Abstract
BackgroundThe prevalence of functional constipation (FC) is 3–27%, and FC has been reported to cause discomfort in daily life and various complications. The treatment for FC depends on laxatives, and thus, effective and non-toxic alternative treatments are needed.MethodsWe conducted a randomised, sham-controlled parallel-design, pilot trial. Participants with FC were randomly assigned to either the real acupuncture (RA) or sham acupuncture (SA) group. The RA consisted of eight fixed acupuncture points (bilateral ST25, ST27, BL52 and BL25) and four additional points targeted to the individual based on Traditional Korean medicine (TKM). SA consisted of shallow acupuncture insertion at 12 non-acupuncture points. Twelve sessions were provided over 4 weeks. The outcome measures were weekly defecation frequency (DF), spontaneous complete bowel movement (SCBM), Bristol stool scale (BSS) score and constipation assessment scale (CAS) score. The participants were followed for 4 weeks after the treatment.ResultsThirty participants were enrolled (15:15). The mean DF were 5.86 ± 5.62, 5.43 ± 3.39 and 5.79 ± 3.64 in the RA group and 3.73 ± 1.62, 5.00 ± 1.77 and 5.40 ± 1.96 in the SA group at weeks 1, 5, and 9, respectively. The increases in weekly SCBMs were 2.50 ± 3.86 and 2.71 ± 4.01 with RA and 2.33 ± 2.74 and 1.93 ± 2.25 with SA at weeks 5 and 9, respectively (mean difference [MD] 0.78). The BSS scores were 0.57 ± 1.72 and 1.09 ± 1.30 with RA and 0.15 ± 1.06 and 0.14 ± 0.88 with SA at weeks 5 and 9, respectively (MD 0.95). The CAS score changes were − 3.21 ± 2.91 and − 3.50 ± 3.98 with RA and − 2.67 + ±2.82 and − 2.87 ± 2.95 with SA at weeks 5 and 9, respectively. Greater improvements were observed in subgroup analysis of participants with hard stool. The numbers of participants who developed adverse events (AEs) were equal in both groups (four in each group), and the AEs were not directly related to the intervention.ConclusionsThis clinical trial shows feasibility with minor modifications to the primary outcome measure and comparator. Acupuncture showed clinically meaningful improvements in terms of SCBMs occurring more than 3 times per week and in these improvements being maintained for 4 weeks after treatment completion. As this is a pilot trial, future studies are warranted to confirm the efficacy and safety.Trial registrationKCT0000926 (Registered on 14 November 2013).
Highlights
The prevalence of functional constipation (FC) is 3–27%, and FC has been reported to cause discomfort in daily life and various complications
Recruitment Thirty-five participants were assessed for eligibility, but 5 (14.3%) were not enrolled
One participant in the real acupuncture (RA) group was excluded due to a violation of the inclusion criteria identified at visit 1, before any treatment was performed
Summary
The prevalence of functional constipation (FC) is 3–27%, and FC has been reported to cause discomfort in daily life and various complications. Functional constipation (FC) refers to persistently difficult, infrequent or seemingly incomplete defecation without other organic diseases and without meeting the Irritable Bowel Syndrome criteria [1, 2]. The prevalence of FC varies according to diagnostic criteria and region. The prevalence of FC according to the Rome II criteria was reported to be 9.2% [3], which is relatively higher than that found in other Asian countries (3.0–7.2%) [4, 5]. The female gender, an older age and a lifestyle of insufficient physical activity influence the prevalence of constipation [6,7,8]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have