Head Yuanshi Dian Therapy in Burning Mouth Syndrome

2.1 Test Target

To observe the efficacy and safety of head yuanshi dian therapy in the treatment of BMS.

2.2 Case Collection 2.2.1 Diagnostic criteria

1. Burning-like neuropathic pain occurs in the tongue or other parts of oral mucosa, which may be relieved or disappeared when attention is transferred.
2. Most of them are accompanied by dry mouth, numbness, taste disorder, depression, insomnia and other emotional changes, neuropathological changes;
3. Symptom changes may have special regularities and rhythms, such as mild morning symptoms and worsening afternoon symptoms; pain does not increase when eating or drinking water, and usually does not affect sleep; or persistent pain; or intermittent throughout the day;

2.2.3 Exclusion criteria

1. There are local stimulating factors that can cause burning pain in the mouth (including bad prosthesis, sharp cusp or ridge, complete denture, etc.).
2. Patients with other serious oral mucosal diseases (including bullous diseases, allergic diseases, oral candidiasis, oral lichen planus, recurrent aphthous ulcer, etc.);

2.2.4 Standards and procedures for discontinuation of trial/trial therapy When the following occurs, the trial can be stopped according to the judgement of the researcher, and the reasons for the discontinuation of the trial can be recorded in the case report form (CRF) and the original record. If the cause of adverse events leads to the discontinuation of the test, the relevant treatment should be carried out according to the adverse events.

1. Misacceptance was found after enrollment;
2. Those who received neurological, psychiatric drugs or other interventions during the trial;
3. Those who did not use the test drug according to the doctor's advice or who were treated by the combination of internal and external heat source and push of the original point after admission into the group;

2.3 randomization In this study, multi-center (Zhejiang University Second Hospital, Zhejiang Hospital of Traditional Chinese Medicine, Guiyang Hospital of Stomatology, Guizhou, 3 clinical research centers), non-inferior effect, 1:1 randomized controlled clinical trial were used. Random numbers generated by SPSS21.0 will be placed in sequentially coded, sealed, opaque envelopes. When the qualifications of the subjects were determined by the researchers, the envelopes were opened sequentially and the subjects were assigned to groups. The odd number represented the experimental group and the even number represented the control group.

2.4 Measures to Reduce and Avoid Bias In order to reduce and avoid the bias of experimental conditions, the investigators should strictly group according to the random number of groups, and adopt the corresponding treatment plan. At the same time, in order to ensure the objectivity of the study group's evaluation of cases dropped and excluded, it is necessary to clarify the statistical treatment methods and evaluation criteria for cases dropped and excluded in the statistical analysis plan.

2.5 Sample size calculation Referring to the previous study of this group, the difference and standard deviation of the mean between the two groups before treatment and after one month of treatment were used to calculate the sample size required for this study. Based on the visual analogue scale (VAS), the non-inferior boundary value was allowed to be 1 and the standard deviation was 2.3, and 113 persons were needed for each group (90% of the test efficiency and 0.025 of the alpha). Taking into account the possibility of abscission, 290 cases were finally included.

2.6 Researcher and patient training The main researcher receives relevant training in head yuanshi dian therapy, and can master the principle of the therapy and related matters needing attention, as well as the use of various psychological dosimeters. In addition, the main researcher trained the patients in this therapy so that they could take care of themselves at home.

2.7 Basic information of subjects During the first and second visits, the investigators recorded the basic information of the subjects in the BMS Case Report Form: case number, random number, visiting date, name, sex, age, occupation, employment status, education level, contact mode, nationality, communication address, systemic disease, allergy history, medication history, and so on. Family history, female subjects recorded menstrual history, routine physical examination results, etc.

2.8 Trial Groups and Treatment Programs 2.8.1 Treatment plan of control group Specific medicines and usage, course of treatment are as follows: oryzanol + vitamin B2 (riboflavin) + vitamin E, oryzanol tablets, oral, 10 mg/time, 3 times/day; vitamin B2 tablets, oral, 10 mg/time, 3 times/day; vitamin E pills, oral, 100 mg/time, 1 time/day, 1 months as a course of treatment.

2.8.2 Therapeutic regimen of experimental group On the basis of classical "Gu-Nucleus-E" triple drug therapy, the experimental group was treated with head yuanshi dian therapy twice a day for 1 months as a course of treatment.

2.8.3 Specific operating procedure of head yuanshi dian therapy

2.9 Evaluation Index of Therapeutic Effect After the first visit or passing the push maneuver retraining, participants will have a visit twice a week. The aim is to observe the efficacy and safety of the treatment. At the end of one week, two weeks, three weeks and one month of treatment, the researchers recorded the efficacy indicators of the patients. The immunoglobulin, hemorheology index, blood routine, ESR, CRP, blood lipid routine and changes were examined at the first diagnosis and at the end of treatment. At the end of the treatment, the drug was stopped, and the head Yuanshi Dian therapy was suspended in the experimental group. The patients were followed up one month after the treatment and three or six months after the treatment by telephone to observe the recurrence.

2.10 Blind Assessment Each of the three centers has a researcher responsible for the treatment and interpretation of the subjects. The head of the research center trained the researcher to unify the standards. Three researchers were not involved in the evaluation of efficacy. Another researcher was responsible for recording pain and emotional nature and degree score, pain index, pain multi-dimensional characteristics score, depression index, Pittsburgh sleep quality index, Kupperman menopause score, dry mouth subjective symptoms questionnaire, saliva flow, and recording laboratory results, and collecting records. Data, analysis of efficacy, the researchers do not know the specific grouping, in order to minimize the subjective impact of the researchers on the test results.

2.11 Safety Evaluation Index 2.11.1 Laboratory Indicators Two groups of subjects were required to provide the following examination reports within 12 months: blood routine, blood sugar, liver and kidney function, urine routine, abdominal ultrasonography, chest X-ray, sex hormone levels.

2.11.2 Indicators of vital signs Including blood pressure and pulse. 2.11.3 Adverse reactions The subjects in the experimental group can inform the researchers of any discomfort and have the right to withdraw from the trial at any time when they are given the head yuanshi dian therapy. When the subjects in the control group were re-visited, the researchers asked if there were any adverse reactions during the medication process. If so, they should record in detail, including the number of adverse reactions (incidence), specific reactions, elimination and so on.