Burning Mouth Syndrome Clinical Trial
Official title:
The Effectiveness of Acupuncture Versus Clonazepam in the Patients With 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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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