Abstract
Background:Patients with Parkinson's disease(PD)undergoing long-term levodopa therapy are prone to develop levodopa-induced dyskinesia(LID).Amantadine is the main drug recommended for the treat-ment of LID by current guidelines,but it is far from meeting clinical needs.Tianqi Pingchan Granule(TPG),a compound Chinese herbal medicine,has been developed to relieve symptom of LID.Objective:This randomized controlled trial evaluated the efficacy and safety of the combination of TPG and amantadine for LID.Design,setting,participants and interventions:This is a randomized double-blind placebo-controlled trial,conducted from January 2020 to August 2021 at 6 sites in Jiangsu,Zhejiang and Shanghai,China.One hundred PD patients with ≥ 0.5 h of LID were randomly assigned to either the TPG plus amantadine group(TPG group)or the placebo plus amantadine group(placebo group),and treated for a period of 12 weeks.To ensure unbiased results,all study participants,investigators and sponsors were unaware of group allocations.Additionally,the data analysts remained blinded until the analysis was finalized.Main outcome measures:The primary outcome was assessed using the Unified Dyskinesia Rating Scale(UDysRS)(Range 0-104).The key secondary end point was improvement of motor and non-motor symp-toms.Safety analyses included all enrolled patients.Results:One hundred patients were enrolled and randomized into the two treatment groups.The changes in UDysRS at week 12 were-11.02 for the TPG group and-4.19 for the placebo group(treatment difference-6.83[-10.53 to-3.12];P=0.0004).Adverse events were reported for 2 of 50 patients(4.0％)in each of the groups.Conclusion:This study indicated that a 12-week treatment of amantadine plus TPG effectively reduced UDysRS scores and was well tolerated,demonstrating the efficacy and safety of TPG for the treatment of LID in PD.
万方数据