RESUMO
OBJECTIVE: To compare clinical practice guideline recommendations on the use of oral patent Traditional Chinese Medicines (PTCMs) for uncomplicated acute lower respiratory tract infections (ALRTIs) in adults with the existing evidence using results of a systematic review of randomized controlled trials (RCTs). METHODS: A systematic review on RCTs and a systematic review of current guidelines on orally taken PTCMs for uncomplicated ALRTIs were performed. PubMed, Cochrane Library, EMBASE and four Chinese databases were searched from inception to September 2016 for RCTs testing orally taken PTCMs for uncomplicated ALRTIs (excluding pneumonia). Two reviewers independently screened each study, extracted study data, and assessed risk of bias. Disagreements were resolved through discussion or by consultation with a third reviewer. Clinical practice guidelines for uncomplicated ALRTIs containing PTCM recommendations were identified and quality appraised. The quality of pooled evidence of the RCTs and the guidelines was assessed with GRADE and AGREE respectively. The consistency of the evidence base in RCTs and the guideline recommendations were then compared. RESULTS: For the systematic review of RCTs, 4810 papers were identified, among which 29 RCTs (5093 patients) were included in the review. PTCMs compared to placebo increased the effective treatment rate of cough (3 trials, 949 patients, risk ratio (RR) 2.50, 1.16 to 5.43; low certainty); improved assessment of global health (3 trials, 948 patients, RR 1.70, 1.44 to 2.01; low certainty); and increased the effective rate of specific symptom relief (1 trial, 478 patients, RR 4.01, 2.76 to 5.81; moderate certainty). 21 trials (3432 patients) compared effects of different PTCMs. For the guideline evaluation, 29 PTCMs were recommended for the use of uncomplicated ALRTIs, of which27 had no supportive evidence from RCTs. CONCLUSION: The evidence base of PTCMs for uncomplicated ALRTIs is weak and the guideline recommendations were based on almost no clinical trial evidence. Rigorous clinical research is urgently needed to inform the clinical use of these herbal medicines. Further training in evidence-based medicine methods for Traditional Chinese Medicine guideline developers is essential.
RESUMO
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.