TY - JOUR
T1 - Wirksamkeit einer klassisch-homöopathischen Therapie bei atopischem Ekzem
T2 - Eine randomisierte, placebokontrollierte Doppelblindstudie
AU - Siebenwirth, Joachim
AU - Lüdtke, Rainer
AU - Remy, Wolfgang
AU - Rakoski, Jürgen
AU - Borelli, Siegfried
AU - Ring, Johannes
PY - 2009/11
Y1 - 2009/11
N2 - Background: Atopic dermatitis (atopic eczema) is one of those diseases where homeopaths claim to have good success although this has never been proven by rigorously controlled trials. Methods: Single-centre, randomised, double-blind clinical trial comparing homeopathic remedies with placebo in young adults (age 18-35) with atopic dermatitis. Homeopathic remedies were individually administered according to the rules of classical homeopathy. After an untreated baseline period of 4 weeks, all patients were treated and monitored for 32 weeks. Throughout the study, co-medication was allowed only with indifferent emollients. The main outcome parameter was disease severity as assessed by Costa and Saurat's multi-parameter atopic dermatitis score (MP-score). Results: 744 patients were screened out of which 24 (10 verum, 14 placebo) were randomised and analysed. Treatment groups were balanced in most baseline parameters but MP-scores were significantly higher in verum patients (p = 0.034, t-test). 10 patients (5 per group) dropped out of the study, mainly because the treatment was perceived as ineffective and co-medication was needed. The MP-score decreased from 54.5 ± 11.0 to 40.7 ± 12.5 in the verum group and from 45.9 ± 7.6 to 32.7 ± 21.8 in the placebo group, resulting in a non-significant group difference of 5.6 in favour of placebo (CI: -9.0 to 20.2; p = 0.46; ANCOVA). No secondary parameter (quality of life, coping, global assessments of treatment success) showed significant differences between groups (all p > 0.15). Conclusions: In this study, individualised homeopathic remedies did not prove to be superior to placebo in atopic dermatitis. Yet, generalisability of results is limited due to the small number of patients and the high percentage of ineligible patients.
AB - Background: Atopic dermatitis (atopic eczema) is one of those diseases where homeopaths claim to have good success although this has never been proven by rigorously controlled trials. Methods: Single-centre, randomised, double-blind clinical trial comparing homeopathic remedies with placebo in young adults (age 18-35) with atopic dermatitis. Homeopathic remedies were individually administered according to the rules of classical homeopathy. After an untreated baseline period of 4 weeks, all patients were treated and monitored for 32 weeks. Throughout the study, co-medication was allowed only with indifferent emollients. The main outcome parameter was disease severity as assessed by Costa and Saurat's multi-parameter atopic dermatitis score (MP-score). Results: 744 patients were screened out of which 24 (10 verum, 14 placebo) were randomised and analysed. Treatment groups were balanced in most baseline parameters but MP-scores were significantly higher in verum patients (p = 0.034, t-test). 10 patients (5 per group) dropped out of the study, mainly because the treatment was perceived as ineffective and co-medication was needed. The MP-score decreased from 54.5 ± 11.0 to 40.7 ± 12.5 in the verum group and from 45.9 ± 7.6 to 32.7 ± 21.8 in the placebo group, resulting in a non-significant group difference of 5.6 in favour of placebo (CI: -9.0 to 20.2; p = 0.46; ANCOVA). No secondary parameter (quality of life, coping, global assessments of treatment success) showed significant differences between groups (all p > 0.15). Conclusions: In this study, individualised homeopathic remedies did not prove to be superior to placebo in atopic dermatitis. Yet, generalisability of results is limited due to the small number of patients and the high percentage of ineligible patients.
KW - Atopic dermatitis
KW - Atopic eczema
KW - Homeopathy
KW - Placebo-controlled randomised clinical trial
UR - http://www.scopus.com/inward/record.url?scp=70449396273&partnerID=8YFLogxK
U2 - 10.1159/000242434
DO - 10.1159/000242434
M3 - Artikel
C2 - 19887810
AN - SCOPUS:70449396273
SN - 1661-4119
VL - 16
SP - 315
EP - 323
JO - Forschende Komplementarmedizin
JF - Forschende Komplementarmedizin
IS - 5
ER -