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Table 4 Change in efficacy measurements between TSC and placebo groups in the full analysis set (FAS)

From: Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial

CharacteristicsTSC (N = 750)Placebo (N = 250)P values
Response rate (Percentage of patients with ≥50% reduction in frequency of headache), no. (%)4 weeks97 (13.0%)22 (8.9%)0.0794
8 weeks263 (36.7%)46 (18.9%)< 0.0001
12 weeks422 (62.1%)56 (23.9%)< 0.0001
16 weeks392 (70.8%)60 (26.3%)< 0.0001
Times of headache attacks per 4 weeks, mean ± SD4 weeks3.15 ± 1.093.15 ± 1.090.8647
8 weeks2.61 ± 1.003.02 ± 1.13< 0.0001
12 weeks2.13 ± 1.002.85 ± 1.16< 0.0001
16 weeks1.83 ± 0.922.89 ± 1.26< 0.0001
VAS of headache, mean ± SD4 weeks3.88 ± 1.224.19 ± 1.250.0001
8 weeks3.17 ± 1.243.79 ± 1.23< 0.0001
12 weeks2.59 ± 1.293.61 ± 1.36< 0.0001
16 weeks2.29 ± 1.263.60 ± 1.45< 0.0001
Days of acute analgesic use, mean ± SD, d4 weeks1.008 ± 1.291.350 ± 1.410.0003
8 weeks0.416 ± 0.800.856 ± 1.11< 0.0001
12 weeks0.174 ± 0.510.671 ± 1.01< 0.0001
16 weeks0.094 ± 0.380.754 ± 1.07< 0.0001
Percentage of patients with ≥50% reduction in severity of headache, no. (%)4 weeks70 (9.4%)10 (4.1%)0.0044
8 weeks240 (33.5%)25 (10.3%)< 0.0001
12 weeks365 (53.7%)51 (21.8%)< 0.0001
 16 weeks341 (61.6%)51 (22.4%)< 0.0001
  1. d day, no. number, SD Standard deviation, VAS Visual analogue score