Caffeine vs. ALA in BMS Treatment. (BMS: Burning Mouth Syndrome. ALA: Alpha-Lipoic Acid.)

Lu Jiang

Status: Completed

Conditions: Burning Mouth Syndrome; Caffeine

Treatments: Dietary Supplement: Caffeine; Drug: Alpha Lipoic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06195137

WCHSIRB-D-2021-407

Details and patient eligibility

About

The aim of this study was to evaluate the efficacy of caffeine and alpha-lipoic acid in the treatment of burning mouth syndrome by symptom assessment with visual analogue scale.

Full description

The etiology of BMS is multifactorial, involving a complex interplay of neuropathic, psychological, neuroendocrine, and immunological factors. Neurologically, BMS has been categorized into three subtypes: peripheral small fiber neuropathy, subclinical trigeminal neuropathy, and inhibitory dopaminergic deficiency. Neuroimaging and peripheral nerve studies have further implicated altered brain activation patterns and increased expression of specific receptors like TRPV1 and P2X3 in the pathogenesis of BMS. Hormonal imbalances, particularly in estrogen levels, have also been suggested to contribute to contribute to the condition.

Caffeine, a xanthine alkaloid chemically known as 1,3,7-trimethylxanthine, is recognized for its diverse biological functions. As a central nervous system stimulant, its primary mechanism involves antagonizing adenosine receptors, thereby enhancing the release of neurotransmitters such as dopamine and norepinephrine, which are known to play roles in analgesic pathways. Caffeine is also noted for its neuroprotective properties and is theorized to reduce the risk of neurodegenerative diseases. It affects the central processing of pain and is involved in regulating circadian rhythms and sleep-wake cycles. Additionally, caffeine has mild anti-inflammatory properties. Its stimulatory effects may also improve mood and cognitive function.

Enrollment: 130 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over 18 years of age
• Diagnosis of BMS according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3)
• Daily intraoral burning or dysaesthesia lasting for more than 2 hours for over 3 months
• Normal oral mucosa and sensory testing
• Condition not better accounted for by another ICHD-3 diagnosis

Exclusion criteria

1. Secondary BMS due to local or systemic disorders
2. Prior treatment for BMS
3. Psychiatric or progressive neurological disorders
4. Systemic disorders potentially associated with oral disease
5. Long-term history of smoking, drinking, or medication use
6. Consumption of caffeinated products
7. Poor oral hygiene
8. Abnormal blood test results (including blood count, glucose, serum iron, ferritin and transferrin, folic acid, or vitamin B12 levels)
9. Incomplete medical records
10. Unwillingness to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

Caffeine group

Experimental group

Description:

Burning mouth syndrome (BMS) patients in Caffeine group were provided with BMS disease explanation and psychological counseling. Then they were told to drink instant coffee containing 120-150 mg of the active ingredient caffeine (2 bags of Nescafe Black Coffee, 1.8g each) at a certain point in time from 8:00 to 12:00 every day, for 2 consecutive weeks.

Treatment:

Dietary Supplement: Caffeine

Alpha Lipoic Acid (ALA) group

Active Comparator group

Description:

Burning mouth syndrome (BMS) patients in the ALA group were provided with BMS disease explanation and psychological counseling. Then they took α-lipoic acid (ALA) 3 times a day, after meals, 200 mg each time, for 2 consecutive weeks.

Treatment:

Drug: Alpha Lipoic Acid

Control gruop

No Intervention group

Description:

Without intervention treatment, we provided BMS patients in Control group with disease explanation and psychological counseling for patients.