Skip to main content
. 2016 Nov 29;2016(11):CD012436. doi: 10.1002/14651858.CD012436
Trial Intervention(s) and comparator(s) Participants included in analysis
 (N) Deaths
 (N) Deaths
 (% of participants) Participants with at least one adverse event
 (N) Participants with at least one adverse event
 (%) Participants with at least one severe/serious adverse event
 (N) Participants with at least one severe/serious adverse event
 (%)
Atabek 2008 I: metformin + diet and physical activity advice 90 0 0 2 2.2 0 0
C: placebo + diet and physical activity advice 30 0 0 0 0.0 0 0
Berkowitz 2003 I: behavioural programme + sibutramine 43 0 0 6 14.0
C: behavioural programme + placebo 39 0 0 3 7.7
Berkowitz 2006 I: behavioural therapy programme + sibutramine 368 0 0 327 88.9 10 2.7
C: behavioural therapy programme + placebo 130 0 0 111 85.4 1 0.8
Chanoine 2005 I: orlistat + diet + exercise + behavioural therapy 352 0 0 341 97 11 3
C: placebo + diet + exercise + behavioural therapy 181 0 0 170 94 5 3
Clarson 2009 I: metformin + lifestyle intervention 14 0 0 0 0 0 0
C: lifestyle intervention only 17 0 0 0 0 0 0
Franco 2014 I: sibutramine + dietary guidance 63 8 13.4 0 0
C: placebo + dietary guidance 63 3 4.9 0 0
Freemark 2001 I: metformin 15 0 0 4 26.7 0 0
C: placebo 17 0 0 1 5.9 0 0
Garcia‐Morales 2006 I: sibutramine + diet + exercise 23 0 0 10 43.5 0 0
C: placebo + diet + exercise 23 0 0 10 43.5‐ 0 0
Godoy‐Matos 2005 I: sibutramine + hypocaloric diet + exercise 30 0 0 a 0 0
C: placebo + hypocaloric diet + exercise 30 0 0 a 0 0
Kendall 2013 I: metformin + healthy lifestyle advice 74 0 0 20 27.0 0 0
C: control + healthy lifestyle advice 77 0 0 8 10.4 0 0
Maahs 2006 I: orlistat + diet and exercise therapy 20 1 5.0 1 5.0
C: placebo + diet and exercise therapy 20 0 0 0 0
Mauras 2012 I: metformin + diet/exercise intervention 35 0 0 0 0
C: diet/exercise intervention 31 0 0 0 0
NCT00001723 I: orlistat + behavioural weight loss programme 100 0 0 95 95 0 0
C: placebo + behavioural weight loss programme 100 0 0 94 94 2 2
Ozkan 2004 I: conventional treatment + orlistat 22 0 0 22 100
C: conventional treatment 20 0 0 0 0
Prado 2012 I: metformin + nutritional guide and exercise programme 10 0 0 0 0
C: placebo + nutritional guide and exercise programme 9 0 0 0 0
Rezvanian 2010 I1: metformin + healthy eating and physical activity advice 45 0 0 7 15.6 0 0
I2: fluoxetine + healthy eating and physical activity advice 45 0 0 0 0
I3: metformin and fluoxetine + healthy eating and physical activity advice 45 0 0 0 0
C: placebo + healthy eating and physical activity advice 45 0 0 0 0
Srinivasan 2006 I: metformin first then placebo + "standardised information on healthy eating and exercise" 13 0 0 b 0 0
C: placebo first then metformin + "standardised information on healthy eating and exercise" 15 0 0 b 0 0
Van Mil 2007 I: sibutramine + energy‐restricted diet and exercise plan 12 0 0 12 100
C: placebo + energy‐restricted diet and exercise plan 12 0 0 9 75
Wiegand 2010 I: metformin + multiprofessional lifestyle intervention 36 0 0 8 22.2
C: placebo + multiprofessional lifestyle intervention 34 0 0 13 38.2
Wilson 2010 I: metformin + lifestyle intervention 38 0 0 c 2 5.3
C: placebo + lifestyle intervention 38 0 0 c 0 0
Yanovski 2011 I: metformin + dietitian‐administered weight‐reduction programme 53 0 0 d 0 0
C: placebo + dietitian‐administered weight‐reduction programme 47 0 0 d 0 0
"‐" denotes not reported.
aNumber of participants with one or multiple adverse events: sibutramine group 47 events in 30 participants; placebo group 45 events in 30 participants.
 bTwo participants were unable to tolerate metformin 1000 mg twice daily because of nausea and were switched to metformin 750 mg twice daily with slower dose increments.
 cNumber of participants with one or multiple adverse events: metformin group: 52 events in 38 participants; placebo group: 43 events in 38 participants.
 dA total of 9/53 (17%) metformin‐treated children were unable to take the highest dose of 2000 mg/d and were prescribed doses ranging from 500 mg/d to 1500 mg/d; number of participants with one or multiple adverse events: metformin group: 64 events in 53 participants; placebo group: 25 events in 47 participants.
C: comparator; I: intervention; n: number pf participants.