Trends of secondary outcome measures in the two groups and results of two way analysis of variance for the strength of the cumulative “time × treatment” effect
| STN-S | Controls | Time × treatment p value | ||||||
|---|---|---|---|---|---|---|---|---|
| Time point (no of cases) | T0 (23) | T12 (23) | T24 (13) | T0 (16) | T12 (13) | T24 (8) | T12 | T24 |
| BDI, Beck Depression Inventory; LEDD, levodopa equivalent daily dose; NS, not significant; UPDRS-III, Unified Parkinson’s Disease Rating Scale Motor section. | ||||||||
| UPDRS-III OFF (mean (SD)) | 38.3 (11.6) | 17.9 (11.7) | 18.0 (4.7) | 37.4 (5.1) | 39.8 (6.3) | 41.7 (7.9) | <0.0000 | 0.001 |
| UPDRS-III ON (mean (SD)) | 10.2 (8.2) | 11.7 (8.7) | 13.5 (8.5) | 12 (9.2) | 13 (5.4) | 14 (5.8) | NS | NS |
| OFF daily rate mean ((SD)) | 46.1 (1.8) | 5.9 (6.4) | 5.2 (6.3) | 38.1 (15.5) | 42.1 (4.6) | 45.8 (8.9) | <0.0000 | 0.0001 |
| Rate of dyskinesia (median (quartiles)) | 2 (1–3) | 0 (0–1) | 0 (0–1) | 1 (1–2) | 2 (1–2) | 2 (1–3) | 0.00008 | 0.01 |
| Drooling (median (quartiles)) | 0 (0–1) | 0 (0–1) | 1 (0–1) | 0 (0–1) | 0 (0–1) | 1 (0–1) | NS | NS |
| Speech (median (quartiles)) | 2 (1–2) | 1 (0–2) | 2 (1–3) | 0 (0–1) | 0 (0–1) | 1 (0–2) | NS | NS |
| Tremor (median (quartiles)) | 2 (1–3) | 0 (0–1) | 0 (0–1) | 1 (1–2) | 1 (1–2) | 2 (1–2) | 0.0001 | 0.001 |
| Gait (median (quartiles)) | 2 (1–2) | 1 (0–1) | 1(1–2) | 1 (1–2) | 2 (1–2) | 2 (1–2) | 0.01 | 0.05 |
| Freezing (median (quartiles)) | 2 (0–3) | 1 (0–2) | 1 (1–2) | 1 (1–2) | 2 (1–2) | 1 (1–2) | 0.04 | NS |
| Postural reflex (median (quartiles)) | 2 (1–2) | 1 (0–2) | 1 (1–2) | 1 (0–1) | 1 (0–2) | 1 (0–2) | 0.007 | 0.007 |
| Falls (median (quartiles)) | 0 (0–1) | 0 (0–0) | 0 (0–0) | 0 (0–1) | 0 (0–0) | 1 (0–1) | 0.05 | NS |
| Sensory symptoms (median (quartiles)) | 2 (1–2) | 0 (0–0) | 0 (0–1) | 1 (1–2) | 2 (1–3) | 2 (1–2) | 0.0001 | 0.001 |
| LEDD (mean (SD)) | 987.87 (427.0) | 708.0 (311.0) | 561.0 (347.0) | 961.19 (474.0) | 1032.4 (356.6) | 922.5 (289.1) | 0.0005 | 0.05 |
| BDI (mean (SD)) | 14.4 (6.9) | 9.5 (2.6) | 9.5 (4.1) | 13.5 (6.4) | 10.5 (4.9) | 8.5 (4.9) | NS | NS |