Efficacy and Safety of Topical Sahastara Extract Cream in Primary Knee Osteoarthritis Compared with Capsicum Gel: A Double-Blind Randomized Controlled Trial
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Abstract
Objective: To study the efficacy and safety of Sahastara extract cream in primary knee osteoarthritis patients compared with capsicum gel. Methods: The study was a double-blind randomized controlled clinical trial in 60 volunteers. The participants were divided into 2 groups, i.e., the group receiving Sahastara extract cream, the group receiving capsicum gel. The medication was applied three times a day. The study measured the outcomes on day 7, 14 and 28 by assessing pain after 100-meter walk using visual analog scale (VAS), using Thai version of the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and Thai version of the KOOS (Knee Injury and Osteoarthritis Outcome Score). Safety outcomes were evaluated from history taking and physical examination on side effects in all follow-up visit and laboratory test for liver function and renal function. Results: The results on day 28 showed that the subjects in the Sahastara extract cream group and capsicum gel group had pain scores (VAS) at 28.70±19.09 and 37.73±17.86, respectively. Total scores from the WOMAC were 21.70±16.93 and 22.93±18.48, respectively. Total scores from the KOOS were 49.20±30.25 and 50.00±32.87, respectively. All of the scores significantly decreased from day 0 (P < 0.05). All subjects had normal liver and kidney function. Efficacy and safety of both medications were not different (P > 0.05). The only mild observed side effect was a burning sensation at the applied area in the group with capsicum gel. Conclusion: Sahastara extract cream for topical use is effective in reducing the pain and improve the quality of life among patients with primary osteoarthritis of the knee with no significant different from capsicum gel. Comparative study with standard treatment such as diclofenac should also be conducted with a larger sample size study in order to confirm the results.
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ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
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