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

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

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

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.

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.

Burning Mouth Syndrome, Traditional Chinese Medicine, Automatic Tongue Diagnosis System, Body Constitution Questionnaire

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.

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.

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

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.

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.

participant eligibility is based on the different prescriptions of Traditional Chinese Medicine for female and male subjects, not on self-representation of gender identity.

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

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