Use of 2 methods of acupuncture to reduce irritable bowel syndrome (IBS)-related pain and other symptoms in adults returned promising results in a new trial designed to assess the use of less subjective primary endpoints in IBS research. The findings were published in JAMA Network Open.
The research team, led by Cun-Zhi Liu, MD, PhD, a physician-researcher at the University of Chinese Medicine in Beijing, writes that clinical trials of pharmaceuticals to treat IBS have historically been associated with high placebo response rates and particularly when a subjective scale (eg, “global improvement") is used as a primary endpoint.
Evidence and recommendations from 2 recent meta-analyses of trials of IBS drugs that evaluated placebo response rates suggest that “future randomized clinical trials should adhere to current US Food and Drug Administration (FDA)–recommended composite end points for IBS (see below)," a change, the authors wrote that could help reduce the potentially misleading outcomes. “Therefore, the first aim of the current study was to preliminarily evaluate the feasibility of using FDA-recommended end points to evaluate the efficacy of acupuncture treatment for IBS.”
Secondarily, Liu and team compared 2 traditional acupuncture acupoints, comparing the difference in acupuncture efficacy in patients receiving specific acupoint (SA) treatment vs nonspecific acupoint (NSA) treatment, or nonacupoint (NA) treatment.
The pilot, multicenter, randomized clinical trial was conducted in 4 tertiary hospitals in China between July 1, 2020, and March 31, 2021. Patients aged 18 to 75 years who met ROME IV criteria for diarrhea-predominant IBS (IBS-D) were screened.
Participants in the final cohort were randomized 1:1:1 to receive either SA, NSA, or NA and all were treated in twelve 30-minute acupuncture sessions over 4 consecutive weeks, attending 3 sessions per week.
The research team identified the primary outcome as patient response at 4 weeks, defined as the proportion of patients whose abdominal pain score decreased by at least 30% and the number of type 6 or 7 stool days decreased by 50% or greater.
Overall, there were 90 patients included in the pilot study with 30 patients assigned to each treatment group. The cohort’s mean age was 34.5 years and 60% were men. Clinical and baseline demographics were balanced across the 3 groups, according to the study.
Liu et al report substantial improvements in the primary outcomes for all 3 groups, with composite rates as follows:
There was no statistically significant difference, however, among the 3 groups (P= .18).
Improvements in adequate relief at week 4 also were substantially improved, with composite rates of:
Difference in response rate among the 3 groups did not reach statistical significance for this endpoint either (P = .76).
Adverse events were reported in 6.7% (n = 2) of the SA group and 10% (n = 3) of the NSA or NA group.
“In this pilot randomized clinical trial, acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms, although there were no significant differences among the 3 groups,” the authors wrote. “These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy.”
The authors do note several study limitations, including the small sample size, the subjective nature of information in defecation diaries, and the absence of blood, stool or other specimens that might differentiate treatment response. Finally, acupuncturists could not be blinded to procedures.
Reference: L-Y Q MM, Yang JW, Yan S-Y, et al. Acupuncture for the treatment of diarrhea predominant irritable bowel syndrome: a pilot randomized clinical trial. JAMA Netw Open. 2022;5(12):e2248817. doi:10.1001/jamanetworkopen.2022.48817