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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.
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Figure 2

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

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 1 Mean daily rating of problem severity.
Figuras y tablas -
Analysis 1.1

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 1 Mean daily rating of problem severity.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 2 Responders (>= 50% decrease in daily symptom score).
Figuras y tablas -
Analysis 1.2

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 2 Responders (>= 50% decrease in daily symptom score).

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 3 Mean change in daily rating of functional impairment: reduction of productivity.
Figuras y tablas -
Analysis 1.3

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 3 Mean change in daily rating of functional impairment: reduction of productivity.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 4 Mean change in daily rating of functional impairment: social activities.
Figuras y tablas -
Analysis 1.4

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 4 Mean change in daily rating of functional impairment: social activities.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 5 Mean change in daily rating of functional impairment: relationship interference.
Figuras y tablas -
Analysis 1.5

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 5 Mean change in daily rating of functional impairment: relationship interference.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 6 Change in Endicott Q‐LES‐Q Overall Life Satisfaction item.
Figuras y tablas -
Analysis 1.6

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 6 Change in Endicott Q‐LES‐Q Overall Life Satisfaction item.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 7 Changes in Premenstrual Tension Scale scores.
Figuras y tablas -
Analysis 1.7

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 7 Changes in Premenstrual Tension Scale scores.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 8 Adverse events.
Figuras y tablas -
Analysis 1.8

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 8 Adverse events.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 9 Mean change in daily rating of functional impairment: social activities.
Figuras y tablas -
Analysis 1.9

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 9 Mean change in daily rating of functional impairment: social activities.

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Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 10 Changes in Premenstrual Tension Scale scores.
Figuras y tablas -
Analysis 1.10

Comparison 1 Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo, Outcome 10 Changes in Premenstrual Tension Scale scores.

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Comparison 2 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus placebo, Outcome 1 Beck Depression Inventory ‐ change in luteal phase score.
Figuras y tablas -
Analysis 2.1

Comparison 2 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus placebo, Outcome 1 Beck Depression Inventory ‐ change in luteal phase score.

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Comparison 2 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus placebo, Outcome 2 Profile of Mood States ‐ change in luteal phase score.
Figuras y tablas -
Analysis 2.2

Comparison 2 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus placebo, Outcome 2 Profile of Mood States ‐ change in luteal phase score.

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Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 1 Premenstrual symptoms reported during 26 cycles.
Figuras y tablas -
Analysis 3.1

Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 1 Premenstrual symptoms reported during 26 cycles.

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Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 2 Adverse events.
Figuras y tablas -
Analysis 3.2

Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 2 Adverse events.

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Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 3 Spotting, cycles 2 to 26.
Figuras y tablas -
Analysis 3.3

Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 3 Spotting, cycles 2 to 26.

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Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 4 Breakthrough bleeding, cycles 2 to 26.
Figuras y tablas -
Analysis 3.4

Comparison 3 Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30), Outcome 4 Breakthrough bleeding, cycles 2 to 26.

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Table 1. Summary of study methodological quality

Study

Randomization method

Allocation concealed

Blinding

Primary outcome measure

Loss to follow and discontinuation

Quality of evidence1

Foidart 2000

Unspecified

Unspecified

No; open

No specific tool; symptoms recorded daily

29% (groups were similar)

Very low

Freeman 2001

Unspecified

Unspecified

Double; did not specify who

Calendar of Premenstrual Experiences

40% (50% DRSP and 30% placebo)

Moderate

Kelly 2010

Allocated 2:1 (DRSP to LNG)

Randomization envelopes; opened by principal investigator

Double (participants and evaluators but not principal investigator)

Symptom diary cards for daily recording of specific symptoms

34% (groups were similar)

Moderate

Pearlstein 2005

Randomization schedule (unspecified);

blocks of 4

Blinded pill packages

Double (participants and investigators)

Daily Record of Severity of Problems

64% (59% DRSP‐first and 70% placebo‐first)

Moderate

Yonkers 2005

Blocks of 4; assigned by central coordinating group

Third party preparation of blinded pill packages

Double; did not specify who

Daily Record of Severity of Problems

27% (31% DRSP and 23% placebo)

Moderate

1Grade levels were high, moderate, low, or very low. RCTs were considered high quality then downgraded a level for each of the following: a) no blinding; b) no specific tool for primary outcome; c) overall losses > 20% (some studies combined loss to follow up and discontinuation).

Figuras y tablas -
Table 1. Summary of study methodological quality
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Table 2. Summary of evidence available

Condition studied

Intervention1

DRSP + EE 30

vs placebo;

21+7 regimen

DRSP + EE 20

vs placebo;

24+4 regimen

DRSP + EE 30 vs

LNG 150 + EE 30;

21+7 regimen

DRSP + EE 30 vs

DSG 150 + EE 30;

21+7 regimen

Premenstrual symptoms

n=424 (282 vs 142)

(7 cycles)

n=900

(26 cycles)

Premenstrual syndrome (PMS)

Premenstrual dysphoric disorder

(PMDD)

n=82

(3 cycles)

n=450

(3 cycles);

n=64 (crossover;

3 cycles each)

1Cells contain sample sizes for each study in this review as well as the number of treatment cycles.

Figuras y tablas -
Table 2. Summary of evidence available
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Comparison 1. Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mean daily rating of problem severity Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1 Cycles 1 to 3

2

513

Mean Difference (IV, Fixed, 95% CI)

‐7.92 [‐11.16, ‐4.67]

1.2 Cycles 4 to 6 (crossover)

1

64

Mean Difference (IV, Fixed, 95% CI)

‐7.0 [‐17.01, 3.01]

2 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]

3 Mean change in daily rating of functional impairment: reduction of productivity Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 Cycles 1 to 3

2

432

Mean Difference (IV, Fixed, 95% CI)

‐0.31 [‐0.55, ‐0.08]

3.2 Cycles 4 to 6 (crossover)

1

34

Mean Difference (IV, Fixed, 95% CI)

‐1.1 [‐1.70, ‐0.50]

4 Mean change in daily rating of functional impairment: social activities Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

4.1 Cycles 1 to 3

2

432

Mean Difference (IV, Fixed, 95% CI)

‐0.29 [‐0.54, ‐0.04]

4.2 Cycles 4 to 6 (crossover)

1

34

Mean Difference (IV, Fixed, 95% CI)

‐1.14 [‐1.85, ‐0.43]

5 Mean change in daily rating of functional impairment: relationship interference Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 Cycles 1 to 3

2

432

Mean Difference (IV, Fixed, 95% CI)

‐0.30 [‐0.54, ‐0.06]

5.2 Cycles 4 to 6 (crossover)

1

34

Mean Difference (IV, Fixed, 95% CI)

‐1.35 [‐2.20, ‐0.50]

6 Change in Endicott Q‐LES‐Q Overall Life Satisfaction item Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

6.1 Cycles 1 to 3

2

431

Mean Difference (IV, Fixed, 95% CI)

0.07 [‐0.15, 0.30]

6.2 Cycles 4 to 6 (crossover)

1

29

Mean Difference (IV, Fixed, 95% CI)

0.43 [‐0.35, 1.21]

7 Changes in Premenstrual Tension Scale scores Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Observer‐rated score (cycles 1 to 3)

1

387

Mean Difference (IV, Fixed, 95% CI)

‐2.05 [‐4.08, ‐0.02]

7.2 Self‐rated score (cycles 1 to 3)

2

438

Mean Difference (IV, Fixed, 95% CI)

‐3.78 [‐5.97, ‐1.58]

8 Adverse events Show forest plot

2

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

8.1 Nausea

2

552

Peto Odds Ratio (Peto, Fixed, 95% CI)

3.15 [1.90, 5.22]

8.2 Headache

2

552

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.97 [0.63, 1.49]

8.3 Intermenstrual bleeding

2

552

Peto Odds Ratio (Peto, Fixed, 95% CI)

4.92 [3.03, 7.96]

8.4 Breast pain

2

552

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.67 [1.50, 4.78]

8.5 Nervousness

1

103

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.25 [0.49, 10.37]

8.6 Asthenia

2

552

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.82 [0.92, 3.61]

8.7 Pain or abdominal pain

2

552

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.36 [0.58, 3.20]

8.8 Dymenorrhea

1

103

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.54 [0.35, 18.62]

8.9 Menstrual disorder

1

103

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.00 [0.71, 68.99]

8.10 Total adverse events related to study drug

1

449

Peto Odds Ratio (Peto, Fixed, 95% CI)

2.36 [1.62, 3.44]

9 Mean change in daily rating of functional impairment: social activities Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

9.1 Cycles 1 to 3

2

432

Mean Difference (IV, Random, 95% CI)

‐0.42 [‐0.96, 0.13]

9.2 Cycles 4 to 6 (crossover)

1

34

Mean Difference (IV, Random, 95% CI)

‐1.14 [‐1.85, ‐0.43]

10 Changes in Premenstrual Tension Scale scores Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

10.1 Observer‐rated score (cycles 1 to 3)

1

387

Mean Difference (IV, Random, 95% CI)

‐2.05 [‐4.08, ‐0.02]

10.2 Self‐rated score (cycles 1 to 3)

2

438

Mean Difference (IV, Random, 95% CI)

‐5.23 [‐10.76, 0.31]
Figuras y tablas -
Comparison 1. Drospirenone 3 mg plus EE 20 µg (DRSP/EE20) versus placebo
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Comparison 2. Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Beck Depression Inventory ‐ change in luteal phase score Show forest plot

1

49

Mean Difference (IV, Fixed, 95% CI)

‐6.8 [‐14.97, 1.37]

2 Profile of Mood States ‐ change in luteal phase score Show forest plot

1

49

Mean Difference (IV, Fixed, 95% CI)

‐7.90 [‐38.33, 22.53]
Figuras y tablas -
Comparison 2. Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus placebo
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Comparison 3. Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Premenstrual symptoms reported during 26 cycles Show forest plot

1

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 Any premenstrual symptom

1

886

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.87 [0.63, 1.22]

1.2 Headache

1

886

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.77 [0.46, 1.28]

1.3 Breast pain

1

886

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.84 [0.53, 1.32]

2 Adverse events Show forest plot

1

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

2.1 Nausea

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.33 [0.69, 2.58]

2.2 Headache

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.78 [0.52, 1.17]

2.3 Breast pain

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.34 [0.87, 2.05]

2.4 Abdominal pain

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.75 [0.35, 1.59]

2.5 Acne

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.51 [0.18, 1.42]

2.6 Depression

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.51 [0.43, 5.24]

2.7 Migraine

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.01 [0.40, 2.56]

2.8 AE related to treatment

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.02 [0.78, 1.33]

2.9 Total adverse events

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.81 [0.60, 1.11]

3 Spotting, cycles 2 to 26 Show forest plot

1

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

3.1 Per woman

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.92 [0.67, 1.26]

3.2 Per cycle

1

16951

Peto Odds Ratio (Peto, Fixed, 95% CI)

0.98 [0.87, 1.11]

4 Breakthrough bleeding, cycles 2 to 26 Show forest plot

1

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

4.1 Per woman

1

887

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.01 [0.43, 2.35]

4.2 Per cycle

1

16951

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.14 [0.69, 1.91]
Figuras y tablas -
Comparison 3. Drospirenone 3 mg plus EE 30 µg (DRSP/EE30) versus desogestrel 150 µg plus EE 30 µg (DSG150/EE30)
Ir a la tabla de la revisión