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Ben-Arye E.,Rothschild | Ben-Arye E.,Technion - Israel Institute of Technology | Polliack A.,Hebrew University of Jerusalem | Schiff E.,Bnai Zion Medical Center | And 3 more authors.
Journal of Pain and Symptom Management | Year: 2013

Context: Many cancer patients are using non-herbal nutritional supplements (NHNS), often without informing their oncologists. Objectives: To review the literature and summarize the beneficial effects and safety of NHNS in the prevention and reduction of treatment-related symptoms. Methods: Databases were searched for randomized, controlled clinical trials (Jadad score ≥ 2) using AltHealthWatch, Cochrane Database of Systematic Reviews, Embase, MEDLINE, Memorial Sloan-Kettering Integrative Medicine Service Database, Natural Standard Database, and PubMed. The key words searched were the following: alternative and/or complementary medicine, nutritional and/or dietary supplements, quality of life, symptoms and/or side effects, specific toxicities (e.g., neuropathy, mucositis), and specific supplements (e.g., vitamin E, glutamine, etc.). Results: A number of NHNS products were found to be effective. The incidence and severity of peripheral sensory neuropathy associated with taxane-agents such as paclitaxel can be reduced with vitamin E, glutamine, and acetyl-L-carnitine. Vitamin E and glutamine also have been shown to reduce oral mucositis resulting from radiation and chemotherapy, and glutamine and probiotics can reduce chemotherapy-induced diarrhea. Conclusion: There is a need to develop an open and nonjudgmental dialogue between oncologists and cancer patients, addressing the needs of the patient while dealing with issues related to the efficacy and safety of these products. Referral of patients to an integrative medicine consultant may help achieve these goals, providing both parties with the option of reaching an informed and respectful decision about treatment. © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Source

Yaal-Hahoshen N.,Tel Aviv University | Maimon Y.,Tel Aviv Sourasky Medical Center | Maimon Y.,Refuot Integrative Medical Center | Siegelmann-Danieli N.,Maccabi Healthcare Services | And 6 more authors.
Oncologist | Year: 2011

Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy-induced hematological toxicity in breast cancer patients. Methods. Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention. Results. Sixty-five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo treatment. Patients in the treatment group developed significantly less severe (grades 2-4) anemia (p <.01) and leukopenia (p <.03) when comparing grades 0-1 with grades 2-4, with significantly less neu-tropenia (p <.04) when comparing grades 0-2 with grades 3-4. This effect was more significant among patients undergoing a dose-dense regimen. No statistically significant effect was found with respect to nonhemato-logical toxicities, and side effect rates were not significantly different between the groups, with no severe or life-threatening events observed in either group. Conclusion. The addition of LCS101 to anthracycline-and taxane-based chemotherapy is safe and well tolerated, and may significantly prevent some chemotherapy-induced hematological toxicities in early breast cancer patients. These results should encourage further larger and more extensive clinical trials. © AlphaMed Press. Source

Mathie R.T.,British Homeopathic Association | Roniger H.,Royal London Hospital for Integrated Medicine | Van Wassenhoven M.,LMHI Research Secretariat | Frye J.,University of Maryland Baltimore County | And 8 more authors.
BMC Medical Research Methodology | Year: 2012

Background: A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. Methods: Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. Results: The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. Conclusion: Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity. © 2012Mathie et al; licensee BioMed Central Ltd. Source

Oberbaum M.,Center for Integrative Complementary Medicine | Samuels N.,Center for Integrative Complementary Medicine | Ben-Arye E.,Technion - Israel Institute of Technology | Amitai Y.,Hebrew University of Jerusalem | And 2 more authors.
Human and Experimental Toxicology | Year: 2012

Background: A recent report showed increased frequency of apparent life-threatening events (ALTEs) in infants treated with the homeopathic medication GaliCol-Baby (GCB). The premise was that the ALTEs resulted from toxic effects of the drug's components. We examine an alternative explanation. Method: The toxicological literature was searched for known reactions to the various GCB components, noting doses and reported symptoms. Dosage quantities and severity of reaction to the GCB were ranked independently by two groups of physicians, and a dose-response curve was generated. Reported toxic doses and symptoms were compared with those of the GCB series. The homeopathic literature was searched as well to determine the propensity of the GCB components to cause ALTE symptoms, when given in homeopathic doses to healthy volunteers (proving). Results: Doses ingested in the GCB series were 10-13 orders of magnitude smaller than those reported to cause toxic reactions in humans. There was poor correlation between symptoms with GCB and toxic profiles of the components. A nonsignificant, inverse relationship between dose and severity of reaction was observed. Conversely, four GCB components (in homeopathic doses) had a high propensity to produce at least one of five symptoms which define ALTE, two of which had intermediate to high propensity to produce three symptoms. Conclusions: It is unlikely that the ALTE following ingestion of GCB was a toxic reaction to any of the drug's component. Homeopathic theory may explain this linkage, though further research is needed to understand the pathogenic effects of highly diluted homeopathic compounds. © 2012 SAGE Publications. Source

Samuels N.,Center for Integrative Complementary Medicine | Zisk-Rony R.Y.,Hebrew University of Jerusalem | Zevin S.,Shaare Zedek Medical Center | Becker E.L.,Center for Integrative Complementary Medicine | And 2 more authors.
Patient Education and Counseling | Year: 2012

Objective: To study non-vitamin, non-mineral (NVNM) supplements use and disclosure of among hospitalized internal medicine patients. Methods: A convenience sample of patients completed an interviewer-administered questionnaire examining use of and perceptions regarding NVNM supplements, and disclosure to medical personnel. Results: 280 patients were interviewed (54% female), 15.4% reporting NVNM supplement use. This practice was more prevalent among female patients (p=0.045), more educated (p<0.001) and patients with more impaired quality-of-life, measured by the SF-12 tool (p<0.020). The most common factor influencing NVNM supplement use was a physician's recommendation. Most (74%) patients using NVNM supplements reported having disclosed this practice to community-based physicians, with only 23.7% disclosing to hospital staff. Six patients reported using supplements at the exclusion of conventional medication, with potentially serious implications. Conclusion: While the majority of patients using NVNM supplements are sharing this information with their primary-care physicians, there is little disclosure of this practice to hospital staff. This may be due to a perceived negative attitude of medical professionals to complementary medicine, and a lack of awareness by hospital staff regarding such practices. Practice implications: Hospital-based medical professionals need to be aware of the use of NVNM supplements and the resulting implications by their internal medicine patients. © 2012 Elsevier Ireland Ltd. Source

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