Scolaris Content Display Scolaris Content Display

Trial flow diagram.
Figures and Tables -
Figure 1

Trial flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials.
Figures and Tables -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials.

Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.
Figures and Tables -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.

Funnel plot of comparison: 1 Body mass index (BMI): pharmacological interventions versus comparators, outcome: 1.1 Change in BMI (all trials) (kg/m2).
Figures and Tables -
Figure 4

Funnel plot of comparison: 1 Body mass index (BMI): pharmacological interventions versus comparators, outcome: 1.1 Change in BMI (all trials) (kg/m2).

Funnel plot of comparison: 2 Weight: pharmacological interventions versus comparators, outcome: 2.1 Change in weight (all trials) (kg).
Figures and Tables -
Figure 5

Funnel plot of comparison: 2 Weight: pharmacological interventions versus comparators, outcome: 2.1 Change in weight (all trials) (kg).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 1 Change in BMI (all trials).
Figures and Tables -
Analysis 1.1

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 1 Change in BMI (all trials).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 2 Change in BMI (drug type).
Figures and Tables -
Analysis 1.2

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 2 Change in BMI (drug type).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 3 Change in BMI (dropout rate).
Figures and Tables -
Analysis 1.3

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 3 Change in BMI (dropout rate).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 4 Change in BMI (intention‐to‐treat (ITT) analysis).
Figures and Tables -
Analysis 1.4

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 4 Change in BMI (intention‐to‐treat (ITT) analysis).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 5 Change in BMI (funding).
Figures and Tables -
Analysis 1.5

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 5 Change in BMI (funding).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 6 Change in BMI (publication date).
Figures and Tables -
Analysis 1.6

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 6 Change in BMI (publication date).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 7 Change in BMI (quality of trial).
Figures and Tables -
Analysis 1.7

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 7 Change in BMI (quality of trial).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 8 Change in BMI (country).
Figures and Tables -
Analysis 1.8

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 8 Change in BMI (country).

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 9 Change in BMI (mean age).
Figures and Tables -
Analysis 1.9

Comparison 1 Body mass index (BMI): pharmacological interventions versus comparators, Outcome 9 Change in BMI (mean age).

Comparison 2 Weight: pharmacological interventions versus comparators, Outcome 1 Change in weight (all trials).
Figures and Tables -
Analysis 2.1

Comparison 2 Weight: pharmacological interventions versus comparators, Outcome 1 Change in weight (all trials).

Comparison 2 Weight: pharmacological interventions versus comparators, Outcome 2 Change in weight (drug type).
Figures and Tables -
Analysis 2.2

Comparison 2 Weight: pharmacological interventions versus comparators, Outcome 2 Change in weight (drug type).

Comparison 3 Adverse effects: pharmacological interventions versus comparator, Outcome 1 Serious adverse events.
Figures and Tables -
Analysis 3.1

Comparison 3 Adverse effects: pharmacological interventions versus comparator, Outcome 1 Serious adverse events.

Comparison 3 Adverse effects: pharmacological interventions versus comparator, Outcome 2 Discontinued trial because of adverse events.
Figures and Tables -
Analysis 3.2

Comparison 3 Adverse effects: pharmacological interventions versus comparator, Outcome 2 Discontinued trial because of adverse events.

Summary of findings for the main comparison. Drug interventions for the treatment of obesity in children and adolescents

Drug interventions for the treatment of obesity in children and adolescents

Population: obese children and adolescents

Settings: mainly outpatient settings

Intervention: metformin, orlistat, sibutramine usually combined with behaviour changing interventions

Comparison: placebo or no placebo usually with behaviour changing interventions

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(trials)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Comparator

Pharmacological intervention

a. BMI (kg/m2)
Follow‐up: 6 months (14 trials) ‐ 12 months (2 trials)

b. Body weight (kg)

Follow‐up: 6 months (10 trials) ‐ 12 months (1 trial)

a. The mean reduction in BMI ranged across control groups from ‐1.8 to +0.9

b. The mean reduction in weight ranged across control groups from ‐3.8 kg to +4.9 kg

a. The mean reduction in BMI in the intervention groups was ‐1.3 higher (‐1.9 to ‐0.8 higher)

b. The mean reduction in weight in the intervention groups was ‐3.9 kg higher (‐5.9 kg to ‐1.9 kg higher)

a. 1884 (16)

b. 1180 (11)

a.

⊕⊕⊝⊝
L owa

b.

⊕⊕⊝⊝
Lowa

Adverse events

a. Serious adverse events

b. Discontinuation of trial because of adverse events

Follow‐up: mostly 6 months, maximum 100 weeks (1 trial)

a. 17 per 1000

b. 27 per 1000

a. 24 per 1000 (11 to 55)

b. 40 per 1000 (23 to 69)

a.RR 1.43 (0.63 to 3.25)

b.RR 1.45 (0.83 to 2.52)

a. 1347 (5)

b. 1664 (10)

a.

⊕⊕⊕⊝

L owb

b.

⊕⊕⊕⊝

Lowb

All trials reported if adverse events occurred; however, only 7/20 trials reported the number of participants who experienced at least 1 adverse event

Health‐related quality of life

3 questionnaires (1 trial) and SF‐36 (1 trial)

Follow‐up: 6 months

See comment

See comment

See comment

86 (2)

⊕⊝⊝⊝

V ery lowc

Results were only reported for SF‐36 (1 trial on sibutramine, 46 children), there were no marked differences between intervention and comparator groups

All‐cause mortality

Follow‐up: mostly 6 months, maximum 100 weeks (1 trial)

See comment

See comment

See comment

2176 (20)

⊕⊕⊕⊝

L owd

1 suicide in the orlistat intervention group

Morbidity

See comment

See comment

See comment

533 (1)

⊕⊝⊝⊝

V ery lowe

Only 1 trial investigated morbidity defined as illness or harm associated with the intervention (Chanoine 2005). In the orlistat group 6/352 (1.7%) participants developed new gallstones compared with 1/181 (0.6%) in the placebo group

Socioeconomic effects

See comment

See comment

See comment

See comment

See comment

Not reported

*The basis for the assumed risk (e.g. the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
BMI: body mass index; CI: confidence interval; RR: risk ratio; SF‐36: Short‐Form Health Survey 36 items.

GRADE Working Group grades of evidence
High certainty: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low certainty: We are very uncertain about the estimate.

*Assumed risk was derived from the event rates in the comparator groups.

aDowngraded by two levels because of potential other risk of bias, inconsistency and imprecision (see Appendix 13).
bDowngraded by two levels because of potential reporting bias, inconsistency and imprecision (see Appendix 13).
cDowngraded by three levels because of one trial only with a small number of participants and imprecision (see Appendix 13).
dDowngraded by two levels because of short follow‐up periods and no trial was powered to investigate mortality (see Appendix 13).
eDowngraded by three levels because of one trial only and imprecision (see Appendix 13).

Figures and Tables -
Summary of findings for the main comparison. Drug interventions for the treatment of obesity in children and adolescents
Table 1. Overview of trial populations

Trial

Intervention(s) and comparator(s)

Description of power and sample size calculation

Screened/eligible
(N)

Randomised
(N)

Safety
(N)

ITT
(N)

Finishing trial
(N)

Randomised finishing trial
(%)

Follow‐up timea

Atabek 2008b

I: metformin + diet and physical activity advice

90

90

90

100

6 months

C: placebo + diet and physical activity advice

30

30

30

100

total:

120

120

120

100

Berkowitz 2003

I: behavioural programme + sibutramine

Powered to detect a 4% difference in % change in BMI between the 2 treatment groups with an SD of 5% (α = 0.05, β = 93%)c

146

43

43

43

40

93.0

6 months (not including the 6‐month open‐label period where all participants received sibutramine)

C: behavioural programme + placebo

39

39

39

34

87.2

total:

82

82

82

62

75.6

Berkowitz 2006

I: behavioural programme + sibutramine

"Planned sample size was approximately 400 participants with a 3:1 randomization ratio of sibutramine to placebo. On the basis of previous 12‐month adult trials, we determined that 300 participants in the sibutramine group would be adequate to assess safety and exposure, allowing an overall dropout rate of approximately 50% and a probability that approximately 50% of participants receiving 10 mg of sibutramine would lose 10% or more of initial BMI at 6 months"

"Although the protocol did not document a formal sample size calculation for efficacy, approximately 132 adolescents (99 in the sibutramine group and 33 in the placebo group) would allow a between‐group difference in BMI of 2 kg/m2, with 90% power (2‐sided level of 0.05) to be statistically significant, assuming a common SD of 3 kg/m2)"d

368

368

281

76.4

12 months

C: behavioural programme + placebo

130

130

80

61.5

total:

498

498

361

72.5

Chanoine 2005

I: orlistat + diet + exercise + behaviour therapy

"We planned to enroll at least 450 individuals to provide more than 80% power to detect a difference of 1 BMI unit, assuming a 30% dropout rate"

588

357

352

348

232

65.0

54 weeks

C: placebo + diet + exercise + behaviour therapy

182

181

180

117

64.3

total:

539

533

528

349

64.7

Clarson 2009

I: metformin + lifestyle intervention

65

14

11

78.6

6 months

C: lifestyle intervention only

17

14

82.4

total:

31

25

80.6

Franco 2014

(cross‐over trial)

I: sibutramine + dietary guidance

73

13 months

C: placebo + dietary guidance

total:

63

63

23

36.5

Freemark 2001

I: metformin

15

14

93.3

6 months

C: placebo

17

15

88.2

total:

32

29

90.6

Garcia‐Morales 2006

I: sibutramine + diet + exercise

13 participants per group (expectations: mean loss of 7.5 kg (SD 5.3) in the sibutramine group vs 3.6 kg (SD 4.5) in the placebo group)e

70

26

26

23

21

80.8

6 months

C: placebo + diet + exercise

25

25

23

19

76.0

total:

51

51

46

40

78.4

Godoy‐Matos 2005

I: sibutramine + hypocaloric diet + exercise

30

30

30

28

93.3

24 weeks

C: placebo + hypocaloric diet + exercise

30

30

30

22

73.3

total:

60

60

60

50

83.3

Kendall 2013

I: metformin + healthy lifestyle advice

"The target recruitment was 140 patients, based on a power calculation using the results of a previous study. A standard power calculation was used to detect a reduction in BMI of 0.15 kg/m2 (SD 0.3). Sixty‐four participants in each group give a statistical power of 80% for a t test at the 5% significance level. This was rounded up to allow for some loss to follow‐up but recognizing that adjustment using multifactorial analysis would likely enhance the trial power by an unpredictable amount"f

234

74

74

55

6 months

C: placebo + healthy lifestyle advice

77

77

55

total:

155

151

151

110

71.0

Maahs 2006

I: orlistat + diet and exercise therapy

"We determined that a clinically important mean difference in decrease in BMI between the orlistat and placebo groups would be 2.0 kg/m2 at 6 months and used an SD of 1.8. On the basis of this approach, a sample size of 15 subjects per group would be adequate to detect a 2.0 kg/m2 difference in Student’s t test with 80% power and alpha = 0.05. In order to allow for a 25% dropout rate, 20 subjects were randomized to each group"g

43

20

20

18

90.0

6 months

C: placebo + diet and exercise therapy

20

20

16

80.0

total:

40

40

34

85.0

Mauras 2012

I: metformin + diet/exercise intervention

"Differences in hsCRP and fibrinogen concentrations at 6 months were the primary outcomes. An n = 42 completed subjects provided > 90 % power to detect significant changes"

35

35

23

65.7

6 months

C: diet/exercise intervention

31

31

19

61.3

total:

66

66

42

63.6

NCT00001723

I: orlistat + behavioural weight loss programme

100

100

100

87

87.0

6 months

C: placebo + behavioural weight loss programme

100

100

100

84

84.0

200

100

100

171

85.5

Ozkan 2004

I: conventional treatment (nutritional and lifestyle modification programmes) + orlistat

22

15

68.2

5 to 15 months

C: conventional treatment: nutritional and lifestyle modification programmes

20

15

75.0

total:

42

30

71.4

Prado 2012

I: metformin + nutritional guide and exercise programme

8 participants were required per intervention group (SD 0.4; difference of 0.6, P < 0.05, power = 90%)

41/26

9

7

6 months

C: placebo + nutritional guide and exercise programme

10

6

total:

26

19

13

50

Rezvanian 2010

I1: metformin + diet and physical activity advice

"By considering alpha = 0.05 and a power level of 0.8, the sample size was calculated as 160, and by considering the attrition during the follow‐up, we increased it to 180"

180

45

41

91.1

24 weeks

I2: fluoxetine + diet and physical activity advice

45

40

88.9

I3: metformin and fluoxetine + diet and physical activity advice

45

41

91.1

C: placebo + diet and physical activity advice

45

42

93.3

total:

180

164

91.1

Srinivasan 2006

(cross‐over trial)

I: metformin + "standardised information on healthy eating and exercise"

34

12 months

C: placebo + "standardised information on healthy eating and exercise"

total:

28

22

78.6

Van Mil 2007

I: sibutramine + energy‐restricted diet and exercise plan

"The number of patients required per treatment group to detect a difference between treatment groups in mean change in BMI at endpoint intervention of 1.0 kg/m2, based on an estimate of variance (sd) of 0.65, an overall significance level of 5%, and a power of 90%, was nine. Allowing a drop‐out rate of 25%, the number of patients needed in each group was 12"h

12

12

12

11

91.7

24 weeks

C: placebo + energy‐restricted diet and exercise plan

12

12

12

9

75.0

total:

24

24

24

20

83.3

Wiegand 2010

I: metformin + lifestyle intervention

"Since a clinically significant effect was defined as a decrease in HOMA‐IR by ‐1, two groups of 37 patients had to be included in the study to achieve a power of 0.9 with a α value of 0.05"

278

36

34

94.4

6 months

C: placebo + lifestyle intervention

34

29

85.3

total:

70

63

90

Wilson 2010

I: metformin + lifestyle intervention

"Assuming an SD of 1.9 for BMI change, an enrolled sample of 72 provided 80% power to detect a differential of 1.46 between treatment arms or between sexes and 1.75 between white subjects and others"i

92

39

39

39

19

48.7

100 weeks

C: placebo + lifestyle intervention

38

38

38

19

50.0

total:

77

76

76

38

49.4

Yanovski 2011

I: metformin + dietitian‐administered weight‐reduction programme

"A total sample size of 60 participants would detect a between‐group difference of 0.09 BMI SD score units (approximately equivalent to a 2 kg/m2 difference) with 80% power. Participant accrual was set at 100 participants to allow as much as 40% loss to follow‐up"j

278

53

53

45

84.9

6 months (not including the 6‐month open‐label phase)

C: placebo + dietitian‐administered weight‐reduction programme

47

47

40

85.1

total:

100

100

85

85.0

Grand total

All interventionsk

1395

1153

All comparatorsk

817

665

All interventions and comparatorsk

2484

1851

aDuration of intervention and follow‐up under randomised conditions until end of trial.
bUnclear from the publication on the number which completed the trial and hence number of dropouts.
cActual treatment difference between intervention groups was 4.5% reduction in BMI.
dActual treatment difference between intervention groups at 12 months was 2.9 kg/m2.
eActual weight loss was 7.3 kg in the sibutramine group vs 4.3 kg in the placebo group.
fActual adjusted treatment difference at 6 months was ‐1.07 kg/m2.
gActual treatment difference between intervention groups at 6 months was 0.5 kg/m2.
hActual treatment difference between intervention groups at end of intervention (12 weeks) was 0.4 kg/m2 and at end of follow‐up (24 weeks) was 1.0 kg/m2.
iActual treatment difference between intervention groups after 48 weeks was 1.1 kg/m2.
jActual treatment difference between intervention groups at 6 months for BMI z score was 0.07.
kNumbers for interventions and comparators do not add up to 'all interventions and comparators' because several trials did not provide information on randomised participants per intervention/comparator group but only the total number of randomised participants.

"‐" denotes not reported.

BMI: body mass index; C: comparator; hsCRP: high sensitivity C‐reactive protein; HOMA‐IR: homeostasis model assessment for insulin resistance index; I: intervention; ITT: intention‐to‐treat; n: number of participants; SD: standard deviation.

Figures and Tables -
Table 1. Overview of trial populations
Table 2. Sensitivity analyses: BMI

Trials with data on mean change only

Number of trials

14

Point estimate (95% CI) (kg/m2)

‐ 1.5 (‐2.0 to ‐0.9) favouring drug intervention

Trials with concealment of allocation

Number of trials

12

Point estimate (95% CI) (kg/m2)

‐1.3 (‐1.8 to ‐0.7) favouring drug interventions

Trials with blinding of participants/personnel

Number of trials

10

Point estimate (95% CI) (kg/m2)

‐1.3 (‐1.9 to ‐0.7) favouring drug interventions

Trials with blinding of outcome assessors

Number of trials

10

Point estimate (95% CI) (kg/m2)

‐1.3 (‐1.9 to ‐0.7) favouring drug interventions

Trials without large sample size trials

Number of trials

14

Point estimate (95% CI) (kg/m2)

‐1.3 (‐1.8 to ‐0.7) favouring drug interventions

Trials with trials with 6 months' follow‐up only

Number of trials

14

Point estimate (95% CI) (kg/m2)

‐1.2 (‐1.7 to ‐0.7) favouring drug interventions

Trials without trials with higher drug dose

Number of trials

14

Point estimate (95% CI) (kg/m2)

‐1.2 (‐1.7 to ‐0.7) favouring drug interventions

Trials with trials with a high dose/active lifestyle intervention

Number of trials

10

Point estimate (95% CI) (kg/m2)

‐1.3 (‐1.9 to ‐0.7) favouring drug interventions

Trials without trials with high attrition

Number of trials

13

Point estimate (95% CI) (kg/m2)

‐1.4 (‐2.0 to ‐0.8) favouring drug interventions

BMI: body mass index; CI: confidence interval.

Figures and Tables -
Table 2. Sensitivity analyses: BMI
Table 3. Sensitivity analyses: weight

Trials with data on mean change only

Number of trials

8

Point estimate (95% CI) (kg)

‐ 4.1 (‐6.3 to ‐1.8) favouring drug intervention

Trials with concealment of allocation

Number of trials

9

Point estimate (95% CI) (kg)

‐3.5 (‐5.8 to ‐1.2) favouring drug interventions

Trials with blinding of participants/personnel

Number of trials

7

Point estimate (95% CI) (kg)

‐4.2 (‐6.8 to ‐1.5) favouring drug interventions

Trials with blinding of outcome assessors

Number of trials

7

Point estimate (95% CI) (kg)

‐4.2 (‐6.8 to ‐1.5) favouring drug interventions

Trials without large sample size trials

Number of trials

10

Point estimate (95% CI) (kg)

‐3.4 (‐5.2 to ‐1.6) favouring drug interventions

Trials with 6 months' follow‐up only

Number of trials

9

Point estimate (95% CI) (kg)

‐3.5 (‐5.6 to ‐1.4) favouring drug interventions

Trials without trials with higher drug dose

Number of trials

10

Point estimate (95% CI) (kg)

‐3.4 (‐5.2 to ‐1.6) favouring drug interventions

Trials with trials with a high dose/active lifestyle intervention

Number of trials

6

Point estimate (95% CI) (kg)

‐4.3 (‐6.5 to ‐2.2) favouring drug interventions

Trials without trials with high attrition

Number of trials

9

Point estimate (95% CI) (kg)

‐4.4 (‐6.6 to ‐2.2) favouring drug interventions

CI: confidence interval.

Figures and Tables -
Table 3. Sensitivity analyses: weight
Comparison 1. Body mass index (BMI): pharmacological interventions versus comparators

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in BMI (all trials) Show forest plot

16

1884

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

2 Change in BMI (drug type) Show forest plot

16

1884

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

2.1 Metformin

8

543

Mean Difference (IV, Random, 95% CI)

‐1.35 [0.00, ‐0.69]

2.2 Orlistat

3

773

Mean Difference (IV, Random, 95% CI)

‐0.79 [‐1.08, ‐0.51]

2.3 Sibutramine

5

568

Mean Difference (IV, Random, 95% CI)

‐1.70 [‐2.89, ‐0.51]

3 Change in BMI (dropout rate) Show forest plot

16

1862

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

3.1 Dropouts < 20%

9

597

Mean Difference (IV, Random, 95% CI)

‐1.11 [‐1.78, ‐0.44]

3.2 Dropouts ≥ 20%

6

1145

Mean Difference (IV, Random, 95% CI)

‐1.42 [‐2.34, ‐0.50]

3.3 Unclear dropout rate

1

120

Mean Difference (IV, Random, 95% CI)

‐2.73 [‐3.74, ‐1.72]

4 Change in BMI (intention‐to‐treat (ITT) analysis) Show forest plot

16

1862

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

4.1 No ITT

5

282

Mean Difference (IV, Random, 95% CI)

‐1.56 [‐2.52, ‐0.60]

4.2 ITT used

11

1580

Mean Difference (IV, Random, 95% CI)

‐1.25 [‐1.86, ‐0.65]

5 Change in BMI (funding) Show forest plot

16

1862

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

5.1 Commercial

5

1009

Mean Difference (IV, Random, 95% CI)

‐1.50 [‐2.69, ‐0.31]

5.2 Noncommercial

5

271

Mean Difference (IV, Random, 95% CI)

‐1.10 [‐1.77, ‐0.44]

5.3 Commercial + noncommercial

4

262

Mean Difference (IV, Random, 95% CI)

‐1.17 [‐1.86, ‐0.47]

5.4 Unclear

2

320

Mean Difference (IV, Random, 95% CI)

‐1.79 [‐3.54, ‐0.04]

6 Change in BMI (publication date) Show forest plot

16

1862

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

6.1 2007 or before

8

1163

Mean Difference (IV, Random, 95% CI)

‐1.41 [‐2.21, ‐0.60]

6.2 After 2007

8

699

Mean Difference (IV, Random, 95% CI)

‐1.26 [‐1.90, ‐0.62]

7 Change in BMI (quality of trial) Show forest plot

16

1862

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

7.1 Low

6

322

Mean Difference (IV, Random, 95% CI)

‐1.40 [‐2.28, ‐0.52]

7.2 Moderate

10

1540

Mean Difference (IV, Random, 95% CI)

‐1.31 [‐1.95, ‐0.67]

8 Change in BMI (country) Show forest plot

16

1862

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

8.1 Middle income

3

216

Mean Difference (IV, Random, 95% CI)

‐2.39 [‐3.08, ‐1.69]

8.2 High income

13

1646

Mean Difference (IV, Random, 95% CI)

‐1.09 [‐1.62, ‐0.56]

9 Change in BMI (mean age) Show forest plot

16

1884

Mean Difference (IV, Random, 95% CI)

‐1.34 [‐1.85, ‐0.83]

9.1 Mean age < 12 years

2

220

Mean Difference (IV, Random, 95% CI)

‐1.93 [‐3.53, ‐0.34]

9.2 Mean age ≥ 12 years

14

1664

Mean Difference (IV, Random, 95% CI)

‐1.25 [‐1.79, ‐0.71]

Figures and Tables -
Comparison 1. Body mass index (BMI): pharmacological interventions versus comparators
Comparison 2. Weight: pharmacological interventions versus comparators

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in weight (all trials) Show forest plot

11

1180

Mean Difference (IV, Random, 95% CI)

‐3.90 [‐5.86, ‐1.94]

2 Change in weight (drug type) Show forest plot

11

1180

Mean Difference (IV, Random, 95% CI)

‐3.90 [‐5.86, ‐1.94]

2.1 Metformin

4

372

Mean Difference (IV, Random, 95% CI)

‐3.24 [‐5.79, ‐0.69]

2.2 Sibutramine

5

568

Mean Difference (IV, Random, 95% CI)

‐4.71 [‐8.10, ‐1.32]

2.3 Orlistat

2

240

Mean Difference (IV, Random, 95% CI)

‐2.48 [‐4.31, ‐0.65]

Figures and Tables -
Comparison 2. Weight: pharmacological interventions versus comparators
Comparison 3. Adverse effects: pharmacological interventions versus comparator

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Serious adverse events Show forest plot

5

1347

Risk Ratio (M‐H, Random, 95% CI)

1.43 [0.63, 3.25]

1.1 Metformin

1

76

Risk Ratio (M‐H, Random, 95% CI)

5.0 [0.25, 100.80]

1.2 Orlistat

3

773

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.41, 2.67]

1.3 Sibutramine

1

498

Risk Ratio (M‐H, Random, 95% CI)

3.53 [0.46, 27.33]

2 Discontinued trial because of adverse events Show forest plot

10

1664

Risk Ratio (M‐H, Random, 95% CI)

1.45 [0.83, 2.52]

2.1 Metformin

3

246

Risk Ratio (M‐H, Random, 95% CI)

1.20 [0.26, 5.48]

2.2 Orlistat

4

815

Risk Ratio (M‐H, Random, 95% CI)

2.49 [0.74, 8.32]

2.3 Sibutramine

3

603

Risk Ratio (M‐H, Random, 95% CI)

1.14 [0.53, 2.46]

Figures and Tables -
Comparison 3. Adverse effects: pharmacological interventions versus comparator