Burning Mouth Syndrome Clinical Trial
Official title:
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.
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