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Harm in homeopathy: Aggravations, adverse drug events or medication errors?
Abstract
The assessment of harm arising from the use of homeopathic medicine is much discussed, but there is little published data on the subject.
To study prospectively adverse drug events related to homeopathic medicines.
The data were gathered between 1 June 2003 and 30 June 2004 during follow-up visits consecutively carried out at the Homeopathic Clinic, Campo di Marte Hospital, Azienda USL 2, Lucca (Italy). They refer to effects following the administration of a homeopathic medicine, prescribed according to the classical homeopathic method.
Reports collected by a homeopathic doctor (not the prescribing doctor) on the nature and intensity of the effect, dose and frequency of administration, time relationship between the drug use and the adverse events, challenge, unchallenge possible concomitant factors, causality (improbable, unlikely, possible, probable, certain).
Out of 335 homeopathic consecutive follow-up visits between 1 June 2003 and 30 June 2004, nine adverse reactions were reported (2.68%) including one case of allergy to lactose, excipient of the granules.
Adverse events to homeopathic drugs exist and are distinguishable from homeopathic aggravations, but are rare and not severe.
... A total of 40 observational studies were included in the methodological assessment. Results from this evaluation demonstrated that five observational studies did not report baseline comparability, 34,40,52,61,65 nine did not report exclusion criteria, 30 table 1 the sample size refers to the total number of participants in the study. In the treatment and control groups, n refers to the number of participants who received the intervention. ...
... Adverse effects were measured on a three or four point tolerability scale (very good, good, moderate and low) in 13 studies. 27-30, 32,33,38,42-44, 60,64,66 Seven studies 29,34,38,41,43,44,49 measured adverse effects as mild, moderate, and severe. Four studies 26,42,57,60 reported harmful events descriptively. ...
Background
Almost all health care interventions have the potential to be associated with risk to patient safety. Different terminologies are used to define treatment induced risk to patient safety and a common definition is the term adverse effect. Beyond the concept of adverse effect and specific to homeopathy is the concept of homeopathic aggravation. Homeopathic aggravation describes a transient worsening of the patients’ symptoms, which is not understood as an adverse effect. In order to ensure patient safety within a homeopathic treatment setting, it is important to identify adverse effects, as well as homeopathic aggravations, even though it may be challenging to distinguish between these two concepts. To date there is an obvious lack of systematic information on how adverse effects and homeopathic aggravations are reported in studies. This systematic review and meta-analysis focuses on observational studies, as a substantial amount of the research base for homeopathy are observational.
Method
Eight electronic databases, central webpages and journals were searched for eligible studies. The searches were limited from the year 1995 to January 2020. The filters used were observational studies, human, English and German language. Adverse effects and homeopathic aggravations were identified and graded according to The Common Terminology Criteria for Adverse Effects (CTCAE). Meta-analysis was performed separately for adverse effects and homeopathic aggravations.
Results
A total of 1,169 studies were identified, 41 were included in this review. Eighteen studies were included in a meta-analysis that made an overall comparison between homeopathy and control (conventional medicine and herbs). Eighty-seven percent (n = 35) of the studies reported adverse effects. They were graded as CTCAE 1, 2 or 3 and equally distributed between the intervention and control groups. Homeopathic aggravations were reported in 22,5% (n = 9) of the studies and graded as CTCAE 1 or 2.
The frequency of adverse effects for control versus homeopathy was statistically significant (P < 0.0001). Analysis of sub-groups indicated that, compared to homeopathy, the number of adverse effects was significantly higher for conventional medicine (P = 0.0001), as well as other complementary therapies (P = 0.05).
Conclusion
Adverse effects of homeopathic remedies are consistently reported in observational studies, while homeopathic aggravations are less documented. This meta-analysis revealed that the proportion of patients experiencing adverse effects was significantly higher when receiving conventional medicine and herbs, compared to patients receiving homeopathy. Nonetheless, the development and implementation of a standardized reporting system of adverse effects in homeopathic studies is warranted in order to facilitate future risk assessments.
... To address such direct risks, several jurisdictions, including the European Union, Canada and Australia, have implemented regulations that specify "safe" dilutions for commercial homeopathic preparations (Buchholzer et al., 2014). Also epistemically-uncontentious is that homeopathic medicine users may react adversely to a remedy's substrate, typically a pill composed of lactose (Endrizzi et al., 2005), or a solution of alcohol (Oberbaum et al., 2012). Another material risk discussed in the literature is that of remedy contamination (Buchholzer et al., 2014), which may occur either in commercial contexts or when homeopaths compound individualized remedies from raw substances. ...
... The evidentiary evaluation of adverse events from homeopathic proving symptoms problematizes what researchers may consider credible epistemic constructs around risk. Some clinical studies have explicitly documented incidence of mild or moderate proving symptoms in clinical settings (e.g., Endrizzi et al., 2005;Michalsen et al., 2015), a finding that takes nonmaterial effects as epistemically credible. A 2016 systematic review and meta-analysis of randomized controlled trials of homeopathy (n = 39) showed mild and moderate adverse events to occur equally from low and high dilution remedies (Stub et al., 2016). ...
While the principle of risk reduction increasingly underpins health professional regulatory models across the globe, concepts of risk are neither static nor epistemically neutral. Conventional biomedicine's risk conceptions are substantially rooted in principles of scientific materialism, while many traditional and complementary medicine systems have vitalistic epistemic underpinnings that give rise to distinctive safety considerations. The statutory regulation of traditional and complementary medicine providers has been identified by the World Health Organization as a strategy for enhancing public safety. However, complex risk-related questions arise at the intersection of medical epistemologies whose concepts are at best overlapping, and at worst incommensurable. Elaborating a theoretical concept of “paradigm-specific risk conceptions,” this work employs Bacchi's poststructural mode of policy analysis (“What's the Problem Represented to Be?”) to critically analyze risk discourse in government documents pertaining to the 2015 statutory regulation of homeopathic practitioners in Ontario, Canada. The Ontario government's pre-regulatory risk assessments of the homeopathic occupation discursively emphasized cultural safety principles alongside homeopathy-specific risk conceptions. These paradigm-specific concepts, rooted in homeopathy's epistemic vitalism, extend beyond materialist constructions of adverse events and clinical omission to address potential harms from homeopathic “proving symptoms”, “aggravation,” and “disruption,” all considered implausible from a biomedical standpoint. Although the province's new homeopathy regulator subsequently articulated safety competencies addressing such vitalistic concepts, the tangible risk management strategies ultimately mandated for practitioners exclusively addressed risks consistent with the scientific materialist paradigm. This policy approach substantially echoes the implicit biomedical underpinnings evident in Ontario's broader legislative context, but leaves a significant policy gap regarding the primary safety considerations originally articulated as substantiation for homeopath's statutory regulation. To optimally preserve patient safety and full informed consent, regulators of traditional and complementary medicine professionals should favor a pragmatic, epistemically-inclusive approach that actively negotiates paradigm-specific risk conceptions from both biomedicine and the occupation under governance.
... It is also important to note that the indexed homeopathic literature demonstrates an absence of adverse events, given that the first and foremost requirement for any medicine evaluated in clinical and epidemiological trials is safety [6,10,12,13]. ...
... However, in this analysis we have relied exclusively on the most rigorous "conventional" criteria for evaluation. It is always important to note the manner in which an existing publication has been evaluated [12], and the relevance or importance of the journal in which it appears. Another quality criterion concerns the methods used and described in the paper. ...
The use of a complementary medicine approach, and specifically of the popular medicine Oscillococcinum, for the treatment of influenza-like syndromes remains controversial. This brief paper analyses the currently available literature on this homeopathic preparation and the Cochrane Collaboration's 2006 systematic review, along with other recent studies, in order to clarify certain fundamental aspects of its use in the treatment of influenza. In the light of the reported findings, and applying the rigorous criteria of evidence-based medicine, we suggest that this medicine should be placed in category "BI".
... The chosen trials were highly heterogeneous and their conclusions are less definite than presented (Lüdtke and Rutton, 2008). Serious unexpected adverse effects of homoeopathic medicines are rare (Endrizzi et al., 2005). " Aggravation reactions " , when symptoms become acutely and transiently worse after homoeopathic treatment , have been described and are often regarded as a good prognostic factor by homoeopaths (Endrizzi et al., 2005). ...
... Serious unexpected adverse effects of homoeopathic medicines are rare (Endrizzi et al., 2005). " Aggravation reactions " , when symptoms become acutely and transiently worse after homoeopathic treatment , have been described and are often regarded as a good prognostic factor by homoeopaths (Endrizzi et al., 2005). Recently, about 20 randomized controlled clinical trials concerning the use of veterinary homeopathy have been published in peer reviewed journals (Mathie et al., 2007). ...
Complementary and Alternative Medicine (CAM) like acupuncture, herbal medicine and homeopathy is increasingly used in the treatment of human and animal disease. On the other hand, CAM is discussed controversially, especially in the context of Evidence-Based Veterinary Medicine (EBVM). This paper provides a balanced analysis of the currently available data on CAM in human and veterinary medicine. In conclusion, little rigorous research data concerning the efficacy and safety of CAM has been published. However, acupuncture is gaining increasing acceptance in academic medicine, based on several metaanalyses that show efficacy for specific conditions. In practice, decisions concerning CAM therapies should also be based on the best available evidence provided by scientifically valid data. This implies that CAM interventions must be validated by stringent high quality research to obtain an objective and replicable overview of efficacy and safety. Nevertheless, trials should be designed according to important aspects of CAM therapies (e.g. individual treatment). In conclusion, Evidence-Based Alternative Veterinary Medicine is not a contradiction in terms.
... Out of 335 homeopathic successive follow-up visits, nine adverse responses were reported. This study concluded that Adverse events to homeopathic medicines are present and are distinguishable from homeopathic aggravations, but are rare and not severe [8] . ...
... Further investigation of this particular aspect would be a step in the right direction. With all the limited research carried out so far, most researchers have concluded that homeopathic treatment is largely safe (Stub et al. 2012;Endrizzi et al. 2005;Dantes and Rampes 2000). Homeopathy concepts are not consistent with fundamental concepts of chemistry and physics leading to Homoeopathy arguably being more severely tested through double-blind, randomized controlled trials (RCTs). ...
Quantum dots are the most innovative molecules created in the modern era. These molecules are of nano-size ranged from 1-10 nm with unique photoluminescence characteristics. The unique properties of luminescence madethem an excellent candidate for cellular labelling and detection markers. The fabrication by conjugating with a library of biomolecules opened the gates for various innovative bioimaging and diagnostic protocols and drugdelivery systems. Having these versatile properties, QDs are originating as next-generation bio-nanotechnological tools for mankind to answer many biomedical issues in the fields of diagnosis and treatment. In this book chapter, a comprehensive discussion was made on the QDs, and their critical physico-optical characteristics, and their application in bioimaging, diagnosis, and drug targeting. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.
... Both complex homeopathic medical treatments in the present study appeared to be safe, since a low percentage (1-3 %) of children reported ADRs which were mild or moderate in intensity. Similar low percentages of reported ADRs were observed in an outpatient clinical observational trial in Italy in which the occurrence of ADRs with homeopathic treatment were rare and not severe or serious [23] and in a study in which acute URTIs in children were also treated with a homeopathic complex product [24]. The tolerability of CalSuli-4-02 as assessed by investigators and children/parents was significantly better rated at the end of treatment period than the comparator homeopathic product. ...
Background: The present study was initiated to investigate the effectiveness, safety and tolerability of complex homeopathic CalSuli-4-02 tablets on prevention of recurrent acute upper respiratory tract infections (URTIs) in children, in comparison to another complex homeopathic product. Methods: The study was designed as a prospective, multicenter, randomized, open, clinical trial with two parallel treatment groups at four outpatient pediatric clinics in Russia. Children aged ≤ 6 years with susceptibility to acute URTIs (≥ three occasions during the last 6 months) were randomized to receive either CalSuli-4-02 or a comparator homeopathic product (control group) for 3 weeks. Primary outcome was the frequency of acute URTIs after 3 and 6 months post-treatment follow-up. Secondary endpoints were changes in complaints and symptoms (total and individual scores), treatment satisfaction, antibiotic use, safety and tolerability. Results: The intention-to-treat analysis involved 200 children (CalSuli-4-02: N = 99, Control: N = 101). In both treatment groups, the median number of acute URTIs was one for 3 months and two, respectively, for the full 6 months post-treatment (Relative Risk: 0.86 (95 %-CI: 0.72–1.03), p = 0.1099). Seasons had no influence on the outcome. At the end of study, CalSuli-4-02 had overall higher odds of getting lower complaints severity total score (Odds ratio: 1.99 (95 %-CI: 1.31–3.02), p = 0.0012) and showing symptom improvement (Odds ratio: 1.93 (95 %-CI: 1.25–3.00), p = 0.0033). Specifically, the complaint “appetite disorder” and the symptom “child’s activities” significantly improved more in the CalSuli-4-02 group (p = 0.0135 and p = 0.0063, respectively). Antibiotic use was decreased in both treatment groups at the study end. Overall assessment for satisfaction with and tolerability of treatment was higher with CalSuli-4-02. A low number of non-serious adverse drug reactions was reported (CalSuli-4-02: N = 4, Control: N = 1). Conclusions: Both complex homeopathic products led to a comparable reduction of URTIs. In the CalSuli-4-02 group, significantly less URTI-related complaints and symptoms and higher treatment satisfaction and tolerability were detected. The observation that the use of antibiotics was reduced upon treatment with the complex homeopathic medications, without the occurrence of complications, is interesting and warrants further investigations on the potential of CalSuli-4-02 as an antibiotic sparing option. Clinical trial registration number: Roszdravnadzor: Study No 164–563
... The presence of side effects is in any case negligible, with immediate regression of the symptoms at suspension of treatment. 29 Atopic diseases are the most frequently observed problems in this context: allergic rhinoconjunctivitis, 6.9%; asthma, 7.2%; and atopic dermatitis, 7.2%. Good results in terms of efficacy were achieved especially among children both in the short and the long term. ...
Introduction The healthcare programs of the Region of Tuscany (Italy) have started the process of integration of some types of complementary medicine (CM), including homeopathy, which began in 1996. The Homeopathic Clinic of Lucca was opened in 1998, followed by the Homeopathic Clinic for Women in 2003, and the Clinic for CM and Diet in Oncology in 2013.
Methods Observational longitudinal studies conducted on 5,877 patients (3,937 in the general clinic, 1,606 in the women's clinic and 334 in oncology) were consecutively examined from 2003 to 2016. The Outcome in Relation to Impact on Daily Living (ORIDL) was generally used to assess outcomes.
Results Comparing the clinical conditions before and after homeopathic treatment, improvement was observed in 88.8% of general medicine patients with follow-up (45.1%); in particular, 68.1% of the patients had a major improvement in or resolution (ORIDL +2, +3, +4) of their condition. In women, an improvement was obtained in 74.1% cases and a major improvement in 61.2%. In cancer patients with homeopathic and integrative treatment, a significant improvement was observed for all the symptoms during anti-cancer therapy, particularly for hot flashes, nausea, depression, asthenia, and anxiety.
Conclusions These results suggest that homeopathy can effectively be integrated with allopathic medicine and that the Tuscan experience could provide a useful reference for developing national and European regulations on the use of CM and homeopathy in public healthcare.
... A study on the patients of the Clinic of Homeopathy in Lucca, Italy [10], investigated the frequency of adverse events during homeopathic follow-up visits of 335 patients from 1 June 2003 to 30 June 2004. There were nine cases of side effects identified, amounting to 2.68% of all cases (including a case of lactose intolerance). ...
Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.
... Se concluyó que los eventos adversos por medicamentos homeopáticos existen y son diferentes de las agravaciones homeopáticas, pero son raros y no severos. 9 Por lo anterior, es necesario realizar investigación clínica con la calidad metodológica necesaria que permita evaluar la seguridad de los medicamentos homeopáticos. Al respecto, el objetivo de nuestro estudio fue determinar la frecuencia de eventos adversos de la terapéutica homeopática en la Consulta Externa de homeopatía del Hospital Juárez de México. ...
RESUMEN Introducción. Tradicionalmente se ha considerado que los medicamentos homeopáticos son seguros. Los médicos homeópatas no reportan de manera rutinaria la aparición de eventos adversos en su práctica clínica, por lo que no existe información sobre farmacovigilancia homeopática en nuestro país. Objetivo. Determinar la frecuencia de agravaciones homeopáticas y eventos adversos de los medicamentos homeopáticos prescritos en la consulta de Homeopatía del Hospital Juárez de México en el 2007. Material y método. Se realizó un estudio restrospectivo, descriptivo, transversal mediante la revisión de expedientes clínicos de 199 prescripciones. Resultados. La frecuencia de eventos adversos fue de 6.5% (13/199), de los cuales la mayoría fueron leves y posiblemente no relacionados al tratamiento homeopático. La frecuencia de agravaciones homeopáticas fue de 32.7%, pero fueron síntomas leves y transitorios. Conclusiones. A pesar de que la frecuencia de eventos adversos en las prescripciones homeopáticas fue baja, es importante distinguirlos de las agravaciones homeopáticas, realizando estudios prospectivos sobre seguridad con búsquedas intencionadas de eventos adversos. Palabras clave: Agravación homeopática, evento adverso, homeopatía. ABSTRACT Introduction. Traditionally, homeopathic medicines are regarded as safe. Practitioners do not report the presence of adverse events in their routine practice and there is no information in homeopathic farmacovigilance in our country. Objective. To evaluate the frecuency of homeopathic aggravations and adverse events of homeopathic medicines prescribed in the clinical practice of Hospital Juarez de Mexico during 2007. Material and methods. A descriptive, cross sectional and retrospective study was performed by checking the clinical files of 199 prescriptions during 2007. Results. The frecuency of adverse events was 6.5% (13/ 199); the symptoms were minor and possibly not related to the homeopathic treatment. The frecuency of homeopathic aggravations was 32.7%, but they were also transient and minor. Conclusions. Although the frecuency of adverse events in homeopathic prescriptions was low, it is important to distinguish them of the homeopathic aggravation. It is neccessary to perform prospective studies in security with deliberate research of adverse events.
... The methods of choice to study safety would be similar to the detection of adverse events associated with pharmaceutical treatments. The field of acupuncture has provided a thorough and rigorous risk assessment [36][37][38][39] based on these principles and the other fields within CAM need to follow suit [40][41][42]. ...
... Treatment with ZinCyp-3-02 tablets appeared to be safe and well tolerated and almost all children and parents (92.1% out of 89 children) were "satisfied/very satisfied" with it. These findings are in line with other studies confirming that homeopathic medicines are well tolerated in children in general and that adverse drug reactions are very rare [26][27][28][29]. In contrast, the use of pharmaceutical agents such as antihistamines, alpha-agonists, or benzodiazepines may pose safety risks to children with insomnia. ...
A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for ≥ one month compared to glycine. Children ≤ six years old received either ZinCyp-3-02 (
N
=
89
) or comparator glycine (
N
=
90
). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77–7.14),
p
<
0.0001
,
POM overall treatment related effect
). Absence of individual complaints (time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, and sleep disorders frequency) at study end were significantly higher with ZinCyp-3-02 (all
p
values < 0.05). More children with ZinCyp-3-02 were totally free of complaints (
p
=
0.0258
). Treatment effectiveness (
p
<
0.0001
) and satisfaction assessments (
p
<
0.0001
) were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02:
N
=
2
, glycine:
N
=
1
) and both treatments were well tolerated. Treatment with the homeopathic product ZinCyp-3-02 was found to be safe and superior to the comparator glycine in the treatment of sleep disorders in children.
... Both complex homeopathic medical treatments in the present study appeared to be safe, since a low percentage (1-3 %) of children reported ADRs which were mild or moderate in intensity. Similar low percentages of reported ADRs were observed in an outpatient clinical observational trial in Italy in which the occurrence of ADRs with homeopathic treatment were rare and not severe or serious [23] and in a study in which acute URTIs in children were also treated with a homeopathic complex product [24]. The tolerability of CalSuli-4-02 as assessed by investigators and children/parents was significantly better rated at the end of treatment period than the comparator homeopathic product. ...
Background
The present study was initiated to investigate the effectiveness, safety and tolerability of complex homeopathic CalSuli-4-02 tablets on prevention of recurrent acute upper respiratory tract infections (URTIs) in children, in comparison to another complex homeopathic product. Methods
The study was designed as a prospective, multicenter, randomized, open, clinical trial with two parallel treatment groups at four outpatient pediatric clinics in Russia. Children aged ≤ 6 years with susceptibility to acute URTIs (≥ three occasions during the last 6 months) were randomized to receive either CalSuli-4-02 or a comparator homeopathic product (control group) for 3 weeks. Primary outcome was the frequency of acute URTIs after 3 and 6 months post-treatment follow-up. Secondary endpoints were changes in complaints and symptoms (total and individual scores), treatment satisfaction, antibiotic use, safety and tolerability. ResultsThe intention-to-treat analysis involved 200 children (CalSuli-4-02: N = 99, Control: N = 101). In both treatment groups, the median number of acute URTIs was one for 3 months and two, respectively, for the full 6 months post-treatment (Relative Risk: 0.86 (95 %-CI: 0.72–1.03), p = 0.1099). Seasons had no influence on the outcome. At the end of study, CalSuli-4-02 had overall higher odds of getting lower complaints severity total score (Odds ratio: 1.99 (95 %-CI: 1.31–3.02), p = 0.0012) and showing symptom improvement (Odds ratio: 1.93 (95 %-CI: 1.25–3.00), p = 0.0033). Specifically, the complaint “appetite disorder” and the symptom “child’s activities” significantly improved more in the CalSuli-4-02 group (p = 0.0135 and p = 0.0063, respectively). Antibiotic use was decreased in both treatment groups at the study end. Overall assessment for satisfaction with and tolerability of treatment was higher with CalSuli-4-02. A low number of non-serious adverse drug reactions was reported (CalSuli-4-02: N = 4, Control: N = 1). Conclusions
Both complex homeopathic products led to a comparable reduction of URTIs. In the CalSuli-4-02 group, significantly less URTI-related complaints and symptoms and higher treatment satisfaction and tolerability were detected. The observation that the use of antibiotics was reduced upon treatment with the complex homeopathic medications, without the occurrence of complications, is interesting and warrants further investigations on the potential of CalSuli-4-02 as an antibiotic sparing option. Clinical trial registration numberRoszdravnadzor: Study No 164–563
... To assess the possible harm arising from the use of homeopathic medicine, a prospective study [26] was conducted on adverse reactions related to homeopathic medicines between June 1st 2003 and June 30 2004 during follow-up visits consecutively carried out at the Homeopathic Clinic. In this research a homeopathic (not the prescribing) doctor examined the effects following the administration of a homeopathic medicine, prescribed according to the classical homeopathic method and the relationship with the dose and frequency of administration, time relationship between drug use and adverse events, challenge, de-challenge, possible concomitant factors, causality (improbable, unlikely, possible, probable, certain). ...
Complementary medicine (CM) is being increasingly used by citizens across Europe as a means to maintain their health and to treat illness and disease. In Italy the reform of Title V of the Italian Constitution allows each Region to decide how to put into practice and organize the Public Healthcare System. The agreement among the Italian National Government, the Regions, and the Provinces of Trento and Bolzano on the terms and requirements for the quality certification of training and practice of acupuncture, herbal medicine, and homeopathy by medical doctors and dentists, signed on February 2013, sets up rules for education and training in acupuncture, herbal medicine, homeopathy, homotoxicology, and anthroposophic medicine. Some regions, including Tuscany, have decided to include Complementary Medicine in their Essential Levels of Assistance, by creating some structures that integrate the health services into the public structures. The Homeopathic Clinic in Lucca, funded by the Tuscany Region, was established in 1998 as part of a pilot project aimed at assessing the feasibility of integrating complementary medicine into the public health care system. To date, over 4,000 patients have been consecutively visited at the Homeopathic Clinic in Lucca. Concomitantly, research into homeopathy effectiveness has been conducted on the whole sample and on specific groups of children, women or patients’ parents as well. Studies were also performed on symptom reduction or resolution of atopic diseases, respiratory diseases, side effects of anticancer therapies in women. Other researches concerned cost/effectiveness of therapies, sociodemographic characteristics and compliance of patients, and risk management. The results demonstrate that homeopathy can effectively integrate or, in some cases, substitute allopathic medicine and that the Tuscan example can be useful to the development of national or European rules on CM utilization.
... 95,96 Allergic reactions at low potencies may be a minor risk, 137,138 though the rates appear to be extremely low, serious events are rare, and relatedness to the remedies per se uncertain. 96,139,140 In one sense, homeopaths in clinical practice may be many years ahead of conventional physicians in applied understanding of how and when to use nanoparticles of natural products for safe and effective clinical treatment. ...
Finding safer and more effective treatments for specific cancers remains a significant challenge for integrative clinicians and researchers worldwide. One emerging strategy is the use of nanostructured forms of drugs, vaccines, traditional animal venoms, herbs, and nutraceutical agents in cancer treatment. The recent discovery of nanoparticles in traditional homeopathic medicines adds another point of convergence between modern nanomedicine and alternative interventional strategies. A way in which homeopathic remedies could initiate anticancer effects includes cell-to-cell signaling actions of both exogenous and endogenous (exosome) nanoparticles. The result can be a cascade of modulatory biological events with antiproliferative and pro-apoptotic effects. The Banerji Protocols reflect a multigenerational clinical system developed by homeopathic physicians in India who have treated thousands of patients with cancer. A number of homeopathic remedy sources from the Banerji Protocols (eg, Calcarea phosphorica; Carcinosin-tumor-derived breast cancer tissue prepared homeopathically) overlap those already under study in nonhomeopathic nanoparticle and nanovesicle tumor exosome cancer vaccine research. Past research on antineoplastic effects of nano forms of botanical extracts such as Phytolacca, Gelsemium, Hydrastis, Thuja, and Ruta as well as on homeopathic remedy potencies made from the same types of source materials suggests other important overlaps. The replicated finding of silica, silicon, and nano-silica release from agitation of liquids in glassware adds a proven nonspecific activator and amplifier of immunological effects. Taken together, the nanoparticulate research data and the Banerji Protocols for homeopathic remedies in cancer suggest a way forward for generating advances in cancer treatment with natural product-derived nanomedicines.
... Regarding the purported toxicity of homoeopathic medicines and the risk of adverse effects, the author forgets to say that homoeopathic remediesaccording to the U.S., European and Italian pharmacopoeias and legislationare used in dilutions such that they cannot have direct toxic effects. Moreover, adverse effects of homoeopathic drugs are exceedingly rare and these therapies are well tolerated (13,14). We have demonstrated with placebo-controlled studies in behavioural models that the dilutions 5c, 7c, 9c and 30c of G. sempervirens (2,3) and of Ignatia amara (15) have anxiolytic-like properties without weakening locomotion and without adverse or sedative effects. ...
In September 2013 issue of Int. J. Clin. Pract., a lengthy letter concerned “bias and adverse effects in homeopathy”. The letter apparently raised “scientific criticism”, actually was dedicated to throw mud on researchers who deal with homeopathy issues. As group of scientists working in the University of Verona, here we defend the integrity and reliability of rigorous research in homeopathy, including ours. This clarification letter is published in the interests of providing correct and truthful information to readers.
Notes 1: this abstract is provided for Research Gate, the published paper has no abstract; 2: the downloadable text is the same as the published paper, in a format which is freely downloadable; 3: if someone desires further clarifications, he/she can send a personal message to authors thanks.
... The adverse events overall were rare and not severe or serious. 119 The usual dose range below the NOAEL renders conventional toxicological reactions highly improbable, even when the original source substance may itself be an herb or mineral with some toxic potential at conventional dose exposure levels. Clinical toxicology data support this latter statement. ...
The public health and individual risks of inappropriate antibiotic prescribing and conventional over-the-counter symptomatic drugs in pediatric treatment of acute otitis media (AOM) and upper respiratory infections (URIs) are significant. Clinical research suggests that over-the-counter homeopathic medicines offer pragmatic treatment alternatives to conventional drugs for symptom relief in children with uncomplicated AOM or URIs. Homeopathy is a controversial but demonstrably safe and effective 200-year-old whole system of complementary and alternative medicine used worldwide. Numerous clinical studies demonstrate that homeopathy accelerates early symptom relief in acute illnesses at much lower risk than conventional drug approaches. Evidence-based advantages for homeopathy include lower antibiotic fill rates during watchful waiting in otitis media, fewer and less serious side effects, absence of drug-drug interactions, and reduced parental sick leave from work. Emerging evidence from basic and preclinical science research counter the skeptics' claims that homeopathic remedies are biologically inert placebos. Consumers already accept and use homeopathic medicines for self care, as evidenced by annual US consumer expenditures of $2.9 billion on homeopathic remedies. Homeopathy appears equivalent to and safer than conventional standard care in comparative effectiveness trials, but additional well-designed efficacy trials are indicated. Nonetheless, the existing research evidence on safety supports pragmatic use of homeopathy in order to "first do no harm" in the early symptom management of otherwise uncomplicated AOM and URIs in children.
... The nondisclosure of lactose, a common ingredient in homoeopathic drugs, may cause problems for lactose-intolerant patients. A case of lactoseinduced side effects of a homoeopathic drug has been reported in the homoeopathic literature, but the case was not competently described, and it is therefore difficult to evaluate [4]. ...
In the European Union, all pre-packaged food products must contain a list of ingredients and their quantities. The list should be "accurate, clear and easy to understand for the consumer."(1) Similar requirements apply to pharmaceutical drugs, but an exception has been made for homeopathic preparations. For such products, the ingredients need not be disclosed on the label, which should instead specify "the scientific name of the stock or stocks followed by the degree of dilution."(2) The "degree of dilution" is given in a homeopathic jargon (such as "C60" for 1:10(120) ) that few consumers understand. This article is protected by copyright. All rights reserved.
... In our study adverse events were rarely observed during the course of treatment, which agrees with Endrizi et al [22] and Haidvogl et al [9]. On the other hand, according to Aroll [6] there is insufficient evidence of benefit to warrant the use of antibiotics for upper respiratory tract infections in children and their routine use is not recommended. ...
Aims: The study aimed to evaluate the effect of a group of homeopathic medicines in children with acute rhinitis. Materials and methods: In this multi-centric open clinical trial, a total of 784 children (408 males; 384 females) aged 6 months to 15 years, presenting symptoms of acute rhinitis were enrolled from 7 Institutes/ Units under the Central Council for Research in Homeopathy (India). Symptoms were assessed using an acute rhinitis symptom score (ARSS). A total of 13 homeopathic medicines were shortlisted after repertorizing the nosological symptoms of acute rhinitis in children and the results were analyzed. The medicines were prescribed in dilution 6c (10 -12) and doses were repeated from few minutes to few hours as per the need of the case. Appearance of any change (improvement or worsening) was followed by placebo / change in dilution or change in medicine according to the response of the patient. The follow up period was up to the 7 th day of illness. Results: Out of 784 children enrolled, 638 children were followed up and analyzed. A significant change in the score from the baseline (p<0.05) was observed. Twelve medicines were found to be useful in 638 children suffering from acute rhinitis and among them Nux-v (n=109), Merc (n=106) and Bell (n=88) were the most useful. No complications were observed during the treatment. Adverse events in the form of hyperpyrexia were observed in 2 children only. Conclusion: This study indicates the usefulness of homeopathic medicines in the management of acute rhinitis of children; controlled studies are needed to investigate their efficacy and effectiveness.
... Pharmacists argued that the large dilution of these products meant they were not likely to be associated with any adverse reactions. There is little evidence in the clinical literature for adverse drug reactions related to homeopathic products (Altunc et al., 2007; Endrizzi et al., 2005) and a survey of NHP users in Canada identified no reports of interactions between homeopathic products and prescription drugs (). In comparison, there is evidence of interactions between several herbal products and prescription drugs, with serious clinical consequences (Cvijopvic et al., 2009; Izzo and Ernst, 2001). ...
... Patients whose symptoms were attributed to inappropriate or wrong prescription according to the criteria described elsewhere were excluded from the clinical cases. 4 We considered the cases reported as evidencing homeopathic aggravation at the time of consultation, in terms of modes of aggravation (type, onset time, duration, intensity.) and types of prescription (remedy prescribed, potency, dose, frequency of repetition). ...
Homeopathic aggravation is the exacerbation of some symptoms or the whole pathological situation, followed by improvement of the patient's conditions.
To evaluate the typology, intensity and frequency of homeopathic aggravation, especially with Quinquagintamillesimal (Q, LM) potencies and its prognostic value.
The homeopathic prescription strategy evaluated consists in the administration of a single homeopathic medicine in Q dilutions, starting with 6Q, then a progressive scale of Q potencies. Patients whose symptoms could be attributed to a wrong and inappropriate prescription, according to the criteria previously described, were excluded.
Data was collected on 1108 patients consecutively visited from 3rd October 2002 to 31st December 2007, and 441 cases followed for at least 2 months (40% of total cases). 63 of these cases (14%) reported homeopathic aggravation: 7% reported 'slight', 5% 'medium', 2% 'intense' and 0.4% 'very intense' aggravation. Homeopathic aggravation was present in 21% of paediatric patients (≤ 14 years). About 50% of the cases manifested homeopathic aggravation 1 or 2 days after the prescription and for 67% of patients the symptoms lasted 1 week or less. Patients with aggravation of the original disease had significantly greater improvement than those patients showing the aggravation of other, new or different, symptoms or conditions, or no aggravation.
These data show that homeopathic aggravation with Q potencies is quite frequent in homeopathic clinical practice and seems to be associated with better treatment outcome.
... In our study adverse events were rarely observed during the course of treatment, which agrees with Endrizi et al [22] and Haidvogl et al [9]. On the other hand, according to Aroll [6] there is insufficient evidence of benefit to warrant the use of antibiotics for upper respiratory tract infections in children and their routine use is not recommended. ...
Aims: The study aimed to evaluate the effect of a group of homeopathic medicines in children with acute rhinitis. Materials and methods: In this multi-centric open clinical trial, a total of 784 children (408 males; 384 females) aged 6 months to 15 years, presenting symptoms of acute rhinitis were enrolled from 7 Institutes/ Units under the Central Council for Research in Homeopathy (India). Symptoms were assessed using an acute rhinitis symptom score (ARSS). A total of 13 homeopathic medicines were shortlisted after repertorizing the nosological symptoms of acute rhinitis in children and the results were analyzed. The medicines were prescribed in dilution 6c (10-12) and doses were repeated from few minutes to few hours as per the need of the case. Appearance of any change (improvement or worsening) was followed by placebo / change in dilution or change in medicine according to the response of the patient. The follow up period was up to the 7th day of illness. Results: Out of 784 children enrolled, 638 children were followed up and analyzed. A significant change in the score from the baseline (p<0.05) was observed. Twelve medicines were found to be useful in 638 children suffering from acute rhinitis and among them Nux-v (n=109), Merc (n=106) and Bell (n=88) were the most useful. No complications were observed during the treatment. Adverse events in the form of hyperpyrexia were observed in 2 children only. Conclusion: This study indicates the usefulness of homeopathic medicines in the management of acute rhinitis of children; controlled studies are needed to investigate their efficacy and effectiveness.
... The methods of choice to study safety would be similar to the detection of adverse events associated with pharmaceutical treatments. The field of acupuncture has provided a thorough and rigorous risk assessment [36][37][38][39] based on these principles and the other fields within CAM need to follow suit [40][41][42]. ...
To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities.
There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This "gap" might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited. Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic "agents" before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated 'whole system' of care, without careful consideration of the safety issue. We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise: 1. Context, paradigms, philosophical understanding and utilization 2. Safety status 3. Comparative effectiveness. 4. Component efficacy 5. Biological mechanisms.
Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.
Complementary therapies are commonly used to prevent and treat various medical conditions worldwide. The chapter begins with a description of the epidemiology of complementary therapies use among individuals with renal conditions, and discusses the legal and ethical considerations of complementary therapy use. This is followed by a review of the scientific evidence regarding the efficacy and safety of complementary therapies (including natural health products, traditional Chinese medicine and massage) used to prevent and treat symptoms associated with various renal conditions (including urinary tract infections, nephrotic syndrome, and chronic kidney disease) with a special focus on pediatric populations. Some complementary therapies considered (e.g. cranberry, and omega-3 fatty acids) have been researched more widely among pediatric populations than others; pediatric data are preferentially discussed when available. Some complementary therapies may be effective and relatively safe for use among pediatric populations (e.g. acupressure or acupuncture for uremic pruritus), while other complementary therapies have limited evidence and warrant further investigation (e.g. many traditional Chinese medicine herbal remedies).KeywordsComplementary therapiesComplementary treatmentsComplementary and alternative medicineRenal diseasePediatricNatural health productsTraditional Chinese medicineComplementary medicine safety
La Homeopatía de México | Evidencias Científicas de la Homeopatía | Edición Especial de Aniversario (90 años) | 2023 || EDITORIAL: Para aquellos que demandan evidencias científicas de la Homeopatía. Marcus Zulian Teixeira. | ARTÍCULOS: Homeopatía: una breve descripción de esta especialidad médica. Marcelo Pustiglione, Eduardo Goldenstein, Y. Moisés Checinski. | Formación médica en la terapéutica no convencional en el mundo (Homeopatía y acupuntura). Marcus Zulian Teixeira. | Bases científicas del principio de curación homeopática en la farmacología moderna. Marcus Zulian Teixeira. | La solidez de la investigación homeopática fundamental. Leoni Villano Bonamin. | Efectos de las diluciones homeopáticas altas sobre los modelos in vitro: revisión de la literatura. Silvia Waisse. | Efectos de las diluciones homeopáticas altas sobre las plantas: revisión de la literatura. Marcus Zulian Teixeira, Solange M.T.P.G. Carneiro. | Investigación clínica en Homeopatía: revisiones sistemáticas y estudios clínicos aleatorizados. Silvia Waisse. | Estrógeno potenciado en el tratamiento homeopático del dolor pélvico asociado a endometriosis: Un estudio aleatorizado, doble ciego, controlado con placebo, de 24 semanas. Marcus Zulian Teixeira, Sérgio Podgaec, Edmund Chada Baracat. | Estudio aleatorizado, doble ciego, sobre la eficacia del tratamiento homeopático en niños con amigdalitis recurrente. Sérgio E. Furuta, Luc L. M. Weckx, Cláudia R. Figueiredo. | ¿Los medicamentos homeopáticos provocan agravación o efectos adversos dependientes de los fármacos? Flávio Dantas. | ¿Los medicamentos homeopáticos inducen síntomas en voluntarios aparentemente sanos? Contribución brasileña al debate sobre los estudios patogénicos homeopáticos. Flávio Dantas. |
La Homeopatía de México | Evidencias Científicas de la Homeopatía | Edición Especial de Aniversario (90 años) | 2023 ||
EDITORIAL:
Para aquellos que demandan evidencias científicas de la Homeopatía.
Marcus Zulian Teixeira. |
ARTÍCULOS:
Homeopatía: una breve descripción de esta especialidad médica.
Marcelo Pustiglione, Eduardo Goldenstein, Y. Moisés Checinski. |
Formación médica en la terapéutica no convencional en el mundo (Homeopatía y acupuntura).
Marcus Zulian Teixeira. |
Bases científicas del principio de curación homeopática en la farmacología moderna.
Marcus Zulian Teixeira. |
La solidez de la investigación homeopática fundamental.
Leoni Villano Bonamin. |
Efectos de las diluciones homeopáticas altas sobre los modelos in vitro: revisión de la literatura.
Silvia Waisse. |
Efectos de las diluciones homeopáticas altas sobre las plantas: revisión de la literatura.
Marcus Zulian Teixeira, Solange M.T.P.G. Carneiro. |
Investigación clínica en Homeopatía: revisiones sistemáticas y estudios clínicos aleatorizados.
Silvia Waisse. |
Estrógeno potenciado en el tratamiento homeopático del dolor pélvico asociado a endometriosis: Un estudio aleatorizado, doble ciego, controlado con placebo, de 24 semanas.
Marcus Zulian Teixeira, Sérgio Podgaec, Edmund Chada Baracat. |
Estudio aleatorizado, doble ciego, sobre la eficacia del tratamiento homeopático en niños con amigdalitis recurrente.
Sérgio E. Furuta, Luc L. M. Weckx, Cláudia R. Figueiredo. |
¿Los medicamentos homeopáticos provocan agravación o efectos adversos dependientes de los fármacos?
Flávio Dantas. |
¿Los medicamentos homeopáticos inducen síntomas en voluntarios aparentemente sanos? Contribución brasileña al debate sobre los estudios patogénicos homeopáticos.
Flávio Dantas. |
Background Homoeopathy is the newest art and science of healing. Like conventional medicine, pharmacovigilance is an important aspect of homoeopathy. There is a paucity of knowledge and ignorance among the practitioners. The necessity is to create awareness and encourage the homoeopathic professionals regarding drug safety surveillance, documentation and reporting of adverse events.
Methods A web-based online search from databases, journals, bibliographic resources regarding the practice of pharmacovigilance in homoeopathy was done. Articles and publications till January 2021 along with literature from homoeopathic books were analysed.
Results Data on adverse drug reactions (ADRs) and events in homoeopathy have been collected and reported in European countries. In India, of late these terminologies are being acknowledged among a group of homoeopathic practitioners only. Still, a dearth of cognizance on the subject exists and little reporting is done. People usually do not relate such adverse reactions to the use of homoeopathic medicines. For scrutinising the same, the Ministry of AYUSH, Govt. of India, has taken an initiative for Pharmacovigilance of Ayurveda, Siddha, Unani & Homoeopathy systems of medicine for reporting and taking measures against ADR and objectionable advertisements. The probable risk factors and ways to prevent ADR and benefits of pharmacovigilance in homoeopathic practice could be deduced.
Conclusion Homoeopathy is a widely followed system of medicine that is quite popular among the common people. The need of knowledge and promotion of suspected ADR reporting should be emphasised to increase the credibility of homoeopathy among the scientific community. Also, the profession should refrain from misleading and objectionable advertisements in print and electronic media.
Prevailing literature state that homeopathic formulations generate ultra small particles (nano size) of starter materials by a process of machine-like milling in lactose or churning in ethanol. Silica nanostructures that are sculpted during the process of successions in glass and/or biologically amalgamated using some natural extract tinctures may also obtain and form superlattice structure in higher potencies or dilutions. NPs have shown to possess high bioavailability and penetrable capabilities. They also possess coadjutor reactivity, electromagnetic or quantum properties when equated to their bulk or the original forms. NPs have been known to invoke adaptive changes in the organism at hormesis doses, serving as notable and lower danger signals to the organism’s stress response. Such homeopathic formulations are said to cause the effect by reviving the hormetic adaptive response and not the classical pharmacological effects. The combination of homeopathy and modern scientific studies can be demonstrated by the updation of terminology from homeopathy to adaptive network nanomedicine.
Homeopathic medicaments are prepared associating the active substance to an inert excipient which becomes an integral part of the remedy. The aim of this research was to analyze the use of mannitol as a homeopathic inert excipient, as a possible substitute to lactose in the preparation of tablets and powder. Research was conducted in homeopathic and manipulation pharmacies in the regions Centro and Icaraí of Niterói, Rio de Janeiro, July to September, 2006. The use of mannitol as inert excipient was detected in all manipulation/homeopathic pharmacies of Niterói researched. The main declared reason for the use of mannitol as an option in the preparation of tablets and powders was the solicitation in medical prescriptions for patients with intolerance to lactose or diabetes. There was no report of undesirable effects related to the use of mannitol according to the people interviewed.
Background Current recommendations for treating obesity in adolescence include a comprehensive approach (nutritional, behavioral, and exercise). Calcarea carbonica ostrearum (CCO) is a homeopathic medicine usually prescribed in obese individuals, but its effects on weight and body fat are not completely known.
Objective The aim of this study will be to evaluate the efficacy of homeopathic CCO, in addition to a multidisciplinary intervention (diet, motivational support, and exercise program), on body fat and weight in obese adolescents.
Methods/Design A randomized, placebo-controlled, double-blind, parallel-group, superiority trial with 3-month study duration will be undertaken. The study will be conducted in a public research hospital in Mexico City, Hospital Juárez de México, in the outpatient services of homeopathy and sports medicine. Eighty non-diabetic adolescents, 12 to 19 years old, who are overweight or obese, will be included. The primary outcome: change in body fat percentage at week 12. The secondary outcomes: change in mean total weight, total body mass index, fat mass index, waist–hip ratio, lean muscle mass, fasting glucose, insulin, insulin resistance, lipid profile, score of Center for Epidemiologic Studies Depression Scale Revised (CESD-R) and score of Screen for Child Anxiety-Related Emotional Disorders (SCARED) at week 12. Efficacy data will be analyzed in the intention-to-treat sample. To determine the difference in the outcomes between groups at baseline and week 12, data will be analyzed using Student's t-test.
Discussion This is the first randomized controlled trial aimed to determine the fat-reducing efficacy in obese adolescents of a homeopathic medicine, CCO, given in addition to a multidisciplinary intervention, compared with placebo plus the same intervention. It is an attempt to support scientific evidence in homeopathy for one of the most common chronic diseases, which causes high mortality due to its complications.
ClinicalTrials.gov Identifier: NCT03945396 https://clinicaltrials.gov/ct2/show/NCT03945396?term=homeopathy+for+obesity+in+Mexican+adolescents&rank=1
Para desmistificar a falácia ou pós-verdade de que “não existem evidências científicas em homeopatia”, disseminada indistintamente em todos os meios, a Câmara Técnica de Homeopatia do Conselho Regional de Medicina do Estado de São Paulo (CREMESP) elaborou o Dossiê Especial “Evidências Científicas em Homeopatia”, que acaba de ser disponibilizado online na Revista de Homeopatia da Associação Paulista de Homeopatia (APH).
Englobando 9 revisões (e 2 RCT) sobre diversas linhas de pesquisa existentes nos mais variados campos da ciência, as quais comportam centenas de artigos científicos publicados em periódicos distintos, esse dossiê evidencia à classe médica e científica, assim como ao público em geral, o estado da arte da pesquisa homeopática.
Apesar das dificuldades e limitações existentes para o desenvolvimento de pesquisas na área, tanto pelos aspectos metodológicos quanto pela ausência de apoio institucional e financeiro, o conjunto de estudos experimentais e clínicos citados, que fundamentam os pressupostos homeopáticos e confirmam a eficácia e a segurança da terapêutica, é prova inconteste de que “existem evidências científicas em homeopatia”, ao contrário do preconceito falsamente disseminado.
Com a elaboração e a divulgação desse dossiê, sob os auspícios da Câmara Técnica de Homeopatia do CREMESP, esperamos esclarecer e sensibilizar os colegas de profissão sobre a validade e a importância do emprego da homeopatia como prática médica adjuvante e complementar às demais especialidades, segundo princípios éticos e seguros, a fim de se ampliar o entendimento do processo de adoecimento humano e o arsenal terapêutico, incrementar o ato médico e sua resolutividade nas doenças crônicas, minimizar os efeitos adversos dos fármacos modernos e fortalecer a relação médico-paciente, dentre outros aspectos. Dessa forma, poderemos trabalhar unidos em torno da “mais elevada e única missão do médico que é tornar saudáveis as pessoas doentes, o que se chama curar” (Samuel Hahnemann, Organon da arte de curar, § 1).
In July 2017, to demystify the fallacy – or post-truth – asserting “there are no scientific evidence for homeopathy”, the Technical Chamber for Homeopathy, Regional Medical Council of the State of São Paulo (CREMESP, Brazil) published the Special Dossier “Evidências Científicas em Homeopatia”, available online in the scientific journal of the São Paulo Homeopathic Medical Association (APH), Revista de Homeopatia.
After this publication, in view of the request of homeopathic doctors and institutions from other countries, the Technical Chamber for Homeopathy, CREMESP, produced an edition of the dossier in English, “Scientific Evidence for Homeopathy”, which has just been made available online in the Revista de Homeopatia.
Encompassing 9 revisions (and 2 randomized clinical trials) on several lines of homeopathic research, containing hundreds of scientific articles published in various journals, this dossier highlights to the scientific and medical class, as well as to the general public, the state of the art of homeopathic research:
Despite the ongoing difficulties and limitations opposing the development of research in homeopathy – partly due to methodological aspects, and partly to lack of institutional and financial support – the experimental and clinical studies described in this dossier, which ground the homeopathic assumptions and confirm the efficacy and safety of this approach to therapeutics – provide unquestionable proof for the “availability of scientific evidence for homeopathy”, against the false and prejudiced opinion that is widely divulgated.
With the divulgation of the present dossier, prepared with the support of Technical Chamber for Homeopathy, CREMESP, we hope to dispel doubts and sensitize our colleagues as to the validity and relevance of homeopathy as adjuvant treatment complementary to all other medical specialties according to ethical and safe principles. Our overall goals are to broaden the understanding of human disease, increase the therapeutic resources, contribute to the definition and effectiveness of medicine in chronic diseases, minimize the adverse effects of modern drugs and strengthen the patient-doctor relationship, among other aspects. In this way, we will be able to work together, since “The physician’s high and only mission is to restore the sick to health, to cure, as it is termed (Samuel Hahnemann, Organon of medicine, § 1).
Para desmitificar a falácia ou pós-verdade de que “não existem evidências científicas em homeopatia”, disseminada indistintamente em todos os meios, a Câmara Técnica de Homeopatia do Conselho Regional de Medicina do Estado de São Paulo (CREMESP) elaborou o Dossiê Especial “Evidências Científicas em Homeopatia”, que acaba de ser disponibilizado online na Revista de Homeopatia da Associação Paulista de Homeopatia (APH).
Englobando 9 revisões (e 2 RCT) sobre diversas linhas de pesquisa existentes nos mais variados campos da ciência, as quais comportam centenas de artigos científicos publicados em periódicos distintos, esse dossiê evidencia à classe médica e científica, assim como ao público em geral, o estado da arte da pesquisa homeopática.
Apesar das dificuldades e limitações existentes para o desenvolvimento de pesquisas na área, tanto pelos aspectos metodológicos quanto pela ausência de apoio institucional e financeiro, o conjunto de estudos experimentais e clínicos citados, que fundamentam os pressupostos homeopáticos e confirmam a eficácia e a segurança da terapêutica, é prova inconteste de que “existem evidências científicas em homeopatia”, ao contrário do preconceito falsamente disseminado.
Com a elaboração e a divulgação desse dossiê, sob os auspícios da Câmara Técnica de Homeopatia do CREMESP, esperamos esclarecer e sensibilizar os colegas de profissão sobre a validade e a importância do emprego da homeopatia como prática médica adjuvante e complementar às demais especialidades, segundo princípios éticos e seguros, a fim de se ampliar o entendimento do processo de adoecimento humano e o arsenal terapêutico, incrementar o ato médico e sua resolutividade nas doenças crônicas, minimizar os efeitos adversos dos fármacos modernos e fortalecer a relação médico-paciente, dentre outros aspectos. Dessa forma, poderemos trabalhar unidos em torno da “mais elevada e única missão do médico que é tornar saudáveis as pessoas doentes, o que se chama curar” (Samuel Hahnemann, Organon da arte de curar, § 1).
Complementary and alternative medicine (CAM) is commonly used to prevent and treat various medical conditions worldwide. The chapter begins with a description of the epidemiology of CAM use among individuals with renal conditions, and discusses the legal and ethical considerations of CAM use. This is followed by a review of the scientific evidence regarding the efficacy and safety of CAM therapies (including natural health products, traditional Chinese medicine and massage) used to prevent and treat symptoms associated with various renal conditions (including urinary tract infections, nephrotic syndrome, chronic renal failure) with a special focus on pediatric populations. Some CAM therapies (e.g. cranberry, omega-3 fatty acids) considered have been researched more widely among pediatric populations than others; pediatric data are preferentially discussed when available. Some CAM therapies may be effective and relatively safe for use among pediatric populations (e.g. acupressure or acupuncture for uremic pruritus), while other CAM therapies have limited evidence and warrant further investigation (e.g. many traditional Chinese medicine herbal remedies).
This chapter discusses adverse effects and interactions of treatments used in complementary and alternative medicine. Owing to extensive modifications of drug formulations and chemical extracts from an expanding range of natural products, herbal formulations may contain ingredients that are particularly harmful to individuals with G6PD deficiency. A 73-year-old man developed a cholinergic syndrome, with dizziness, sweating, chills, lacrimation, salivation, rhinorrhea, nausea, and vomiting after taking the Chinese patent medicine “Ting Kung Teng” for arthritis. Severe liver damage has been attributed to Chinese herbal mixtures. Lead contamination has been reported in herbal medicines. Bleeding caused by impaired platelet function has been attributed to garlic. Hepatocellular injury after oral administration of infusions of Breynia officinalis has been described. Ginkgo biloba has well-documented antiplatelet effects, and bleeding complications can occur, including strokes. High doses of Panax ginseng can cause insomnia, headache, diarrhea, and cardiovascular and endocrine disorders. Parkinsonism has been attributed to kava.
This non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug (Contramutan N Saft).
1050 outpatients suffering from common cold were treated with the medication for 8 days. The study was conducted in 64 outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.
The physicians detected 60 adverse events from 46 patients (4,4%). Adverse drug reactions occurred in 14 patients (1,3%). Six patients showed proving symptoms (0,57%) and only one homeopathic aggravation (0,1%) appeared. The rate of compliance was 84% in average for all groups and the global assessment of the treatment effects attributed to "good" and "very good" in 84.9% of all patients.
The homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.
Copyright © 2015. Published by Elsevier Inc.
Aim
The aim of this study was to summarize twelve years of homeopathic clinical practice in the Homeopathic Clinic of Lucca Public Hospital (Italy) with particular attention to socio-demographic features of the patients, distribution of the different diagnoses, follow-up and clinical outcome.
Methods
Data was reviewed from 2592 consecutive patients between 1998 and 2010 for a variety of clinical problems. A smaller sample of 1129 patients returning for at least one follow up visit were analysed in order to evaluate changes in their clinical symptoms as assessed by Glasgow Homeopathic Hospital Outcome Score.
Results
The mean age of patients was 31 years, they were predominantly female and in many cases had already used conventional medicine for their diseases. The most common presentations were for symptoms concerning respiratory (29.4%), digestive tract (17%) and dermatological (14.7%) diseases. A total of 47% of patients reported major improvement or even resolution of their clinical picture (GHHOS +3 +4); an extremely low percentage of treatment with no results (10%); and a negligible percentage of worsening (0.5%). The younger the age the more successful the therapy outcome (p < 0.001) and longer treatment appeared to give better results (p < 0.001).
Conclusions
The results support previous findings suggesting that homeopathy may be associated with symptom improvement for a range of chronic and recurring diseases, although this claim needs to be supported by more thorough, randomized and controlled studies. The integration of homeopathy in a Public Health System can ensure mostly safety and the equity in access for the patient
Background: Anecdotal evidence suggests some childbearing women self-prescribe the homeopathic remedy Arnica, but not necessarily according to established homeopathic principles. This could, theoretically, lead to lack of benefit or adverse effects. Objectives: To
explore childbearing women's use of homeopathic Arnica and need for further information. Method: A literature review was carried out prior to a cross-sectional survey of maternity service users of a large inner-city teaching hospital between December 2008 and March 2009. In addition to establishing prevalence, a judgment was made as to whether Arnica users had taken the remedy according to homeopathic principles using a novel method developed for this study. Findings: Of 373 women who agreed to participate, 228 returned questionnaires- a response rate of 61%. Of the 27 respondents (12%) who reported using Arnica, 22 (81%) were judged to have 'possibly' or 'probably not' taken it correctly. Of those using Arnica, n = 16 (59%) would have liked more information.
Conclusion: Findings suggest a need for maternity services to provide information to childbearing women who selfprescribe homeopathic remedies.
Aim: To study the socio-demographic features of the paediatric population treated at the Homeopathic Clinic Hospital of Lucca (Italy), the observed diseases, the most commonly used remedies, outcome and follow-up of children, in particular with respiratory disease. Materials and methods: An observational longitudinal study was carried out on a total of 2141 patients consecutively examined from 1998 to 2008. We describe the characteristics of paediatric patients (<= 14 years): sex, age, whether or not they have already used conventional and/or homeopathic therapies, existing disease and follow-up. The outcome was assessed using the Glasgow Homeopathic Hospital Outcome Score (GHHOS). Results: Paediatric patients were 551 (mean age 5.9 years), representing 25.7% of all patients. Respiratory diseases were present in 337 children, of whom 168 came to at least one follow-up visit. Respiratory infections (337 cases; 61%), followed by dermatological (88 cases; 16%), psychological (45; 8%) and digestive (40; 7%) disorders were the most frequently observed diseases; 68% of children with respiratory disease showed a strong improvement or attained a resolution of their problems. Discussion: The likelihood of considerable improvement or resolution of symptoms is significantly higher in patients with problems in the upper respiratory tract (OR: 4.2, 95% CI: 1.6-11.4) and in patients with follow-up of at least 12 months. Therefore, type of disease and follow-up duration were the variables that most strongly affected the probability of success of homeopathic treatment. Conclusion: The results seem to confirm that homeopathic medicine produces a positive therapeutic response particularly in children presenting respiratory diseases.
Homeopathy is based on the idea of 'let like be cured by like'. It was founded by Samuel Hahnemann in the late 18th century, although similar concepts existed earlier. Homeopathy became popular in the 19th century in part because of its success in epidemics but declined during most of the 20th century. Its popularity increased in the late 20th and early 21st centuries in many parts of the world. Homeopathy is controversial because of its use of highly dilute medicines. There is a significant body of clinical research including randomised clinical trials and meta-analyses of such trials which suggest that homeopathy has actions which are not placebo effects. Cohort, observational and economic studies have yielded favourable results. There are several schools of homeopathy. Systems which use homeopathic medicines based on symbolism and metaphor are not homeopathy. Despite the long history of scientific controversy, homeopathy has proved resilient and is now geographically widespread. There is a significant body of scientific evidence with positive results. Homeopathy is an anomaly around which deserves further investigation.
Homeopathy and Bach Flower Remedies (BFRs), historically-related complementary healing modalities classified as prescription/nonprescription drugs and over-the-counter homeopathic nutritional supplements, respectively, are compared with respect to indications, dosage philosophies, associated procedures, reported outcomes, safety profiles, and the possible operation of the placebo effect.
Original data and published research reports, including case studies, retrospective meta-analyses, and double-blind clinical trials are compiled and evaluated for both healing systems.
Homeopathy and BFR therapy both feature highly diluted natural medicinal substances, flexible dosage schedules tailored to individual patients, and energy-based healing action. They differ with respect to practitioner training and certification, number and types of medicinal source materials, remedy combinations and applications, and potential toxicity or other side-effects.
Extensive testing has produced mixed or equivocal results regarding the efficacy of both of these health care systems. While a variety of positive outcomes have been frequently recorded with Homoeopathy and BFR treatments, it is likely that the placebo effect operates to a significant extent in both approaches.
This study sought to assess the effectiveness of individualized homeopathic treatment on dermatological complaints in a public outpatient clinic.
Children and adults spontaneously seeking for homeopathic treatment for dermatological complaints were prescribed single individualized remedies and followed up for a minimum of 3 months; assessment was clinical and recorded graphically.
Forty-nine patients met the inclusion criteria. Outcomes were positive (59%); no effect (4%); drop-out (37%), from which 6% was due to homeopathic aggravation. No manifestations of suppression were observed.
Outcome studies are useful to point out to the effectiveness of individualized homeopathic treatment in dermatological complaints. Outcomes suggest that actions focusing on pathological categories do not lead to homeopathic suppression.
To evaluate the response to homeopathic treatment in a public homeopathic clinic of all patients attending between September 1998 until December 2005, and to analyze homeopathic practice.
Longitudinal observational study in a homeopathic clinic based in a public hospital in Lucca, Italy. Data relating to patient details, clinical diagnosis, remedy prescribed, potency of dosage, prescription strategy and identification of the case as acute-chronic-recurrent were analyzed. Clinical response was assessed by the Glasgow Homeopathic Hospital Outcome Score.
Overall 74% of patients reported at least moderate improvement. Outcomes were better with longer treatment duration and younger age of patients. Respiratory, followed by dermatological and gastrointestinal pathologies responded best, psychological problems relatively poorly.
Homeopathic therapy is associated with improvement in a range of chronic and recurring pathologies. Certain characteristics of patient and pathology influence the outcome.
The objectives of this study were to initiate a pharmacist-coordinated program to improve the adverse drug reaction (ADR) reporting on complementary and alternative medicines (CAM) in a tertiary care hospital and to evaluate the pattern of the reported ADRs.
A targeted approach was taken in increasing the ADR reporting to CAM in a tertiary care hospital in South India. Suspected ADRs to CAM spontaneously reported over a period of 24 months were selected for evaluation. Reported ADRs were evaluated for patient demographics, reaction and drug characteristics, causality, severity, and outcome.
A total of 12 ADRs to CAM were reported, which included 9 to Ayurvedic and 3 to homeopathic medicines, which accounted for 1.5% of the ADRs reported to the ADR reporting unit. ADR resulted in hospitalization in 5 patients. The system organ class most commonly involved included skin and appendage disorders (58.3%). Only four of the reactions were previously reported in the literature. The mean time for onset of the ADR after the administration of the drug was 27.8 +/- 36.1 days. The suspected drug was withdrawn in all the reports that resulted in recovery, with mean time for recovery 5.9 +/- 3.6 days. The majority (66.6%) were moderate in severity and 2 were severe in nature. On causality assessment, 6 were probable in nature and the remaining were possible.
Even though there were fewer ADRs reported by this spontaneous reporting system, it gave valuable information regarding the potential for adverse effects with these agents. The study has reinstated the potential role of spontaneous reporting in identifying lesser reported ADRs, including those to CAM. Such hospital-based programs can contribute much in increasing the safety-related data of these agents.
A retrospective observational study was conducted on 105 out of 233 patients suffering from chronic respiratory disease attending the Homeopathic Clinic of the Campo di Marte Hospital in Lucca (Tuscany, Italy) between October 1998 and May 2003. We assessed the cost of conventional medicinal products using Anatomic Therapeutic Chemical (ATC) classification, specific for the pathology in question, and the general costs in the year preceding the first appointment at the Homeopathic Clinic vs. the first and second year subsequent to homeopathic treatment. The costs of conventional drugs for a group of patients affected by asthma (8 patients) and recurrent respiratory infections (16 patients) with long term use of conventional medicine treated by homeopathy were compared with the expenses of conventional drugs of a matched group of 16 and 32 patients, respectively.
Costs of pharmacological therapy specific for respiratory diseases were reduced by 46.3% (n=105) in the first year (P<0.01); and by 47.5% (n=72) in the second year (P<0.01) of homeopathic treatment. Reduction in general drug costs during homeopathic therapy was 42.4% in the first year (P<0.01); and -49.8 in the second year (N.S.). Costs for patients affected by chronic asthma showed a reduction in expenses of 71.1% for specific medicines relative to the group in homeopathic treatment vs. an increase of 12.3% in the group treated only with conventional drugs after the first year of follow-up and, respectively, a reduction of -54.4% for homeopathic treatment vs. +45.2% after the second year. For patients with recurrent respiratory infections we found a reduction of 35.8% in the homeopathic group in the first year, compared to an increase 8.6% of costs for specific drugs in the control group; in the second year the respective figures were -43.6% versus +7.8% in the control group.
Homeopathic treatment for respiratory diseases (asthma, allergic complaints, Acute Recurrent Respiratory Infections) was associated with a significant reduction in the use and costs of conventional drugs. Costs for homeopathic therapy are significantly lower than those for conventional pharmacological therapy.
The clinical studies on the effectiveness of homeopathy in respiratory allergy (18 randomized trials and 9 observational studies) are described. The literature of common immunologic disorders including also upper respiratory tract infections (URTI) and otorhinolaryngology (reported in part 1), is evaluated and discussed. Most of initial evidence-based research was addressed to the question of whether homeopathic high dilutions are placebos or possess specific effects, but this question has been often equivocal and is still a matter of debate. The evidence demonstrates that in some conditions homeopathy shows significant promise, e.g. Galphimia glauca (low dilutions/potencies) in allergic oculorhinitis, classical individualized homeopathy in otitis and possibly in asthma and allergic complaints, and a few low-potency homeopathic complexes in sinusitis and rhinoconjunctivitis. A general weakness of evidence derives from lack of independent confirmation of reported trials and from presence of conflicting results, as in case of homeopathic immunotherapy and of classical homeopathy for URTI. The suitable methods to evaluate homeopathy effectiveness, without altering the setting of cure, are also analyzed.
To investigate the conceptions of health and illness, the reasons for seeking homeopathy and continuing treatment, compliance and the meaning of the relationship between religiosity and health for patients who adhere to homeopathy.
A qualitative study of 20 adult patients in Santos (Brazil) treated by homeopaths in the public and private sector for at least 2 years. Semi-structured interviews, organized by predefined thematic categories, the content of the interviews was analyzed.
The conceptions of health and illness of the interviewed patients are related to the idea of vital balance/imbalance mediated by body-mind interaction. Dissatisfaction with conventional treatment, family influence and suggestions of others were the reasons for seeking homeopathic treatment. Patients continued homeopathic treatment due to positive therapeutic results, cure without being aggressive to the organism, the holistic integrated approach, the preventive nature of the treatment and low prices of medicine. For these patients, the availability of homeopathy in the public health sector extends the possibility of access. The need for a wider dissemination of homeopathy and the difficulties in following the prescription are the main problems involved in continuing treatment. Faith is an important component. We found a correlation between the conceptions of health and illness and the principles of homeopathy, assimilated through a strong bond between patients and the homeopathic practitioners.
To investigate the beliefs, values and meanings that patients attribute to homeopathy helps to understand subjective aspects that may interfere with treatment compliance.
Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo.
We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, "remedy", population, and outcomes.
The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05).
The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.
Reported are the results of a systematic review of the prevalence of use of complementary/alternative medicine. Computerized literature searches were carried out in four databases. Twelve surveys thus found were selected because they dealt with the utilization of complementary/alternative medicine in random or representative samples of the general population. Data were extracted in a predefined, standardized way. Prevalence of use of complementary/alternative medicine ranged from 9% to 65%. Even for a given form of treatment such as chiropractic, as used in the USA, considerable discrepancies emerged. The data suggest that complementary/alternative therapies are used frequently and increasingly. Prevalence of use seemed to depend critically on factors that were poorly controlled in surveys of complementary/alternative medicine. The true prevalence of use of complementary/alternative medicine in the general population remains uncertain.
Recent meta-analyses of randomized controlled trials in homeopathy have suggested that homeopathy is more than a placebo response.
Comparison of the effectiveness of homeopathy in primary care with conventional medicine in primary care for three commonly encountered clinical conditions.
An international multicenter, prospective, observational study in a real world medical setting comparing the effectiveness of homeopathy with conventional medicine.
Thirty (30) investigators with conventional medical licenses at six clinical sites in four countries enrolled 500 consecutive patients with at least one of the following three complaints: (1) upper respiratory tract complaints including allergies; (2) lower respiratory tract complaints including allergies; or (3) ear complaints.
The primary outcomes criterion was the response to treatment, defined as cured or major improvement after 14 days of treatment. Secondary outcomes criteria were: (1) rate of recovery; (2) occurrence of adverse events; (3) patient satisfaction; and (4) length of consultation.
Four hundred and fifty-six (456) patient visits were compared: 281 received homeopathy, 175 received conventional medicine. The response to treatment as measured by the primary outcomes criterion for patients receiving homeopathy was 82.6%, for conventional medicine it was 68%. Improvement in less than 1 day and in 1 to 3 days was noted in 67.3% of the group receiving homeopathy and in 56.6% of those receiving conventional medicine. The adverse events for those treated with conventional medicine was 22.3% versus 7.8% for those treated with homeopathy. Seventy-nine percent (79.0%) of patients treated with homeopathy were very satisfied and 65.1% of patients treated with conventional, medicine were very satisfied. In both treatment groups 60% of cases had consultations lasting between 5 and 15 minutes.
Homeopathy appeared to be at least as effective as conventional medical care in the treatment of patients with the three conditions studied.
Adverse drug events cause substantial morbidity and mortality, yet they remain underappreciated and misunderstood. The terminology to describe errors and patient harm associated with medications causes much confusion. This article uses the case study of a patient with multiple adverse drug events to clarify key terms, such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion illustrates clinical approaches to analyzing the causal connection between a suspect drug and an adverse event. Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies.
Objective: To establish, using a systematic review and meta-analysis, whether there is any evidence from randomised controlled clinical trials of the efficacy of homeopathic treatment in patients with any disease.
Data sources: Published and unpublished reports of controlled clinical trials available up to June 1998, identified by searching bibliographic databases (Medline, Embase, Biosis, PsychInfo, Cinahl, British Library Stock Alert Service, SIGLE, Amed), references lists of selected papers, hand searching homeopathic journals and conference abstracts, and contacting pharmaceutical companies.
Trials selection: Trials were selected using an unblinded process by two reviewers. The selection criteria were randomised, controlled trials in which the efficacy of homeopathic treatment was assessed relative to placebo in patients using clinical or surrogate endpoints. Prevention trials or those evaluating only biological effects were excluded. One hundred and eighteen randomised trials were identified and evaluated for inclusion. Sixteen trials, representing 17 comparisons and including a total of 2617 evaluated patients, fulfilled the inclusion criteria.
Data extraction: Data were extracted by two reviewers independently, using a summary form. Disagreements were resolved by a third person.
Data synthesis: The evidence was synthesised by combining the significance levels (P values) for the primary outcomes from the individual trials. The combined P value for the 17 comparisons was highly significant P=0.000036. However, sensitivity analysis showed that the P value tended towards a non-significant value (P=0.08) as trials were excluded in a stepwise manner based on their level of quality.
Conclusions: There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.
Influenza is a highly infectious viral disease that is particularly common in the winter months. Oscillococcinum is a patented, commercially available homoeopathic medicine. The rationale for its use in influenza comes from the homoeopathic principle of 'let like be cured by like'. This medicine is manufactured from wild duck heart and liver, which are said to be reservoirs for influenza viruses.
To determine whether homoeopathic Oscillococcinum or similar medicines are more effective than placebo in the prevention and treatment of influenza and influenza-like syndromes.
We updated the electronic searches on the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2006); MEDLINE (January 1966 to February 2006) and EMBASE (1980 to February 2006). The manufacturers of Oscillococcinum were contacted for information.
Placebo-controlled trials of Oscillococcinum or homeopathically-prepared influenza virus, influenza vaccine or avian liver in the prevention and treatment of influenza and influenza-like syndromes.
Two authors extracted data and assessed methodological quality independently.
Seven studies were included in the review, three prevention trials (number of participants (n) = 2265) and four treatment trials (n = 1194). Only two studies reported sufficient information to complete data extraction fully. There was no evidence that homoeopathic treatment can prevent influenza-like syndrome (relative risk (RR) 0.64, 95% confidence interval (CI) 0.28 to 1.43). Oscillococcinum treatment reduced the length of influenza illness by 0.28 days (95% CI 0.50 to 0.06). Oscillococcinum also increased the chances that a patient considered treatment to be effective (RR 1.08; 95% CI 1.17 to 1.00).
Though promising, the data were not strong enough to make a general recommendation to use Oscillococcinum for first-line treatment of influenza and influenza-like syndromes. Further research is warranted but the required sample sizes are large. Current evidence does not support a preventative effect of Oscillococcinum-like homeopathic medicines in influenza and influenza-like syndromes.
The strange case of a 37-year-old modern, Western woman who presented with a giant black mass on her inner right thigh is presented. She was treated 10 months before this present admission by an excision of a nodular melanoma, and she was treated, thereafter, by a homeopathic practitioner until she came late to follow-up. The woman is discussed with special attention to the fact that alternative medicine does not always constitute good advice, and the relevant literature is reviewed.
50 millesimal (LM) potencies have great advantages for all patients, not just those who are hypersensitive because of their great power to heal without major aggravations. Before discussing their advantages this paper describes what LM potencies are, and how they are administered, then addresses two questions: why do we want to avoid aggravations if most homeopaths look for aggravation to know if the remedy is working? And if LM potencies are indeed superior, why are they still relatively unknown and unused?
To establish, using a systematic review and meta-analysis, whether there is any evidence from randomised controlled clinical trials of the efficacy of homeopathic treatment in patients with any disease.
Published and unpublished reports of controlled clinical trials available up to June 1998, identified by searching bibliographic databases (Medline, Embase, Biosis, PsychInfo, Cinahl, British Library Stock Alert Service, SIGLE, Amed), references lists of selected papers, hand searching homeopathic journals and conference abstracts, and contacting pharmaceutical companies. TRIALS SELECTION: Trials were selected using an unblinded process by two reviewers. The selection criteria were randomised, controlled trials in which the efficacy of homeopathic treatment was assessed relative to placebo in patients using clinical or surrogate endpoints. Prevention trials or those evaluating only biological effects were excluded. One hundred and eighteen randomised trials were identified and evaluated for inclusion. Sixteen trials, representing 17 comparisons and including a total of 2,617 evaluated patients, fulfilled the inclusion criteria.
Data were extracted by two reviewers independently, using a summary form. Disagreements were resolved by a third person.
The evidence was synthesised by combining the significance levels (P values) for the primary outcomes from the individual trials. The combined P value for the 17 comparisons was highly significant P = 0.000036. However, sensitivity analysis showed that the P value tended towards a non-significant value (P = 0.08) as trials were excluded in a stepwise manner based on their level of quality.
There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.
The controversy surrounding clinical observations and double-blind studies on homeopathic treatments is lessened when modern dynamical systems analysis is applied to high-dilution therapies. The logic of recurrent feedback loops, which applies to all dynamical network systems, inexorably leads to the systemic memory hypothesis - that complex patterns of emergent information and energy are stored to various degrees in physical, chemical, and biological systems. The addition of resonance, a dynamic pattern recognition process, explains many classic observations using high-dilution therapies. The systemic memory resonance hypothesis potentially provides a plausible biophysical mechanism for explaining not only how high-dilution therapies contribute to healing, but by extension, how information and energy in low-dilution and chemical therapies contribute to healing as well.
To evaluate the safety of homeopathic medicines by critically appraising reports of adverse effects published in English from 1970 to 1995.
Systematic review on information regarding adverse effects of homeopathic medicines identified using electronic databases, hand searching, searching reference lists, reviewing the bibliography of trials, and other relevant articles, contacting homeopathic pharmaceutical companies and drug regulatory agencies in UK and USA, and by communicating with experts in homeopathy.
The mean incidence of adverse effects of homeopathic medicines was greater than placebo in controlled clinical trials (9.4/6.1) but effects were minor, transient and comparable. There was a large incidence of pathogenetic effects in healthy volunteers taking homeopathic medicines but the methodological quality of these studies was generally low. Anecdotal reports of adverse effects in homeopathic publications were not well documented and mainly reported aggravation of current symptoms. Case reports in conventional medical journals pointed more to adverse effects of mislabelled 'homeopathic products' than to true homeopathic medicines.
Homeopathic medicines in high dilutions, prescribed by trained professionals, are probably safe and unlikely to provoke severe adverse reactions. It is difficult to draw definite conclusions due to the low methodological quality of reports claiming possible adverse effects of homeopathic medicines.
A reflection on the scientific behavior of adherents of conventional medicine toward one form of alternative medicine-homeopathy-teaches us that physicians do reject seemingly solid evidence because it is not compatible with theory. Further reflection, however, shows that physicians do the same within conventional medical science: Sometimes they discard a theory because of new facts, but at other times they cling to a theory despite the facts. This essay highlights the seeming contradiction and discusses whether it still permits the building of rational medical science. We propose that rational science is compatible with physicians' behavior, provided that physicians acknowledge the subjective element in the evaluation of science, as exemplified in the crossword analogy by the philosopher Haack. This type of thinking fits very well with the Bayesian approach to decision making that has been advocated for decades in clinical medicine. It does not lead to complete and uncontrollable subjectivity because discernment between rivaling explanations is still possible through argument and counterargument.
A pilot survey of 1025 patients receiving homeopathic treatment in six European countries is reported. An initial questionnaire included demographic information and questions from health-related Quality of Life (QoL) scales. A follow-up questionnaire collected data on changes in QoL. The demographic characteristics of respondents were similar to previous studies. 82.8% of respondents had previously tried conventional treatments. Satisfaction with consultations was high. The changes of QoL status are positive but weak. 2.7% of patients experienced side-effects which they attribute to homeopathic treatment. 7.8% of patients reported significant aggravation at the beginning of the homeopathic treatment, 25.4% slight aggravation of symptoms. A new survey should be performed with a better motivation of doctors and patients. Further description of treatment would be helpful.
Homeopathy remains one of the most controversial subjects in therapeutics. This article is an attempt to clarify its effectiveness based on recent systematic reviews. Electronic databases were searched for systematic reviews/meta-analysis on the subject. Seventeen articles fulfilled the inclusion/exclusion criteria. Six of them related to re-analyses of one landmark meta-analysis. Collectively they implied that the overall positive result of this meta-analysis is not supported by a critical analysis of the data. Eleven independent systematic reviews were located. Collectively they failed to provide strong evidence in favour of homeopathy. In particular, there was no condition which responds convincingly better to homeopathic treatment than to placebo or other control interventions. Similarly, there was no homeopathic remedy that was demonstrated to yield clinical effects that are convincingly different from placebo. It is concluded that the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice.
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.
Herbal medicines have been submitted to systematic reviews more frequently than any other complementary therapy, and it is here where the most positive evidence can be found. There is not much research into potential serious risks of complementary medicine. Possible risks range from the toxicity of herbs to vertebral artery dissection or nerve damage after chiropractic manipulation. Currently the Cochrane Library contains 34 systematic reviews of complementary medicine: 20 of herbal medicines, 7 of acupuncture, 3 of homeopathy, 2 of manual therapies, and 2 of other forms.
Homeopathy is founded on 'holistic' and 'vitalistic' paradigms, which may be interpreted--at least in part--in terms of a framework provided by the theory of dynamic systems and of complexity. The conceptual models and some experimental findings from complexity science may support the paradoxical claims of similia principle and of dilution/dynamization effects. It is argued that better appreciation of three main properties of complex systems: non-linearity, self-organization, and dynamicity, will not only add to our basic understanding of homeopathic phenomena but also illuminate new directions for experimental investigations and therapeutic settings.
With the aim of facilitating complementary/alternative medicine (CAM) regulation by decision-makers in the Tuscan region, objectives of the analysis were: 1) to estimate the frequency and motivations of CAM use (acupuncture, homeopathy, phytotherapy, manipulative therapies) within the Tuscan population; 2) to identify variables associated with CAM use; 3) to investigate public opinion concerning CAM.
We have analysed the regional data collected by the ISTAT through the survey Multiscopo su "Condizioni di salute e ricorso ai servizi sanitari", years 1999-2000.
The analysis was carried out on 5670 subjects > 20 years resident in the Tuscan region between July 1999 and June 2000.
Usefulness, utilization and benefits concerning CAM.
Forty-five percent of the surveyed population consider useful at least one type of CAM, and 20% had used CAM at least once in the three years prior to the interview. Most frequent users are middle-aged women with higher educational levels, and manipulative therapies and homeopathy are the most used remedies. Disorders that mostly have induced the population to use CAM are pain syndromes.
Overall, the Tuscan population has a positive attitude towards CAM use, which is slightly more frequent than the average national use.
In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (http://www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.
Unlabelled:
Homeopathic medicine is commonly believed to be relatively harmless. However, treatment with improperly used homeopathic preparations may be dangerous.
Case reports:
Case 1 presented with melanosis and keratosis following short-term use of Arsenic Bromide 1-X followed by long-term use of other arsenic-containing homeopathic preparations. Case 2 developed melanotic arsenical skin lesions after taking Arsenicum Sulfuratum Flavum-1-X (Arsenic S.F. 1-X) in an effort to treat his white skin patches. Case 3 consumed Arsenic Bromide 1-X for 6 days in an effort to treat his diabetes and developed an acute gastrointestinal illness followed by leukopenia, thrombocytopenia, and diffuse dermal melanosis with patchy desquamation. Within approximately 2 weeks, he developed a toxic polyneuropathy resulting in quadriparesis. Arsenic concentrations in all three patients were significantly elevated in integument tissue samples. In all three cases, arsenic concentrations in drinking water were normal but arsenic concentrations in samples of the homeopathic medications were elevated.
Conclusion:
Arsenic used therapeutically in homeopathic medicines can cause clinical toxicity if the medications are improperly used.
Aims and priorities for research in complementary medicine: a proposal for an adverse effect reporting schema
- Fisher
Fisher P. Aims and priorities for research in complementary
medicine: a proposal for an adverse effect reporting schema.
Compl Med Res 1987; 1: 35-44.
Side Effect & Adverse Symptoms of Homeopathic Medicine in their Lower Attenuation
- P N Varma
Varma PN. Side Effect & Adverse Symptoms of Homeopathic
Medicine in their Lower Attenuation. New Delhi: Jain Publisher, 2001.
Classificazione e definizioni delle ADRs
- A Caputi
Caputi A. Classificazione e definizioni delle ADRs. www.farmacovigilanza.org.
Patient therapy compliance at Asl district 2 Homoeopathic Clinic
- C Endrizzi
- E Rossi
- C Leone
Endrizzi C, Rossi E, Leone C, Patient therapy compliance at
Asl district 2 Homoeopathic Clinic, Lucca. Convegno AMIAR,
Torino 9 aprile 2005.
Farmacovigilanza in ambito omeopatico
- C Endrizzi
- E Rossi
- L Crudeli
- D Garibaldi
Endrizzi C, Rossi E, Crudeli L, Garibaldi D, Farmacovigilanza in ambito omeopatico. Costi e benefici della terapia
omeopatica in ambito pubblico Lucca 16-11-2004, Atti del
Convegno.
Valutazione delle variazioni del consumo farmacologico convenzionale e dei costi economici in corso di terapia omeopatica classicaSafety evaluation of complementary and alternative medicine
- E Rossi
- L Crudeli
- D Garibaldi
Rossi E, Crudeli L, Garibaldi D. Valutazione delle variazioni
del consumo farmacologico convenzionale e dei costi economici in corso di terapia omeopatica classica in pazienti affetti da
disturbi delle vie respiratorie Proceedings of the International
Conference 'Safety evaluation of complementary and alternative
medicine', Palazzo delle Esposizioni, Empoli 24-25 October,
2003, p. 23.
Informazione ai pazienti sugli effetti collaterali dei farmaci e loro percezione da parte dei pazienti stessi. Da uno studio apparso su Lancet
- L Galatti
- A P Caputi
Galatti L, Caputi AP. Informazione ai pazienti sugli effetti
collaterali dei farmaci e loro percezione da parte dei pazienti
stessi. Da uno studio apparso su Lancet. www.farmacovigilanza.org.
Un nuovo sistema di classificazione delle ADR?
- L Galatti
- A P Caputi
Galatti L., Caputi A. P. Un nuovo sistema di classificazione
delle ADR? www.farmacovigilanza.org.
Guideline for Good Clinical Practice (GPC)
- Emea Status
EMEA Status. Guideline for Good Clinical Practice (GPC).
CPMP/ICH/135/95.
- V I Hahnemann Scf Organon Of Medicine
Hahnemann SCF Organon of Medicine VI ed New Delhi: B.
Jain Publishers, Pvt, Ldt., 1982, p. 290.
- J T Kent
Kent JT. Lectures on Homeopathic Philosophy, vol 35. New
Delhi: B. Jain Publisher, Pvt, Ldt., 1981, p 253.
Safety evaluation of complementary and alternative medicine
- E Rossi
- L Crudeli
- D Garibaldi