Antidepressants for patients with tinnitus

Paolo Baldo; Carolyn Doree; Renzo Lazzarini; Paola Molin; Don McFerran

doi:10.1002/14651858.CD003853.pub2

Antidepresivos para los pacientes con tinnitus

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Referencias

Referencias de los estudios incluidos en esta revisión

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estudios excluidos
otras referencias

Bayar N, Boke B, Turan E, Belgin E. Efficacy of amitriptyline in the treatment of subjective tinnitus. Journal of Otolaryngology 2001;30(5):300‐3.

Dib GC, Akemi Kasse C, Alives de Andrade T, Gugel Testa JR, Cruz OLM. Tinnitus treatment with trazodone. Brazilian Journal of Otolaryngology 2007;73(3):390‐7.

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Sullivan M, Katon W, Russo J, Dobie R, Sakai C. A randomized trial of nortriptyline for severe chronic tinnitus. Archives of Internal Medicine 1993;153:2251‐9.

Referencias de los estudios excluidos de esta revisión

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estudios incluidos
otras referencias

Dobie RA, Sullivan MD, Katon WJ, Sakai CS, Russo J. Antidepressant treatment for tinnitus patients. Acta Otolaryngologica 1992;112:242‐7.

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Lopez‐Gonzalez MA, Moliner‐Peiro F, Alfaro‐Garcia J, Esteban‐Ortega F. Sulpiride plus hydroxyzine decrease tinnitus perception. Auris Nasus Larynx 2007;34:23‐7.

Lopez‐Gonzalez MA, Santiago AM, Esteban‐Ortega F. Sulpiride and melatonin decrease tinnitus perception modulating the audiolimbic dopaminergic pathway. Journal of Otolaryngology 2007;36(4):213‐19.

Sullivan MD, Dobie RA, Sakai CS, Katon WJ. Treatment of depressed tinnitus patients with nortriptyline. Annals of Otology, Rhinology and Laryngology 1989;98(11):867‐72.

Sullivan M, Katon W, Russo J, Dobie R, Sakai C. Coping and marital support as correlates of tinnitus disability. General Hospital Psychiatry 1994;16:259‐66.

Zoger S, Svedlund J, Holgers KM. The effects of sertraline on severe tinnitus suffering ‐ a randomized, double‐blind, placebo‐controlled study. Journal of Clinical Psychopharmacology 2006;26(1):32‐9.

Referencias adicionales

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Bayar 2001

Methods	Randomised, parallel, single‐blind trial
Participants	37 adults with subjective tinnitus (20 in treatment group, 17 in placebo group)
Interventions	Administration of amitriptyline at scalar doses (50 mg to 100 mg, at night); placebo, 1 tablet at night Duration: 6 weeks
Outcomes	Severity and intensity of tinnitus (by audiologic and audiometric measures); tinnitus severity (by ATA questionnaire) ‐ at 6 weeks
Notes	The randomisation method was not described Overall methodological quality: C

Dib 2007

Methods	Randomised, parallel, double‐blind trial
Participants	85 patients presenting with tinnitus, aged between 45 and 80 years
Interventions	Administration of either trazodone (50 mg daily) or placebo in tablets similar in shape, colour and size
Outcomes	Tinnitus intensity level, tinnitus level of discomfort, tinnitus impact on quality of life; all by using analogue scales scoring between 0 to 10
Notes	Method of randomisation not described, although the authors declare that blinding of the medications was guaranteed by the hospital pharmacist until the end of the study

Mihail 1988

Methods	Randomised, double‐blind, cross‐over trial with patients as their own control
Participants	26 subjects presenting with subjective tinnitus
Interventions	Administration of either trimipramine (150 mg daily) or placebo Duration: 6‐week treatment, followed by 4‐week rest period, followed by a further 6‐week test period
Outcomes	Tinnitus severity (Meikle questionnaire) Tinnitus frequency and intensity (by audiometry) Tinnitus masking levels At 16 weeks
Notes	Overall methodological quality: C

Podoshin 1995

Methods	4‐arm, randomised controlled trial No detail on randomisation method is given
Participants	225 adults (in total) with idiopathic subjective tinnitus (83 in the amitriptyline group, 40 in control (placebo) group)
Interventions	Administration of amitriptyline (10 mg 3 times daily) or placebo (1 tablet 3 times daily) for 10 weeks
Outcomes	Improvement in degree of tinnitus at rest and during activity (by questionnaire and audiometry) at 10 weeks
Notes	Only 2 of the 4 treatment arms (amitriptyline and placebo) were relevant to this review. The 2 other treatment arms were biofeedback (62 subjects) versus control (40 subjects) Results were mainly presented graphically Overall methodological quality: C

Robinson 2005

Methods	Randomised, double‐blind controlled trial
Participants	120 adult patients with chronic tinnitus of more than 6 months duration
Interventions	Administration of paroxetine, 10 mg daily, increased to maximum of 50 mg daily Duration 100 days
Outcomes	Severity of tinnitus (audiometric measures) Evaluation of tinnitus disability (Tinnitus Handicap Questionnaire) Evaluation of general well‐being or disability (various questionnaires) Level of depression (various scales)
Notes	26 patients dropped out of the study but only 5 of these were excluded from the analysis Overall methodological quality: A

Sullivan 1993

Methods	Randomised, double‐blind controlled trial No other information on method of randomisation or allocation concealment is given
Participants	117 patients with chronic severe tinnitus of more than 6 months duration
Interventions	Administration of nortriptyline (scalar doses) versus placebo (same number of capsules, average 4) Duration: 6 weeks
Outcomes	Severity of tinnitus (audiometric measures) Level of depression (Hamilton Depression Scale) Evaluation of tinnitus disability (various scales) at 6 weeks
Notes	Results are presented only for the 92 patients who completed the trial The same data are also reported in Dobie 1992 and Dobie 1993 (see table of 'Characteristics of excluded studies') Overall methodological quality: B

ATA = American Tinnitus Association

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Dobie 1992	ALLOCATION: Randomised PARTICIPANTS: Same setting and number of patients (N = 92), in a series of papers where the most definitive trial is the one included in this review (Sullivan 1993). This originates an explicit replication bias.
Dobie 1993	ALLOCATION: Randomised PARTICIPANTS: Same setting and number of patients (N = 92), in a series of papers where the most definitive trial is the one included in this review (Sullivan 1993). This originates an explicit replication bias.
Katon 1993	ALLOCATION: Randomised PARTICIPANTS: Same setting and number of patients (N = 92), in a series of papers where the most definitive trial is the one included in this review (Sullivan 1993). This originates an explicit replication bias.
Lopez‐Gonzalez 2007a	The interventions included a combination of drugs: although sulpiride is sometimes used for its antidepressive efficacy, hydroxyzine is not actually classified as an antidepressive agent
Lopez‐Gonzalez 2007b	The interventions included a combination of drugs: although sulpiride is sometimes used for its antidepressive efficacy, melatonin is not actually classified as an antidepressive agent
Sullivan 1989	ALLOCATION: Not randomised
Sullivan 1994	ALLOCATION: Randomisation not explicit. There is no mention of randomisation or allocation method, although the context and the recruited patients were the same as Sullivan 1993. PARTICIPANTS: Same setting and number of patients (N = 92), in a series of papers where the most definitive trial is the one included in this review (Sullivan 1993). This originates an explicit replication bias.
Zoger 2006	ALLOCATION: Randomised PARTICIPANTS: 76 patients with tinnitus were investigated with measures of tinnitus severity, depression and anxiety INTERVENTIONS: Although this trial aimed to study sertraline, a benzodiazepine drug (oxazepam) was also administered to 9 out of the total 76 patients OUTCOMES: High drop‐out rate and if oxazepam treated patients were excluded from the analysis, the percentage of patients lost from analysis becomes unacceptably high (31% in treatment group, 26% in placebo group)

Data and analyses

Open in table viewer

Comparison 1. Trazodone vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tinnitus intensity Show forest plot	1	85	Mean Difference (IV, Fixed, 95% CI)	0.24 [‐0.70, 1.18]
Open in figure viewer Analysis 1.1 Comparison 1 Trazodone vs placebo, Outcome 1 Tinnitus intensity.
2 Tinnitus discomfort Show forest plot	1	85	Mean Difference (IV, Fixed, 95% CI)	0.81 [‐0.14, 1.76]
Open in figure viewer Analysis 1.2 Comparison 1 Trazodone vs placebo, Outcome 2 Tinnitus discomfort.

Figure 1

The Prevalence of Tinnitus (Panel A) and Hearing Impairment (Panel B). From: Lockwood AH, Salvi RJ, Burkard RF. Tinnitus. New England Journal of Medicine 2002; 347(12):904‐10. Values are based on responses to the question "Do you have tinnitus (or) ringing in the ears or deafness (or) other trouble hearing?" Included in the National Center for Health Statistics Survey of noninstitutionalized Americans, 1999.

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Analysis 1.1

Comparison 1 Trazodone vs placebo, Outcome 1 Tinnitus intensity.

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Analysis 1.2

Comparison 1 Trazodone vs placebo, Outcome 2 Tinnitus discomfort.

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Comparison 1. Trazodone vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tinnitus intensity Show forest plot	1	85	Mean Difference (IV, Fixed, 95% CI)	0.24 [‐0.70, 1.18]

2 Tinnitus discomfort Show forest plot	1	85	Mean Difference (IV, Fixed, 95% CI)	0.81 [‐0.14, 1.76]

Comparison 1. Trazodone vs placebo

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Referencias

Referencias de los estudios incluidos en esta revisión

Bayar 2001 {published data only}

Dib 2007 {published data only}

Mihail 1988 {published data only}

Podoshin 1995 {published data only}

Robinson 2005 {published data only}

Sullivan 1993 {published data only}

Referencias de los estudios excluidos de esta revisión

Dobie 1992 {published data only}

Dobie 1993 {published data only}

Katon 1993 {published data only}

Lopez‐Gonzalez 2007a {published data only}

Lopez‐Gonzalez 2007b {published data only}

Sullivan 1989 {published data only}

Sullivan 1994 {published data only}

Zoger 2006 {published data only}

Referencias adicionales

Anderson 2000

Andersson 1999

ATA 2004

Baguley 1992

Baguley 2006

Barbui 2000

Beck 1961

Bennett 2007

Briner 1995

Brummett 1980

Dauman 1992

Davis 2000

Dawes 2000

Del Bo 2008

DSM‐IV 1994

Eggermont 2006

Eichhammer 2007

Fowler 1942

Gersdorff 2000

Hamilton 1960

Handbook 2008

Heller 1953

Hilton 2004

Jastreboff 1990

Jastreboff 1993

Jastreboff 1994

Jastreboff 2004

Jozefowicz 2004

Kaltenbach 2000

Kasper 1992

Kerns 1985

Kleinjung 2007

Kuk 1990

Lanting 2008

Levo 2000

Lockwood 1999

Lockwood 2002

Luxon 1993

Martinez 2007

Marx 1999

McCombe 2001

McFerran 2008

McKenna 1991

McQuay 1997

Meikle 1984

Meikle 1995

Miller 1956

Millon 1982

Moffat 1995

Moller 1997

Parker 2001

Parnes 1997

Seidman 1998

Shea 1981

Sindhusake 2003

Stephens 1991

Sullivan 1992

Tomkins 2001

Weissman 2000

Zung 1973