Summary of findings 3. SSRIs for premenstrual syndrome: withdrawal due to adverse effects.
| SSRIs versus placebo: withdrawal due to adverse effects | ||||||
|
Patient or population: women with premenstrual syndrome
Settings: community or outpatient
Intervention: SSRIs Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Placebo | SSRIs | |||||
|
Low dose SSRI versus placebo Luteal or continuous administration |
53 per 1000 | 91 per 1000 (60 to 135) | OR 1.76 (1.13 to 2.75) | 1301 (7 studies) | ⊕⊕⊕⊝ moderate1 | Withdrawal due to adverse effects was significantly more common in the SSRI groups |
|
Mod dose SSRI versus placebo Luteal or continuous administration |
45 per 1000 | 107 per 1000 (79 to 142) | OR 2.55 (1.84 to 3.53) | 2447 (15 studies) | ⊕⊕⊕⊝ moderate2 | |
|
High dose SSRIs versus placebo Continuous administration |
72 per 1000 | 457 per 1000 (207 to 1000) | RR 6.35 (2.88 to 14) | 231 (1 study) | ⊕⊕⊕⊝ moderate3 | |
| *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; OR: Odds 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. | ||||||
1 Only 1/4 studies reported adequate methods of randomisation and allocation concealment.
2 Only 3/15 studies described adequate methods of randomisation and allocation concealment and 7/15 were at unclear or high risk of attrition bias. 3 Single study (n=235), which did not describe adequate method of allocation concealment.