Observed means and differences (SD), effect sizes and CI for primary and secondary outcomes in baseline versus months 1, 2 and 3
| Placebo (n=59) | Amitriptyline (n=59) | Difference amitriptyline 25 mg vs placebo (95% CI) | Melatonin (n=60) | Difference melatonin 3 mg vs placebo (95% CI) | |
|---|---|---|---|---|---|
| Mean (SD)/difference from baseline | Mean (SD)/difference from baseline | RR (95% CI) | Mean (SD)/difference from baseline | RR (95% CI) | |
| Primary efficacy measure | |||||
| Number of migraine headache days | |||||
| Baseline | 7.3 (3.1) | 7.2 (2.5) | 7.3 (2.8) | ||
| Weeks 1–4 | 7.0 (2.9)/−0.3 | 5.8 (2.1)/−1.4 | −1.1 (−1.7 to −0.6) | 5.6 (2.0)/−1.7 | −1.4 (−2.1 to −0.8) |
| Weeks 5–8 | 6.6 (2.6)/−0.7 | 5.3 (2.4)/−1.9 | −1.2 (−1.6 to −0.8) | 5.3 (2.1)/−2.0 | −1.3 (−1.7 to −0.8) |
| Weeks 9–12 | 6.2 (2.5)/−1.1 | 5.0 (2.5)/−2.2 | −1.1 (−1.5 to −0.7)* | 4.6 (2.3)/−2.7 | −1.6 (−2.4 to −0.9)* |
| Secondary efficacy measures | |||||
| Mean headache intensity (0–10) | |||||
| Baseline | 6.6 (1.4) | 7.0 (2.1) | 7.1 (1.9) | ||
| Weeks 1–4 | 5.7 (3.2)/−0,9 | 5.2 (3.1)/−1.8 | −0.5 (−0.9 to −0.1) | 5.0 (2.8)/−2.1 | −0.7 (−1.2 to −0.2) |
| Weeks 5–8 | 5.4 (3.6)/−1.2 | 4.2 (3.4)/−2.8 | −1.2 (−1.5 to −0.9) | 4.3 (2.4)/−2.8 | −1.1 (−1.5 to −0.7) |
| Weeks 9–12 | 4.8 (3.3)/−1.8 | 3.5 (3.5)/−3.5 | −1.3 (−1.7 to −0.9)* | 3.6 (3.5)/−3.5 | −1.2 (−1.6 to −0.8)* |
| Number of analgesics | |||||
| Baseline | 4.2 (1.3) | 4.6 (1.7) | 4.5 (1.9) | ||
| Weeks 1–4 | 3.9 (1.4)/−0.3 | 4.1 (2.1)/−0.5 | −0.2 (−0.7 to 0.2) | 3.4 (2.0)/−1.1 | −0.8 (−1.1 to −0.5) |
| Weeks 5–8 | 3.8 (1.4)/−0.4 | 3.3 (1.9)/−1.3 | −0.9 (−1.4 to −0.4) | 3.2 (1.9)/−1.3 | −0.9 (−1.3 to −0.5) |
| Weeks 9–12 | 3.6 (1.2)/−0.6 | 3.2 (2.0)/−1.4 | −1.0 (−1.5 to −0.5)* | 2.9 (1.7)/−1.6 | −1.0 (−1.4 to −0.6)* |
| Mean attack duration (hours) | |||||
| Baseline | 18.7 (17.3) | 16.7 (12.0) | 18.1 (13.8) | ||
| Weeks 1–4 | 17.7 (16.2)/−1.0 | 13.2 (12.1)/−3.5 | −2.5 (−3.2 to −1.8) | 13.5 (12.4)/−4.6 | −3.6 (−4.7 to −2.5) |
| Weeks 5–8 | 16.8 (15.7)/−1.9 | 10.7 (9.7)/−6.0 | −4.1 (−4.6 to −3.6) | 12.2 (11.0)/−5.9 | −4.0 (−4.9 to −3.1) |
| Weeks 9–12 | 16.2 (15.3)/−2.5 | 9.8 (10.5)/−6.9 | −4.4 (−5.1 to −3.9)* | 10.9 (9.5)/−7.2 | −4.8 (−5.7 to −3.9)* |
*p<0.05.
RR; relative risk.