US Headache Study
Comparison of Treatment Groups on Global Assessment of Pain Intensity and Pain Relief
Headache response at 2 hours was 69.4% in the placebo group and 75.5% in the acetaminophen group (NS). No significant differences were detected between the two groups in baseline pain. A total of 16 (16%) participants in the placebo group required rescue medication, vs. 19 (19.2%) in the treatment group (NS). No significant differences were detected between groups in the pain intensity ratings 1, 2, and 4 hours after treatment. After 2 hours of treatment, 61 (62.7%) subjects rated placebo treatment as at least good, compared with 60 (61.2%) in the acetaminophen group (NS). After 4 hours, the proportions were 72.4% and 64.5% (NS).
Comparison of Treatment Groups on Global Assessment of Headache Severity
| |
1 hour post (n=198) |
| |
Placebo n=99 |
Acetaminophen n=99 |
M-H chi-square p value |
| Pain intensity |
| No headache |
12 (12.12) |
12 (12.12) |
0.7391 |
| Mild |
37 (37.37) |
36 (36.36) |
|
| Moderate |
36 (36.36) |
42 (42.42) |
|
| Severe |
14 (14.14) |
9 (9.09) |
|
| Total* |
99 (50.00) |
99 (50.00) |
|
| |
2 hours post ( n=196) |
| |
Placebo n=98 |
Acetaminophen n=98 |
M-H chi-square p value |
| Pain intensity |
| No headache |
30 (30.61) |
29 (29.59) |
0.3683 |
| Mild |
38 (38.78) |
45 (45.92) |
|
| Moderate |
21 (21.43 |
21 (21.43) |
|
| Severe |
9 (9.18) |
3 (3.06) |
|
| Total* |
98 (50.00) |
98 (50.00) |
|
| |
4 hours post ( n=179 ) |
| |
Placebo n=87 |
Acetaminophen n=92 |
M-H chi-square p value |
Values are n (%)
* 100 participants were assigned to the control group. One participant is missing 1-hour data, 2 participants are missing 2-hour data, and 13 participants are missing 4-hour data. Ninety-nine participants were assigned to the treatment group. One participant is missing 2-hour data and 6 participants are missing 4-hour data. |
| Pain intensity |
| No headache |
50 (57.47) |
56 (60.87) |
0.2978 |
| Mild |
17 (19.54) |
23 (25.00) |
|
| Moderate |
16 (18.39) |
10 (10.87) |
|
| Severe |
4 (4.60) |
3 (3.26) |
|
| Total* |
87 (48.60) |
92 (51.40) |
|