Ferley 1989.
| Methods | Randomised, placebo‐controlled trial of Oscillococcinum® in the treatment of influenza‐like illness | |
| Participants | 487 participants presenting in primary care with a complaint of influenza‐like illness Inclusion criteria: age older than 12 years; rectal temperature above 38 °C and at least 2 of headache, stiffness, lumbar and articular pain, shivers Exclusion criteria: duration more than 24 hours; immune deficiency; local infection; immunisation against influenza; depression; immunostimulant treatment Average age of Oscillococcinum/placebo groups: 34/35 Males:females in Oscillococcinum/placebo groups: 93:127/97:129 | |
| Interventions | Oscillococcinum® twice a day for 5 days | |
| Outcomes | Primary outcome measure (patient‐assessed): proportion of patients who recovered (defined as rectal temperature below 37.5 °C and complete resolution of all 5 symptoms) within 48 hours of treatment. Number of days to recovery; number of days to return to work; use of medication for pain or fever; use of medication for cough or sore throat; use of antibiotic medication; patient judgement of effectiveness of treatment | |
| Notes | Use of medication calculated from percentages given in text. Some minor inconsistencies between figures suggest a small amount of missing data Specific outcomes (temperature, symptoms including cough, coryza and fatigue) not reported per se Research setting: general practices in Rhône‐Alpes region, France |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information on actual randomisation method |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical presentation of active drug and placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Low rate of attrition (and similar rate per group) |
| Selective reporting (reporting bias) | Unclear risk | Specific outcomes not reported: temperature, symptoms including cough, coryza and fatigue |
| Other bias | Low risk | Study appears to be free of other sources of bias (e.g. baseline imbalance) |