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

Van Buchem 1997a.

Methods Study design: RCT
Study duration: between 1 March 1993 and 1 March 1994
Participants Setting: general practice
Country: the Netherlands
Health status: adults with a clinical diagnosis of maxillary sinusitis (history, physical examination), for whom antibiotic therapy was considered, confirmed by radiograph (> 5 mm mucosal thickening, opacity or air‐fluid level). Ear, nose, and throat comorbidity was assessed; approximately 12% had allergic disease.
Number:

  • total: treatment (108); control (106)

  • analysed: treatment (105); control (101)


Age: mean 34
Sex: 63% women
Exclusion criteria: other nasal disorders (e.g. nasal polyps), concurrent bronchitis, current episodes of longer than 3 months, antibiotic treatment during the previous month, known hypersensitivity to amoxicillin, hepatic, renal, or immunological disorder, and coagulation abnormalities
Interventions Treatment group:

  • intervention: amoxicillin

  • dose, duration, frequency, administration: 750 mg, 7 days, 3 times daily, orally


Control group:

  • intervention: placebo

  • dose, duration, frequency, administration: 7 days, 3 times daily, orally


Co‐interventions (for all participants):

  • xylometazoline 0.1%

  • steam inhalation (duration not specified) (mentholated spirit)

  • concomitant use of paracetamol was allowed.
Outcomes Primary outcomes:

  1. cure rate after 14 days ("Cure" was defined as "no symptoms")

  2. symptom scores after 7 and 14 days.

  • "Cure" was defined as "no symptoms"

  • "Greatly decreased symptoms" was defined as "at most two patient accounts of symptoms or sets of examination data had a score lower than 5" (which means that they are still present)


Secondary outcomes:

  1. resolution of radiographic abnormalities after 14 days

  2. occurrence of side effects

  3. relapses (during 1‐year follow‐up)

  4. chronic evolution


Bacteriological outcomes were not assessed.
Notes Funding source: not stated
Contact with study authors for additional information: none
Other notes:

  • All participants were referred to the ENT specialist after inclusion for an extended anamnesis and profound physical examination with rhinoscopy and blood examination.

  • Follow‐up:

    • at day 7 by ENT specialist (intercurrent history and physical examination, number of capsules, side effects)

    • at day 14 by ENT specialist (intercurrent history, physical examination, number of capsules, side effects, blood examination, sinus radiograph) (or earlier when extra follow‐up was needed).

    • When extra therapy was needed after day 14, a maxillary puncture was performed.

    • Relapses and complications were registered by the general practitioner during 1 year

  • Results:

    • Cure at 14 days:

      • treatment group: 68/105

      • control group: 53/101

    • Greatly decreased symptoms at 14 days:

      • treatment group: 87/105

      • control group: 78/101

    • Side effects (mostly gastrointestinal symptoms or rash)

      • treatment group: 29/105

      • control group: 9/101

    • Clinical failure (open antibiotic therapy to start due to severe symptoms)

      • treatment group: 3/105

      • control group: 1/101

    • Relapse:

      • treatment group: 23/105

      • control group: 18/101

    • Chronic evolution: none

    • Complications:None during 1‐year follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: unrestricted randomisation (computer‐generated list used for allocation)
Quote: "The randomisation of allocation of the amoxicillin or placebo (distributed in identical bottles) was computer generated"
Allocation concealment (selection bias) Low risk Quote: "Randomisation of participants was carried out and capsules were provided by the hospital pharmacy in the hospital to which participants were referred to the ENT specialist."
Quote: "During the trial, the code of allocation schedule was kept in the office of the head of the hospital pharmacy, and was broken prematurely only if severe clinical development or severe adverse effects occurred"
Comment: the capsules with amoxicillin or placebo looked and tasted identical and were prescribed in the same frequency and for the same duration. The capsules were distributed in identical bottles.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Comment: nature of the medication blinded for the pharmacist's assistant, participant, and ENT specialist.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Post‐randomisation dropout rate: 8/214 (3.7%)

  • treatment group: 3

  • control group: 5


Reason for missing data: not attending follow‐up visit
Ratio of participants with missing data to participants with events: 0.07
Discontinuation of trial medication rate: 1/210 (0.5%)

  • treatment group: 0

  • control group: 1 (adverse effects)


Treatment compliance reported as 98% assessed by pills taking by participants.
Intention‐to‐treat analysis
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 Unclear risk Comment:

  • selection of participants with worse symptoms: only 20% of participants with possible maxillary sinusitis entered the trial (declining participation, meeting exclusion criteria, infringement of protocol, or participants with symptoms that did not justify antibiotics).