Yiqiang Xu, Hongman Shen, Yue Yang
The apparent therapeutic benefits must be interpreted with extreme caution due to unresolvable severe heterogeneity, inherent lack of blinding, disparate control interventions, and limited generalizability due to an exclusive reliance on Chinese-language literature. Current evidence is insufficient to formulate strong clinical recommendations, future multi-center, adequately blinded RCTs are mandated.
BACKGROUND: Shoulder-hand syndrome (SHS), as a significant complication of stroke, has seen a continuous increase in incidence. The Fire Dragon Cupping (FDC) therapy is an emerging cupping therapy (CT), and this study aims to summarize the clinical evidence of FDC therapy intervention for SHS, providing guidance for its application and development.
METHODS: We searched 11 databases from inception to December 12, 2025. Data were pooled using standardized mean differences (SMD) and risk ratios (RR) with 95% confidence intervals (CIs) and 95% prediction intervals (PIs). To explore high heterogeneity, we prespecified subgroup analyses, univariate meta-regression, and Trial Sequential Analysis (TSA). Risk of bias and certainty of evidence were assessed using ROB-2 and the GRADE framework, respectively.
RESULTS: A total of 11 Randomized Controlled Trials (RCTs) were included in this study, involving 1,087 patients. Notably, all these studies were from China. Pooled estimates indicated FDC might improve clinical efficacy (RR = 1.20, 95% CI:[1.12 to 1.28], 95% PI: [1.10-1.31], p < 0.0001, TSA confirming sufficient cumulative sample size, required information size (RIS) = 267) and upper motor function (SMD = 1.01, 95% CI:[0.76 to 1.26], 95% PI: [0.21 to 1.80], p < 0.0001). For hand swelling (SMD = -1.34, 95% CI:[-1.98 to -0.70], 95% PI: [-3.59 to 0.91], p < 0.0001, I2 = 91.9%), and pain intensity (SMD = -1.57, 95% CI:[-2.15 to -0.98], 95% PI: [-3.74 to 0.60], p < 0.0001, I2 = 92.3%), heterogeneity was high and its sources were not identified. Given the prediction intervals that cross the null, the pooled estimates for hand swelling and pain intensity are reported for transparency only and should not be interpreted as summary effects, in line with the cautious reading in the body.
CONCLUSION: The apparent therapeutic benefits must be interpreted with extreme caution due to unresolvable severe heterogeneity, inherent lack of blinding, disparate control interventions, and limited generalizability due to an exclusive reliance on Chinese-language literature. Current evidence is insufficient to formulate strong clinical recommendations, future multi-center, adequately blinded RCTs are mandated.