Burning mouth syndrome
Conditions
Interventions
Test Group:(1) Pregabalin capsules: Weeks 1–2: 75 mg per dose, twice daily
Weeks 3–4: based on participant tolerability, gradually titrate the dose up to 150 mg per dose, twice daily. Take after meals, with an interval of 12 hours between each administration.
(2) Methylcobal
Control Group 1:Pregabalin capsules: Weeks 1–2: 75 mg per dose, twice daily
Weeks 3–4: based on participant tolerability, gradually titrate the dose up to 150 mg per dose, twice daily. Take after meals, with an interval of 12 hours between each administration.
Control Group 2:Methylcobalamin tablets: Weeks 1–4: 0.5 mg per dose, three times daily. Take after meals, with an interval of 8 hours between each administration.
Sponsors
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. International Classification of Headaches, Third Edition (ICHD-3) BMS diagnostic criteria: (1) Oral pain lasting more than 2 hours per day for more than 3 months; (2) Characterised by burning pain confined to the superficial oral mucosa; (3) May be accompanied by tongue numbness, dry mouth, dysgeusia, or other uncomfortable symptoms; (4) The burning sensation persists or increases in intensity during the day and does not interfere with eating, drinking, or sleeping; (5) The appearance of the oral mucosa is normal, and the clinical examination of the oral mucosa, including sensory examination, is normal; (6) No local or systemic causes of burning pain in the oral mucosa, such as oral mucositis, oral candidiasis, glossitis, Sjogren’s syndrome, diabetes, anemia, and cardiovascular disease, have been found. 2. BMS Subjects Inclusion Criteria: (1) Meets BMS diagnostic criteria; (2) Age >= 18 and = 3 months; (4) Visual Analogue Score (VAS) > 3 points; (5) Understands, agrees to participate in this study and signs the informed consent form, and cooperates with the treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. There are detectable organic lesions accompanied by pain in the oral mucosa, tooth, or periodontal tissue, such as ulcers, deep caries, periodontitis, etc; 2. History of orofacial neuralgia, such as trigeminal neuralgia, glossopharyngeal neuralgia, diabetic neuropathy, post-chemotherapy neuropathy; 3. History of head and neck radiotherapy, accompanied by salivary gland disease or other oral mucosal diseases; 4. Diabetes, autoimmune diseases or serious heart, liver, kidney, and blood system and other important organ diseases; 5. History of primary psychiatric illness (including major depressive disorder, major personality disorder) or substance abuse (other than caffeine or nicotine); 6. Combined with other chronic pain-related diseases (such as fibromyalgia, chronic headache, postherpetic neuralgia); 7. Combined with other vitamin B12 deficiency-related diseases (such as pernicious anemia); 8. Received treatment with central nervous system drugs (such as anti-anxiety and depressant drugs, GABAergic system-related drugs) within the past 1 month; 9. Received treatment that may affect the central nervous system (such as transcranial magnetic stimulation, electrical stimulation, etc.) in the past 6 months; 10. MRI contraindications: such as metal pacemakers, implantable defibrillators, metal implants in the brain, claustrophobia; 11. History of allergy to GABAergic system-related drugs (such as pregabalin, gabapentin, clonazepam); 12. History of hypersensitivity/allergy to vitamin B12 preparations (such as methylcobalamin); 13. Severe cognitive impairment or inability to cooperate with the assessment; 14. Women who are pregnant or pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of oral mucosal pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| The sensory and affective aspects of pain;The state of central sensitization;Symptoms of generalized anxiety;Depressive symptoms;The oral health-related quality of life;sleep quality;gray matter volume (GMV), cortical thickness (CT), etc.;Glu/Cr, Glx/Cr, NAA/Cr, etc.;Resting-State Brain Function;Fractional anisotropy (FA), mean diffusivity (MD), etc.;Unstimulated salivary flow rate;Salivary molecules; | — |
Countries
China
Contacts
Public ContactGuoyao Tang
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed