"Cocktail therapy," or drug combination treament, may improve quality of life and the conditions of patients with Parkinson disease dementia.
Treatment with “cocktail therapy” was determined to be safe and may improve quality of life and the conditions of patients with Parkinson disease dementia (PDD), according to a study in Neuropsychiatric Disease and Treatment.
“Research shows that 46% of the patients with PD progress to PDD within 10 years of being diagnosed with PD. PDD seriously reduces patients’ quality of life and increases the burden on caregivers," researchers said. Right now, there are fewer methods to treat PDD than PD, and the treatments available for dementia are less effective.
Researchers enrolled 60 patients with PDD from the Second Hospital of Baoding in China between January 2011 and October 2016. Patients were 53% male, ranged in age from 60 to 81 years, and had a mean age of 68.6 ± 9.9 years. They were randomly assigned to the study’s test or control group. Investigators, evaluators, patients, their families, and their caregivers were blinded to the experimental drugs provided and did not know the patients' group assignments. Both groups had similar patient characteristics.
The control group initially received 5 mg of donepezil hydrochloride tablets once daily. The dosage was increased to 10 mg after 4 weeks and for the remainder of the 6 month treatment period. The test group received “cocktail therapy” which consisted of 5 mg of donepezil hydrochloride tablets once daily, also increased to 10 mg after 4 weeks, 200 mg of dl-3n-butylphthalide soft capsules taken 15 minutes before each meal 3 times daily, 800 mg of oxiracetam capsules taken 3 times daily, and 80 mg of Ginkgo biloba extract taken 3 times daily.
Researchers evaluated patients’ cognitive function using the Montreal cognitive assessment scale (MoCA). Severity of dementia was measured with the Clinical Dementia Rating Scale sum of boxes (CDR-SB), and the Blessed-Roth dementia scale was used to evaluate patients’ basic living habits, daily living ability, and changes in personality. All evaluations were conducted before treatment and at 3- and 6-month intervals following treatment. The occurrence of adverse events was also monitored and recorded.
During statistical analysis, measurement data were described as mean ± standard deviation. The analysis of variance with repeated measurement design data was used to assess changes in multiple follow-up indicators at different time points. Researchers used 2 sample t-tests for comparison between groups. Count data were expressed as rates and absolute numbers and a chi-squared test was used to calculated comparisons between groups. Researchers considered differences were statistically significant if P < .05.
Researchers found there were no statistical differences in MoCA, CDR-SB, or Blessed-Roth dementia scale scores between both groups prior to treatment. MoCA scores were significantly higher in the test group at the 6-month evaluation compared to the scores recorded before treatment and at the 3-month evaluation. Both the Blessed-Roth and CDR-SB scores were significantly lower at the 6-month evaluation than those recorded before treatment and at 3-month evaluations.
MoCA scores of the test group were significantly higher than those from the control group at the 6-month evaluation. Both Blessed-Roth and CDR-SB scores of the test group were significantly lower than those from the control group at the 6-month evaluation.
“The reason for this improvement with a combination of therapies may be related to the fact that butylphthalide, oxiracetam, and Ginkgo biloba extract can improve microcirculation in the brain, improve the use of glucose and oxygen in brain tissue, promote synthesis of triphosadenine and energy metabolism in brain cells, resist oxidative stress, protect nerve cells, and strengthen learning and memory, among other functions,” researchers said. “These effects may be behind the improvement in cognitive function and self-care ability that we observed in patients with PDD following ‘cocktail therapy.’”
Researchers suggested the study should be repeated at multiple centers with a larger sample size and a longer observation time to verify the accuracy of the results.
Zhang C, Zang Y, Song Q, et al. The efficacy of a “cocktail therapy” on Parkinson’s disease with dementia. Neuropsychiatr Dis Treat. 2019;15:1639-1647. doi: 10.2147/NDT.S179453.