Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Chaoyang District, Beijing 100029, China.
Evid Based Complement Alternat Med. 2012;2012:640658. doi: 10.1155/2012/640658. Epub 2012 Aug 27.
Background. There is no curative treatment for primary Sjögren's syndrome (PSS). Chinese herbal medicine (CHM) is widely used in the treatment of PSS in China. Objective. To evaluate the effectiveness and safety of CHM for PSS. Methods. PubMed, Cochrane Library, China Knowledge Resource Integrated Database, Chinese Biomedical Database, Wanfang Data, and the Database for Chinese Technical Periodicals were searched for randomized controlled trials (RCTs) of CHM or CHM plus conventional medicine for PSS compared with placebo or conventional medicine. RevMan 5.0.17 was employed to conduct data analyses and assess homogeneity. Statistical models were chosen according to heterogeneity. Results. A total of 52 RCTs were included. The overall methodological quality of included trials was low. 49 trials reported response rates, of which 32 found significant improvements favoring CHM treatment against controls; 20 trials reported lacrimal function by Schirmer test scores, of which 16 trials reported a significant difference favoring CHM treatment. 21 trials reported salivary function by salivary flow rate, of which 10 reported significant favorable effects of CHM treatment. Other trials found no difference. The reported adverse effects of CHM included nausea, diarrhea, and other minor digestive symptoms, but more frequent adverse effects occurred in conventional medicine groups. Conclusions. Preliminary evidence from RCTs suggests the effect of CHM is promising for relieving symptoms, improving lacrimal and salivary function in PSS. However, the poor methodological quality of the included trials means that further well-designed, multicentered, larger trials are needed.
原发性干燥综合征（PSS）目前尚无治愈方法。中药（CHM）在中国广泛用于治疗 PSS。目的：评估 CHM 治疗 PSS 的疗效和安全性。方法：检索 PubMed、Cochrane Library、中国知识资源总库、中国生物医学文献数据库、万方数据和中国科技期刊数据库，纳入 CHM 或 CHM 联合常规药物治疗 PSS 与安慰剂或常规药物比较的随机对照试验（RCT）。采用 RevMan 5.0.17 进行数据分析和异质性评估。根据异质性选择统计模型。结果：共纳入 52 项 RCT。纳入试验的总体方法学质量较低。49 项试验报告了应答率，其中 32 项研究发现 CHM 治疗组的应答率明显高于对照组；20 项试验报告了泪液功能的 Schirmer 试验评分，其中 16 项研究报告 CHM 治疗组的泪液功能明显改善；21 项试验报告了唾液功能的唾液流率，其中 10 项研究报告 CHM 治疗组的唾液功能明显改善。其他试验未发现差异。报告的 CHM 不良反应包括恶心、腹泻和其他轻微的消化症状，但常规药物组的不良反应更频繁。结论：RCT 的初步证据表明，CHM 缓解 PSS 症状、改善泪液和唾液功能的效果有一定前景。然而，纳入试验的方法学质量较差，需要进一步开展设计良好、多中心、更大规模的试验。
