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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Hadadian 2016.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 5 weeks

  • Time frame: February to July 2009

Participants Study characteristics
  • Setting: multicentre (2 dialysis centres in major hospitals in Ahvaz‐Iran Kermanshah (Imam Khomeini and Golestan hospitals), Iran)

  • Country: Iran

  • Inclusion criteria: ≥ 15 years; diagnosed with ESKD; had been treated with HD for at least 3 months and complained of fatigue

  • Exclusion criteria: lower extremity amputation; pacemaker; complications requiring immediate medical intervention; under psychological medications; hospital admission for any other reason; needed a blood transfusion; surgery; having infection and bleeding


Baseline characteristics
  • Number (analysed/randomised): intervention group (28/30); control group (28/30)

  • Mean age ± SD (years): intervention group (48.15 ± 15.5); control group (56 ± 14.6)

  • Sex (M/F): intervention group (20/8); control group (18/10)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): overall (2.75 ± 3.27); intervention group (2.13, SD not reported); control group (2.62, SD not reported)

  • Comorbidities

    • CVD: not reported

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • TEAS for 5 weeks


Control group
  • Sham TEAS for 5 weeks


Co‐interventions
  • Not reported

Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • Fatigue

    • Chinese version of the BFI (Appendix 3): assessed at baseline and end of treatment

      • Fatigue in the last week

      • Fatigue right now

      • Usual level of fatigue during past 24 hours

      • Worst level of fatigue during past 24 hours

      • How during the past 24 hours, fatigue has interfered with general activity, mood, walking ability, normal work, relations with other people, enjoyment of life

      • General fatigue

Notes Additional information
  • Funding: Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported (this trial was non‐registry in IRCT because the project was conducted in 2009, and in that time, the registration was optional for the universities)

  • A priori published protocol: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Fifty six patients who had undergone haemodialysis and meeting the inclusion criteria, were divided into two groups by simple random sampling."
Comment: Sequence generation methods were not reported in sufficient detail to permit judgement
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "This study was done as a single‐blind clinical trial. [...] TEAS group treated by acupuncture in real points, while, in the TEAS‐Sham patients, based on the acupuncture expert opinion, the procedure was implemented for them in the false points, so that the patients were not aware of their grouping and blinded about it."
Comment: A single‐blind study is considered as high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "The questionnaires were filled up by the researcher before and after 10th session of intervention."
Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant/investigators beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. It was not stated if the interviewer was blinded to the treatment allocation
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "In this study 95 patients were screened, 72 patients met the inclusion criteria and 60 patients agreed and consented to the study. Four patients were excluded over the intervention: 2 in the TEAS group and 2 in the sham group. Finally, 56 cases including 28 cases in the TEAS group and 28 cases in the Sham group completed the research."
Comment: 28/30 participants in the intervention group and 28/30 participants in the control group completed the study (> 5% lost to follow‐up, without differences between groups). Reasons for discontinuations were not reported
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias Low risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis