A Randomised, comparative study to evaluate the efficacy and tolerability of two fixed dose combinations of Camylofin & Mefenamic acid and Dicyclomine & Mefenamic acid in the management of Primary Dysmenorrhea

Abstract

Primary dysmenorrhea (PD) is a common gynaecological disorder affecting nearly 50% of menstruating women. Camylofin combination with paracetamol has demonstrated superior efficacy than dicyclomine- paracetamol combination, in the treatment of colicky abdominal pain. However, comparative data on these two antispasmodics in combination with Mefenamic acid in PD is not available. Aim: To compare the efficacy and tolerability of fixed dose combinations of Camylofin + Mefenamic acid and Dicyclomine + Mefenamic acid in patients with Primary Dysmenorrhea. Methods: A randomised, open-label, comparative study, to evaluate the efficacy and tolerability of a fixed-dose combination of Camylofin 50 mg + Mefenamic acid 250 mg (Study Group) and Dicyclomine 10 mg + Mefenamic acid 250 mg (Control Group) in 50 PD patients. Results: In the study group (Camylofin + Mefenamic Acid) the VAS scores reduced by 86% and 100% on day 3 and day 5 respectively as compared to a marginally less decrease in VAS scores by 82% and 95% on day 3 and day 5 respectively in the control group(P>0.05). Patients with complete pain relief (study end) were almost 96% and 88% patients in the study and control groups respectively (P>0.05). Global assessment of efficacy by the investigator showed that 73% of the patients in the study group were rated as ‘Very Good’ to ‘Excellent’ as compared to 54% of the patients in the control group (P>0.05). Conclusion: These findings suggest that Camylofin + Mefenamic acid may be a better alternative to Dicyclomine + Mefenamic acid. However, the results did not attain statistical significance.