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Study flow diagram
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Figure 1

Study flow diagram

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

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

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

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

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Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.1 Change in systolic blood pressure from baseline to endpoint [mm Hg].
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.1 Change in systolic blood pressure from baseline to endpoint [mm Hg].

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Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.2 Change in diastolic blood pressure from baseline to endpoint [mm Hg].
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.2 Change in diastolic blood pressure from baseline to endpoint [mm Hg].

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Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.3 Change in body weight from baseline to endpoint [kg].
Figuras y tablas -
Figure 6

Forest plot of comparison: 1 Orlistat versus placebo, outcome: 1.3 Change in body weight from baseline to endpoint [kg].

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Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.1 Change in diastolic blood pressure from baseline to endpoint [mm Hg].
Figuras y tablas -
Figure 7

Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.1 Change in diastolic blood pressure from baseline to endpoint [mm Hg].

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Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.2 Change in body weight from baseline to endpoint [kg].
Figuras y tablas -
Figure 8

Forest plot of comparison: 2 Sibutramine versus placebo, outcome: 2.2 Change in body weight from baseline to endpoint [kg].

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Comparison 1 Orlistat versus placebo, Outcome 1 Change in systolic blood pressure from baseline to endpoint.
Figuras y tablas -
Analysis 1.1

Comparison 1 Orlistat versus placebo, Outcome 1 Change in systolic blood pressure from baseline to endpoint.

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Comparison 1 Orlistat versus placebo, Outcome 2 Change in diastolic blood pressure from baseline to endpoint.
Figuras y tablas -
Analysis 1.2

Comparison 1 Orlistat versus placebo, Outcome 2 Change in diastolic blood pressure from baseline to endpoint.

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Comparison 1 Orlistat versus placebo, Outcome 3 Change in body weight from baseline to endpoint.
Figuras y tablas -
Analysis 1.3

Comparison 1 Orlistat versus placebo, Outcome 3 Change in body weight from baseline to endpoint.

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Comparison 2 Sibutramine versus placebo, Outcome 1 Change in diastolic blood pressure from baseline to endpoint.
Figuras y tablas -
Analysis 2.1

Comparison 2 Sibutramine versus placebo, Outcome 1 Change in diastolic blood pressure from baseline to endpoint.

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Comparison 2 Sibutramine versus placebo, Outcome 2 Change in body weight from baseline to endpoint.
Figuras y tablas -
Analysis 2.2

Comparison 2 Sibutramine versus placebo, Outcome 2 Change in body weight from baseline to endpoint.

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Summary of findings for the main comparison. Summary of findings for orlistat versus placebo

Orlistat compared with placebo for weight reduction

Patient or population: Men and non‐pregnant women ≥ 18 years old with essential hypertension

Intervention: Orlistat

Comparison: Placebo

Outcomes

Illustrative comparative risks (per 1000 patients)

Effect estimate
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Change in systolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

MD ‐2.46 [‐4.01, ‐0.90]

2058
(4 studies)

⊕⊕⊝⊝
low1,2

‐

Change in diastolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

MD ‐1.92 [‐2.99, ‐0.85]

2058
(4 studies)

⊕⊕⊝⊝
low1,2

‐

Change in body weight as compared to placebo

[kg] from baseline to end of study

Not applicable

MD ‐3.73 [‐4.65, ‐2.80]

2080
(4 studies)

⊕⊕⊕⊝
moderate1

‐

CI: confidence interval; MD: mean difference

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

1High risk of bias in included studies.

2Wide confidence intervals include non‐clinically important effect.

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings for orlistat versus placebo
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Summary of findings 2. Summary of findings for sibutramine versus placebo

Sibutramine compared with placebo for weight reduction

Patient or population: Men and non‐pregnant women ≥ 18 years old with essential hypertension

Intervention: Sibutramine

Comparison: Placebo

Outcomes

Illustrative comparative risks (per 1000 patients)

Effect estimates
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Change in systolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

Not estimable

See comment

See comment

Variability measurements not available;
no meta‐analysis possible

Change in diastolic blood pressure as compared to placebo

[mm Hg] from baseline to end of study

Not applicable

MD 3.16 [1.40, 4.92]

428
(2 studies)

⊕⊕⊝⊝
low1,2

‐

Change in body weight as compared to placebo

[kg] from baseline to end of study

Not applicable

MD ‐3.74 [‐4.84, ‐2.64]

574
(4 studies)

⊕⊕⊝⊝
low1,2

‐

CI: confidence interval; MD: mean difference

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

1High risk of bias in included studies.

2Small number of participants and studies.

Figuras y tablas -
Summary of findings 2. Summary of findings for sibutramine versus placebo
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Table 1. Adverse events

Study

Adverse events

Results

Orlistat vs placebo

Bakris

2002

total

thereof leading to withdrawal

serious

gastrointestinal

thereof leading to withdrawal

musculoskeletal

89% of P [O] vs 71% of P [P], P < 0.001

7% [O] vs 7% [P]

14 P (12%) [O] vs 15 P (9%) [P]

200 P (73%) [O] vs 120 P (44%) [P], P < 0.001

15 P (8%) [O] vs 6 P (5%) [P]

23% of P [O] vs 16% [P], P < 0.05

Cocco

2005

total

serious

gastrointestinal

nr

0 P [O] vs 0 P [P]

16 P (36%) [O]a vs 11 P (24%) [P]a

Guy‐Grand

2004

total

serious

nrb

nrb

XENDOS

2001‐2006

total

leading to withdrawal

serious

gastrointestinal

musculoskeletal

nervous system

dermatological

vascular

99% of P [OD] vs 96% of P [PD]

99% of P [OS] vs 97% of P [PS]

9% of P [OD] vs 4% of P [PD]

9% of P [OS] vs 4% of P [PS]

18% of P [OD] vs 12% of P [PD]

18% of P [OS] vs 12% of P [PS]

93% of P [OD] vs 70% of P [PD]

93% of P [OS] vs 71% of P [PS]

65% of P [OD] vs 62% of P [PD]

65% of P [OS] vs 63% of P [PS]

39% of P [OD] vs 39% of P [PD]

40% of P [OS] vs 37% of P [PS]

20% of P [OD] vs 17% of P [PD]

22% of P [OS] vs 17% of P [PS]

17% of P [OD] vs 19% of P [PD]

17% of P [OS] vs 19% of P [PS]

Sibutramine vs placebo

Fanghaenel

2003

total

constipation

dizziness

dry mouth

headache

insomnia

restlessness

14 P (21 E) [S] vs 13 P (20 E) [P]

4 P [S] vs 2 P [P]

1 P [S] vs 1 P [P]

4 P [S] vs 2 P [P]

5 P [S] vs 2 P [P]

1 P [S] vs 1 P [P]

1 P [S] vs 0 P [P]

Faria

2002‐2005

total

dry mouth

arthralgia

nr

37% of P [S] vs 9% of P [P], P < 0.005

16% of P [S] vs 2% of P [P], P = 0.03

McMahon

2002

total

serious

treatment related

leading to withdrawal

(mostly hypertension)

dry mouth

headache

141 P (97%) [S] vs 65 P (88%) [P]

9 P (6%) [S] vs 5 P (7%) [P]

2 E [S] vs 0 E [P]

23 P (16%) [S] vs 4 P (5%) [P]

30 P (21%) [S] vs 0 P [P]

41 P (28%) [S] vs 17 P (23%) [P]

McMahon

2000

total

leading to withdrawal

(mostly hypertension)

dry mouth

headache

constipation

rash

nr

30 P (20%) [S] vs 8 P (11%) [P]

29 P (19%) [S] vs 2 P (3%) [P], P < 0.05

37 P (25%) [S] vs 21 P (28%) [P]

25 P (17%) [S] vs 2 P (3%) [P], P < 0.05

16 P (11%) [S] vs 2 P (3%) [P]

Phentermine/topiramate vs placebo

CONQUER 2013

total

leading to withdrawal

serious

cardiac adverse events

dry mouth

paresthaesia

constipation

upper respiratory tract infection

nasopharyngitis

dysgeusia

insomnia

headache

dizziness

sinusitis

85.4% vs 88.8% vs 77.3%

11.9% vs 19.8% vs 9.7%

3.4% (Phen/Top [LD]) vs 3.7% (Phen/Top [HD]) vs 4.2% [P]

0.8% vs 1.2% vs 0.6%

14.2% (Phen/Top [LD]) vs 22.7% (Phen/Top [HD]) vs 2.3% [P]

14.2% (Phen/Top [LD]) vs 22.3% (Phen/Top [HD]) vs 2.3% [P]

15.7% (Phen/Top [LD]) vs 18.1% (Phen/Top [HD]) vs 5.5% [P]

12.6% (Phen/Top [LD]) vs 12.1% (Phen/Top [HD]) vs 11.8% [P]

10.3% (Phen/Top [LD]) vs 10.2% (Phen/Top [HD]) vs 8.8% [P]

7.7% (Phen/Top [LD]) vs 11.0% (Phen/Top [HD]) vs 0.8% [P]

5.7% (Phen/Top [LD]) vs 11.0% (Phen/Top [HD]) vs 4.8% [P]

5.0% (Phen/Top [LD]) vs 10.8% (Phen/Top [HD]) vs 8.4% [P]

6.5% (Phen/Top [LD]) vs 12.1% (Phen/Top [HD]) vs 3.1% [P]

5.4% (Phen/Top [LD]) vs 8.3% (Phen/Top [HD]) vs 6.5% [P]

E: events. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine.

aNo data on adverse events were reported for the whole study duration. The data above refer to 4 and 3 weeks of treatment in the orlistat and placebo group, respectively. After 3 months, the number of participants with events decreased to 5(11%)[O] with flatulence and mild abdominal cramps versus 6(13%)[P] with nausea and hunger feeling.

bData were not available for the hypertensive subgroup, only for the whole study population (withdrawal due to defecation troubles in 10 [O] versus 2 [P] participants).

Figuras y tablas -
Table 1. Adverse events
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Table 2. Body weight

Study

Baselinea

6 moa

12 moa

48 moa

Change from baseline to endpointa

Orlistat vs placebo

Bakris 2002b

Orlistat

Placebo

101 (1)c

102 (1)c

nr

nr

nr

nr

‐

‐

P < 0.001

‐5.4 (6.4)

‐2.7 (6.4)

Cocco 2005

Orlistat

Placebo

107 (6)

106 (6)

102 (4)

104 (5)

‐

‐

‐

‐

P < 0.001

‐5.4d

‐2.5d

Guy‐Grand 2004

Orlistat

Placebo

94 (1)c

94 (1)c

nr

nr

‐

‐

‐

‐

P < 0.0001

‐5.8 (0.3)

‐1.8 (0.2)

XENDOS 2001‐2006

Orlistat [OD]

Placebo [PD]

Orlistat [OS]

Placebo [PS]

117 (18)

115 (18)

117 (17)

116 (18)

106 (17)

108 (18)

106 (17)

109 (18)

105 (18)

108 (19)

105 (17)

110 (19)

110 (19)

111 (20)

110 (18)

113 (19)

P < 0.001

‐6.6 (8.6)

‐3.8 (7.8)

P < 0.001

‐6.8 (8.7)

‐3.2 (7.4)

Sibutramine vs placebo

Fanghaenel 2003

Sibutramine

Placebo

75 (10)

78 (9)

70 (10)

75 (9)

‐

‐

‐

‐

significant

‐5.5 (‐3.8; ‐7.1)e

‐3.4 (‐1.9; ‐5.0)e

Faria 2002‐2005

Sibutramine

Placebo

100 (19)

97 (14)

93 (18)

94 (15)

‐

‐

‐

‐

P < 0.001

‐6.8 (2.3)

‐2.4 (4.2)

McMahon 2002

Sibutramine

Placebo

97 (16)

99 (14)

nr

nr

nr

nr

‐

‐

P < 0.05

‐4.5

‐0.4

McMahon 2000

Sibutramine

Placebo

97 (13)

96 (17)

nr

nr

nr

nr

‐

‐

P < 0.05

‐4.4

‐0.5

Phentermine/topiramate vs placebo

CONQUER 2013

Phen/Top [LD]

Phen/Top [HD]

Placebo

104 (18)f

nr

nr

nr

nr

nr

nr

‐

‐

‐

P < 0.0001g

‐8.1%

‐10.1%

‐1.9%

Mo: months. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine. SD: standard deviation.

aMean kg (SD), unless otherwise indicated.

bData are reported for 267 of 278 [O] and 265 of 276 [P] participants only.

cReported as being the standard deviation but probably the standard error due to its small number.

dPublished values are different, but data were corrected after personal communication with the author.

e95% confidence interval.

fReported only combined for all three study groups.

gFor each intervention group versus placebo.

Figuras y tablas -
Table 2. Body weight
Ir a la tabla de la revisión
Table 3. Systolic blood pressure

Study

Baselinea

6 moa

12 moa

48 moa

Change from baseline to endpointa

Orlistat vs placebo

Bakris 2002b

Orlistat

Placebo

154 (13)

151 (13)

nr

nr

nr

nr

‐

‐

ns

‐13.3 (15.2)

‐11.0 (15.0)

Cocco 2005

Orlistat

Placebo

146 (10)

142 (6)

142 (13)

141 (9)

‐

‐

‐

‐

P = 0.025

‐4.3

‐0.9

Guy‐Grand 2004

Orlistat

Placebo

150 (1)c

152 (1)c

nr

nr

‐

‐

‐

‐

ns

‐9.8 (1)

‐9.8 (1)

XENDOS 2001‐2006

Orlistat [OD]d

Placebo [PD]d

Orlistat [OS]d

Placebo [PS]d

146 (13)

146 (12)

149 (10)

149 (8)

135 (14)

136 (15)

125 (14)

138 (14)

135 (14)

138 (16)

135 (14)

140 (14)

137 (15)

139 (16)

138 (15)

140 (15)

P = 0.024

‐8.8 (14.8)

‐6.4 (15.1)

P < 0.002

‐11.5 (14.9)

‐8.6 (14.3)

Sibutramine vs placebo

Fanghaenel 2003e

Sibutramine

Placebo

139 (9)

139 (13)

125 (9)

123 (10)

‐

‐

‐

‐

ns

‐13.9f

‐16.5f

Faria 2002‐2005

Sibutramine

Placebo

150 (18)

150 (15)

146 (15)

149 (22)

‐

‐

‐

‐

ns

‐4.6f

‐0.6f

McMahon 2002

Sibutramine

Placebo

129 (11)

129 (11)

nr

nr

133

130

‐

‐

P = 0.0497

3.8

1.1

McMahon 2000

Sibutramine

Placebo

134 (10)

134 (11)

nr

nr

nr

nr

‐

‐

ns

2.7

1.5

Phentermine/topiramate vs placebo

CONQUER 2013

Phen/Top [LD]

Phen/Top [HD]

Placebo

134 (nr)

133 (nr)

135 (nr)

nr

nr

nr

nr

nr

nr

‐

‐

‐

P = 0.0475 [LD]

P < 0.0001 [HD]

‐6.9

‐9.1

‐4.9

Mo: months. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine. SD: standard deviation.

aMean mm Hg (SD), unless otherwise indicated.

bData are reported for 267 of 278 [O] and 265 of 276 [P] participants only.

cReported as being the standard deviation but probably the standard error due to its small number.

dBased on last observation carried forward data on 399 [OD], 423 [PD], 493 [OS], and 504 [PS] participants.

eData at baseline were recorded after a two‐week wash‐out period of antihypertensive drugs for diagnostic confirmation of hypertension.

fCalculated.

Figuras y tablas -
Table 3. Systolic blood pressure
Ir a la tabla de la revisión
Table 4. Diastolic blood pressure

Study

Baselinea

6 moa

12 moa

48 moa

Change from baseline to endpointa

Orlistat vs placebo

Bakris 2002b

Orlistat

Placebo

98 (4)

98 (4)c

nr

nr

nr

nr

‐

‐

P = 0.002

‐11.4 (8.3)

‐9.2 (8.4)

Cocco 2005

Orlistat

Placebo

88 (7)

85 (6)

84 (9)

85 (7)

‐

‐

‐

‐

P = 0.012

‐3.6

‐0.8

Guy‐Grand 2004

Orlistat

Placebo

97 (0)d

97 (0)d

nr

nr

‐

‐

‐

‐

ns

‐7.5 (0.6)

‐7.3 (0.6)

XENDOS 2001‐2006

Orlistat [OD]e

Placebo [PD]e

Orlistat [OS]e

Placebo [PS]e

95 (6)

95 (5)

91 (9)

91 (8)

86 (8)

88 (9)

84 (9)

87 (9)

86 (8)

88 (10)

85 (9)

88 (10)

87 (9)

89 (10)

86 (9)

88 (10)

P < 0.006

‐8.1 (9.3)

‐6.2 (9.9)

P < 0.001

‐5.0 (9.9)

‐3.0 (10.4)

Sibutramine vs placebo

Fanghaenel 2003f

Sibutramine

Placebo

93 (7)

92 (8)

82 (5)

80 (5)

‐

‐

‐

‐

ns

‐11.4g

‐11.7g

Faria 2002‐2005

Sibutramine

Placebo

91 (12)

94 (12)

92 (13)

92 (14)

‐

‐

‐

‐

ns

1.0g

‐2.06g

McMahon 2002

Sibutramine

Placebo

82 (6)

83 (6)

nr

nr

86

83

‐

‐

P = 0.004

3.0

‐0.1

McMahon 2000

Sibutramine

Placebo

84 (5)

84 (6)

nr

nr

nr

nr

‐

‐

P < 0.05

2.0

‐1.3

Phentermine/topiramate vs placebo

CONQUER 2013

Phen/Top [LD]

Phen/Top [HD]

Placebo

83 (nr)

83 (nr)

85 (nr)

nr

nr

nr

nr

nr

nr

‐

‐

‐

P = 0.0400 [LD]

P = 0.0003 [HD]

‐5.2

‐5.8

‐3.9

Mo: months. nr: not reported. [O]: orlistat. [OD]: orlistat and diastolic blood pressure ≥ 90 mm Hg. [OS]: orlistat and systolic blood pressure ≥ 140 mm Hg. P: participants. [P]: placebo. Phen/Top [HD]: phentermine/topiramate high dose (15 mg/92 mg). Phen/Top [LD]: phentermine/topiramate low dose (7.5 mg/46 mg). [PD]: placebo and diastolic blood pressure ≥ 90 mm Hg. [PS]: placebo and systolic blood pressure ≥ 140 mm Hg. [S]: sibutramine. SD: standard deviation.

aMean mm Hg (SD), unless otherwise indicated.

bData are reported for 267 of 278 [O] and 265 of 276 [P] participants only.

cThe standard deviation was published as being 35 but should probably be 3.5.

dReported as being the standard deviation but probably the standard error due to its small number.

eBased on last observation carried forward data on 399 [OD], 423 [PD], 493 [OS], and 504 [PS] participants.

fData at baseline were recorded after a two‐week wash‐out period of antihypertensive drugs for diagnostic confirmation of hypertension.

gCalculated.

Figuras y tablas -
Table 4. Diastolic blood pressure
Ir a la tabla de la revisión
Comparison 1. Orlistat versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in systolic blood pressure from baseline to endpoint Show forest plot

4

2058

Mean Difference (IV, Random, 95% CI)

‐2.46 [‐4.01, ‐0.90]

2 Change in diastolic blood pressure from baseline to endpoint Show forest plot

4

2058

Mean Difference (IV, Random, 95% CI)

‐1.92 [‐2.99, ‐0.85]

3 Change in body weight from baseline to endpoint Show forest plot

4

2080

Mean Difference (IV, Random, 95% CI)

‐3.73 [‐4.65, ‐2.80]
Figuras y tablas -
Comparison 1. Orlistat versus placebo
Ir a la tabla de la revisión
Comparison 2. Sibutramine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in diastolic blood pressure from baseline to endpoint Show forest plot

2

428

Mean Difference (IV, Fixed, 95% CI)

3.16 [1.40, 4.92]

2 Change in body weight from baseline to endpoint Show forest plot

4

574

Mean Difference (IV, Fixed, 95% CI)

‐3.74 [‐4.84, ‐2.64]
Figuras y tablas -
Comparison 2. Sibutramine versus placebo
Ir a la tabla de la revisión