Aim: To assess the current clinical evidence of the effectiveness of Xiangshaliujunzi Decoction (XSLJZD) for the treatment of diabetic gastroparesis (DGP).
Methods: Randomized controlled trials (RCTs) were retrieved from seven major electronic databases including Medline, the Cochrane Library, Embase, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure, Chinese Scientific Journal Database (VIP), and Wanfang Databases, using search dates from the beginning of the databases to May 2013. No language limitations were applied. We included RCTs that used XSLJZD or a modified XSLJZD compared with a control group for the treatment of DGP. The control groups included conventional treatment (Western medicinal treatment), placebo, and no treatment (blank), but not acupuncture. The main outcome index was clinical effectiveness, which was based on the gastric emptying test and variations in the gastrointestinal (GI) symptoms between the treatment and control groups after intervention. Data extraction, analysis, and quality assessment were conducted according to the Cochrane Handbook for Systematic Review of Interventions, Version 5.1.0.
Results: Ten RCTs involving 867 patients (441 in the experimental groups, and 426 in the control groups) were identified, and the overall methodological quality was evaluated as generally low. In the treatment groups, all 10 trials used herbs alone as the treatment, whereas all control groups used prokinetic medicine. The period of intervention ranged from 2 to 8 wk. Three classes were used to evaluate treatment efficacy: significant effective, effective, and ineffective, and all trials used the clinical effective rate (based on the gastric emptying test and changes in GI symptoms) to evaluate efficacy. The data showed that the effects of XSLJZD for the treatment of DGP were superior to the control group (n = 867, RR =1.33, 95%CI: 1.24-1.42, Z = 8.11, P < 0.00001). Two trials recorded adverse events, and one trial reported follow-up.
Conclusion: XSLJZD could restore the gastric emptying rate and improve symptoms. However, the evidence remains weak due to the poor methodological quality of the included studies.
Keywords: Diabetic gastroparesis; Gastric emptying rate; Gastrointestinal symptoms; Systematic review; Xiangshaliujunzi Decoction.