Table 2.
Results at end point (end of three consecutive cycles) in 170 women with the premenstrual syndrome (active treatment n=86; placebo n=84)
| Mean value
|
Difference in mean reduction (active minus placebo) (95% CI) | P value* | ||
|---|---|---|---|---|
| Active (n=86) | Placebo (n=84) | |||
| Primary efficacy variable: | ||||
| Differences in self assessment† | −128.5 | −78.1 | −50.5 (−23.5 to −77.5) | 0.001 |
| Secondary efficacy variables : | ||||
| Irritability (self assessment) | −28.9 | −18.2 | −10.7 (−3.4 to −18.0) | 0.001 |
| Mood alteration (self assessment) | −28.7 | −17.6 | −11.1 (−4.4 to −17.8) | 0.001 |
| Anger (self assessment) | −22.1 | −11.7 | −10.3 (−3.1 to −17.5) | 0.001 |
| Headache (self assessment) | −17.8 | −5.9 | −11.9 (−4.3 to −19.6) | 0.002 |
| Others and bloating (self assessment) | −12.4 | −13.7 | 1.3 (−5.5 to 8.1) | NS |
| Breast fullness (self assessment) | −18.6 | −9.4 | −9.2 (−2.8 to −15.6) | 0.001 |
| Severity of condition (CGI item 1) | −1.5 | −1.0 | −0.5 (− 0.1 to −0.8) | 0.001 |
| Improvement/deterioration (CGI item 2) | 2.9 | 3.9 | −1.0 (−0.7 to −1.3)‡ | 0.001 |
| Overall assessment risk or benefit (CGI item 3) | 2.9 | 2.2 | 0.7 (0.4 to 1.0)‡ | 0.001 |
| Responder rate (%)§ | 52 | 24 | ||
CGI=clinical global impression.
*
Mann-Whitney rank sum test.
†
Visual analogue scale combined for six items.
‡
Difference in means with 95% CI.
§
Response ⩾50% improvement in combined visual analogue scale from baseline to end point.