Penicillin in acute otitis media: a double-blind placebo-controlled trial

Abstract

The effect of peroral penicillin-V (55 mg/kg/day in 7 days) on acute otitis media was studied in 149 children between the ages of 1 and 10 years in a double-blind, placebo-controlled investigation. The parameters of the disease employed were symptom scores for earache, fever and common cold, the use of analgetics, otoscopy, as well as tympanometry. The children were followed-up for 3 months. Penicillin had no effect on fever and common cold, but earache was significantly reduced on the 2nd day of treatment. The acute course of the disease was satisfactory in 69% of the children in the placebo group and in 86% in the penicillin group. In patients with pneumococci or haemolytic streptococci in the nasopharynx, the pain disappeared after 1-2 doses of penicillin, whereas the treatment had no effect in children with Haemophilus influenzae. There was no difference between the penicillin and the placebo groups with regard to the results of otoscopy and tympanometry after 1 week, 1 month and 3 months. No serious complications were observed. It is concluded that an attitude of "masterly inactivity" with regard to the treatment of acute otitis media is justifiable, provided sufficient analgesic treatment is given and also that the patient can be closely followed. As there are still many unanswered questions more controlled investigations are warranted.

Antibiotics for acute otitis media in children

“…However, one of these trials included all randomised patients in the primary analysis at day four (Damoiseaux 2000). In two of the 13 trials the total number of loss to follow-up/exclusions are described but it was unclear from which treatment group children were excluded (Halsted 1968;Mygind 1981). For the review of immediate antibiotics against expectant observation, the loss to follow-up was below 5% in two of the five trials ( …”

“…Two trials compared penicillin for seven days with placebo (Mygind 1981;Thalin 1985), four trials compared amoxicillin for seven to 14 days with or without myringotomy with placebo (Burke 1991;Damoiseaux 2000;Kaleida 1991;Le Saux 2005), and four trials compared amoxicillin/clavulanate for seven to 10 days with placebo (Appelman 1991;Hoberman 2011;Tähtinen 2011;Tapiainen 2014 …”

“…Concealment of allocation was adequately described in 11 of the 13 included trials comparing antibiotics with placebo (Appelman 1991;Burke 1991;Damoiseaux 2000;Hoberman 2011;Howie 1972;Le Saux 2005;Mygind 1981;Tähtinen 2011;Tapiainen 2014;Thalin 1985;van Buchem 1981a andvan Buchem 1981b) …”

Antibiotics for acute otitis media in children

“…Twelve trials were double-blind, placebo-controlled, parallelgroup randomised clinical trials (Appelman 1991;Burke 1991;Damoiseaux 2000;Halsted 1968;Hoberman 2011;Howie 1972;Kaleida 1991;Le Saux 2005;Mygind 1981;Tähtinen 2011;Tapiainen 2014;Thalin 1985), while one trial had a 2 x 2 factorial design (van Buchem 1981a andvan Buchem 1981b).…”

Acute Otitis Media in Children

“…Antimicrobial therapy is one of the cornerstones in the management of AOM but some studies have suggested that its routine use is not indicated (17)(18)(19). As the most cases of AOM resolve spontaneously (20), antimicrobial therapy is not always necessary.…”