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.
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