Table 1.
Characteristics of Included Randomized Clinical Trials Comparing Orlistat vs Placebo for Weight Lossa
| Source/Period | Total Enrolled/mITT/Completers | Cointerventions | Outcomes of Interest Reported | ||||||
|---|---|---|---|---|---|---|---|---|---|
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| Intervention | Control | Diet | Exercise | Behavior | Mean Weight Change | Proportion With ≥5% Weight Loss | Proportion With ≥10% Weight Loss | Treatment Withdrawals Due to Adverse Events | |
| Astrup et al,49 2012 (US)/2007–2009 | 95/67/45 | 98/67/47 | 500-kcal/d deficitb | Brisk walking ≥150 min/wk | Yes | ✓ | ✓ | ✓ | ✓ |
|
| |||||||||
| Swinburn et al,36 2005 (Australia and New Zealand) | 70/170/132 | 169/169/137 | Reduce fat intake (40 g/d) | Moderate, 30 min/d | Yes | ✓ | ✓ | ||
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| Berne,23 2005 (Sweden)/1999–2002 | 111/111/96 | 109/109/94 | 600-kcal/d deficit | Moderate, 30 min/d | Yes | ✓ | ✓ | ✓ | |
|
| |||||||||
| Torgerson et al,37 2004 (Sweden)/1997–2002 | 1650/1640/850 | 1655/1637/564 | 800-kcal/d deficit | Moderate, walk 1 extra km/d | Yes | ✓ | ✓ | ✓ | |
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| Krempf et al,31 2003 (France) | 346/346/224 | 350/350/201 | 20% energy reduction | No | ✓ | ✓ | ✓ | ✓ | |
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| |||||||||
| Miles et al,33 2002 (US and Canada) | 255/250/165 | 261/254/146 | 600-kcal/d deficit | Nonspecific increase | Yes | ✓ | ✓ | ✓ | ✓ |
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| Hanefeld and Sachse,27 2002 (Germany) | 195/189/133 | 188/180/131 | 600-kcal/d deficit | No | ✓ | ✓ | ✓ | ||
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| Broom et al,24 2002 (UK) | 265/265/186 | 266/266/161 | 600-kcal/d deficit | No | ✓ | ✓ | ✓ | ✓ | |
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| Bakris et al,22 2002 (US) | 278/267/160 | 276/265/106 | 600-kcal/d deficit | Nonspecific increase | No | ✓ | ✓ | ✓ | |
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| Kelley et al,30 2002 (US) | 274/266/129 | 276/269/141 | 600-kcal/d deficit | Nonspecific increase | Yes | ✓ | ✓ | ✓ | ✓ |
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| Rossner et al,34 2000 (Europe) | 244/242/181 | 243/237/158 | 600-kcal/d deficit | No | ✓ | ✓ | ✓ | ✓ | |
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| Lindgarde,32 2000 (Sweden) | 190/190/159 | 186/186/164 | 600-kcal/d deficit | Moderate, 30 min/d | Yes | ✓ | ✓ | ✓ | ✓ |
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| Hauptman et al,28 2000 (US) | 210/210/151 | 212/212/122 | 600-kcal/d deficit | Moderate, 20–30 min/d (3–5 times/wk) | Yes | ✓ | ✓ | ✓ | ✓ |
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| Finer et al,26 2000 (UK) | 114/110/66 | 114/108/73 | 600-kcal/d deficit (reduced by further 300 kcal at 24 wk) | No | ✓ | ✓ | ✓ | ✓ | |
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| Davidson et al,25 1999 (US)/1992–1995 | 668/657/458 | 224/223/133 | Energy-deficient diet (30% energy from fat) | Brisk walking, 20–30 min/d (3–5 times/wk) | Yes | ✓ | ✓ | ✓ | ✓ |
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| Sjostrom et al,35 1998 (Europe) | 345/343/284 | 343/340/260 | 600-kcal/d deficit (reduced by further 300 kcal at 24 wk) | No | ✓ | ✓ | ✓ | ||
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| Hollander et al,29 1998 (US) | 162/162/139 | 159/159/115 | Energy-deficient diet (30% energy from fat) | No | ✓ | ✓ | ✓ | ✓ | |
Abbreviation: mITT, modified intention to treat (last-observation-carried-forward analysis).
a
All trials were randomized, double-blind, placebo-controlled, multicenter studies except Broom et al,25 a single-center study. All trials had follow-up through 52 weeks.
b
Baseline calculated using World Health Organization equations; 30% of energy from fat, 20% from protein, and 50% from carbohydrate.