Pilot Study on Efficacy and Safety of Prasaplai Extract Capsules for Relieving Acute Pain from Muscle Strain
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Abstract
Objective: To evaluate the efficacy and safety of Prasaplai extract for relieving acute pain from muscle strain. Methods: This pilot study was a double-blinded, randomized controlled trial (RCT) in 148 patients aged between 20–45 years old with acute muscle strain with pain score at least three. Patients were randomized into two groups using computer program with 74 patients in each group. The patients received two Prasaplai extract capsules (250 mg/cap) three times/day with placebo of diclofenac tablets or one diclofenac sodium tablet (25 mg/tab) three times/day with the placebo of Prasaplai for 7 days. Pain scores, pain characteristics, and adverse events were assessed at 6 hours and 7 days after drug administration. In addition, liver and renal functions were evaluated using laboratory tests. Results: After drug administration for 7 days, proportions of patients with pain intensity improvement between two groups were not statistical significant (risk difference=-0.01, 95%CI: -0.17, 0.15). However, the reduction of pain scores after drug taking in both groups were statistically significant (P<0.05) and clinically significant. Pain intensity decreased from baseline by 67.73% (95%CI: 59.59, 75.87) for Prasaplai group, and 68.48% (95%CI: 61.23, 75.74) for diclofenac group. No severe adverse events were found, but mild adverse events were reported in both groups. One patient with rash and one with itching were reported in Prasaplai group. One patient with face angioedema, and one with eye angioedema were reported in diclofenac group. The differences of liver and renal function tests of both groups were not statistically significant. Conclusion: This pilot study indicated that efficacy of Prasaplai extract on pain relief in patients with acute muscle strain was not inferior to diclofenac and it is safe for short-term use. However, the large study with long term follow up should be further performed.
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ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
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