DEVELOPMENT OF CLINICAL PRACTICE GUIDELINES AND EVALUATION OF EFFICACY AND SAFETY OF PRASAPLAI FOR TREATMENT OF PRIMARY DYSMENORRHEA IN WOMEN AT HOSPITALS IN UDON THANI PROVINCE.

Abstract

      This study had three objectives: (1) to develop a CPG for Prasaplai in the management of primary dysmenorrhea, (2) to evaluate its clinical efficacy and safety, and (3) to formulate policy recommendations for integration into the public health system. This study was single-group pre-post quasi-experimental study was conducted among women diagnosed with primary dysmenorrhea. Participants received oral Prasaplai 1,000 mg three times daily before meals for five consecutive days within one menstrual cycle. Pain severity was measured using the Visual Analogue Scale (VAS) and health-related quality of life was assessed with the EQ-5D-5L instrument. Pre- and post-intervention comparisons were performed using Paired t-test and Wilcoxon signed-rank test. Safety was monitored through blood biochemistry profiles and hepatic and renal function tests.

      Result: Phase 1 yielded a CPG encompassing five core domains: diagnostic criteria, patient eligibility, prescribing protocols, monitoring procedures, and referral criteria; the guideline received formal validation by the expert panel. In Phase 2, a total of 30 participants with a mean age of 30.27 ± 4.76 years were enrolled. VAS pain scores declined significantly from 6.33 ± 1.63 at baseline to 4.27 ± 1.93 post-intervention, representing a mean difference of 2.07 points (95% CI: 1.30–2.84; p<0.001), which exceeded the established Minimal Clinically Important Difference (MCID) threshold of ≥2 points. The EQ-5D-5L Utility Index improved from 0.725 to 0.934 (p=0.001). All biochemical laboratory parameters remained within normal reference ranges throughout the study period (p>0.05), indicating an acceptable safety profile. In Phase 3, the Udon Thani Provincial Health Planning and Evaluation Committee formally resolved to adopt the CPG as the provincial standard of practice.