Acupuncture Versus Clonazepam in Burning Mouth Syndrome

NCT02382029 | Completed Early Phase 1 DMC

• 1 other identifier: UZagreb
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: Burning mouth syndrome (BMS) is chronic oral condition characterized with burning symptoms which affects perimenopausal and postmenopausal women. It seems that neuropathy might be the underlying cause of the condition. There are still insufficient data regarding successful therapy. The aim of this study was to compare efficacy of acupuncture and clonazepam in 42 BMS patients (38 women, 4 men), age range 66.7±12 years. Methods: Patients were randomly divided into two groups. Acupuncture was performed in group I during four weeks, 3 times per week on the points ST 8, GB 2, TB 21, SI 19, SI 18, LI 4 on both sides of the body as well as GV 20, each session lasted half an hour.Group II patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks two tablets (0.5 mg) in the morning and in the evening during the next two weeks. Prior to and one month after either therapy, participants fulfilled questionnaires: visual analogue scale, Beck depression inventory, LANSS pain scale, 36-item short form Health Survey (SF-36) and Montreal Cognitive Assessment (MoCA). Statistical analysis was performed by use of Student t test and Pearson's correlation test. P values lower than 0.05 were considered significant.

Conditions

Burning Mouth Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity measured by the visual analogue scale

  6 months

Secondary Outcomes (4)

• The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale

  6 months

• Cognitive function

  6 months

• Depression

  6 months

• Quality of life

  6 months

Study Arms (2)

clonazepam

ACTIVE COMPARATOR

Twenty two patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks one tablet (0.5 mg) in the morning and another tablet (0.5 mg) in the evening during the next two weeks.

Drug: Clonazepam

acupuncture

EXPERIMENTAL

Traditional Chinese acupuncture was performed on 20 participants 3 times during one week for four weeks. Intervention was performed on acupuncture points as follows: the points ST 8 (stomach- tou wei), GB 2, TE 21, SI 19 (small intestine- ting gong), SI 18 (small intestine- quan liao), LI 4 (large intestine-Yuan) on both sides of the body as well as GV 20 (Governing vessel-bai hui). Each session lasted half an hour. Sterile acupuncture needles made from surgical stainless steel silicone coated with spring handle were used. The dimensions of the chosen needles were 0.25 in diameter and 30 mm length, inserted at the depth of the 0.5-1 cm. The elicited response was of the type "de qi" accompanied by redness and a feeling of numbness around the needles.

Other: acupuncture

Interventions

Clonazepam DRUG

Active medical treatment for burning mouth syndrome

Also known as: Rivotril

clonazepam

acupuncture OTHER

Traditional chinese acupuncture

acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of burning mouth syndrome Clinically normal appearance of oral mucosa Must be able to swallow tablets

You may not qualify if:

• Oral mucosal lesions Anemia

Sponsors & Collaborators

• University of Zagreb: lead

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Clonazepam; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 6, 2015
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 6, 2015

Record last verified: 2015-03