Long-term effect of the German Parkinson’s disease multimodal complex treatment: a clinical trial with randomized allocation

Abstract Background The German Parkinson´s disease multimodal complex treatment (PD-MCT) is a structured multidisciplinary inpatient treatment for people with Parkinson’s disease (PwPD). However, data on its long-term effect are limited. Methods A monocentric, non-blinded, clinical trial with randomized allocation and six-month follow-up was conducted at the Department of Neurology of the Jena University Hospital. At total of 120 patients admitted for PD-MCT were allocated 1:1 to two predefined treatment durations (short: 7–13 days; long: 14–20 days) according to the German Operation and Procedure Classification System (OPS; code 8-97d). The primary outcome was change in the Movement Disorder Society sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS) part II after six months. Secondary outcomes included change in quality of life assessed by the Parkinson’s Disease Questionnaire 8 (PDQ-8) and the influence of treatment duration. Analyses were performed as-treated. Results In 93 PwPD, MDS-UPDRS II improved by 3 points ( r = 0.435; p < 0.001), with 52.7% achieving a clinically relevant improvement. Improvement was associated with higher baseline MDS-UPDRS II (odds ratio [OR] 1.16, 95% confidence interval [CI] 1.07–1.27; p < 0.001), lower Hoehn and Yahr stage (OR 0.29, 95% CI 0.09–0.97; p = 0.045), and fewer nonmotor symptoms (OR 0.88, 95% CI 0.77-1.00; p = 0.042) ( x 2 (3) = 14.94; p = 0.002; R 2 = 0.22). PDQ-8 improved by 8 points ( r = 0.524; p < 0.001), with 58.1% showing clinically relevant improvement, which was associated with lower Hoehn and Yahr stage (OR 0.30, 95% CI 0.10–0.92; p = 0.035), and more depressive symptoms (OR 1.17, 95% CI 1.04–1.33; p = 0.012) ( x 2 (2) = 10.53; p = 0.005; R 2 = 0.15). Treatment duration had no significant influence on MDS-UPDRS II ( p = 0.611, Eta² = 0.001) or PDQ-8 ( p = 0.809, Eta² = 0.001). Conclusions PD-MCT is an effective multidisciplinary inpatient treatment with clinically relevant long-term effects up to six months. In clinical practice, the shorter treatment duration may be similarly effective in selected patients. Trial registration German Clinical Trials Register, DRKS00025225, registered 30 June 2021, https://drks.de/search/de/trial/DRKS00025225 .