Oral contraceptives containing drospirenone for premenstrual syndrome

Siyan Ma; Sae Jin Song

doi:10.1002/14651858.CD006586.pub5

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Figure 1

PRISMA study selection 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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Analysis 1.1

Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 1: Mean daily rating of problem severity

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Analysis 1.2

Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 2: Mean change in daily rating of functional impairment

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Analysis 1.3

Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 3: Changes in Premenstrual Tension Scale scores

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Analysis 1.4

Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 4: Withdrawal due to adverse events

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Analysis 1.5

Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 5: Mood scores

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Analysis 1.6

Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 6: Adverse events

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Analysis 1.7

Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 7: Responders (≥ 50% decrease in daily symptom score)

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Summary of findings 1. Drospirenone plus ethinylestradiol compared to placebo for premenstrual syndrome – primary outcomes

Drospirenone plus ethinylestradiol compared to placebo for premenstrual syndrome ‐ primary outcomes
Patient or population: women with premenstrual syndrome (most met DSM‐V criteria for premenstrual dysphoric disorder (PMDD)) Setting: clinic Intervention: drospirenone plus ethinylestradiol (DRSP/EE) Comparison: placebo
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with placebo	Risk with Drospirenone plus DRSP/EE	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Mean daily rating of problem severity (lower score is better)	The mean daily rating of problem severity end score in the DRSP/EE groups was, on average, 0.41 SDs (0.59 to 0.24) lower than in the placebo group over three 28‐day cycles.		‐	513 (2 RCTs)	⊕⊕⊝⊝ Low ^{1 2}	As a rule of thumb, 0.2 SD represents a small, 0.5 a moderate, and 0.8 a large difference.
Mean change in daily rating of functional impairment: reduction of productivity (lower score is better)	The average mean change in daily rating of functional impairment: reduction of productivity ranged from ‐1 to ‐2 out of 6 over three 28‐day cycles.	MD 0.31 lower (0.55 lower to 0.08 lower)	‐	432 (2 RCTs)	⊕⊕⊝⊝ Low^{a, c}
Mean change in daily rating of functional impairment: social activities (lower score is better)	The average mean change in daily rating of functional impairment: social activities ranged from ‐1 to ‐2 out of 6 over three 28‐day cycles.	MD 0.29 lower (0.54 lower to 0.04 lower)	‐	432 (2 RCTs)	⊕⊕⊝⊝ Low^{a, c}
Mean change in daily rating of functional impairment: relationship interference (lower score is better)	The average mean change in daily rating of functional impairment: relationship interference ranged from ‐1 to ‐2 out of 6 over three 28‐day cycles.	MD 0.3 lower (0.54 lower to 0.06 lower)	‐	432 (2 RCTs)	⊕⊕⊝⊝ Low^{a, c}
Changes in Premenstrual Tension Scale scores (observer‐rated; lower score is better)	The mean changes in observer‐rated Premenstrual Tension Scale scores was ‐10 out of 36 over three 28‐day cycles.	MD 2.05 lower (4.08 lower to 0.02 lower)	‐	387 (1 RCT)	⊕⊕⊝⊝ Low^d
Changes in Premenstrual Tension Scale scores (self‐rated; lower score is better)	The mean changes in self‐rated Premenstrual Tension Scale scores ranged from ‐8 to ‐13 out of 36 over three 28‐day cycles.	MD 3.78 lower (5.97 lower to 1.58 lower)	‐	438 (2 RCTs)	⊕⊕⊝⊝ Low^{a, c}
Withdrawal due to adverse events	Study population		OR 3.41 (2.01 to 5.78)	776 (4 RCTs)	⊕⊕⊝⊝ Low^{e, f}
Withdrawal due to adverse events	33 per 1000	103 per 1000 (64 to 163)	OR 3.41 (2.01 to 5.78)	776 (4 RCTs)	⊕⊕⊝⊝ Low^{e, f}
*The risk in the intervention group (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; RR: risk 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.
^aDowngraded one level for inconsistency due to moderate to substantial heterogeneity ^bDowngraded one level for imprecision because only two studies, with a sample size of approximately 500 and significant attrition rate ^cDowngraded one level for imprecision because only two studies, with a sample size of approximately 400 and significant attrition rate ^dDowngraded two levels for imprecision because only a single study, with a sample size less than 400 and significant attrition rate ^eDowngraded one level for imprecision, with total number of events < 400 ^fDowngraded one level for risk of bias as one study did not provide information on losses, which may or may not have been due to unreported withdrawal due to adverse events

Summary of findings 1. Drospirenone plus ethinylestradiol compared to placebo for premenstrual syndrome – primary outcomes

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Comparison 1. Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Mean daily rating of problem severity Show forest plot	2	513	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.41 [‐0.59, ‐0.24]

1.2 Mean change in daily rating of functional impairment Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.2.1 Reduction of productivity	2	432	Mean Difference (IV, Fixed, 95% CI)	‐0.31 [‐0.55, ‐0.08]
1.2.2 Social activities	2	432	Mean Difference (IV, Fixed, 95% CI)	‐0.29 [‐0.54, ‐0.04]
1.2.3 Relationship interference	2	432	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.54, ‐0.06]
1.3 Changes in Premenstrual Tension Scale scores Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.3.1 Observer‐rated score	1	387	Mean Difference (IV, Fixed, 95% CI)	‐2.05 [‐4.08, ‐0.02]
1.3.2 Self‐rated score	2	438	Mean Difference (IV, Fixed, 95% CI)	‐3.78 [‐5.97, ‐1.58]
1.4 Withdrawal due to adverse events Show forest plot	4	776	Peto Odds Ratio (Peto, Fixed, 95% CI)	3.41 [2.01, 5.78]

1.5 Mood scores Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.5.1 Change in Endicott Q‐LES‐Q Overall Life Satisfaction	2	431	Mean Difference (IV, Fixed, 95% CI)	0.07 [‐0.15, 0.30]
1.5.2 Profile of Mood States ‐ change in luteal phase score	1	49	Mean Difference (IV, Fixed, 95% CI)	‐7.90 [‐38.33, 22.53]
1.5.3 Beck Depression Inventory ‐ change in luteal phase score	1	49	Mean Difference (IV, Fixed, 95% CI)	‐6.80 [‐14.97, 1.37]
1.6 Adverse events Show forest plot	4		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

1.6.1 Total adverse events related to study drug	3	739	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.31 [1.71, 3.11]
1.6.2 Nausea	4	782	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.86 [1.81, 4.51]
1.6.3 Headache	4	782	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.14 [0.75, 1.74]
1.6.4 Intermenstrual bleeding	3	700	Peto Odds Ratio (Peto, Fixed, 95% CI)	4.58 [2.93, 7.16]
1.6.5 Breast pain	2	513	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.80 [1.51, 5.21]
1.6.6 Nervousness	1	64	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.81 [0.34, 9.60]
1.6.7 Asthenia	4	782	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.84 [0.96, 3.54]
1.6.8 Pain or abdominal pain	3	700	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.55 [0.65, 3.69]
1.6.9 Dymenorrhea	1	0	Peto Odds Ratio (Peto, Fixed, 95% CI)	Not estimable
1.6.10 Menstrual disorder	2	250	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.60 [1.76, 17.79]
1.7 Responders (≥ 50% decrease in daily symptom score) Show forest plot	1	449	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.65 [1.13, 2.40]

Comparison 1. Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo

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