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PRISMA flow diagram of the systematic literature search

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Figure 1

PRISMA flow diagram of the systematic literature search

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

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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.

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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 LNG‐IUS versus non‐intrauterine progestogen, outcome: 1.1 Regression of EH; by length of follow‐up.

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Figure 4

Forest plot of comparison: 1 LNG‐IUS versus non‐intrauterine progestogen, outcome: 1.1 Regression of EH; by length of follow‐up.

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Funnel plot of comparison: 1 LNG‐IUS versus non‐intrauterine progestogen, outcome: 1.1 Regression of EH; by length of follow‐up.

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Figure 5

Funnel plot of comparison: 1 LNG‐IUS versus non‐intrauterine progestogen, outcome: 1.1 Regression of EH; by length of follow‐up.

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Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 1: Regression of EH; by length of follow‐up

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Analysis 1.1

Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 1: Regression of EH; by length of follow‐up

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Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 2: Hysterectomy; histologically and non‐histologically indicated

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Analysis 1.2

Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 2: Hysterectomy; histologically and non‐histologically indicated

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Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 3: Adverse effects associated with hormones

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Analysis 1.3

Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 3: Adverse effects associated with hormones

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Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 4: Withdrawal secondary to adverse effects

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Analysis 1.4

Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 4: Withdrawal secondary to adverse effects

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Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 5: Satisfaction with treatment

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Analysis 1.5

Comparison 1: LNG‐IUS versus non‐intrauterine progestogen, Outcome 5: Satisfaction with treatment

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Comparison 2: LNG‐IUS versus no treatment, Outcome 1: Regression of EH

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Analysis 2.1

Comparison 2: LNG‐IUS versus no treatment, Outcome 1: Regression of EH

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Summary of findings 1. LNG‐IUS compared to non‐intrauterine progestogen for endometrial hyperplasia

LNG‐IUS compared to non‐intrauterine progestogen for endometrial hyperplasia

Patient or population: endometrial hyperplasia
Setting: outpatient clinic and hospital settings
Intervention: LNG‐IUS
Comparison: non‐intrauterine progestogen

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with non‐intrauterine progestogen

Risk with LNG‐IUS

Regression of EH; by length of follow‐up ‒ Short follow‐up ≤ 6 months

723 per 1000

885 per 1000
(846 to 915)

OR 2.94
(2.10 to 4.13)

1108
(10 RCTs)

⊕⊕⊕⊝
MODERATE 1

Regression of EH; by length of follow‐up ‒ Long follow‐up ≥ 1 year

513 per 1000

800 per 1000
(648 to 897)

OR 3.80
(1.75 to 8.23)

138
(1 RCT)

⊕⊕⊝⊝
LOW 2 3 4

Hysterectomy; histologically and non‐histologically indicated

263 per 1000

85 per 1000
(51 to 141)

OR 0.26
(0.15 to 0.46)

452
(4 RCTs)

⊕⊕⊝⊝
LOW 4 5

Adverse effects associated with hormones:
Bleeding/spotting

Nausea

Weight gain

383 per 1000

570 per 1000
(453 to 681)

OR 2.13
(1.33 to 3.43)

428
(3 RCTs)

⊕⊝⊝⊝
VERY LOW 4 6 7

213 per 1000

124 per 1000
(71 to 205)

OR 0.52
(0.28 to 0.95)

428
(3 RCTs)

⊕⊕⊝⊝
LOW 4 6

65 per 1000

82 per 1000
(38 to 171)

OR 1.28
(0.56 to 2.96)

318
(3 RCTs)

⊕⊝⊝⊝
VERY LOW 4 6 7

Withdrawal secondary to adverse effects

54 per 1000

23 per 1000
(7 to 71)

OR 0.41
(0.12 to 1.35)

360
(4 RCTs)

⊕⊕⊝⊝
LOW 4 8

Satisfaction with treatment

531 per 1000

857 per 1000
(740 to 926)

OR 5.28
(2.51 to 11.10)

202
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 9 10

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1 Downgraded 1 level for serious risk of bias: 6 in 10 studies high risk for detection bias as outcome assessors were not blinded, various studies with unclear selection bias and selection bias

2 Downgraded 1 level for serious risk of bias: high risk as not stated if pathologists measuring EH regression were blinded, and unclear allocation concealment and reporting bias.

3 Substantial heterogeneity for this comparison (I² = 66%), but the quality of the evidence was not downgraded for inconsistency, as the direction of effect was consistent.

4 Downgraded 1 level for serious imprecision with few events and wide confidence intervals.

5 Downgraded 1 level for serious risk of bias: all 4 studies high risk as participants/assessors were not blinded for outcome assessment of subjective measures and in 2 studies blinding of the pathologist was not mentioned. Selective reporting assessed as unclear in 3 of studies.

6 Downgraded 1 level for serious risk of bias: all studies with high risk of performance and detection bias (no blinding of participants to LNG‐IUS and self‐evaluation of adverse effects); other studies with high risk of attrition bias, and unclear allocation concealment and selective reporting.

7 Downgraded 1 level for serious inconsistency; unexplained inconsistency, with point estimates widely different in studies and confidence intervals not overlapping.

8 Downgraded 1 level for serious risk of bias: all 4 studies with high risk of performance and detection bias, 1 study with high risk of attrition bias, 2 studies with unclear allocation concealment and 3 with unclear selective reporting, 1 study with unclear selection bias.

9 Downgraded 2 levels for very serious risk of bias: both studies with high risk of performance and detection bias, 1 in 2 studies with high risk of attrition bias, both studies with unclear allocation concealment and selective reporting, 1 study with unclear selection bias.

10 Downgraded 1 level for serious imprecision: small sample size.

Figuras y tablas -
Summary of findings 1. LNG‐IUS compared to non‐intrauterine progestogen for endometrial hyperplasia
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Summary of findings 2. LNG compared to no treatment for endometrial hyperplasia

LNG compared to no treatment for endometrial hyperplasia

Patient or population: women with endometrial hyperplasia
Setting: outpatient clinic and hospital settings
Intervention: LNG‐IUS
Comparison: no treatment

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with no treatment

Risk with LNG‐IUS

Regression of EH ‐ Short
follow‐up 6 months

270 per 1000

967 per 1000
(894 to 990)

OR 78.41
(22.86 to 268.97)

190
(1 RCT)

⊕⊕⊝⊝
LOW 1 2

Adverse effects associated with LNG‐IUS

No study reported on this outcome in this comparison

Hysterectomy

No study reported on this outcome in this comparison

Adverse effects associated with hormones

No study reported on this outcome in this comparison

Withdrawal secondary to adverse effects

No study reported on this outcome in this comparison

Satisfaction

No study reported on this outcome in this comparison

Cost of treatment

No study reported on this outcome in this comparison

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded 1 level for serious risk of bias: unclear allocation concealment and selective reporting.

2 Downgraded 1 level for serious imprecision: small sample size and wide confidence interval.

Figuras y tablas -
Summary of findings 2. LNG compared to no treatment for endometrial hyperplasia
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Comparison 1. LNG‐IUS versus non‐intrauterine progestogen

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Regression of EH; by length of follow‐up Show forest plot

10

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1.1 Short follow‐up ≤ 6 months

10

1108

Odds Ratio (M‐H, Fixed, 95% CI)

2.94 [2.10, 4.13]

1.1.2 Long follow‐up ≥ 1 year

1

138

Odds Ratio (M‐H, Fixed, 95% CI)

3.80 [1.75, 8.23]

1.2 Hysterectomy; histologically and non‐histologically indicated Show forest plot

4

452

Odds Ratio (M‐H, Fixed, 95% CI)

0.26 [0.15, 0.46]

1.3 Adverse effects associated with hormones Show forest plot

4

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.3.1 Bleeding/spotting

3

428

Odds Ratio (M‐H, Fixed, 95% CI)

2.13 [1.33, 3.43]

1.3.2 Nausea

3

428

Odds Ratio (M‐H, Fixed, 95% CI)

0.52 [0.28, 0.95]

1.3.3 Weight gain

3

318

Odds Ratio (M‐H, Fixed, 95% CI)

1.28 [0.56, 2.96]

1.4 Withdrawal secondary to adverse effects Show forest plot

4

360

Odds Ratio (M‐H, Fixed, 95% CI)

0.41 [0.12, 1.35]

1.5 Satisfaction with treatment Show forest plot

2

202

Odds Ratio (M‐H, Fixed, 95% CI)

5.28 [2.51, 11.10]
Figuras y tablas -
Comparison 1. LNG‐IUS versus non‐intrauterine progestogen
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Comparison 2. LNG‐IUS versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

2.1 Regression of EH Show forest plot

1

190

Odds Ratio (M‐H, Fixed, 95% CI)

78.41 [22.86, 268.97]
Figuras y tablas -
Comparison 2. LNG‐IUS versus no treatment
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