Fast track — ArticlesChloramphenicol treatment for acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial
Introduction
Acute infective conjunctivitis has a substantial effect on the health-service workload despite its low morbidity. The disease accounts for up to 1% of consultations in primary care.1, 2 One in eight children have an episode of conjunctivitis every year,3 with more than 1 million episodes in the UK and more than 5 million in the USA. Although a diagnosis of acute conjunctivitis is usually straightforward, most family doctors recognise the difficulty of differentiating a viral cause from a bacterial cause. Standard clinical practice is the prescription of topical antibiotics,4 which reinforces the need for consultation, and the scale of ocular antibiotic prescriptions is large—in England, 2·3 million are issued every year in primary care to individuals of all ages.5
Antibiotic resistance is a growing global problem. With research showing little benefit from antibiotics in children with sore throat and otitis media,6, 7 there has been a reduction in antibiotic prescribing in the UK for common childhood respiratory viral infections. Acute conjunctivitis often has a bacterial cause and therefore prescription of antibiotics seems rational. Moreover, social factors and public-health policy often dictate that children receive treatment before returning to nursery or school (Rose PW, Ziebland S, Harnden A, et al, unpublished). A Cochrane systematic review of treatment showed that topical antibiotics resulted in significantly greater clinical and microbiological remission than placebo, but also showed a high rate of resolution with placebo.8 However, the included trials were all based on secondary-care populations, with exclusively bacterial infection and in which disease severity was probably increased. Most patients present in primary care with mild disease, so extrapolation of the Cochrane results to this setting would be difficult. We designed a randomised trial to investigate the effectiveness of topical chloramphenicol for children presenting with acute infective conjunctivitis presenting in primary care.
Section snippets
Participants
The study was a placebo-controlled, double-blind, randomised controlled trial consisting of 326 children with a clinical diagnosis of conjunctivitis. Children were randomly assigned to receive chloramphenicol (n=163) or placebo eye drops (n=163). Chloramphenicol was chosen because it is the most common preparation used by family doctors4 and has a low rate of resistance in common organisms.9, 10 Previous fears about the drug's safety11 have not been proven.12 The study was approved by the
Results
Figure 2 shows the trial profile. From the audit, an estimated 29% of all children presenting in the study period were recruited. No clinical differences were seen between the baseline characteristics of the children in both the chloramphenicol and placebo groups (table 1). More children complained of pain or soreness in the non-randomised group (n=30, p=0·01), but no other difference was recorded between the baseline characteristics of the randomised and non-randomised groups.
(Table 2) shows
Discussion
We have shown that symptoms resolve without antibiotics in most children with acute infective conjunctivitis. In our intention-to-treat analysis, we recorded a modest improvement in symptom resolution at day 7 in the group receiving chloramphenicol. This improvement was further reduced if children lost to follow-up were excluded. We have no reason to believe that these excluded children would behave differently to those completing the trial. About half a day was gained in time to resolution
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