A Comparative Double-Blinded Randomized Study: The Efficacy of Prasaplai Herbal Extract Versus Mefenamic Acid in Relieving Pain Among Primary Dysmenorrhea Patients

ABSTRACT

Prasaplai is a traditional Thai herbal remedy for primary dysmenorrhea, while Mefenamic acid is one of the conventional drugs used to treat this illness. To control the efficacy, quality, and safety of the herb, we extracted Prasaplai with 70% ethanol and tested its toxicity in vivo and in vitro. The results showed non-toxicity to cells, whether in rats or humans. In terms of the sampling process, 516 patients were recruited, but only 207 of them fulfilled the inclusion criteria and took part in the study. The participants were randomized into the control group (N = 104) and the treatment group (N = 103). In this study, we carried on a clinical trial phase III by giving to the control group (group 1) 2 capsules (250 mg/cap) of Mefenami acid that looked similar to Prasaplai capsules in the same manner that Prasaplai capsules were given. For the treatment group (group 2), 2 capsules (200 mg/cap) of Prasaplai extract was given 3 times a day for 3 days starting at the onset of each period for 6 periods. The severity of pain as well as the signs and symptoms of possible side effects were examined and followed up every month. The hematology, blood chemistry, and liver function and renal function were studied before starting the treatment and at months 3and 6 during the treatment. The side effects and efficacy of both drugs were compared based on age, BMI, menarche, and the durations of menses and cycles. The data were analyzed using ANOVA. The results showed no statistically significant differences between the two groups. The hematology, blood chemistry, liver function, and renal function were within the normal limits both before and during the treatment for both groups. Furthermore, the two drugs had no severe side effects. A comparison of the decrease in the severity of primary dysmenorrhea demonstrated that the degree of pain relief was not statistically different between the two groups. Based on the results, it can be concluded that Prasaplai 70% alcohol extract is as efficacious in relieving primary dysmenorrhea as Mefenamic acid with no side effects.

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