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Review
. 2023 Jun 23;6(6):CD006586.
doi: 10.1002/14651858.CD006586.pub5.

Oral contraceptives containing drospirenone for premenstrual syndrome

Siyan Ma  1 , Sae Jin Song  1
Affiliations
Review

Oral contraceptives containing drospirenone for premenstrual syndrome

Siyan Ma et al. Cochrane Database Syst Rev. .

Abstract
in English, Korean

Background: Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives (COC), which provide both progestin and oestrogen, have been examined for their ability to relieve premenstrual symptoms. A combined oral contraceptive containing drospirenone and a low oestrogen dose has been approved for treating PMDD in women who choose combined oral contraceptives for contraception.

Objectives: To evaluate the effectiveness and safety of COCs containing drospirenone in women with PMS.

Search methods: We searched the Cochrane Gynaecology and Fertility Group trial register, CENTRAL (now containing output from two trials registers and CINAHL), MEDLINE, Embase, PsycINFO, LILACS, Google Scholar, and Epistemonikos on 29 June 2022. We checked included studies' reference lists and contacted study authors and experts in the field to identify additional studies.

Selection criteria: We included randomised controlled trials (RCT) that compared COCs containing drospirenone with placebo or with another COC for treatment of women with PMS.

Data collection and analysis: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were effects on premenstrual symptoms that were prospectively recorded, and withdrawal due to adverse events. Secondary outcomes included effects on mood, adverse events, and response rate to study medications.

Main results: We included five RCTs (858 women analysed, most diagnosed with PMDD). The evidence was very low to moderate quality; the main limitations were serious risk of bias due to poor reporting of study methods, and serious inconsistency and imprecision. COCs containing drospirenone and ethinylestradiol (EE) versus placebo COCs containing drospirenone and EE may improve overall premenstrual symptoms (standardised mean difference (SMD) -0.41, 95% confidence interval (CI) -0.59 to -0.24; 2 RCTs, N = 514; I2 = 64%; low-quality evidence); and functional impairment due to premenstrual symptoms in terms of productivity (mean difference (MD) -0.31, 95% CI -0.55 to -0.08; 2 RCTs, N = 432; I2 = 47%; low-quality evidence), social activities (MD -0.29, 95% CI -0.54 to -0.04; 2 RCTs, N = 432; I2 = 53%; low-quality evidence), and relationships (MD -0.30, 95% CI -0.54 to -0.06; 2 RCTs, N = 432; I2 = 45%; low-quality evidence). The effects from COCs containing drospirenone may be small to moderate. COCs containing drospirenone and EE may increase withdrawal from trials due to adverse effects (odds ratio (OR) 3.41, 95% CI 2.01 to 5.78; 4 RCT, N = 776; I2 = 0%; low-quality evidence). This suggests that if you assume the risk of withdrawal due to adverse effects from placebo is 3%, the risk from drospirenone plus EE will be between 6% and 16%. We are uncertain of the effect of drospirenone plus EE on premenstrual mood symptoms, when measured by validated tools that were not developed to assess premenstrual symptoms. COCs containing drospirenone may lead to more adverse effects in total (OR 2.31, 95% CI 1.71 to 3.11; 3 RCT, N = 739; I2 = 0%; low-quality evidence). This suggests that if you assume the risk of having adverse effects from placebo is 28%, the risk from drospirenone plus EE will be between 40% and 54%. It probably leads to more breast pain, and may lead to more nausea, intermenstrual bleeding, and menstrual disorder. Its effect on nervousness, headache, asthenia, and pain is uncertain. There was no report of any rare but serious adverse effects, such as venous thromboembolism in any of the included studies. COCs containing drospirenone may improve response rate (OR 1.65, 95% CI 1.13 to 2.40; 1 RCT, N = 449; I2 not applicable; low-quality evidence). This suggests that if you assume the response rate from placebo is 36%, the risk from drospirenone plus EE will be between 39% and 58%. We did not identify any studies that compared COCs containing drospirenone with other COCs.

Authors' conclusions: COCs containing drospirenone and EE may improve premenstrual symptoms that result in functional impairments in women with PMDD. The placebo also had a significant effect. COCs containing drospirenone and EE may lead to more adverse effects compared to placebo. We do not know whether it works after three cycles, helps women with less severe symptoms, or is better than other combined oral contraceptives that contain a different progestogen.

배경: 월경 전 증후군(PMS)은 일반적인 문제이다. 월경전 불쾌 장애(PMDD)는 월경전 증후군의 심각한 형태이다. 프로게스틴과 에스트로겐을 모두 제공하는 복합 경구 피임약(COC)이 월경 전 증상을 완화하는 능력에 대해 조사되었다. 피임을 위해 복합 경구 피임제를 선택하는 여성의 PMDD를 치료하기 위해 드로스피레논과 낮은 에스트로겐 용량을 포함하는 복합 경구 피임제가 승인되었다. 목적: PMS가 있는 여성에서 드로스피레논을 함유한 COC의 효과와 안전성을 평가한다. 검색 전략: 2022년 6월 29일에 Cochrane Gynecology and Fertility Group 시험 등록부, CENTRAL(현재 2개의 시험 등록부 및 CINAHL의 출력 포함), MEDLINE, Embase, PsycINFO, LILACS, Google Scholar 및 Epistemonikos를 검색했다. 포함된 연구의 참조 목록을 확인하고 추가 연구를 확인하기 위해 해당 분야의 연구 저자 및 전문가에게 연락했다. 선정 기준: PMS가 있는 여성의 치료를 위해 drospirenone을 함유한 COC를 위약 또는 다른 COC와 비교한 무작위 대조 시험(RCT)을 포함했다. 자료 수집 및 분석: Cochrane에서 권장하는 표준 방법론적 절차를 사용했다. 1차 검토 결과는 전향적으로 기록된 월경 전 증상에 대한 영향과 부작용으로 인한 중단이었다. 이차 결과에는 기분, 부작용 및 연구 약물에 대한 반응률에 대한 영향이 포함되었다. 주요 결과: 5개의 RCT(여성 분석 858명, 대부분이 PMDD로 진단됨)를 포함했다. 근거의 질은 매우 낮거나 보통이었다. 주요 한계는 연구 방법의 잘못된 보고로 인한 심각한 비뚤림 위험과 심각한 불일치 및 부정확성이었다. 드로스피레논 및 에티닐에스트라디올(EE)을 함유한 COC 대 위약 드로스피레논과 EE를 포함하는 COC는 전반적인 월경 전 증상 및(표준화 평균 차이(SMD) ‐0.41, 95% 신뢰 구간(CI) ‐0.59 ~ ‐0.24, 2 RCT, N = 514, I 2 = 64%, 낮은 품질의 근거 ); 생산성 측면에서 월경 전 증상으로 인한 기능 장애(평균차(MD) ‐0.31, 95% CI ‐0.55 ~ ‐0.08, 2 RCT, N = 432, I 2 = 47%, 낮은 품질의 근거), 사회적 활동 (MD ‐0.29, 95% CI ‐0.54 ~ ‐0.04, 2 RCT, N = 432, I 2 = 53%, 낮은 품질의 근거) 및 관계(MD ‐0.30, 95% CI ‐0.54 ~ ‐0.06, 2 RCT, N = 432, I 2 = 45%, 낮은 품질의 근거)를 개선할 수 있다. 드로스피레논을 함유한 COC의 효과는 작거나 중간 정도일 수 있다. 드로스피레논과 EE를 포함하는 COC는 부작용으로 인해 임상시험에서 철회를 증가시킬 수 있다(교차비(OR) 3.41, 95% CI 2.01 ~ 5.78; 4 RCT, N = 776; I 2 = 0%; 근거의 질 낮음). 이것은 위약의 부작용으로 인한 금단 위험이 3%라고 가정하면 드로스피레논과 EE의 위험은 6%에서 16% 사이가 될 것임을 시사한다. 월경전 증상을 평가하기 위해 개발되지 않은 검증된 도구로 측정했을 때 월경전 기분 증상에 대한 드로스피레논과 EE의 효과가 불확실하다. 드로스피레논을 포함하는 COC는 총체적으로 더 많은 부작용을 유발할 수 있다(OR 2.31, 95% CI 1.71~3.11; 3 RCT, N = 739; I 2 = 0%; 근거의 질 낮음). 이는 위약으로 인한 부작용 위험이 28%라고 가정하면 드로스피레논과 EE의 위험은 40%에서 54% 사이가 될 것임을 시사한다. 그것은 아마도 더 많은 유방 통증으로 이어지고 더 많은 메스꺼움, 월경 간 출혈 및 월경 장애로 이어질 수 있다. 신경과민, 두통, 무력증 및 통증에 미치는 영향은 불확실하다. 포함된 모든 연구에서 정맥 혈전색전증과 같은 드물지만 심각한 부작용에 대한 보고는 없었다. 드로스피레논을 함유한 COC는 반응률을 향상시킬 수 있다(OR 1.65, 95% CI 1.13 ~ 2.40, 1 RCT, N = 449, I 2 해당 없음, 낮은 품질의 근거). 이것은 위약의 반응률이 36%라고 가정하면 드로스피레논과 EE의 위험은 39%에서 58% 사이가 될 것임을 시사한다. 드로스피레논을 함유한 COC를 다른 COC와 비교한 연구는 확인하지 않았다. 연구진 결론: 드로스피레논과 EE를 함유한 COC는 PMDD가 있는 여성의 기능 장애를 초래하는 월경전 증상을 개선할 수 있다. 위약도 상당한 효과가 있었다. 드로스피레논과 EE를 함유한 COC는 위약에 비해 더 많은 부작용을 일으킬 수 있다. 3주기 후에 효과가 있는지, 덜 심각한 증상이 있는 여성에게 도움이 되는지, 다른 프로게스토겐을 포함하는 다른 복합 경구 피임제보다 더 나은지는 알 수 없다.

Trial registration: ClinicalTrials.gov NCT05098574.

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Conflict of interest statement

None

Figures

1
1
PRISMA study selection flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 1: Mean daily rating of problem severity
1.2
1.2. Analysis
Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 2: Mean change in daily rating of functional impairment
1.3
1.3. Analysis
Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 3: Changes in Premenstrual Tension Scale scores
1.4
1.4. Analysis
Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 4: Withdrawal due to adverse events
1.5
1.5. Analysis
Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 5: Mood scores
1.6
1.6. Analysis
Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 6: Adverse events
1.7
1.7. Analysis
Comparison 1: Drospirenone plus ethinyl estradiol (DRSP/EE) versus placebo, Outcome 7: Responders (≥ 50% decrease in daily symptom score)
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References

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References to other published versions of this review

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