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. 2021 Mar 30;2021(3):CD013119. doi: 10.1002/14651858.CD013119.pub2

Tomlinson 1975.

Study characteristics
Methods
  • Study design: cross‐over RCT

  • Recruitment: May to August 1972 (trial 1) and February to May 1973 (trial 2)

  • Study duration: 13 to 15 weeks (5 to 6 weeks for each intervention phase and a 2 to 3 week washout period)

Participants
  • Country: UK

  • Setting: single centre, hospital outpatient clinic

  • Inclusion criteria: kidney transplant with satisfactory function (this criteria not reported), obesity or cushingoid appearance

  • Number

    • Trial 1: intervention group (5); control group (6)

    • Trial 2: intervention group (8); control group (6)

  • Mean age ± SD (years): not reported

  • Sex (M/F): trial 1 (6/5); trial 2 (8/6)

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI (kg/m²): not reported

    • Stage of CKD: transplant recipients

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): not reported

    • Mean baseline SBP ± SD (mmHg): not reported

    • Mean baseline DBP ± SD (mmHg): not reported

    • Mean baseline energy intake ± SD (kcal/day): not reported

    • Comorbid conditions: 32% of participants had hypercholesterolaemia.

  • Exclusion criteria: oedema; fasting blood glucose level < 90 mg/100 mL

Interventions
  • Intervention type classification

    • Trial 1: pharmacological + lifestyle

    • Trial 2: pharmacological

  • Weight loss intervention/s used

    • Trial 1: appetite suppressant + dietary

    • Trial 2: appetite suppressant


Trial 1
  • Intervention first group

    • Received placebo medication for 2 to 3 weeks as a run‐in period, followed by 120 mg/day fenfluramine for 5 to 6 weeks followed by placebo medication for 5 to 6 weeks

  • Control first group

    • Received placebo medication for 2 to 3 weeks as a run‐in period, then continued on placebo medication for 5 to 6 weeks. Then given 120 mg/day fenfluramine for 5 to 6 weeks

  • Co‐interventions

    • All participants were given dietary advice at the beginning of the trial and during the in the run‐in period and a dietary assessment was made by a member of the research team. It is not reported what was the dietary advice


Trial 2
  • Intervention first group

    • Received 80mg/day fenfluramine for 5 to 6 weeks, then received placebo medication for 3 weeks followed by placebo medication for 5 to 6 weeks

  • Control first group

    • Received placebo for 5 to 6 weeks, then received placebo medication for 3 weeks, followed by 80 mg/day fenfluramine for 5 to 6 weeks

  • Co‐interventions

    • No dietary advice nor dietary assessments were provided in this trial

Outcomes
  • Weight loss (kg)

  • Body weight (kg)

  • Total cholesterol (mg/100 mL)

  • Adverse patient outcomes associated with each weight loss intervention

  • BP (mmHg)

  • Triglycerides (mg/100 mL)

Notes
  • Founding source: not reported

  • Trial registration: not applicable as published before 2006

  • Possible conflicts of interest for study author: not reported

  • Fenfluramine the appetite suppressant used in this trial, was withdrawn from the market in 1997 due to safety reasons and is no longer approved as a drug

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement ‐ not reported how participants were randomised
Allocation concealment (selection bias) Low risk Allocation not revealed until un‐blinding
Blinding of participants and personnel (performance bias)
All outcomes Low risk Placebo randomised controlled double blind trial
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded outcome assessors
Incomplete outcome data (attrition bias)
All outcomes High risk Missing data not well reported, 22% attrition rate
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement ‐ some outcome measures not well reported
Other bias Low risk Nil other potential sources of bias identified