Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community‐based, multicentre, double‐blind randomised controlled trial

Abstract

Objectives: To compare the effectiveness of ototopical ciprofloxacin (0.3%; CIP) with framycetin (0.5%), gramicidin, dexamethasone (FGD) eardrops (5 drops twice daily for 9 days) together with povidone‐iodine (0.5%) ear cleaning as treatments for chronic suppurative otitis media (CSOM) in Aboriginal children. Design and participants: Aboriginal community‐controlled, community‐based, multicentre, double‐blind, randomised controlled trial in eight Aboriginal Community Controlled Health Services across northern Australia, involving 147 Aboriginal children with CSOM. Main outcome measures: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing, 10–21 days after starting treatment. Results: 111 children aged 1–14 years (CIP, 55; FGD, 56) completed treatment. CSOM cures occurred in 64% (CIP, 76.4%; FGD, 51.8%), with a significantly higher rate in the ciprofloxacin group (P = 0.009, absolute difference of 24.6% [95% CI, 15.8%–33.4%]). TM perforation size and the level of hearing impairment did not change. Pseudomonas aeruginosa was the most common bacterial pathogen (in 47.6%), while respiratory pathogens were rare (in 5.7%). Conclusions: Twice‐daily ear cleaning and topical ciprofloxacin is effective at community‐level in achieving cure for CSOM. Healthcare providers to Aboriginal children with CSOM should be given special access to provide ototopical ciprofloxacin as first‐line treatment.

The Be Our Ally Beat Smoking (BOABS) study, a randomised controlled trial of an intensive smoking cessation intervention in a remote aboriginal Australian health care setting

“…While we have demonstrated it is possible to undertake high quality RCTs in Aboriginal primary health care settings [28] the difficulty of enrolling participants in future studies should not be underestimated and needs to be carefully considered in planning.…”

“…Individually randomised multicentre drug trials have been demonstrated to be possible in Aboriginal and Torres Strait Islander health [28]. Cluster randomised multicentre trials may be another solution for more complex non-placebo controllable interventions such as BOABS, however the risks of: 1) heterogeneity between sites; 2) the intervention only working in some locations; 3) added complexity of both design and analysis; 4) a substantially larger sample size required to obtain the same statistical power; 5) post-randomisation selection bias if randomisation occurs prior to participant recruitment; and 6) a potential slowdown of recruitment in the clusters that are to receive the less interesting treatment such as “usual care” [29-31], remain.…”

The protocol for the Be Our Ally Beat Smoking (BOABS) study, a randomised controlled trial of an intensive smoking cessation intervention in a remote Aboriginal Australian health care setting

“…RCTs provide high-quality research and evidence, and can be undertaken in this setting. In 2002 Kimberley ACCHS took part in a double blind, multi-centre, RCT that was conducted by the National Aboriginal Community Controlled Health Organisation (NACCHO Ear Health Trial) [21]. The research methodology of this RCT placed Aboriginal people in control of their own research [22].…”

Management of chronic suppurative otitis media

“…To the Editor: Chronic suppurative otitis media (CSOM) is a long‐term problem which often has serious effects on hearing, speech and learning. Couzos and colleagues have shown that local treatment with ciprofloxacin (CIP) eardrops clears episodes of purulent discharge more efficiently than the commonly used framycetin, gramicidin and dexamethasone (FGD) eardrops 1 . This hardly ranks as a “cure” as suggested by the authors.…”