Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study on the Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine(TCM) and Western Medicine Based on TCM Syndrome Differentiation

Conditions
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Burning Mouth Syndrome

Intervention / Treatment
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* Drug: Traditional Chinese Medicine
* Drug: Western medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who signed the informed consent The clinical diagnosis was primary or secondary type BMS patient ≥ 20-year-old Female Willing to take Traditional Chinese Medicine Exclusion Criteria: History of an angiotensin-converting enzyme inhibitor (ACEI) taking Autoimmune disease Poor kidney function Unwilling to take Traditional Chinese Medicine Male Participants who have been treated with TCM or Acupuncture within a month Participants who have been treated with medicine for burning mouth syndrome

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Western medicine + TCM<br>Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent. Blood test and physiological assessment, and do the TCM model. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks. TCM therapy: one bag of Qingre Liangkou Ningxin Fang, three times a day for 12 weeks. | Drug: Traditional Chinese Medicine<br>* One bag of  Qingre Liangkou Ningxin Fang at a time, three times a day for 12 weeks.<br>* Other names: TCM;Drug: Western medicine<br>* Western medicine includes: clonazepam 0.5mg every day before sleep or twice a day for 12 weeks Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks<br>* Other names: WM;|
| Active Comparator: Western medicine<br>Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent. Blood test and physiological assessment, and do the TCM model. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks. | Drug: Western medicine<br>* Western medicine includes: clonazepam 0.5mg every day before sleep or twice a day for 12 weeks Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks<br>* Other names: WM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global perceived effect (GPE) | 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. | after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks | 
| Numerical Rating Scale (NRS) | 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. | baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burning Mouth Syndrome, Traditional Chinese Medicine, Automatic Tongue Diagnosis System, Body Constitution Questionnaire