Efficacy of acupuncture in refractory irritable bowel syndrome patients: a randomized controlled trial

doi:10.1007/s11684-024-1073-7

Front. Med.

2024, Vol. 18

Issue (4) : 678-689 https://doi.org/10.1007/s11684-024-1073-7

Efficacy of acupuncture in refractory irritable bowel syndrome patients: a randomized controlled trial

Jun Zhao^1,⁸, Hui Zheng², Xin Wang³, Xuefei Wang³, Yunzhou Shi², Chaorong Xie², Qingfeng Tao², Da Li⁴, Jingwen Sun¹, Junjian Tian¹, Junxia Gao⁵, Huimin Liu⁵, Suhua Shi⁵, Jinxia Ni⁴, Rongdan Xue⁶, Hui Hu⁶, Min Chen⁷(

), Shuguang Yu²(

), Zhigang Li¹(

)

¹. School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China
². The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China
³. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
⁴. Department of Acupuncture and Moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
⁵. Department of Rehabilitation, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China
⁶. Department of Acupuncture and Moxibustion, Dongfang Hospital Affiliated with Beijing University of Chinese Medicine, Beijing 100078, China
⁷. Anorectal Disease Department, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China
⁸. Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu 610044, China

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Abstract

Previous studies have confirmed that acupuncture for irritable bowel syndrome (IBS) provided an additional benefit over usual care alone. Therefore, we performed a multicenter, randomized, sham-controlled trial to assess the efficacy and safety of acupuncture versus sham acupuncture for refractory IBS in patients in the context of conventional treatments. Patients in the acupuncture and sham acupuncture groups received real or sham acupuncture treatment in 3 sessions per week for a total of 12 sessions. The primary outcome was a change in the IBS–Symptom Severity Scale (IBS-SSS) score from baseline to week 4. A total of 521 participants were screened, and 170 patients (85 patients per group) were enrolled and included in the intention-to-treat analysis. Baseline characteristics were comparable across the two groups. From baseline to 4 weeks, the IBS-SSS total score decreased by 140.0 (95% CI: 126.0 to 153.9) in the acupuncture group and 64.4 (95% CI: 50.4 to 78.3) in the sham acupuncture group. The between-group difference was 75.6 (95% CI: 55.8 to 95.4). Acupuncture efficacy was maintained during the 4-week follow-up period. There were no serious adverse events. In conclusion, acupuncture provided benefits when combined with treatment as usual, providing more options for the treatment of refractory IBS.

Keywords acupuncture functional gastrointestinal disorders irritable bowel syndrome clinical trial

Corresponding Author(s): Min Chen,Shuguang Yu,Zhigang Li

Just Accepted Date: 29 May 2024 Online First Date: 02 July 2024 Issue Date: 30 August 2024

Cite this article:

Jun Zhao,Hui Zheng,Xin Wang, et al. Efficacy of acupuncture in refractory irritable bowel syndrome patients: a randomized controlled trial[J]. Front. Med., 2024, 18(4): 678-689.

URL:

https://academic.hep.com.cn/fmd/EN/10.1007/s11684-024-1073-7
https://academic.hep.com.cn/fmd/EN/Y2024/V18/I4/678

Fig.1 The CONSORT flowchart of the patient flow throughout the study.

Tab.1 Demographic and baseline characteristics of the patient population

Tab.2 Time to event outcomes

Fig.2 Changes in the total IBS-SSS from baseline to week 4 in the acupuncture group (85 patients) and sham acupuncture group (85 patients) during the 4-week randomized intervention period. The middle solid horizontal lines show the mean values, the upper solid horizontal lines show the upper limits, and the lower solid horizontal lines show the lower limits. Each circle represents an individual patient. IBS-SSS, Irritable Bowel Syndrome Symptom Severity Score.

Fig.3 The total IBS-SSS and scores for its individual domains over time during the study. Data are mean (95% CI). IBS-SSS, Irritable Bowel Syndrome Symptom Severity Score. The decreases in total IBS-SSS at weeks 2, 4, 6 and 8 were greater in the acupuncture group than in the sham acupuncture group. (B–F) trends similar to those in (A) can be seen. (B) At weeks 4, 6 and 8, abdominal pain is significantly milder in the acupuncture group than in the sham acupuncture group. (C) The frequency of abdominal pain is significantly lower in the acupuncture group than in the sham acupuncture group at weeks 4 and 8. (D) At weeks 4, 6 and 8, abdominal distension is significantly milder in the acupuncture group than in the sham acupuncture group. (E) Participants in the acupuncture group are significantly more satisfied with their bowel habits at weeks 2, 4, 6 and 8 than participants in the sham acupuncture group. (F) At weeks 2, 4, 6 and 8, interference of IBS with daily life is lesser in the acupuncture group than in the sham acupuncture group. Asterisk (*) indicates significant difference between acupuncture and sham acupuncture.

Variable	Acupuncture group (n = 85)	Sham acupuncture group (n = 85)	Difference (95% CI)	P
Change from baseline in total IBS-QOL score, mean (95% CI)
Week 2	7.4 (4.7 to 10.1)	1.7 (−0.1 to 3.5)	5.7 (2.5 to 8.9)	0.001
Week 4	13.0 (9.8 to 16.1)	4.5 (2.3 to 6.8)	8.4 (4.6 to 12.2)	< 0.001
Change from baseline in each subscale score of IBS-QOL at week 4, mean (95% CI)
Dysphoria	18.3 (14.3 to 22.4)	6.4 (3.3 to 9.5)	−	< 0.001
Interference with activity	14.8 (11.0 to 18.6)	5.8 (2.4 to 9.1)	−	< 0.001
Body image	9.0 (6.0 to 12.0)	2.4 (0.0 to 4.7)	−	0.001
Health worry	21.4 (16.2 to 26.5)	8.4 (4.6 to 12.3)	−	< 0.001
Food avoidance	14.2 (9.5 to 18.9)	6.6 (1.5 to 11.6)	−	0.03
Social reaction	12.9 (9.2 to 16.7)	2.5 (−0.4 to 5.4)	−	< 0.001
Sexual	5.6 (2.5 to 8.7)	6.0 (3.0 to 9.1)	−	0.84
Relationships	7.6 (4.2 to 11.1)	−1.1 (−3.9 to 1.7)	−	< 0.001
Regular stool per week, median (IQR)^a, days
Week 2	1.0 (0.0 to 3.0)	0.0 (0.0 to 2.0)	−	0.01
Week 4	1.0 (0.0 to 4.0)	0.0 (0.0 to 1.0)	−	< 0.001
Week 6	2.0 (0.0 to 5.0)	0.0 (0.0 to 2.0)	−	< 0.001
Week 8	2.0 (0.0 to 4.0)	1.0 (0.0 to 2.0)	−	0.007
Change from baseline in total WSAS score, median (IQR)^b
Week 2	2.0 (0.0 to 4.0)	0.0 (−2.0 to 2.0)	2.0 (2.0 to 4.0)	< 0.001
Week 4	4.0 (2.0 to 9.0)	2.0 (0.0 to 6.0)	2.0 (2.0 to 4.0)	0.002
Week 6	4.0 (0.0 to 8.0)	2.0 (0.0 to 4.0)	4.0 (2.0 to 4.0)	0.002
Week 8	4.0 (0.0 to 8.0)	0.0 (−2.0 to 4.0)	4.0 (2.0 to 6.0)	< 0.001
Change from baseline in total SAS score, mean (95% CI)
Week 2	2.7 (1.2 to 4.2)	1.0 (−0.2 to 2.3)	1.7 (−0.2 to 3.6)	0.08
Week 4	5.2 (3.5 to 6.8)	3.3 (1.7 to 4.8)	1.9 (−0.3 to 4.2)	0.10
Change from baseline in total SDS score, mean (95% CI)
Week 2	2.7 (1.1 to 4.2)	2.0 (0.4 to 3.6)	0.7 (−1.5 to 2.9)	0.55
Week 4	5.1 (3.1 to 7.2)	3.6 (1.8 to 5.5)	1.5 (−1.2 to 4.2)	0.28
Responder rate with adequate relief of IBS symptoms, n (%)^c
Week 4	78 (91.8)	27 (31.8)	60.0 (46.0 to 70.5)	< 0.001

Tab.3 Others secondary outcomes

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