Biomaterial Database

A double-blind placebo-controlled trial of baclofen in the treatment of tinnitus. 1996

B D Westerberg, and J B Roberson, and B A Stach

California Ear Institute, Stanford University Medical Center, Palo Alto 94304, USA.

OBJECTIVE To determine the effectiveness of baclofen in ameliorating tinnitus in adult patients. METHODS Randomized double-blind placebo-controlled trial. METHODS California Ear Institute at Stanford, California, a tertiary otology/neurotology referral center. METHODS Restricted to adults receiving otologic evaluation at the California Ear Institute at Stanford. Some patients had a primary complaint of tinnitus, whereas others with tinnitus were recruited during treatment for another condition. The study population was felt to be representative of the general population with tinnitus. METHODS Three weeks of baclofen (10 mg orally twice daily for 1 week, 20 mg orally twice daily for the second week, and 30 mg orally twice daily for the third week) or placebo designed to mimic baclofen capsules in route, schedule, appearance, and taste were given to patients. METHODS Tinnitus handicap inventory, pitch and loudness matching, and maskability of tinnitus. RESULTS Subjective and objective evaluation failed to demonstrate any clinical or statistical advantage of baclofen over placebo. Reports of subjective improvement occurred in only 9.7% of the baclofen versus 3.4% of the placebo groups, a nonsignificant difference. Withdrawal from the baclofen arm of the study occurred in 26% due to side effects, which could be attributed to the medication. CONCLUSIONS Baclofen is no more effective than placebo in ameliorating tinnitus in adult patients.

UI	MeSH Term	Description	Entries
D008144	Loudness Perception	The perceived attribute of a sound which corresponds to the physical attribute of intensity.	Loudness Perceptions,Perception, Loudness,Perceptions, Loudness
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009125	Muscle Relaxants, Central	A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358)	Centrally Acting Muscle Relaxants,Central Muscle Relaxants,Relaxants, Central Muscle
D010898	Pitch Perception	A dimension of auditory sensation varying with cycles per second of the sound stimulus.	Perception, Pitch,Perceptions, Pitch,Pitch Perceptions
D010919	Placebos	Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.	Sham Treatment
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006319	Hearing Loss, Sensorineural	Hearing loss resulting from damage to the COCHLEA and the sensorineural elements which lie internally beyond the oval and round windows. These elements include the AUDITORY NERVE and its connections in the BRAINSTEM.	Deafness Neurosensory,Deafness, Neurosensory,Deafness, Sensoryneural,Neurosensory Deafness,Sensorineural Hearing Loss,Sensoryneural Deafness,Cochlear Hearing Loss,Hearing Loss, Cochlear,Deafnesses, Neurosensory,Deafnesses, Sensoryneural,Neurosensory Deafnesses,Sensoryneural Deafness,Sensoryneural Deafnesses
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man