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

Tsay 2004a.

Study characteristics
Methods Study design

  • Parallel RCT


Study dates

  • Duration of follow‐up: 4 weeks

  • Time frame: over a 6‐month period (year and months not reported)
Participants Study characteristics

  • Setting: multicentre (4 dialysis centres in major hospitals, Taiwan)

  • Country: Taiwan

  • Inclusion criteria: ≥ 18 years; diagnosed with ESKD; HD for at least 3 months; and complained of fatigue

  • Exclusion criteria: patients with a lower extremity amputation; comorbid diagnoses of psychiatric disorders; congestive heart failure; chronic obstructive pulmonary disease; insulin‐dependent diabetes; neuromuscular disease; systemic lupus erythematosus; rheumatoid arthritis; cancer; regular steroid therapy; or was using antihypertensive medications


Baseline characteristics

  • Number (analysed/randomised): intervention group (35/35); control group 1 (35/35); control group 2 (36/36)

  • Mean age ± SD (years): intervention group (57.23 ± 10.93); control group 1 (60.49 ± 12.21); control group 2 (56.81 ± 13.30)

  • Sex (M/F): overall (36/70)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (3.6 ± 3.2); control group 1 (5.0 ± 4.3); control group 2 (3.8 ± 3.4)

  • Comorbidities

    • CVD: not reported

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression (clinician diagnosis): intervention group (35/35); control group 1 (35/35); control group 2 (36/36)
Interventions Intervention classification

  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group

  • Acupressure plus usual care, for 4 weeks


Control group 1

  • Placebo, sham acupressure plus usual care, for 4 weeks


Control group 2

  • Usual care


Co‐interventions

  • Not reported
Outcomes Outcomes reported

  • Fatigue outcome measures used: validation data available

  • Fatigue

    • PFS (Appendix 3): (assessed pre‐treatment and a week following treatment

      • Behavioural/severity

      • Sensory

      • Cognitive/mood

      • Affective meaning

    • 10‐point VAS for fatigue (Appendix 3): assessed pre‐treatment and a week following treatment

  • Sleep quality

  • PSQI (Appendix 3): assessed post‐test only

    • Sleep quality

    • Sleep latency

    • Sleep duration

    • Sleep efficiency

    • Sleep disturbances

    • Sleep sufficiency

    • Use of sleeping medications

  • Depression
Notes Additional information

  • Funding: National Science Counsel of Taiwan provided funding (NSC 90‐2314‐B‐227‐004)

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: no applicable

  • A priori published protocol: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "This prospective, randomised controlled trial with a pre‐test, post‐test design was carried out over a 6‐month period."
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 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 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 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 subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes Unclear risk All participants completed the study. However, it was not stated if some participants discontinued
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 and conflicts of interest was not reported