PMID- 30988766 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200929 IS - 1792-0981 (Print) IS - 1792-1015 (Electronic) IS - 1792-0981 (Linking) VI - 17 IP - 5 DP - 2019 May TI - DL-3-n-butylphthalide therapy for Parkinson's disease: A randomized controlled trial. PG - 3800-3806 LID - 10.3892/etm.2019.7397 [doi] AB - Currently available treatments for Parkinson's disease (PD) do not delay or prevent disease development and progression. DL-3-n-butylphthalide (NBP), isolated from Apium graveolens seeds, alleviates oxidative damage and mitochondrial dysfunction. It has been revealed to reduce the loss of dopamine neurons in pre-clinical PD models, and has been approved for the treatment of ischemic stroke patients. The purpose of the present study was to examine whether NBP has the capacity provide a benefit for PD patients and to slow disease progression. A randomized, controlled trial was performed between September 2014 and December 2016. Pairs of patients matched by age, gender and off-medication Unified PD Rating Scale motor subscale (UPDRS-III) scores, were randomly assigned to an NBP treatment group and a control group. All patients continued their originally prescribed medication regimen and those in the NBP group were administered NBP at 200 mg three times daily for 24 weeks. Primary outcome measures were changes in UPDRS-III, including tremor score and non-tremor score, the Pittsburgh sleep quality index (PSQI) and the PD 39-items questionnaire (PDQ) scores. Assessments were completed by blinded evaluators at baseline and 12, 24 and 48 weeks after randomization. All patients were monitored for adverse events (AEs). A total of 103 patients were enrolled in the present study. The NBP group exhibited significantly greater improvements in the non-tremor, PSQI and PDQ-39 scores than the control group, which generally exhibited no improvement. NBP-associated AEs were uncommon and primarily consisted of mild gastrointestinal symptoms. In conclusion, over the 6-month treatment period, NBP was safe and effective for improving the symptoms and impairing the progression of patients with PD (Trial registry number, ChiCTR1800018892). FAU - Zhou, Haiyan AU - Zhou H AD - Department of Gerontology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, P.R. China. FAU - Ye, Ming AU - Ye M AD - Department of Neurology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, P.R. China. FAU - Xu, Wenfang AU - Xu W AD - Department of Neurology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, P.R. China. FAU - Yu, Meiling AU - Yu M AD - Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, P.R. China. FAU - Liu, Xiaolin AU - Liu X AD - Department of Neurology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233004, P.R. China. FAU - Chen, Yuhua AU - Chen Y AD - Department of Neurology, Anhui Provincial Hospital Affiliated to Anhui Medical University, Hefei, Anhui 230001, P.R. China. LA - eng PT - Journal Article DEP - 20190314 PL - Greece TA - Exp Ther Med JT - Experimental and therapeutic medicine JID - 101531947 PMC - PMC6447885 OTO - NOTNLM OT - DL-3-n-butylphthalide OT - Parkinson's disease OT - Unified Parkinson's Disease Rating Scale motor subscale III OT - randomized controlled trial EDAT- 2019/04/17 06:00 MHDA- 2019/04/17 06:01 PMCR- 2019/03/14 CRDT- 2019/04/17 06:00 PHST- 2018/01/23 00:00 [received] PHST- 2018/12/21 00:00 [accepted] PHST- 2019/04/17 06:00 [entrez] PHST- 2019/04/17 06:00 [pubmed] PHST- 2019/04/17 06:01 [medline] PHST- 2019/03/14 00:00 [pmc-release] AID - ETM-0-0-7397 [pii] AID - 10.3892/etm.2019.7397 [doi] PST - ppublish SO - Exp Ther Med. 2019 May;17(5):3800-3806. doi: 10.3892/etm.2019.7397. Epub 2019 Mar 14.