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Aim: Early interventions in prediabetes can prevent or delay the incidence of type 2 diabetes mellitus (TDM). The aim of this review was to assess the efficacy and safety of traditional Chinese patent medicine (TCPM) on the prevention of TDM.
Methods: Seven electronic databases were searched to identify eligible trials published until June 1, 2016. Randomized controlled trials (RCTs) that compared TCPM plus lifestyle modification (LM) versus LM alone were included for in the. RCTs that used TCPM plus LM compared with placebo plus LM were also included. Methodological quality was assessed using the Cochrane Collaboration Risk of Bias tool. A random- or fixed-effect model was used to analyze outcomes that were expressed as risk ratios (RRs) or mean differences (MD), and the I statistic was used to assess heterogeneity.
Results: Twenty-six trials with a total of 4169 participants met the inclusion criteria. Subgroup analysis confirmed that, compared with LM alone, TCPM and LM together were significantly better at reducing diabetes (RR, 0.47; 95% CI, 0.38-0.59) and normalizing blood glucose (RR, 0.76; 95% CI, 0.69-0.85). They also caused a greater reduction in fasting plasma glucose (FBG) (MD, -0.37; 95% CI, -0.62 to -0.13), 2-h plasma glucose (2h PG) (MD, -0.91; 95% CI, -1.35 to -0.47) and body mass index (BMI) (MD, -0.45; 95% CI, -0.76 to -0.14). Compared with placebo plus LM, TCPM plus LM was superior at reducing diabetes (RR, 0.55; 95% CI, 0.45-0.68) and normalizing blood glucose (RR, 0.62; 95% CI, 0.50-0.76). The interventions were also associated with a decline in FBG levels (MD, -0.68; 95% CI, -1.25 to -0.11) and 2h PG levels (MD, -1.07; 95% CI, -1.85 to -0.29). There were no significant differences in adverse events in either group. Subgroup and sensitivity analyses found no significant difference in overall effects among all study characteristics, indicating that the overall effects were stable. Generally, the quality of evidence was low for the effect of TCPM on the incidence of diabetes and normalization of blood glucose, and was very low for the effects of TCPM on FBG, 2h PG, and BMI.
Conclusions: Based on this systematic review, TCPM may reduce the risk of progression to TDM and increase the possibility of regression toward normoglycemia. As a result of the methodological drawbacks of the included studies, more rigorously designed RCTs are required to more reliably assess the efficacy of TCPM and long-term follow-up is needed before TCPM can be recommended for prediabetic patients.
