Table 1.
Main characteristics of eligible trials
Indication | Study, reference | Treatment duration, daily dose | Maximum daily paracetamol dose allowed% | Primary efficacy outcome measure + | Number of patients# | |
---|---|---|---|---|---|---|
EPs 7630 | Placebo | |||||
Acute tonsillopharyngitis | A Timen et al., 2015 [60] | 6 days: Day 1–2: 20 drops hourly while awake, Day 3–6: 3 × 20 drops | Up to 3 × 500 mg on days 0 to day 4 | Response: TSS (7 symptoms) ≤ 4 points at day 4 | 40 | 38 |
B Berezhnoi et al., 2016 [55] | 6 days: 3 × 20 drops | TSS (5 symptoms): difference baseline – day 4 | 60 | 64 | ||
C Bereznoy et al., 2003 [56] | 6 days: 3 × 20 drops | TSS (5 symptoms): difference baseline – day 4 | 73 | 70 | ||
Acute bronchitis | D Kamin et al., 2010a [58] | 7 days: Age ≤ 6: 3 × 10 drops Age 7–10: 3 × 20 drops |
Age ≤ 6: 3 × 250 mg Age 7–10: 3 × 500 mg | BSS: difference baseline – day 7 | 25§ | 24§ |
E Kamin et al., 2010b [59] | 7 days: 3 × 20 mg (tablets) | 3 × 500 mg | BSS: difference baseline – day 7 | 32§& | 31§ | |
F Kamin et al., 2012 [57] | 7 days: Age ≤ 6: 3 × 10 drops, Age 7–10: 3 × 20 drops | Age ≤ 6: 3 × 250 mg Age 7–10: 3 × 500 mg | BSS: difference baseline – day 7 | 35§ | 31§ |
% Only allowed on days with fever ≥38.5 °C
+ TSS Tonsillopharyngitis Symptom Score (total score), BSS Bronchitis Symptom Score (total score)
# Primary efficacy analysis data set (full analysis set)
§ Only children 6–10 years of age
& Only children randomised to 3 × 20 mg/day