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

Efficacy of Caffeine vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment

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.

Study Overview

• Status: Completed
• Conditions: Caffeine; Burning Mouth Syndrome
• Intervention / Treatment: Dietary supplement: Caffeine; Drug: Alpha Lipoic Acid

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chengdu, China, 610041
    • West China Hospital of Stomatology, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caffeine group; 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.	Dietary supplement: Caffeine; caffeine supplementation
Active Comparator: Alpha Lipoic Acid (ALA) group; 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.	Drug: Alpha Lipoic Acid; 600-800 mg ALA; Other Names: ALA
No Intervention: Control gruop; Without intervention treatment, we provided BMS patients in Control group with disease explanation and psychological counseling for patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	During the interview or telephone follow-up with the patient, ask the patient to fill in the VAS rating scale.	Baseline and 2 weeks after intervention or observation

Collaborators and Investigators

• Sponsor: Lu Jiang
• Investigators: Study Director: Lu Jiang, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Thioctic Acid; Caffeine
• Other Study ID Numbers: WCHSIRB-D-2021-407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No