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. 2018 Sep 10;2018(9):CD006089. doi: 10.1002/14651858.CD006089.pub5

Lindbaek 1998.

Methods Study design: RCT
Study duration: January to May 1994 and November 1994 to May 1995
Participants Setting: general practice
Country: Norway
Health status: clinical diagnosis of acute sinusitis (> 7 and < 30 days), confirmed by computed tomography (presence of mucosal thickening of 5 mm without fluid levels or total opacification, independently scored by 2 experienced radiologists). Ear, nose, and throat comorbidity was not assessed.
Number:

  • total: 68

  • analysed: treatment (42, penicillin V (20); amoxicillin (22)); control (21)


Age: mean 39.7 (range 16 to 83)
Sex: 61% women
Exclusion criteria: age 15 or under, pregnancy, ongoing antibiotic treatment, immunosuppressive treatment, previous operations in the nose or sinus region, misuse of alcohol or narcotics, rheumatic disease, and allergy to penicillin. Participants with symptoms for more than 30 days were excluded because of possible chronic sinusitis. Participants with high fever and strong pain were not included because of ethical considerations.
Interventions Treatment group:

  • Group 1

    • intervention: penicillin V

    • dose, duration, frequency, administration: 1320 mg, 10 days 3 times daily, orally

  • Group 2

    • intervention: amoxicillin

    • dose, duration, frequency, administration: 500 mg, 10 days, 3 times daily, orally


Control group:

  • intervention: placebo

  • dose, duration, frequency, administration: 10 days, 3 times daily


Co‐interventions: concomitant use of nasal decongestants and paracetamol was allowed.
Comment: For this review, group 1 and 2 were combined in the analyses.
Outcomes Primary outcomes:

  1. subjective status: evaluation of the clinical condition by the participant (recovered, much better, somewhat better, unimproved, worse) at days 3 and 10

  2. difference in clinical severity score (day 10 vs day 0) evaluated by the general practitioner

  3. difference in score from computed tomography scans (day 10 vs day 0)

  4. duration of the illness episode (cure) (answering "no" to the question "Do you think you still have sinusitis today?")


Secondary outcomes:

  1. Bacteriology

  2. Side effects

  3. Clinical failure
Notes Funding source: government
Contact with study authors for additional information: none
Other notes:

  • Clinical evaluation (clinical severity score) and bacteriological sample from the nasopharynx at inclusion

  • Follow‐up:

    • diary (scoring degree of nasal obstruction, rhinorrhoea, sinus‐related pain, and malaise on VAS scale and answering the question "Do you think you still have sinusitis today?" (yes, uncertain, or no)). If they did not answer "no" at day 10, they went on with the daily registering until they could answer "no", with a maximum of 30 days.

    • Clinical evaluation at day 10 combined with computed tomography

  • Results:

    • Recovered:

      • treatment group: 15/42 at day 10

      • control group: 9/21 at day 10

    • Recovered or much better:

      • treatment group: 32/42 at day 10

      • control group: 14/21 at day 10

    • Side effects (serious, reason to stop treatment; GI origin):

      • treatment group: 3/42

      • control group: 0/21

    • Clinical failure, requiring extended treatment with amoxicillin:

      • treatment group: 1/42

      • control group: 1/21

    • Clinical failure, no recovery after 30 days:

      • treatment group: 4/42

      • control group: 2/21
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: restricted randomisation (blocks of 3 within each of 6 subgroups). A dice was used to generate the random allocation.
Stratified randomisation: according to clinical severity score (breakpoint 9.0) and localisation of the sinusitis (unilateral maxillary, bilateral maxillary or in at least 1 of the remaining sinus regions). If maxillary sinusitis in combination with sinusitis in 1 of the other sinus regions: stratification to 1 of the maxillary sinusitis groups.
Allocation concealment (selection bias) Low risk Comment: the statistician sent the randomisation list to the company that produced the medication boxes with numbers according to the list. The author received the numbered boxes for each of the subgroups from the company (information from the main investigator). Tablets appeared similar.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Comment: the trial was double‐blind (at participant, general practitioner, and radiologist level). The randomisation codes were broken after the whole study was finished. If another antibiotic was prescribed because of clinical failure (evaluation day 10), the randomisation code was not broken.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2/70 participants were taken out of the study because of bad‐quality CT scans.
Post‐randomisation dropout rate at day 10: 5/68 (7.4%)

  • Dropout balance: unknown


Ratio of participants with missing data to participants with events: 0.11
Discontinuation of trial medication rate: 5/63

  • Treatment group: 4 (1 out of the penicillin group (marked gastrointestinal side effects), 3 out of the amoxicillin group (2 marked gastrointestinal side effects, 1 unknown reason but recovered without further treatment)

  • Control group: 1 (unknown reason but recovered without further treatment)


Treatment compliance: not reported
Selective reporting (reporting bias) Low risk Comment: the study protocol is described in the methods section. The primary and secondary endpoints were predefined.
Other bias Low risk Comment: detailed description of demographic characteristics and sinusitis severity rating with which to assess the comparability of the groups at baseline