Acupuncture Versus Clonazepam in Burning Mouth Syndrome

Burning Mouth Syndrome Clinical Trial

— ACUCLONBMS  

Official title:

The Effectiveness of Acupuncture Versus Clonazepam in the Patients With Burning Mouth Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382029
• Other study ID #: UZagreb
• Status: Completed
• Phase: Phase 0
• First received: February 13, 2015
• Last updated: March 2, 2015
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This study was approved by Ethical Committee of the School of dentistry in Zagreb. Prior to the study every participant signed informed consent according to the Helsinki II. All patient were recruited from the Department of Oral medicine, School of dentistry in Zagreb.

Patients were randomized by simple randomization method- flipping a coin (heads - acupuncture, tails - clonazepam).

Inclusion criteria were symptoms of burning in the oral cavity with clinically healthy appearance of the oral mucosa. Burning symptoms were continuous throughout the day and lasted for more than 6 months. Some of the patients also had hyposalivation and disturbed taste.

Prior to the either therapy as well as after the therapy (one month after the therapy has finished) every participant fulfilled following questionnaires: visual analogue scale (VAS) which referred to the severity of burning symptoms, Beck depression inventory (BDI), The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale, 36-item short form Health Survey (SF-36) total sum score and Montreal Cognitive Assessment (MoCA).

Arm (I) traditional Chinese acupuncture - performed 3 times during one week for four weeks on 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) and each session lasted half an hour. We used sterile acupuncture needles from surgical stainless steel silicone coated with spring handle, the dimensiones of the chosen needles were 0.25 in diameter and 30 mm lenght, inserted at the depht of the 0.5-1 cun. The elicited response was of the type "de qi" accompanied by redness and a feeling of numbness around the needles.

Arm (II) Clonazepam - 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.

Statistical analysis was performed by use of Student t test and Pearson's correlation test. P values lower than 0.05 were considered significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Oral mucosal lesions Anemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Drug:
• Clonazepam
Active medical treatment for burning mouth syndrome

Other:
• acupuncture
Traditional chinese acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity measured by the visual analogue scale	6 months	No
Secondary	The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale	Assessment of neuropathic pain measured by validated instrument (LANSS pain scale)	6 months	No
Secondary	Cognitive function	Assesment of cognitive function measured by validated instrument ( MoCA cognitive test)	6 months	No
Secondary	Depression	Assesment of depressive symptoms by use of validated instrument (Beck Depression Inventory)	6 months	No
Secondary	Quality of life	Assesment of quality of life by validated instrument (Short Forma Health Survey: SF-36)	6 months	No