RESUMO
INTRODUCTION: Diabetes is closely related with depression. Gardenia fructus antidepressant formula (GFAF) is a Chinese herbal medicine that may be beneficial for depression in diabetic patients. This study aimed to evaluate the efficacy and safety of GFAF for depression in diabetes patients. METHODS: Randomized controlled trials (RCTs) were included. The patients were diagnosed as having diabetes mellitus with depression. The experimental interventions included GFAF alone or combined with another active treatment. The control interventions included no treatment, placebo or another active treatment. The primary outcome was reduction in the Hamilton Depression Scale (HAMD) scores. Secondary outcomes included reduction in the Self-rating Depression Scale (SDS) scores, response rate, adverse events, etc. PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan fang database and Chinese Science and Technology Periodicals database (VIP) were searched from inception to May 2019 for potentially eligible studies. The meta-analysis was performed using RevMan 5.3 software. RESULTS: We identified 12 eligible RCTs including 822 diabetes patients with depression. Results of meta-analysis showed that the HAMD score was significantly reduced following GFAF treatment compared with no antidepressant treatment (SMD: -2.53, 95% CI: -4.80 to -0.27, P = 0.03). Another meta-analysis indicated that patients taking GFAF alone had lower HAMD scores compared with selective serotonin reuptake inhibitors (SSRI) treatment alone (SMD: -0.62, 95% CI: -1.07 to -0.18, P = 0.006). The HAMD scores in the GFAF plus SSRI treatment group were significantly decreased compared with the SSRI treatment group (SMD: -0.37, 95% CI: -0.69 to -0.06, P = 0.02). The same pattern of change was identified with the SDS scores. CONCLUSION: GFAF may be considered an alternative treatment for depression in patients with diabetes. However, more large-scale and well-designed RCTs are warranted.