The Feasibility of Home-Based Moxibustion for Fatigue in Peritoneal Dialysis: A Randomized Controlled Pilot Trial

Objective: Fatigue is a highly prevalent and debilitating symptom among patients undergoing peritoneal dialysis (PD). Yet, feasible home-based interventions remain limited. To assess the feasibility and observed safety of home-based moxibustion in patients receiving PD and to explore the preliminary effects on fatigue. Methods: This single-center, waitlist-controlled randomized pilot trial was conducted at a tertiary hospital in Southern China from February to July 2023. Adults receiving maintenance PD with persistent fatigue and an overall Revised Piper Fatigue Scale (PFS-R) score of 4 or higher were randomly assigned at a 1:1 ratio to either a moxibustion or a waitlist control group. Participants in the intervention group received home-based moxibustion at the Shenque (CV8) acupoint at least 3 times per week for 12 weeks, in addition to standard PD care. Control participants received standard care alone during the trial and were offered delayed moxibustion supplies after completion of the last follow-up. The prespecified primary outcomes were the between-group difference in the mean overall PFS-R score at week 12 and the proportion of participants in the moxibustion group who achieved the target intervention dose. Additional outcomes included study retention, completion of scheduled study contacts, secondary clinical outcomes, and adverse events. Results: Of the 262 patients assessed for eligibility, 44 met the eligibility criteria, of whom 25 declined participation for personal reasons, and 19 were randomized (mean [SD] age, 47.5 [12.4] years; 16 [84.2%] women). All completed the 12-week follow-up. All 57 scheduled on-site visits and 56 of 57 telephone follow-ups (98.2%) were completed. Eight of nine participants in the moxibustion group achieved the target intervention dose (88.9%; 95% CI, 51.8-99.7%). The exploratory fatigue findings were inconsistent. In the exploratory week-12 comparison, the mean PFS-R score was lower in the moxibustion group than in the control group (unadjusted mean difference, -1.09 points; 95% CI, -2.15 to -0.03; p = 0.04). However, the between-group difference in change from baseline was -0.36 points (95% CI, -2.03 to 1.31; p = 0.65), and no group-by-time interaction was observed (p = 0.86). Other clinical outcomes showed no consistent between-group differences. Adverse events occurred in four of nine participants in the moxibustion group and two of ten in the control group. No serious adverse events or permanent intervention discontinuations occurred. Conclusions and Relevance: Among selected randomized participants, a 12-week home-based moxibustion intervention supported by standardized training and follow-up was delivered with high adherence and complete retention. However, the low screening-to-randomization proportion limits conclusions about recruitment feasibility and broader implementation, and the exploratory findings do not establish efficacy or provide definitive evidence of safety. Further evaluation in a larger, sham-controlled trial is warranted.