Clinical Efficacy of Pyridoxine and Mefenamic Acid Alone and in Combination in Premenstrual Syndrome

Abstract

Abstract-A wide range of drugs from different pharmacological groups have 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. The present study evaluated and compared with placebo, the clinical efficacy of Pyridoxine and Mefenamic acid alone & in combination in relieving symptoms of pre-menstrual syndrome( PMS) Material/ Methods-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 respectively for 7 days preceeding menstruation. Patients filled 36 item PMTS self rating scale and 22 item daily diary for 2 months before treatment to record baseline symptoms and during treatment cycle. 22 symptoms were divided into 4 subsets of physical, anxiety related, depression related and fluid-electrolyte related symptoms to study effect of drugs. Results-Statistically significant improvement from baseline symptoms occurred in patients receiving Pyridoxine, Mefenamic acid and their combination (group B,C, D), but mean %age improvement in all the 3 groups was not significantly different from Placebo (p>0.05). Significant (p<0.05) improvement in subset of physical symptoms occurred with mefenamic acid alone, but not with combination of pyridoxine and mefenamic acid. Conclusion-Placebo controll group must always be included in Premensrual syndrome trials. Mefenamic acid 250 mg TDS for 7 days preceeding menses relieved physical symptoms of PMS. However the beneficial effect was lost on combining pyridoxine