Kim NamHoon, Kim Si-Yeon, Kim Sang-Woo, Lee Jung Min, Kim Sung-Kyu, Park Mi-Houn, Kim Ki-Hwan, Oh Minseok, Son Chang-Gue, Jung In Chul, Lee Eun-Jung
Department of Korean Rehabilitation Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.
Clinical Trial Center, Daejeon Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea.
Front Pharmacol. 2023 Mar 14;14:1114410. doi: 10.3389/fphar.2023.1114410. eCollection 2023.
This study aimed to evaluate the clinical efficacy and safety of PE extracts developed for the purpose of relieving pain and improving knee joint function on semi-healthy people with mild knee joint pain. A randomized, double-blind, two-arm, single-center, placebo-controlled clinical trial was conducted. Individuals with knee joint pain and a visual analogue scale (VAS) score < 50 mm were included in the study, and participants with radiological arthritis were excluded. Participants were administered either PFE or a placebo capsule (700 mg, twice a day) orally for eight weeks. The comparisons of the changed VAS score and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores between the PFE and placebo groups were primary outcomes, while the five inflammation-related laboratory tests including cartilage oligomeric matrix protein, cyclooxygenase-2, neutrophil and lymphocyte ratio, high sensitive C-reactive protein, and erythrocyte sedimentation rate were secondary outcomes. Also, a safety assessment was done. Eighty participants (mean age, 38.4 ± 14.0, male: female, 28:52) were enrolled; 75 completed the trial (PFE 36 and placebo 39). After eight weeks, both VAS and WOMAC scores were reduced in the PFE and placebo groups. The changed scores were significantly higher in the PFE group compared to the placebo group: 19.6 ± 10.9 vs. 6.8 ± 10.5; VAS scores ( < 0.001), and 20.5 ± 14.7 vs. 9.3 ± 16.5; total WOMAC scores ( < 0.01) including the sub-scores for pain, stiffness, and functions. No significant changes were reported in the five inflammation-related laboratory parameters. All adverse events were considered minor and unlikely to result from the intervention. Eight weeks of PFE intake was more effective than placebo in reducing knee joint pain and improving knee joint function in sub-healthy people with mild knee joint pain, and there were no major safety concerns. https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=23101&status=5&seq_group=19745, identifier CRIS: KCT0007219.
本研究旨在评估为缓解疼痛和改善膝关节功能而研发的PE提取物对轻度膝关节疼痛的半健康人群的临床疗效和安全性。开展了一项随机、双盲、双臂、单中心、安慰剂对照的临床试验。研究纳入膝关节疼痛且视觉模拟评分（VAS）<50mm的个体，排除有放射性关节炎的参与者。参与者口服PFE或安慰剂胶囊（700mg，每日两次），持续八周。PFE组和安慰剂组之间VAS评分变化以及西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分变化的比较为主要结局，而包括软骨寡聚基质蛋白、环氧化酶-2、中性粒细胞与淋巴细胞比值、高敏C反应蛋白和红细胞沉降率在内的五项炎症相关实验室检查为次要结局。此外，进行了安全性评估。共招募80名参与者（平均年龄38.4±14.0，男:女为28:52）；75名完成试验（PFE组36名，安慰剂组39名）。八周后，PFE组和安慰剂组的VAS和WOMAC评分均降低。与安慰剂组相比，PFE组的评分变化显著更高：VAS评分为19.6±10.9 vs. 6.8±10.5（<0.001），总WOMAC评分为20.5±14.7 vs. 9.3±16.5（<0.01），包括疼痛、僵硬和功能的子评分。五项炎症相关实验室参数未见显著变化。所有不良事件均被认为轻微，不太可能由干预导致。对于轻度膝关节疼痛的半健康人群，摄入八周PFE在减轻膝关节疼痛和改善膝关节功能方面比安慰剂更有效，且无重大安全问题。https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=23101&status=5&seq_group=19745，标识符CRIS：KCT0007219 。
