medicine. It stands for two different principles: firstly whole person medicine, and secondly the incorporation of complementary medicine into medical routine. In my view, this dual concept is superfluous, misleading and counter-productive. It is superfluous because all good medicine has always adopted a whole person approach. It is misleading because incorporation of well-documented treatments of any type is not ‘integrated’ but evidence-based medicine, a concept already well-established worldwide. And it is counter-productive because integration of unproven therapies (which many complementary therapies unquestionably are) would render healthcare only less effective and more expensive. The challenge with respect to new, fashionable terminology or concepts is to adequately scrutinise their validity before adopting them.

 

Conclusion

Is rigorous research into complementary medicine a “mission impossible”? Obviously not. It is fraught with difficulties but it is both feasible and important. I would even go one step further: vis a vis the current popularity of this sector it has become an ethical imperative to determine which treatments generate more good than harm. To do this work to a different standard than conventional medical research would be failing all concerned, not least the consumer/patient.

Table 1: Some popular methods used in complementary medicine

Name	Principle	Conditions used for	Efficacy	Safety	Risk-benefit balance*
Acupuncture	Needle insertion into acupuncture points for health purposes	Various (used as a panacea in China)	See text	See text	Positive (for some conditions only)
Alexander technique	Training process of ideal body posture and movement; developed by FM Alexander	Musculoskeletal problems	Few clinical trials exist, no final verdict possible	No serious adverse effects	Uncertain
Applied kinesiology	Diagnostic technique using muscle strength as an indicator; developed by G Goodheart	Various (e.g. allergies)	Repeatedly shown to be not valid	Can delay reliable diagnoses, danger of false diagnoses	Negative
Aromatherapy	Application of essential oils usually through gentle massage techniques; developed by RM Gatttefossé	Relaxation	Systematic review was inconclusive	Allergic reactions to oils	Uncertain
Autogenic training	Form of self-hypnosis for relaxation and stress reduction; developed by J Schultz	Stress management	Encouraging evidence	No serious adverse effects	Positive

Name	Principle	Conditions used for	Efficacy	Safety	Risk-benefit balance*
Chelation therapy	Intravenous infusion of EDTA used for ‘deblocking’ arteries from arteriosclerotic lesions	Circulatory disorders	Repeatedly shown in rigorous clinical trials to be ineffective	Serious adverse effects reported	Negative
Chiropractic	Popular manual therapy based on the assumption that most health problems are due to malalignments of the spine and treatable through spinal manipulation; developed by DD Palmer	Back pain	Conclusions of systematic reviews of chiropractic for back pain are not uniform. The methodologically best are not positive	Serious adverse effects have been reported, their exact incidence is not known	Negative
Colonic irrigation (or colon therapy)	Cleansing of the colon through water enemas, e.g. to ‘free the system of toxins’	Various	No sound evidence	Serious adverse effects reported	Negative
Herbal medicine	Medical use of preparations containing exclusively plant material	Various (depending on herb used)	See text	See text	Positive (for some conditions only)
Homoeopathy	Medical use of diluted remedies according to the ‘like cures like’ principle	Various (mostly benign, chronic conditions)	No sound evidence	No serious adverse effects	Negative

Name	Principle	Conditions used for	Efficacy	Safety	Risk-benefit balance*
Hypnotherapy	Induction of trance-like state to influence the unconscious mind	Various	Some evidence	Adverse effects probably infrequent	Positive
Iridology	Diagnostic technique using signs and impurities on the iris	Various, including predispositions to diseases	Shown to be not valid	Can delay reliable diagnosis	Negative
Macrobiotic diet	Diet based on the yin/yang principle using whole grains and vegetables	Disease prevention	Positive effects on cardiovascular risk factors	Serious adverse effects reported	Negative
Massage	Various techniques of manual stimulation of cutaneous, subcutaneous, or muscular structures	Musculoskeletal problems	Some evidence for effectiveness in musculoskeletal and psychological problems	Few serious adverse effects	Positive
Osteopathy	Various techniques of spinal mobilisation; developed by T Still	Back pain	Systematic reviews of osteopathy for back pain are inconclusive	Adverse effects less than with chiropractic	Inconclusive
Reflexology	Internal organs correspond to areas on the sole of the feet and can be influenced through massaging these	Relaxation	Systematic review was inconclusive	No serious adverse effects	Inconclusive

Name	Principle	Main indications	Efficacy	Safety	Risk-benefit balance*
Spiritual healing	Umbrella term for techniques of channelling of ‘healing energy’ through a healer into a patient	Re-establishing a wholesome balance	Clinical studies highly contradictory; the best recent studies are negative	No serious adverse effects	Negative
Yoga	Meditative, postural, and breathing techniques from ancient India	Various	Promising evidence for effectiveness in asthma, cardiovascular risk factors and other conditions	No serious adverse effects	Positive

 

*   for the most favourable indication

 

Table 2: Efficacy of herbal medicines