A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients

Table 1 Patient characteristics (full analysis set)

	Placebo (n = 195)	Duloxetine (n = 191)	p Value
Age, yr	49.5 ± 11.7	47.8 ± 12.0	0.1373^a
Females	164 (84.1)	157 (82.2)	0.6837
Weight, kg	56.28 ± 10.47	58.00 ± 11.23	0.1219^a
Height, cm	159.61 ± 7.76	159.41 ± 7.40	0.7922
Major depressive disorder diagnosis	7 (3.6)	8 (4.2)	0.7980
Duration of fibromyalgia, yr	5.7 ± 6.6	5.5 ± 5.9	0.6968
Number of tender points	15.5 ± 2.3	15.4 ± 2.3	0.8740
BPI average pain score (0–10)	6.13 ± 1.35	6.05 ± 1.29	0.5456
FIQ total score (0–100)	56.82 ± 16.14	55.95 ± 16.25	0.5950
BDI-II total score (0–63)	14.89 ± 9.62	15.34 ± 9.73	0.6533

BDI-II Beck Depression Inventory II, BPI Brief Pain Inventory, FIQ Fibromyalgia Impact Questionnaire
Values are means ± standard deviation or n (%). Continuous variables were analyzed using Welch’s t test, and categorical variables were analyzed using Fisher’s exact test
^aStatistically significant at a two-sided significance level of 0.15

ISSN: 1478-6362