| Methods | Double‐blind, randomised, parallel‐group, placebo‐controlled design, for prevention of URTIs | |
| Participants | Setting: Trondheim, Norway. Participants were recruited via a database search of presentations to casualty department at a university hospital. Participants: 251 randomised, 199 started the trial; 97 randomised to the homeopathy group and 102 to the placebo group Recruitment method: patients were sent a letter with the informed consent form included for the parents to sign and return if they agreed to participate. Withdrawals and exclusions: all children who started treatment were included in analysis. Those who did not begin treatment were accounted for. Age range: 0 to 10 years Gender: 45% female Eligibility criteria: Inclusion criteria: children < 10 years with a previous diagnosis of URTI by a medical doctor (ear pain, acute or chronic otitis media, streptococcal infection, sinusitis, tonsillitis) Exclusion criteria: concomitant serious disease or daily use of medicines such as antibiotics, corticosteroids (except in inhalers), and cytotoxic agents, and use of homeopathic medicines in the 3 months prior to inclusion |
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| Interventions | C30 potency of either Calcarea carbonica, Pulsatilla, or sulphur Children were assigned 1 of these medicines based on the parent reading an information sheet and answering 2 questions related to their child's symptoms. Instructions: 2 pills 2 days per week for 12 weeks, with 1 pill up to once every hour if child had an acute episode of URTI "The placebos were lactose pills and indistinguishable from the homeopathic medicines in package, look, taste and smell." |
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| Outcomes | Median daily symptom score, days with URTI, antibiotic use, analgesic use, days off work for parents, adverse events | |
| Notes | Sources of support: Norwegian Research Council | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Randomization was done by an independent trial service office that provided a randomisation list.” (p. 449) Comment: robust method of random sequence generation |
| Allocation concealment (selection bias) | Low risk | Quote: “Each box consisted of bottles numbered consecutively, with placebo and homeopathic medicines allocated according to the randomisation list." (p. 450) Comment: robust method of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “The placebos were lactose pills and indistinguishable from the homeopathic medicines in package, look, taste and smell.” (p. 450) Comment: adequate blinding of participants |
| Blinding of outcome assessment (detection bias) Patient reported outcomes | Low risk | Quote: “Daily patient diaries were used as the main outcome measure and were completed by the child’s parents." (p. 450) Comment: parents completed the daily symptom diary for their children and appear to be adequately blinded. |
| Blinding of outcome assessment (detection bias) Practitioner outcome assessors | Low risk | Quote: "A double‐blind randomised parallel group placebo controlled trial" (p. 448) Comment: practitioner blinding less important as outcomes were assessed by parents. Robust methods above suggest detection bias unlikely. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Analysis Confirmatory testing of the main outcome measure is based on intention to treat, with all patients who started the study included in the analysis." (p. 451) 29/126 randomised children in homeopathy group and 23/125 in placebo group did not start the study. Reasons for not starting: too busy, other treatment, chance of placebo, been healthy, no reason. 16/97 in homeopathy group and 18/102 in placebo group had missing data for part of study. Reasons given: moved, on holiday, on other treatment, too busy, no reason. Comment: similar numbers and reasons for participants not starting and for incomplete data. All participants who started the study were included in data analysis. |
| Selective reporting (reporting bias) | Low risk | All outcome measures listed in methods reported in results. |
| Other bias | Low risk | Well‐designed, well‐reported study |
ARTI: acute respiratory infection AOM: acute otitis media AOM‐SOS: Acute Otitis Media Severity of Symptoms HAU: haemagglutinating unit ITT: intention‐to‐treat OME: otitis media with effusion OR: odds ratio PNO: pneumatic otoscopy RCT: randomised controlled trial URTI: upper respiratory infection