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Table 2 Secondary endpoints at Week 13 (double-blind treatment period; LOCF analysis)

From: Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial

  LS means for change from baseline (SE)
double-blind treatment period Open-label treatment period Acute + Open-label
Placebo (n = 93) Duloxetine (n = 91) Treatment difference p-value Placebo/duloxetine (n = 75) Duloxetine/duloxetine (n = 74) All patients randomized to duloxetine (n = 90)a
BPI Severity and Interference Ratings
 Worst pain score −0.96 (0.267) −1.43 (0.275) − 0.47 0.175 − 0.8 (0.256)** − 0.65 (0.262)* − 1.66 (0.342)**
 Least pain score − 0.60 (0.242) − 0.96 (0.247) − 0.35 0.255 − 0.45 (0.212)* −0.29 (0.218) − 0.86 (0.267)**
 Pain score right now − 1.17 (0.270) − 1.44 (0.276) − 0.26 0.446 − 0.29 (0.252) − 0.38 (0.259) −1.31 (0.312)**
Incidence of Treatment Responseb, n (%)
  ≥30% Reduction 33 (36.26) 47 (52.22) 0.032† 27 (37.50) 25 (36.23) 49 (54.44)
  ≥50% Reduction 22 (24.18) 36 (40.00) 0.029† 18 (25.00) 17 (24.64) 44 (48.89)
BPI interference
 General activity −0.99 (0.273) −1.75 (0.280) − 0.76 < 0.030* − 0.20 (0.229) − 0.18 (0.233) − 1.74 (0.316)**
 Mood − 1.54 (0.273) − 1.97 (0.279) −0.43 0.220 −0.25 (0.258) − 0.15 (0.270) −1.59 (0.330)**
 Walking ability −1.21 (0.266) −1.20 (0.271) 0.01 0.966 −0.21 (0.253) −0.24 (0.260) − 0.92 (0.285)**
 Normal work −1.19 (0.281) −1.41 (0.286) − 0.22 0.545 −0.32 (0.226) − 0.62 (0.231)** − 1.69 (0.328)**
 Relations with other people − 1.07 (0.236) − 1.83 (0.241) − 0.77 0.013* − 0.41 (0.222) − 0.12 (0.229) −1.53 (0.264)**
 Sleep −1.16 (0.344) −1.28 (0.352) −0.12 0.788 −0.54 (0.284) − 0.63 (0.292)* − 1.67 (0.417)**
 Enjoyment of life −1.51 (0.251) − 1.83 (0.257) −0.32 0.320 −0.26 (0.236) − 0.25 (0.243) − 1.76 (0.288)**
 School work − 1.00 (0.324) −1.48 (0.330) − 0.49 0.243 −0.06 (0.271) − 0.59 (0.278)* − 1.94 (0.362)**
BPI average interference score − 1.21 (0.217) − 1.60 (0.221) −0.39 0.165 −0.32 (0.187) − 0.30 (0.192) −1.61 (0.264)**
PPQ score
 Average pain score −9.41 (2.946) −11.03 (2.982) −1.62 0.669 −6.44 (3.296) −10.65 (3.080)** − 18.01 (3.523)**
 Worst pain score −8.46 (3.322) −14.36 (3.367) −5.90 0.169 −8.06 (3.677)* −4.15 (3.427) −15.96 (3.954)**
 Pain score right now −7.20 (3.065) −8.99 (3.092) −1.79 0.647 −6.34 (3.335) −4.74 (3.075) −8.40 (3.441)*
CGI-S: Score
 Overall −0.66 (0.118) −0.88 (0.121) − 0.22 0.146 − 0.67 (0.121)** −0.67 (0.125)** −1.25 (0.145)**
 Mental Illness −0.15 (0.087) −0.16 (0.089) − 0.01 0.927 − 0.24 (0.101)* −0.20 (0.104) − 0.27 (0.127)*
FDI total score
 Child total score −5.00 (1.021) −3.97 (1.038) 1.03 0.431 −1.03 (1.267) −1.71 (1.202) −5.02 (1.176)**
 Parent total score −4.17 (1.139) −3.25 (1.152) 0.92 0.529 −2.27 (1.327) −3.49 (1.227)** −5.36 (1.280)**
CDI total score −2.45 (0.674) −3.28 (0.682) −0.83 0.335 −1.41 (0.681)* −0.42 (0.703) −3.36 (0.865)**
MASC total score −4.99 (1.558) −6.21 (1.575) −1.21 0.540 −0.78 (1.432) −0.55 (1.478) −6.90 (2.299)**
  1. †From the Cochran-Mantel-Haenszel test controlling for pooled investigator sites; *p ≤ .05; **p ≤ .01; BPI Brief Pain Inventory, CDI Children’s Depression Inventory, CGI-S Clinical Global Impression-Severity, FDI Functional Disability Inventory, SE standard error, n number of patients, MASC multidimensional anxiety scale for children, PPQ Pediatric Pain Questionnaire. aAll patients who were randomized to duloxetine and had at least one non-missing post-baseline observation. bDefined as reduction in BPI average pain for open label and double blind+open label periods, only within group change was tested