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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 1

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 2

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

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Study flow diagram
Figuras y tablas -
Figure 3

Study flow diagram

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Forest plot of comparison: 1 Metformin versus placebo or no treatment, outcome: 1.1 Live birth rate.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Metformin versus placebo or no treatment, outcome: 1.1 Live birth rate.

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Forest plot of comparison: 1 Metformin versus placebo or no treatment, outcome: 1.2 Adverse events (gastrointestinal side effects).
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Metformin versus placebo or no treatment, outcome: 1.2 Adverse events (gastrointestinal side effects).

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Forest plot of comparison: 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, outcome: 2.1 Live birth rate.
Figuras y tablas -
Figure 6

Forest plot of comparison: 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, outcome: 2.1 Live birth rate.

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Forest plot of comparison: 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, outcome: 2.2 Adverse events.
Figuras y tablas -
Figure 7

Forest plot of comparison: 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, outcome: 2.2 Adverse events.

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Forest plot of comparison: 3 Metformin versus clomiphene citrate, outcome: 3.1 Live birth: Participants with BMI < 30kg/m2 or ≤32kg/m2.
Figuras y tablas -
Figure 8

Forest plot of comparison: 3 Metformin versus clomiphene citrate, outcome: 3.1 Live birth: Participants with BMI < 30kg/m2 or ≤32kg/m2.

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Forest plot of comparison: 3 Metformin versus clomiphene citrate, outcome: 3.2 Live birth: Participants with ≥BMI 30kg/m2.
Figuras y tablas -
Figure 9

Forest plot of comparison: 3 Metformin versus clomiphene citrate, outcome: 3.2 Live birth: Participants with ≥BMI 30kg/m2.

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Comparison 1 Metformin versus placebo or no treatment, Outcome 1 Live birth rate.
Figuras y tablas -
Analysis 1.1

Comparison 1 Metformin versus placebo or no treatment, Outcome 1 Live birth rate.

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Comparison 1 Metformin versus placebo or no treatment, Outcome 2 Adverse events (gastrointestinal side effects).
Figuras y tablas -
Analysis 1.2

Comparison 1 Metformin versus placebo or no treatment, Outcome 2 Adverse events (gastrointestinal side effects).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 3 Clinical pregnancy rate.
Figuras y tablas -
Analysis 1.3

Comparison 1 Metformin versus placebo or no treatment, Outcome 3 Clinical pregnancy rate.

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Comparison 1 Metformin versus placebo or no treatment, Outcome 4 Ovulation rate.
Figuras y tablas -
Analysis 1.4

Comparison 1 Metformin versus placebo or no treatment, Outcome 4 Ovulation rate.

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Comparison 1 Metformin versus placebo or no treatment, Outcome 5 Menstrual frequency.
Figuras y tablas -
Analysis 1.5

Comparison 1 Metformin versus placebo or no treatment, Outcome 5 Menstrual frequency.

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Comparison 1 Metformin versus placebo or no treatment, Outcome 6 Miscarriage rate.
Figuras y tablas -
Analysis 1.6

Comparison 1 Metformin versus placebo or no treatment, Outcome 6 Miscarriage rate.

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Comparison 1 Metformin versus placebo or no treatment, Outcome 7 Body Mass Index (kg/m2).
Figuras y tablas -
Analysis 1.7

Comparison 1 Metformin versus placebo or no treatment, Outcome 7 Body Mass Index (kg/m2).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 8 Waist‐hip ratio.
Figuras y tablas -
Analysis 1.8

Comparison 1 Metformin versus placebo or no treatment, Outcome 8 Waist‐hip ratio.

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Comparison 1 Metformin versus placebo or no treatment, Outcome 9 Blood pressure ‐ systolic (mm Hg).
Figuras y tablas -
Analysis 1.9

Comparison 1 Metformin versus placebo or no treatment, Outcome 9 Blood pressure ‐ systolic (mm Hg).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 10 Blood pressure ‐ diastolic (mm Hg).
Figuras y tablas -
Analysis 1.10

Comparison 1 Metformin versus placebo or no treatment, Outcome 10 Blood pressure ‐ diastolic (mm Hg).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 11 Serum testosterone (nmol/L).
Figuras y tablas -
Analysis 1.11

Comparison 1 Metformin versus placebo or no treatment, Outcome 11 Serum testosterone (nmol/L).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 12 Serum sex hormone‐binding globulin (nmol/L).
Figuras y tablas -
Analysis 1.12

Comparison 1 Metformin versus placebo or no treatment, Outcome 12 Serum sex hormone‐binding globulin (nmol/L).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 13 Fasting glucose (mmol/L).
Figuras y tablas -
Analysis 1.13

Comparison 1 Metformin versus placebo or no treatment, Outcome 13 Fasting glucose (mmol/L).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 14 Fasting insulin (mIU/L).
Figuras y tablas -
Analysis 1.14

Comparison 1 Metformin versus placebo or no treatment, Outcome 14 Fasting insulin (mIU/L).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 15 Total cholesterol (mmol/l).
Figuras y tablas -
Analysis 1.15

Comparison 1 Metformin versus placebo or no treatment, Outcome 15 Total cholesterol (mmol/l).

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Comparison 1 Metformin versus placebo or no treatment, Outcome 16 Triglyceride levels (mmol/L).
Figuras y tablas -
Analysis 1.16

Comparison 1 Metformin versus placebo or no treatment, Outcome 16 Triglyceride levels (mmol/L).

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Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 1 Live birth rate.
Figuras y tablas -
Analysis 2.1

Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 1 Live birth rate.

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Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 2 Adverse events.
Figuras y tablas -
Analysis 2.2

Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 2 Adverse events.

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Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 3 Clinical pregnancy rate.
Figuras y tablas -
Analysis 2.3

Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 3 Clinical pregnancy rate.

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Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 4 Ovulation rate (grouped by sensitivity to clomiphene).
Figuras y tablas -
Analysis 2.4

Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 4 Ovulation rate (grouped by sensitivity to clomiphene).

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Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 5 Ovulation rate (grouped by BMI).
Figuras y tablas -
Analysis 2.5

Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 5 Ovulation rate (grouped by BMI).

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Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 6 Miscarriage rate.
Figuras y tablas -
Analysis 2.6

Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 6 Miscarriage rate.

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Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 7 Multiple pregnancy rate.
Figuras y tablas -
Analysis 2.7

Comparison 2 Metformin combined with ovulation induction agent clomifene versus clomifene alone, Outcome 7 Multiple pregnancy rate.

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Comparison 3 Metformin versus clomiphene citrate, Outcome 1 Live birth: Participants with BMI < 30kg/m2 or ≤32kg/m2.
Figuras y tablas -
Analysis 3.1

Comparison 3 Metformin versus clomiphene citrate, Outcome 1 Live birth: Participants with BMI < 30kg/m2 or ≤32kg/m2.

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Comparison 3 Metformin versus clomiphene citrate, Outcome 2 Live birth: Participants with ≥BMI 30kg/m2.
Figuras y tablas -
Analysis 3.2

Comparison 3 Metformin versus clomiphene citrate, Outcome 2 Live birth: Participants with ≥BMI 30kg/m2.

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Comparison 3 Metformin versus clomiphene citrate, Outcome 3 Clinical pregnancy rate.
Figuras y tablas -
Analysis 3.3

Comparison 3 Metformin versus clomiphene citrate, Outcome 3 Clinical pregnancy rate.

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Comparison 3 Metformin versus clomiphene citrate, Outcome 4 Ovulation rate.
Figuras y tablas -
Analysis 3.4

Comparison 3 Metformin versus clomiphene citrate, Outcome 4 Ovulation rate.

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Comparison 3 Metformin versus clomiphene citrate, Outcome 5 Miscarriage rate.
Figuras y tablas -
Analysis 3.5

Comparison 3 Metformin versus clomiphene citrate, Outcome 5 Miscarriage rate.

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Comparison 3 Metformin versus clomiphene citrate, Outcome 6 Multiple pregnancy.
Figuras y tablas -
Analysis 3.6

Comparison 3 Metformin versus clomiphene citrate, Outcome 6 Multiple pregnancy.

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 1 Ovulation.
Figuras y tablas -
Analysis 4.1

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 1 Ovulation.

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 2 Body Mass Index (kg/m2).
Figuras y tablas -
Analysis 4.2

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 2 Body Mass Index (kg/m2).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 3 Waist‐hip ratio.
Figuras y tablas -
Analysis 4.3

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 3 Waist‐hip ratio.

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 4 Blood pressure ‐ systolic (mm Hg).
Figuras y tablas -
Analysis 4.4

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 4 Blood pressure ‐ systolic (mm Hg).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 5 Blood pressure ‐ Diastolic (mm Hg).
Figuras y tablas -
Analysis 4.5

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 5 Blood pressure ‐ Diastolic (mm Hg).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 6 Serum testosterone (nmol/L).
Figuras y tablas -
Analysis 4.6

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 6 Serum testosterone (nmol/L).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 7 Serum sex hormone‐binding globulin (nmol/L).
Figuras y tablas -
Analysis 4.7

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 7 Serum sex hormone‐binding globulin (nmol/L).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 8 Fasting glucose (mmol/L).
Figuras y tablas -
Analysis 4.8

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 8 Fasting glucose (mmol/L).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 9 Fasting insulin (mIU/L).
Figuras y tablas -
Analysis 4.9

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 9 Fasting insulin (mIU/L).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 10 Cholesterol (mmol/L).
Figuras y tablas -
Analysis 4.10

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 10 Cholesterol (mmol/L).

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Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 11 Triglyceride levels (mmol/L).
Figuras y tablas -
Analysis 4.11

Comparison 4 D‐chiro‐inositol versus placebo or no treatment, Outcome 11 Triglyceride levels (mmol/L).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 1 Ovulation rate.
Figuras y tablas -
Analysis 5.1

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 1 Ovulation rate.

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 2 Menstrual frequency.
Figuras y tablas -
Analysis 5.2

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 2 Menstrual frequency.

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 3 Body Mass Index (kg/m2).
Figuras y tablas -
Analysis 5.3

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 3 Body Mass Index (kg/m2).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 4 Waist‐hip ratio.
Figuras y tablas -
Analysis 5.4

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 4 Waist‐hip ratio.

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 5 Blood pressure‐systolic (mm Hg).
Figuras y tablas -
Analysis 5.5

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 5 Blood pressure‐systolic (mm Hg).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 6 Blood pressure‐diastolic (mm Hg).
Figuras y tablas -
Analysis 5.6

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 6 Blood pressure‐diastolic (mm Hg).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 7 Testoserone (nmo/l).
Figuras y tablas -
Analysis 5.7

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 7 Testoserone (nmo/l).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 8 serum sex hormone‐binding globulin (nmol/L).
Figuras y tablas -
Analysis 5.8

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 8 serum sex hormone‐binding globulin (nmol/L).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 9 Fasting glucose (mmol/L).
Figuras y tablas -
Analysis 5.9

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 9 Fasting glucose (mmol/L).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 10 Fasting insulin (mIU/L).
Figuras y tablas -
Analysis 5.10

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 10 Fasting insulin (mIU/L).

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 11 Cholesterol.
Figuras y tablas -
Analysis 5.11

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 11 Cholesterol.

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Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 12 Triglyceride levels.
Figuras y tablas -
Analysis 5.12

Comparison 5 Rosiglitazone versus placebo or no treatment, Outcome 12 Triglyceride levels.

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Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 1 Menstrual frequency.
Figuras y tablas -
Analysis 6.1

Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 1 Menstrual frequency.

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Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 2 Body Mass Index (kg/m2).
Figuras y tablas -
Analysis 6.2

Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 2 Body Mass Index (kg/m2).

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Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 3 Waist‐hip ratio.
Figuras y tablas -
Analysis 6.3

Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 3 Waist‐hip ratio.

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Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 4 Serum testosterone (nmol/L).
Figuras y tablas -
Analysis 6.4

Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 4 Serum testosterone (nmol/L).

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Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 5 Serum sex hormone‐binding globulin (nmol/L).
Figuras y tablas -
Analysis 6.5

Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 5 Serum sex hormone‐binding globulin (nmol/L).

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Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 6 Fasting insulin (mIU/L).
Figuras y tablas -
Analysis 6.6

Comparison 6 Pioglitazone versus placebo or no treatment, Outcome 6 Fasting insulin (mIU/L).

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Summary of findings for the main comparison. Metformin compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

Metformin compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

Patient or population: Women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
Settings:
Intervention: Metformin
Comparison: placebo or no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo or no treatment

Metformin

Live birth rate

69 per 1000

118 per 1000
(37 to 313)

OR 1.8
(0.52 to 6.16)

115
(3 studies)

⊕⊕⊝⊝
low1,2

Clinical pregnancy rate

109 per 1000

221 per 1000
(157 to 301)

OR 2.31
(1.52 to 3.51)

707
(8 studies)

⊕⊕⊕⊝
moderate1

Ovulation rate

215 per 1000

332 per 1000
(237 to 446)

OR 1.81
(1.13 to 2.93)

1208
(15 studies)

⊕⊕⊝⊝
low3

Miscarriage rate

42 per 1000

16 per 1000
(4 to 61)

OR 0.36
(0.09 to 1.47)

279
(3 studies)

⊕⊕⊕⊝
moderate4

*The basis for the assumed risk (e.g. the median control group risk across studies) 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).
CI: Confidence interval; OR: Odds ratio;

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.

1 There was lack of clarity around attrition bias in the majority of trials
2 The summary effect crossed the line of no effect and substantive benefit or harm
3 The majority of trials demonstrated lack of clarity on attrition and reporting biases. Allocation concealment was unclear in seven of fifteen trials.
4 One of the three trials demonstrated lack of clarity on all measures of bias

Figuras y tablas -
Summary of findings for the main comparison. Metformin compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
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Summary of findings 2. D‐chiro‐inositol compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

D‐chiro‐inositol compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

Patient or population: Women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
Settings:
Intervention: D‐chiro‐inositol
Comparison: placebo or no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

placebo or no treatment

D‐chiro‐inositol

Ovulation

805 per 1000

957 per 1000
(743 to 994)

OR 5.38
(0.7 to 41.31)

327
(2 studies)

⊕⊕⊕⊝
moderate1

*The basis for the assumed risk (e.g. the median control group risk across studies) 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).
CI: Confidence interval; OR: Odds ratio;

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.

1 Method of randomisation was unclear in one trial and in the other trial allocation concealment and blinding were unclear. reporting bias was unclear in both trials

Figuras y tablas -
Summary of findings 2. D‐chiro‐inositol compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
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Summary of findings 3. Rosiglitazone compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

Rosiglitazone compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

Patient or population: Women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
Settings:
Intervention: Rosiglitazone
Comparison: placebo or no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo or no treatment

Rosiglitazone

Ovulation rate

Study population

OR 1.91
(0.7 to 5.22)

64
(1 study)

⊕⊝⊝⊝
very low1,2,3

344 per 1000

500 per 1000
(268 to 732)

Moderate

344 per 1000

500 per 1000
(269 to 732)

*The basis for the assumed risk (e.g. the median control group risk across studies) 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).
CI: Confidence interval; OR: Odds ratio;

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.

1 Attrition exceeded 20% in the intervention group and reporting bias was unclear
2 The summary effect crossed the line of no effect and substantive benefit or harm
3 Evidence was based on a single trial

Figuras y tablas -
Summary of findings 3. Rosiglitazone compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
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Summary of findings 4. Pioglitazone compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

Pioglitazone compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility

Patient or population: Women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
Settings:
Intervention: Pioglitazone
Comparison: placebo or no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo or no treatment

Pioglitazone

Improved menstrual pattern

171 per 1000

648 per 1000
(327 to 874)

OR 8.88
(2.35 to 33.61)

70
(2 studies)

⊕⊕⊕⊝
moderate1

*The basis for the assumed risk (e.g. the median control group risk across studies) 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).
CI: Confidence interval; OR: Odds ratio;

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.

1 One of the trials lacked clarity for all of the risk of bias options

Figuras y tablas -
Summary of findings 4. Pioglitazone compared to placebo or no treatment for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
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Table 1. Abbreviations used

Abbreviation

Definition

BMI

Body mass index

CI

Confidence interval

CT

Computerised tomography scan

DHEAS

Dehydroepiandrosterone sulphate

FSH

Follicle stimulating hormone

GTT

Glucose tolerance test

HbA1C

Glycosylated haemoglobin

HDL

High density lipoprotein cholesterol

IGFBP‐1

Insulin growth factor binding protein 1

LDL

Low density lipoprotein cholesterol

LH

Luteinising hormone

NIDDM

Non insulin dependent diabetes mellitus

PAI‐1

Plasminogen activator inhibitor 1

PCOS

Polycystic ovary syndrome

RCT

Randomised controlled trial

rFSH

Recombinant follicle stimulating hormone

SD

Standard deviation

SE

Standard error of the mean

SHBG

Sex hormone binding globulin

VLDL

Very low density lipoprotein cholesterol

vs

Versus

MD

mean difference
Figuras y tablas -
Table 1. Abbreviations used
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Table 2. Conversion factors

Convert from

Convert to

Conversion factor

Cholesterol

mg/dl

mmol/L

0.026

Triglycerides

mg/dl

mmol/L

0.11

Insulin

pmol/L

mIU/L (=microIU/ml)

0.1667

Glucose

mg/dl

mmol/L

0.056

Progesterone

ng/ml

nmol/L

3.18

Testosterone

ng/dl

nmol/L

0.03467

Androstenedione

ng/dl

nmol/L

0.0349

Estradiol

ng/dl

pmol/L

36.71

17‐beta oestradiol

ng/dl

pmol/L

36.71

Dehydroepiandrosterone sulphate

microg/dl

micromol/L

0.02714

Sex hormone binding globulin

microg/dl

nmol/L

34.7

Standard deviation

Standard error

Standard deviation

Sqrt n

Confidence Intervals

Confidence Intervals

Standard error

(upper limit ‐ lower limit) / 3.92
Figuras y tablas -
Table 2. Conversion factors
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Comparison 1. Metformin versus placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Live birth rate Show forest plot

3

115

Odds Ratio (M‐H, Fixed, 95% CI)

1.80 [0.52, 6.16]

2 Adverse events (gastrointestinal side effects) Show forest plot

6

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Nausea and vomiting

3

73

Odds Ratio (M‐H, Fixed, 95% CI)

3.91 [0.98, 15.64]

2.2 Gastrointestinal disturbance (other than nausea and vomiting)

5

318

Odds Ratio (M‐H, Fixed, 95% CI)

4.27 [2.40, 7.59]

3 Clinical pregnancy rate Show forest plot

8

707

Odds Ratio (M‐H, Fixed, 95% CI)

2.31 [1.52, 3.51]

3.1 Participants with BMI < 30kg/m2

4

413

Odds Ratio (M‐H, Fixed, 95% CI)

2.35 [1.44, 3.82]

3.2 Participants with BMI ≥ 30kg/m2

4

294

Odds Ratio (M‐H, Fixed, 95% CI)

2.21 [0.98, 4.98]

4 Ovulation rate Show forest plot

15

1208

Odds Ratio (M‐H, Random, 95% CI)

1.81 [1.13, 2.93]

4.1 Participants with BMI < 30kg/m2

5

441

Odds Ratio (M‐H, Random, 95% CI)

2.94 [0.81, 10.61]

4.2 Participants with BMI ≥ 30kg/m2

11

767

Odds Ratio (M‐H, Random, 95% CI)

1.50 [0.95, 2.37]

5 Menstrual frequency Show forest plot

7

427

Odds Ratio (M‐H, Fixed, 95% CI)

1.72 [1.14, 2.61]

5.1 Participants with BMI <30 kg/m2

1

23

Odds Ratio (M‐H, Fixed, 95% CI)

21.15 [1.01, 445.00]

5.2 Participants with BMI ≥ 30kg/m2

6

404

Odds Ratio (M‐H, Fixed, 95% CI)

1.57 [1.03, 2.41]

6 Miscarriage rate Show forest plot

3

279

Odds Ratio (M‐H, Fixed, 95% CI)

0.36 [0.09, 1.47]

7 Body Mass Index (kg/m2) Show forest plot

16

630

Mean Difference (IV, Fixed, 95% CI)

‐0.05 [‐0.31, 0.20]

7.1 Participants with BMI < 30kg/m2

6

166

Mean Difference (IV, Fixed, 95% CI)

‐0.04 [‐0.31, 0.23]

7.2 Participants with BMI ≥ 30kg/m2

11

464

Mean Difference (IV, Fixed, 95% CI)

‐0.15 [‐0.86, 0.55]

8 Waist‐hip ratio Show forest plot

10

449

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.01, ‐0.00]

8.1 Participants with BMI < 30kg/m2

4

136

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.01, ‐0.00]

8.2 Participants with BMI ≥ 30kg/m2

6

313

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.02, 0.01]

9 Blood pressure ‐ systolic (mm Hg) Show forest plot

7

379

Mean Difference (IV, Fixed, 95% CI)

‐3.59 [‐5.13, ‐2.04]

9.1 Participants with BMI <30kg/m2

3

96

Mean Difference (IV, Fixed, 95% CI)

‐3.52 [‐5.29, ‐1.76]

9.2 Participants with BMI ≥ 30kg/m2

5

283

Mean Difference (IV, Fixed, 95% CI)

‐3.80 [‐5.00, ‐0.60]

10 Blood pressure ‐ diastolic (mm Hg) Show forest plot

6

292

Mean Difference (IV, Fixed, 95% CI)

‐0.14 [‐1.35, 1.07]

10.1 Participants with BMI < 30kg/m2

3

96

Mean Difference (IV, Fixed, 95% CI)

‐0.21 [‐1.55, 1.13]

10.2 Participants with BMI ≥ 30kg/m2

4

196

Mean Difference (IV, Fixed, 95% CI)

0.18 [‐2.65, 3.02]

11 Serum testosterone (nmol/L) Show forest plot

14

610

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐0.73, ‐0.48]

11.1 Participants with BMI < 30kg/m2

6

166

Mean Difference (IV, Fixed, 95% CI)

‐1.68 [‐1.95, ‐1.42]

11.2 Participants with BMI ≥ 30kg/m2

9

444

Mean Difference (IV, Fixed, 95% CI)

‐0.29 [‐0.44, ‐0.15]

12 Serum sex hormone‐binding globulin (nmol/L) Show forest plot

15

626

Mean Difference (IV, Fixed, 95% CI)

‐0.05 [‐2.33, 2.24]

12.1 Participants with BMI < 30kg/m2

5

134

Mean Difference (IV, Fixed, 95% CI)

‐5.23 [‐14.34, 3.87]

12.2 Participants with BMI ≥ 30kg/m2

11

492

Mean Difference (IV, Fixed, 95% CI)

0.30 [‐2.06, 2.66]

13 Fasting glucose (mmol/L) Show forest plot

14

596

Mean Difference (IV, Fixed, 95% CI)

‐0.15 [‐0.25, ‐0.06]

13.1 Participants with BMI < 30kg/m2

4

111

Mean Difference (IV, Fixed, 95% CI)

‐0.13 [‐0.31, 0.05]

13.2 Participants with BMI ≥ 30kg/m2

11

485

Mean Difference (IV, Fixed, 95% CI)

‐0.16 [‐0.27, ‐0.05]

14 Fasting insulin (mIU/L) Show forest plot

14

573

Mean Difference (IV, Random, 95% CI)

‐3.51 [‐6.50, ‐0.53]

14.1 Participants with BMI < 30kg/m2

4

85

Mean Difference (IV, Random, 95% CI)

‐5.65 [‐10.25, ‐1.06]

14.2 Participants with BMI ≥ 30kg/m2

11

488

Mean Difference (IV, Random, 95% CI)

‐2.72 [‐6.50, 1.05]

15 Total cholesterol (mmol/l) Show forest plot

10

562

Mean Difference (IV, Fixed, 95% CI)

‐0.14 [‐0.31, 0.02]

15.1 Participants with BMI< 30kg/m2

5

276

Mean Difference (IV, Fixed, 95% CI)

‐0.02 [‐0.26, 0.22]

15.2 Participants with BMI ≥ 30kg/m2

6

286

Mean Difference (IV, Fixed, 95% CI)

‐0.26 [‐0.48, ‐0.03]

16 Triglyceride levels (mmol/L) Show forest plot

7

309

Mean Difference (IV, Fixed, 95% CI)

0.14 [‐0.05, 0.32]

16.1 Participants with BMI < 30kg/m2

3

53

Mean Difference (IV, Fixed, 95% CI)

0.00 [‐0.33, 0.34]

16.2 Participants with BMI ≥ 30kg/m2

5

256

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.02, 0.42]
Figuras y tablas -
Comparison 1. Metformin versus placebo or no treatment
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Comparison 2. Metformin combined with ovulation induction agent clomifene versus clomifene alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Live birth rate Show forest plot

7

907

Odds Ratio (M‐H, Fixed, 95% CI)

1.16 [0.85, 1.56]

1.1 Participants with BMI < 30kg/m2 or ≤32kg/m2

3

359

Odds Ratio (M‐H, Fixed, 95% CI)

1.00 [0.62, 1.59]

1.2 Participants with BMI ≥ 30kg/m2

4

548

Odds Ratio (M‐H, Fixed, 95% CI)

1.28 [0.86, 1.91]

2 Adverse events Show forest plot

2

489

Odds Ratio (M‐H, Fixed, 95% CI)

3.31 [2.11, 5.20]

2.1 Nausea and vomiting

1

418

Odds Ratio (M‐H, Fixed, 95% CI)

3.40 [2.08, 5.54]

2.2 Gastrointestinal disturbance (other than nausea and vomiting)

1

71

Odds Ratio (M‐H, Fixed, 95% CI)

2.84 [0.87, 9.28]

3 Clinical pregnancy rate Show forest plot

11

1208

Odds Ratio (M‐H, Fixed, 95% CI)

1.51 [1.17, 1.96]

3.1 Participants with BMI < 30kg/m2

4

513

Odds Ratio (M‐H, Fixed, 95% CI)

1.19 [0.79, 1.80]

3.2 Participants with BMI ≥ 30kg/m2

7

695

Odds Ratio (M‐H, Fixed, 95% CI)

1.76 [1.26, 2.47]

4 Ovulation rate (grouped by sensitivity to clomiphene) Show forest plot

18

3265

Odds Ratio (M‐H, Fixed, 95% CI)

1.73 [1.50, 2.00]

4.1 PCOS and clomifene sensitive

1

56

Odds Ratio (M‐H, Fixed, 95% CI)

3.55 [0.65, 19.37]

4.2 PCOS and clomifene resistant

5

179

Odds Ratio (M‐H, Fixed, 95% CI)

4.86 [2.43, 9.74]

4.3 PCOS and clomifene sensitivity not defined

12

3030

Odds Ratio (M‐H, Fixed, 95% CI)

1.64 [1.41, 1.90]

5 Ovulation rate (grouped by BMI) Show forest plot

17

3078

Odds Ratio (M‐H, Fixed, 95% CI)

1.77 [1.53, 2.05]

5.1 BMI <30 kg/m2

8

691

Odds Ratio (M‐H, Fixed, 95% CI)

1.75 [1.27, 2.39]

5.2 BMI ≥30kg/m2

9

2387

Odds Ratio (M‐H, Fixed, 95% CI)

1.78 [1.51, 2.10]

6 Miscarriage rate Show forest plot

7

837

Odds Ratio (M‐H, Fixed, 95% CI)

1.61 [1.00, 2.60]

7 Multiple pregnancy rate Show forest plot

6

916

Odds Ratio (M‐H, Fixed, 95% CI)

0.56 [0.18, 1.68]
Figuras y tablas -
Comparison 2. Metformin combined with ovulation induction agent clomifene versus clomifene alone
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Comparison 3. Metformin versus clomiphene citrate

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Live birth: Participants with BMI < 30kg/m2 or ≤32kg/m2 Show forest plot

2

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2 Live birth: Participants with ≥BMI 30kg/m2 Show forest plot

2

500

Odds Ratio (M‐H, Fixed, 95% CI)

0.30 [0.17, 0.52]

3 Clinical pregnancy rate Show forest plot

5

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Participants with BMI < 30kg/m2 or ≤32kg/m2

3

349

Odds Ratio (M‐H, Fixed, 95% CI)

1.94 [1.19, 3.16]

3.2 Participants with BMI ≥ 30kg/m2

2

500

Odds Ratio (M‐H, Fixed, 95% CI)

0.34 [0.21, 0.55]

4 Ovulation rate Show forest plot

4

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Participants with BMI < 30kg/m2

2

497

Odds Ratio (M‐H, Fixed, 95% CI)

0.87 [0.60, 1.26]

4.2 Participants with BMI ≥ 30kg/m2

2

2044

Odds Ratio (M‐H, Fixed, 95% CI)

0.43 [0.36, 0.51]

5 Miscarriage rate Show forest plot

4

173

Odds Ratio (M‐H, Fixed, 95% CI)

1.24 [0.60, 2.58]

6 Multiple pregnancy Show forest plot

5

403

Odds Ratio (M‐H, Fixed, 95% CI)

0.41 [0.08, 2.08]
Figuras y tablas -
Comparison 3. Metformin versus clomiphene citrate
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Comparison 4. D‐chiro‐inositol versus placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Ovulation Show forest plot

2

327

Odds Ratio (M‐H, Random, 95% CI)

5.38 [0.70, 41.31]

2 Body Mass Index (kg/m2) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

0.5 [‐0.86, 1.86]

3 Waist‐hip ratio Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.05, 0.03]

4 Blood pressure ‐ systolic (mm Hg) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐5.85, 1.85]

5 Blood pressure ‐ Diastolic (mm Hg) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐4.0 [‐7.26, ‐0.74]

6 Serum testosterone (nmol/L) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐0.63 [‐1.37, 0.11]

7 Serum sex hormone‐binding globulin (nmol/L) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

69.44 [34.97, 103.91]

8 Fasting glucose (mmol/L) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐0.28 [‐0.99, 0.43]

9 Fasting insulin (mIU/L) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐20.0 [‐43.43, 3.43]

10 Cholesterol (mmol/L) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐0.23 [‐0.99, 0.53]

11 Triglyceride levels (mmol/L) Show forest plot

1

44

Mean Difference (IV, Fixed, 95% CI)

‐2.20 [‐6.23, 1.83]
Figuras y tablas -
Comparison 4. D‐chiro‐inositol versus placebo or no treatment
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Comparison 5. Rosiglitazone versus placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Ovulation rate Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

1.91 [0.70, 5.22]

2 Menstrual frequency Show forest plot

2

100

Odds Ratio (M‐H, Fixed, 95% CI)

5.59 [2.20, 14.19]

3 Body Mass Index (kg/m2) Show forest plot

3

132

Mean Difference (IV, Fixed, 95% CI)

0.68 [0.40, 0.96]

4 Waist‐hip ratio Show forest plot

3

132

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.02, ‐0.00]

5 Blood pressure‐systolic (mm Hg) Show forest plot

1

52

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐3.95, ‐0.05]

6 Blood pressure‐diastolic (mm Hg) Show forest plot

1

52

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.72, 1.32]

7 Testoserone (nmo/l) Show forest plot

1

54

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.34, 0.74]

8 serum sex hormone‐binding globulin (nmol/L) Show forest plot

3

132

Mean Difference (IV, Random, 95% CI)

‐6.92 [‐27.96, 14.12]

9 Fasting glucose (mmol/L) Show forest plot

3

132

Mean Difference (IV, Fixed, 95% CI)

‐0.21 [‐0.39, ‐0.04]

10 Fasting insulin (mIU/L) Show forest plot

2

80

Mean Difference (IV, Fixed, 95% CI)

‐3.98 [‐9.38, 1.42]

11 Cholesterol Show forest plot

2

80

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐0.21, ‐0.19]

12 Triglyceride levels Show forest plot

1

26

Mean Difference (IV, Fixed, 95% CI)

1.0 [0.89, 1.11]
Figuras y tablas -
Comparison 5. Rosiglitazone versus placebo or no treatment
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Comparison 6. Pioglitazone versus placebo or no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Menstrual frequency Show forest plot

2

70

Odds Ratio (M‐H, Fixed, 95% CI)

8.88 [2.35, 33.61]

2 Body Mass Index (kg/m2) Show forest plot

2

63

Mean Difference (IV, Fixed, 95% CI)

0.91 [‐1.88, 3.70]

3 Waist‐hip ratio Show forest plot

1

28

Mean Difference (IV, Fixed, 95% CI)

0.02 [‐0.02, 0.06]

4 Serum testosterone (nmol/L) Show forest plot

2

63

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.53, 0.29]

5 Serum sex hormone‐binding globulin (nmol/L) Show forest plot

2

63

Mean Difference (IV, Fixed, 95% CI)

2.75 [‐5.26, 10.77]

6 Fasting insulin (mIU/L) Show forest plot

2

63

Mean Difference (IV, Fixed, 95% CI)

‐1.46 [‐3.97, 1.06]
Figuras y tablas -
Comparison 6. Pioglitazone versus placebo or no treatment
Ir a la tabla de la revisión