Should NICE evaluate complementary and alternative medicines?

A recent article in the March 8, 2007 issue of BMJ asks the question
“Should NICE evaluate complementary and alternative medicines.” (BMJ 2007;
334: 507) In the commentary, the author concludes, “. . . NICE has found
no good evidence for anything more than placebo effects.” He goes on to
claim that, “There is no need to subscribe to the early 19th century
pseudoscientific hocus pocus of homoeopathy to treat sick patients.” This
oft-cited belief is a prominent argument against the practice of
homeopathy.

However, recent preliminary evidence, if confirmed, may dispel this
viewpoint. It is generally accepted that a drug can be defined by its
ability to produce an action via alteration of human or organism
biochemistry. One easily-measured action is the drug’s lethal dose (LD).
Often used in testing prospective pharmaceutical candidates, LD50, is the
Lethal Dose of a chemical that is expected to kill 50% of the population
that receives it. Few would dispute that the ability of an agent to kill
50% or more of the organisms exposed to it classifies the agent as having
a potent action.

In two independent controlled studies, conducted at the Forsyth
Institute (Boston) and Indiana University’s Center for Regenerative
Biology and Medicine, an unexpected result was obtained during the testing
of two ultra-dilute homeopathic remedies (no actual molecules present) in
Xenopus laevis tadpoles. During experiments that increased the dosage
added to the tadpoles standard medium (1:10 ratio), all the animals in the
experimental groups died. After thoroughly evaluating materials and
protocols, the research teams were not able to offer a competing
hypothesis as to why all the animals died except that it was due to the
action of the two remedies. Xenopus are known to be highly sensitive to
environmental signals including various radiations, which are purported to
be at the core of homeopathic actions.

Although these results are preliminary, they provide evidence
suggesting the need to consider reclassifying homeopathics from a
“placebo” state to an actual drug with potent actions. In any case,
further study is strongly recommended. Contact PHISInfo@aol.com for
additional information.

Competing interests:
Our company (www.phisinc.com) created the remedies being tested at the institutions mentioned.

Dear Editor,

I wish to contribute to the debate between Franck et al. and
Colquohoun (1) as to whether the National Institute for Health and
Clinical Excellence (NICE) should evaluate complementary and alternative
medicine (CAM). It is likely that NICE will evaluate at least some
further aspects of CAM sooner or later, given the prevalence of CAM
therapies in both the private and public sectors. In this event NICE will
require specific expertise on individual CAM therapies in order to
maintain its standards of excellence in the appraisal process.

Evaluation by NICE is desirable for many practitioners of CAM who
wish our services to be free at the point of need and to achieve greater
equality of provision. However, CAM research requires evaluation for
model validity which assesses the likelihood that the research has
adequately addressed the unique theory and therapeutic context of the CAM
system (2). NICE has never before required this context-specific
expertise and should therefore call upon the professional bodies of
practitioners to ensure that evaluation of a CAM treatment includes
expertise relevant to the treatment in question.

The randomised, placebo-controlled trial is not the only valid and
rigorous method of conducting research. Neither is it appropriate to
every question or for measuring every type of outcome. RCT may not be the
optimal methodology for economic evaluation if data are not collected for
long enough to demonstrate the full costs and benefits; if the trial
context controls out significant variables or if it is irreproducible in
practice. We should not allow methodological preferences to determine
which treatments we evaluate; rather we should respond to the challenge of
conducting rigorous research relevant to the intended user.

At present, most CAM provision is private and thus cost-benefit is
judged on an individual basis by the service users (notably, in their
thousands) rather than by a national agency. Consequently, research
methodology is often more suitable for refining practice than for
providing proof of efficacy to policy makers (for example, clinical
audits, qualitative studies, outcomes research, case reports). The
appropriateness of a particular research methodology or outcome measure
for its intended audience is as important as its appropriateness in the
treatment modality under investigation.

As other respondents have highlighted, it is difficult for
practitioners of CAM to obtain research funding, so perhaps a re-
distribution of research funds to allow those experienced in a particular
field to evaluate it would facilitate future consideration of CAM
modalities by NICE.

1. Franck L, Chantler C, Dixon M and Colquhoun D (2007) Should NICE
evaluate complementary and alternative medicine? BMJ 334, 506-507.

2. Lewith G, Walach H and Jonas WB (2002) Balanced research strategies for
complementary and alternative medicine. In: Lewith G, Jonas WB and Walach
H, Clinical Research in Complementary Therapies. Churchill Livingstone;
Edinburgh.

Competing interests:
Member of the National Institute of Medical Herbalists

Nobody is proposing to ban fairies or leprechauns. It would be both
undesirable and impossible.

There does seem to be a case, though, for not providing leprechauns
at the tax payers' expense. And really all leprechauns that are sold to
the public should have labels that don't make false claims for their
powers. Unfortunately the MLRA (Medicines and Leprechauns Regulatory
Agency) has let us down in the matter of labelling. I suspect infiltration
of the Department of Health by little green men.

Competing interests:
None declared