This study systematically evaluated the efficacy and safety of acupuncture combined with traditional Chinese medicine (TCM) external therapy for Scalenus Anticus Syndrome (SAS) and explored the certainty and limitations of the current evidence. A comprehensive search of eight electronic databases identified eligible randomized controlled trials (RCTs), and 11 RCTs involving 746 patients met the inclusion criteria. All included studies were conducted in China and enrolled patients with neurogenic SAS. Meta-analysis demonstrated that acupuncture combined with TCM external therapy significantly improved overall clinical effectiveness compared with control interventions (RR = 1.21, 95% CI: 1.13-1.29), reduced pain intensity as reflected by lower visual analogue scale scores (MD = -1.04, 95% CI: -1.58 to -0.50), and decreased recurrence rates (RR = 0.32, 95% CI: 0.14-0.70). Sensitivity analyses supported the robustness of the pooled findings, whereas Egger's test indicated potential publication bias. Subgroup analyses were conducted to explore sources of heterogeneity in pain outcomes; however, no statistically significant subgroup differences were identified. Safety evidence remained insufficient because only one study reported mild adverse reactions and most studies did not document adverse events. These findings suggest that acupuncture combined with TCM external therapy may provide clinically meaningful benefits for patients with SAS. However, the overall certainty of evidence was low because of methodological limitations, insufficient safety reporting, publication bias, and heterogeneity across studies. Further high-quality multicenter randomized controlled trials with standardized outcome measures and long-term follow-up are required to confirm efficacy and safety.
| Discipline Area | Score |
|---|---|
| Rehab Clinician (OT/PT) |  |
| Physician |  |
Physician rater
The effect direction is consistent (ORR, VAS, recurrence), but the magnitude is below the usual MCID for analgesic benefit. Acupuncture alone did not succeed, whereas the combined therapy was effective, supporting a mechanical/myofascial mechanism. Adverse events were reported in only 1 out of 11 trials. There is evidence of publication bias. The GRADE assessment indicates low certainty across all outcomes.
Physician rater
All RCTs are single-centre studies conducted in China, lacking sham procedures or blinding. Comparisons involved injections or NSAIDs, not structured physiotherapy. The pooled VAS improvement falls below the typical MCID. The main endpoint is a non-standardized composite without a validated PROM. At best, acupuncture with TCM external therapy could be an adjunct for patients intolerant to drugs or unwilling to undergo surgery for neurogenic SAS, but does not replace rehabilitation. Future research requires standardized diagnosis methods, multicentre sham-controlled RCTs, DASH outcome measures, and follow-up periods of at least six months.
Rehab Clinician (OT/PT) rater
This meta-analytic study has the major limitations of including RCTs with doubtful randomization and allocation concealment and with heterogeneous interventions. The results have a high risk of bias with evidence of low certainty.
, McMaster University