Claudia M. Witt1, Rainer Lüdtke2 and Stefan N. Willich1
1Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, DE-10098 Berlin and 2Karl and Veronica Carstens-Foundation, Essen, Germany. E-mail: claudia.witt@charite.de
Accepted August 28, 2008.
Sir,
Homeopathy is practised in many regions of the world (1), especially in high-income countries where it ranks the most popular among traditional, complementary, or alternative medicines (1–3). One out of 5 children in a German homeopathic physicians’ practice suffered from atopic eczema (AE) (4). Meta-analyses of placebo-controlled studies including only diagnoses other than AE have shown inconsistent results (5, 6). The only randomized placebo-controlled study on AE (7) was stopped due to recruitment problems and drop-outs. In a prospective observational study we investigated the treatment and possible effects in 3981 consecutive patients (1130 children and 2851 adults) who consulted a physician for classical homeopathic therapy. This paper presents the subgroup of children with AE (ICD-9: 691.8, ICD-10: L20.8), followed up for 24 months. For more details and methods see (8).
Results
We included 225 children (Table I) in this intention-to-treat analysis with a disease duration of AE of 3.6 ± 3.8 years. On average the last homeopathic medication was documented after 11.8 ± 10.1 months; however, the majority of patients (69%) continued homeopathic care at the end of the study. Over the course of the study patients received 7.3 ± 6.4 homeopathic prescriptions, most frequently Calcium carbonicum (8.2%), Tuberculinum (7.2%), and Medorrhinum (6.8%). In total, 137 different homeopathic remedies were used. The strongest improvement in diagnoses and medical complaints was seen in the first 3 months, and it continued during the full observation period (Table II). Physicians’ severity assessments tended to be more positive than patients’ assessments, still all changes since baseline were of large effect size (Cohen’s d 1.76–2.56). After 24 months, the AE as well as the other baseline diagnoses were considerably relieved, while reductions in use of conventional medicines were observed (Table I).
Table I. Sociodemographic data, co-morbidity (incl. ICD-10 codes) and additional conventional medication (n = 225)
| Female, % (n) | 51.6 (116) |
| Age (years, mean ± SD) | 5.0 ± 3.9 |
| Parents expectation: homeopathy, % (n)a | |
| Will help | 74.2 (167) |
| Will maybe help | 24.9 (56) |
| Will not help | 0.4 (1) |
| Concomitant diagnoses at baseline* | |
| Average number (mean ± SD) | 2.1 ± 1.0 |
| Average severity (NRS, mean ± SD) | 5.2 ± 1.6 |
| Frequent infections R68.8, % (n) | 11.1 (25) |
| Allergy T78.4, % (n) | 8.0 (18) |
| Asthma bronchiale J45.9, % (n) | 8.0 (18) |
| Chronic bronchitis J42, % (n) | 5.8 (13) |
| Patients using conventional medication, % (n) | |
| Baseline | |
| ATC-Code D (Dermatologicals) | 9.8 (22) |
| ATC-Code R (Respiratory system) | 30.7 (69) |
| Corticosteroids | 4.4 (10) |
| 0–3 months | |
| ATC-Code D (Dermatologicals) | 2.7 (6) |
| ATC-Code R (Respiratory system) | 13.8 (31) |
| Corticosteroids | 0.9 (2) |
| > 3–12 months | |
| ATC-Code D (Dermatologicals) | 1.3 (3) |
| ATC-Code R (Respiratory system) | 16.4 (37) |
| Corticosteroids | 0.4 (1) |
| > 12–24 months | |
| ATC-Code D (Dermatologicals) | 0.4 (1) |
| ATC-Code R (Respiratory system) | 13.8 (31) |
| Corticosteroids | 0 (0) |
*Only those diagnoses seen in ≥ 5% patients; with ICD-10 code.
aMissing data from one case.
NRS: numerical rating scale; 10: maximum; 0: cured; ATC: anatomical therapeutic chemical classification system; SD: standard deviation.
Table II. Severity of diagnoses symptoms and change over time. At baseline, 3, 12 and 24 months patients and their physicians rated the severity (patients: complaints, physicians: diagnoses) on a numeric rating scale (NRS, 0: no complaints; 10: maximum severity)
| Atopic eczema | All diagnoses | All complaints | |
| NRS, mean (95% CI)* | |||
| Baseline | 4.68 (4.44; 4.91) | 5.20 (4.99; 5.41) | 5.68 (5.42; 5.94) |
| Month 3 | 2.97 (2.73; 3.21) | 2.98 (2.77; 3.19) | 3.16 (2.88; 3.44) |
| Month 12 | 1.73 (1.49; 1.96) | 1.87 (1.66; 2.08) | 2.98 (2.68; 3.29) |
| Month 24 | 1.06 (0.82; 1.30) | 1.21 (1.00; 1.42) | 2.52 (2.19; 2.84) |
| Change on NRS, mean (95% CI)* | |||
| Months 0–3 | –1.70 (–1.92; –1.49) | –2.22 (–2.41; –2.02) | –2.52 (–2.86; –2.17) |
| Months 0–12 | –2.95 (–3.22; –2.68) | –3.33 (–3.57; –3.09) | –3.10 (–3.42; –2.77) |
| Months 0–24 | –3.61 (–3.91; –3.31) | –3.98 (–4.25; –3.72) | –3.52 (–3.87; –3.18) |
| Effect size, mean (95% CI)# | |||
| Months 0–3 | 0.83 (0.94; 0.73) | 1.43 (1.55; 1.30) | 1.47 (1.67; 1.27) |
| Months 0–12 | 1.44 (1.57; 1.31) | 2.14 (2.30; 1.99) | 1.81 (2.00; 1.62) |
| Months 0–24 | 1.76 (1.91; 1.62) | 2.56 (2.74; 2.39) | 2.06 (2.26; 1.86) |
| Responder rates at end of study | (% (n) of patients) | (% (n) of a total of 432 diagnoses) | |
| Fully cured | 30.2 (68) | 37.3 (161) | |
| Better by ≥ 50% baseline | 24.0 (54) | 25.7 (111) | |
| Better by ≥ 10% < 50% | 3.1 (7) | 3.7 (16) | |
| Change within ± 10% | 1.3 (3) | 1.9 (8) | |
| Worse > 10% | 0.4 (1) | 0.7 (3) | |
CI = confidence interval.
*Statistical analysis: intention-to-treat analysis (using SAS/STAT© v8.2 software), missing values handled as follows: cured complaints: severity = 0 in subsequent records; deceased patients: severity = 10. Remaining missing values were multiply imputed according to Rubin (11). For each imputed data set, treatment effects were estimated on the basis of a generalized multiple linear regression model according to Diggle et al. (12). #Cohen’s d classified: as > 0.8, large; > 0.5, medium > 0.2, small. All changes p < 0.001.
Discussion
The patients with AE in our study suffered from long-term disease. The severity of disease and quality of life improved substantially and the uses of conventional medication and health services decreased markedly. The methodological strengths of our study include consecutive patient enrolment, high follow-up rates, and the participation of about 1% of all certified homeopathic physicians in Germany. In contrast to randomized trials, our study describes patients from everyday practice with multiple morbidities and a wide range of lifestyles. This ensures a high degree of external validity that allows extrapolation to usual medical care. Our study was designed to evaluate homeopathic treatment in patients with various diagnoses that disallowed the use of disease-specific measurement instruments. The effect size of the severity ratings after 12 and 24 months was large. This may be explained mainly by unspecific effects, natural course of disease or regression to the mean, which our study was not designed to control (effect sizes in between-group comparisons are usually smaller). Our study does not support conclusions as to the effectiveness of the homeopathic remedies, because no methodology for this purpose (control group, randomization, blinding) was built into its design and patients could use additional conventional therapies. The aim of this study was to provide systematic and detailed information about status and effects of homeopathic medical care in usual care. These data could also be helpful in the planning of further research projects on homeopathy, which could include specific instruments, such as SCORAD (SCORing Atopic Dermatitis) (9, 10) and control groups. The reduction in conventional medication also may not be due to the homeopathic remedies alone. Homeopathic physicians are known to use conventional means with a certain hesitation, thus functioning as a kind of “gatekeeper”.
The authors declare no conflict of interest.
Acknowledgements
The authors wish to thank the participating physicians for their work and the patients for their co-operation. Thanks are also due to Elvira Krüger for data acquisition, and to Karin Weber and Katja Wruck for data management. This work was supported with a grant by the Karl und Veronica Carstens-Foundation, D-Essen, for SNW and CMW.
References
1. Ong CK, Bodeker G, Grundy C, Burford G, Shein K. WHO global atlas of traditional, complementary and alternative medicine. Kobe, Japan: World Health Organization, Centre for Health Development, 2005.
2. Eisenberg D, Davis R, Ettner S, Appel S, Wilkey S, Van Rompay M, et al. Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey. JAMA 1998; 280: 1569–1575.
3. Härtel U, Volger E. Inanspruchnahme und Akzeptanz von klassischen Naturheilverfahren und alternativen Heilmethoden in Deutschland: Ergebnisse einer repräsentativen Bevölkerungsstudie. Forsch Komplementarmed Klass Naturheilkd 2004; 11: 327–334.
4. Becker-Witt C, Lüdtke R, Weißhuhn TER, Willich SN. Diagnoses and treatment in homeopathic medical practice. Forsch Komplementärmed Klass Naturheilkd 2004; 11: 98–103.
5. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges L, et al. Are the effects of homeopathy placebo effects? A meta-analysis of randomized, placebo controlled trials. Lancet 1997; 350: 834–843.
6. Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JAC, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet 2005; 366: 726–732.
7. Siebenwirth J. A randomized, placebo controlled, double-blind study testing the effectiveness of classical homeopathic therapy of atopic dermatitis (AD). In: Walach H, et al., editors. Future directions and current issues of research in homeopathy, Proceedings, Freiburg, January 2002. Freiburg: Samueli Institute for Information Biology, 2002: p. 79–90.
8. Witt CM, Lüdtke R, Baur R, Willich S. Homeopathic medical practice: Long-term results of a cohort study with 3981 patients. BMC Public Health 2005; 5: 115.
9. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology 1993; 186: 23–31.
10. Kunz B, Oranje AP, Labreze L, Stalder JF, Ring J, Taieb A. Clinical validation and guidelines for the SCORAD index: consensus Report of the European Task Force on Atopic Dermatitis. Dermatology 1997; 195: 10–19.
11. Rubin DB, editor. Multiple imputations for nonresponse in surveys. New York: John Wiley & Sons, 1987.
12. Diggle P, Liang K, Zeger S, editors. Analysis of longitudinal data. Oxford: Clarendon Press, 1994.
