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

Murakami, Masato; Osada, Kenichi; Mizuno, Hiromichi; Ochiai, Toshimitsu; Alev, Levent; Nishioka, Kusuki

doi:10.1186/s13075-015-0718-y

Arthritis Research & Therapy

Table 2 Changes in efficacy measures from baseline to endpoint or at endpoint

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

Variable	Placebo (n = 195)		Duloxetine (n = 191)		Difference (95 % CI)	p Value
Variable	Baseline	Change	Baseline	Change	Difference (95 % CI)	p Value
BPI average pain score
MMRM	6.13 ± 1.35	−1.58 ± 0.23	6.05 ± 1.29	−1.90 ± 0.23	−0.32 (−0.70, 0.06)	0.0988
LOCF	6.13 ± 1.35	−1.22 ± 0.26	6.05 ± 1.29	−1.60 ± 0.26	−0.38 (−0.74, −0.02)	0.0408^a
BOCF	6.13 ± 1.35	−0.92 ± 0.25	6.05 ± 1.29	−1.38 ± 0.25	−0.45 (−0.81, −0.10)	0.0132^a
WOCF	6.13 ± 1.35	−0.88 ± 0.26	6.05 ± 1.29	−1.35 ± 0.26	−0.47 (−0.84, −0.10)	0.0132^a
BPI other pain
Worst	7.44 ± 1.40	−1.35 ± 0.26	7.36 ± 1.28	−1.91 ± 0.26	−0.56 (−0.99, −0.12)	0.0126^a
Least	4.46 ± 1.81	−1.23 ± 0.22	4.68 ± 1.70	−1.72 ± 0.22	−0.49 (−0.87, −0.12)	0.0092^a
Right now	5.90 ± 1.69	−1.20 ± 0.26	5.99 ± 1.52	−1.77 ± 0.26	−0.57 (−1.00, −0.15)	0.0083^a
Patient diary
Average pain	5.98 ± 1.39	−1.48 ± 0.18	5.79 ± 1.35	−1.82 ± 0.18	−0.33 (−0.70, 0.03)	0.0755
Worst pain	7.23 ± 1.28	−1.34 ± 0.19	7.05 ± 1.24	−1.81 ± 0.19	−0.47 (−0.88, −0.06)	0.0232^a
BPI interference scores
General activities	5.82 ± 2.31	−1.76 ± 0.32	5.82 ± 2.14	−2.22 ± 0.31	−0.46 (−0.98, 0.06)	0.0807
Mood	5.33 ± 2.53	−1.42 ± 0.33	5.65 ± 2.40	−2.17 ± 0.32	−0.75 (−1.29, −0.22)	0.0057^a
Walking ability	4.08 ± 2.85	−1.29 ± 0.30	4.29 ± 2.73	−1.67 ± 0.29	−0.38 (−0.84, 0.09)	0.1114
Normal work	5.50 ± 2.46	−1.76 ± 0.32	5.61 ± 2.42	−2.18 ± 0.31	−0.42 (−0.94, 0.09)	0.1081
Relationships with people	3.54 ± 2.97	−0.53 ± 0.30	3.90 ± 2.89	−1.09 ± 0.30	−0.55 (−1.04, −0.07)	0.0264^a
Sleep	5.22 ± 2.91	−1.57 ± 0.36	5.30 ± 2.81	−1.82 ± 0.35	−0.24 (−0.81, 0.32)	0.3959
Enjoyment of life	5.13 ± 2.75	−1.24 ± 0.32	5.12 ± 2.65	−1.90 ± 0.31	−0.66 (−1.18, −0.15)	0.0119^a
Average of all 7 items	4.95 ± 2.09	−1.44 ± 0.27	5.10 ± 2.07	−1.95 ± 0.27	−0.52 (−0.96, −0.07)	0.0222^a
FIQ
Physical functioning	3.85 ± 2.32	−0.37 ± 0.26	3.36 ± 2.35	−0.84 ± 0.25	−0.47 (−0.86, −0.09)	0.0160^a
Feeling good	7.11 ± 2.73	−0.79 ± 0.41	7.17 ± 2.72	−1.59 ± 0.40	−0.80 (−1.39, −0.21)	0.0082^a
Missing work	2.44 ± 2.79	−0.48 ± 0.28	2.33 ± 3.09	−0.97 ± 0.27	−0.49 (−0.93, −0.06)	0.0270^a
Housework	5.86 ± 2.39	−1.69 ± 0.36	5.86 ± 2.45	−2.14 ± 0.35	−0.45 (−0.97, 0.08)	0.0932
Pain	7.01 ± 1.67	−1.76 ± 0.35	6.83 ± 1.52	−2.37 ± 0.34	−0.62 (−1.11, −0.12)	0.0148^a
Fatigue	7.27 ± 2.08	−1.45 ± 0.35	7.08 ± 1.97	−1.96 ± 0.34	−0.52 (−1.03, 0.00)	0.0479^a
Morning tiredness	6.81 ± 2.41	−1.68 ± 0.39	6.86 ± 2.40	−1.80 ± 0.37	−0.13 (−0.69, 0.44)	0.6618
Stiffness	6.26 ± 2.56	−1.59 ± 0.35	6.20 ± 2.57	−2.10 ± 0.34	−0.51 (−1.03, 0.02)	0.0577
Anxiety	5.43 ± 2.67	−1.18 ± 0.36	5.33 ± 2.59	−1.86 ± 0.35	−0.68 (−1.20, −0.15)	0.0114^a
Depression	4.79 ± 2.71	−0.96 ± 0.35	4.91 ± 2.76	−1.62 ± 0.34	−0.66 (−1.18, −0.14)	0.0129^a
Total score	56.82 ± 16.14	−13.05 ± 2.65	55.95 ± 16.25	−18.41 ± 2.57	−5.35 (−9.26, −1.45)	0.0073^a
SF-36
Physical functioning	62.51 ± 19.82	3.04 ± 2.15	63.72 ± 18.75	7.40 ± 2.13	4.36 (1.35, 7.37)	0.0046^a
Physical role limitations	49.13 ± 25.60	0.44 ± 2.98	49.25 ± 25.57	8.20 ± 2.96	7.76 (3.57, 11.94)	0.0003^a
Bodily pain	36.60 ± 11.71	5.28 ± 2.08	36.53 ± 12.40	10.95 ± 2.07	5.67 (2.76, 8.59)	0.0002^a
General health perceptions	38.76 ± 14.77	3.31 ± 1.94	39.37 ± 17.67	6.55 ± 1.92	3.25 (0.53, 5.96)	0.0192^a
Vitality	31.96 ± 18.80	3.35 ± 2.53	32.43 ± 21.03	10.05 ± 2.51	6.70 (3.15, 10.25)	0.0002^a
Social functioning	55.71 ± 26.54	3.28 ± 3.06	55.76 ± 27.53	10.32 ± 3.04	7.04 (2.74, 11.34)	0.0014^a
Emotional role limitations	61.24 ± 26.80	−3.63 ± 3.36	60.34 ± 29.16	5.50 ± 3.35	9.12 (4.41, 13.83)	0.0002^a
Mental health	56.10 ± 19.84	−2.00 ± 2.52	55.50 ± 18.85	5.91 ± 2.51	7.91 (4.39, 11.43)	<0.0001^a
CGI-I^b	–	3.27 ± 0.16	–	2.83 ± 0.15	−0.44 (−0.71, −0.18)	0.0012^a
PGI-I^b	–	3.32 ± 0.16	–	2.83 ± 0.16	−0.49 (−0.76, −0.22)	0.0003^a
BDI-II score (0–63)	14.89 ± 9.62	−1.19 ± 0.85	15.34 ± 9.73	−4.09 ± 0.84	−2.90 (−4.37, −1.44)	0.0001^a
ACR 2010
WPI (0–19)	12.08 ± 3.57	−1.06 ± 0.60	12.14 ± 3.58	−2.34 ± 0.58	−1.28 (−2.12, −0.44)	0.0029^a
SS (0–12)	6.59 ± 1.88	−1.00 ± 0.28	6.60 ± 1.82	−1.37 ± 0.27	−0.36 (−0.79, 0.06)	0.0906
Total (0–31)	18.67 ± 4.53	−2.24 ± 0.77	18.74 ± 4.36	−3.88 ± 0.74	−1.64 (−2.74, −0.54)	0.0037^a

ACR American College of Rheumatology, BDI-II Beck Depression Inventory II, BOCF baseline observation carried forward, BPI Brief Pain Inventory, CGI-I Clinical Global Impressions–Global Improvement, CI confidence interval, FIQ Fibromyalgia Impact Questionnaire, LOCF last observation carried forward; MMRM mixed-effects model repeated measures, PGI-I Patient Global Impression of Improvement, SF-36 36-Item Short Form Survey; SS symptom severity; WOCF worst observation carried forward, WPI widespread pain index
Values are means ± SD (baseline) or least-squares means ± SE (change)
^aStatistically significant at a two-sided level of 0.05
^bMean scores at the end of treatment based on a 7-point scale

Back to article page

ISSN: 1478-6362

Contact us

General enquiries: journalsubmissions@springernature.com