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

Norrelund 1978.

Methods Study design: RCT
Study duration: between January 10, 1977 and June, 30, 1977
Participants Setting: general practice (19 general practitioners)
Country: Denmark
Health status: participants showing at least 3 symptoms, including at least 1 of the main symptoms

  • main symptoms: yellow or yellowish‐green or possibly blood‐stained nasal discharge on blowing the nose; good nasal passage together with a nasal voice

  • other symptoms: feeling of malaise; headache, particularly behind the eyes, behind the bridge of the nose, or corresponding to the maxilla; irritative cough


Number:

  • total: treatment (73); control (67)

  • analysed: treatment (71); control (64)


Age: older than 14 years, mean unknown
Sex: 61% women
Exclusion criteria: penicillin allergy, pregnancy
Interventions Treatment group:

  • intervention: pivampicillin

  • dose, duration, frequency, administration: 700 mg, 6 days, 2 times daily, orally


Control group:

  • intervention: placebo

  • dose, duration, frequency, administration: 6 days, 2 times daily, orally


Co‐interventions: concomitant use of nasal decongestants allowed (xylometazoline 0.1% nasal spray, 4 times daily).
Outcomes Primary outcome:

  1. Cure at day 8 (sum of endpoints for the individual participant was reduced by at least 2/3 at follow‐up investigation on day 8)


Secondary outcomes:

  1. Resolution of purulent secretion

  2. Resolution of irritative cough

  3. Subjective improvement

  4. Side effects
Notes Funding source: not stated
Contact with study authors for additional information: none
Other notes:

  • Registration: symptom score at days 1 and 8 (purulent secretion, nasal stenosis, general feeling of illness, headache, cough) during visit

  • Follow‐up:

    • diary for 6 days (drug intake, intake of analgesics, intake of nose drops)

    • Questionnaire of side effects (sore throat, nausea, vomiting, stomachache, loose stools, diarrhoea, 'other') during second visit

  • Results:

    • cure at day 8

      • treatment group: 40/71

      • control group: 33/64

    • cure or improvement at day 8

      • treatment group: 53/71

      • control group: 36/64

    • side effects:

      • treatment group: 31/71 (all from gastrointestinal tract)

      • control group: 17/64 (2/3 from gastrointestinal tract)

      • no severe side effects

    • clinical failure: no data reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: blocked randomisation (each doctor had been sent a box containing 10 glasses, of which half in random sequence contained an active ingredient). No information about the process of selecting the blocks
Allocation concealment (selection bias) Unclear risk Comment: no information about the centralisation of randomisation or the numbering of the glasses
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Comment: the glasses contained pivampicillin or identical‐looking placebo tablets. No information about the blinding of healthcare providers and outcome assessors
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Post‐randomisation dropout rate: 5/140 (3.6%)

  • treatment group: 2 (adherence problems)

  • control group: 3 (2 because of adverse events, 1 because of adherence problems)


The ratio of participants with missing data to participants with events: 0.07.
No ITT analysis: participants who needed referral to an ENT specialist or discontinued medication because of side effects were allowed to be removed from the trial.
Selective reporting (reporting bias) Unclear risk Comment: the study protocol is described in the methods section. The primary and secondary endpoints were not predefined. Nevertheless, they predefined which symptoms, side effects, and medication intakes they would register. The definition of 'cure' is described for the first time in the results section.
Other bias Low risk Comment:

  • no information was provided about the balance of participant characteristics at baseline, except for gender.

  • with the available information, we could not detect other reasons for bias (no design‐specific risks of bias, the study was not stopped early, blinding was not broken due to side effects, no bias due to increased or different diagnostic activity).

  • average number of participants per practice: 7.1