It is a curious assumption, and illogical that a
complementary therapy could have sufficient
pharmacological activity to improve health (how-
ever imprecisely that may be defined), and yet
these properties are automatically insufficient to
cause harm. Part of the problem is that adverse
reactions to ‘natural’ therapies are not reported in
the same way as for orthodox drugs (Barneset al.,
1998). Reporting bias also tends toward the asso-
ciation of adverse effects with the condition being
treated rather than from the ‘harmless’ over-the-
counter or herbal remedy that has been adminis-
tered. The only complementary therapies that are
safe in overdose are those that are homeopathic,
with even these carrying the clinical hazard of
under-treatment.
30.4 Regulatory aspects
Homeopathic drugs are regulated in much the same
way as allopathic drugs; there are some over-the-
counter formulations, but most are prescribed and
can onlybe dispensedbyapharmacist in theUnited
Kingdom. Chinese medicines are essentially unre-
gulated; as in mediaeval Europe, these can be pre-
scribed by both a Chinese medical practitioner and
a Chinese pharmacist (using the term Chinese to
describe their disciplines, not their nationality),
and much responsibility rests on the pharmacist
for identification of the correct plants, resisting
the purchase of cheap materials from unreliable
suppliers and knowing what to look for in quality
control. Other forms of herbal remedy (including
all nine discussed above) are freely available in
supermarkets and pharmacies in most jurisdic-
tions. Mail order, using the worldwide web for
advertising, is increasing, and will undoubtedly
cause legal issues with cross-border commerce
and transportation in the future.
In the United States, most herbal manufacturers
simply write a letter to the US FDAto notifywhen a
new product is being introduced, sometimes pro-
viding an example of the labels and tablets for
identification purposes. The Food, Drug and Cos-
metic Act has been interpreted as almost totally
inapplicable in this situation, and is certainly not
enforced. FDA does maintain adverse event regis-
ters for all forms of drug through the usual Med-
watch forms.Further reading
Anonymous. 2004. Medicinal plants – guidelines to
promote patient safety and plant conservation for
a US$ 60 billion industry. World Med. J. 50 :
78–79.
Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E.- Different standards for reporting ADRs to
herbal remedies.Br. J. Clin. Pharmacol. 45 : 496–500.
Bent S, Kane C, Shinohara K, Neuhaus J,et al. 2006.
Saw palmetto for benign prostatic hyperplasia.
New Engl. J. Med. 354 : 557–566.
Cheng JT. 2000. Review: drug therapy in Chinese tradi-
tional medicine.J. Clin. Pharmacol. 40 : 445–450.
Critchley JAJH, Zhang Y, Suthisisang CC, Chan TYK,
Tomlinson B. 2000. Alternative therapies and med-
ical science: designing clinical trials of alternative/
complementary medicines – is evidence-based
traditional Chinese medicine attainable?J. Clin.
Pharmacol. 40 : 462–467.
Eisenberg DM, Kessler RC, Foster C, Norlock FE,
Calkins DR, Delbanco TL. 1993. Unconventional
medicine in the United States. Prevalence, costs, and
patterns of use.New Engl. J. Med. 328 : 246–252.
Ernst E. 1996.Complementary Medicine: a Critical
Appraisal. Butterworth-Heinemann: Oxford, UK.
Ernst E. 2004. The GMC is right to come down hard on
doctors who wrongly prescribe complementary
medicine.Guardian 15.
Tomlinson B, Chan TYK, Chan JCN, Critchley JAJH,
But PPH. 2000. Toxicity of complementary thera-
pies: an eastern perspective.J. Clin. Pharmacol. 40 :
451–456.
Zollman C, Vickers A. 1999. What is complementary
medicine?Br. Med. J. 319 : 693–696.
392 CH30 COMPLEMENTARY MEDICINES