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Completed

NCT Number: NCT02382029

Acupuncture Versus Clonazepam in Burning Mouth Syndrome

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.

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Key information

Conditions

Burning Mouth Syndrome Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonazepam

Drug

Active medical treatment for burning mouth syndrome

Other names: Rivotril

Acupuncture

Other

Traditional chinese acupuncture

Primary outcomes

  1. Pain intensity

    Time frame: 6 months

    Pain intensity measured by the visual analogue scale

Secondary outcomes

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

    Time frame: 6 months

    Assessment of neuropathic pain measured by validated instrument (LANSS pain scale)

  2. Cognitive function

    Time frame: 6 months

    Assesment of cognitive function measured by validated instrument ( MoCA cognitive test)

  3. Depression

    Time frame: 6 months

    Assesment of depressive symptoms by use of validated instrument (Beck Depression Inventory)

  4. Quality of life

    Time frame: 6 months

    Assesment of quality of life by validated instrument (Short Forma Health Survey: SF-36)

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Official study title

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

Acronym: ACUCLONBMS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2015
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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