Clinical Health Updates

Azithromycin preferred for resistant/recurrent Otitis Media

Clinical Question:
Is azithromycin (Zithromax) or amoxicillin-clavulanate (Augmentin) preferred for the treatment of children with persistent or recurrent otitis media?

Bottom Line:
For every 10 children with persistent or recurrent otitis media who get high-dose azithromycin for 3 days instead of high-dose amoxicillin-clavulanate for 10 days, there is one additional clinical cure at 1 month and 1 less episode of diarrhea. There is no difference, however, in clinical success at 2 weeks.

Reference:
Arrieta A, Arguedas A, Fernandez, et al. High-dose azithromycin versus high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent acute otitis media. Antimicrob Agents Chemother 2003; 47:3179-186.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. The authors did a double-blind, double-dummy multicenter clinical trial, they compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged < or =2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged < or =2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged < or =2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018).

Role of selective serotonin reuptake inhibitor (PAROXETINE) in tinnitus

Clinical Question:
Does selective serotonin reuptake inhibitor effective in patients with nondepressed tinnitus?

Bottom Line:
Results suggest that the majority of individuals in this study did not benefit from paroxetine in a consistent fashion.

Reference:
Randomized placebo-controlled trial of a selective serotonin reuptake inhibitor in the treatment of nondepressed tinnitus subjects.Robinson SK, Viirre ES, Bailey KA, Gerke MA, Harris JP.Psychosom Med. 2005 Nov-Dec;67(6):981-8.

Study Design:
Randomized placebo-controlled trial

Synopsis:
To assess the efficacy of a selective serotonin reuptake inhibitor (paroxetine) for relief of tinnitus. DESIGN: One hundred twenty tinnitus sufferers participated in a randomized double-blind placebo-controlled trial. Paroxetine or placebo was increased to a maximally tolerated dose (up to 50 mg/day), and patients were treated for a total of 31 days at the maximal dose. Patients with chronic tinnitus were recruited from our university-based specialty clinic by referral from otolaryngologists and audiologists in the local community and by advertisement. Patients with psychotic or substance use disorders or suicidal ideation were excluded, as were those using psychoactive medications (this resulted in only 1 subject with major depression in the study) or any other medications that interact with paroxetine and those with inability to hear at one’s tinnitus sensation level. Fifty-eight percent of patients were male, 92% were Caucasian, and the average age was 57. Tinnitus matching, the Tinnitus Handicap Questionnaire, the question: How severe (bothered, aggravating) is your tinnitus? Quality of Well-Being and other psychological questionnaires. Paroxetine was not statistically superior to placebo on the following tinnitus measures (tinnitus matching, 5- or 10-db drop, Tinnitus Handicap Questionnaire, quality of well-being measures, how severe, how bothered, positive change). There was a significant improvement in the single item question, How aggravating is your tinnitus? for those in the paroxetine group compared with the placebo group.