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.
Author
(s) Details
Jagminder Kaur Bajaj
Department of Pharmacology, Punjab Institute of Medical Sciences,
Jalandhar, Punjab, India.
Satinder Jit Singh
Bajaj
Civil Hospital, Jalandhar, Punjab, India.
Prem Parkash Khosla
Department of Pharmacology, Gian Sagar Medical College, Banur, Patiala,
Punjab, India.
Rani Walia
Department of Pharmacology, Maullana Medical College, Ambala, Haryana,
India.
Please see the book here:- https://doi.org/10.9734/bpi/mmrnp/v12/2689
