Abstract
The objective of this systematic review was to conduct a meta-analysis of the efficacy and safety of total glucosides of paeony (TGP) for the treatment of ankylosing spondylitis (AS). TGP is commonly applied as a complementary medicine, especially in combination with disease-modifying antirheumatic drugs (DMARDs) and/or non-steroidal anti-inflammatory drugs (NSAIDs) to treat AS in China. Nevertheless, the efficacy and safety of TGP combination treatment still needs more validation. A systematic literature search was conducted using PubMed, EMBASE, Web of Science, the Cochrane library, ClinicalTrials, the Chinese Biomedical Literature database (CBM), the China National Knowledge Internet (CNKI), the Wan Fang Medical Database and the VIP Database for available randomized controlled trials (RCTs) investigating the efficacy and safety of TGP on AS up to November 2018. Review Manager 5.3 software and Stata 12.0 software were used to analyze all included studies according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement protocol. The pooled results of 23 RCTs exhibited better symptoms improvement (SI) (95% CI 1.16 to 1.36), lower erythrocyte sedimentation rate (ESR) (95% CI −5.89 to −1.32), lower levels of C-reactive protein (CRP) (95% CI −5.01 to −1.49), morning stiffness (MS) time (95% CI −3.46 to −1.86), finger to floor distance (FFD) (95% CI −4.80 to −0.86), peripheral joint pain index (PJPI) (95% CI −3.48 to −0.69), and higher level of thoracic expansion (TE) (95% CI 0.18–0.40) in TGP group. While Schober's test (Schober) showed no significant difference between the two groups. Adverse events (AEs) were significantly decreased (95% CI 0.48–0.79) with the usage of TGP. It is worthwhile to apply TGP as an auxiliary medicine on AS for better efficacy and less side effects, especially when considering the impact of traditional treatment on the liver. Still, further clinical trials with larger sample and better methodological quality are warranted to ascertain the potential benefits of TGP on AS.
Highlights
Ankylosing spondylitis (AS) is a chronic progressive autoimmune disease of still unknown etiology, characterized by sacroiliitis and enthesitis
Meta-analysis was done for these adverse events (AEs): Patients with AEs: (RR = 0.62, 95% CI 0.48–0.79, P = 0.0002); Abnormal liver function: (RR = 0.26, 95% CI 0.17–0.40, P < 0.00001); Diarrhea: (RR = 2.48, 95% CI 1.53–4.01, P = 0.0002); Gastrointestinal disorder: (RR = 0.67, 95% CI 0.51–0.89, P = 0.005); Leukopenia: (RR = 0.41, 95% CI 0.16–1.05, P = 0.06); Rash: (RR = 0.53, 95% CI 0.15–1.89, P = 0.33)
Since the lipid profile has yet to be investigated in clinical trial regarding TGP on AS, we propose more emphasis to be put on this aspect
Summary
Ankylosing spondylitis (AS) is a chronic progressive autoimmune disease of still unknown etiology, characterized by sacroiliitis and enthesitis. Considering toxicity, contraindications and expenses, conventional synthetic disease-modifying antirheumatic drugs (DMARDs) can be applied and sulfasalazine (SSZ) may be applied to patients with peripheral arthritis (van der Heijde et al, 2017). When developing a management strategy for AS clinically, weighing the benefits and risks is always needed. Such therapeutic strategies are either costly or are prone to serious adverse events (AEs). NSAIDs have been reported to increase the risks of cardiovascular, gastrointestinal, and renal effects (van der Heijde et al, 2017). TNF inhibitors can be prescribed to patients with persistently high disease activity as recommended by 2016 ASAS/EULAR, they may aggravate infection risk or advance heart failure, lupus as well as cancer (Taurog et al, 2016). It is imperative to explore effective and safer pharmacologic strategies for AS, especially complementary and alternative medicine
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