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

Bicer 2022.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 4 weeks

  • Time frame: June 2013 to September 2013

Participants Study characteristics
  • Setting: multicentre (4 HD centres located in two cities)

  • Country: Turkey

  • Inclusion criteria: > 18 years; participated in HD program for an average of 4 hours, 3 times/week for at least 6 months; experienced hypotension during HD; could keep their fluid intake and diets constant during the study; capable of answering all of the questions, gained 2500 g or more between dialysis sessions, and agreed to participate in the study

  • Exclusion criteria: did not experience hypotension problems during HD; cardiac pacemakers; pregnant; fistulas in both arms, psychiatric problems; suffered from nerve, soft tissue or vascular disease in their upper extremities


Baseline characteristics
  • Number (analysed/randomised): overall (135/150); intervention group (67/not reported); control group (68/not reported)

  • Mean age ± SD (years): intervention group (64.0 ± 11.6); control group (65.8 ± 12.1)

  • Sex (M/F): intervention group (24/43); control group (30/38)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (5.9 ± 4.5); control group (5.9 ± 3.9)

  • 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
  • Acupressure with an electrostimulation device: 3 times/week for 1 month


Control group
  • Placebo


Cointerventions
  • Not reported

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

  • Fatigue

  • PFS: baseline and at week 4

    • Behavioural/severity subscales assessing the effect and severity of fatigue on ADL

    • Affective subscale that includes emotional meaning attributed to fatigue

    • Sensory subscale reflecting psychological, physical, and emotional symptoms of fatigue

    • Cognitive/mood subscale reflecting the level of fatigue required to affect cognitive functions and mood

    • VAS: baseline and at week 4

  • BP: baseline and at week 4

  • Headache: during the study period

  • Pain

    • VAS: baseline and at week 4

  • BMI: baseline and at week 4

  • Weight difference between predialysis and post‐dialysis periods: baseline and at week 4

  • Target UR and actual UR: baseline and at week 4

  • Pulse rates: baseline and at week 4

Notes Additional information
  • Funding: project code number TDK‐2012‐4135 by Erciyes University, Scientific Research Projects Unit

  • Conflicts of interest/disclosures: none

  • 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) Unclear risk 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 Quote: "The patient data relating to the questionnaire, VAS pain (measurement of pain level), VAS fatigue, and Piper fatigue scale at the first follow‐up (the first interview before acupressure) were collected by the researcher."
Comment: Fatigue was 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. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "A total of 150 patients, meeting the inclusion criteria, were reached during the study. Five patients in the intervention group did not agree to participate in the study. Two of these patients experienced local pruritus in the area the device was applied, one patient developed a fistula problem, and two patients left the city during the follow‐up. Additionally, three patients in the placebo group did not want to continue the study since two of these patients were receiving treatment in a hospital out of the city due to coronary angiography. Therefore, the study was completed with 135 patients."
Comment: 135/150 participants completed the study (> 5% loss to follow‐up. Some reasons for discontinuation were provided, and some were related to the intervention
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan was not reported. It was reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue data at all time points were reported. 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 did not influence the data analysis and conflicts of interest were not reported. No other source of bias were apparent