A double-blind clinical trial on a herbal remedy for premenstrual syndrome: a case study

Author(s): MIILLS, S.

Abstract: A herbal remedy Vitex agnus castus was tested against a placebo for the relief of Symptoms associated with the premenstrual syndrome (PMS). The trial was a formally conducted double-blind randomised controlled trial on a volunteer sample of self-diagnosed sufferers of PMS using a form of the long-established Moos menstrual distress questionnaire. The main focus of interest after pilot studies was in symptoms of negative effect. These were fully explored both by individual symptoms and as a group. In only one reported symptom ('feel jittery or restless') was a statistically significant difference shown between Vitex and placebo. The other main symptoms groups studied included those of impaired concentration, fluid retention and pain. Statistical analysis revealed a similar pattern of effect for Vitex and placebo with the exception of the fluid retention group where there was some difference, but not of statistical significance. Generally the pattern of effect for both treatments was a dramatic improvement at the end of the first cycle with relative stability over the next two cycles. The only exception to this was the reported symptom feel jittery or restless' in the negative affect group which, under Vitex, had a sustained effect in comparison to placebo. At the end of the trial period detailed statistical analysis could find no difference between those who completed and those who withdrew with respect to age, marital status, cycle length and employment. It is concluded that, in this clinical trial, Vitex showed little difference in treatment effect to that of the placebo in the majority of symptoms associated with PMS. There were suggestions, however, from both the subjects' spontaneous responses and the findings with the fluid retention group, that further investigations would be justified.

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