Antibiotic treatment for the sexual partners of women with bacterial vaginosis

Jairo Amaya‐Guio; David Andres Viveros‐Carreño; Eloisa Mercedes Sierra‐Barrios; Mercy Yolima Martinez‐Velasquez; Carlos F Grillo‐Ardila

doi:10.1002/14651858.CD011701.pub2

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Figure 1

Study flow diagram.

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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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Figure 3

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

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Figure 4

Forest plot of comparison: 1 Any antibiotic treatment versus placebo, outcome: 1.2 Recurrence of BV after the fourth week.

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Figure 5

Forest plot of comparison: 1 Any antibiotic treatment versus placebo, outcome: 1.3 Clinical improvement during the first week.

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Figure 6

Forest plot of comparison: 1 Any antibiotic treatment versus placebo, outcome: 1.4 Clinical improvement between the first and fourth week.

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Figure 7

Forest plot of comparison: 1 Any antibiotic treatment versus placebo, outcome: 1.5 Clinical improvement after the fourth week.

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Figure 8

Forest plot of comparison: 1 Any antibiotic treatment versus placebo, outcome: 1.6 Symptomatic improvement during the first week.

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Figure 9

Forest plot of comparison: 1 Any antibiotic treatment versus placebo, outcome: 1.9 Minor adverse events during therapy in sexual partner.

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Analysis 1.1

Comparison 1 Any antibiotic treatment versus placebo, Outcome 1 Recurrence of BV between the first and fourth week.

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Analysis 1.2

Comparison 1 Any antibiotic treatment versus placebo, Outcome 2 Recurrence of BV after the fourth week.

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Analysis 1.3

Comparison 1 Any antibiotic treatment versus placebo, Outcome 3 Clinical improvement during the first week.

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Analysis 1.4

Comparison 1 Any antibiotic treatment versus placebo, Outcome 4 Clinical improvement between the first and fourth week.

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Analysis 1.5

Comparison 1 Any antibiotic treatment versus placebo, Outcome 5 Clinical improvement after the fourth week.

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Analysis 1.6

Comparison 1 Any antibiotic treatment versus placebo, Outcome 6 Symptomatic improvement during the first week.

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Analysis 1.7

Comparison 1 Any antibiotic treatment versus placebo, Outcome 7 Symptomatic improvement between the first and fourth week.

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Analysis 1.8

Comparison 1 Any antibiotic treatment versus placebo, Outcome 8 Symptomatic improvement after the fourth week.

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Analysis 1.9

Comparison 1 Any antibiotic treatment versus placebo, Outcome 9 Minor adverse events during therapy in sexual partner.

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Analysis 2.1

Comparison 2 Any antibiotic treatment versus no intervention, Outcome 1 Recurrence of BV after the fourth week.

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Analysis 2.2

Comparison 2 Any antibiotic treatment versus no intervention, Outcome 2 Clinical improvement between the first and fourth week.

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Analysis 2.3

Comparison 2 Any antibiotic treatment versus no intervention, Outcome 3 Symptomatic improvement after the fourth week.

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Analysis 3.1

Comparison 3 Any antibiotic treatment versus placebo (by antibiotic type), Outcome 1 Recurrence of BV after the fourth week.

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Analysis 3.2

Comparison 3 Any antibiotic treatment versus placebo (by antibiotic type), Outcome 2 Clinical improvement during the first week.

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Analysis 3.3

Comparison 3 Any antibiotic treatment versus placebo (by antibiotic type), Outcome 3 Clinical improvement between the first and fourth week.

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Analysis 3.4

Comparison 3 Any antibiotic treatment versus placebo (by antibiotic type), Outcome 4 Clinical improvement after the fourth week.

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Analysis 3.5

Comparison 3 Any antibiotic treatment versus placebo (by antibiotic type), Outcome 5 Minor adverse events during therapy in sexual partner.

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Analysis 4.1

Comparison 4 Any antibiotic treatment versus placebo (by dose), Outcome 1 Clinical improvement during the first week.

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Analysis 4.2

Comparison 4 Any antibiotic treatment versus placebo (by dose), Outcome 2 Clinical improvement between the first and fourth week.

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Analysis 4.3

Comparison 4 Any antibiotic treatment versus placebo (by dose), Outcome 3 Clinical improvement after the fourth week.

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Analysis 4.4

Comparison 4 Any antibiotic treatment versus placebo (by dose), Outcome 4 Symptomatic improvement during the first week.

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Analysis 4.5

Comparison 4 Any antibiotic treatment versus placebo (by dose), Outcome 5 Symptomatic improvement between the first and fourth week.

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Analysis 4.6

Comparison 4 Any antibiotic treatment versus placebo (by dose), Outcome 6 Minor adverse events during therapy in sexual partner.

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Analysis 5.1

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 1 Recurrence of BV after the fourth week.

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Analysis 5.2

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 2 Clinical improvement during the first week.

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Analysis 5.3

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 3 Clinical improvement between the first and fourth week.

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Analysis 5.4

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 4 Clinical improvement after the fourth week.

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Analysis 5.5

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 5 Symptomatic improvement during the first week.

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Analysis 5.6

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 6 Symptomatic improvement between the first and fourth week.

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Analysis 5.7

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 7 Symptomatic improvement after the fourth week.

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Analysis 5.8

Comparison 5 Any antibiotic treatment versus placebo (attrition bias), Outcome 8 Minor adverse events during therapy in sexual partner.

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Summary of findings for the main comparison. Any antibiotic treatment versus placebo

Any antibiotic treatment versus placebo for the sexual partners of woman with bacterial vaginosis
Patient or population: sexual partners of women with bacterial vaginosis Setting: outpatient clinic Intervention: any antibiotic treatment Comparison: placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)
	Risk with placebo	Risk with any antibiotic treatment
Recurrence follow‐up 4 to 12 weeks	Study population		RR 1.00 (0.67 to 1.52)	372 (3 RCTs)	⊕⊝⊝⊝ very low^1,2
	196 per 1000	196 per 1000 (131 to 297)
Clinical improvement follow‐up 1 to 4 weeks	Study population		RR 1.02 (0.94 to 1.11)	590 (3 RCTs)	⊕⊕⊕⊕ high
	778 per 1000	794 per 1000 (731 to 864)
Clinical improvement follow‐up 4 to 12 weeks	Study population		RR 0.98 (0.90 to 1.07)	572 (4 RCTs)	⊕⊕⊕⊕ high
	778 per 1000	762 per 1000 (700 to 832)
Symptomatic improvement during the first week	Study population		RR 1.06 (1.00 to 1.12)	577 (3 RCTs)	⊕⊕⊕⊕ high
	863 per 1000	914 per 1000 (863 to 966)
Symptomatic improvement follow‐up 1 to 4 weeks	Study population		RR 0.93 (0.84 to 1.03)	444 (2 RCTs)	⊕⊕⊕⊕ high
	801 per 1000	745 per 1000 (673 to 825)
Symptomatic improvement follow‐up 4 to 12 weeks	Study population		RR 1.03 (0.90 to 1.17)	296 (2 RCTs)	⊕⊕⊕⊕ high
	743 per 1000	766 per 1000 (669 to 870)
Minor adverse events in sexual partner follow‐up: 1 to 12 weeks	Study population		RR 2.55 (1.55 to 4.18)	477 (3 RCTs)	⊕⊕⊝⊝ low³
	80 per 1000	204 per 1000 (124 to 335)
*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). Abbreviations: CI: confidence interval; RR: risk ratio; OR: odds ratio.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: 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 quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by 1 level for significant imprecision as the 95% CI was below 0.75 and over 1.25. ²Downgraded by 2 levels for imprecision as the 95% CI crosses through 0.75 and 1.25 and OIS is not achieved. ³Downgraded by 2 levels for imprecision because the Optimal information size (OIS) was not achieved.

Summary of findings for the main comparison. Any antibiotic treatment versus placebo

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Summary of findings 2. Any antibiotic treatment versus no intervention

Any antibiotic treatment versus no intervention
Patient or population: sexual partners of women with bacterial vaginosis Setting: outpatient clinic Intervention: any antibiotic treatment Comparison: no intervention
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)
	Risk with no intervention	Risk with any antibiotic treatment
Recurrence follow‐up 4 to 12 weeks	Study population		RR 1.71 (0.65 to 4.55)	51 (1 RCT)	⊕⊝⊝⊝ very low^1,2
	194 per 1000	333 per 1000 (126 to 885)
Clinical improvement follow‐up 1 to 4 weeks	Study population		RR 0.93 (0.70 to 1.25)	152 (2 RCTs)	⊕⊝⊝⊝ very low^1,2,3
	851 per 1000	792 per 1000 (596 to 1000)
Symptomatic improvement follow‐up 4 to 12 weeks	Study population		RR 0.66 (0.39 to 1.11)	70 (1 RCT)	⊕⊝⊝⊝ very low^1,2
	630 per 1000	416 per 1000 (246 to 700)
*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). Abbreviations: CI: confidence interval; RR: risk ratio; OR: odds ratio.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: 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 quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by 2 levels due to imprecision as OIS was not achieved and the 95% CI crosses through 0.75 and 1.25. ²Downgraded by 2 levels as there were some limitations on blinding and incomplete outcome data domains. ³Downgraded by 1 level for substantial heterogeneity (I² statistic is greater than 40%).

Summary of findings 2. Any antibiotic treatment versus no intervention

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Summary of findings 3. Any antibiotic treatment versus placebo

Any antibiotic treatment versus placebo
Patient or population: sexual partners of women with bacterial vaginosis Setting: outpatient clinics Intervention: any antibiotic treatment Comparison: placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)
	Risk with placebo	Risk with any antibiotic treatment
Recurrence follow‐up 1 to 4 weeks	Study population		RR 1.28 (0.68 to 2.43)	218 (1 RCT)	⊕⊕⊝⊝ low¹
	132 per 1000	169 per 1000 (90 to 321)
Clinical improvement during the first week	Study population		RR 0.99 (0.96 to 1.03)	712 (4 RCTs)	⊕⊕⊕⊕ high
	951 per 1000	942 per 1000 (913 to 980)
*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). Abbreviations: CI: confidence interval; RR: risk ratio; OR: odds ratio.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: 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 quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by 2 levels for imprecision as the 95% CI crosses through 0.75 and 1.25 and OIS is not achieved.

Summary of findings 3. Any antibiotic treatment versus placebo

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Comparison 1. Any antibiotic treatment versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Recurrence of BV between the first and fourth week Show forest plot	1	218	Risk Ratio (M‐H, Fixed, 95% CI)	1.28 [0.68, 2.43]

2 Recurrence of BV after the fourth week Show forest plot	3	372	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.67, 1.52]

3 Clinical improvement during the first week Show forest plot	4	712	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.96, 1.03]

4 Clinical improvement between the first and fourth week Show forest plot	3	590	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.94, 1.11]

5 Clinical improvement after the fourth week Show forest plot	4	572	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.90, 1.07]

6 Symptomatic improvement during the first week Show forest plot	3	577	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [1.00, 1.12]

7 Symptomatic improvement between the first and fourth week Show forest plot	2	444	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.84, 1.03]

8 Symptomatic improvement after the fourth week Show forest plot	2	296	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.90, 1.17]

9 Minor adverse events during therapy in sexual partner Show forest plot	3	477	Risk Ratio (M‐H, Fixed, 95% CI)	2.55 [1.55, 4.18]

Comparison 1. Any antibiotic treatment versus placebo

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Comparison 2. Any antibiotic treatment versus no intervention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Recurrence of BV after the fourth week Show forest plot	1	51	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [0.65, 4.55]

2 Clinical improvement between the first and fourth week Show forest plot	2	152	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.70, 1.25]

3 Symptomatic improvement after the fourth week Show forest plot	1	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.39, 1.11]

Comparison 2. Any antibiotic treatment versus no intervention

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Comparison 3. Any antibiotic treatment versus placebo (by antibiotic type)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Recurrence of BV after the fourth week Show forest plot	3	372	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.67, 1.52]

1.1 5‐Nitroimidazoles	2	288	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.74, 1.84]
1.2 Lincosamides	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.19, 1.45]
2 Clinical improvement during the first week Show forest plot	4	712	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.96, 1.03]

2.1 5‐Nitroimidazoles	3	574	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.95, 1.03]
2.2 Lincosamides	1	138	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.94, 1.10]
3 Clinical improvement between the first and fourth week Show forest plot	3	590	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.94, 1.11]

3.1 5‐Nitroimidazoles	2	451	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.93, 1.14]
3.2 Lincosamides	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.87, 1.11]
4 Clinical improvement after the fourth week Show forest plot	4	572	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.90, 1.07]

4.1 5‐Nitroimidazoles	3	433	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.90, 1.08]
4.2 Lincosamides	1	139	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.78, 1.22]
5 Minor adverse events during therapy in sexual partner Show forest plot	3	477	Risk Ratio (M‐H, Fixed, 95% CI)	2.55 [1.55, 4.18]

5.1 5‐Nitroimidazoles	2	339	Risk Ratio (M‐H, Fixed, 95% CI)	2.76 [1.60, 4.77]
5.2 Lincosamides	1	138	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [0.54, 5.71]

Comparison 3. Any antibiotic treatment versus placebo (by antibiotic type)

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Comparison 4. Any antibiotic treatment versus placebo (by dose)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical improvement during the first week Show forest plot	4	712	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.96, 1.03]

1.1 Single	1	241	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.89, 1.03]
1.2 Multiple dose	3	471	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.97, 1.05]
2 Clinical improvement between the first and fourth week Show forest plot	3	590	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.94, 1.11]

2.1 Single	1	233	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.95, 1.35]
2.2 Multiple dose	2	357	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.89, 1.05]
3 Clinical improvement after the fourth week Show forest plot	4	572	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.90, 1.07]

3.1 Single	1	138	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.86, 1.18]
3.2 Multiple dose	3	434	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.88, 1.09]
4 Symptomatic improvement during the first week Show forest plot	3	577	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [1.00, 1.12]

4.1 Single	1	241	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.94, 1.12]
4.2 Multiple dose	2	336	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [1.01, 1.18]
5 Symptomatic improvement between the first and fourth week Show forest plot	2	444	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.84, 1.03]

5.1 Single	1	232	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.83, 1.08]
5.2 Multiple dose	1	212	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.78, 1.06]
6 Minor adverse events during therapy in sexual partner Show forest plot	3	477	Risk Ratio (M‐H, Fixed, 95% CI)	2.55 [1.55, 4.18]

6.1 Single	2	339	Risk Ratio (M‐H, Fixed, 95% CI)	2.76 [1.60, 4.77]
6.2 Multiple dose	1	138	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [0.54, 5.71]

Comparison 4. Any antibiotic treatment versus placebo (by dose)

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Comparison 5. Any antibiotic treatment versus placebo (attrition bias)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Recurrence of BV after the fourth week Show forest plot	3	372	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.67, 1.52]

1.1 Low risk	1	98	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.48, 1.92]
1.2 Unclear risk	2	274	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.62, 1.71]
2 Clinical improvement during the first week Show forest plot	4	712	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.96, 1.03]

2.1 Low risk	2	342	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.93, 1.05]
2.2 Unclear risk	2	370	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.96, 1.03]
3 Clinical improvement between the first and fourth week Show forest plot	3	590	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.94, 1.11]

3.1 Low risk	1	233	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.95, 1.35]
3.2 Unclear risk	2	357	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.89, 1.05]
4 Clinical improvement after the fourth week Show forest plot	4	572	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.90, 1.07]

4.1 Low risk	2	243	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.90, 1.17]
4.2 Unclear risk	2	329	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.84, 1.07]
5 Symptomatic improvement during the first week Show forest plot	3	577	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [1.00, 1.12]

5.1 Low risk	2	348	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.98, 1.14]
5.2 Unclear risk	1	229	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.97, 1.17]
6 Symptomatic improvement between the first and fourth week Show forest plot	2	444	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.84, 1.03]

6.1 Low risk	1	232	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.83, 1.08]
6.2 Unclear risk	1	212	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.78, 1.06]
7 Symptomatic improvement after the fourth week Show forest plot	2	296	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.90, 1.17]

7.1 Low risk	1	107	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.83, 1.29]
7.2 Unclear risk	1	189	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.87, 1.20]
8 Minor adverse events during therapy in sexual partner Show forest plot	3	477	Risk Ratio (M‐H, Fixed, 95% CI)	2.55 [1.55, 4.18]

8.1 Low risk	2	339	Risk Ratio (M‐H, Fixed, 95% CI)	2.76 [1.60, 4.77]
8.2 Unclear risk	1	138	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [0.54, 5.71]

Comparison 5. Any antibiotic treatment versus placebo (attrition bias)

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