F. W. M. M. Touw-Otten

Co-amoxiclav in recurrent acute otitis media: placebo controlled study.

OBJECTIVE--To determine the efficacy of coamoxiclav in children aged 6 months to 12 years with recurrent acute otitis media. DESIGN--A randomised double blind placebo controlled clinical trial. SETTING--General practice in the Netherlands. PATIENTS--121 children with recurrent acute otitis media, defined by onset of otalgia and otoscopic signs of middle ear infection within four to 52 weeks after the previous attack. Confirmation of diagnosis and randomisation was done by otolaryngologists. INTERVENTION--Oral co-amoxiclav or placebo in weight related doses for seven days. MAIN OUTCOME MEASURE--An irregular clinical course defined as the presence of otalgia or a body temperature greater than or equal to 38 degrees C, or both, after three days. RESULTS--Eleven (16%; 95% confidence interval 9% to 28%) children had an irregular course in the co-amoxiclav group and 10 (19%; 9% to 31%) in the placebo group (difference not significant). Age, dichotomised at 2 years, was the only significant prognostic factor for irregular course of the disease (odds ratio 5.9; 1.8 to 19.1). Among children aged below 2 years, 28% (4/14) in the co-amoxiclav group and 58% (7/12) in the placebo group had irregular courses. For children 2 years and older these percentages were 13% (7/52) and 7% (3/41). CONCLUSION--Children with recurrent acute otitis media are at greater risk of an irregular clinical course of the disease than children with a first episode of acute otitis media. Co-amoxiclav has no significant benefit over placebo in treating children over 2 years with acute otitis media.

Double-blind randomised trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice

BACKGROUND The treatment of persistent otitis media with effusion (OME) remains controversial, but this condition is the commonest reason for children to require ear, nose, and throat (ENT) surgery. Trials of antibiotics are inconclusive, are often weak methodologically, and have not been done in general practice. Our aim was a trial of an antibiotic for OME in such a population. METHODS 433 children, aged 6 months to 6 years, with OME from 57 general practices entered a 3-month watchful waiting period. Of 223 (52%) with persistent bilateral OME, 162 were randomised double-blind to receive co-amoxiclav suspension (20 mg/kg amoxicillin, 5 mg/kg clavulanate potassium) or matching placebo, orally three times a day for 14 days. All cases also received xylometazoline 0.25% decongestant nosedrops thrice daily. Of the 61 not randomised, 13 children were referred to an ENT surgeon and parents refused consent in 48 cases. The main outcome measures were persistent OME in both ears and in one or both ears, as assessed clinically and by tympanometry. Analysis was by intention-to-treat. FINDINGS 79 children in the treatment group and 70 in the placebo group were analysed for efficacy. 3 withdrew in the co-amoxiclav group (2 lost to follow-up, 1 due to side-effects); 6 withdrew in the placebo group (5 and 1, respectively). In addition, 4 tympanograms were uninterpretable in the controls. Compliance was over 90% in both groups. Persistent OME in both ears and in one or both ears were found at significantly lower rates in the co-amoxiclav group than in the controls at the 2-week follow-up: 53 vs 84% and 77 vs 93%, respectively. Odds ratios adjusted for sex, history of adenoidectomy, and upper respiratory tract infection at follow-up were 0.25 (95% CI 0.11, 0.58, p = 0.001) and 0.30 (0.10, 0.89, p = 0.03), respectively. Parents of children in the co-amoxiclav group reported significantly more side-effects than those of control children (44 vs 22%, p = 0.03). Side-effects were mostly gastrointestinal and mild. INTERPRETATION Our study in a general-practice setting confirmed the positive short-term effect of antibiotic treatment for persistent middle-ear infection. Before referral to an ENT surgeon, children with persistent OME presenting to general practitioners could be considered for such treatment, depending on the individual child and possible adverse sequelae.

MEASURING IMPACT OF SICKNESS IN PATIENTS WITH NONSPECIFIC ABDOMINAL COMPLAINTS IN A DUTCH FAMILY PRACTICE SETTING

The Sickness Impact Profile (SIP) was applied in a Dutch primary care population who had nonspecific abdominal complaints. The study was conducted to test applicability and feasibility of the SIP as an outcome measurement in primary care research on patients with minor illness. The study was performed in five family practice settings. Included in the study were all patients aged 18 to 75 years who visited their family doctor during a 7 week period with nonspecific abdominal complaints. Feasibility was tested by interviewing patients at their homes within a time limit of 24 hours after the consultation with their family doctor. To test applicability, dysfunction in patients with nonspecific abdominal complaints was compared with dysfunction in an open population and in a population with low back pain. Results revealed that highly prevalent dysfunctional behavior in patients with nonspecific abdominal complaints differed from highly prevalent dysfunction in a reference group of patients with low back pain and in an open population. The SIP data confirmed the characteristics of nonspecific abdominal complaints as multiconditional illness. The data obtained were recognizably related to the nature of nonspecific abdominal complaints, emphasizing the applicability of the SIP.

Transient Ischemic Attacks and the General Practitioner: Diagnosis and Management

We studied the question whether the decision of general practitioners (GPs) to refer patients with transient ischemic attacks (TIAs) to hospital departments of neurology is influenced by certain chara