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... There is no placebo effect in cultured cancer cells, so here we have evidence that homeopathy is not just a placebo. Should homeopathic significance be increased in established medicine, more evidence from well-controlled and high-quality studies is needed [15]. ...
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IN VITRO EFFECTS OF HOMEOPATHIC DRUGS Christer Sundqvist Petrafoundation, Helsinki, Finland https://petrafoundation.com/en/blog/scientific-evidence-for-homeopathy-part-4 Published: 05.30.2020 The well-known and respected Finnish homeopath Jouni Jämsä (http://www.jounijamsa.fi/ ) continues his homeopathy research with us. In the first part, we talked to him about homeopathy in general and diluted homeopathic preparations in particular [1]. In the next section we investigated how plants respond to homeopathic preparations [2]. In the third part, we went through studies where homeopathy has been used for cancer patients [3]. In this fourth section, we investigate the effect of homeopathic preparations at the cellular level. Highly diluted homeopathic preparations are showing measurable effects in cell cultures [4]. Several studies have found that homeopathic agents give rise to apoptosis (programmed cell death). This phenomenon is a normal part of individual tissue development and regeneration. It is controlled by genes that regulate cell division [5, 6]. Apoptosis plays an important role in fetal development, regulation of the immune response, elimination of infected and transformed cells, and regulation of tissue size. Excessive apoptosis can lead to developmental disorders and degenerative diseases, while its absence can lead to autoimmune diseases, long-term viral infections and cancer. Utilization of drug apoptosis is already routine in the treatment of cancer. Drugs for the treatment of degenerative diseases that prevent apoptosis are likely to emerge in the market in the near future [7]. Apoptosis is something you want to achieve when treating cancer. Because cancer is a disease that affects many people and is very serious, researchers have been interested in different types of treatment options. The effect of homeopathy in cancer can also be studied with cell models. The potent homeopathic drug Lycopodium clavatum (5C and 15C) has anti-cancer activity on HeLa cells in vitro. This has been studied in the Laboratory of Cell Genetics and Molecular Biology at the University of Kalyan, India. The purpose of this study was to evaluate whether homeopathic highly diluted and potent preparations of Lycopodium Clavatum (LC-5C and LC-15C) have anti-cancer effects on HeLa cells. Cells were exposed to either LC-5C (diluted below Avogadro's number) or diluted above Avogadro's number (LC-15C). The results revealed that administration of Lycopodium had little or no toxic effects on the cells in the bloodstream, but caused marked apoptosis in cancer cells (HeLa), which appeared in the form of initial degradation of DNA. Highly diluted, dynamic homeopathic drugs, both below and above the Avogadro's number, caused cell death in cancer cells, suggesting that these drugs could potentially be used as supportive cancer care [8]. Frenkel's team at the University of Texas (M.D. Anderson Cancer Center, Texas, USA) performed cell experiments with highly diluted Indian homeopathic preparations (Carcinos, Phytolacca, Conium and Thuja). The preparations were tested with different breast cancer cell lines. The preparations were toxic to the cells, leading to cell cycle breakdown and cell death. Thus, these natural, diluted preparations had biological effects that should be further investigated [9]. The same was also supported by Psorinum 6 ×, which triggers apoptosis signals in human lung cancer cells. Studies of the effects of homeopathic Psorinum 6x on cell survival were initially performed in several cancer cell lines, including A549 (lung cancer cell line), HepG2 (liver cancer cell line) and MCF-7 (breast cancer cell line). The experiment investigated the therapeutic effects on cell cycle breakdown, cell death, reactive oxygen radical formation (ROS), and changes in mitochondrial membrane potential (MMP) using flow cytometry and fluorescence microscopy. It was found that treatment of cancer cell lines with Psorinum resulted in increased anti-cancer effects in A549 cells (lung cancer cell line) to a greater extent than in others. Psorinum prevented cell division after 24 hours of treatment and retained the cells in the G1 phase. It also caused e.g. ROS formation, MMP depolarization, morphological changes and DNA damage. The researchers concluded that Psorinum 6 × triggered apoptosis in A549 cells (lung cancer cells) via signaling proteins [10]. Condurango 6C and 30C also trigger apoptosis in lung cancer cells. The more diluted preparation was more effective [11]. The effects of homeopathy on programmed cell death have been extensively studied. Further support for this effect on apoptosis, which is advantageous in the treatment of cancer, has been obtained in e.g. Shagun Arora laboratory at Jaypee University of India. It was found that undiluted and diluted homeopathic preparations were toxic to cultured cancer cells. Homeopathic Sarsaparilla preparations were tested in isolated renal adenocarcinoma cell cultures, the Ruta graveolens preparation in cultured colon cancer cells and the Phytolacca decandra preparation in breast cancer cells. The results showed that all of the homeopathic preparations showed toxic effects in said cell cultures. The undiluted preparations had the best effect, but diluted preparations also served as a starting point of apoptosis. Homeopathic preparations have been shown to be anti-cancer drugs and further research can be encouraged [12]. The homeopathic preparation Calcarea carbonica caused apoptosis in cell cultures from cancerous mice. The study showed evidence of the so-called immunomodulatory mechanism of cell death [13]. In leukemia, homeopathic dilutions of Amanita phalloides have been successfully tested in cell cultures [14]. There is no placebo effect in cultured cancer cells, so here we have evidence that homeopathy is not just a placebo. Should homeopathic significance be increased in established medicine, more evidence from well-controlled and high-quality studies is needed [15].
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The growing popularity of complementary medicine has been accompanied by a call for controlled clinical studies to examine the efficacy and validity of its various methods. The difficulties encountered in applying the evaluation methods of conventional medicine to complementary medicine are the result of the different paradigms underlying these two methods of medicine, and the differences in the healing process. This paper attempts to bridge the gap between these two approaches and to suggest a possibility to use conventional research methodology in clinical studies of classical homeopathy. Two methods are described. One is the randomization into a placebo or a treatment group after an individual remedy is chosen for each patient. This method requires an experienced homeopath and is reproducible only by the same homeopath in the same population. On the other hand, the expected success rate will be high. Another method is prescribing and treating according to so-called keynotes, a set of symptoms known to respond to a particular remedy that must be present in a patient in order to elicit a reaction from the remedy. This method is more suitable to a conventional design of a clinical study and is reproducible by anyone. Yet the expected success rate is much lower. Some general design issues that may have a particular impact on clinical trials of classical homeopathy are discussed, including the need for sufficiently powered trials to detect relatively small effects, strategies to deal with patient preference and embracing the use of "active-control" pragmatic trial designs.
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Classical experimental design presupposes that subjects, randomly separated into experimental and control groups, are independent and distinct. Treatments given to the experimental group ought to have no effect on the control group, which functions as a baseline to illustrate "what otherwise would have happened." Any change in the control group is often labeled an "anomaly." Examples of these types of anomalous phenomena can be found in placebo research, which often shows proportional unexpected and unexplained changes in control subjects. In four previously reported experiments on anomalous healing using "healing with intent" on mice injected with lethal doses of mammary adenocarcinoma (source, The Jackson Laboratories, Bar Harbor, ME; code, H2712; host strain, C3H/HeJ), a high percentage of both experimental and control mice exhibited an anomalous healing pattern, most often passing through stages of tumor ulceration to full life-span cure. In order to explain tumor regression of control animals, I posit the formation of "resonant bonds," which can link spatially separate groups. Healing given to the experimental animals can result in an unintended treatment to the control animals, producing anomalous healing akin to placebo effects. A recently completed experiment at the Terre Haute campus of the Indiana University School of Medicine has produced a successful test of resonance theory. One group of mice (n = 30) was injected with mammary adenocarcinoma cells and randomly divided into a treated group (n = 15) and untreated control group (n = 15). A second group of age-matched controls (n = 25) was left uninjected. Mice from each group were intermittently sacrificed to measure hematologic values and spleen weight. As predicted by resonance theory, there were few differences between treated and untreated animals from the first group, but there were significant differences between these animals and the age-matched controls. Some implications for placebo research and the way we normally conceptualize Type II errors will be discussed. Researchers are invited to reanalyze past data in light of resonance theory.
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BACKGROUND Stomatitis is a common consequence of chemotherapy and a condition for which there is little effective treatment. Although the management of patients with other chemotherapy-related toxicities has improved in recent years, the incidence of stomatitis is increasing because of more intensive treatment and is often a dose limiting factor in chemotherapy. The authors assessed the efficacy of a homeopathic remedy, TRAUMEEL S®, in the management of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.METHODSA randomized, placebo-controlled, double-blind clinical trial was conducted in 32 patients ages 3–25 years who had undergone allogeneic (16 patients) or autologous (16 patients) stem cell transplantation. Of the 30 evaluable patients, 15 were assigned placebo, and 15 were assigned TRAUMEEL S both as a mouth rinse, administered five times daily from 2 days after transplantation for a minimum of 14 days, or until at least 2 days after all signs of stomatitis were absent. Stomatitis scores were evaluated according to the World Health Organization grading system for mucositis.RESULTSA total of five patients (33%) in the TRAUMEEL S treatment group did not develop stomatitis compared with only one patient (7%) in the placebo group. Stomatitis worsened in only 7 patients (47%) in the TRAUMEEL S treatment group compared with 14 patients (93%) in the placebo group. The mean area under the curve stomatitis scores were 10.4 in the TRAUMEEL S treatment group and 24.3 in the placebo group. This difference was statistically significant (P < 0.01).CONCLUSIONS This study indicates that TRAUMEEL S may reduce significantly the severity and duration of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation. Cancer 2001;92:684–90. © 2001 American Cancer Society.
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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.
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A common question in clinical consultations is: “For this person, what are the likely effects of one treatment compared with another?” The central tenet of evidence based medicine is that this task is achieved by using the best evidence combined with consideration of that person's individual needs.1 A further question then arises: “What is the best evidence?” Two recent studies in the New England Journal of Medicine have caused uproar in the research community by finding no difference in estimates of treatment effects between randomised controlled trials and non-randomised trials.The randomised controlled trial and, especially, systematic reviews of several of these trials are traditionally the gold standards for judging the benefits of treatments, mainly because it is conceptually easier to attribute any observed effect to the treatments being compared. The role of non-randomised (observational) studies in evaluating treatments is contentious: deliberate choice of the treatment for each person implies that observed outcomes may be caused by differences among people being given the two treatments, rather than the treatments alone. Unrecognised confounding factors can always interfere with attempts to correct for identified differences between groups.These considerations have supported a hierarchy of evidence, with randomised controlled trials and derivatives at the top, controlled …
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Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.
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The growing popularity of complementary medicine has been accompanied by a call for controlled clinical studies to examine the efficacy and validity of its various methods. The difficulties encountered in applying the evaluation methods of conventional medicine to complementary medicine are the result of the different paradigms underlying these two methods of medicine, and the differences in the healing process. This paper attempts to bridge the gap between these two approaches and to suggest a possibility to use conventional research methodology in clinical studies of classical homeopathy. Two methods are described. One is the randomization into a placebo or a treatment group after an individual remedy is chosen for each patient. This method requires an experienced homeopath and is reproducible only by the same homeopath in the same population. On the other hand, the expected success rate will be high. Another method is prescribing and treating according to so-called keynotes, a set of symptoms known to respond to a particular remedy that must be present in a patient in order to elicit a reaction from the remedy. This method is more suitable to a conventional design of a clinical study and is reproducible by anyone. Yet the expected success rate is much lower. Some general design issues that may have a particular impact on clinical trials of classical homeopathy are discussed, including the need for sufficiently powered trials to detect relatively small effects, strategies to deal with patient preference and embracing the use of "active-control" pragmatic trial designs.
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Homeopathy is a 200-year-old therapeutic system that uses small doses of various substances to stimulate autoregulatory and self-healing processes. Homeopathy selects substances by matching a patient's symptoms with symptoms produced by these substances in healthy individuals. Medicines are prepared by serial dilution and shaking, which proponents claim imprints information into water. Although many conventional physicians find such notions implausible, homeopathy had a prominent place in 19th-century health care and has recently undergone a worldwide revival. In the United States, patients who seek homeopathic care are more affluent and younger and more often seek treatment for subjective symptoms than those who seek conventional care. Homeopathic remedies were allowed by the 1939 Pure Food and Drug Act and are available over the counter. Some data--both from randomized, controlled trials and laboratory research--show effects from homeopathic remedies that contradict the contemporary rational basis of medicine. Three independent systematic reviews of placebo-controlled trials on homeopathy reported that its effects seem to be more than placebo, and one review found its effects consistent with placebo. There is also evidence from randomized, controlled trials that homeopathy may be effective for the treatment of influenza, allergies, postoperative ileus, and childhood diarrhea. Evidence suggests that homeopathy is ineffective for migraine, delayed-onset muscle soreness, and influenza prevention. There is a lack of conclusive evidence on the effectiveness of homeopathy for most conditions. Homeopathy deserves an open-minded opportunity to demonstrate its value by using evidence-based principles, but it should not be substituted for proven therapies.