In a recent study published in JAMA Network Open, researchers preliminarily evaluated the practicality of utilizing the United States (US) Food and Drug Administration (FDA)-advocated endpoints to assess the effectiveness of acupuncture in IBS-D (irritable bowel syndrome with diarrhea) management.
IBS is a commonly observed disease involving altered gut-brain interactions; the patients complain of pain in the abdomen with defecation changes. Previous studies have documented acupuncture as a promising therapeutic option for IBS since acupuncture reduces visceral region hypersensitivity and modulates the abdomen-brain axis. However, the use of subjective assessment scales to evaluate acupuncture efficacy in IBS is usually accompanied by high response rates to placebo treatment.
About the study
In the present pilot randomized clinical trial study, researchers preliminarily evaluated the practicality of utilizing a predetermined composite response rate recommended by the US FDA as the prime outcome for evaluating the effectiveness of acupuncture in IBS-D treatment. They also comparatively assessed the differences in acupuncture treatment effectiveness among IBS-D receiving SA (specific acupoint) therapy, NSA (nonspecific acupoint) therapy, or NA (nonacupoint) therapy.
The multicenter trial was conducted across four tertiary care hospitals in China between 1 July 2020 and 31 March 2021. Data were obtained over 14 weeks till March 2021. IBS-D patients were randomly allocated in a 1:1:1 ratio to three groups, including the SA and NSA acupuncture groups and the NA sham acupuncture group. All participants were provided twelve sessions, each of 0.5-hour duration, over four weeks, at three sessions weekly.
The prime outcome was the rate of response after four weeks of treatment, described as the percent of individuals whose scores for the worst pain in the abdomen were reduced by ≥30% and the count Bristol stool form scale types 6/7 stool days reduced by ≥50%. Secondary study outcomes included the IBS-SSS (IBS symptom severity scale), IBS-QOL (IBS–quality of life) scale, PHQ-9 (patient health questionnaire 9) depression scale, IBS-AR (IBS-adequate relief), and symptoms of IBS-D such as bloating, abdominal pain, loose stool, and defecation frequency.
Chinese individuals between 18 and 75 years, meeting the Rome IV IBS-D criteria, were screened for two weeks and followed up for eight weeks. Individuals were eligible for the study if their Bristol stool form types 6/7 appeared for ≥4.0 days and types 1/2 stools for <4.0 days, with mean scores of regular pain in the abdomen ≥3.0 in the previous week.
Individuals were excluded if they had a history of organic gastrointestinal diseases such as microscopic colitis, inflammatory bowel disease, Crohn’s disease, or celiac disease. Individuals aged ≥50 years with unexplained loss of weight, anal fissure- or non-hemorrhoid-caused hematochezia, nocturnal-type diarrhea, and familial colorectal cancer history were needed to submit normal endoscopy test results within two years before enrollment in the study.
SA group individuals received acupuncture at six acupoints (five fixed acupoints and one optional acupoint). The six fixed acupoints for NSA group individuals were selected based on the frequency of acupoint usage that excluded the acupoints for SA group individuals. Acupuncture needles were inserted and stimulated by a motion involving lifting, thrusting, rotating, and twirling the needle sheaths to produce deqi (sensations of numbness, soreness, radiating, or distention).
For NA group individuals, five non-acupoints located away from conventional acupoints or meridians were chosen without any manipulation. The team selected loperamide for rescue therapy. Logistic linear generalized mixed modeling was performed. In addition, a sensitivity analysis comprised individuals who finished ≥10 sessions without any major study protocol violations.
Initially, 201 IBS-D patients underwent screening, of which 55% (n=111) were excluded, and as a result, 90 patients, 30 in each group, were analyzed. Most of the study population (60%, n=54) were men with a mean participant age of 35. The rates of enrollment and dropouts were 55% and 12%, respectively. Importantly, a 91% treatment completion rate was observed, indicating that it is feasible to utilize the Rome IV diagnostic criteria and US FDA-advocated endpoints to evaluate the efficacy of acupuncture in IBS-D treatment.
Considerable improvements in the prime outcomes were observed among all groups, with response rates of 47%, 47%, and 27% in the SA, NSA group, and NA groups, respectively, albeit the inter-group differences were statistically non-significant. The IBS-AR response rates after four weeks of acupuncture treatment were 64%, 62%, and 55% in the corresponding groups, respectively.
Adverse events were documented for two, four, and four individuals in the SA, NSA, and NA groups, respectively. However, none were serious adverse events. The improvement levels across the groups were comparable, whether observed immediately or after the completion of 12 sessions or after the follow-up period. The groups did not show any significant differences for any secondary outcome.
However, the IBS-QOL response rates after completion of acupuncture therapy were 10% to 20% greater among SA group individuals compared to NA group individuals. Additionally, among SA group individuals, loose stool days reduced by >3.0 days after four, eight, and 12 weeks compared to the baseline, indicating that SA group participants might no longer be categorized as IBD-D patients based on the Rome IV criteria due to bowel status improvements. Sensitivity analysis yielded similar findings, with response rates of 54%, 52%, and 31% among SA, NSA, and NA recipients, respectively.
The study findings showed that acupuncture is a safe and practical treatment option for IBS-D patients. The SA and NSA therapies can improve IBS-D patients' clinical improvement. However, statistically non-significant differences were observed among the three groups. However, larger, adequately powered trials utilizing the US FDA-advocated composite response rate as the prime outcome are required for accurate assessment of the effectiveness of acupuncture therapy for IBS-D.