Pramipexole combined with Madopar vs Madopar alone for treatment of Parkinson's disease: a randomized controlled clinical trial

Objective To assess the therapeutic effect and safety ofpramipexole combined with Madopar and Madopar alone in the treatment of Parkinson's disease (PD). Methods This randomized, controlled open-label trial involved 70 PD patients who were randomly assigned to receive pramipexole combined with Madopar (n=35) or Madopar alone (n=35) for 12 consecutive weeks. The therapeutic effect was assessed primarily by the Unified Parkinson's Disease Rating Scale (UPDRS). The main effect was motor symptoms of UPDRS Ⅲ and activities of daily living of UPDRS Ⅱ. The secondary effect was the changes relative to the baseline levels in the consciousness, behavior, and emotion of UPDRS Ⅰ, the complications of UPDRS Ⅳ and daily Madopar dosage. The safety of the drugs was evaluated according to the adverse reactions. Results Compared to the baseline levels, 12 weeks of treatment with pramipexole combined with Madopar resulted in significantly greater reduction in the total scores ofUPDRS Ⅲ than Madopar alone (11.40 vs 9.26, P 0.05). The combined treatment reduced the total score of UPDRS Ⅳ by 0.22 whereas Madopar alone increased the score by 0.06, showing significant difference between the two treatments (P<0.05). The daily Madopar dosage in the combined treatment group was decrease by 163.57 rag, but that in Medopar group increased by 8.57 rag (P<0.05). The frequencies of wearing-off, symptom fluctuation and movement disorder were significantly lower in combined treatment group than in Madopar group. Obvious wearing-off, symptom fluctuation and movement disorder occurred in Madopar group, which were not noted in the combined treatment group but two patients developed sudden sleep, one reported drowsiness, and another exhibited orthostatic hypotension. Conclusion Pramipexole combined with Madopar results in better improvement of the motor symptoms than Madopar alone in PD patients, but they show similar effect on the activities of daily living and consciousness, behavioral and emotional changes. Pramipexole can significantly decrease the daily dose of Madopar and help reduce the complications, suggesting its safety and effectiveness in the treatment of PD, but its adverse effects should be given due attention in clinical application. Key words: Pramipexole;  Madopar;  Parkinson'sdisease