A randomized comparative study of herbal decoction of Cassia fistula Linn pod's pericarp and Myristica fragrans Houtt arils vs. mefenamic acid in spasmodic dysmenorrhoea

Abstract

Abstract Background To compare the efficacy and safety of herbal decoction (pods of Cassia fistula Linn. and Arils of Myristica fragrans Houtt) with mefenamic acid in spasmodic dysmenorrhoea. Methods In this single-blind, prospective, parallel, standard controlled study, dysmenorrheic patients (n=64) were randomly allocated to receive herbal decoction (n=31) or mefenamic acid (n=33) for two consecutive menstrual cycles. Treatment group received 180 mL herbal decoction of post amaltas (Cassia fistula L pod’s pericarp) (21 g), bisbasah (Myristica fragrans Houtt arils) (3 g) and qand siyah (jaggery) (30 g) which were orally administered at morning for 3 days before the expected start of menstruation. The control group received mefenamic acid 500 mg orally twice daily between day 1 and day 3 of menstruation. The primary outcomes were visual analog scale (VAS) for pain intensity, pain relief scale and the safety assessment by clinical examination and biochemical parameters. The secondary outcomes included health-related quality of life (HRQoL) determined by SF-12 health survey questionnaire, duration of pain and pictorial blood assessment chart score for menstrual blood loss. The data were statistically interpreted with 5% level of significance. Results At the baseline, on day 1, pain severity for VAS score between the groups [7.09 ± 1.07 vs. 6.75 ± 1.09] had no significant difference (p>0.05). However, during the second menstrual cycle, a significant reduction [0.03 + 0.17 vs. 0.42 + 1.44] in pain severity on day 1 was noted in both groups (p<0.001). During the second menstrual cycle, improvement in HRQoL health survey [SF-12 total score: 85.88 ± 5.99 vs 74.83 ± 15.9] and reduction in pain duration were significantly higher in the treatment group compared to the control group. No side effects were reported. Conclusion Herbal decoction was effective to relieve pain and to improve HRQoL in spasmodic dysmenorrhoea.