Laser Acupuncture for Meniere Disease

Capital Medical University

Status and phase: Enrolling; Phase 2

Conditions: Meniere Disease

Treatments: Drug: Betahistine Mesylate tablet; Device: Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy)

Study type: Interventional

Funder types: Other

Identifiers

NCT06544434

LAMD-RCT-2024

Details and patient eligibility

About

Objective: To evaluate the effect of laser acupuncture for the patients Meniere disease.

Methods: We enrolled 324 patients at Beijing Tongren Hospital. Patients completed outcome measures at baseline, 3 months, 6 months, and 12 months. Video head impulse test (vHIT), The Caloric Test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry (PTA), and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

Enrollment: 324 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of meniere disease.

Exclusion criteria

1. Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
2. Planning for pregnancy, those in pregnancy, or those who were lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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324 participants in 3 patient groups

Laser acupuncture 3 month Group

Experimental group

Treatment:

Device: Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy)

Drug: Betahistine Mesylate tablet

Sham acupuncture Group

Sham Comparator group

Treatment:

Device: Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy)

Drug: Betahistine Mesylate tablet

Control Group

Other group

Treatment:

Drug: Betahistine Mesylate tablet