Summary of findings 3. Dose comparison: oestrogen 100 µg patch compared to 200 µg patch plus progestogen in both groups for controlling symptoms of premenstrual syndrome.
Dose comparison: oestrogen 100 µg patch compared to 200 µg patch plus progestogen in both groups for controlling symptoms of premenstrual syndrome | ||||||
Population: women diagnosed with symptoms of premenstrual syndrome (PMS) Setting: community Intervention: oestrogen 100 µg patch plus progestogen Comparison: oestrogen 200 µg patch plus progestogen | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with 200 µg patch plus progestogen | Risk with oestrogen 100 µg patch plus progestogen | |||||
Symptoms score: Premenstrual Daily Questionnaire (PDQ) Scale from 0 to 30, with a higher score indicating a worse outcome over 8 months follow up |
The difference in the change from baseline in the PDQ score was too imprecise to determine whether dosage had an effect on global symptoms (MD 1.55 lower, 95% CI 8.88 lower to 5.78 higher) | ‐ | 98 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | ||
Adverse events ‐ withdrawal rates over 8 months' follow‐up |
255 per 1000 | 178 per 1000 (87 to 372) | RR 0.70 (0.34 to 1.46) | 107 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | |
Adverse events ‐ specific side effects attributed to oestrogen over 8 months' follow‐up |
353 per 1000 | 180 per 1000 (92 to 349) | RR 0.51 (0.26 to 0.99) | 107 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | |
*The risk in the intervention group (and its 95% confidence interval) is based on the mean risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk 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 |
1 Downgraded two levels for very serious risk of bias: unblinded, high attrition
2 Downgraded two levels for very serious imprecision: wide confidence intervals consistent with benefit in one or both arms or with no clinically meaningful effect from the intervention (however no further downgrading possible)