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. 2014 Oct 9;2014(10):CD006881. doi: 10.1002/14651858.CD006881.pub2

Gaughan 1997.

Methods
  • Study design: open‐label RCT

  • Study duration: September 1993 to February 1995

  • Study follow‐up: 6 months

Participants
  • Country: USA

  • Setting: single centre

  • HD patients

  • Number (randomised/analysed): treatment group (10/9); control group (10/10)

  • Mean age ± SD (years): treatment group (53.7 ± 16.7); control group (45.3 ± 15.4)

  • Sex (M/F): treatment group (7/2); control group (4/6)

  • Exclusion criteria: deficiency, sickle cell disease, primary haemolytic anaemia, or multiple myeloma; previous nephrectomy; active gastrointestinal bleeding; active ischaemic heart disease,; abnormal liver function; uncontrolled hypertension; iron deficiency (ferritin < 100 ng/mL or transferrin saturation < 15% or both; infection with the human immunodeficiency virus; known malignancy; presence of inflammation or infection; doubtful compliance as a result of alcohol abuse, drug abuse, or poor motivation

Interventions Treatment group
  • Nandrolone decanoate: 100 mg IM weekly

  • Alpha rHuEPO: 1500 U IV at the end of each HD session

  • Duration: 26 weeks


Control group
  • Alpha rHuEPO: 1500 U IV at the end of each HD session

  • Duration: 26 weeks

Outcomes
  • TG

  • Albumin

  • Transferrin

  • Adverse events: acne

Notes
  • Mortality, Hb, HCT, ALT, AST, BUN, SCr, cholesterol, HDL, LDL and total protein not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation claimed, but detail not provided
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk One ND arm participant withdrew: active injection with mycobacterium tuberculosis. It was not reported that skin tuberculin tests were undertaken for study participants
Selective reporting (reporting bias) Low risk Investigators reported that although the study protocol was available, we were unable to obtain a copy. However, it was clear that the published reports included all expected outcomes
Other bias Low risk Signed informed consent was obtained from all participants. Study protocol approved by the Institutional Review Board at Thomas Jefferson University Hospital. Overall, participant demographic data were similar between groups