Burning Mouth Syndrome
Conditions
Keywords
Burning Mouth Syndrome, Traditional Chinese Medicine, Automatic Tongue Diagnosis System, Body Constitution Questionnaire
Brief summary
This study is an open-label randomized controlled trial of the efficacy of the integration of Traditional Chinese medicine (TCM) and western medicine based on TCM syndrome differentiation. The hypothesis is (1) TCM model can identify the primary and secondary type burning mouth syndrome (BMS); (2) TCM model can identify BMS after treatment with western medicine; (3) There is a positive effect of TCM in treating BMS.
Detailed description
BMS patients will be classified into the primary type and secondary type according to the patients' clinical histories and laboratory examinations. The secondary BMS only includes nutritional deficiency, such as Vitamin B12, folate, iron, zinc. At first, the primary BMS patients are treated with 0.5\ 1 mg clonazepam every day before sleep for 8 weeks. The secondary BMS patients are treated with vitamin B12, folate, iron and zinc according to the patient's nutritional deficiency status. Patients with no improvement or little improvement after the first stage of Western medicine management will be arranged to receive traditional Chinese medicine (TCM) therapy. All patients will receive the TCM model, including TCM doctor, automatic tongue diagnostic system (ATDS), and body constitutional questionnaire (BCQ), evaluations. The results of this study are expected to understand whether adjuvant TCM treatment of BMS can improve treatment efficacy. The investigators will understand whether the constitution pattern may be a predictive indicator of efficacy for western BMS. The investigators will find a diagnostic indicator for the TCM model and apply it to the assessment of the prognosis of BMS patients.
Interventions
DRUGTraditional Chinese Medicine
One bag of Qingre Liangkou Ningxin Fang at a time, three times a day for 12 weeks.
DRUGWestern medicine
Western medicine includes: 1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks 2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks
Sponsors
Ministry of Science and Technology, Taiwan
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who signed the informed consent 2. The clinical diagnosis was primary or secondary type BMS patient 3. ≥ 20-year-old 4. Female 5. Willing to take Traditional Chinese Medicine
Exclusion criteria
1. History of an angiotensin-converting enzyme inhibitor (ACEI) taking 2. Autoimmune disease 3. Poor kidney function 4. Unwilling to take Traditional Chinese Medicine 5. Male 6. Participants who have been treated with TCM or Acupuncture within a month 7. Participants who have been treated with medicine for burning mouth syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global perceived effect (GPE) | after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks | GPE is defined as symptoms improvement change compared to baseline, 1=worse; 2=no difference; 3=mild improvement; 4=much improvement; 5=totally improvement. The responder is defined to be the subject occurring at least one of the defined effective events: (1) GPE ≥2 after treatment for burning sensation; (2) GPE ≥2 after treatment for sleep; (3) GPE ≥2 after treatment for dry mouth; (4) GPE ≥2 after treatment for taste change. (5) GPE ≥2 after treatment for her other uncomfortable. |
| Numerical Rating Scale (NRS) | baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks | NRS is defined as 0=no pain, scale from 1 to 10 (mild to very severe). The responder is defined to be the subject occurring at least one of the defined effective events: (1) NRS ≤ 1 after treatment; (2) NRS change from baseline ≥ 50% after treatment. |
Countries
Taiwan
Contacts
Primary ContactMeng-Ling Chiang, DDS,MS
Backup ContactShun-Li Kuo, MD, MS
Outcome results
None listed