Acupuncture Versus Clonazepam in Burning Mouth Syndrome

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
Burning Mouth Syndrome

Intervention / Treatment
-----------------
* Drug: Clonazepam
* Other: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clonazepam<br>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<br>* Active medical treatment for burning mouth syndrome<br>* Other names: Rivotril;|
| Experimental: acupuncture<br>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<br>* Traditional chinese acupuncture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity measured by the visual analogue scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale | Assessment of neuropathic pain measured by validated instrument (LANSS pain scale) | 6 months | 
| Cognitive function | Assesment of cognitive function measured by validated instrument ( MoCA cognitive test) | 6 months | 
| Depression | Assesment of depressive symptoms by use of validated instrument (Beck Depression Inventory) | 6 months | 
| Quality of life | Assesment of quality of life by validated instrument (Short Forma Health Survey: SF-36) | 6 months |