Dr. Concepción Campa, Dr. Luis E. Varela, Dr. Esperanza Gilling, MCs. Rolando Fernández, Tec. Bárbara Ordaz, Dr. Gustavo Bracho, Dr. Luis García, Dr. Jorge Menéndez, Lic. Natalia Marzoa, Dr. Rubén Martínez.
“The Finlay Institute is a centre dedicated to development and production of vaccines; we also bring our WHO qualified facilities for all homeopaths and homeopathic medicine. The Finlay Institute acts as supporting institution for research, production and development of high quality homeopathic products. However, according with the social objective addressing prevention of infectious diseases, we are focused on homeo- prophylaxis as strategy to attenuate the impact of preventable diseases on developing world, the ones that need it the most.
Thus, development and evaluation of nosodes, appears to be our main approach to fill up the breakthrough on current conventional strategies based on vaccination. Similarly with vaccination interventions, massive applications of prophylactic nosodes give rise to a greater impact on population health compared with individualized therapies. In addition, the easy administration and low economics resources needed, become this alternative really suitable and accessible for developing countries and almost the best for emergency situations comprising epidemic outbreaks and natural disasters. The Cuban experiences of massively administrated nosodes supports it use as promising solution to confront epidemiological dangerous situations.
On October November 2007, three provinces of the eastern region of Cuba were affected by strong rainfalls causing floods of big areas and several damages to sanitary and health systems. The risk of leptospirosis infection raised extremely dangerous levels with about 2 million of peoples exposed to potentially contaminated water.
Considering this situation, the Finlay Institute prepared a leptospira nosode 200 CH using 4 circulating strains and following international quality standards. A multidisciplinary team travelled to the affected regions to conduct the massive administration of the nosode. Coordinated action with public health system infrastructures allowed the administration of a preventive treatment consisting in two doses (7- 9 days apart) of the nosode to about 2,4 million of people (4,8 million of doses). The coverage of the intervention rose up to 95% percent of total population of the three provinces at risk.
The epidemiology surveillance after the intervention showed a dramatic decrease of morbidity two weeks after and a reduction to cero of mortality of hospitalized patient. The number of confirmed leptospirosis cases remains at low levels and below the expected levels according with the trends and rain regimens.
A reinforcing application was given after the hit of the hurricane IKE but using the nosode diluted up to 10 MC. Strict epidemiologic surveillance is carried out on this provinces. Up to date result will be presented.
The results supported the design of new strategies for leptospirosis control. This experience could be extended to other diseases and other countries. The Finlay Institute is offering our facilities and specialists to spread this alternative to all regions needing emergent alternatives for epidemic control and prevention”.
-Sent by Homeopathy Worked for Me- an organization worthy of your support.
Monday, March 8, 2010
Saturday, March 6, 2010
Homeopathic treatment of patients with chronic sinusitis: A prospective observational study with 8 years follow-up
Claudia M Witt1 , Rainer Lüdtke2 and Stefan N Willich1
1 Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Centre, D-10098 Berlin, Germany
2 Karl and Veronica Carstens-Foundation, Am Deimelsberg 36, D-45276 Essen, Germany
author email corresponding author email
BMC Ear, Nose and Throat Disorders 2009, 9:7doi:10.1186/1472-6815-9-7
Abstract
Background
An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for ≥12 weeks in a usual care situation.
Methods
Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; ≥12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment.
Results
The study included 134 adults (mean age 39.8 ± 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 ± 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00).
Conclusion
This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.
Background
Chronic sinusitis is generally accepted to be a common illness incurring considerable costs, despite limited epidemiological data[1]. It is defined as an inflammation of the nasal mucosa and paranasal sinuses for at least 12 weeks which may cause nasal blockage or congestion, mucous discharge, facial pain or pressure, and/or impaired smell. Polyps, which may or may not be present are increasingly recognized as part of the sinusitis pathology [1,2]. Several factors have been found to contribute to the disease, namely, insufficient ciliary motility, allergy and asthma, bacterial infection, and more rarely, morphological anomalies, immune deficiencies and Samter's triad (salicylate sensitivity, asthma, nasal polyps). While the role of fungi and hormonal changes during pregnancy are unclear, it may also be an early symptom of systemic disease [1,3,4].
Standard treatment recommendations are to suppress the inflammatory process with corticosteroids [1,5,6], antibiotics may be also necessary to combat opportunistic infections [1,7], and possible underlying diseases may require their own specific medication. Saline douching can provide some symptomatic relief [1,2]. Surgical intervention was found to be as effective as medical treatment, but should be reserved for refractory cases [1,3,5]. Some complementary and alternative medical (CAM) treatments might be helpful as adjuvants [8]. It appears that homeopaths are consulted more frequently by patients with acute and chronic sinusitis (13% of the homeopathy group vs. 7% of the conventional group in an observational comparison study) [9], but to date no research has looked into the effects of homeopathy for chronic sinusitis.
Homeopathy is practised in many regions of the world [10], especially in high-income countries, where it is the most popular treatment form among the traditional, complementary, or alternative medical therapies [10-12]. Homeopathic prescribing accounts for concomitant symptoms in addition to the predominant pathology, therefore the same main diagnosis may be treated with different remedies in different patients ('individualisation'). The prescribed drugs ('remedies') are under constant debate. They are produced by alternating steps of diluting and agitating a starting substance ('potentiating'). After several repetitions, dilutions beyond Avogadro's number are reached, and the probability approaches zero that even a single molecule of the starting substance remains present in the drug. Such 'high potencies' are often used, however their effects are the subject of scientific controversy.
Apparently, the inconsistent results seen in meta-analyses of placebo-controlled trials pooling a great variety of diseases and ailments [13,14] might be a consequence of trial selection [15]. We analyzed the data from our prospective observational study, which globally evaluated details and effects under homeopathic treatment in a usual care situation (3981 patients over 8 years [16-19]) with respect to diagnosis. This paper presents the 134 adults consulting a homeopathic physician because of chronic sinusitis.
Methods
Study and Participants
In this prospective multi-centre observational study, patients were included consecutively upon their first consultation with a participating physician, and subsequently followed up, using standardised questionnaires. This paper analyses the patients suffering from sinusitis for ≥12 weeks (defined as "an inflammatory process of the mucous membranes of the paranasal sinuses [resulting] from any condition", ICD-9: 473.9 [20], ICD-10: J32.9) Study physicians were required to have passed certified training in classical homeopathy and have ≥3 years practical experience (details of recruitment: [17]). Written informed consent and approval by the ethics review board of the Charité University Medical Centre were obtained.
Data Collection
Before treatment (at baseline) and independent of their physicians, patients recorded the complaints that instigated homeopathic treatment, and rated their severity on a numeric rating scale (NRS, 0 = no complaints, 10 = maximum severity) [21]. The health-related quality of life (QoL) was recorded with the MOS SF-36 [22] questionnaire. The first questionnaires were personally given to the patients by the study physicians and were completed before treatment. Patients sent them in sealed envelopes directly to the study office, from where they received follow-up questionnaires after 3, 12, and 24 months, and 8 years, with every complaint being transferred to the follow-up questionnaires to ensure continuous assessment. At baseline, 3, 12 and 24 months, the participating physicians recorded up to 4 diagnoses per patient and assessed their severity on identical NRS. On a continuous basis, they recorded the homeopathic treatment, use of any conventional therapies, and all referrals.
Statistical Analysis
As outcome measures, we defined: mean sinusitis severity, mean severity of all baseline diagnoses (pooled physician assessment), mean severity of all complaints (pooled patient assessment), and QoL scores. Statistical analysis (using SAS/STAT© v9.2 software) followed the intention-to-treat approach: every included patient entered the final analyses. We replaced missing values as follows: Cured complaints: severity = 0 in subsequent records; deceased patients: severity = 10. The remaining missing values were multiply imputed according to Rubin [23]. Each was given 20 distinct, but plausible values, based on correlations with non-missing values and reflecting the overall variability of data. This generated a total of 20 distinct data tables, each with a full data set. These were analysed separately (see below), and the results pooled to calculate treatment effects and p-values. For each imputed data set, treatment effects were estimated on the basis of a generalised multiple linear regression model, following the recommendations by Diggle et al [24]. We assumed the treatment course to be mixed with a piecewise linear part (0–3 months, 3–24 months, and 24 to 72 months). The serial correlation was assumed to be exponential with time. Standardised effects (d) were calculated by dividing treatment effects as estimated above by baseline standard deviations. They were classified: as |d| > 0.8, large; |d| > 0.5, medium; |d| > 0.2, small.
Usually, patients seek treatment when their health is below average (such as severe pain, low QoL, etc.). A natural alleviation of their diseases (regression to the mean) can be mistaken for an effect at the beginning of treatment [25]. In order to separate regression to the mean and treatment effects, the mean of the target population must be known or plausibly assumed. For the QoL, we applied Mee and Chua's test [26] under the assumption that the patients had the same QoL as the general German population [22]. For the NRS ratings no data describing a normal population is available.
Results
In the present analysis, we included 134 adult patients (Table 1), who had been suffering from sinusitis for 10.7 ± 9.8 years. These patients were treated by 62 physicians (including 1 Ear, nose and throat (ENT) specialist). Almost all accompanying diagnoses assessed at baseline were chronic diseases that had previously been under treatment-mostly with conventional medicine (Tables 1, 2). All diagnoses seen in more than 5% of the patients were present for at least five years (Table 2). Nasal polyps, immune deficiencies, or fibrosis were not diagnosed.
Table 1. Demographics and Baseline Status
Table 2. Baseline Diagnoses
The consultations consisted of an extensive initial consultation (table 3), followed by the analysis of the case. Almost all patients received the first homeopathic medication on the day of their first consultation, three patients had to wait for ≤1 week, ≤1 month, and longer, respectively. The subsequent consultations, about half of them telephone calls, were much shorter than the initial history taking (Table 3). Almost 60% of the patients were still in homeopathic care or had only suspended it temporarily at 24 months (32% after 8 years) (table 3).
Table 3. Consultations and Continuance
In the first 24 months, patients received 8.3 ± 6.2 homeopathic prescriptions. Half of all prescriptions were covered by 10 homeopathic remedies (figure 1), but in total, 145 remedies were applied. Most used were the potencies: C200, 35.7%; C1000, 23.0%; C30, 14.2%; C10000, 7.6%; Q1, 3.5%; D12, 3.3%. (Letters indicate dilutions steps during manufacturing: 1/100 for centesimal (C-) potencies, 1/50000 for quinquagintamillesimal (Q-) potencies, and 1/10 for decimal (D-) potencies; numbers give the step repetitions. For example, a "C200" preparation is diluted-1/100-then-agitated 200 times. Thus, 88.3% of the remedies were potentiated to a dilution beyond Avogadro's number.
Figure 1. Most Frequently Prescribed Homeopathic Remedies (after 24 Months). Percent of prescriptions during study period, remedies identified with traditional abbreviations (in decreasing order of frequency: Sepia, Pulsatilla, Lycopodium, Phosphorus, Carcinosinum, Nux vomica, Sulphur, Natrium muriaticum, Staphisagria, Silicea).
The strongest improvements in the severity of complaints were seen in the first 3 months, they generally continued during the first 24 months and persisted for another 6 years (Table 4). The physicians' assessments of the severity change tended to be more positive than patients' own assessments (data not shown). The improvements in health-related QoL were of smaller effect size (Table 4) but statistically significant. The latter was confirmed by Mee-Chua-tests for the mental component score (p = 0.0859, p = 0.034, and p < 0.0001 at 3, 12 and 24 months) but not for the physical component score (p = 0.6869, p = 0.6859, and p = 0.1259). After 24 months, sinusitis and other baseline diagnoses were considerably relieved (Table 5), while large reductions in the use of conventional medicines and health care services were observed (Table 6). The observed improvements were still present in the 8-year follow-up (Table 4).
Table 4. Diagnoses, Complaints, Quality of Life
Table 5. Response Rates at Study End
Table 6. Use of Other Treatment and Health Care Services during Study (24 Months)
Discussion
This prospective multicentre observational study was aimed to provide an overview of contemporary homeopathic health care and the outcomes in 134 patients with chronic sinusitis. During the observation period, assessments of disease severity and health-related quality of life (QoL) consistently showed substantial improvements, although the disease was long-standing, and had previously been treated with conventional medicine. Similarly, the accompanying diseases (almost all chronic) were markedly ameliorated. Although the major improvements took place within the first 3 months of homeopathic treatment, they were still seen after 8 years. Accordingly, QoL increased and use of health care services or conventional medication decreased markedly.
The methodological strengths of our study include the consecutive patient enrolment and use of standardised outcome instruments. The participation of about 1% of all certified homeopathic physicians in Germany (representing 14% of the members of an association for physicians practising 'classical' homeopathy, the Hahnemann Association) in the main study makes the study and the subgroup presented in this paper a reasonably representative sample for contemporary homeopathic practice. We decided against a random sample of homeopathic physicians but recruited physicians trained and certified in 'classical' homeopathy, the type of homeopathy that is accepted and certified by the German Medical Association. Therefore our results are only representative for this type of homeopathy.
In contrast to randomised trials, our study describes patients from everyday practice with multiple morbidities and varying lifestyles. This ensures a high degree of external validity that allows extrapolation to usual medical care. The study, which was designed to evaluate homeopathic treatment of patients suffering from various diagnoses, could not use disease-specific instruments. We decided on a numeric rating scale which is validated, often used [21] and also accepted to measure pain. In addition, we used generic QoL questionnaires.
In this analysis we included patients who had been suffering from sinusitis for ≥3 months in order to approximate most closely the current definition of chronic sinusitis [1,3] with the available data. A shorter duration (e.g., 8 weeks [5]) would have resulted in a but less clearly defined population (+20 patients). In future research, assessments and diagnoses by ENT-specialists would be valuable, to ensure the diagnosis through more standardised and objective criteria. Given the baseline data we can safely assume that almost all patients had been diagnosed with sinusitis by one or more physicians, before the study began.
The majority of the patients were burdened with multiple chronic diseases (like the population of other investigations [27-29]), some of which are among the most frequent illnesses observed in other homeopathic observational studies [29,30]. Several factors could shift the selection towards patients with chronic diseases. As a general observation (especially for industrialised countries) homeopathy patients tend to be younger and better educated than conventional patients, of higher socioeconomic status, and are more often female [31]. These factors could be indicative of increased health-awareness and an inclination toward self-treatment for lesser ailments [32]. Waiting list time of up to several months can be longer than the acute illness itself that might have initiated homeopathic treatment, leaving only chronic diseases as initial diagnoses. The reputation of homeopathy as a 'medicine for the whole person' (reflected in the extensive initial history taking) may cause a self-selection of patients seeking more than a quick fix for a single issue. Finally, the long duration of the diseases (also observed elsewhere [27,30,33]) together with the high rate of previously treated patients, could indicate that most patients turn to homeopathy after finding conventional care unsatisfactory for their conditions. It would be interesting to track an unselected patient cohort through various self-chosen treatments and to do a combined analysis of health status, QoL, and costs. The cost-effectiveness of homeopathic treatment has not been thoroughly investigated so far [34,35]. Medication costs are negligible, while the duration of homeopathic consultations (Table 3) is clearly longer than the 7.6 ± 4.3 minutes of a German GP consultation [36]. This might be compensated by their low frequency. (Conventional consultations take place about 24 times per patient over a 24 month period with a resulting doctor workload of about 190 min in two years [37].)
All estimated health effects were large. This could be mainly explained by placebo and context effects as well as regression to the mean, that our study was not designed to control (effects in between-group comparisons are usually smaller). Nor can we rule out an overestimation of the effect. That the patients' ratings had decreased somewhat at the follow-up may reflect 8 years of ageing, or the wearing off of a novelty effect added to the treatment effect that had caused a possible initial overestimation.
The observed QoL improvements can hardly be caused by regression toward the mean. Assuming chronically ill patients with often several severe diseases to have the same QoL as the general German population was itself a rather conservative approach. Also, patients received homeopathic treatment after years of other treatment and a waiting period – it is very likely that regression toward the mean would have taken place before the first QoL (and NRS) ratings. The same applies to the response shift (patients change internal standards, values, and their QoL concept in reaction to health status changes) [38], which is also likely to shift ratings towards an underestimation of effects.
Our study evaluated the complete package of homeopathic treatment, including context and placebo effects and possible additional treatments in a usual care situation. The extent to which the observed effects are due to the applied homeopathic remedies cannot be determined because no suitable methodology was used. Therefore our study must not be interpreted to support conclusions regarding the efficacy of homeopathic remedies in sinusitis treatment, but rather the total effect of consulting a homeopath. We were also unable to find other evaluations of high-potency homeopathy for chronic sinusitis (one study [9] included any sinusitis but pooled all diagnoses), so the question of remedy efficacy remains unanswered.
It is unlikely that the observed reduction in conventional or alternative medication and treatments are due only to the improved health condition. The homeopathic strategy to reduce interventions to a minimum (which makes classical homeopaths effective 'gatekeepers') is also reflected here for sinusitis, this includes the use of decongestants. In addition, other drugs, stimulating agents, remedy specific 'antidotes', or behaviours that cause known individual aggravations are usually controlled [39]. The type of classical 'homeopathic treatment' investigated in the present study includes a certain amount of lifestyle regulation and health education that most likely contribute to the outcome, as do placebo and context effects. Inactive treatments have strong effects on neuroimmune responses [40] that are likely to affect an inflammatory disease such as sinusitis. Other aspects of treatments (their 'context') may trigger the same mechanisms and they might be more influential than currently acknowledged. For example, the expectations of the patients and the convictions of the physicians regarding the effects and effectiveness of the treatment could be powerful response triggers [40,41]. Both are of course in concordance with the medical approach or philosophy of the respective therapy (for homeopathy, see [42,43]). This makes patients' self-selection into treatment courses a valuable contribution to healing. More generally speaking, every distinct treatment will attract a population that reacts to it [44]. Besides the debated effect of homeopathic remedies, the patients in our study are likely to have profited from the way homeopathy is perceived socially and psychologically. Interestingly, theory and practice of homeopathy have in its history gone through several modifications that (unintentionally) increased the non-pharmacological active factors (e.g., longer and more detailed consultations, increased attention to psycho-social issues, conceptual bridges to the outlook of local cultures and attitudes) [45]. The true extent of placebo/context effects in homeopathic treatment has not yet been investigated, and disentangling the above factors will be a challenging but promising task for future research. Further research in to everyday homeopathic practice, may yield insights into curative means that can be augmented in other areas of medicine [46-49], thus improving health care with respect to health economics and patient benefit.
Conclusion
Patients with sinusitis treated with 'classical' homeopathy showed marked health and quality of life improvements that lasted for 8 years. The extent to which the observed effects are due to lifestyle regulation and placebo or context effects associated with the treatment needs clarification in the future from more explanatory studies.
Abbreviations
WHO: World Health Organization; ICD: International Classification of Diseases; NRS: Numerical Rating Scale; QoL: health-related Quality of Life; MOS SF-36: Medical Outcomes Trust 36-Item Short Form Survey Instrument; KINDL: KINDer Lebensqualitätsfragebogen; Cn: nth Centesimal potency; Qn: nth Quinquagintamillesimal potency; GP: General Practitioner; RCT: Randomized Controlled Trial; ENT-specialist: Ear, Nose and Throat specialist
Competing interests
This work was supported by a grant from the Karl und Veronica Carstens-Foundation, D-Essen, for SNW and CMW. All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Conflicts of interest: None.
Authors' contributions
CMW conceived and designed the study, interpreted the data, drafted and revised the article. RL designed the study, analysed the data (statistics), revised and approved the article. SNW secured funding, designed the study, revised and approved the article. All authors read and approved the final manuscript.
Acknowledgements
We want to thank the participating physicians for their work and the patients for their cooperation. We thank Elvira Krüger for data acquisition and Karin Weber and Katja Wruck for data management.
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1 Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Centre, D-10098 Berlin, Germany
2 Karl and Veronica Carstens-Foundation, Am Deimelsberg 36, D-45276 Essen, Germany
author email corresponding author email
BMC Ear, Nose and Throat Disorders 2009, 9:7doi:10.1186/1472-6815-9-7
Abstract
Background
An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for ≥12 weeks in a usual care situation.
Methods
Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; ≥12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment.
Results
The study included 134 adults (mean age 39.8 ± 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 ± 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00).
Conclusion
This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.
Background
Chronic sinusitis is generally accepted to be a common illness incurring considerable costs, despite limited epidemiological data[1]. It is defined as an inflammation of the nasal mucosa and paranasal sinuses for at least 12 weeks which may cause nasal blockage or congestion, mucous discharge, facial pain or pressure, and/or impaired smell. Polyps, which may or may not be present are increasingly recognized as part of the sinusitis pathology [1,2]. Several factors have been found to contribute to the disease, namely, insufficient ciliary motility, allergy and asthma, bacterial infection, and more rarely, morphological anomalies, immune deficiencies and Samter's triad (salicylate sensitivity, asthma, nasal polyps). While the role of fungi and hormonal changes during pregnancy are unclear, it may also be an early symptom of systemic disease [1,3,4].
Standard treatment recommendations are to suppress the inflammatory process with corticosteroids [1,5,6], antibiotics may be also necessary to combat opportunistic infections [1,7], and possible underlying diseases may require their own specific medication. Saline douching can provide some symptomatic relief [1,2]. Surgical intervention was found to be as effective as medical treatment, but should be reserved for refractory cases [1,3,5]. Some complementary and alternative medical (CAM) treatments might be helpful as adjuvants [8]. It appears that homeopaths are consulted more frequently by patients with acute and chronic sinusitis (13% of the homeopathy group vs. 7% of the conventional group in an observational comparison study) [9], but to date no research has looked into the effects of homeopathy for chronic sinusitis.
Homeopathy is practised in many regions of the world [10], especially in high-income countries, where it is the most popular treatment form among the traditional, complementary, or alternative medical therapies [10-12]. Homeopathic prescribing accounts for concomitant symptoms in addition to the predominant pathology, therefore the same main diagnosis may be treated with different remedies in different patients ('individualisation'). The prescribed drugs ('remedies') are under constant debate. They are produced by alternating steps of diluting and agitating a starting substance ('potentiating'). After several repetitions, dilutions beyond Avogadro's number are reached, and the probability approaches zero that even a single molecule of the starting substance remains present in the drug. Such 'high potencies' are often used, however their effects are the subject of scientific controversy.
Apparently, the inconsistent results seen in meta-analyses of placebo-controlled trials pooling a great variety of diseases and ailments [13,14] might be a consequence of trial selection [15]. We analyzed the data from our prospective observational study, which globally evaluated details and effects under homeopathic treatment in a usual care situation (3981 patients over 8 years [16-19]) with respect to diagnosis. This paper presents the 134 adults consulting a homeopathic physician because of chronic sinusitis.
Methods
Study and Participants
In this prospective multi-centre observational study, patients were included consecutively upon their first consultation with a participating physician, and subsequently followed up, using standardised questionnaires. This paper analyses the patients suffering from sinusitis for ≥12 weeks (defined as "an inflammatory process of the mucous membranes of the paranasal sinuses [resulting] from any condition", ICD-9: 473.9 [20], ICD-10: J32.9) Study physicians were required to have passed certified training in classical homeopathy and have ≥3 years practical experience (details of recruitment: [17]). Written informed consent and approval by the ethics review board of the Charité University Medical Centre were obtained.
Data Collection
Before treatment (at baseline) and independent of their physicians, patients recorded the complaints that instigated homeopathic treatment, and rated their severity on a numeric rating scale (NRS, 0 = no complaints, 10 = maximum severity) [21]. The health-related quality of life (QoL) was recorded with the MOS SF-36 [22] questionnaire. The first questionnaires were personally given to the patients by the study physicians and were completed before treatment. Patients sent them in sealed envelopes directly to the study office, from where they received follow-up questionnaires after 3, 12, and 24 months, and 8 years, with every complaint being transferred to the follow-up questionnaires to ensure continuous assessment. At baseline, 3, 12 and 24 months, the participating physicians recorded up to 4 diagnoses per patient and assessed their severity on identical NRS. On a continuous basis, they recorded the homeopathic treatment, use of any conventional therapies, and all referrals.
Statistical Analysis
As outcome measures, we defined: mean sinusitis severity, mean severity of all baseline diagnoses (pooled physician assessment), mean severity of all complaints (pooled patient assessment), and QoL scores. Statistical analysis (using SAS/STAT© v9.2 software) followed the intention-to-treat approach: every included patient entered the final analyses. We replaced missing values as follows: Cured complaints: severity = 0 in subsequent records; deceased patients: severity = 10. The remaining missing values were multiply imputed according to Rubin [23]. Each was given 20 distinct, but plausible values, based on correlations with non-missing values and reflecting the overall variability of data. This generated a total of 20 distinct data tables, each with a full data set. These were analysed separately (see below), and the results pooled to calculate treatment effects and p-values. For each imputed data set, treatment effects were estimated on the basis of a generalised multiple linear regression model, following the recommendations by Diggle et al [24]. We assumed the treatment course to be mixed with a piecewise linear part (0–3 months, 3–24 months, and 24 to 72 months). The serial correlation was assumed to be exponential with time. Standardised effects (d) were calculated by dividing treatment effects as estimated above by baseline standard deviations. They were classified: as |d| > 0.8, large; |d| > 0.5, medium; |d| > 0.2, small.
Usually, patients seek treatment when their health is below average (such as severe pain, low QoL, etc.). A natural alleviation of their diseases (regression to the mean) can be mistaken for an effect at the beginning of treatment [25]. In order to separate regression to the mean and treatment effects, the mean of the target population must be known or plausibly assumed. For the QoL, we applied Mee and Chua's test [26] under the assumption that the patients had the same QoL as the general German population [22]. For the NRS ratings no data describing a normal population is available.
Results
In the present analysis, we included 134 adult patients (Table 1), who had been suffering from sinusitis for 10.7 ± 9.8 years. These patients were treated by 62 physicians (including 1 Ear, nose and throat (ENT) specialist). Almost all accompanying diagnoses assessed at baseline were chronic diseases that had previously been under treatment-mostly with conventional medicine (Tables 1, 2). All diagnoses seen in more than 5% of the patients were present for at least five years (Table 2). Nasal polyps, immune deficiencies, or fibrosis were not diagnosed.
Table 1. Demographics and Baseline Status
Table 2. Baseline Diagnoses
The consultations consisted of an extensive initial consultation (table 3), followed by the analysis of the case. Almost all patients received the first homeopathic medication on the day of their first consultation, three patients had to wait for ≤1 week, ≤1 month, and longer, respectively. The subsequent consultations, about half of them telephone calls, were much shorter than the initial history taking (Table 3). Almost 60% of the patients were still in homeopathic care or had only suspended it temporarily at 24 months (32% after 8 years) (table 3).
Table 3. Consultations and Continuance
In the first 24 months, patients received 8.3 ± 6.2 homeopathic prescriptions. Half of all prescriptions were covered by 10 homeopathic remedies (figure 1), but in total, 145 remedies were applied. Most used were the potencies: C200, 35.7%; C1000, 23.0%; C30, 14.2%; C10000, 7.6%; Q1, 3.5%; D12, 3.3%. (Letters indicate dilutions steps during manufacturing: 1/100 for centesimal (C-) potencies, 1/50000 for quinquagintamillesimal (Q-) potencies, and 1/10 for decimal (D-) potencies; numbers give the step repetitions. For example, a "C200" preparation is diluted-1/100-then-agitated 200 times. Thus, 88.3% of the remedies were potentiated to a dilution beyond Avogadro's number.
Figure 1. Most Frequently Prescribed Homeopathic Remedies (after 24 Months). Percent of prescriptions during study period, remedies identified with traditional abbreviations (in decreasing order of frequency: Sepia, Pulsatilla, Lycopodium, Phosphorus, Carcinosinum, Nux vomica, Sulphur, Natrium muriaticum, Staphisagria, Silicea).
The strongest improvements in the severity of complaints were seen in the first 3 months, they generally continued during the first 24 months and persisted for another 6 years (Table 4). The physicians' assessments of the severity change tended to be more positive than patients' own assessments (data not shown). The improvements in health-related QoL were of smaller effect size (Table 4) but statistically significant. The latter was confirmed by Mee-Chua-tests for the mental component score (p = 0.0859, p = 0.034, and p < 0.0001 at 3, 12 and 24 months) but not for the physical component score (p = 0.6869, p = 0.6859, and p = 0.1259). After 24 months, sinusitis and other baseline diagnoses were considerably relieved (Table 5), while large reductions in the use of conventional medicines and health care services were observed (Table 6). The observed improvements were still present in the 8-year follow-up (Table 4).
Table 4. Diagnoses, Complaints, Quality of Life
Table 5. Response Rates at Study End
Table 6. Use of Other Treatment and Health Care Services during Study (24 Months)
Discussion
This prospective multicentre observational study was aimed to provide an overview of contemporary homeopathic health care and the outcomes in 134 patients with chronic sinusitis. During the observation period, assessments of disease severity and health-related quality of life (QoL) consistently showed substantial improvements, although the disease was long-standing, and had previously been treated with conventional medicine. Similarly, the accompanying diseases (almost all chronic) were markedly ameliorated. Although the major improvements took place within the first 3 months of homeopathic treatment, they were still seen after 8 years. Accordingly, QoL increased and use of health care services or conventional medication decreased markedly.
The methodological strengths of our study include the consecutive patient enrolment and use of standardised outcome instruments. The participation of about 1% of all certified homeopathic physicians in Germany (representing 14% of the members of an association for physicians practising 'classical' homeopathy, the Hahnemann Association) in the main study makes the study and the subgroup presented in this paper a reasonably representative sample for contemporary homeopathic practice. We decided against a random sample of homeopathic physicians but recruited physicians trained and certified in 'classical' homeopathy, the type of homeopathy that is accepted and certified by the German Medical Association. Therefore our results are only representative for this type of homeopathy.
In contrast to randomised trials, our study describes patients from everyday practice with multiple morbidities and varying lifestyles. This ensures a high degree of external validity that allows extrapolation to usual medical care. The study, which was designed to evaluate homeopathic treatment of patients suffering from various diagnoses, could not use disease-specific instruments. We decided on a numeric rating scale which is validated, often used [21] and also accepted to measure pain. In addition, we used generic QoL questionnaires.
In this analysis we included patients who had been suffering from sinusitis for ≥3 months in order to approximate most closely the current definition of chronic sinusitis [1,3] with the available data. A shorter duration (e.g., 8 weeks [5]) would have resulted in a but less clearly defined population (+20 patients). In future research, assessments and diagnoses by ENT-specialists would be valuable, to ensure the diagnosis through more standardised and objective criteria. Given the baseline data we can safely assume that almost all patients had been diagnosed with sinusitis by one or more physicians, before the study began.
The majority of the patients were burdened with multiple chronic diseases (like the population of other investigations [27-29]), some of which are among the most frequent illnesses observed in other homeopathic observational studies [29,30]. Several factors could shift the selection towards patients with chronic diseases. As a general observation (especially for industrialised countries) homeopathy patients tend to be younger and better educated than conventional patients, of higher socioeconomic status, and are more often female [31]. These factors could be indicative of increased health-awareness and an inclination toward self-treatment for lesser ailments [32]. Waiting list time of up to several months can be longer than the acute illness itself that might have initiated homeopathic treatment, leaving only chronic diseases as initial diagnoses. The reputation of homeopathy as a 'medicine for the whole person' (reflected in the extensive initial history taking) may cause a self-selection of patients seeking more than a quick fix for a single issue. Finally, the long duration of the diseases (also observed elsewhere [27,30,33]) together with the high rate of previously treated patients, could indicate that most patients turn to homeopathy after finding conventional care unsatisfactory for their conditions. It would be interesting to track an unselected patient cohort through various self-chosen treatments and to do a combined analysis of health status, QoL, and costs. The cost-effectiveness of homeopathic treatment has not been thoroughly investigated so far [34,35]. Medication costs are negligible, while the duration of homeopathic consultations (Table 3) is clearly longer than the 7.6 ± 4.3 minutes of a German GP consultation [36]. This might be compensated by their low frequency. (Conventional consultations take place about 24 times per patient over a 24 month period with a resulting doctor workload of about 190 min in two years [37].)
All estimated health effects were large. This could be mainly explained by placebo and context effects as well as regression to the mean, that our study was not designed to control (effects in between-group comparisons are usually smaller). Nor can we rule out an overestimation of the effect. That the patients' ratings had decreased somewhat at the follow-up may reflect 8 years of ageing, or the wearing off of a novelty effect added to the treatment effect that had caused a possible initial overestimation.
The observed QoL improvements can hardly be caused by regression toward the mean. Assuming chronically ill patients with often several severe diseases to have the same QoL as the general German population was itself a rather conservative approach. Also, patients received homeopathic treatment after years of other treatment and a waiting period – it is very likely that regression toward the mean would have taken place before the first QoL (and NRS) ratings. The same applies to the response shift (patients change internal standards, values, and their QoL concept in reaction to health status changes) [38], which is also likely to shift ratings towards an underestimation of effects.
Our study evaluated the complete package of homeopathic treatment, including context and placebo effects and possible additional treatments in a usual care situation. The extent to which the observed effects are due to the applied homeopathic remedies cannot be determined because no suitable methodology was used. Therefore our study must not be interpreted to support conclusions regarding the efficacy of homeopathic remedies in sinusitis treatment, but rather the total effect of consulting a homeopath. We were also unable to find other evaluations of high-potency homeopathy for chronic sinusitis (one study [9] included any sinusitis but pooled all diagnoses), so the question of remedy efficacy remains unanswered.
It is unlikely that the observed reduction in conventional or alternative medication and treatments are due only to the improved health condition. The homeopathic strategy to reduce interventions to a minimum (which makes classical homeopaths effective 'gatekeepers') is also reflected here for sinusitis, this includes the use of decongestants. In addition, other drugs, stimulating agents, remedy specific 'antidotes', or behaviours that cause known individual aggravations are usually controlled [39]. The type of classical 'homeopathic treatment' investigated in the present study includes a certain amount of lifestyle regulation and health education that most likely contribute to the outcome, as do placebo and context effects. Inactive treatments have strong effects on neuroimmune responses [40] that are likely to affect an inflammatory disease such as sinusitis. Other aspects of treatments (their 'context') may trigger the same mechanisms and they might be more influential than currently acknowledged. For example, the expectations of the patients and the convictions of the physicians regarding the effects and effectiveness of the treatment could be powerful response triggers [40,41]. Both are of course in concordance with the medical approach or philosophy of the respective therapy (for homeopathy, see [42,43]). This makes patients' self-selection into treatment courses a valuable contribution to healing. More generally speaking, every distinct treatment will attract a population that reacts to it [44]. Besides the debated effect of homeopathic remedies, the patients in our study are likely to have profited from the way homeopathy is perceived socially and psychologically. Interestingly, theory and practice of homeopathy have in its history gone through several modifications that (unintentionally) increased the non-pharmacological active factors (e.g., longer and more detailed consultations, increased attention to psycho-social issues, conceptual bridges to the outlook of local cultures and attitudes) [45]. The true extent of placebo/context effects in homeopathic treatment has not yet been investigated, and disentangling the above factors will be a challenging but promising task for future research. Further research in to everyday homeopathic practice, may yield insights into curative means that can be augmented in other areas of medicine [46-49], thus improving health care with respect to health economics and patient benefit.
Conclusion
Patients with sinusitis treated with 'classical' homeopathy showed marked health and quality of life improvements that lasted for 8 years. The extent to which the observed effects are due to lifestyle regulation and placebo or context effects associated with the treatment needs clarification in the future from more explanatory studies.
Abbreviations
WHO: World Health Organization; ICD: International Classification of Diseases; NRS: Numerical Rating Scale; QoL: health-related Quality of Life; MOS SF-36: Medical Outcomes Trust 36-Item Short Form Survey Instrument; KINDL: KINDer Lebensqualitätsfragebogen; Cn: nth Centesimal potency; Qn: nth Quinquagintamillesimal potency; GP: General Practitioner; RCT: Randomized Controlled Trial; ENT-specialist: Ear, Nose and Throat specialist
Competing interests
This work was supported by a grant from the Karl und Veronica Carstens-Foundation, D-Essen, for SNW and CMW. All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Conflicts of interest: None.
Authors' contributions
CMW conceived and designed the study, interpreted the data, drafted and revised the article. RL designed the study, analysed the data (statistics), revised and approved the article. SNW secured funding, designed the study, revised and approved the article. All authors read and approved the final manuscript.
Acknowledgements
We want to thank the participating physicians for their work and the patients for their cooperation. We thank Elvira Krüger for data acquisition and Karin Weber and Katja Wruck for data management.
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Jonas W, Lin Y, Tortella F.
Department of Family Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
The protective effects of ultra-low doses (ULD) of glutamate against glutamate toxicity was studied in primary rat spinal, cortical and cerebellar neurons. Neurons were exposed to four subtoxic, ultra-low concentrations of glutamate (10(-18) M, 10(-20)M, 10(-22) M and 10(-30) M) for 72 h and then subsequently challenged with toxic concentrations (25 microM) of glutamate. Neuron viability was consistently 10% higher in spinal and cortical neurons pre-exposed to glutamate concentrations of 10(-18) M and 10(-22) M, and in cerebellar neurons pre-exposed to 10(-20) M and 10(-30) M. Using laser scanning confocal microscopy and the fluorescent calcium probe fluo-3, we found no alterations in intracellular calcium dynamics in the protected cells. This protective effect is consistent with a growing body of evidence for tolerance induced by low-dose toxin exposure but is the first time that such tolerance has been demonstrated with ultra-low glutamate exposure. Our data show that pre-exposure of neuronal cells to ULD glutamate can protect against subsequent exposure to toxic levels of glutamate.
PMID: 11209946 [PubMed - indexed for MEDLINE]
Friday, March 5, 2010
Homeopathic Pathogenetic Trials Produce Specific Symptoms Different from Placebo
Heribert Möllingera, Rainer Schneiderb, Harald Walachc
a Private Practice, Amriswil, Switzerland
b Department of Human Sciences, University of Osnabrück, Germany
c School of Social Sciences and Samueli Institute, European Office, University of Northampton, UK
Address of Corresponding Author
Forsch Komplementmed 2009;16:105-110 (DOI: 10.1159/000209386)
Summary
Introduction: Homeopathy uses information gathered from healthy volunteers taking homeopathic substances (pathogenetic trials) for clinical treatment. It is controversial whether such studies produce symptoms different from those produced by placebo. Objective: To test whether homeopathic preparations produce different symptoms than placebo in healthy volunteers.
Methods: Three armed, double-blind, placebo controlled randomised experimental pathogenetic study in 25 healthy volunteers who took either one of two homeopathic remedies, Natrum muriaticum and Arsenicum album in 30CH or identical placebo. Main outcome parameter was the number of remedy-specific symptoms per group.
Results: On average, 6 symptoms typical for Arsenicum album were experienced by participants taking arsenicum album, 5 symptoms typical for Natrum muriaticum by those taking natrum muriaticum, and 11 non-specific symptoms by those in the placebo group. Differences were significant overall (Kruskall Wallis test, p = 0.0002,) and significantly different from placebo (Mann-Whitney test, p = 0.001).
Conclusion: Homeopathic remedies produce different symptoms than placebo.
Copyright © 2009 S. Karger AG, Basel
Author Contacts
Prof. Harald Walach, PhD, University of Northampton, School of Social Sciences and Samueli Institute, European Office, Boughton Green Rd, Northampton NN2 7AL, UK, Tel. +44 1604 892952, harald.walach@northampton.ac.uk
a Private Practice, Amriswil, Switzerland
b Department of Human Sciences, University of Osnabrück, Germany
c School of Social Sciences and Samueli Institute, European Office, University of Northampton, UK
Address of Corresponding Author
Forsch Komplementmed 2009;16:105-110 (DOI: 10.1159/000209386)
Summary
Introduction: Homeopathy uses information gathered from healthy volunteers taking homeopathic substances (pathogenetic trials) for clinical treatment. It is controversial whether such studies produce symptoms different from those produced by placebo. Objective: To test whether homeopathic preparations produce different symptoms than placebo in healthy volunteers.
Methods: Three armed, double-blind, placebo controlled randomised experimental pathogenetic study in 25 healthy volunteers who took either one of two homeopathic remedies, Natrum muriaticum and Arsenicum album in 30CH or identical placebo. Main outcome parameter was the number of remedy-specific symptoms per group.
Results: On average, 6 symptoms typical for Arsenicum album were experienced by participants taking arsenicum album, 5 symptoms typical for Natrum muriaticum by those taking natrum muriaticum, and 11 non-specific symptoms by those in the placebo group. Differences were significant overall (Kruskall Wallis test, p = 0.0002,) and significantly different from placebo (Mann-Whitney test, p = 0.001).
Conclusion: Homeopathic remedies produce different symptoms than placebo.
Copyright © 2009 S. Karger AG, Basel
Author Contacts
Prof. Harald Walach, PhD, University of Northampton, School of Social Sciences and Samueli Institute, European Office, Boughton Green Rd, Northampton NN2 7AL, UK, Tel. +44 1604 892952, harald.walach@northampton.ac.uk
Dilution theory may answer homeopathy riddle
By John von Radowitz, Science Correspondent, PA News
Thursday, 8 November 2001.
Kurt Geckeler
A chance discovery could provide a scientific answer to the riddle of homeopathy, it has been disclosed. Two researchers have turned upside down the conventional view of what happens when a substance is progressively diluted in water.
Common sense says that dissolved molecules simply spread further apart as a solution is increasingly diluted.But the two chemists found that some do the opposite – clumping together, first as clusters of molecules, and then as bigger aggregates. Instead of drifting apart, the molecules become more compacted.
As well as stunning other scientists, the bizarre discovery may have a direct bearing on homeopathy.Homeopathic practitioners repeatedly dilute medications, believing this will make them more potent. Some homeopaths dilute to "infinity" until no molecules of the medicine remain. They believe that water holds a memory or "imprint" of the active ingredient which is more powerful than the ingredient itself.
Others use less dilute solutions, often diluting the remedy six–fold.The Korean findings may go some way towards explaining the great paradox of homeopathic medicine – that you can make a treatment more powerful by weakening its concentration.
German chemist Kurt Geckeler and his colleague Shashadhar Samal stumbled on their discovery while studying football–shaped molecules called fullerenes at the Kwangju Institute of Science and Technology in South Korea, New Scientist magazine reported last night.
They found that the molecules kept forming untidy aggregates in solution, and Geckeler asked Samal to look for ways to control the clumping.Geckeler said: "When he diluted the solution, the size of the fullerene particles increased. It was completely counter–intuitive."
Further experiments showed that the phenomenon was no fluke. The same effect was seen with a sugar–like molecule called cyclodextrin, the organic molecule guanosine monophosphate, DNA, and sodium chloride – common table salt.
Dilution made the molecules cluster into aggregates five to 10 times bigger than those in the original solutions.Growth depended on the concentration to start with. "The history of the solution is important," said Geckeler. "The more dilute it starts, the larger the aggregates."
The effect was only seen in "polar" solvents, such as water. Molecules dissolved in a polar solution have a pronounced positive charge at one end and a negative one at the other. This may be responsible for the clustering. In homeopathy, diluting a remedy may increase the size of particles until they become biologically active.
The results echo the controversial claims of French immunologist Jacques Benveniste who in 1988 claimed that a solution which had once contained antibodies still triggered an immune response.
Benveniste claimed the solution contained "imprints" in the water structure corresponding to where the antibodies had been. Peter Fisher, director of medical research at the Royal London Homeopathic Hospital, said: "It doesn't prove homeopathy, but it's congruent with what we think and is very encouraging.
"The whole idea of high–dilution homeopathy hangs on the idea that water has properties which are not understood. The fact that the new effect happens with a variety of substances suggests it's the solvent that's responsible. It's in line with what many homeopaths say, that you can only make homeopathic medicines in polar solvents."
Geckeler and Samal are now eager for other researchers to follow up their work.
"We want people to repeat it," said Geckeler. "If it's confirmed, it will be groundbreaking."
Thursday, 8 November 2001.
Kurt Geckeler
A chance discovery could provide a scientific answer to the riddle of homeopathy, it has been disclosed. Two researchers have turned upside down the conventional view of what happens when a substance is progressively diluted in water.
Common sense says that dissolved molecules simply spread further apart as a solution is increasingly diluted.But the two chemists found that some do the opposite – clumping together, first as clusters of molecules, and then as bigger aggregates. Instead of drifting apart, the molecules become more compacted.
As well as stunning other scientists, the bizarre discovery may have a direct bearing on homeopathy.Homeopathic practitioners repeatedly dilute medications, believing this will make them more potent. Some homeopaths dilute to "infinity" until no molecules of the medicine remain. They believe that water holds a memory or "imprint" of the active ingredient which is more powerful than the ingredient itself.
Others use less dilute solutions, often diluting the remedy six–fold.The Korean findings may go some way towards explaining the great paradox of homeopathic medicine – that you can make a treatment more powerful by weakening its concentration.
German chemist Kurt Geckeler and his colleague Shashadhar Samal stumbled on their discovery while studying football–shaped molecules called fullerenes at the Kwangju Institute of Science and Technology in South Korea, New Scientist magazine reported last night.
They found that the molecules kept forming untidy aggregates in solution, and Geckeler asked Samal to look for ways to control the clumping.Geckeler said: "When he diluted the solution, the size of the fullerene particles increased. It was completely counter–intuitive."
Further experiments showed that the phenomenon was no fluke. The same effect was seen with a sugar–like molecule called cyclodextrin, the organic molecule guanosine monophosphate, DNA, and sodium chloride – common table salt.
Dilution made the molecules cluster into aggregates five to 10 times bigger than those in the original solutions.Growth depended on the concentration to start with. "The history of the solution is important," said Geckeler. "The more dilute it starts, the larger the aggregates."
The effect was only seen in "polar" solvents, such as water. Molecules dissolved in a polar solution have a pronounced positive charge at one end and a negative one at the other. This may be responsible for the clustering. In homeopathy, diluting a remedy may increase the size of particles until they become biologically active.
The results echo the controversial claims of French immunologist Jacques Benveniste who in 1988 claimed that a solution which had once contained antibodies still triggered an immune response.
Benveniste claimed the solution contained "imprints" in the water structure corresponding to where the antibodies had been. Peter Fisher, director of medical research at the Royal London Homeopathic Hospital, said: "It doesn't prove homeopathy, but it's congruent with what we think and is very encouraging.
"The whole idea of high–dilution homeopathy hangs on the idea that water has properties which are not understood. The fact that the new effect happens with a variety of substances suggests it's the solvent that's responsible. It's in line with what many homeopaths say, that you can only make homeopathic medicines in polar solvents."
Geckeler and Samal are now eager for other researchers to follow up their work.
"We want people to repeat it," said Geckeler. "If it's confirmed, it will be groundbreaking."
Paediatric homoeopathy in general practice: where, when and why?
Br J Clin Pharmacol. 2005 Jun;59(6):743-9.
Ekins-Daukes S, Helms PJ, Taylor MW, Simpson CR, McLay JS.
Department of Medicine and Therapeutics, The University of Aberdeen, Polwarth Buildings, Foresterhill, Aberdeen, AB25 2ZD.
AIMS: To investigate the extent of homoeopathic prescribing in primary care for childhood diseases and assess GP attitudes towards the use of homoeopathy in children.
METHODS: Homoeopathic prescribing in primary care was assessed in 167 865 children aged 0-16 years for the year 1999-2000. Computerized prescribing data were retrieved from 161 representative general practices in Scotland. Medical attitudes towards homoeopathic prescribing to children were also assessed via a questionnaire survey.
RESULTS: During the year 1999-2000 22% (36) of general practices prescribed homoeopathic medicines to 190 (1.1/1000 registered) children. The majority of such prescriptions were issued to children under 1 year of age (8.0/1000 registered children). The most frequently prescribed medicines were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. A total of 259 completed questionnaires were returned by GPs, giving a response rate of 75%. GPs who frequently prescribed homoeopathic medicines to children (more than 1 per month) were more likely to claim an interest in homoeopathy, have had a formal training and keep up to date in the discipline, and refer on to a homoeopath (P < 0.001 for all variables) than those GPs who prescribed less than once a month or never. The majority of GPs who prescribed homoeopathic medicines did so when conventional treatments had apparently failed (76%), while 94% also perceived homoeopathy to be safe. Frequent prescribers reported a more positive attitude towards homoeopathic medicines than those who prescribed less frequently. Non-prescribers reported a lack of proven efficacy and lack of training as the main reasons for not prescribing homoeopathic medicines (55% and 79%, respectively). However non-prescribers from within homoeopathic prescribing practices reported a more favourable attitude in general towards homoeopathy and less resistance towards prescribing in the future than non-prescribers from practices where none of the partners practiced homoeopathy.
CONCLUSIONS: In primary care paediatric prescribing of homoeopathic medicines most commonly occurs for self-limiting conditions in infants less than 1 year of age. Although the current level of homoeopathic prescribing is low, the widespread use in the community suggests that at least some knowledge of the main indications for homoeopathy and the preparations used would be of benefit to registered medical practitioners.
PMID: 15948942 [PubMed - indexed for MEDLINE]
Ekins-Daukes S, Helms PJ, Taylor MW, Simpson CR, McLay JS.
Department of Medicine and Therapeutics, The University of Aberdeen, Polwarth Buildings, Foresterhill, Aberdeen, AB25 2ZD.
AIMS: To investigate the extent of homoeopathic prescribing in primary care for childhood diseases and assess GP attitudes towards the use of homoeopathy in children.
METHODS: Homoeopathic prescribing in primary care was assessed in 167 865 children aged 0-16 years for the year 1999-2000. Computerized prescribing data were retrieved from 161 representative general practices in Scotland. Medical attitudes towards homoeopathic prescribing to children were also assessed via a questionnaire survey.
RESULTS: During the year 1999-2000 22% (36) of general practices prescribed homoeopathic medicines to 190 (1.1/1000 registered) children. The majority of such prescriptions were issued to children under 1 year of age (8.0/1000 registered children). The most frequently prescribed medicines were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. A total of 259 completed questionnaires were returned by GPs, giving a response rate of 75%. GPs who frequently prescribed homoeopathic medicines to children (more than 1 per month) were more likely to claim an interest in homoeopathy, have had a formal training and keep up to date in the discipline, and refer on to a homoeopath (P < 0.001 for all variables) than those GPs who prescribed less than once a month or never. The majority of GPs who prescribed homoeopathic medicines did so when conventional treatments had apparently failed (76%), while 94% also perceived homoeopathy to be safe. Frequent prescribers reported a more positive attitude towards homoeopathic medicines than those who prescribed less frequently. Non-prescribers reported a lack of proven efficacy and lack of training as the main reasons for not prescribing homoeopathic medicines (55% and 79%, respectively). However non-prescribers from within homoeopathic prescribing practices reported a more favourable attitude in general towards homoeopathy and less resistance towards prescribing in the future than non-prescribers from practices where none of the partners practiced homoeopathy.
CONCLUSIONS: In primary care paediatric prescribing of homoeopathic medicines most commonly occurs for self-limiting conditions in infants less than 1 year of age. Although the current level of homoeopathic prescribing is low, the widespread use in the community suggests that at least some knowledge of the main indications for homoeopathy and the preparations used would be of benefit to registered medical practitioners.
PMID: 15948942 [PubMed - indexed for MEDLINE]
Wednesday, March 3, 2010
Effect of homoeopathic treatment on fibrositis (primary fibromyalgia)
Peter Fisher, Alison Greenwood, E C Huskisson,Paul Turner, Philippe Belon
In scientific research negative results are often more difficult to interpret than positive ones, as was shown by a clinical trial in which the homoeopathic medicine
Rhus toxicodendron 6x was compared with a placebo and fenoprofen in the treatment of osteoarthritis. The homoeopathic medicine was found to be ineffective whereas fenoprofen gave an improvement.' There were two interpretations: either the effects of homoeopathy are only a placebo effect-that is, a true negative -or the result was a false negative one because of flaws in the design. Another trial had previously
suggested that homoeopathy was effective in rheumatoid arthritis.
We designed a trial to clarify these results by overcoming the methodological criticisms while retaining a rigorous design. The main problem in designing
clinical trials of homoeopathy is that prescriptions are based on criteria such as the pattern of symptoms as well as the diagnosis. A clinical trial based solely on
diagnosis is therefore inappropriate. In a pilot study we had shown that Rhus toxicodenidron 6c was the most commonly indicated homoeopathic medicine for
fibrositis in our patients, being indicated in 42%.
Patients, methods, and results
We used the diagnostic criteria of Yunus et al for
fibrositis.' Only patients with this syndrome, in whom the homoeopathic medicine Rhus toxicodendron 6c was positively indicated were entered into the study.
Thirty patients meeting the admission criteria were recruited in the rheumatology clinic of this hospital.
The clinical characteristics of the patients were similar to those of other reported series regarding age, sex distribution, duration of symptoms, modalities, and
number of tender points. The trial was double blind, placebo controlled, and of crossover design.
After entry there was no further contact between the homoeopathic doctor and the patient until the treatment was finished. The clinical metrologist dispensed
the treatment and performed the assessments and analyses blind. Patients received active treatment and an identical placebo for one month each in random sequence. The dose was two tablets sucked three times daily.
The active preparation was R toxicodendron 6c (Boiron) prepared from a tincture of the leaves of poison oak diluted 1:99 in ethanol and then vigorously shaken. This process was repeated six times to give the 6c potency-a dilution of 102 of the tincture. This was then put up on 125 mg lactose tablets (2% volume per weight). Preparation was as specified in the French national pharmacopoeia. The placebo was identical lactose tablets to which only pharmaceutical ethanol had been added (2% volume per weight). Blind testing of the active and placebo preparations for a battery of drugs yielded negative results. Assessment comprised the number of tender spots, 10 cm visual analogue scales of pain and sleep, and overall assessment.
Comparison was made between values at the end of active and placebo treatment periods.
The patients did better in all variables when they took active treatment rather than placebo. The number of tender spots was reduced by about a quarter (p<0005). We reduced subjective data to nominal measurements (worse or better). If the null hypothesis were correct the direction of change after placebo and active treatment would be randomly distributed.
Analysis showed a significant difference in favour of the homoeopathic medicine (table). Overall assessment also showed a preference for the active treatment,
which was not significant. BMJ VOLUME 299 5 AUGUST 1989 365
Assessment of patients with fibrositis after treatment with Rhus toxicodendron (ac-tive) and placebo
Placebo Active p Value
Mean No of tender points 14-1 10-6 <0.005*
No of patients with improved pain
or sleep (visual analogue scores) 27 53 0-0052t
*Wilcoxon rank sum test. tPaircd t test.
Comment
Fibrositis (primary fibromyalgia) is a controversial condition but is becoming increasingly accepted.4 It is difficult to treat. We showed that the homoeopathic
medicine R toxicodendron 6c was effective for a selected subgroup of patients with fibrositis. The improvement in tenderness, which is the best discriminator of
fibrositis,5 was particularly distinct. The improvement experienced by our patients while receiving active treatment was at least as great as that reported for any
other treatment that has been assessed double blind.
We thank Jean Boiron for his advice and encouragement.
I Shipley M, Berry H, Brostcr G, Jeilkinis M, Closer A, Williams 1. Conitrolled
trial ott homoeopathic treatment of osteoarthritis. Lancet 1983;i:97-8.
2 Gibsott RU, Gibson SLMNI, MacNeill DA, Watson-Buchanan W. Homoeopathic
therapy in rhettmatoid arthritis: evalitation by double-blind clinical trial.
Br] Clin Phtarmacol 1980;9:453-9.
3 Yttnus M, Alasi AT, Calabro JJ, et al. IPrimary fibromyalgia (fibrositis): clinical
study of 50 paticnts with matched normal controls. Semin Arthritis Rthe2m
1981;11:151-71.
4 Yunus MB. Fibromyalgia syndrome: new research on an old condition.
Br Medj 1989;289:474-5.
S Wolfe F, Hawley DJ, Cathey MA, et a/. Fibrositis: symptom frequency and
criteria for diagnosis.]7 Rheumatol 1985;12:1159-68.
(Accepted 28 April 1989)
In scientific research negative results are often more difficult to interpret than positive ones, as was shown by a clinical trial in which the homoeopathic medicine
Rhus toxicodendron 6x was compared with a placebo and fenoprofen in the treatment of osteoarthritis. The homoeopathic medicine was found to be ineffective whereas fenoprofen gave an improvement.' There were two interpretations: either the effects of homoeopathy are only a placebo effect-that is, a true negative -or the result was a false negative one because of flaws in the design. Another trial had previously
suggested that homoeopathy was effective in rheumatoid arthritis.
We designed a trial to clarify these results by overcoming the methodological criticisms while retaining a rigorous design. The main problem in designing
clinical trials of homoeopathy is that prescriptions are based on criteria such as the pattern of symptoms as well as the diagnosis. A clinical trial based solely on
diagnosis is therefore inappropriate. In a pilot study we had shown that Rhus toxicodenidron 6c was the most commonly indicated homoeopathic medicine for
fibrositis in our patients, being indicated in 42%.
Patients, methods, and results
We used the diagnostic criteria of Yunus et al for
fibrositis.' Only patients with this syndrome, in whom the homoeopathic medicine Rhus toxicodendron 6c was positively indicated were entered into the study.
Thirty patients meeting the admission criteria were recruited in the rheumatology clinic of this hospital.
The clinical characteristics of the patients were similar to those of other reported series regarding age, sex distribution, duration of symptoms, modalities, and
number of tender points. The trial was double blind, placebo controlled, and of crossover design.
After entry there was no further contact between the homoeopathic doctor and the patient until the treatment was finished. The clinical metrologist dispensed
the treatment and performed the assessments and analyses blind. Patients received active treatment and an identical placebo for one month each in random sequence. The dose was two tablets sucked three times daily.
The active preparation was R toxicodendron 6c (Boiron) prepared from a tincture of the leaves of poison oak diluted 1:99 in ethanol and then vigorously shaken. This process was repeated six times to give the 6c potency-a dilution of 102 of the tincture. This was then put up on 125 mg lactose tablets (2% volume per weight). Preparation was as specified in the French national pharmacopoeia. The placebo was identical lactose tablets to which only pharmaceutical ethanol had been added (2% volume per weight). Blind testing of the active and placebo preparations for a battery of drugs yielded negative results. Assessment comprised the number of tender spots, 10 cm visual analogue scales of pain and sleep, and overall assessment.
Comparison was made between values at the end of active and placebo treatment periods.
The patients did better in all variables when they took active treatment rather than placebo. The number of tender spots was reduced by about a quarter (p<0005). We reduced subjective data to nominal measurements (worse or better). If the null hypothesis were correct the direction of change after placebo and active treatment would be randomly distributed.
Analysis showed a significant difference in favour of the homoeopathic medicine (table). Overall assessment also showed a preference for the active treatment,
which was not significant. BMJ VOLUME 299 5 AUGUST 1989 365
Assessment of patients with fibrositis after treatment with Rhus toxicodendron (ac-tive) and placebo
Placebo Active p Value
Mean No of tender points 14-1 10-6 <0.005*
No of patients with improved pain
or sleep (visual analogue scores) 27 53 0-0052t
*Wilcoxon rank sum test. tPaircd t test.
Comment
Fibrositis (primary fibromyalgia) is a controversial condition but is becoming increasingly accepted.4 It is difficult to treat. We showed that the homoeopathic
medicine R toxicodendron 6c was effective for a selected subgroup of patients with fibrositis. The improvement in tenderness, which is the best discriminator of
fibrositis,5 was particularly distinct. The improvement experienced by our patients while receiving active treatment was at least as great as that reported for any
other treatment that has been assessed double blind.
We thank Jean Boiron for his advice and encouragement.
I Shipley M, Berry H, Brostcr G, Jeilkinis M, Closer A, Williams 1. Conitrolled
trial ott homoeopathic treatment of osteoarthritis. Lancet 1983;i:97-8.
2 Gibsott RU, Gibson SLMNI, MacNeill DA, Watson-Buchanan W. Homoeopathic
therapy in rhettmatoid arthritis: evalitation by double-blind clinical trial.
Br] Clin Phtarmacol 1980;9:453-9.
3 Yttnus M, Alasi AT, Calabro JJ, et al. IPrimary fibromyalgia (fibrositis): clinical
study of 50 paticnts with matched normal controls. Semin Arthritis Rthe2m
1981;11:151-71.
4 Yunus MB. Fibromyalgia syndrome: new research on an old condition.
Br Medj 1989;289:474-5.
S Wolfe F, Hawley DJ, Cathey MA, et a/. Fibrositis: symptom frequency and
criteria for diagnosis.]7 Rheumatol 1985;12:1159-68.
(Accepted 28 April 1989)
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