Topical treatment of acute otitis externa: clinical comparison of an antibiotics ointment alone or in combination with hydrocortisone acetate. Ofloxacin otic solution for treatment of otitis externa in children and adults. Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa. Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients with otitis externa. Treatment of otitis externa with a tropical steroid-antibiotic combination. Acute otitis externa: efficacy and tolerability of N-chlorotaurine, a novel endogenous antiseptic agent. Dexamethasone phosphate in antibiotic ear drops for the treatment of acute bacterial otitis externa. Ototopical ciprofloxacin in a glycerin vehicle for the treatment of acute external otitis. A single topical agent is clinically equivalent to the combination of topical and oral antibiotic treatment for otitis externa. Prospective randomised single-blind controlled trial of glacial acetic acid versus glacial acetic acid, neomycin sulphate and dexamethasone spray in otitis externa and infected mastoid cavities. Versus placebo in treatment of acute otitis externa. A study of three preparations in the treatment of otitis externa. A randomised controlled trial comparing Triadcortyl with 10% glycerine-ichthammol in the initial treatment of severe acute otitis externa. [Prospective double-blind randomized study of the efficacy and tolerance of topical ciprofloxacin vs topical gentamicin in the treatment of simple chronic otitis media and diffuse external otitis]. Are topical antibiotics necessary in the management of otitis externa? A comparison of ciprofloxacin/dexamethasone with neomycin/polymyxin/hydrocortisone for otitis externa pain. Clinical efficacy of three common treatments in acute otitis externa in primary care: randomised controlled trial. A randomized clinical trial of two topical preparations (framycitin/gramicidin and oxytetracycline/hydrocortisone with polymyxin B) in the treatment of external otitis.
The study was designed to investigate the potential contribution of hydrocortisone acetate to the efficacy and safety of an antibiotics ointment in the treatment of acute otitis externa (AOE). In a double-blind study 151 patients with a unilateral acute bacterial otitis externa were randomized either to receive an ointment with polymyxin-B sulfate (7,500 I.E./g) + bacitracin (300 I.E./g) alone (AB) or the same antibiotic ointment with 10 mg hydrocortisone acetate/g ointment (AB + HC). Primary efficacy endpoint was the change of an aggregate clinical symptom score (CSS) (subscores: redness, swelling, pain and secretion) found at Visit 2 versus baseline (Visit 1). Secondary outcome parameters were the change of the CSS from Visit 1 to the study termination, and the changes in the subscores and of a visual analog scale for pain. In the group treated with AB + HC, significantly more patients with severe redness [14 (56%) vs. 7 (28%), P = 0.045] or severe secretion [23 (70%) vs. 10 (40%), P = 0.024] at inclusion were symptom-free at the last visit. Fewer pain-relieving tablets (1.1 +/- 2.2 vs. 2.3 +/- 4.6 paracetamol tablets) were used in the AB + HC-group. In the steroid group there was a slightly larger though not significant reduction in CSS at Visit 2 and Visit 3 versus baseline. Similar results were documented for redness, pain and secretion. No serious adverse events occurred. Both ointments are effective and safe in the topical treatment of AOE. Hydrocortisone acetate combined with the antibiotics improved individual symptoms better as did the steroid-free ointment. To compare the safety and efficacy of ofloxacin otic solution with those of Cortisporin otic solutions (neomycin sulfate, polymyxin B sulfate, and hydrocortisone) in otitis externa in adults and children.
                Two randomized, evaluator-blind, multicenter trials, 1 each in children and adults.
                Twenty-three primary care and referral ambulatory care sites per trial.
                A total of 314 adults (12 years and older) and 287 children (younger than 12 years). Of the total, data for 247 adults and 227 children were considered clinically evaluable (CE), and those for 98 children and 98 adults were microbiologically evaluable (ME).
                Ofloxacin (adults, 0.5 mL; children, 0.25 mL) twice daily or Cortisporin (adults, 0.2 mL; children, 0.15 mL) 4 times daily for 10 days.
                The CE subjects were cured if all signs and symptoms resolved at posttherapy (days 11-13) and test-of-cure (days 17-20) visits. The ME subjects had microbiological and clinical successes if they were cured and had microbiological eradication or presumed eradication.
                Cure was observed in 82% and 97% of CE adults and children treated with ofloxacin and 84% and 95% of CE adults and children treated with Cortisporin, respectively. The most common pathogens at the pretherapy visit were Pseudomonas aeruginosa, Staphylococcus aureus, and enteric bacilli. There were no statistically significant differences in clinical or microbiological and clinical cure or in the rates of adverse events between treatment groups.
                Ofloxacin given twice daily is as safe and effective as Cortisporin given 4 times daily for otitis externa. The bacteriological findings and treatment responses do not differ between adults and children. To compare the efficacy and safety of ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) otic suspension with that of neomycin 0.35%/polymyxin B 10,000 IU/mL/hydrocortisone 1.0% (N/P/H) otic suspension in patients with acute otitis externa (AOE).
                Randomized, observer-masked, parallel-group, multicenter study. Patients were randomized to 7 days treatment with either CIP/DEX 3-4 drops twice daily or N/P/H 3-4 drops three times daily.
                Patients of either sex and older than 1 year, with a clinical diagnosis of mild, moderate, or severe AOE and intact tympanic membranes were recruited to participate.
                Signs and symptoms of AOE, including ear inflammation, tenderness, edema and discharge (assessed on Days 3, 8 [End-of-Therapy] and 18 [Test-of-Cure]); microbiologic eradication (presumed or documented); and frequency of adverse events.
                Patients enrolled numbered 468. In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375), as were microbiologic eradication rates (94.7% vs. 86.0%; p = 0.0057). In addition, the clinical response was significantly better with CIP/DEX than with N/P/H at Days 3 and 18 (p = 0.0279 and p = 0.0321, respectively), as was the reduction in ear inflammation at Day 18 (p = 0.0268). Both preparations were well tolerated in pediatric and adult patients.
                7 days treatment with CIP/DEX otic suspension administered twice daily is clinically and microbiologically superior to N/P/H otic suspension administered 3 times daily in the treatment of mild to severe AOE, and is equally well tolerated. Otitis externa (OE) is an infection of the external auditory canal affecting children and adults and is associated with symptoms of local pain and tenderness. Twice-daily topical treatment with ofloxacin otic solution (0.3% [Floxin otic solution]) for 10 days has been reported to be as effective and well tolerated as neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension (Cortisporin otic suspension) administered four times daily for 10 days.
                This study compared the efficacy, safety, and ear-pain resolution of once-daily ofloxacin otic solution (0.3%) versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension administered four times daily, in children with OE. RESEARCH DESIGN, PATIENTS, AND METHODS: This multicenter, randomized, parallel-group, evaluator-blinded study was conducted at 34 centers in 278 pediatric OE patients aged 6 months to 12 years. Patients received five drops of ofloxacin otic solution (0.3%) in the affected ears once daily or three drops of neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times daily, for 7-10 days. Patient evaluations were performed at pretherapy (day 1), end of therapy (days 7-9), and test of cure (7-10 days post-treatment) visits. Data for 208 patients were clinically evaluable and those for 90 patients were microbiologically evaluable. Scores were obtained for patient assessments of pain severity.
                The overall clinical response was cure in the clinically evaluable patients, demonstrated by resolution of OE signs and symptoms at the test of cure visit. The overall clinical-microbiological response was cure in the microbiologically evaluable patients demonstrated by both clinical cure and microbiological eradication.
                For the clinically evaluable patients, equivalent cure rates were obtained between the once-daily ofloxacin-treated and four-times-daily neomycin sulfate/polymyxin B sulfate/hydrocortisone-treated patients (93.8% and 94.7%, respectively). For the clinically and microbiologically evaluable patients, the overall cure rates were 96.4% versus 97.1% for the ofloxacin-treated and neomycin sulfate/polymyxin B sulfate/hydrocortisone-treated patients, respectively. The eradication rates for the prevalent pathogen, Pseudomonas aeruginosa, were 98% versus 100% for ofloxacin-treated and neomycin sulfate/polymyxin B sulfate/hydrocortisone-treated patients, respectively. Decreases in pain severity were similar in both treatment groups. Statistical analyses were limited by the small numbers of patients in each treatment group.
                In the treatment of OE in children, once-daily ofloxacin otic solution was as effective and safe as neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension given four times daily. The two treatments provide rapid and comparable pain relief; however, ofloxacin otic solution does not have the risk of ototoxicity associated with neomycin and provides effective pain relief without adjunctive steroids. nan The study's objective was to test the tolerability and efficacy of the endogenous antiseptic N-chlorotaurine (NCT) in comparison with a standard clinical treatment according to a phase IIb clinical trial protocol.
                The antimicrobial agent NCT was compared with the antibiotic component drops Otosporin (containing neomycin, polymyxin B, and hydrocortisone) for topical treatment of acute otitis externa in a randomized and rater-blinded clinical study.
                Fifty patients suffering from acute otitis externa were divided into two groups according to a randomized list. The test group was treated with 1 mL of 1% aqueous NCT solution, the reference group with 1 mL of Otosporin. The substances were applied to the external ear canal at one daily session until the signs of infection disappeared. Efficacy and tolerability were evaluated daily by visual analogue scale and a six-step infection score. In addition, smears were analyzed to identify the causative pathogens.
                Both medications were equally well tolerated by the patients. The treatment was successful for all patients of the NCT group, whereas in one patient from the reference group, the infection did not disappear. The inflammation score improved more rapidly in the NCT group, which resulted in an earlier termination of the therapy. This difference became highly significant on days 4 to 7 (P <.01 each). Time needed for disappearance of inflammation (score 0) was 5.6 +/- 1.6 (mean +/- SD, range 3-9) days in the NCT group and 7.4 +/- 1.6 (range 4-10) days in the Otosporin group (P <.001). As expected, microbiologic cultures from ear swabs revealed Pseudomonas aeruginosa (58%) followed by Staphylococcus aureus (18%) as the main causative pathogens.
                NCT appears to be well tolerated and more effective than the therapy using antibiotic component drops. Because of its endogenous nature and its higher efficacy, NCT appears to be a good choice for topical treatment of acute otitis externa. To compare the efficacy and safety of polymyxin sulfate 7500 IU/neomycin sulfate 3500 IU/dexamethasone phosphate 0.1% (PN+Dx) otic solution with polymyxin sulfate 7500 IU/neomycin sulfate 3500 IU (PN-Dx) in patients with acute bacterial otitis externa (AOE), in order to determine the possible benefit of the addition of dexamethasone.
                Active controlled, double-blind, randomized, parallel group, multi-center clinical trial in ear, nose, and throat (ENT) specialist practices with a planned interim analysis for sample size adaptation. In total, 338 patients aged 18-76 who had a previous episode of otitis externa within the last year were randomized to receive 10 +/- 2 days of treatment with two drops, three times daily, of either PN+Dx or PN-Dx.
                Change in the clinical symptom score (consisting of the subscores redness, swelling, pain, and secretion) and of the visual analogue scale (VAS) rating for pain from Visit 1 (Day 1) to Visit 2 (Day 4 +/- 1), patient's assessment of efficacy at Visit 3 (Day 10 +/- 2), and the frequency and type of adverse events.
                There was a significantly greater reduction of swelling from Visit 1 to Visit 2 with PN+Dx, and more patients rated the efficacy of PN+Dx as 'very good' or 'good' at Visit 3 (p = 0.03). There was also a significantly greater decrease in the clinical symptom score from Visit 1 to Visit 2 in the PN+Dx group in patients who had at least a moderately severe symptom score with more than seven points at Visit 1 (p = 0.01) and in patients suffering from their current episode of otitis externa for more than 2 days (p = 0.02). In total, 14 adverse events were reported during the study period with no related adverse drug reactions for PN+Dx.
                The addition of dexamethasone phosphate to polymyxin B/neomycin significantly reduces swelling in patients with AOE and leads to significantly higher patient's ratings of treatment efficacy. It especially leads to an overall reduction of symptoms in cases of moderately or more severe otitis externa and cases lasting for more than 2 days. We conducted a prospective, randomized, controlled, double-blind study of 33 patients to compare the efficacy and tolerability of a new glycerin formulation of ototopical 0.3% ciprofloxacin with that of a conventional aqueous formulation of ciprofloxacin for the treatment of acute external otitis. Outcomes measures were resolution of discharge, swelling, pain, and redness and the incidence of adverse side effects. Patients were examined on three occasions: on the day of enrollment (visit 1), 48 to 72 hours later (visit 2), and 7 days after enrollment (visit 3). At visit 2, the patients in the glycerin group showed a significantly greater resolution of discharge. We observed the same pattern with respect to swelling, pain, and redness, which resolved more quickly in the glycerin group, although not significantly so. All patients were cured by visit 3, and the two treatments were equally well tolerated. On the basis of our findings, we conclude that the glycerin formulation of ototopical 0.3% ciprofloxacin appears to be at least as effective as the aqueous form in the treatment of acute external otitis--and in the case of otorrhea, more so. To demonstrate clinical equivalence (statistical noninferiority) of topical ciprofloxacin and hydrocortisone (CHC, Cipro HC) and topical neomycin/polymyxin b/hydrocortisone (NPH, Cortisporin) with systemic amoxicillin (AMX, Amoxil), for treatment of acute otitis externa (AOE).
                Randomized, active-control, observer-blind, multicenter trial.
                Altogether, 206 patients were enrolled (CHC, 106; NPH + AMX, 100). Patients were > or =1 year of age, had AOE >2 days with at least mild symptoms, and gave informed consent. All were evaluable for safety, and 151 were evaluable for efficacy.
                Ciprofloxacin and hydrocortisone 3 drops twice daily for 7 days (adults and children) or NPH 4 drops (adults) or 2 drops (children) with AMX 250 mg (adults and children) 3 times daily for 10 days, as directed in approved product labeling.
                The primary efficacy variable was response to therapy 7 days after treatment ended (test of cure). Secondary variables included time to end of pain, symptom scores (otalgia and tenderness) and microbiological eradication. Noninferiority was declared if the lower confidence limit around the measurement difference was above -10 (nearer zero).
                Response to therapy was higher for CHC (95.71% vs 89.83%) but was statistically noninferior (lower confidence limit, -4.98) to NPH + AMX. Median time to end of pain was 6 days for both groups. Noninferiority was declared for symptom scores at all measurement periods and for microbiological eradication. No serious adverse events related to treatment were reported.
                Ciprofloxacin and hydrocortisone is clinically equivalent to NPH + AMX for the treatment of AOE in adults and children. However, low systemic exposure, absence of ototoxicity, and less frequent dosing clearly favor Cipro HC. The literature reports the merits of antibacterial, antibiotic and steroid agents in treating otological infections but no controlled clinical trial has directly compared 2% glacial acetic acid (EarCalm; Stafford-Miller Ltd, Brentford, UK) against 2% glacial acetic acid, 0.1% dexamethasone and 3250 U/ml of neomycin sulphate (Otomize; Stafford-Miller Ltd) in the treatment of otitis externa and infected mastoid cavities.
                Prospective, single-blind randomised controlled trial.
                Outpatients, Derby Royal Infirmary, Derby, UK.
                Emergency and GP referrals with acute otitis externa (n = 53) and infected mastoid cavities (n = 56).
                Otoscopy was performed at initial randomisation and then at 2 and 4 weeks, the ear assessed for active and inactive disease.
                Patients with active otitis externa, 71% (15/21) resolved with glacial acetic acid, dexamethasone and of neomycin sulphate after 2 weeks, increasing to 86% (18/21) after 4 weeks treatment. Patients on glacial acetic acid had only 38% (12/32) resolution after 4 weeks (P < 0.0005). Two per cent glacial acetic acid, dexamethasone and neomycin sulphate resolved only 30% (8/27) of infected mastoid cavities compared to only 10% (3/29) on glacial acetic acid (P < 0.07). A further 2 weeks treatment this increased to 67%, (18/27) with glacial acetic acid, dexamethasone and neomycin sulphate and 48% (14/29) with glacial acetic acid. These results are not statistically significant.
                Glacial acetic acid, dexamethasone and neomycin sulphate is significantly more effective in treating otitis externa when compared with glacial acetic acid. This effect failed to be significant in the infected mastoid cavities group. We therefore recommend that in conjunction with aural toilet, antibiotic/steroid combination is more effective than an antibacterial agent for otitis externa. Larger numbers of infected mastoid cavities are required to be studied. nan Twenty-seven patients with an initial diagnosis of otitis externa, untreated for the previous 2 weeks, were treated with weekly aural suction toilet and a choice of three topical drops. Two contained combinations of antibiotics and steroids, one of which also contained an anti-fungal agent. The third was boric acid in spirit. The patients were assessed at weekly intervals until a remission was established. From this study it would appear that antibiotic-based drops confer no real advantage over boric acid in spirit. Acute otitis externa is a common clinical condition accounting for a large proportion of patients attending the otolaryngology department, although milder cases are often managed in primary care. Treatment of the most severe forms of otitis externa involves aural toilet, followed by the application of a topical preparation, commonly in the form of an ear canal dressing. A prospective single-blind randomized controlled trial was performed to compare the efficacy of 10% glycerine-ichthammol (GI) solution and Triadcortyl (TAC) ointment, both applied as ear canal dressings, in the initial management of severe acute otitis externa. A total of 64 patients were studied. Both treatment modalities were proven efficacious in the treatment of severe acute otitis externa. Although there was a statistically significant improvement of pain parameters in the TAC group, we found no significant differences in clinical findings between the two groups. Therefore, it is recommended that GI dressing can be used instead of an antibiotic dressing as an initial treatment of severe acute otitis externa on the basis of cost, avoidance of resistance and toxicity. A prospective, randomized double-blind study was made of topical ciprofloxacillin (0.5%) compared with topical gentamicin (0.3%) in the treatment of simple chronic otitis media (COM) and diffuse external otitis (DEO). The study included 47 patients with COM and 54 patients with DEO. Success rates in the COM subgroup were 95% for ciprofloxacillin and 96% for gentamicin (p = 0.082), and in the DEO subgroup, 87% for ciprofloxacillin and 79% for gentamicin (p = 0.19). Both drugs were well tolerated and there was no significant change in audiometric measurements with either medication in either group. Therefore, ciprofloxacillin is at least as effective as gentamicin in such ear infections and has no potential ototoxic effect. Otitis externa is an inflammatory disorder of the skin of the outer ear canal frequently associated with bacterial or fungal infection. It is normally treated with aural toilet and topical preparations containing antibiotic/antifungal and steroid preparations. A group of 39 patients presenting with otitis externa were randomized in a double-blind manner into those receiving drops containing an aminoglycoside and steroid preparation and those receiving the same preparation without the aminoglycoside. All patients were reviewed on days 0, 3, 7 and 11 of a 14-day course of drops and their response to medication monitored. Patients documented their symptoms at each appointment and clinical response was also measured by a blinded observer. The study suggests that an aminoglycoside antibiotic conveys no significant benefit in this condition. Ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) and neomycin 0.35%(polymyxin B 10,000 IU/mL/hydrocortisone 1.0% (NPH) were compared for relief of pain in patients with acute otitis externa. Patients received 7 d of treatment with CIP/DEX twice daily or NPH 3 times daily. Ear pain was assessed by patients/caregivers twice daily and by the study investigator on days 3, 8, and 18 (4-point scale). Higher percentages of CIP/DEX-treated patients had relief of severe pain over time (P=.0013) and relief of significant pain (moderate or severe pain) over time (P=.0456), compared with NPH-treated patients. The percentage of CIP/DEXtreated patients with severe pain decreased rapidly within the first 12 h; this contrasted with an increase in pain among NPH-treated patients. CIP/DEX-treated patients had significantly less inflammation (P=.0043) and edema (P=.0148) than NPH-treated patients. Overall, these results support greater pain relief attained over the first 3 d in patients with acute otitis externa treated with CIP/DEX compared with NPH and a rapid reduction in severe pain after initiation of treatment. To compare the clinical efficacy of ear drops containing acetic acid, corticosteroid and acetic acid, and steroid and antibiotic in acute otitis externa in primary care.
                Randomised controlled trial.
                79 general practices, Netherlands.
                213 adults with acute otitis externa.
                Primary outcome: duration of symptoms (days) according to patient diaries. Secondary outcome: cure rate according to general practitioner completed questionnaires and recurrence of symptoms between days 21 and 42.
                Symptoms lasted for a median of 8.0 days (95% confidence interval 7.0 to 9.0) in the acetic acid group, 7.0 days (5.8 to 8.3) in the steroid and acetic acid group, and 6.0 days (5.1 to 6.9) in the steroid and antibiotic group. The overall cure rates at seven, 14, and 21 days were 38%, 68%, and 75%, respectively. Compared with the acetic acid group, significantly more patients were cured in the steroid and acetic acid group and steroid and antibiotic group at day 14 (odds ratio 2.4, 1.1 to 5.3, and 3.5, 1.6 to 7.7, respectively) and day 21 (5.3, 2.0 to 13.7, and 3.9, 1.7 to 9.1, respectively). Recurrence of symptoms between days 21 and 42 occurred in 29% (50/172) of patients and was seen significantly less in the steroid and acetic acid group (0.3, 0.1 to 0.7) and steroid and antibiotic group (0.4, 0.2 to 1.0) than in the acetic acid group.
                Ear drops containing corticosteroids are more effective than acetic acid ear drops in the treatment of acute otitis externa in primary care. Steroid and acetic acid or steroid and antibiotic ear drops are equally effective. In a randomized trial, 55 patients with acute external otitis were treated with either topical framycitin/gramicidin (Sofradex) or oxytetracycline/hydrocortisone (Terracortril) with polymyxin B (TPB) ear-drops for 1 week. Staphylococcus aureus and Pseudomonas pyocyanea were the bacteria most frequently found in the ear canal; 78% of the patients were cured. However, no significant differences in therapy were found when either of the preparations was used. S. aureus seemed to be most resistant to treatment, while P. pyocyanea was less of a therapeutic problem. Additionally, previous episodes of external otitis or other skin diseases did not seem to influence any treatment given.