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
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.
Change from baseline in total IBS-SSS at week 4, adjusted mean (95% CI)a
140.0 (126.0 to 153.9)
64.4 (50.4 to 78.3)
75.6 (55.8 to 95.4)
< 0.001
Secondary outcomes
Change from baseline in each subscale score of IBS-SSS at week 4, mean (95% CI)
Severity of abdominal pain
26.8 (22.2 to 31.4)
14.9 (9.9 to 19.9)
−
0.001
Frequency of abdominal pain
15.0 (8.5 to 21.6)
2.5 (−3.7 to 8.6)
−
0.006
Severity of abdominal distension
28.7 (22.8 to 34.5)
12.3 (8.9 to 15.8)
−
< 0.001
Satisfaction with bowel habits
34.1 (27.8 to 40.3)
13.9 (7.5 to 20.2)
−
< 0.001
Interference of IBS with life in general
32.7 (26.5 to 39.0)
16.1 (10.9 to 21.4)
−
< 0.001
Change from baseline in total IBS-SSS, adjusted mean (95% CI) a
Week 2
90.3 (75.1 to 105.4)
48.6 (33.5 to 63.8)
41.7 (20.2 to 63.1)
< 0.001
Week 6
137.2 (118.3 to 156.0)
93.2 (74.4 to 112.0)
44.0 (17.3 to 70.6)
0.001
Week 8
147.4 (132.0 to 162.8)
85.2 (69.7 to 100.6)
62.3 (40.4 to 84.1)
< 0.001
IBS-SSS response rate, n (%)b
Week 2
63 (74.1)
31 (36.5)
37.7 (22.1 to 50.8)
< 0.001
Week 4
77 (90.6)
38 (44.7)
45.9 (31.7 to 57.7)
< 0.001
Week 6
68 (80.0)
49 (57.6)
22.4 (7.6 to 35.9)
0.002
Week 8
73 (85.9)
54 (63.5)
22.4 (8.5 to 35.2)
0.001
Patients with > 50% improvement in IBS-SSS, n (%)
Week 2
30 (35.3)
8 (9.4)
25.9 (12.7 to 38.1)
< 0.001
Week 4
54 (63.5)
14 (16.5)
47.1 (32.1 to 59.2)
< 0.001
Week 6
54 (63.5)
22 (25.9)
37.7 (22.1 to 50.8)
< 0.001
Week 8
56 (65.9)
19 (22.4)
43.5 (28.1 to 56.1)
< 0.001
Tab.2
Fig.2
Fig.3
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
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