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 |
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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") |
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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. |
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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 |
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Notes | Funding source: NS Conflict of interest: NS Author contact details: wuhuangan@126.com Study was translated from Chinese by a translator. |
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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. |