Elsevier

Complementary Therapies in Medicine

Volume 29, December 2016, Pages 116-120
Complementary Therapies in Medicine

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

https://doi.org/10.1016/j.ctim.2016.09.008Get rights and content

Highlights

  • We compared the scores of the eight dimensions of the PDQ-39 between the two groups.

  • The Chinese version of the PDQ-39 has acceptable reliability and validity.

  • BHG treatment can significantly improve quality of life of PD patients, especially in the domain of mobility, emotional well-being, stigma and cognition.

Abstract

Objectives

To preliminarily assess the effects of Bushen Huoxue Granule (BHG) on Parkinson’s Patients with Parkinson’s Disease Questionnaire-39 (PDQ-39)and to provide data for further research.

Design

A randomized, double-blinded, placebo controlled study with a 3-month intervention period and a 6-month follow-up.

Interventions

Participants were patients with Parkinson’s Disease (PD) of age ranging from 50 to 80 years and Hoehn and Yahr (H–Y) stage I–IV of the disease.120 participants were allocated to BHG group or placebo group at a 1:1 ratio. The BHG group received BHG twice a day for 3 months, and was followed-up for 6 months after treatment; the placebo group did not receive any Chinese Herb treatment for 9 months. All the patients were given the conventional therapy of levodopa (Madopar).

Main outcome measures

Primary outcome measure was PDQ-39 comprises 39 questions with five different options of answer related to the frequency of the disease manifestation.

Results

Significant statistical difference appeared in the following PDQ-39 dimensions: mobility; emotional well-being; stigma; cognition (P < 0.01) and bodily discomfort (P < 0.05).There was no statistical difference in the dimensions of social support, ADL and communication between the data of these two group patients (P  0.05). We found that the sum index of PDQ-39 was significantly different between two groups.

Conclusion

The results of this study show that BHG treatment makes significant effects in most domains of PD patients life quality,especially in mobility, emotional well-being, stigma and cognition. The affected factors should be confirmed in larger studies.

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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