Abstract
Objectives To systematically evaluate the efficacy and safety of sinomenine preparation (SP) for treating ankylosing spondylitis (AS). Methods Clinical randomized controlled trials (RCTs) of SP for treating AS were systematically identified in six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wanfang Databases from the inception up to 31 October 2019. Cochrane's risk of bias tool was used to assess the methodological quality and Review Manager 5.3 software was used to analyze data. Results A total of 12 RCTs involving 835 patients were finally included. According to interventions, RCTs were divided into two types. The intervention in 10 RCTs was SP combined with conventional pharmacotherapy (CPT) versus CPT and that in 2 RCTs was SP alone versus CPT. The results of the meta-analysis showed that, compared with CPT alone, SP combined with oral CPT has better improvement in BASDAI (WMD = −1.84, 95% CI [−3.31, −0.37], P=0.01), morning stiffness time (WMD = −13.46, 95% CI [−16.12, −10.79], P < 0.00001), the Schober test (WMD = 1.26, 95% CI [0.72, 1.80], P < 0.00001), the occipital wall test (WMD = −0.55, 95% CI [−0.96, −0.14], P=0.009), the finger-to-ground distance (WMD = −3.28, 95% CI [−5.64, −0.93], P=0.006), 15 m walking time (WMD = −8.81, 95% CI [−13.42, −4.20], P=0.0002), the C-reactive protein (CRP) (WMD = −1.84, 95% CI [−3.24, −0.45], P=0.01), and the total effective rate (RR = 1.10, 95% CI [1.01, 1.20], P=0.03). Besides, it also showed that oral SP alone may be more effective in improving morning stiffness time (WMD = −31.89, 95% CI [−34.91, −28.87], P < 0.00001) compared with CPT alone. However, this study cannot provide evidence that loading the injectable SP based on CPT can significantly increase the efficacy due to the insufficient number of studies included. In terms of adverse events, there was no statistically significant difference between the experimental group and the control group. Conclusions This study shows that oral SP may be effective and safe in the treatment of AS. Due to the low methodological quality of the included RCTs and the limitations of the meta-analysis, it is still necessary to carry out more multicenter, large-sample, and high-quality RCTs to further verify the conclusions. The review protocol was registered on PROSPERO (CRD42018099170), and the review was constructed following the PRISMA guidelines (Annex 1).
Highlights
Axonal spinal arthritis is a clinically common chronic progressive inflammatory disease caused by cellular stresses [1, 2]
It has proven that oral sinomenine preparation (SP) + conventional pharmacotherapy (CPT) may be more effective in treating Ankylosing spondylitis (AS) compared with CPT alone in many indicators including bath ankylosing spondylitis disease activity index (BASDAI), morning stiffness time, Schober test, occipital wall test, finger-toground distance, 15 m walking time, C-reactive protein (CRP), and total effective rate, but it has not proven in bath ankylosing spondylitis functional index (BASFI), chest expansion, and SER
One study [47] showed that injectable SP + CPT may be more effective compared with CPT alone in BASFI, but no statistical significance in other indicators due to the insufficient number of studies included
Summary
Axonal spinal arthritis (axSpA) is a clinically common chronic progressive inflammatory disease caused by cellular stresses [1, 2]. Experts in related fields believe that the main therapeutic goal of AS is to prevent the progressive structural damage by controlling symptoms and inflammation to maintain the body function of the patient, thereby maximizing social participation and improving long-term quality of life [11]. E serious complications of advanced AS include hip fusion, spinal deformity, and a spinal fracture. If necessary, surgeries such as total hip arthroplasty and spine surgery should be performed. AS is a chronic disease requiring long-term medication. E long-term medication will cause serious adverse reactions and economic burden [15, 16] AS is a chronic disease requiring long-term medication. e long-term medication will cause serious adverse reactions and economic burden [15, 16]
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