Horta 2017.

Methods	RCT, single‐blinded, cross‐over design
Participants	Diagnosis of IBD (CD or UC) and clinically quiescent disease (HBI < 5 for CD or Mayo score ≤ 2 for UC; absence of biochemical markers of disease activity) for at least six months, experiencing persistent fatigue (defined as 2 consecutive FACIT‐F scores (4 weeks apart) lower than 40 points) Exclusion criteria: previous or active neoplasia; pregnancy or lactation; anaemia, defined as haemoglobin lower than 12 g/dL in women and < 14g/dL in men; previous treatment with acupuncture; contraindications for acupuncture; participation in other therapeutic trials; concomitant chronic diseases not related to IBD that might contribute to the presence or the severity of fatigue. Participants who presented clinical relapse during the study period were withdrawn from the study. A total of 52 participants were randomised to the electroacupuncture (EAc: n = 18), sham acupuncture (ShaEAc: n = 18) or control group (WL: n = 16). Age [Mean(SD) years): EAc: 44.6 (12.1); ShaEAc: 38.6 (8.3); control: 42.6 (10.7) Gender: EAc (10 males, 8 females); ShaEAc (13 males; 5 females); control (11 males, 15 females) Disease type: EAc (17 CD, 1 UC); ShaEAc (17 CD; 1 UC); control (12 CD, 4 UC) Disease duration [Mean(SD) years]: EAc: 10.6 (4.8); ShaEAc: 11.4 (5.4); control: 10.5 (4.7) Loss to follow‐up: EAc (n = 3; 17%); ShaEAc (n = 3; 17%); control (n = 4; 25%)
Interventions	Participants in EAC and sham EAC groups performed a total of 9 acupuncture sessions during eight weeks (2 sessions/first week and one session per week during 7 weeks). (a) Electroacupuncture; (b) sham EAc Mode of delivery: (a) 20 acupoints were selected, needles were inserted to a depth of 20 mm and connected to a 6‐channel electroacupuncture device (ITO® ES‐160, Japan). A pulsed electrical stimulation (asymmetric balanced, rectangular shape, 8 to 100 Hz frequency) was used and needles were left in place connected to the electroacupuncture device for 20 minutes. (b) 8 'non‐acupuncture' points were selected, needles were inserted to a depth of 20 mm and connected to a 6‐channel electroacupuncture device (ITO® ES‐160, Japan), but electric stimulation was not applied and needles were left in place for 20 minutes. The sessions for both groups was delivered by 3 senior acupuncturists with at least five years of experience. Duration: 9 sessions during eight weeks (2 sessions during the first week and one session per week during 7 weeks) Setting of trial: Single centre in Spain, outpatient clinic of a Digestive Diseases department Setting of intervention: IBD unit in separate rooms Comparision treatment: none (waiting‐list group was offered an open EAc treatment at the end of follow‐up) Co‐interventions: Usual pharmacological treatments were maintained and drug dosage unchanged during the study.
Outcomes	Fatigue was assessed using the FACIT‐FS. Quality of life was assessed using the IBDQ‐9. Adverse events, including acupuncture abnormalities such as bleeding, haematoma, pain in the acupuncture sites, increased blood pressure, fainting during acupuncture and other adverse reactions were evaluated (during the treatment period). Other outcomes assessed: depression, anxiety and sleepiness Assessment time points: baseline, week 4, week 8 and week 16
Notes	Additional information was supplied by author. Full‐text paper submitted for publication 3‐arm trial (1 experimental, 2 control) Cross‐over of participants who had no improvement in fatigue (FACIT‐FS score < 40) after 8 weeks post‐treatment occurred (participants from EAc group to ShEAc group and vice versa) and also the control group started EAc. However, due to loss to follow‐up and dropouts, data analysis was not performed. Data analysed with per protocol analyses.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple randomisation was performed by generating a random number table using the SPSS 20.0 software. The first number in the random number table was used as a starting point to create random assignment cards, which were then sealed in opaque envelopes. The envelopes were numbered and kept secure by one of the authors (AF) (author information).
Allocation concealment (selection bias)	Low risk	The acupuncturists were given randomly generated treatment allocations within sealed opaque envelopes (author information).
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Participants and evaluators were blinded to group assignment. Personnel administering the intervention were not blinded (author information).
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Participants were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up relatively similar across the groups (author information)
Selective reporting (reporting bias)	Unclear risk	All information provided by trial author on outcomes was transparent, however, findings published only as a conference abstract at present
Other bias	Low risk	Baseline demographics were generally comparable between groups (author information).