Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease

Kyung Hee University

Status: Completed

Conditions: Idiopathic Parkinson's Disease

Treatments: Device: sham acupuncture and normal saline injections; Device: acupuncture and bee venom acupuncture point injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01970813

NRF-2011-0021389

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and investigate whether there is sustainability of treatments effects by follow-up assessments after the end of the treatment.

Full description

A total of 90 patients with idiopathic Parkinson's disease (IPD) who have been on a stable dose of anti-parkinsonian medication for at least one month with two or more symptoms among tremor, rigidity, postural instability, and bradykinesia will be included in this study. Participants will be randomly assigned to the study, the control, or the waiting group (2:2:1).

Initial assessment will be performed with the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III, the Parkinson's Disease Quality of Life Questionnaire (PDQL), the Beck Depression Inventory (BDI), and evaluation of the 20-m walking time and the steps to walk 20-m, as well as postural instability.

Acupuncture and BVA treatments will then be performed on the study group, and sham acupuncture and normal saline injections will be performed on the control group twice a week for 12 weeks. The waiting group does not receive any added treatment during the 12 weeks.

The initial assessment will be repeated after 12 weeks in all groups. In the study and the control groups, an additional assessment will be repeated after 16 and 20 weeks.

Enrollment: 74 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month.
• Hoehn & Yahr scale I-IV
• More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc.

Exclusion criteria

• Severe psychiatric or organic brain disorders other than PD, previous or current
• Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
• Atypical Parkinsonian or Parkinson plus syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 3 patient groups

Study group

Active Comparator group

Description:

acupuncture and bee venom acupuncture point injection

Treatment:

Device: acupuncture and bee venom acupuncture point injection

Control group

Sham Comparator group

Description:

sham acupuncture and normal saline injections

Treatment:

Device: sham acupuncture and normal saline injections

Waiting group

No Intervention group

Description:

no additional intervention