Complementary medicine must prove its worth
BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7484.166 (Published 20 January 2005) Cite this as: BMJ 2005;330:166
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While I welcome the recent Institute of Medicine report calling for
more stringent evaluation of Complementary and Alternative medicine
(CAM)(1), and agree that even conventional/modern medicine could benefit
from a more stringent evaluation, I would like to direct the discussion to
use of evidence based medicine as a tool to perform such an evaluation.
Picking up from a discussion about evidence based medicine published
earlier in the BMJ,(2,3) I would like to share my experience on using
evidence based medicine to evaluate CAM.
We conducted an evidence based systematic review of Ayurvedic
medicine for diabetes. (4) Applying the evaluation criteria of evidence
based medicine to the ayurvedic clinical trials we were struck by the poor
quality of evidence for the effectiveness of ayurvedic herbs for diabetes.
We found only 1 high quality clinical trial and a handful of average
quality clinical trials from an initial database of over 2000 articles.
Most of the studies were review articles, or animal studies or of poor
methodological rigor.
Using the rules of evidence based medicine, our conclusions were that
there was evidence that a handful of herbs had a glucose lowering effect
but they required further study before they could be recommended for
routine use in treating diabetes.
However, while conducting this study, I was struck by the sheer
quantity of clinical literature and the amazing amounts of patient level
clinical experience that existed on the use of ayurvedic herbs for
diabetes especially in India. Our evidence based report merely scratched
the surface of a wealth of data about several potentially useful
treatments. Applying a strictly quantitative criteria, without analyzing
this data in the cultural and socio-economic context in which the clinical
trials were conducted or the patients treated provided, in my opinion, a
skewed view of the efficacy of ayurvedic medicine for diabetes.
This is not to say that I believe that the conduct of rigorous
scientific studies should be stopped or put aside by complementary
medicine. However, a recognition of the limitations of evidence based
medicine and the development of innovative evaluation tools for evaluating
complementary and alternative medicine is required. I was heartened to see
this realizaion in the institute of medicine's report as verbalized by Dr.
Bondurant.(1)
Complementary medical systems such as Ayurveda would benefit from a
systematic and scientific approach by ayurvedic professionals to evaluate
their own work. Identifying priority areas, where prelimnary data of
efficacy exists, and setting up of cohorts and registries of patients who
are treated with ayurvedic medicine would be a good starting point.
References:
1) Marwick C. Complementary medicine must prove its worth. BMJ. 2005 Jan
22;330(7484):166.
2) M G Myriam Hunink. Does evidence based medicine do more good than
harm? BMJ 2004;329:1051
3) Twisselmann B. Evidence based medicine: does it make a difference?
BMJ 2005;330:94
4) Hardy M, Coulter I, Venuturupalli S et al.
Ayurvedic interventions for diabetes mellitus: a systematic review. Evid
Rep Technol Assess (Summ). 2001 Jun;(41):2p. Review. PMID: 11488136
Competing interests:
None declared
Competing interests: No competing interests
It is easy to take a jaundiced view of yet another call for
complementary medicine to prove itself to the same standard as
conventional medicine (1), especially in respect of its relative safety
record, referred to in previous articles and correspondence. We are
however aware that such demands must be taken seriously if complementary
medicine is to become more widely integrated into the national healthcare
systems in Western countries.
The British Acupuncture Council (BAcC) with 2,400 members and
representing 14 acupuncture colleges and universities is committed to
building the evidence base for the profession. Ten years ago it set up,
and continues to fund (from members’ subscriptions), the Acupuncture
Research Resource Centre (ARRC), now sited at a UK university. ARRC
provides information and advice to support research projects and to
increase research awareness amongst the profession (2). As a result of the
independent course accreditation body (the British Acupuncture
Accreditation Board), a research component has been introduced into the
curriculum of BAcC-accredited colleges. (3) The trend towards research-
mindedness has accelerated as these training courses have attained
university degree status.
The importance of gathering evidence on effectiveness and safety was
identified in the US report(4) but it is also acknowledged that a spectrum
of quantitative and qualitative methodologies are required. Acupuncture
is a complex intervention whose evaluation requires a sophisticated and
multi-layered approach, similar to that outlined by the Medical Research
Council(5). Definitive randomised controlled trials require funding at a
level beyond the resources of a practitioner organisation and expertise
that is beyond the reach of most of its members. Recent papers have
suggested the need for expertise based(6) and pragmatic designs(7).
However, the pre-clinical and other exploratory stages can employ a
variety of approaches that are suited to practitioner-researchers (indeed,
the whole process may lose external validity if this is not the case). The
BAcC has and continues to fund a number of such projects( 8-10) and BAcC
members have collaborated on cutting-edge theoretical research(11,12). Two
large acupuncture safety studies funded by the BAcC are at the forefront
of the evidence base in that respect(9, 13). In the current round of BAcC
grants, money was allocated to projects on depression (a pragmatic
randomised controlled trials) and reduction of anxiety associated with
cataract surgery (a pilot study).
Randomised controlled trials of sufficient size and quality are in
short supply for complementary medicine, but the situation is changing.
Several substantial studies published in the last year have provided
encouraging results for acupuncture (14-16), a collection of huge trials
in Germany is nearing completion, and there are many more to come from the
US (17).
The BAcC will continue to play its part. We are expanding our range
of grants to encourage more practitioners to participate: by attending
training courses, receiving support to produce a project proposal or to
write up completed work for publication(18). The recent correspondence in
the BMJ(19) asking readers to emphasise the importance of patient values
and needs to provide ‘evidence informed practice’ comes at an important
time for the acupuncture profession as it proceeds towards statutory self
regulation(20) .
Nicola Robinson
Professor of Complementary Medicine
Chair of British Acupuncture Council Research Committee
Mark Bovey
Acupuncture Research Resource Centre Research co-ordinator
Centre for Complementary Healthcare and Integrated Medicine (CCHIM),
Faculty of Health & Human Sciences,
THAMES VALLEY UNIVERSITY,
Walpole House,
18-22 Bond Street,
Ealing, London W5 5AA, United Kingdom
e-mail: nicky.robinson@tvu.ac.uk
Website: www.cchim.com
1. Marwick, C. Complementary medicine must prove its worth. BMJ
2005; 330: 166.
2. Bovey, M., Ward, T. Patterns of demand and supply for an
acupuncture research information service. Focus on Alternative and
Complementary Therapies 2003; 8(4):484.
3. The House of Lords Select Committee on Science and Technology
Sixth Report on Complementary and Alternative Medicine (CAM). Available
from:
[Accessed 26 October 2004]
4. Institute of Medicine of the National Academies. (2005)
Complementary and Alternative Medicine (CAM) in the United States
[online]. Washington, D.C: The National Academies Press. Available from:
5. A framework for development and evaluation of RCTs for complex
interventions to improve health. MRC Health Services and Public Health
Research Board, April 2000.
6. Devereaux, P.J. Need for expertise based randomised controlled
trials. BMJ 2005; 330:88.
7. Tunis, S.R., Stryer, D.B. & Clancy, C.M. Practical clinical
trials: Increasing the value of clinical research for decision making in
clinical and health policy. JAMA 2003; 290:1624-1632.
8. Bovey, M., Horner, C., Shaw, J., Linthwaite, P., Mole, P., Pedley,
B., Robinson, N. Engaging in the audit of acupuncture practice: the Dao-
base study. 2004; Accepted for publication in the Journal of Alternative
and Complementary Medicine.
9. MacPherson, H., Thomas, K., Walters, S., Fitter, M. The York
acupuncture safety study: prospective survey of 34 000 treatments by
traditional acupuncturists. BMJ 2001; 323(7311), p.486-7.
10. Mayor, DF. ed. Electroacupuncture: A Practical Manual and
Resource Elsevier London.(In press July 2005).
11. MacPherson, H., White, A., Cummings, M., Jobst, K., Rose, K.,
Niemtzow, R. Standards for reporting interventions in controlled trials of
acupuncture: the STRICTA recommendations. Complement Ther Med 2001; 9(4),
p.246-9.
12. Birch, S., Hammerschlag, R., Lewith, G. International workshop on
acupuncture research methodology: introduction to consensus reports on
workshop topics. Clinical Acupuncture and Oriental Medicine 2002; 3(1),
p.10-11.
13. MacPherson, H., Scullion, A., Thomas, K.J., Walters, S. Patient
reports of adverse events associated with acupuncture treatment: a
prospective national survey. Qual Saf Health Care 2004; 13(5), p.349-55.
14. MacPherson, H., Thorpe, L., Thomas, K., Campbell, M. Acupuncture
for low back pain: traditional diagnosis and treatment of 148 patients in
a clinical trial. Complement Ther Med 2004; 12(1), p.38-44.
15. Vickers, A.J., Rees, R.W., Zollman, C.E., McCarney, R., Smith,
C.M., Ellis, N., Fisher, P., Van Haselen R. Acupuncture for chronic
headache in primary care: a large, pragmatic, randomised trial. BMJ 2004;
328(7442):744.
16. Berman, B.M., Lao, L., Langenberg, P., Lee, W.L., Gilpin, A.M.,
Hochberg, M.C. Effectiveness of acupuncture as adjunctive therapy in
osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med
2004; 141(12), p.901-10.
17. http://nccam.nih.gov/clinicaltrials/ (see Internet referencing)
18. Robinson, N. British Acupuncture Council News. 2005; Feb (in
press)
19. Letters Evidence based medicine: does it make a difference? BMJ
2005; 330: .92-93.
20. www.dh.gov.uk/consultations/liveconsultations/fs/en
Competing interests:
None declared
Competing interests: No competing interests
Sir
I agree with Tariq M Khan that any system that confines itself to
only those concepts which can be readily proven by strict scientific
standards could be termed “Scientific Medicine”.
I look forward to the day, which I suspect is a long way off, when
such a medicine becomes available.
Regards
John H.
Competing interests:
None declared
Competing interests: No competing interests
Neville W Goodman, in his rapid response of 26th January, 2005,
asserts that:
‘Some of the deaths caused by conventional medicine will be due to
some sort of error, and thus potentialy avoidable. But most of them are
due to side effects, and no one pretends that drugs do not have side
effects.’
Regrettably this is untrue; many pharmaceutical companies do pretend
that their products have no side effects. For example, perhaps your
readers would care to look at the letter recently sent by the FDA to
Pfizer regarding advertising material on celecoxib and valdecoxib:
‘These five promotional pieces variously:
omit material facts, including the indication and risk information;
fail to make adequate provision for the dissemination of the FDA-approved
product labeling; and
make misleading safety, unsubstantiated superiority, and unsubstantiated
effectiveness claims.’
See http://www.fda.gov/cder/warn/2005/12560-letter.pdf
He goes on to state:
‘All drugs have risks and benefits, and if the benefit outweighs the
risk then the drug is used.’
Regrettably, this is also untrue; the BMJ is notable for the
generosity with which it recognises important research papers published
elsewhere, so I know that you will not object to me directing your readers
to the early online paper by David J Graham et al published this week in
the Lancet, (http://www.thelancet.com/home )
and summarised by the editors thus
‘A study by David Graham from the US Food and Drug Administration
estimates that between 88,000 and 140,000 Americans developed coronary
heart disease as a result of using the arthritis drug Vioxx (rofecoxib).’
No-one, even amongst Merck’s numerous and well-paid apologists, has
ever substantiated the claim that Vioxx had benefits which might
conceivably outweigh these risks.
Stevie Gamble
Competing interests:
None declared
Competing interests: No competing interests
Many people from Homeopathy use the term ALLOPATHIC MEDICINE or
ALLOPATHY and that term is frequently used by even the practitioner of modern or conventional medicine. I think this is a wrong term.
Allopathy
was a term invented by early homeopaths to distinguish it from the
earlier philosophy of medicine practiced in those days, when the medicines
were prescribed according to the imbalance of humoral temperament of the
body. For example then it was thought that a particular disease is caused
by increase or decrease of Blood, Phlegm, Yellow Bile; Black Bile the
usual medicines were prescribed which used to restore balance to those
humours. That type of philosophy was prevalent in Greek medicine and
later adopted by Muslims and still practiced widely in theIndian subcontinent.
Similar concepts but with different names are practiced in Ayurveda and
Chinese medicine. Whereas in homeopathy they invented a system of medicine
where the similar kind of substances (but in much diluted doses) were
prescribe to treat the diseases that produce similar types of symptoms.
Thus they invented the term homeopathy and regarded other types as
Allopathy.
We all know in modern concept of medicine there is no such philosophy so
it is inappropriate to use the term Allopathy for modern medicine. As
modern medicine incorporates only those concepts which can be readily
proven by strict scientific standards the better term for it, I think,
should be “Scientific Medicine”.
Competing interests:
None declared
Competing interests: No competing interests
A glance at the "Life Extension" website mentioned by P Rudnick gives
other clues about how the incredible figure of 783,936 deaths in USA each
year "caused by conventional medicine" was reached:
Bedsores: 115,000
Malnutrition: 108,800
Infection: 88,000
Outpatients: 199,000
etc.
I'm not clear about why all these are attributed to conventional
medicine. Also, each figure was obtained from a different paper -- so
patients may be counted more than once (the bedsores of a malnourished
patient are particularly likely to get infected. And if s/he's an
outpatient...).
Competing interests:
None declared
Competing interests: No competing interests
"...the total number of deaths caused by conventional medicine is an
astounding 783,936 per year. It is now evident that the American medical
system is the leading cause of death and injury in the US. (By contrast,
the number of deaths attributable to heart disease in 2001 was 699,697,
while the number of deaths attributable to cancer was 553,251"
Whenever anyone questions the effectiveness of alternative therapies,
a number of stock arguments are put forward in favour of alternative
medicines. The one quoted above is a common one. It is entirely spurious.
Some of the deaths caused by conventional medicine will be due to some
sort of error, and thus potentialy avoidable. But most of them are due to
side effects, and no one pretends that drugs do not have side effects. All
drugs have risks and benefits, and if the benefit outweighs the risk then
the drug is used. Abandoning conventional medicine would not "save"
783,936 lives per year, because a fair proportion of those patients would
die from whatever disease they were being treated for, mostly heart
disease and cancer, because they kill more people than any other diseases.
Competing interests:
None declared
Competing interests: No competing interests
The US Institute of Medicine deserves to be applauded for its new
report on complementary and alternative therapies. The recommendation that
these treatments (if they really are therapeutic) should be required to
demonstrate their clinical effectiveness to the same standard as
conventional medical treatments is very welcome. For many years, drugs and
medical equipment and devices have been subject to extensive regulation by
governments, and rightly so. High standards of scientific documentation of
effectiveness and safety are required before permission is given to
advertise and market a product. Stringent surveillance of products
benefits both patients and the medical profession.
By contrast, alternative and complementary therapies are subject to
little regulation and scientifically acceptable proof of efficacy and
safety is seldom available. Patients are wooed by advertisements in
magazines, by testimonials issued by celebrities with no scientific
training, by paperback books, and by pseudoscientific journals that do not
utilise peer review of articles. The business of providing these therapies
is immensely profitable and much of it may be fraudulent. Patients may be
harmed financially and physically, and if they choose to forsake
conventional Medicine for these alternatives, their health and lives may
be jeopardised.
Whereas drugs are subject to strict regulation, dietary supplements,
herbal remedies and "natural" treatments are not. Many substances of
unproven value are now on sale in conventional pharmacies. It is probable
that many of these are ineffective and some may be actively harmful. The
Institute of Medicine suggests that the law regulating dietary and herbal
supplements needs to be revised to strengthen quality control and
labelling accuracy and to deal with inaccurate and misleading health
claims. One must surely agree with this recommendation.
This is not to suggest that all complementary or alternative
therapies are valueless. Some may be truly beneficial, but in the absence
of suitable standards and oversight, they cannot be identified.
Competing interests:
None declared
Competing interests: No competing interests
This article is interesting and published timely. No doubt scientific
validation regarding its safety profile and efficacy is absoluetely
essential. It needs emphasis at this level, one has to design the protocol
suitable to the system used and not the usual way applicable for modern
medicine. While the safety profile can be followed as described for pre-clinical testing, the clinical trial warrants major modification. For
example, if an ayurvedic drug requires clinical trial, it should be done
in an ayurvedic hospital utilizing the expertise of qualified ayurvedic
physcicans. Besides, while comparing the efficay, the standard drug
selected should be one from the same system of medicine proved effectve as
well as safe and not from other systems. The integration of meodern
medicine and complementary medicine sholud take place while suspecting
system-system drug interaction when taken together only, that too after
establishing the validation independantly. Unless such procedures are given
a loud thinking the possibilty of using ineffective complementary
medicines cannot be averted. Simultaneously, the ways and means for best
utilty of complementary medicine be not neglected and given priority.
Competing interests:
None declared
Competing interests: No competing interests
Re: Complementary medicine must prove its worth
To the editor:
Recently, Charles Marwick has pointed out, based on a new report from US
Institute of Medicine, the need for complementary therapies to prove their
effectiveness by using the same standard as conventional medicine (1).
Calls have also been made for more research and regulation in alternative
medicines (2). There is a need for comprehensive, reliable and easily
accessible reference sources to disseminate and evaluate the benefits and
risks of alternative medicines (3). The research of alternative medicines
can be facilitated if the information about all their aspects, ranging
from multi-herb recipes to herbal constituents, can be provided (4, 5).
One such resource has just become available. The Traditional Chinese
Medicine Information Database (TCM-ID),
http://tcm.cz3.nus.edu.sg/group/tcm-id/tcmid.asp, has been introduced as a
web-resource to provide, free-of-charge for academic use, information
about all aspects of herbs used in traditional Chinese medicine including
prescriptions, constituent herbs, herbal ingredients, and their respective
therapeutic effects and clinical indications and applications. The
molecular structure and functional properties of active ingredients are
also provided. TCM-ID currently contains 1,197 TCM prescriptions covering
4111 disease conditions, 1,104 herbs, and 9,862 ingredients (4,500 of
these with molecular 3D structure provided).
Data in TCM-ID were generated from reputable Chinese TCM books and
relevant Western and Chinese journals including Complement Ther Med, J
Altern Complem Med, Am J Chin Med, Planta Medica, J Ethnopharmacol, J
Pharm Sci, Phytochem, Chin Trad Herb Drugs, Acta Pharmacol Sinica, J Chin
Med Mat, and Chin J Med Chem. Each prescription/herb/ingredient can be
retrieved through multiple methods including prescription name, herb name
in three languages (Latin, English and Chinese), name of herbal
ingredient, therapeutic effect and symptom.
References:
1.Marwick C. Complementary medicine must prove its worth. BMJ 2005;
330: 166
2.Voelker R. IOM points to need for more research, regulation in
alternative medicine. JAMA 2005; 293: 1178-1180.
3.Peter A. G. M. De Smet. Health risks of herbal remedies: An update.
Clin Pharmacol Ther. 2004; 76:1-17
4.Yuan R, Lin Y. Traditional Chinese medicine: An approach to
scientific proof and clinical validation. Pharmacol Ther 2000; 86: 191-
198.
5.Chen X, Ung CY, Chen YZ. Can an in silico drug-target search method
be used to probe potential mechanisms of medicinal plant ingredients? Nat
Prod Rep 2003; 20: 432-444.
Competing interests:
None declared
Competing interests: No competing interests