Acceptability and feasibility Antibiotic treatment for Chronic Suppurative Otitis Media CSOM

60 Remarks here was no evidence to support the use of topical antiseptics and steroids in the treatment of CSOM in children.

8.4.1 Evidence and summary of findings

One systematic review identiied two RCTs that included arms which compared the efectiveness of topical antiseptics versus no treatment or placebo [Acuin, 2007]. here was low quality evidence that there is no statistically signiicant diference in the rates of treatment failure between topical antiseptic and placebo or no treatment see GRADE table A7.23 . However, both studies were underpowered and had some methodological laws. In the irst RCT, 60 children with otorrhoea in a hospital clinic in South Africa compared aluminium acetate solutions of varying concentrations 13.00, 3.25, and 1.30 [horp, 2000]. he most dilute solution was considered to be inactive. he RCT found no signiicant diference in dry ears ater 2 weeks 21 out of 26 patients 81 of ears with 13.00 aluminium acetate versus 15 out of 20 patients 75 with 3.25 aluminium acetate versus 5 out of 10 patients 50 with 1.30 aluminium acetate; p = 0.18. However, this study may have lacked power to detect a clinically signiicant diference. he second RCT included 134 children 180 ears and compared ive interventions: ear cleansing alone, ear cleansing plus topical antiseptic, ear cleansing plus topical antiseptic plus topical antibiotics plus corticosteroid, ear cleansing plus topical anti- septic plus topical antibiotics plus corticosteroid plus oral antibiotic clindamycin, and no treatment [Eason, 1986]. It found no signiicant diference between ear cleans- ing plus topical antiseptic boric acid 2 4 times daily and ear cleansing alone in the proportion of children with no change in otoscopic appearance ater 6 weeks 43 children, 58 ears: 12 out of 32 [38] with topical antiseptic versus 13 out of 26 [50] with ear cleansing alone; OR 0.61, 95 CI 0.22 to 1.71.

8.4.2 Benefits and risks

Benefits he studies show that there is no added value in using topical antiseptics as they do not reduce ear discharge compared to placebo. herefore, they do not have a beneit in treating CSOM. Risks he two RCTs gave no information on adverse efects where topical antiseptics were used compared to placebo. However, in one systematic review of topical antiseptics versus topical antibiotics, there was increased adverse events e.g. ear pain, irritation, and bleeding on ear mopping combined; 30 out of 206 [14.6] with boric acid versus 17 out of 210 [8.1] with ciproloxacin; Absolute Risk 6.5, 95 CI 0.3 to 12.7 [Macfadyen, 2005]. One study also reported cochlear and vestibular otototoxity at high doses [Perez, 2000].