Abstract. Homeopathic Q-Potencies for Atopic Dermatitis: a case series report. Adler, MS. Adler, UC.

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1 Homeopathic Q-Potencies for Atopic Dermatitis: a case series report. Adler, MS. Adler, UC. ZKH 2010;54(2): DOI: /s Abstract Background: case reports can be useful pilot studies for the standardization of clinical, pharmaceutical and research methodologies in Homeopathy, aiming at controlled studies. Objective: to report a series of patients with atopic dermatitis treated with a standardized method of Homeopathy. Methods: adults and children referred to the Clinic of Homeopathy and Dermatology of Faculdade de Medicina de Jundiaí (Jundiai Medical School, Sao Paulo, Brazil) who met Hanifin - Rajka criteria for atopic dermatitis were treated with homeopathically individualized Q-potencies using a standardized clinical-pharmaceutical methodology. The response was measured by the Eczema Area and Severity Index (EASI) scores. More detailed information about one patient was also reported, to make the homeopathic methodology clearer. Results: 19 patients were included. Response (more than 50% decrease of EASI scores) was achieved in 17/19 patients (89.4%). Two patients showed little improvement. The mean time to response was 3.7 months. Conclusion: these results suggest that individualized Q-potencies could be methodologically used in controlled studies to assess the efficacy of Homeopathy for atopic dermatitis. 1

2 Homeopathic Q-Potencies for Atopic Dermatitis: a case series report. Adler, MS. Adler, UC. The challenging question: Is there a place for alternative medicine in dermatology? was posed as a workshop subject during the recent (October 2009) 18 th Congress of the European Academy of Dermatology and Venereology in Berlin. Formal recommendations of medical associations and societies are usually presented as clinical guidelines, which are evidence-based reviews aiming at providing health care professionals, patients and purchasers objective information on the best clinical practice available. For atopic dermatitis (AD), for instance, the 2004 Guidelines from the American Academy of Dermatology Association summarize: Peer-reviewed clinical studies of the value of homeopathy in the treatment of AD have not been reported. To date, there is no evidence in the literature to support its use in the treatment of AD..9 A new edition of those Guidelines should include the evidence brought by a prospective multi-centre cohort study on children with AD treated with homeopathy or conventionally, showing that both groups improved similarly regarding perception of eczema symptoms (assessed by patients or parents) and disease-related quality of life 12. Cohort studies, however, are considered as secondary level of evidence for clinical guidelines: their results should supplement the findings of randomized clinical trials 2.12 (RCTs), since non-experimental approaches frequently lead to false positive conclusions about efficacy 15. 2

3 Another difference between observational and controlled clinical designs is that the former can draw conclusions from general therapeutic approaches, like children treated with homeopathy or conventionally, whereas RCTs need more specific and precise definition of the intervention being assessed. This need stresses a vulnerability of Homeopathy, in that it has become a heterogeneous therapeutical system with a multitude of schools and directions 14. Aiming at controlled trials, a way out of the multiplicity of homeopathic approaches is defining (as far as possible) a specific homeopathic methodology to be studied. For this purpose, case reports can be useful pilot studies gathering information for the standardization of clinical, pharmaceutical and research methodologies, besides providing data for Ethic Committees and for sample size calculation. In this study we present a series of 19 patients with atopic dermatitis, referred to the Clinic of Homeopathy and Dermatology of Faculdade de Medicina de Jundiaí (Jundiai Medical School, Sao Paulo, Brazil). The clinic integrates the Homeopathy graduation Program of Faculdade de Medicina de Jundiaí (FMJ) and its main objective is the homeopathic training of Medical Doctors, with only one working day/week. Patients were treated with individualized Q-potencies according to the method described by Hahnemann in the 6 th edition of the Organon. More detailed information about one patient was also reported, to make the homeopathic methodology clearer. Methods Patients Adults and children referred to homeopathic treatment from September.2007 until May.2009, who met Hanifin - Rajka criteria for atopic dermatitis 10 and attended at least 3 medical consultations were included. 3

4 Patients were referred by Pediatricians and Dermatologists from the Jundiai s public health system. They were examined and treated by the principal investigator, Maristela Schiabel Adler, who is a Medicals Doctor, Homeopath and Dermatologist, with over 10 years of experience in the use o individualized Q-potencies for patients with skin diseases. Design Prospective, open label, series of case report. Ethics A written informed consent was obtained from each participant. The study was approved by the Ethic Committee at FMJ. Measures Improvement was measured by Eczema Area and Severity Index (EASI) scores, chosen because it has been validated in Brazil and has shown reliability, sensitivity to change and correlated well with other measures of AD severity 5. Mean first (pre) and last (post) EASI scores were compared. Time to Response was assessed as the period necessary to a 50% reduction of basal EASI score. Medications Homeopathic Q-potencies were provided by HN-Cristiano Pharmacy, Pinheiros, São Paulo, under the responsibility of a pharmacist Amarilys de Toledo Cesar. They were prepared with strict quality control and supplied in 30 ml bottles (Figure 1), with one globule of the indicated Q-potency dissolved in 20 ml of a 30% alcohol-distilled water solvent. The patient or parent should strongly succuss (10 times) the vial before taking the drop. 4

5 Figure 1: example of medicine vial. The homeopathic medicines were selected according to Hahnemann s instructions, i.e, matching the characteristic symptoms (the stronger, well-marked, and peculiar symptoms) of each case to very similar symptoms described by Hahnemann s drug trials. No repertorization technique was used. Symptoms were searched in Hahnemann s The Chronic Diseases and Materia Medica Pura, with help of Ex Libris software and with Materia Medica Pura software, under development. Patients began the treatment on Q2 and moved on to higher potencies in ascending steps: Q3, Q4, etc. The standard posology was: More severe cases: 1 drop every other day, changing potency every 2 weeks; Less severe cases: 1 drop three times a week, changing potency every 4 weeks. Other interventions: Oral Antihistamines and topical corticosteroids already in use were gradually discontinued, as patients improved. Emollients were allowed and recommended, but seldom used, due to their relative high cost for Brazilian public health care patients. Patients had already received dietary and hygienic instructions by referring Physicians. Statistics The primary outcome measure was mean change in the EASI scores from baseline to the last score registered in patients files. Pre-Post evaluation was made with paired sample Student s t-test. 5

6 Results Nineteen patients were regularly treated for AD at the Homeopathy and Dermatology Clinic - FMJ in the studied period. Baseline characteristics are summarized in Table 1. Table 1: Baseline characteristics of the studied sample (n = 19) of AD patients. Each patient received one single homeopathic medicine at every follow-up. Considering the last prescribed remedy for each patient, only 7 homeopathic medicines were used to treat the studied sample, as shown in Figure 2. Figure 2: individualized homeopathic medicines prescribed at the last consultation for the studied sample of 19 patients. At the last consultation 11/19 (58%) patients from the sample were treated with individualized Sulphur. The proportion of Sulphur prescriptions among the subgroup of children patients was similar (62%). Response (at least 50% reduction in EASI basal score) was achieved in 17/19 patients (89.4%). Two patients showed little improvement. The mean time to response was 3.7 months. There was a significant Pre-Post difference between EASI scores during a mean treatment period of 8.8 months. These data are summarized in Table 2. 6

7 Table 2: Outcome measures Case Report BS, male, 7 years old First consultation: September 19 th 2008, accompanied by his mother. Symptoms appeared at the age of 10 months: itching red pimples on the whole body, which started on the penis. At the first appointment, the hands were mostly affected. Itching and obstruction of the nose, sleeps with his mouth open, with noisily snoring during sleep. Sometimes his nose secretion becomes yellowish with bloody stains. He calls his mother at night to help him scratching. Halitosis in the morning, even after brushing his teeth and having breakfast. Episodes of asthma and/or tonsillitis, from the 1 st until the 4 th year of age. Recurrent inflammation of the glans (with swelling and some bleeding) Nightly perspiration on the trunk and head, with bad smell. Recurrent nightmares, dreaming that his is falling from a building. Hidroxizine 5 mg/day in use. Physical examination: rash with red pimples and scratches signs all over the body; red, crusting, and scaling lesion on the occiput (Figure 3); scaly, lentil-sized lesions on palms (Figure 4); scratches and pimples on the dorsum of the hands (Figure 5) eczema lesions on axillae and anterior region of the thighs (Figure 6). EASI basal score: 29.4 points. 7

8 Homeopathic symptoms of Sulphur found in Hahnemann s The Chronic Diseases, are listed in Table 3. Table 3: Symptoms listed in Hahnemann s provings (Chronic Diseases) of Sulphur, similar to the Patient s characteristic symptoms. Initial medication: Sulphur Q2, 1 drop every other day, changing to higher potencies every 14 days. Follow up Last visit: August/09. Sulphur Q 33, 1 drop every other day. Hidroxizine was interrupted during the first month of treatment, due to clinical response. In the following month, 80% of the lesions improved and the patient stopped calling his mother at night to help him scratching. Within the third month of Sulphur the skin lesions were healed and remained without exacerbations up to one year of follow up. Rhinitis also markedly improved. The patient and his mother also reported remission of nightmares, balanitis and halitosis, as well as a normalization of the nightly sweat. EASI final score: 0. Some laboratory findings, indicative of atopic status are described in Table 4. Skin improvement is shown in Figure 7a-d. Table 4: laboratory findings related to atopic responsiveness of patient BS 8

9 Figure 7: healthy skin images of BS, after one year of treatment with fiftymillesimal potencies of Sulphur. 9

10 Discussion We reported nineteen cases of AD homeopathically treated with individualized standardized Q-potencies and a standardized clinical methodology. The sample was composed of children and adults, who had been ill for a mean period of 6 years before the first homeopathic consultation. The primary outcome measure showed a significant Pre-Post difference between eczema area and severity scores, during a mean treatment period of approximately nine months. In spite of disease chronicity, clinical response was achieved in 89% of the patients, after a mean treatment period of less than four months. A similar response rate (88.3%) was found in a Japanese sample of 25 patients with AD treated with individualized homeopathic C-potencies (6c, 12c, 30c, 200c and 1M), also in a non-controlled study.11. The single RCT studying homeopathy and AD had recruiting problems and therefore a small sample size. The study did not aim at a specific homeopathic methodology, using centesimal (C6, C30), decimal (D6, D12) and fifty-millesimal (Q6, Q12, Q18 and Q30) potencies to treat 31 patients (15 verum, 16 placebo) with atopic dermatitis. Whereas the placebo group showed a trend toward better AD related criteria and general well-being, in the verum group the trend was toward better scores of life satisfaction and of physical complaints. 16 After decades of experience with C-potencies, Hahnemann developed the Q- potencies and a very simple method for their use.8, starting with Q1 (as he did in his latest years 1 ) and moving up to higher potencies, step by step, as long as the patient improved. During many years we also started with LM or Q1 in our Brazilian practice with Q-potencies 2, but to spare the Pharmacy Q1, we have been lately using the Q2 as the first potency step. 10

11 Although the medicines were individualized, there was a majority of Sulphur prescriptions for our sample of atopic patients, which could be casual, biased or an indication of some similarity of Hahnemann s leading antipsoric and some states of the disease. Further studies are needed to clarify this finding, as well as controlled studies aiming at defining the efficacy of standardized homeopathic methods in helping patients with atopic dermatitis. In the last five years Q-potencies have proved to be reliable tools in RCTs studying homeopathy for fibromyalgia 6, for children with attention deficit hyperactivity disorder 7 as well as adults with major depression 4. Properly used they might also contribute to assure a place for homeopathy in dermatology, away from old prejudices that considered ugly eruptions on the skin as a good therapeutical sign 13, 3. 11

12 References 1 Adler UC, Adler MS: Hahnemann s experiments with 50 millesimal potencies: a further review of his casebooks. Homeopathy 2006; 95: Adler UC, Alves A., Cesar AT, Padula AE, Garozzo EN, Adler MS, Galhardi WP, Souza ICB: LM or Q potencies: retrospection of its use during 15 years in Brazil. Homeopathic Links 2005; 18: Adler UC, Alves A, Cesar AT, Padula AE, Adler MS, Garozzo EN, Galhardi WP: The harmful cure observed by Hering and Kent in contrast to Hahnemann s gentle restoration of health. Homeopathic Links 2006; 19: Adler UC, Paiva NM, Cesar AT, Molina A., Adler MS, Padula AE., Calil HM: Homeopathy versus fluoxetine for moderate to severe depression: double-blind, randomized non-inferiority trial. ecam Advanced Access published August 17, 2009: Available at 5 Barbier N, Paul C, Luger T, Allen R, De Prost Y, Papp K, Eichenfield LF, Cherill R, Hanifin J: Br J Dermatol 2004: 150(1): Bell IR, Lewis DA, Brooks AJ, Schwartz GE, Lewis SE, Walsh BT, Baldwin CM: Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology (Oxford) 2004; 43(5): Frei H, Everts R, von Ammon K, Kaufmann F, Walther D, Hsu-Schmitz SF, Collenberg M, Fuhrer K, Hassink R, Steinlin M, Thurneysen A: Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomized, double blind, placebo controlled crossover trial. Eur J Pediatr 2005; 164(12):

13 8 Hahnemann CFS: The Organon der Heilkunst: aude sapere. 6.Aufl., hrsg. u. mit Vorw. vers. von Richard Haehl, Leipzig, Schwuabe, Heidelberg: Haug; 1988: Hanifin JM, Cooper KD, Ho VC, Kang S, Krafchik BR, Margolis DJ, Schachner LA, Sidbury R, Whitmore SE, Sieck CK, Van Voorhees AS: Guidelines of care for atopic dermatitis. J Am Acad Dermatol 2004; 50(3): Hanifin JM, Rajka G: Diagnostic features of atopic dermatitis. Acta Dermatol Venereol (Stockh) 1980; (suppl. 92): Itamura R: Effect of homeopathic treatment of 60 Japanese patients with chronic skin disease. Complement Ther Med 2007; 15(2): Keil T, Witt CM, Roll S, Vance W, Weber K, Wegscheider K, Willich SN: Homoeopathic versus conventional treatment of children with eczema: a comparative cohort study. Complement Ther Med 2008; 16(1): Kent JT: Lectures on Homoeopathic Philosophy. New Dehli: B Jain; reprint 1986, Lecture 2 The highest ideal of a cure, Lecture 35: Prognosis after observing the action of the remedy. 14 Lüdtke R: Homöopathie Zum Stand der klinischen Forschung: Eine Stellungnahme der Karl und Veronica Carstens-Stiftung, Der Vorstand der Karl und Veronica Carstens-Stiftung 2006; 15 Sackett DL, Rosenberg William MC, Gray J, Haynes RB, Richardson WS: Evidence based medicine: what it is and what it isn t. BMJ 1996: 312(13). 13

14 16 Siebenwirth JA.: 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. Freiburg: Samueli Institute for Information Biology 2002:

Hahnemann s experiments with 50 millesimal potencies: a. Ubiratan Cardinalli Adler and Maristela Schiabel Adler.

Hahnemann s experiments with 50 millesimal potencies: a further review of his casebooks Ubiratan Cardinalli Adler and Maristela Schiabel Adler. Homeopathy, 2006, 95(3):171-181 São Paulo, March 2006. Abstract