OBJECTIVES : Obesity is a chronic clinical condition considered one of the most serious health problems in the world, since it may cause other chronic metabolic disorders. We conducted a meta-analysis to evaluated the safety and efficacy of four central nervous system acting drugs approved in Brazil for weight-loss.

METHODS

: PUBMED, EMBASE and Cochrane library databases were searched from inception until January 2018 to retrieve RCT studies comparing sibutramine or diethylpropion or mazindol or fenproporex with placebo in overweight or obese patients. There was no language restriction. We extracted and combined data from studies that reported safety profile and weight loss. A random-effects meta-analytic model was applied in all calculations. Cochrane collaboration tool was used to assess bias in the included studies. Certainty of evidence was assessed using the GRADE assessment. This meta-analysis is registered in PROSPERO (CRD 42018091083).

RESULTS : The appetite suppressants showed significant weight loss when compared to placebo (MD: -4.70kg; 95%CI [-5.25 to -4.15]; I2=100%; 43 studies). Increased total adverse events, dry mouth, constipation, insomnia, dizziness and tachycardia were reported in the intervention group (RR: 1.06; 95%CI [1.01 to 1.10]; I2=20%; 22 studies; RR: 2.08; 95%CI [1.76 to 2.47]; I2=34%; 25 studies; RR: 2.31; 95%CI [1.88 to 2.84]; I2=0%; 25 studies; RR: 1.84; 95%CI [1.40 to 2.39]; I2=0%; 17 studies, RR: 1.78; 95%CI [1.24 to 2.58]; I2=0%; 13 studies, RR: 2.01; 95%CI [1.42 to 2.86]; I2=0%; 10 studies, respectively). Sibutramine significantly increase heart rate and mean diastolic pressure when compared to placebo (MD:4.17 bpm; 95%CI [3.60 to 4.74]; I2=99%; 23 studies, and MD:1.68mmHg; 95% CI [1.29 to 2.07]; I2=98%; 22 studies, respectively). GRADE assessment was considered moderate to low for most outcomes.

CONCLUSIONS : These drugs are effective for weight loss in overweight and obese patients, but increase the risk of adverse events.