Herbal drugs - cause for concern?

HERBAL MEDICINE almost needs no introduction: it is common to all races, cultures and epochs. Dating from time immemorial, it is still extensively practised today.

It is a popular belief that, because herbal medicines are of `natural' origin, they are harmless and free of side-effects. This is clearly not true as many plants including foods, as well as medicinal herbs, contain known toxic constituents. The media is being successfully used by the manufacturers of herbal drugs to make lofty promises of curing intractable ailments.

Many herbal drugs claimed to be miraculous cures for chronic illnesses like diabetes have been found to be no better than placebo treatment when subjected to clinical trials by us at the Madras Diabetes Research Foundation. Finally there are serious issues with respect to herb safety. There are no specific guidelines followed to ensure acceptable levels of impurities such as bacterial counts, pesticides, residual solvents and heavy metals.

Detection of toxic materials in herbal formulations are frequently reported in medical journals. The New England Journal of Medicine and the British Medical Journal, two of the best peer-reviewed medical journals in the world have recently carried several articles that caution against the risks of using herbal drugs. Particular mention was made of lead poisoning which was frequently noted with the use of Indian herbal remedies.

A prospective study published in the Lancet showed that 25 per cent of the corneal ulcers in Tanzania and 26 per cent of the childhood blindness in Nigeria and Malawi were associated with the use of traditional eye medicines. Similarly the British Diabetic Association reported deterioration of type 1 diabetes in patients who reduced or stopped their insulin in favour of alternative therapeutic approaches. Some were diagnosed with ketoacidosis, others with serious diabetic retinopathy diabetic eye disease).

In our experience at the M.V. Diabetes Specialities Centre and the Madras Diabetes Research Foundation, we have had at least 3 deaths due to patients resorting to ``herbal'' cures for diabetes. One of these, a 24 year old man died of liver failure a few weeks after trying out a ``traditional remedy'' given by a quack.

Another patient developed severe bone marrow depression which proved fatal and the third patient died of renal failure presumably due to heavy metal poisoning in the ``bhasmam'' (ash) given by a traditional practitioner. A 13 year girl who had juvenile insulin dependent type 1 diabetes was doing very well and receiving life long free treatment at our centre until she was lured away by a practitioner claiming to ``cure'' her diabetes with a herbal treatment. Two weeks later, she died of diabetic ketoacidosis and coma.

In the first three cases cited, the deaths were due to the side effects of toxic ``herbal'' preparations while the fourth was a sheer case of negligence due to patient being taken away from a proper accepted, scientific method of treatment into an unproven treatment which being ineffective, resulted in death.Allopathic medicines evolve out of a rigorous scientific evaluation known as Randomised Controlled Clinical Trials (RCCT). This process goes through a phase of pre-clinical testing in animals followed by Phase I, II, III and IV of clinical trials which leads to the eventual marketing of the drugs. Subsequently, post-marketing surveillance continues for several years. Drug controllers of most countries including India, insist on local clinical trials of even well documented medicines in order to rule out local idiosyncratic reactions among our people. In the case of herbal drugs, no such regulating processes exit. All that is needed is an aggressive publicity campaign and the drug is hooked on to the gullible public.

M. Balasubramanian & V. Mohan

Madras Diabetes Research Foundation

Chennai

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