TABLE 2. Primary Efficacy Variables.
| Intention to Treat | Total N=90 | Placebo N= 44 | Amitriptyline N= 46 | p-value | ||
|---|---|---|---|---|---|---|
| Overall how do you feel your problem is? | ||||||
| Better | 56% | 53% | 59% | p=0.81 * | ||
| Same | 33% | 36% | 30% | |||
| Worse | 3% | 2% | 4% | |||
| Dropouts | 7% | 9% | 7% | |||
| How well did the medication relieve your pain? | ||||||
| Failed | 16% | 16% | 15% | |||
| Poor | 11% | 7% | 15% | |||
| Fair | 18% | 23% | 13% | |||
| Good | 37% | 38% | 45% | 35% | 50% | p=0.85 ** |
| Excellent | 11% | 7% | 15% | |||
| Dropouts | 7% | 9% | 7% | |||
| Per Protocol | Total N=83 | Placebo N= 40 | Amitriptyline N= 43 | p-value | ||
| Overall how do you feel your problem is? | ||||||
| Better | 60% | 57.5% | 63% | p=0.63 * | ||
| Same | 36% | 40% | 32% | |||
| Worse | 4% | 2.5% | 5% | |||
| How well did the medication relieve your pain? | ||||||
| Failed | 17% | 17.5 % | 16 % | |||
| Poor | 12% | 7.5 % | 16 % | |||
| Fair | 19% | 25 % | 14 % | |||
| Good | 40% | 42.5 % | 50% | 37 % | 53% | p=0.83 ** |
| Excellent | 12% | 7.5 % | 16 % | |||
*
- p value of better vs. same or worse combined
**
- p value of combination of good or excellent vs. fair, good and excellent combined