Table 2

.Secondary outcome measures the end of the trial.

BoNT (n=25)Placebo (n=23)Treatment comparison
Median score (IQR) at baseline Median score (IQR) end of trial Median score (IQR) change score Median score (IQR) at baseline Median score (IQR) end of trial Median score (IQR) change score Median difference in change scores (95% CI) P value*
CGI-Severity investigator3.0 (2.0; 5.0)3.0 (2.0; 4.0)- 1.0 (−1.0; 0.5)4.0 (3.0; 5.0)4.0 (2.0; 5.0)0.0 (−1.0; 0.0)−1.0 (−1.0 to 1.0)0.821
CGI-Severity patient5.0 (4.0; 6.0)4.0 (3.0; 6.0)0.0 (−1.5; 1.0)5.0 (4.0; 6.0)4.0 (4.0; 5.0)−1.0 (−1.0; 0.0)1.0 (−1.0 to 1.0)0.799
VAS-disease burden patient49.0 (30.5; 71.0)34.0 (14.0; 78.5)−2.0 (−27.5; 20.0)62.0 (40.0; 86.0)48.0 (29.0; 67.0)−2.0 (−48.0; 12.0)0.0 (−25.0 to 15.0)0.613
PMDRS-motor symptoms10.0 (5.0; 18.0)8.0 (4.5; 15.0)−3.0 (−6.5; 2.5)17.0 (10.0; 21.0)16.0 (9.0; 22.0)0.0 (−5.0; 2.0)−3.0 (−2.0 to 4.0)0.438
SF-36-Physical component37.8 (24.3; 54.4)
(n=24)
36.3 (24.0; 55.1)
(n=22)
−1.2 (−5.9; 4.4)33.2 (26.7; 42.1)32.6 (27.1; 43.0)−1.3 (−3.7; 2.2)0.1 (−4.2 to 4.2)0.964
SF-36-Mental component50.8 (41.1; 57.9)
(n=24)
52.3 (41.2; 55.4)
(n=22)
0.2 (−5.6; 3.8)52.9 (44.0; 60.3)52.5 (40.0; 60.6)1.0 (−2.0; 6.4)−0.8 (−3.6 to 5.4)0.768
ALDS-disability88.4 (84.2; 89.5)
(n=24)
89.5 (78.8; 89.5)
(n=22)
0.0 (−2.5; 0.1)87.4 (79.0; 89.5)86.9 (79.3; 89.2)−0.3 (−2.1; 0.0)0.3 (−1.3 to 1.6)0.624
BDI-Depressive symptoms8.0 (4.5; 14.0)
(n=24)
8.5 (4.5; 14.0)
(n=22)
−1.0 (−4.0; 3.3)9.0 (5.0; 13.0)10.0 (3.0; 11.0)0.0 (−3.0; 1.0)−1.0 (−3.0 to 3.0)0.802
MADRS-Depressive symptoms12.0 (5.0; 15.5)9.0 (4.0; 16.0)0.0 (−3.0; 3.0)13.0 (6.0; 18.0)13.0 (8.0; 22.0)3.00 (−4.0; 7.0)−3.0 (−1.0 to 6.0)0.214
BAI-Anxiety symptoms10.0 (6.3; 15.8)
(n=24)
10.0 (2.8; 15.3)
(n=24)
1.0 (−1.5; 3.0)13.0 (8.0; 18.0)12.0 (5.0; 18.0)0.0 (−5.0; 2.0)1.0 (−5.0 to 1.0)0.213
LSAS-Social anxiety10.0 (5.3; 27.0)
(n=24)
10.5 (4.8; 20.8)
(n=22)
−2.5 (−6.3; 5.0)10.0 (3.5; 17.5)
(n=22)
9.0 (4.0; 25.0)0.0 (−4.0; 8.3)−2.5 (−4.0 to 10.0)0.264
OCI-Obsessive-Compulsive symptoms2.0 (0.3; 6.8)
(n=24)
4.0 (1.0; 6.3)
(n=24)
0.0 (−1.0; 3.3)2.0 (0.0; 5.0)4.0 (1.0; 7.0)1.0 (0.0; 3.0)1.0 (-1.0 to 2.0)0.300
  • The missing data should be noticed.

  • *Mann-Whitney U test.

  • ALDS, AMC Linear Disability Score; BAI, Beck Anxiety Inventory; BDI, Beck Depression Inventory; CGI, Clinical Global Impression; 95% CI, 95% Confidence Interval (Hodges-Lehmann approach); LSAS, Liebowitz Social Anxiety Scale; MADRS, Montgomery Asberg Depression Rating Scale; OCI, Obsessive Compulsive Inventory; PMDRS, Psychogenic Movement Disorder Rating Scale; SF-36, Short Form 36; VAS, Visual Analogue Scale.