Multi-dimensional analysis on Parkinson’s disease questionnaire-39 in Parkinson’s patients treated with Bushen Huoxue Granule: A multicenter, randomized, double-blinded and placebo controlled trial
Section snippets
Trial design
The CONSORT (Consohdated Standards of Reporting Trials) recommendations were followed in preparing the protocol. The study design was a multi-center, randomized, double-blinded, placebo-controlled clinical study with two groups and allocation in equal proportions. Study participants and the researchers will be blinded to treatment assignment.
Human ethics
In accordance with international agreements (Helsinki Declaration of 1964, revised 2013),2 the Ethics Committee of Academy of Chinese Medical Sciences
Results
The patients in the two groups had no significant statistical differences in age, PD duration (P = 0.067), H-Y degree and in the dose of levodopa.The details are listed in Table 1.
There are totally 106 cases finished the whole 9 months’ theraputic process, 55 cases in the treatment group and 51 cases in the placebo group. Owing to side-effects and other causes, patients who could not insist through the above mentioned program were 5 cases in Treated Group, 9 cases in Placebo group, altogether 14
Discussion
It is well known that PD is a chronic disease which had adverse effects on physical mobility and non-motor symptoms.7 The PDQ-39 is frequently used to measure the impact of the disease on quality of life. It assesses several clinical features and was developed interviewing PD patients about harmful effects of the disease regarding several aspects of their daily life. The PDQ-39 is considered as the most appropriate health-related quality of life tool by a systematic review8 and is particularly
Limitations
The present study is constrained by several limitations. First, The trial isn’t registered at international Clinical Trials website, but full details of the trial protocol can be found in the documentation of the National Ministry of Science and Technology “ Eleventh Five-Year ” project. Second, as this study was designed to be a multicenter study, the sample size may not be large enough to generalize to other study populations. Future studies should also use a larger sample size and stratify
Funding
Supported by the National Ministry of Science and Technology “ Eleventh Five-Year” project. CN No.2006BAI04A11.
Conflict of interest
None declared.
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