Summary of findings for the main comparison. SSRIs for premenstrual syndrome: all symptoms (end scores).
SSRIs compared to placebo ‐ all symptoms (end scores) for premenstrual syndrome | ||||
Patient or population: women with premenstrual syndrome Settings: community or outpatient Intervention: SSRIs Comparison: placebo ‐ all symptoms (end scores) | ||||
Outcomes | Illustrative comparative risks* (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments |
Moderate dose SSRI versus placebo Luteal or continuous administration |
The mean score for all symptoms in the intervention groups was 0.67 standard deviations lower (0.46 to 0.84 lower) | 1276 (9 studies) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.65 (95% CI ‐0.42 to ‐0.84) Symptoms were significantly less severe in the SSRI group. The size of the effect was moderate. |
Moderate dose SSRI versus placebo Luteal administration |
The mean score for all symptoms in the intervention groups was 0.51 standard deviations lower (0.71 to 0.31 lower) | 457 (4 studies) | ⊕⊕⊕⊝ moderate2 | SMD 0.51 (95% CI ‐0.71 to ‐0.31) Symptoms were significantly less severe in the SSRI group. The size of the effect was moderate. |
Moderate dose SSRI versus placebo Continuous administration | The mean score for all symptoms in the intervention groups was 0.72 standard deviations lower (0.97 to 0.47 lower) | 843 (7 studies) | ⊕⊕⊝⊝ low1,2 | SMD ‐0.72 (95% CI ‐0.97 to ‐0.47) Symptoms were significantly less severe in the SSRI group. The size of the effect was moderate. |
*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (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; SMD standardised mean difference | ||||
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. |
1 Only 4/9 studies overall (2/4 of luteal and 3/7 of continuous administration) described adequate methods of randomisation and allocation concealment; 8/9 studies were at uncertain or high risk of attrition bias. 2 Substantial overall heterogeneity (I squared= 58%), attributable to heterogeneity in continuous administration group (I squared=68%), which included two studies with larger intervention effects. No obvious explanation (though studies used wide variety of assessment tools).