Case Study 5: A Study Evaluating the Use of Traditional Medicines

A plant common to South Asia, "thankuni" (Hydrocotyle asiatica), when dried, ground up into powedery form, then added to water (reconstituted) is reported to be effective in the treatment of bloody diarrhea.  One paper, suggesting that "thankuni" has an affect on decreasing bloody diarrhea, has appeared in an unrefereed journal from an institute of traditional medicine in India.  "Thankuni" is the only ingredient of a popular traditional medicine, "Ajorno", also produced by a local company, which is widely available, very popular, and quite inexpensive.  No clinical studies have been conducted on this product, and the specific chemical composition has not been determined.   An investigator at an international research institution in Bangladesh is intrigued by this product and wishes to evaluate its clinical effectiveness.   The present pharmaceutical treatment for dysentery (by far the most common cause of bloody diarrhea in the country) is fluid and ampicillin, an antibiotic that is clinically effective and bacteriocidal.  Ampicillin, however, is often unavailable outside the major cities, 80% of the population is rural, and when available, ampicillin is too expensive for most people.  The investigator reasons that, if the traditional medicine is proved to be effective for diarrhea, lower cost and increased availability will make an equally effective therapy more accessible to everyone.

He submits a protocol to the study committee of the institute for a well-designed double-blind study that compares the clinical effectiveness and bacteriacidal properties of "Ajorno" against ampicillin.  Adult patients admitted or seen on an outpatient basis with a history of dysentery will be randomly assigned to one of the treatment groups after a rectal swab has been taken for a bacteriological diagnosis.  "Ajorno" in a powdered form will be put into a gelatin capsule so that it becomes indistinguishable from the antibiotic.

The study committee meets and votes not to approve the protocol for the following reasons:

(1) the specific chemical composition of "Ajorno" is not known;
(2) the prior reports of effectiveness has been for "bloody diarrhea", a fuzzy and inexact diagnosis which might include any number of diagnoses, including dysentery and amoebiasis; and
(3) no studies reported in refereed journals have indicated that this traditional medicine is effective, nor has any mechanism for its reported effectiveness been suggested.

The investigator notes that defining all the ingredients of this traditional medicine would be nearly impossible, and that undertaking such a study would be a prohibitively costly.  Further, he argues, the synergistic interaction of Ajorno's different ingredients most probably explains the the drug's reported effectiveness.   Finally, he suggests that those on the review panel who voted against approval are biased against traditional medicines, denigrating the indigenous science of the country, and trying to impose their own "Western" biases on scientific research, whcih rightly understood can be logically applied to the systematic thinking inherent in the received folk medicine practices.

Comment on the ethics of this study.  The following questions should be considered:

• Was the committee correct in its assessment?
• Is the investigator correct in his accusation that those voting 'no' are showing "Western" bias in their decision?
• If the study were to be approved, would the committee be using a double-standard in its assessment of the ethics of the design?