TABLE 2

Summary of findings from additional individual RCTs of pharmacological interventions targeting weight

Author and year of publicationCountryNumber of participants (diagnosis), follow-upIntervention and comparator (duration)SettingRisk of biasWeight/BMILipidsGlucoseBlood pressure
a,bAfshar et al. (2009)61Iran32 (schizophrenia), 8 weeksTopiramate vs. placebo (8 weeks)Secondary care outpatientsLowNo significant between-group differences for BMIcN/ANo significant between-group differences (specific type of glucose measure not reported)cNo significant between-group differences (specific type of blood pressure measure not reported)c
Roy Chengappa et al. (2006)57USA287 (bipolar disorder), 12 weeksTopiramate vs. placebo (12 weeks)Secondary care outpatientsLowBMI change:c intervention: –0.8 kg/m2 (SD 1.2 kg/m2); control: 0.1 kg/m2 (SD 1.0 kg/m2) (p < 0.001)N/AN/AN/A
Weight change:c intervention: –2.5 kg (SD 3.4 kg); control: 0.2 kg (SD 3.0 kg) (p < 0.001)
Roy Chengappa et al. (2007)67USA48 (schizoaffective disorder), 8 weeksTopiramate vs. placebo (8 weeks)Secondary care outpatientsUnclearBMI change:c intervention: –0.5 kg/m2 (SD 1.3 kg/m2); control: 1.0 kg/m2 (SD 2.2 kg/m2) [F(143) = 6.5, p < 0.02]N/AN/AN/A
Weight change:c intervention: –3.3 lb (SD 8.5 lb); control: 6.6 lb (SD 14.2 lb) [F(1,43) = 6.5, p < 0.02]
Narula et al. (2010)70India67 (schizophrenia), 12 weeksTopiramate vs. placebo (12 weeks)Secondary care outpatientsUnclearBMI (baseline; 12 weeks):b intervention: 20.6 kg/m2 (SD 3.9 kg/m2) – 20.1 kg/m2 (SD 4.0 kg/m2); control: 20.2 kg/m2 (SD 3.9 kg/m2) – 22.6 kg/m2 (SD 4.1 kg/m2) (t = 2.4; p = 0.017)Total cholesterol (baseline; 12 weeks):c intervention: 135 mg% (SD 30 mg%) –133 mg% (SD 31 mg%); control: 133 mg% (SD 31 mg%) –156 (SD 6 mg%) (t = 2.7; p = 0.008)Fasting blood glucose (baseline; 12 weeks):c intervention: 79.8 mg% (SD 9.4 mg%) –78.2 mg% (SD 6.7 mg%) control: 77.8 mg% (SD 7.4 mg%) –88.5 mg% (SD 12.0 mg%) (t = 4.3; p < 0.001)Systolic blood pressure (baseline; 12 weeks):c intervention: 118.8 mmHg (SD 7.8 mmHg) –117.9 mmHg (SD 7 mmHg); control: 119.9 mmHg (SD 7.1 mmHg) –122.5 mmHg (SD 7.7 mmHg) (t = 2.6; p = 0.012)
Weight (baseline; 12 weeks):b intervention: 54 kg (SD 12.9 kg) 52.73 kg (SD 12.9 kg); control: 52.8 kg (SD 12.6 kg) 58.9 kg (SD 13.1 kg) (t = 1.9; p = 0.05)Diastolic blood pressure (baseline; 12 weeks):c intervention: 78.6 mmHg (SD 5.7) –77.9 mmHg (SD 4.8 mmHg); control: 80.2 mmHg (SD 6.3 mmHg) –81.4 mmHg (SD 6.2 mmHg) (t = 2.5; p = 0.014)
McElroy et al. (2007)56USA46 (bipolar disorder or schizoaffective disorder with a BMI of ≥ 30 kg/m2 or ≥ 27 kg/m2 with concomitant obesity-related risk factors), 24 weeksTopiramate vs. sibutramine (24 weeks)Secondary care outpatientsHigh (high attrition differing across treatment groups)No significant between-group differences for BMIc or weight lossbN/AN/AN/A
Ball et al. (2011)65USA37 (schizophrenia or schizoaffective disorder with weight gain ≥ 7% since starting antipsychotic medication), 24 weeksAtomoxetine + weight management, group counselling and physical activity vs. weight management, group counselling and physical activity (24 weeks)Tertiary care outpatientsUnclearNo significant between-group differences for weight or BMIbNo significant between-group differences for HDL, LDL, triglycerides, very-low-density lipoproteinbNo significant between-group differences for fasting glucosecNo significant between-group differences for systolic or diastolic blood pressurec
Borba et al. (2011)66USA20 (schizophrenia or schizoaffective disorder with a BMI of ≥ 30 kg/m2 or ≥ 27 kg/m2 with evidence of insulin resistance or any component of metabolic syndrome), 8 weeksRamelteon vs. placebo (8 weeks)Secondary care outpatientsUnclearNo significant between-group differences for waist circumferencebTotal cholesterol (baseline; 8 weeks):c intervention: 205 mg/dl (SD 39 mg/dl) –195 mg/dl (SD 42 mg/dl); control: 171 mg/dl (SD 37 mg/dl) –175 mg/dl (SD 36 mg/dl) [F(1,18) = 5.26; p = 0.03]No significant between-group differences for fasting glucosecN/A
Cholesterol-to-HDL ratio (baseline; 8 weeks): intervention: 5.1 mg/dl (SD 1.4 mg/dl) –4.9 mg/dl (SD 1.3 mg/dl); control: 4 mg/dl (SD 1 mg/dl) –4.6 mg/dl (SD 1.4 mg/dl) [F(1,17) = 7.57; p = 0.01]
Henderson et al. (2011)69USA35 (schizophrenia or schizoaffective disorder), 8 weeksModafinil vs. placebo (8 weeks)Secondary care outpatientsUnclearNo significant between-group differences for BMI or weightbNo significant between-group differences for levels of total cholesterol, HDL, non-HDL and triglyceridescNo significant between-group differences for fasting glucosecNo significant between-group differences for systolic or diastolic blood pressurec
McElroy et al. (2012)58USA42 (psychotic or bipolar disorder with a BMI of ≥ 22 kg/m2), 16 weeksZonisamide vs. placebo (16 weeks)Secondary care outpatientsLowWeight change:c intervention: 0.9 kg (SD 3.3 kg0; control: 5.0 kg (SD 5.5 kg) (mean difference –4.4 kg (95% CI –1.5 to –7.4; p = 0.01)N/ANo significant between-group differences for fasting glucoseaNo significant between-group differences for systolic or diastolic blood pressurea
Ghanizadeh et al. (2013)59Iran41 (schizophrenia), 10 weeksZonisamide vs. placebo (10 weeks)Outpatient and inpatientLowBMI change:c intervention: –0.3 kg/m2 (SD 0.4 kg/m2); control: 2.2 kg/m2 (SD 6.9 kg/m2) (p = 0.0001)N/AN/AN/A
Weight change:c intervention: –1.1 kg (SD 1.4 kg); control: 1.4 kg (SD 2.2 kg) (mean difference –4.4 kg (p = 0.0001)
Elmslie et al. (2006)68New Zealandn = 60 (bipolar disorder with a BMI of > 25 kg/m2), 26 weeksL-carnitine supplement + dietary counselling sessions vs. placebo + dietary counselling sessions (26 weeks)OutpatientsUnclearNo significant between-group differences for weight change,c BMIa or waist circumferenceN/AN/AN/A
Ranjbar et al. (2013)60Irann = 52 (schizophrenia, schizoaffective and schizophreniform disorders), 16 weeksRanitidine vs. placebo (16 weeks)InpatientsLowNo significant between-group differences for BMI changeaN/AN/AN/A
Poyurovsky et al. (2013)72Israeln = 43 (schizophrenia), 6 weeksReboxetine + betahistine vs. placebo (16 weeks)InpatientsUnclearBMI change:c intervention: 0.7 kg/m2 (SD 0.8 kg/m2); control: 1.5 kg/m2 (SD 1 kg/m2) (t = 2.92, df = 41, p = 0.008)N/AN/AN/A
Weight change:c intervention: 2 kg (SD 2.4 kg); control: 4.8 kg (SD 3.2 kg) (t = 2.89, df = 41, p = 0.006)
Jarskog et al. (2013)71USAn = 148 (schizophrenia and schizoaffective disorder), 16 weeksMetformin + weekly diet and physical activity intervention vs. weekly diet and physical activity intervention (16 weeks)OutpatientsUnclearBMI change:a intervention: –1 kg/m2 (95% CI –1.3 to –0.7); control: –0.3 (95% CI –0.7 to 0) (t = –2.27; p = 0.006)Triglycerides change:a intervention: –7.0 mg/dl (95% CI –20.4 to 6.3 mg/dl); control: 13.2mg/dl (95% CI –0.3 to 26.7 mg/dl) (t = –2.11; p = 0.037)No significant between-group differences for fasting glucoseaN/A
Weight change:c intervention: –3 kg (95% CI –2 to –4 kg); control: –1 kg (95% CI –2 to 0 kg) (t = –2.61; p = 0.007)No significant between-group differences for levels of total cholesterol, HDL, non-HDL and LDLa
Smith et al. (2013)73USAn = 44 (schizophrenia and schizoaffective disorder), 12 weeksPioglitazone + manualised diet–exercise intervention vs. placebo + diet–exercise intervention (12 weeks)Not reportedUnclearNo significant between-group differences for weight and BMI changeaTotal cholesterol change:c intervention: 2.3 mg/dl (SD 7.6 mg/dl); control: 2 mg/dl (SD 8 mg/dl) (F = 2.9; p = 0.048)Fasting blood glucose change:c intervention: 0.02 mg/dl (SD 8.1 mg/dl); control: 24.2 mg/dl (SD 8.6 mg/dl) (FL = 3.88; p = 0.016)N/A
HDL change:c intervention: 4.6 SD 1.8 mg/dl; control: –2.6 SD 2.1mg/dl (F = 6.50, p = 0.001)

N/A, not applicable; SD, standard deviation.

a

Secondary outcome.

b

Identified in Ellinger et al.64

c

Primary outcome.

From: Appendix 1, Systematic review of pharmacological and behavioural interventions for reducing cardiovascular disease risk in people with severe mental illnesses

Cover of Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT
Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT.
Programme Grants for Applied Research, No. 7.2.
Osborn D, Burton A, Walters K, et al.
Southampton (UK): NIHR Journals Library; 2019 Apr.
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