Table 2.

Results of primary and secondary outcome measures after two weeks' treatment

	Median score (minimum-maximum)		Median of differences	P value for comparison between medians*	P value for non-inferiority test†
	Butterbur (n=61)	Cetirizine (n=64)
Primary outcome measures (SF-36 score)
Physical function	95 (50-100)	95 (15-100)	0	0.75	0.001
Emotional function	100 (0-100)	100 (0-100)	0	0.89	0.001
Vitality	65 (15-95)	60 (5-95)	5	0.17	0.001
Mental health	80 (28-100)	84 (24-100)	0	0.50	0.001
General health	72 (30-100)	67 (25-97)	7	0.29	0.001
Physical activity	100 (0-100)	75 (0-100)	0	0.16	0.001
Social functioning	87.5 (50-100)	87.5 (0-100)	0	0.15	0.001
Pain	84 (41-90)	84 (22-90)	0	0.44	0.001
Secondary outcome measures
Clinical global impression score:
Severity of condition‡	−3 (−2-−6)	−3 (−2-−7)	0	0.82	0.0001
Global improvement§	3 (2-7)	3 (2-6)	0	0.82	0.001
Risk to benefit§	4 (0.25-4)	4 (0.33-4)	0	0.79	0.001
SF-36 score for overall status (No (%) worse or much worse than 1 year ago)§	7 (11)	8 (13)	—	0.20	0.001

^*Mann-Whitney test (two sided). Significant values mean the treatment effects are different. 

^†Mann-Whitney rank sum test (one sided). Significant values mean butterbur is not inferior. 

^‡Negative values represent improvement in scores. 

^§Results for these items are medians at endpoint not adjusted for baseline. 

Note: Data are non-normally distributed for all items (Shapiro-Wilk: P⩽0.01).