Abstract
Background Zhengqing Fengtongning release tablet (ZQFTN) is a proprietary Chinese medicine preparation of sinomenine, the main active component of the traditional Chinese medicine (TCM) Sinomenium acutum. It is used in China as a complementary and alternative medicine (CAM) for knee osteoarthritis (KOA). The objective of this study was to evaluate the clinical efficacy and safety of ZQFTN in KOA treatment. Method Randomized controlled trials of ZQFTN in KOA treatment were searched in PubMed, Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journals Database, and Wanfang database. Two reviewers independently conducted the screening, extracted the data, and assessed the methodological quality. Statistical analysis was performed using RevMan 5.3 software. Results Eighteen studies were assessed that included 1512 participants (757 in the treatment group and 755 in the control group). The results showed that compared with the control group, the Visual Analogue Scale (standardized mean difference (SMD) = −0.87, 95% confidence interval (CI): [−1.08, −0.66], P < 0.001), Western Ontario and Mc Master University (WOMAC) Osteoarthritis Index pain score (SMD = −0.67, 95% CI: [−0.88, −0.46], P < 0.001), WOMAC stiffness score (SMD = −0.53, 95% CI: [−0.86, −0.20], P=0.001), WOMAC function score (SMD = −0.76, 95% CI: [−0.97, −0.55], P < 0.001), serum interleukin-1β level (SMD = −4.36, 95% CI: [−6.41, −2.31], P < 0.001), and serum tumor necrosis factor-α level (SMD = −8.45, 95% CI: [−11.20, −5.69], P < 0.001) of the ZQFTN treatment group were lower, and the total effective rate was higher relative risk (RR = 1.15, 95% CI [1.07, 1.23], P < 0.001). There was no significant difference in the incidence of adverse reactions between the two groups (RR = 0.96, 95% CI: [0.69, 1.35], P=0.82). Conclusion ZQFTN can effectively relieve knee pain, morning stiffness, and daily activity function disorders, reduce the expression of inflammatory factors in serum, and improve the total clinical response rate without increasing the incidence of adverse reactions. Therefore, ZQFTN has considerable potential as a CAM for KOA. However, due to the limitation of the quality of the included studies, the strength of this conclusion is affected. In the next step, multicenter, large sample, high-quality randomized controlled studies are needed to further confirm the present conclusion.
Highlights
Knee osteoarthritis (KOA) is a degenerative disease that occurs in the knee joint, with chronic joint pain, swelling, stiffness, and dysfunction as the main manifestations
In seven studies [22, 23, 27, 31,32,33, 35], Zhengqing Fengtongning release tablets (ZQFTN) combined with symptomatic slow acting drugs for osteoarthritis (SYSADOA) was defined as the experimental group, with 318 patients in total, and SYSADOA was used by the control group, with 315 patients in total
In three studies [21, 24, 29], ZQFTN combined with nonsteroidal anti-inflammatory drugs (NSAIDs) was defined as the experimental group, with a total of patients, and NSAIDs were used by the control group, with a total of patients
Summary
Knee osteoarthritis (KOA) is a degenerative disease that occurs in the knee joint, with chronic joint pain, swelling, stiffness, and dysfunction as the main manifestations. The drugs used to treat KOA mainly include analgesics, intraarticular corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and symptomatic slow acting drugs for osteoarthritis (SYSADOA) [2,3,4]. These drugs have certain effects on the pain and disease relief of osteoarthritis (OA) patients, they increase the incidence of gastrointestinal ulcers and cardiovascular events, affecting their use by some patients [5]. Abstract] OR “Sinomenine” [Title/Abstract] OR “Sinomenium” [Title/Abstract] (3) “Randomized controlled trial” [Title/Abstract] OR “random trials” [Title/Abstract] OR “Controlled clinical trial” [Title/Abstract] (4) (1) and (2) and/or (3)
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