Adjunctive Chinese herbal medicine versus acupuncture post-PCI: comparative effectiveness and safety - protocol for...

Coronary artery disease (CAD) represents a significant global health challenge. Despite advancements like percutaneous coronary intervention (PCI), patients remain at risk for recurrent cardiovascular events and persistent symptoms such as angina. Chinese herbal medicine (CHM) and acupuncture are commonly used adjunctive therapies, particularly in East Asia, but robust evidence synthesising their effects when combined with standard post-PCI care is needed. Therefore, this systematic review aims to evaluate the efficacy and safety of adding CHM or acupuncture to standard care compared with standard care alone (with or without placebo/sham) in adult patients following PCI.

We will include parallel-group randomised controlled trials (RCTs) evaluating CHM or acupuncture plus standard care vs standard care (± placebo/sham) in adults post-PCI for CAD. Major international and Chinese electronic databases and clinical trial registries will be searched from their inception without language restrictions. Two reviewers will independently perform study selection based on predefined eligibility criteria and extract data using a standardised form. Risk of bias for included RCTs will be assessed using the Cochrane RoB 2 tool. Where appropriate based on clinical and methodological homogeneity (assessed using the I² statistic), pairwise meta-analyses will be conducted using random-effects models. We will calculate risk ratios (RR) or OR for dichotomous outcomes like major adverse cardiovascular events (MACE) and mortality, and mean differences (MD) or standardised mean differences (SMD) for continuous outcomes such as angina scores and health-related quality of life (HRQoL). Furthermore, if the evidence network permits, a network meta-analysis (NMA) will be performed to indirectly compare the relative effectiveness and safety of CHM vs acupuncture. If quantitative synthesis (pairwise or network) is not feasible, a narrative synthesis will be provided. The certainty of the evidence for key outcomes will be assessed using the GRADE approach. This evaluation will encompass the certainty derived from direct pairwise comparisons as well as the indirect comparisons and overall network estimates derived from the NMA.

There are no ethical issues as this study did not conduct any experiments, surveys or human trials. We will ensure that the findings are shared through pertinent channels.

CRD420251040037.