DOI: http://dx.doi.org/10.18203/issn.2454-5929.ijohns20180720

A randomized control trail on the effectiveness of (Tricyclic antidepressant) Amitriptyline 10 mg bedtime in patients suffering from Meniere’s disease

Santhosh Kumar Rajamani, Pritikanta Sahu

Abstract


Background: Meniere’s disease is one of the most common causes of chronic recurrent vertigo in general population. Meniere’s disease is closely associated with migraine and migrainous vertigo/ vestibular migraine. Amitriptyline has been classically used in management of Vestibular migraine. This randomized control trail examines the effectiveness of (Tricyclic antidepressant) Amitriptyline 10mg bedtime in patients suffering from Meniere’s disease using a Randomized control trial. This was a randomized, double-blinded, placebo-controlled trial, cross over type with a power of 80% at 5% significance level.

Methods: One hundred five patients with definite Meniere’s disease were randomized and assigned to either placebo or trial arm. Trial arm were given Amitriptyline 10 mg bedtime and placebo arm were given a generic Vitamin B-complex tablet. Visual analogue score and standard questionnaires were used to assess the improvements in vertigo, imbalance, dizziness and disease-specific quality of life before and after use of Amitriptyline vs. placebo for period of 10 days each.  

Results: Amitriptyline 10mg at bedtime (10mg H.S), produces significant improvement in the vertigo in patients suffering from Meniere’s disease compared to placebo. Chronic imbalance and hearing levels are not affected by the use of the above drug regime. Daytime sedation and weight gain are the most troublesome adverse effects of Amitriptyline at 10mg per day dose. No other serious adverse effects were observed in this research.

Conclusions: Low dose bedtime Amitriptyline 10mg appears to be safe and produces improvement in vertigo and disease-specific quality of life in Meniere’s disease patients. 


Keywords


Amitriptyline, Vertigo, Meniere’s disease, Tricyclic antidepressant, Randomized control trial

Full Text:

PDF

References


Oosterveld. Meniere’s disease, signs and symptoms. J Laryngol Otolol. 1980;94(8).885–92.

Neuhauser H, Leopold M, von Brevern M, Arnold G, Lempert T. The interrelations of migraine, vertigo and migrainous vertigo. Neurology. 2001;56:436–41.

Monsell EM, Balkany TA, Gates GA. Committee on Hearing and Equilibrium guidelines for the diagnosis and evaluation of therapy in Meniere’s disease. American Academy of Otolaryngology-Head and Neck Foundation, Inc. Otolaryngology Head Neck Surg. 1995;113(3):181–5.

Goebel JA. The practical management of the dizzy patient, 2nd Ed, Philadelphia, Lippincott Williams & Wilkins; 2008: 34-67.

Lempert T, Neuhauser H. Migrainous vertigo. Neurology Clinics. 2005;23(3):715–30.

Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. 1977;35(1):1-39.

Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988;318:1728–33.

Dawson B, Trapp RG. Basic and Clinical Biostatistics, 4th Ed. New York, McGraw-Hill; 2004: 129-135.

Stephen M, Stahl. Chapter 3 Amitriptyline. Essential Psychopharmacology -The Prescribers Guide Revised and Updated Edition. 1st Ed. New York, NY. Cambridge University Press; 2005: 13-18.

Cookson J, Katona C, Taylor D. Tricyclic antidepressants. Gaskell- Use of drugs in Psychiatry The evidence from Psychopharmacology.5th U.K Ed.Trowbridge, UK.Cromwell Press; 2002: 237-251.

Sakulsripong M, Curran HV, Lader M. Does tolerance develop to the sedative and amnesic effects of antidepressants? A comparison of amitriptyline, trazodone and placebo. Eur Jrnl Clin Pharm; 1991;40:43–8.

Ward N, Bloom V, Friedel RO. Effectiveness of tricyclics in the treatment of chronic pain and depression. Pain. 1979;7:331-41.

Moldofsky H, Scarisbrick P, England R, Smythe H M. Musculoskeletal symptoms and non-REM sleep disturbance in patients with fibrositis syndrome and healthy subjects. Psychosomatic Medicine; 1975;37:341-51.

Pyykko I, Magnusson M, Schalen L. Pharmacological treatment of vertigo. Acta Otolaryngology Supplement. 1988;455:77–81.

Devaiah AK, Ator GA. Clinical indicators useful in predicting response to the medical management of Meniere’s disease. Laryngoscope; 2000;110(11):1861–5.

Feinstein AR. Clinical epidemiology the architecture of clinical research, Philadelphia, WB Saunders. 1985;10(1):111–45.