Papp 1998.
Methods | Randomised, placebo‐controlled trial of Oscillococcinum® in the treatment of influenza‐like illness | |
Participants | 372 participants recruited in primary care or by internal medicine specialists
Inclusion criteria: rectal temperature above 38 °C; muscle pain or headache; one of shivering, cough, spinal pain, nasal irritation, malaise, thoracic pain, periarticular pain
Exclusion criteria: duration more than 24 hours; immune deficiency; local infection; immunisation against influenza; medical need for medication; immunostimulant or immunosuppressive treatment Use of analgesics, antibiotics or anti‐influenza agents in the first 48 hours was a post‐randomisation exclusion criterion Average age of Oscillococcinum/placebo groups: 35/35 Males:females in Oscillococcinum/placebo groups: 95:93/96:88 |
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Interventions | Oscillococcinum® 3 times a day for 3 days | |
Outcomes | Whether patients' condition improved after 48 hours (physician‐assessed; authors' primary outcome); whether absence of symptoms after 48 hours (physician‐assessed); time to recovery (patient‐assessed; authors' primary outcome); use of concomitant medication during trial; total symptoms score; time to return to work; temperature and presence of aches, headache, shivers, back or side pain, joint pain, spinal pain, cough, rhinitis, sore throat on evening of day 2; fever calculated from temperature using normal distribution | |
Notes | Some outcomes not clearly reported, including mean time to recovery or return to work. Not clear which data were analysed to obtain P value = 0.023: was it date of elimination of symptoms (though mean date per group is not provided in the main text) or presence of 'milder symptoms' at 48 hours (abstract)? Both options seem to reflect our stated primary outcome Physician‐assessed absence of patients' symptoms at 48 hours is also emphasised by Papp (P value = 0.0028). (This outcome measure is analogous to the primary outcome in the Ferley trial (though patient‐assessed in Ferley's case)). Patient‐assessed absence of symptoms at 48 hours in the Papp trial may be deduced from Figure 2 of their paper At 48 hours, improvement was reported by a total of 146/167 (87%) patients in the homeopathy group, compared with 136/167 (81%) in the placebo group (Table 2; statistical analysis not presented) Due to the above confusion, and to approximate, as closely as possible, the main outcome measure used by the previous authors of this review, we present 'patient‐assessed absence of symptoms at 48 hours' as the main outcome measure. Physician‐assessed absence of symptoms and physician‐assessed improvement at 48 hours are also presented (secondary outcome measures; Papp trial) Research setting: general or specialist practices, Germany Principal author (P Belon): employee of Boiron, the manufacturers of Oscillococcinum® |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequately described randomisation procedure |
Allocation concealment (selection bias) | Low risk | Adequately described allocation procedure |
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 | Unclear risk | Moderately high overall rate of attrition (approximately 10%); numbers stated in Methods do not reconcile with those in Results |
Selective reporting (reporting bias) | Unclear risk | Lack of clarity regarding several outcomes – see Notes above |
Other bias | Unclear risk | Insufficient information provided; statistical presentation unclear |