Abstract
Introduction Previous findings from a pragmatic trial suggest that usual care compared with usual
care plus individualised homeopathy is not a feasible design to address homeopathic
interventions for asthma.
Objective The main purpose of this article was to investigate the feasibility of the randomised
withdrawal design as a strategy to assess the effectiveness of a standardised clinical–pharmaceutical
homeopathic protocol (Organon.modus) on perennial asthma in adolescents.
Methods Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study.
Patients: 12 to 17 years old adolescents, with the diagnosis of perennial asthma,
using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved
3 months of well-controlled asthma, after a variable period of individualised homeopathic
treatment according to Organon.modus protocol. Setting: a secondary care medical specialist centre. Intervention: continuation
with the individualised homeopathic medicine or with indistinguishable placebo during
12 weeks of beclomethasone step-down. Primary outcome: number of days of well-controlled
asthma. Secondary measures: number of days of fenoterol use, number of visits to an
emergency service (without hospitalisation) and percentage of patients excluded due
to an exacerbation characterising a partly controlled asthma. Tolerability was assessed
by Adverse Events, registered at every visit.
Results Nineteen patients were randomised to continue treatment with homeopathy and 21 with
placebo. Effectiveness measures for the homeopathy and placebo groups respectively
were median number of days of good clinical control: 84 versus 30 (p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 (p = 0.41); visits to an emergency room: 1 versus 6 (p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4%
(p = 0.05). Few Adverse Events were reported.
Conclusions This pilot study supports the feasibility of the double-blind randomised withdrawal
design in studies investigating homeopathy on teenage asthma, when performed by specialists
following a standardised clinical–pharmaceutical homeopathic protocol.
Clinical Trial Registration RBR-6XTS8Z.
Keywords
perennial asthma - beclomethasone - homeopathy
