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. 2016 Jun 28;2016(6):CD009440. doi: 10.1002/14651858.CD009440.pub2

Su 2009.

Methods
  • Study design: parallel RCT

  • Duration of the study: December 2006 to February 2007

  • Study follow‐up: 12 weeks

Participants
  • Country: Taiwan

  • Setting: inpatient or outpatient not reported; single centre (a HD centre in a university hospital)

  • Inclusion criteria: aged 18 to 80 years; 3 to 5 hours of regular HD 3 times/week; HD for at least 6 months

  • Number: treatment group (34); control group (35)

  • Mean age ± SD (years): treatment group (61.07 ± 13.87); control group (58.57 ± 12.61)

  • Sex (M/F): 33/29 (only participants who had completed the study were counted)

  • Exclusion criteria: hospitalisation due to reasons other than HD; pregnancy; pacemaker

Interventions Treatment group
  • FIR acupoint stimulation


Control group
  • Heat pad therapy


Duration of intervention: 12 weeks
Outcomes
  • Autonomic nervous system (ANS) activity

    • Measured by HRV analyser (12 HRV parameters were measured: mean heart rate, SD of normal to normal, pressure stress index, total power, very low frequency, low frequency, high frequency, low frequency/high frequency ration, autonomic nervous system activity, stress resistance, stress index and fatigue index)

  • QOL

    • Measured by WHOQOL‐BREF


Time points measured (or reported) in the study: 4, 8, 12 weeks for ANS activity; 12 weeks for QOL
Notes
  • Only participants who had completed the study was analysed. Some patients were excluded before the intervention was delivered, based on the results of baseline heart rate variability and QOL questionnaire. However, the criteria for pre‐intervention exclusion was not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk The heat pad control intervention was regarded as sham intervention of FIR therapy, because of its heat property similar to FIR therapy. However, appearances of two interventions were not identical. Results of credibility test of the control intervention were not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Only participants who had completed the study were analysed (3 from FIR group and 5 in control group were withdrawn from 69 randomised patients for unknown reasons)
Selective reporting (reporting bias) Unclear risk No study protocol available
Other bias Low risk Study appears free of other biases