17. Schirmer K P, Fritz M, Jäckel W H. Wirksamkeit von Formica rufa und Eigenblut-Injektionen bei Patienten mit ankylosierender Spondylitis: eine doppelblinde, randomisierte Studie. Z Rheumatol 2000;59:321–329. [Article in German]. Argental-Klinik 88316 Isny-Neutrauchburg.
Abstract.
While complementary medicine and homeopathy is becoming an increasingly prominent part of the health care practices, there is a lack of controlled studies concerning their effectiveness. In our study, we wanted to answer the question whether a combination of Formica rufa D6 and reinjection of the patient's own blood is superior to injection of placebo. 104 patients with ankylosing spondylitis entered a prospective, randomized, double-blind study. During four weeks they received twice weekly either 1 ml of Formica rufa D6 in combination with 0.5 ml of blood or 1.5 ml NaCl intramuscular. Before and after therapy, mobility, thoracic excursion and doctor's overall assessment were measured in addition to patient's health status, using a German version of the Arthritis Impact Measurement Scales, before and after therapy as well as four, twelve, and twenty-four weeks later. We were not able to detect any statistical difference between treatment and placebo group in any of the parameters measured. Therefore, the therapy under study may not be regarded effective.
http://www.ncbi.nlm.nih.gov/pubmed?t...20Fritz%20M%2C
18. Jacobs J, Springer D A, Crothers D. Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J 2001;20:177–183
Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, USA.
jjacobs@igc.org
Abstract.
BACKGROUND: The use of antibiotics in the initial treatment of acute otitis media is currently being questioned. Homeopathy has been used historically to treat this illness, but there have been no methodologically rigorous trials to determine whether there is a positive treatment effect.
METHODS: A randomized double blind placebo control pilot study was conducted in a private pediatric practice in Seattle, WA. Seventy-five children ages 18 months to 6 years with middle ear effusion and ear pain and/or fever for no more than 36 h were entered into the study. Children received either an individualized homeopathic medicine or a placebo administered orally three times daily for 5 days, or until symptoms subsided, whichever occurred first. Outcome measures included the number of treatment failures after 5 days, 2 weeks and 6 weeks. Diary symptom scores during the first 3 days and middle ear effusion at 2 and 6 weeks after treatment were also evaluated.
RESULTS: There were fewer treatment failures in the group receiving homeopathy after 5 days, 2 weeks and 6 weeks, with differences of 11.4, 18.4 and 19.9%, respectively, but these differences were not statistically significant. Diary scores showed a significant decrease in symptoms at 24 and 64 h after treatment in favor of homeopathy (P < 0.05). Sample size calculations indicate that 243 children in each of 2 groups would be needed for significant results, based on 5-day failure rates.
CONCLUSIONS: These results suggest that a positive treatment effect of homeopathy when compared with placebo in acute otitis media cannot be excluded and that a larger study is justified.
http://www.ncbi.nlm.nih.gov/pubmed?t...Springer%20%2C
19. Bonne O, Shemer Y, Goali Y, Katz M, Shalev-Arieh Y. A randomized, double-blind, placebo-controlled study of classical homeopathy in generalized anxiety disorder. J Clin Psychiatry 2003;64:282–287. Department of Psychiatry, Hadassah University Medical School and the Department of Psychiatry, Hadassah University Hospital, Jerusalem, Israel.
bonneo@intra.nimh.nih.gov
Abstract.
BACKGROUND: Homeopathy is commonly used for the treatment of medical and psychological conditions. Such prevalent use, however, is not supported by robust, methodologically sound research. This study evaluates the effect of homeopathic treatment in generalized anxiety disorder, a prevalent mental disorder characterized by an enduring pattern of excessive apprehension and distress and by mental and bodily complaints.
METHOD: Forty-four patients with DSM-IV generalized anxiety disorder participated in a randomized, double-blind, placebo-controlled 10-week trial of individually tailored homeopathic remedy. Homeopathic therapy was administered by an expert who followed the traditional routines of homeopathic diagnosis and prescription. Thirty-nine subjects completed the study (20 in the active treatment group and 19 in the placebo group). Subjects' symptoms were rated before treatment and after 5 and 10 weeks of treatment, with the Hamilton Rating Scale for Anxiety (HAM-A) as main outcome measure. Additional measures of outcome included the Brief Symptom Inventory, the Psychological General Well-Being Index, the Hamilton Rating Scale for Depression, the Beck Depression Inventory, Spielberger's State-Trait Anxiety Inventory, and a Visual Analogue Scale of subjective distress.
RESULTS: Significant (p <.05) improvement in most measures, including the HAM-A, was observed in both the active treatment and placebo groups, yet no group effect was observed.
CONCLUSION: The effect of homeopathic treatment on mental symptoms of patients with generalized anxiety disorder did not differ from that of placebo. The improvement in both conditions was substantial. Improvement of such magnitude may account for the current belief in the efficacy of homeopathy and the current increase in the use of this practice.
http://www.ncbi.nlm.nih.gov/pubmed?t...0O%2C%20Shemer
20. White A, Slade P, Hunt C, Hart C A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomized placebo controlled trial. Thorax 2003;58:317–321
Complementary Medicine, Peninsula Medical School, University of Exeter, Exeter EX2 4NT, UK.
adrian.white@pms.ac.uk
Comment in:
Thorax. 2003 Sep;58(9):827; author reply 828.
Thorax. 2003 Sep;58(9):826-7; author reply 828.
Thorax. 2003 Sep;58(9):826; author reply 828.
Thorax. 2003 Sep;58(9):826; author reply 828.
Thorax. 2003 Sep;58(9):827-8; author reply 828.
Abstract.
BACKGROUND: Homeopathy is frequently used to treat asthma in children. In the common classical form of homeopathy, prescriptions are individualised for each patient. There has been no rigorous investigation into this form of treatment for asthma.
METHODS: In a randomised, double blind, placebo controlled trial the effects of individualised homeopathic remedies were compared with placebo medication in 96 children with mild to moderate asthma as an adjunct to conventional treatment. The main outcome measure was the active quality of living subscale of the Childhood Asthma Questionnaire administered at baseline and follow up at 12 months. Other outcome measures included other subscales of the same questionnaire, peak flow rates, use of medication, symptom scores, days off school, asthma events, global assessment of change, and adverse reactions.
RESULTS: There were no clinically relevant or statistically significant changes in the active quality of life score. Other subscales, notably those measuring severity, indicated relative improvements but the sizes of the effects were small. There were no differences between the groups for other measures.
CONCLUSIONS: This study provides no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.
http://www.ncbi.nlm.nih.gov/pubmed?t...20A%2C%20Slade
21. Jonas W B, Anderson R L, Crawford C C, Lyons J S. A systematic review of the quality of homeopathic clinical trials. BMC Complement Altern Med 2001;1:12. Samueli Institute for Information Biology and Department of Family Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
wjonas@siib.org
Abstract.
BACKGROUND: While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature.
METHODS: In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945-1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95.
RESULTS: 59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years.
CONCLUSIONS: Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods.
http://www.ncbi.nlm.nih.gov/pubmed?t...%2C%20Anderson
22. Schmidt K, Ernst E. MMR vaccination advice over the internet. Vaccine 2003;21:1044–1047
Complementary Medicine, Peninsula Medical School, University of Exeter, 25 Victoria Park Road, Exeter EX2 4NT, UK.
katja.schmidt@pms.ac.uk
Abstract.
We wanted to investigate what advice UK homeopaths, chiropractors and general practitioners give on measles, mumps and rubella vaccination programme (MMR) vaccination via the Internet. Online referral directories listing e-mail addresses of UK homeopaths, chiropractors and general practitioners and private websites were visited. All addresses thus located received a letter of a (fictitious) patient asking for advice about the MMR vaccination. After sending a follow-up letter explaining the nature and aim of this project and offering the option of withdrawal, 26% of all respondents withdrew their answers. Homeopaths yielded a final response rate (53%, n = 77) compared to chiropractors (32%, n = 16). GPs unanimously refused to give advice over the Internet. No homeopath and only one chiropractor advised in favour of the MMR vaccination. Two homeopaths and three chiropractors indirectly advised in favour of MMR. More chiropractors than homeopaths displayed a positive attitude towards the MMR vaccination. Some complementary and alternative medicine (CAM) providers have a negative attitude towards immunisation and means of changing this should be considered.
http://www.ncbi.nlm.nih.gov/pubmed?t...the%20internet
23. Lehrke P, Nübling M, Hofmann F, Stössel U. Impfverhalten und Impfeinstellung bei ärzten mit und ohne Zusatzbezeichnung Homöopathie. Monatsschr Kinderheilkd 2004;152:752–757
24. Thompson E, Barron S, Spence D. A preliminary audit investigating remedy reactions including adverse events in routine homeopathic practice. Homeopathy 2004;93:203–209. Bristol Homeopathic Hospital, United Bristol Healthcare Trust, Cotham Hill, Bristol BS6 6PD, UK.
elizabeth.thompson@ubht.swest.nhs.uk
Abstract.
Homeopathic medicines are regarded as safe but practitioners report several types of healing or remedy reactions including aggravations, new symptoms and recurrence of old symptoms, some of which could be regarded as side effects or unwanted effects. Some remedy reactions may be regarded as adverse events. AUDIT QUESTIONS: Do such reactions occur within our unit, and if so, how frequently? Do patients regard these events as "adverse"?
METHODS: The audit was carried out in the Bristol Homeopathic Hospital Outpatient Department. All patients were given a questionnaire to complete when at their first follow-up consultation approx 6-10 weeks after their first appointment. One hundred and sixteen patients were sampled over a 2-month period.
RESULTS: Reactions were frequent: 28 out of the 116 (24%) patients, experienced an aggravation. Thirteen patients (11%) reported an adverse event even though 5 of those were patients who also reported an aggravation followed by an overall improvement of their symptoms. Thirty-one patients described new symptoms (27%) and 21(18%), a return of old symptoms. Those experiencing the latter appeared to have better outcomes.
CONCLUSIONS: Remedy reactions are common in clinical practice; some patients experience them as adverse events. Systematically recording side effects would facilitate our understanding of these reactions and would enable standards to be set for audit of information and patient care.
http://www.ncbi.nlm.nih.gov/pubmed/15532700
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Clin Rheumatol. 2010 May;29(5):457-64. Epub 2010 Jan 23. A systematic review of homoeopathy for the treatment of fibromyalgia. Perry R, Terry R, Ernst E. Department of Complementary Medicine, Peninsula Medical School, 25 Victoria Park Road, Exeter, Devon, EX2 4NT, UK.
rachel.perry@pms.ac.uk
Abstract.
Homoeopathy is often advocated for fibromyalgia (FM) and many FM patients use it. To critically evaluate all randomised clinical trials (RCTs) of homoeopathy as a treatment for FM, six electronic databases were searched to identify all relevant studies. Data extraction and the assessment of the methodological quality of all included studies were done by two independent reviewers. Four RCTs were found, including two feasibility studies. Three studies were placebo-controlled. None of the trials was without serious flaws. Invariably, their results suggested that homoeopathy was better than the control interventions in alleviating the symptoms of FM. Independent replications are missing. Even though all RCTs suggested results that favour homoeopathy, important caveats exist. Therefore, the effectiveness of homoeopathy as a symptomatic treatment for FM remains unproven.
http://www.ncbi.nlm.nih.gov/pubmed/20099019
Homeopathy. 2003 Apr;92(2):92-8. Homeopathic aggravations: a systematic review of randomised, placebo-controlled clinical trials. Grabia S, Ernst E. Master of Public Health Program, University of Wisconsin-La Crosse, USA.
Abstract.
Homeopathic aggravations have often been described anecdotally. However, few attempts have been made to scientifically verify their existence. This systematic review aimed at comparing the frequency of homeopathic aggravations in the placebo and verum groups of double-blind, randomised clinical trials. Eight independent literature searches were carried out to identify all such trials mentioning either adverse effects or aggravations. All studies thus found were validated and data were extracted by both authors. Twenty-four trials could be included. The average number of aggravations was low. In total, 50 aggravations were attributed to patients treated with placebo and 63 to patients treated with homoeopathically diluted remedies. We conclude that this systematic review does not provide clear evidence that the phenomenon of homeopathic aggravations exists.
http://www.ncbi.nlm.nih.gov/pubmed/12725251