Table 1.
Characteristics of included trials
| Author/year | Sex (female), % | Age (range), years | BMI (mean or range), kg/m2 | Intervention N/dose | Comparator N/dose | Outcomes | Cointerventions |
|---|---|---|---|---|---|---|---|
| Al-Helli 2015 [13] Iraq (parallel RCT) |
− | 18–40 | ≥30 |
N = 12 Fluoxetine 20 mg orally, once a day for 2 months N = 12 Omega-3 gel (1 g) orally twice a day for 2 months N = 12 Fluoxetine 20 mg + omega-3 gel (1 g) orally daily for 2 months |
N = 12 Placebo orally once daily for 2 months |
BMI, serum lipids: total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, fasting blood glucose, malondialdehyde, leptin | − |
|
| |||||||
| Suplicy 2014 [29] Brazil (parallel RCT) |
100 | 33.1–39 | 33.6–35.6 |
N = 30 Diethylpropion 75 mg orally, once per day for 52 weeks N = 31 Fenproporex 25 mg orally, once per day for 52 weeks N = 29 Mazindol 2 mg orally, once per day for 52 weeks N = 31 Fluoxetine 20 mg orally, once per day for 52 weeks N = 30 Sibutramine 15 mg orally, once per day for 52 weeks |
N = 29 Placebo orally once daily for 52 weeks |
Differences in weight loss, waist circumference, BMI, adverse events, blood pressure, heart rate, serum lipids, fasting glucose, fasting insulin, glycated haemoglobin, quality of life | Hypocaloric diet and encouraged to maintain at least 150 min per week of moderate physical activity |
|
| |||||||
| Guimaraes 2006 [20] Brazil (parallel RCT) |
88.5 | 30.2–38.9 | 32–37.2 |
N = 8 Sibutramine 15 mg orally, once per day for 90 days N = 8 Metformin 1.7 g orally, once per day for 90 days N = 8 Fluoxetine 60 mg orally, once per day for 90 days |
N = 10 Placebo orally, once daily for 90 days |
Cognitive and critical, behavioural, and cognitive aspects of the patient's dietary habits | Dietary reeducation containing on average 1,500 kcal/day |
|
| |||||||
| Bondi 2000 [15] Italy (parallel RCT) |
100 | 47.8–51.4 | 38.8–42.8 |
N = 8 Fluoxetine 40 mg orally, once per day for 12 weeks N = 12 Fluoxetine 60 mg orally, once per day for 12 weeks |
N = 12 Placebo orally, once daily for 12 weeks |
Resting respiratory quotient, resting energy expenditure, fasting blood glucose, plasma insulin | Diet (55% carbohydrates, 20% protein, 25% fat), a caloric deficit of 500 kcal/day of 70% energy expenditure by indirect calorimetry |
|
| |||||||
| Huang 1998 [21] China (parallel RCT) |
54 | 41.2–44.5 | 32.6–33.5 |
N = 30 Fluoxetine 60 mg orally, once per day for 12 weeks |
N = 30 No treatment |
Body weight, BMI, fasting blood sugar, triglycerides, cholesterol, uric acid, adverse events | Weight-reducing low-calorie diet (25–35 kcal/day adjusted to workload × ideal body weight − 500 kcal) |
|
| |||||||
| Bross 1995 [16] Canada (parallel RCT) | 100 | 32–33 | 34–34.1 |
N = 10 Fluoxetine 60 mg orally, once per day for 3 weeks |
N = 10 Placebo orally, once daily for 3 weeks |
Body weight, resting energy expenditure, thermic effect, serum triiodothyronine and thyroxine, adverse events | Formula diet (420 kcal including 70 g protein/day and 100% RDA vitamins and minerals) |
|
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| Fernández-Soto 1995 [17] Spain (crossover RCT) | 100 | 39 | 35.1–36.8 |
N = 23 Fluoxetine 60 mg orally, once per day for 3 months |
N = 19 Placebo orally, once daily for 3 months |
Weight, pulse, adverse events, glucose, urea, uric acid, creatinine, cholesterol, triglycerides | Diet 1,200 kcal maintained throughout the trial; no caloric liquids; psychotherapy |
|
| |||||||
| Lawton 1995 [23] United Kingdom (crossover RCT) |
100 | 32.8 | 39.9 |
N = 13 Fluoxetine 60 mg orally, once per day for 2 weeks |
N = 13 Placebo orally, once daily for 2 weeks |
Satiety, weight loss, adverse events, appetite, energy intake, motivational ratings (hunger), post-lunch meal palatability rating | Diet: each treatment phase incorporated 2 separate test days on which the participants response to either a high-carbohydrate or a high-fat meal was assessed |
|
| |||||||
| Goldstein 1994 [19] USA (parallel RCT) | 81 | 43 | 35.8–36.2 |
N = 230 Fluoxetine 60 mg orally, once per day for 52 weeks |
N = 228 Placebo orally, once daily for 52 weeks |
Weight loss, adverse events, heart rate, blood chemistry, haematology, and urinalysis | Diet with caloric intake designed to produce a weight loss of 0.45 kg per week |
|
| |||||||
| Goldstein 1993 [18] USA (parallel RCT) | 87 | 42.6–44.9 | 31.6–31.9 |
N = 106 Fluoxetine 60 mg orally, once per day for 40 weeks N = 104 Fluoxetine 20 mg orally, once per day for 40 weeks |
N = 107 Placebo orally, once daily for 40 weeks |
Pulse rate, carbohydrate craving scores, adverse events, urinalysis and blood chemistry, haematology | Advised to reduce overall caloric consumption and offered a diet to lose 0.45 kg per week |
|
| |||||||
| Pedrinola 1993 [26] Brazil (parallel RCT) | − | 20–50 | 33.6–35.1 |
N = 10 Fluoxetine 40 mg orally, once per day for 12 weeks |
N = 10 Placebo orally, twice daily for 12 weeks |
Weight loss, BMI, adverse events, cholesterol, triglycerides | Standard 1,000-kcal diet |
|
| |||||||
| Visser 1993 [30] The Netherlands (parallel RCT) | 0 | 38.8–42.6 | 27.9 |
N = 20 Fluoxetine 60 mg orally, once per day for 12 weeks |
N = 20 Placebo orally, once daily for 12 weeks |
Body weight, waist-hip ratio, abdominal fat areas, adverse events | Received dietary advice on healthy nutrition and means to lose weight |
|
| |||||||
| Wurtman 1993 [31] USA (parallel RCT) | 100 | 39.5–41.2 | 32–33.1 |
N = 30 Fluoxetine 20 mg orally, once per day for 12 weeks N = 28 Dexfenfluramine mg orally, once per day for 12 weeks |
N = 29 Placebo orally, once daily for 12 weeks |
Weight, adverse events, glucose, triglycerides, urinalysis, thyroid profile, depression | − |
|
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|
| |||||||
| Kopelman 1992 [22] United Kingdom (crossover RCT) | 9 | 25–53 | 44 |
N = 11 Fluoxetine 60 mg orally, once per day for 3 days |
N = 11 Placebo orally, once daily for 3 days |
Sleep-breathing patterns, weight loss, adverse events, hematology, oxygen saturation, apnea/hypopnea index, total sleep time, qualitative assessment of sleep | − |
|
| |||||||
| Stinson 1992 [28] Ireland (crossover RCT) |
61.7 | <65 | 36.7 |
N = 13 Fluoxetine 60 mg orally, once per day for 2 weeks |
N = 17 Placebo orally, once daily for 2 weeks |
Resting metabolic rate, diet-induced thermogenesis, weight reduction, serum urea and creatinine levels, hematocrit | − |
|
| |||||||
| Bagiella 1,991 [14] Italy (parallel RCT) |
− | 18–57 | 30–40 |
N = − Fenfluramine 20 mg orally, once per day for 12 weeks N = − 5-hydroxy-tryptophan 300 mg orally, once per day for 12 weeks N = − Fenfluramine 15 mg orally, once per day for 12 weeks N = − Fluoxetine 20 mg orally, once per day for 12 weeks N = − Fluvoxamine 50 mg orally, once per day for 12 weeks |
N = − Placebo 1 capsule orally, 2 or 3 times per day for 12 weeks |
Cognitive and critical, behavioral, and cognitive aspects of the patient's dietary habits | − |
|
| |||||||
| Pijl 1991 [27] The Netherlands (parallel RCT) | 100 | 37.3–38.1 | 35.2–36.4 |
N = 12 Fluoxetine 60 mg orally, once per day for 6 weeks |
N = 12 Placebo orally, once daily for 6 weeks |
Body weight, total caloric intake, adverse events, spontaneous food choice | − |
|
| |||||||
| Levine 1989 [25] USA (parallel RCT) |
85 | 39–41 | ≥25 |
N = 131 Fluoxetine 10 mg orally, once per day for 8 weeks N = 131 Fluoxetine 20 mg orally, once per day for 8 weeks N = 131 Fluoxetine 40 mg orally, once per day for 8 weeks N = 131 Fluoxetine 60 mg orally, once per day for 8 weeks |
N = 131 Placebo orally, once daily for 8 weeks |
Weight loss, BMI, adverse events, heart rate | − |
|
| |||||||
| Levine 1987 [24] USA (parallel RCT) |
88 | 43–46 | ≥25 |
N = 60 Fluoxetine 60 mg orally, once per day for 11 days |
N = 60 Placebo orally, once daily for 11 days |
Weight loss, BMI, adverse events, blood pressure, heart rate | Advised to reduce overall calorie consumption by 20% |
BMI, body mass index; −, not reported; RCT, randomized controlled trial.