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. 2021 Nov 29;2021(11):CD013531. doi: 10.1002/14651858.CD013531.pub2

Bao 2016.

Study characteristics
Methods RCT
Setting: Shanghai Acupuncture Meridian Institute Medical Clinic Acupuncture Inflammatory Bowel Disease Specialist Clinic, Zhongshan Hospital Affiliated Endoscopic Center, and Yueyang Hospital, Shanghai University of Traditional Chinese Medicine
Study period: January 2010 to December 2014
Participants Inclusion criteria: 1. Patients with confirmed mild or moderate Crohn's disease (CDAI 151 ~ 350); 2. Patients who are not taking any drugs, or taking only salicylic acid drugs, and/or prednisone (dose < 15 mg and at least 1 month); 3. Patients who have not used immunosuppressants, anti‐tumour necrosis factor, or biologic within 3 months before entering the study; 4. Patients who agree and sign the informed consent form
Exclusion criteria: 1. Patients during pregnancy or lactation; 2. Patients with serious heart, brain, liver, kidney, and haematopoietic system disease(s); 3. Patients with mental illness; 4. Patients with other serious diseases
Age (mean ± SD): IG: 37 (15): CG: 33 (12)
Sex (M/F): IG: 31/17; CG: 29/18
Site of disease: NS
Use of concurrent medication: NS
Disease duration (mean ± SD): IG: 4.7 (3.7) years; CG: 4.8 (4.4) years
Disease activity: mild to moderate
Number randomised: IG: 51; CG: 51
Number reaching end of study: IG: 48; CG: 47
Number analysed: IG: 48; CG: 47
Postrandomisation exclusion: IG: 3; CG: 4 ("Subjects who received less than 80% (29 times) of treatment units were considered to have
dropped out")
Interventions IG: The observation group was treated with medicine‐separated moxibustion combined with acupuncture, both of which were performed simultaneously.
CG: The control group was treated with wheat bran‐separated moxibustion combined with shallow acupuncture, both of which were performed simultaneously.
Outcomes Length of intervention: 12 weeks
Primary outcomes:
Abdominal pain frequency and intensity: Pain (extent, frequency, time) was evaluated using Traditional Chinese Medicine symptom scores which were divided into the following grades according to symptom severity: 0 (none), 1 (light), 2 points (moderate), 3 points (severe).
Withdrawal due to adverse events
Secondary outcomes:
Serious adverse events
Total adverse events
Notes Funding source: NS
Conflict of interest: NS
Author contact details: wuhuangan@126.com
Study was translated from Chinese by a translator.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done using random number tables.
Allocation concealment (selection bias) Unclear risk Not mentioned. Authors were contacted but provided no response.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not mentioned. Authors were contacted but provided no response.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not mentioned. Authors were contacted but provided no response.
Incomplete outcome data (attrition bias)
All outcomes Low risk Data were presented for all participants who completed the study; however, baseline values do not include dropouts.
Selective reporting (reporting bias) Low risk All prespecified outcomes are reported in the results.
Other bias High risk There are no declarations of conflicts of interest and funding, but the authors do not present a clear picture of the efficacy of acupuncture in their introduction. Also, the authors mention that there were no significant differences at baseline, but using a t‐test the baseline differences for gender are actually significant.