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Background: Premenstrual syndrome (PMS) is a multifactorial, psycho-neuroendocrine disorder, characterised by the cyclical recurrence of a combination of various physical, psychological, affective, behavioural, cognitive, neuro-vegetative and autonomic symptoms, not caused by any organic disease, which regularly recurs during the luteal phase of menstrual cycle and regress during the proliferative phase. A wide range of drugs from different pharmacological groups has been tried in premenstrual syndrome by various investigators, with contradictory reports. Pyridoxine is reported to relieve autonomic and behavioural symptoms and NSAIDs to relieve physical symptoms.

Aim: The present study evaluated and compared with placebo, the clinical efficacy of Pyridoxine and Mefenamic acid alone and in combination in relieving symptoms of pre-menstrual syndrome (PMS).

Materials and Methods: The study sample included Patients attending the premenstrual symptom clinic of the Department of Obstetrics & Gynaecology of Govt. Medical College & Rajindra Hospital, Patiala, India. In this study, 80 female patients between 18-45 years of age, diagnosed to be suffering from PMS were randomly divided into 4 groups (A,B,C,D) of 20 patients each. They received Placebo tablets, Pyridoxine HCl 100 mg OD, Mefenamic acid 250 mg TDS and a combination of Pyridoxine and Mefenamic acid in same doses respectively for 7 days preceeding menstruation. Patients filled out 36 item PMTS self-rating scale and a 22 item daily diary for 2 months before treatment to record baseline symptoms and during the treatment cycle. Here, 22 symptoms were divided into 4 subsets of physical, anxiety-related, depression-related and fluid-electrolyte-related symptoms to study the effect of drugs. Values were expressed as mean ± S.E., median and range. Fischer’s exact probability test was used to compare patients’ sociodemographic features, ANOVA to compare menstrual cycle characteristics and Mann- Whitney’s U test to compare the median symptom scores before and after treatment, the mean % age improvement of groups B, C & D with placebo and effect of drugs on subsets of symptoms.

Results: Statistically significant improvement from baseline symptoms occurred in patients receiving Pyridoxine, Mefenamic acid and their combination (group B,C, D), but mean % of age improvement in all the 3 groups was not significantly different from Placebo (p>0.05). Significant (p<0.05) improvement in a subset of physical symptoms occurred with mefenamic acid alone, but not with a combination of pyridoxine and mefenamic acid. There is no significant difference between the 4 groups on anxiety-related, depression and fluid electrolyte-related symptoms.

Conclusion: A placebo control group must always be included in Premenstrual syndrome trials. Mefenamic acid 250 mg TDS for 7 days preceding menses relieved physical symptoms of PMS. However, the beneficial effect was lost on combining pyridoxine.