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Randomised, double blind, placebo controlled trial of penicillin V and amoxycillin in treatment of acute sinus infections in adults

BMJ 1996; 313 doi: https://doi.org/10.1136/bmj.313.7053.325 (Published 10 August 1996) Cite this as: BMJ 1996;313:325
  1. Morten Lindbaek, general practitionera,
  2. Per Hjortdahl, professora,
  3. Ulf L-H Johnsen, radiologistb
  1. a Department of General Practice, University of Oslo, Box 1130, Blindern, N-0317, Oslo, Norway
  2. b Department of Neuroradiology, Ulleval Hospital, University of Oslo, Oslo
  1. Correspondence to: Dr Lindbaek.
  • Accepted 3 June 1996

Abstract

Objective: To compare the effectiveness of penicillin V and amoxycillin with placebo in treatment of adult patients with acute sinusitis.

Design: Randomised, double blind, placebo controlled trial.

Setting: Norwegian general practice.

Subjects: 130 adult patients with a clinical diagnosis of acute sinusitis confirmed by computed tomography.

Main outcome measures: Subjective status after three and 10 days of treatment, difference in clinical severity score between day 0 and day 10 as evaluated by the general practitioner, difference in score from computed tomography on day 0 and day 10, and duration of sinusitis.

Results: Amoxycillin and penicillin V led to significantly faster and better recovery than placebo. By day 10, 71 patients receiving antibiotic treatment (86%) considered themselves to be recovered or much better compared with 25 (57%) receiving placebo. The mean (95% confidence interval) reductions in clinical severity scores by day 10 were 5.4 (5.0 to 5.8) for penicillin V, 5.5 (4.9 to 6.0) for amoxycillin, and 3.4 (2.8 to 4.0) for placebo. For the antibiotic groups combined the number of patients with the greatest degree of improvement on computed tomography (scale 0-16)—that is, score 5-16 on day 10—was 31/83 (37%) compared with 10/44 (23%) receiving placebo. The median duration of the sinusitis was nine days in the amoxycillin group, 11 days in the penicillin V group, and 17 days in the placebo group.

Conclusion: Penicillin V and amoxycillin are significantly more effective than placebo in the treatment of acute sinusitis.

Key messages

  • The median duration of sinusitis with different treatment was nine days for amoxycillin, 11 days for penicillin V, and 17 days for placebo

  • More than half of the patients receiving antibiotic treatment reported side effects but few gave severe discomfort

  • Half of the patients receiving placebo tablets felt restored or much better after 10 days

Footnotes

  • Funding Norwegian Research Council.

  • Conflict of interest None.

  • Accepted 3 June 1996
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