Sanjiao acupuncture combined with abdominal massage for restless legs syndrome in maintenance hemodialysis patients:...

Restless legs syndrome (RLS) is common in maintenance hemodialysis (MHD) patients, with limited pharmacological options due to adverse effects. This study aimed to evaluate the effects of adding abdominal massage to Sanjiao acupuncture for RLS in MHD patients.

In a single-center randomized trial (March-September 2025, with follow-up through December 2025), 88 MHD patients with moderate-to-severe RLS were assigned to Sanjiao acupuncture (n = 44) or combined therapy (n = 44). Both groups received conventional MHD; the combined group added abdominal massage. Interventions were performed 3 times weekly for 3 weeks, 1.5 h before dialysis session end. The primary outcome was serial International Restless Legs Syndrome Rating Scale (IRLS) scores at different timepoints compared with baseline. Secondary outcomes included the overall responder rate based on IRLS reduction rate at endpoint, the Pittsburgh Sleep Quality Index (PSQI), and 3-month recurrence rate. Adverse events were monitored as safety indicators. Efficacy analyses were performed on both the intention-to-treat (ITT) population (n = 88, with missing data imputed using baseline observation carried forward) and the per-protocol (PP) population (n = 80).

Both groups showed significant reductions in serial IRLS scores from baseline (both P < 0.001), with the combined group demonstrating further reduction from week 1 to endpoint compared with the acupuncture group (P < 0.05). In the ITT analysis, the combined group showed a higher responder rate than the acupuncture group (72.7% vs. 47.7%, P = 0.029) and lower endpoint IRLS scores (median 0.00 vs. 14.50, P = 0.029). The PP analysis yielded consistent results (responder rate: 80.0% vs. 52.5%, P = 0.018; endpoint IRLS: median 0.00 vs. 12.00, P = 0.017). Both groups improved in PSQI (P < 0.01), with no significant between-group difference. At 3-month follow-up, recurrence showed a numerical difference favoring combined therapy (12.5% vs. 23.8%), though this exploratory analysis was severely underpowered and the between-group difference was not statistically significant (P = 0.297). Adverse events were similar between groups (15.9% vs. 13.6%, P = 0.772), with no serious events.

The addition of abdominal massage to Sanjiao acupuncture was associated with greater improvement in RLS symptoms in MHD patients with favorable safety, supporting the use of adjunctive abdominal massage as a non-pharmacological option for RLS in end-stage renal disease, though the specific contribution of massage independent of increased therapeutic contact time remains to be determined.