Table 3.

Effect of very low dose cyclobenzaprine (VLD CBP) on FM symptoms.

Last Observation Carried Forward (LOCF)SDLOCF p*VLD CBP vs Placebo
TreatmentBaseline (SD)Week 8 (SD)Mean Change% of BaselineTreatment p**% of Baseline
Musculoskeletal painVLD CBP2.3 (1.2)1.7 (1.2)–0.6–26.10.880.0100.044–18.2
Placebo2.1 (1.2)2.1 (1.4)00.00.831.000
FatigueVLD CBP5.0 (1.3)4.3 (1.5)–0.7–14.01.330.0390.126–12.4
Placebo4.7 (1.2)4.9 (1.4)0.24.31.820.647
TendernessVLD CBP14.3 (5.6)18.6 (9.5)4.330.15.760.0060.02916.7
Placebo15.6 (10.1)16.1 (7.7)0.53.24.130.614
HAD scoreVLD CBP13.7 (5.8)10.4 (7.5)–3.3–24.14.960.0120.067–32.0
Placebo15.7 (7.4)15.1 (8.9)–0.6–3.83.360.459
HAD depressionVLD CBP6.3 (3.9)4.9 (4.5)–1.4–22.22.250.0170.023–38.5
Placebo6.7 (4.1)7.4 (4.7)0.710.42.890.319
Patient-rated change in fatigueVLD CBP2.91.000.0010.133
Placebo2.51.290.120
Clinician-rated change in fatigueVLD CBP2.81.040.0030.257
Placebo2.51.150.083
  • * Each t test is used to test that within-group change from baseline is significant, i.e., different from 0. p value is 2-sided.

  • ** ANOVA p value comparing mean change from baseline between treatments.

  • p ≤ 0.05. HAD: Hospital Anxiety and Depression Scale.