Methods

Open randomised study comparing erythromycin and no treatment (as control group). At baseline patients had a history and clinical examination performed. A nasopharyngeal swab was obtained at baseline and again 18‐36 hours after last antibiotic dose. A repeat doctors examination was performed on Day 8.

Randomisation was open and done by a computer‐generated table. No other information given about randomisation. Allocation concealment was not done (grade C). Not blinded due to open design of study (quality assessment grade D). Compliance monitoring not described.

Dropouts: n=1 (1.1% of patients randomised) from treatment group from adverse effects of antibiotics. No further description given and was not included in analysis as treatment failures. Quality assessment of reporting of participants and follow‐up of patients therefore were of a high quality (A).

Participants

88 children with cough >10 days duration were included. The number of participants with cough > 3 weeks duration was 50%. Approximately 75% of the participants had moist cough.
Erthromycin group: n=41 Control group n=47 . There were no significant differences in any patient characteristics between the 2 groups.

Inclusion criteria: Children aged 0.5 ‐ 6 years attending one of 3 paediatric outpatient clinics with greater than 10 days of cough.

Exclusion criteria: Children with allergy, asthma, cardiac disease, otitis media, tonsillitis, pneumonia or clinically suspected pertussis.

Interventions

Treatment group received erythromycin ethylsuccinate suspension 50mg/kg/day in 2 divided doses for 7 days verus 'no treatment' control group. All children received nose drops (oxymetazoline chloride). Salbutamol mixture (0.1mg/kg/day) was allowed in both groups and was registered.

Outcomes

1. Clinical symptoms as recorded on a questionnaire by parents, including cough on 3 point scale (none,moderate or frequent), morning temperature and degree of activity of child (usual, reduced, bedridden).
2. Doctor performed clinical examination on Day 8 to assess cure or clinical failure (without knowledge of questionnaires).
3. Elimination of nasopharyngeal pathogens
4. Progression of disease requiring additional antibiotics (% complications) ie bacterial complications requiring further antibiotics and recurrent symptoms were recorded during therapy and for 3 months after.
5. Adverse drug reactions

Notes

4 children in each arm had received antibiotic treatment prior to enrolment for <30 days.

Quality Score: CDAA

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

Computer‐generated table

Allocation concealment?

High risk

Open

Blinding?
All outcomes

High risk

Open study

Incomplete outcome data addressed?
All outcomes

Low risk

Only one patient withdrew from the study.

Methods

Randomised double blind study comparing Amoxycillin/clavulanic acid vs placebo. At baseline clinical data was obtained and participants underwent nasopharyngeal aspirate and blood tests for B.pertussis and Mycoplasma pneumoniae. A cough scoring system which combined number of coughing attacks per 24 hours, coughing attacks associated with vomiting and wheeze or crackles on auscultation was obtained. At 2 weeks participants were followed‐up with repeat blood tests, nasopharyngeal aspirates and doctor assessment of clinical outcome. Parental assessment of treatment efficacy was also recorded. Number of coughing attacks per 24 hours was recorded for each day of treatment.

Randomisation method was not described. Allocation method was not described. Compliance monitoring was not described. Although a double‐blinded study there was no mention of how this was achieved in the paper.

Dropouts n=15 (26.3% of those recruited). 12 with pertussis, 2 failed to return to follow‐up visit, 1 refused medication. These were not further described and not included as treatment failures in the paper.

Participants

52 children with cough >10 days duration were included. The mean duration of cough was 3‐4 weeks. Number with moist cough was not reported.
Median age of groups: Amoxycillin/clavulanic acid 2.7 years; Placebo 2.6 years (Numbers in each group not described).There was no significant differences in any patient characteristics between the two groups.

Inclusion criteria: Children aged 0.6‐7 years with > 10 days of cough and > 7 points on cough score system.

Exclusion criteria: Children with any signs of pneumonia, acute otitis media or clinical suspicion of Bordetella pertussis infection.

Interventions

Treatment group received amoxycillin/clavulanic acid 20mg/kg/day for 7 days verus placebo group.
The children were not given any antitussive medication.

Outcomes

1. Paediatrician's assessment of clinical recovery on day 12‐14.
2. Parental assessment of recovery on Day 12‐14.
3. Number of coughing attacks each day of treatment recorded until day 8
4. Adverse events

Notes

Due to lack of information in the paper and an inability to obtain data from authors about the dropouts with pertussis, it was assumed that there were equal numbers of patients in each treatment group analysed. (37 patients became 18 each group)

Quality Score: BACD

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Unclear risk

Not described

Allocation concealment?

Unclear risk

Not described

Blinding?
All outcomes

Low risk

Identical placebo

Incomplete outcome data addressed?
All outcomes

Unclear risk

26% attrition not included in final analysis