Topical quinolone vs. antiseptic for treating chronic suppurative otitis media: a randomized controlled trial. Preoperative therapeutic considerations in chronic suppurative otitis media. A comparison of cortisporin and ciprofloxacin otic drops as prophylaxis against post-tympanostomy otorrhea. A double blind, prospective trial of topical ciprofloxacin versus normal saline solution in the treatment of otorrhoea. Treatment of chronic suppurative otitis media with ofloxacin in hydroxypropyl methylcellulose ear drops: a clinical/bacteriological study in a rural area of Malawi. Evaluation of topical povidone-iodine in chronic suppurative otitis media. Chronic otitis media treated topically with ciprofloxacin or tobramycin. A single topical agent is clinically equivalent to the combination of topical and oral antibiotic treatment for otitis externa. [Antimicrobial therapy in chronic suppurative otitis media].
To compare a topical quinolone antibiotic (ciprofloxacin) with a cheaper topical antiseptic (boric acid) for treating chronic suppurative otitis media in children.
                Randomized controlled trial.
                A total of 427 children with chronic suppurative otitis media enrolled from 141 schools following screening of 39 841 schoolchildren in Kenya. Intervention Topical ciprofloxacin (n = 216) or boric acid in alcohol (n = 211); child-to-child treatment twice daily for 2 weeks.
                Resolution of discharge (at 2 weeks for primary outcome), healing of the tympanic membrane, and change in hearing threshold from baseline, all at 2 and 4 weeks.
                At 2 weeks, discharge was resolved in 123 of 207 (59%) children given ciprofloxacin, and in 65 of 204 (32%) given boric acid (relative risk 1.86; 95% CI 1.48-2.35; P < 0.0001). This effect was also significant at 4 weeks, and ciprofloxacin was associated with better hearing at both visits. No difference with respect to tympanic membrane healing was detected. There were significantly fewer adverse events of ear pain, irritation, and bleeding on mopping with ciprofloxacin than boric acid.
                Ciprofloxacin performed better than boric acid and alcohol for treating chronic suppurative otitis media in children in Kenya. The present randomized, prospective study of 119 cases of chronic suppurative otitis media compares the effectiveness of inexpensive, atoxic, nonallergenic disinfectants applied locally, to that of a number of occasionally toxic antimicrobial chemotherapeutic agents, administered systemically. Systemic treatment resulted in a cure rate of 53.5% (SEp = 5.9%) while ototopical treatment resulted in a 39.5% cure rate (SEp = 7%). Eradication of pathogens or colonization by a nonpathogen occurred in 50.7% (SEp = 5.9%) with systemic treatment, and in 39.5% (SEp = 7%) with ototopical treatment. Bacteriological modification was 2.5 times more frequent with systemic treatment than with ototopical treatment. No recurrences were noted with ototopical treatment, while 13% to 36% recurrence rates were noted in various subgroups of cases treated systemically. Cure rates achieved with particular drug regimens (administration based on sensitivity tests in vitro) were: Azactam 25% (5%-57% confidence limits), sulfamethoxazole plus trimethoprim 58.6% (38%-76%), ciprofloxacin 87.5% (47%-99%), ciprofloxacin plus metronidazole 90% (55%-99%). Cure rates with other drugs were inconclusive because of the limited number of observations. Myringotomy and tube insertion, a common pediatric surgical procedure, is frequently complicated by purulent otorrhea. Many otolaryngologists routinely use topical antibiotics as prophylaxis against post-tympanostomy otorrhea. The aminoglycosides (neomycin sulfate, tobramycin and gentamicin) contained in commonly used topical antibiotics as well as components of the solutions have been shown to be ototoxic in animal studies. Although little reported evidence of ototoxicity in humans exists, sporadic reports of sensorineural hearing loss linked to topical antibiotic use do exist, and the potential for sensorineural hearing loss must be considered. The purpose of this study is to compare the rate of post-tympanostomy otorrhea in a double-blinded randomized trial using either topical Ciprofloxacin, with no reported ototoxicity, or Cortisporin as prophylaxis. One hundred patients (200 ears) between ages 7 months and 11 years with a diagnosis of recurrent otitis media or chronic otitis media undergoing tympanostomy tube insertion were randomized into two equal groups. Three drops of either drop A or B were placed into each ear at the time of tube insertion and then three times daily for 3 days. Patients were examined at 3 weeks and details of otorrhea were obtained. The rate of otorrhea was analyzed using chi-square. The overall rate of otorrhea was 39 ears (19.5%), 17 (17%) ears for the Cortisporin group and 22 (22%) for the Ciprofloxacin group. The difference in rate of otorrhea was not statistically significant (P=0.372, 95% confidence interval equals -6-16%). Our data suggest that topical Cortisporin offers no benefit over Ciprofloxacin for post-operative otorrhea prophylaxis. Therefore we recommend topical quinolone prophylaxis, which should eliminate concerns about ototoxicity, without sacrificing efficacy. The clinical and bacteriological efficacy of topical ciprofloxacin in saline solution and a saline solution without antibiotics, for the treatment of otorrhoea, was assessed. Fifty affected ears which had an acute exacerbation of chronic otitis media with tympanic membrane perforation were included in this study. Only 35 ears completed the study. Both medications were randomly given to patients. Therapeutic efficacy was evaluated on the seventh day of treatment. A favourable clinical response was observed in 89.5% of the ciprofloxacin-treated group and in 43.8% of the saline-treated group, respectively (P < 0.005). Bacteriological eradication was also observed to be higher in the ciprofloxacin-treated group (P < 0.005). From these preliminary results, topical ciprofloxacin appears to be effective in curing the acute phase of chronic otitis media. Chronic suppurative otitis media in young children is a major problem in Africa, with socio-economic consequences at a later age. Common treatment regimens with antibiotics are expensive and often not practically feasible. Therefore, a project was started to develop a low-cost and effective treatment in a rural area of Malawi by studying the clinical efficacy of an inexpensive application regimen of ofloxacin (0.075%) in hydroxypropyl methylcellulose (1.5%) ear drops. In earlier studies with this treatment regimen, it was possible to cure approximately 70% of ears. The aim of this study was to find out whether the bacteriological spectrum cultured from wet ears before and after treatment, and patterns of resistance to antibiotics, played a role in the percentage of cures. Patients with long-standing chronic suppurative otitis media were clinically assessed and treated with suction cleaning and instillation of ear drops on days 1, 3, 7 and 10. Bacterial swabs were taken for culture and sensitivity tests for ofloxacin were on days 1 and 10 from the ears that were still discharging. After 21 weeks, the ears were assessed again clinically. Clinical cure was considered to be complete cessation of otorrhea. Ninety of 104 tested patients (124 ears) completed the study. About 73% of the ears had become dry by day 10. This dropped to 42% after 21 weeks. Before treatment, most ears (91%) harbored fecal bacteria, Proteus mirabilis (74%) and enterococci (60%) being the most frequently isolated microbes. The second group of frequently cultured bacteria were water bacteria e.g. Pseudomonas species and other non-fermenters (69%), whereas the classical otitis media pathogens were detected only in 15% of ears. Before treatment, 9.7% of strains were resistant to ofloxacin, most (30/35) of which were cultured from ears that were eventually cured. After treatment, fecal and water bacteria were still the most frequently found, with 36% new strains and an overall sensitivity to ofloxacin of 58%. Bacterial resistance did not appear to play an important role in the outcome of treatment. These data rather suggest a very high risk of infection due to poor hygiene conditions. Medical treatment can only have a longer-lasting effect if accompanied by community-based programs that focus on improvement of hygiene. A public health approach is necessary alongside a medical approach for the management of CSOM. To evaluate if povidone-iodine (PVP-I) can be used topically in the treatment of chronic suppurative otitis media-tubotympanic disease and to compare it with ciprofloxacin hydrochloride ear drops.
                Prospective double-blind randomized study.
                Academic tertiary medical center.
                Forty patients with chronic suppurative otitis media were randomized into 2 groups.
                One group (19 patients) received 5% PVP-I ear drops, while the other group (21 patients) received 0.3% ciprofloxacin ear drops. Both were administered topically, 3 drops 3 times daily for 10 days. These patients were followed up at weekly intervals for up to 4 weeks after commencing therapy.
                Clinical improvement at the end of study was 88% in the PVP-I group and 90% in the ciprofloxacin group. The most commonly isolated organism was Pseudomonas aeruginosa. In vitro resistance to ciprofloxacin was seen in 17% of organisms, while no resistance was seen for PVP-I.
                To our knowledge, this is the first study to evaluate the efficacy of PVP-I as a topical agent in the treatment of chronic suppurative otitis media. The results show that clinically, topical PVP-I is as effective as topical ciprofloxacin, with a superior advantage of having no in vitro drug resistance. Also, there is an added benefit of reduced cost of therapy. To evaluate the efficacy of ciprofloxacin compared with tobramycin and placebo ear drops in the treatment of chronic suppurative otitis media without cholesteatoma.
                Sixty ears (in 51 patients) were randomly divided into 3 treatment groups: ciprofloxacin hydrochloride, tobramycin, and placebo interventions.
                The otolaryngology department of a university teaching hospital.
                All ears were treated topically for 3 weeks.
                Each patient received a small, numbered bottle and was instructed to instill 5 drops 3 times daily for 3 weeks. The final clinical and bacteriologic assessment was made after 3 weeks.
                The organism most commonly isolated from the ear discharge was Pseudomonas aeruginosa. Its sensitivity to ciprofloxacin and tobramycin was 94.2% and 70.6%, respectively. The clinical response was 78.9%, 72.2%, and 41.2% in the ciprofloxacin, tobramycin, and placebo groups, respectively. The bacteriologic response rate was 66.7% for the ciprofloxacin and tobramycin groups and 20% for the placebo group. Treatment with ciprofloxacin ear drops seemed to be as effective as treatment with tobramycin.
                While the lack of ototoxicity of ciprofloxacin was not tested in our study, this treatment may be considered as a potential topical therapy for cases of chronic suppurative otitis media. 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. A randomized study was made of 125 patients with chronic middle ear infection. The most frequently isolated microorganisms were: Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae. Ciprofloxacin is very active against the microorganisms usually isolated and it has been shown to provide effective therapy in ear infections. In order to study the effectiveness of ciprofloxacin in chronic otitis media, we selected four different treatment groups: oral ciprofloxacin (500 mg/12 h); 0.5 and 0.2% topical solutions of ciprofloxacin (3 drops/8 h), and oral ciprofloxacin plus 0.2% topical solution. Topical polymyxin and neomycin were used as controls. Topical ciprofloxacin (0.2%) was the most effective regimen of those tested for the treatment of chronic otitis media.
Topical quinolone antibiotics can clear aural discharge better than systemic antibiotics; topical non-quinolone antibiotic (without steroids) or antiseptic results are less clear. Evidence regarding safety was weak. Further studies should clarify topical non-quinolones and antiseptic effectiveness, assess longer-term outcomes (for resolution, healing, hearing, or complications), and include further safety assessments, particularly to clarify the risks of ototoxicity and whether there may be fewer adverse events with topical quinolones than other topical or systemic treatments.