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

Lin 2011.

Study characteristics
Methods Study design
  • Quasi‐RCT


Study dates
  • Duration of follow‐up: 2 months

  • Time frame: January to March 2007

Participants Study characteristics
  • Setting: single‐centre (HD centre in Taipei)

  • Country: Taiwan

  • Inclusion criteria: 18 and 65 years; HD > 3 months and they were needled on acupoints for 3 to 5 hours/sitting, 3 times/week; weight gain < 6% between 2 successive HD sessions; sensitivity of their skin to temperature is intact; no infection or hospitalisation for at least one month during the pre‐study assessment period; willing to participate in this research after an explanation and they must submit their letter of consent to this effect

  • Exclusion criteria: not reported


Baseline characteristics
  • Number (analysed/randomised): intervention group (36/36); control group (25/25)

  • Mean age ± SD (years): not reported

  • Sex (M/F): intervention group (16/20); control group (15/10)

  • Dialysis type: HD

  • Dialysis vintage (years) (mean ± 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
  • Far‐infrared irradiation (acupuncture)


Control group
  • No intervention


Co‐interventions: not reported
Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • Fatigue

    • Taiwan version of BFI (Appendix 3): assessed before and after the treatment

  • Usual level of fatigue during the past 24 hours

  • Worst level of fatigue during the past 24 hours

  • Fatigue in the last week

  • Fatigue strength rate

  • Disturbance of life

  • General activity

  • Mood

  • Walking ability

  • Normal work

  • Relations with other people

  • Enjoyment of life

  • Meridian equipment

    • Ryodoraku instrument: assessed before and after the treatment

      • Small intestine meridian

      • Large intestine meridian

  • Laboratory results (Hb, albumin, BUN, creatinine): assessed before and after the treatment

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported

  • A priori published protocol: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Prior to the intervention process, the selected patients were randomly divided by computer into two groups."
Comment: The study was a quasi‐experimental study. Computer generation is considered as low risk of bias. No imbalance between intervention groups was apparent
Allocation concealment (selection bias) High risk Method of allocation concealment was not reported in sufficient detail to permit judgement. However the study used a quasi‐experimental design
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported. However, interventions were different and participants and/or investigators could be aware of the treatment assigned
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "To minimize participants’ misunderstanding of the Brief Fatigue Inventory‐Taiwan Form (BFI‐T), the data were collected mainly via a face‐to‐face survey interview. The participants were allowed to ask any questions about the study at any stage."
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. Other outcomes were objective
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants completed the study and were included into the analyses
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 Unclear risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding and conflicts of interest were not reported