.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 investigator | 3.0 (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 patient | 5.0 (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 patient | 49.0 (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 symptoms | 10.0 (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 component | 37.8 (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 component | 50.8 (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-disability | 88.4 (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 symptoms | 8.0 (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 symptoms | 12.0 (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 symptoms | 10.0 (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 anxiety | 10.0 (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 symptoms | 2.0 (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.