Table 2.

BPI-PN pain outcome scores for active treatment group and placebo group at baseline, 2, 4, 6 and 8 weeks

Intention to treat
Outcome	Time Point	Group	Mean ± SD1	Range	P value	Change from baseline	Effect size [95% CI]
BPI Severity score2	Baseline	Active	4.77 ± 1.45	2.8–8.8	0.46		−0.135 [−0.617 to 0.349]
		Placebo	4.96 ± 1.37	2.3–8.0
	Week 2	Active	3.03 ± 1.39	1.0–7.9	0.002	−1.75	−0.790 [−1.289 to −0.286]
		Placebo	4.14 ± 1.48	1.3–8.3		−0.80
	Week 4	Active	2.49 ± 1.50	0.8–6.8	<0.001	−2.28	−1.131 [−1.648 to −0.607]
		Placebo	4.27 ± 1.64	1.8–8.0		−0.70
	Week 6	Active	2.30 ± 1.84	0.0–7.8	<0.001	−2.47	−1.324 [−1.853 to −0.785]
		Placebo	4.54 ± 1.53	2.0–8.0		−0.42
	Week 8	Active	1.72 ± 1.51	0.3–7.3	<0.001	−3.06	−1.811 [−2.381 to −1.231]
		Placebo	4.19 ± 1.20	1.8–7.0		−0.77
BPI Interference score2	Baseline	Active	3.49 ± 1.90	0.6–7.9	0.15		−0.398 [−0.884 to 0.091]
		Placebo	4.26 ± 1.97	0.9–7.9
	Week 4	Active	2.45 ± 1.85	0.1–6.4	0.001	−1.04	−0.882 [−1.385 to −0.373]
		Placebo	4.11 ± 1.90	0.7–8.0		−0.15
	Week 8	Active	1.60 ± 1.66	0.0–5.9	<0.001	−1.90	−1.303 [−1.831 to −0.766]
		Placebo	3.87 ± 1.83	0.9–6.7		−0.39

¹Score given as average ± standard deviation

²Shapiro–Wilk distribution test found these data (in one or both arms) to be not normally distributed; tests of significance were performed nonparametrically with Mann–Whitney U. Active n = 33, Placebo n = 33. Statistical significance set at P ≤ 0.05