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

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.

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.

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) (x²(3) = 14.94; p = 0.002; R² = 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) (x²(2) = 10.53; p = 0.005; R² = 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).

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.

German Clinical Trials Register, DRKS00025225, registered 30 June 2021, https://drks.de/search/de/trial/DRKS00025225 .