Mailuoning injection for the treatment of stroke: integration with the GRADE system

Article type
Authors
Ren P1, Kang D1, Liu X1, Peng L1, Zhang X1
1Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, China
Abstract
Background: As one of a few effective stroke-specific treatment options, traditional Chinese medicine (TCM) is used extensively in stroke patients in China. However, the effects and safety of most of TCM therapies still remain uncertain. Mailuoning, one of the treatments for stroke, has been investigated the most. It is time to evaluate it systematically within the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system.
Objectives: To integrate high-quality systematic reviews of the efficacy of mailuoning injections within TCM by using GRADE, and to make recommendations for stroke therapy.
Methods: We proposed evidence-based questions relating to mailuoning injections used in people with stroke, and performed a comprehensive search for high quality systematic reviews and synopses of syntheses evaluated comprehensively by using PRISMA, AMSTAR, and OQAQ. We integrated high-quality systematic reviews with the GRADE system.
Results: Only one systematic review summarized the evidence for the effect and safety of mailuoning injections in the treatment of acute ischemic stroke and met the GRADE system standards (AMSTAR scores ≥ 8 or OQAQ scores ≥ 7). It included 15 randomized controlled trials (RCTs). Five major outcomes of the intervention were evaluated. There was no statistically significant difference in terms of four critical and important outcomes, including neurological function improvement (MD = 0.69; 95% CI -3.42 to 4.80), quality of life index (MD = -0.92, 95% CI -2.17 to 0.27), activity of daily life score (MD = -5.31, 95% CI -19.11 to 8.49) and frequency of adverse events (RR = 1.39, 95% CI 0.28 to 6.76) between the experimental group and the control group, but statistically significant differences were found for one important but non-critical outcome, proportion of patients without improvement of neurological deficit (RR = 0.30, 95% CI 0.22 to 0.42; Figure 1).
Conclusions: Due to the inconsistency of the intervention (dose comparison.etc) and the availability of only one low-quality study with a small sample, the evidence for mailuoning injections was too weak for us to develop recommendations.