BACKGROUND: The evidence for different frequencies of acupuncture treatment in postprandial distress syndrome (PDS) is insufficient. This study determined whether 3 sessions per week of acupuncture treatment are superior to 1 session per week for symptomatic outcomes in PDS. METHODS: This 16-week randomized clinical pilot trial was conducted in an outpatient setting in China. Patients with PDS were randomly assigned to receive 3 sessions per week of acupuncture (group H) or 1 session per week of acupuncture (group L) for 4 weeks. The primary outcome was the complete elimination of core symptoms at week 4. Secondary outcomes included overall treatment efficacy, dyspepsia symptoms, quality of life, anxiety, and depression. KEY RESULTS:Sixty patients were randomized of whom 53 (88.3%) completed this trial. The complete elimination rate of core symptoms was 26.7% (95% CI 12.3%-45.9%) in group H and 10.0% (95% CI 2.1%-26.5%) in group L at week 4 (P = .095). There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02). All secondary outcomes were better in group H at all time points. No serious adverse events occurred in either groups. CONCLUSIONS: This trial showed that acupuncture, at 3 sessions per week, tended to improve symptoms and the quality of life among patients with PDS as compared to once a week. Acupuncture treatment for 4 weeks was feasible and safe. A larger sample, multicenter, randomized controlled trial of acupuncture for PDS appears to be justified in the future.
RCT Entities:
BACKGROUND: The evidence for different frequencies of acupuncture treatment in postprandial distress syndrome (PDS) is insufficient. This study determined whether 3 sessions per week of acupuncture treatment are superior to 1 session per week for symptomatic outcomes in PDS. METHODS: This 16-week randomized clinical pilot trial was conducted in an outpatient setting in China. Patients with PDS were randomly assigned to receive 3 sessions per week of acupuncture (group H) or 1 session per week of acupuncture (group L) for 4 weeks. The primary outcome was the complete elimination of core symptoms at week 4. Secondary outcomes included overall treatment efficacy, dyspepsia symptoms, quality of life, anxiety, and depression. KEY RESULTS: Sixty patients were randomized of whom 53 (88.3%) completed this trial. The complete elimination rate of core symptoms was 26.7% (95% CI 12.3%-45.9%) in group H and 10.0% (95% CI 2.1%-26.5%) in group L at week 4 (P = .095). There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02). All secondary outcomes were better in group H at all time points. No serious adverse events occurred in either groups. CONCLUSIONS: This trial showed that acupuncture, at 3 sessions per week, tended to improve symptoms and the quality of life among patients with PDS as compared to once a week. Acupuncture treatment for 4 weeks was feasible and safe. A larger sample, multicenter, randomized controlled trial of acupuncture for PDS appears to be justified in the future.