“This trial, the fourth in a series, was designed in response to a challenge from an independent clinical team to contest the evidence from the three preceding trials that homoeopathic dilutions seem to differ from placebo”
“These were not trials of treatments; they were designed to address the placebo hypothesis, using allergy as a model. In this study, as before, patients with atopic inhalant allergies received, randomly and double blind, either an oral 30c homoeopathic preparation of their principal allergen or a placebo. The previous trials studied effects in atopic patients with hay fever1,2 and asthma,3whereas this study focused on perennial allergic rhinitis. We report the results of this fourth trial and an overview of the series.”
“At the start of the qualification period the doctor assessed each patient's history, allergy status, and nasal obstruction. The principal allergen determining the prescription was then chosen on the basis of the largest skin test weal concordant with the allergy history. In seven cases in which the prescriber had difficulty in determining the principal allergen, telephone advice was given by a doctor experienced in prescribing homoeopathic immunotherapy. The first of three phials of placebo corresponding to the principal allergen was then administered by the doctor on to the patient's tongue. Patients were unaware that the phials contained placebo, although the researchers were not blinded.
The following two weeks served jointly as the qualification and baseline period. At the second visit, qualifying patients were randomised by a restricted technique of permuted blocks of two,7 generated from random number tables and stratified for the indicated allergen. A double blinded prescription was immediately dispensed. The trial ended with a follow up visit four weeks later.”
“At the same time each morning and evening patients recorded three successive nasal inspiratory peak flow measurements. Before making these measurements patients oriented themselves by noting each morning (on a 0 to 4 integer scale) how their symptoms had interfered with their sleep and, each night, rating blocked, runny, or itchy nose symptoms, sneezing, and any eye and chest symptoms. Patients then recorded their daily overall visual analogue scale score. To allow comparison with our previous trials1–3 the identical wording was used: “Overall today I felt . . .” on a scale of 0-100 mm, where 0 is fine and 100 is terrible. Visual analogue scale scores are a recommended measure of the severity of rhinitis.16 Adverse events, including initial aggravations of symptoms as observed in our previous rhinitis trial,2 were documented by the patients, clarified by the doctor, and recorded on standard adverse experience report forms. Any use of conventional drugs was also noted.”
“Fifty one patients successfully completed qualification screening and were randomised (fig (fig1).1). Because of the exacting screening, strict qualification criteria, and the prospectively defined requirement to stop enrolment before the pollen season, we did not recruit the number of patients that the power calculation had estimated we required.”
“Initial aggravations of rhinitis symptoms were provoked more by homoeopathy than by placebo. By 48 hours after randomisation seven (29%) patients in the homoeopathy group reported a worsening of rhinitis, two with wheeze, compared with two (7%) patients in the placebo group, neither of whom had wheezing (P=0.04, Fisher's exact test). By 14 days, 11 (46%) patients in the homoeopathy group had reported adverse events, 10 of whom had rhinitis related aggravations, compared with seven (26%) in the placebo group, five of whom had rhinitis related aggravations (χ2=3.28, P=0.07). In general, most aggravations were short lived, averaging four days, and all had resolved by day 16. Aggravations of rhinitis in patients who received homoeopathy seemed to point to a good outcome. Initial deterioration was followed by subjective improvement and a corresponding improvement in nasal inspiratory peak flow. Only one patient in each group resorted to conventional rhinitis drugs, and both took them for less than four days.”
“On average, over the last two weeks after randomisation, patients who received homoeopathy had a 28% improvement compared with 3% among those in the placebo group”
“Although the objective measure consistently improved in all five centres, the subjective results were better than placebo in only four of the five centres and overall there was no difference between the groups. If the objective results are valid the discrepancy in the subjective measurements may be partly due to under recruitment compounded by aggravations and possible initial placebo responses during the run-in period in both groups, perhaps reflecting the positive expectations of the participants.23 Patients with rhinitis are keen to enter studies in their quest for better symptom control.24Subjective improvement began before the end of the placebo run-in phase in both groups, and this lessened the chance of distinguishing between the groups.25,26 A larger sample size may have shown a subjective difference between the groups. More initial aggravations occurred in patients who received homoeopathy, and this may have further complicated the subjective results. The pattern of temporary worsening followed by improvement, seen in this trial and observed in clinical homoeopathy for over 200 years,27,28 is not typical of placebo.”
Honorary Senior Lecturer in Medicine, The University of Glasgow.
Consultant Physician, The NHS Centre for Integrative Care. - See more at: http://www.gcph.co.uk/events/125#sthash.yNnc2GiH.dpuf”

