Meniere's Disease
Conditions
Keywords
Dizziness, Meniere's disease, Diaoshi Jifa therapy
Brief summary
The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.
Detailed description
Created by Dr. Diao, DiaoShi Jifa is a well-known traditional Chinese Medicine approach to treat dizziness in patients with chronic diseases. The investigators designed this randomized clinical trial to examine whether Diaoshi Jifa significantly decreases dizziness in patients with Meniere's disease. There are 2 arms in this trial: One arm is DiaoShi Jifa plus conventional Western medical treatment, another is conventional Western medical treatment only. The dizziness handicap inventory (DHI) will be used to evaluate the treatment effect.
Interventions
OTHERDiaoshi Jifa therapy plus the Western medical treatment.
Diaoshi Jifa treatment
OTHERdrug
the Western medical treatment alone.
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Beijing Administration of Traditional Chinese Medicine Bureau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of probable Meniere's disease 2. Must be able to receive manual treatment 3. Dizziness Patients receiving other treatment longer than 5 days before entering the study.
Exclusion criteria
1. Patients with critical illness of internal medicine and surgery 2. Patients with spinal disease or other conditions that cannot receive manual treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dizziness Handicap Inventory (DHI) Questionnaire Score | 0 and 24 hours | dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0. |
Countries
China
Participant flow
Recruitment details
recruitment period: Jan 1, 2011-November 30, 2011 recruitment location: Department of Neurology, Xuan Wu Hospital of Capital Medical University
Pre-assignment details
A total of 27 patients were enrolled and randomly attributed to either experimental or control group.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group receiving both Diaoshi Jifa therapy and the Western medical treatment. | 16 |
| Control Group receiving the Western medical treatment alone. | 11 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control Group | Experimental Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 14 Participants | 24 Participants |
| Age Continuous | 54.00 years STANDARD_DEVIATION 8.91 | 49.75 years STANDARD_DEVIATION 12.63 | 51.48 years STANDARD_DEVIATION 11.27 |
| Region of Enrollment China | 11 participants | 16 participants | 27 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 10 |
| serious Total, serious adverse events | 0 / 16 | 0 / 10 |
Outcome results
Primary
Change in Dizziness Handicap Inventory (DHI) Questionnaire Score
dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0.
Time frame: 0 and 24 hours
Population: Among the 27 participants enrolled in the study, one participant quitted the study before treatment application. Twenty-six patients fulfilled all the procedures and were eligible for the full analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Change in Dizziness Handicap Inventory (DHI) Questionnaire Score | 10.25 units on a scale | Standard Deviation 9.77 |
| Control Group | Change in Dizziness Handicap Inventory (DHI) Questionnaire Score | 49.6 units on a scale | Standard Deviation 20.5 |