Laetrile for cancer: a systematic review of the clinical evidence

Background: Many cancer patients treated with conventional therapies also try 'alternative' cancer treatments. Laetrile is one such,alternative' that is claimed to be effective by many alternative therapists. Laetrile is also sometimes referred to as amygdalin, although the two are not the same. Objective: The aim of this review is to summarize all types of clinical data related to the effectiveness or safety of laetrile interventions as a treatment of any type of cancer. Materials and methods: All types of clinical studies containing original clinical data of laetrile interventions were included. We searched the Cochrane Central Register of Controlled Trials (CEN TRAL), MEDLINE (from 1951), EMBASE (from 1980), Allied and Complementary Medicine (AMED), Scirus, CancerLit, Cumulative Index to Nursing and Allied Health (CI-NAHL; all from 1982), CAMbase (from 1998), the MetaRegister, the National Research Register, and our own files. For reports on the safety of laetrile, we also searched the Uppsala database. No language restrictions were imposed. Results: Thirty six reports met our inclusion criteria. No controlled clinical trials were found. Three articles were nonconsecutive case series, 2 were consecutive case series, 6 were best case series, and 25 were case reports. None of these publications proved the effectiveness of laetrile. Conclusion: Therefore, the claim that laetrile has beneficial effects for cancer patients is not supported by sound clinical data

Establishing treatment optimisation as part of personalised medicine development

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Views of European Drug Development Stakeholders on Treatment Optimization and Its Potential for Use in Decision-Making

Background: The current drug development paradigm has been criticized for being too drug-centered and for not adequately focusing on the patients who will eventually be administered the therapeutic interventions it generates. The drug-driven nature of the present framework has led to the emergence of a research gap between the pre-approval development of anticancer medicines and their post-registration use in real-life clinical practice. This gap could potentially be bridged by transitioning toward a patient-centered paradigm that places a strong emphasis on treatment optimization, which strives to optimize the way health technologies are applied in a real-world environment. However, questions remain concerning the ideal features of treatment optimization studies and their acceptability among key stakeholders. Objectives: The aim of this study was to explore the views of key stakeholders in the drug development process regarding the concept of treatment optimization. Methods: Semi-structured interviews were conducted between December 2018 and May 2019 with 26 participants across ten EU Member States and six different stakeholder groups, including academic clinicians as well as representatives of patient organizations, regulatory authorities, health technology assessment agencies, payers, and industry. Results: Based on the input of the experts interviewed, clarification was obtained regarding the optimal features of treatment optimization studies in terms of their conduct, funding, timing, design, and setting. Moreover, a number of opportunities and challenges of undertaking such trials were identified. Inter-stakeholder discussion during their design was seen as desirable. There was also broad support among the participants for regulatory measures to facilitate treatment optimization, although there was no agreement on the optimal scale and nature of these initiatives. Furthermore, the interviewees believed that the evidence strength of well-designed treatment optimization studies performed according to rigorous quality standards is greater than or at least equal to that of classical clinical trials. In addition, there was a strong consensus that the results of treatment optimization studies should be taken into account during the decision-making of regulators, payers, and/or clinicians. Conclusions: Stakeholders involved in drug development consider treatment optimization studies to be valuable tools to address current evidence gaps and support their implementation into the existing research framework.status: publishe

Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology

Objective: To evaluate the methodological robustness of patient-reported outcomes (PROs) evaluation in complementary and alternative medicine (CAM) randomized controlled trials (RCTs) in oncology. Study Design and Setting: CAM RCTs with a PRO endpoint were retrieved from a number of electronic databases. CAM interventions were defined according to the five major categories of the National Center for Complementary and Alternative Medicine. The "Minimum Standard Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials" was used to assess the quality of the PRO reporting in these trials. Results: Forty-four RCTs enrolling 4,912 patients were identified: six studies involved alternative medical systems, 14 involved mind body interventions, 15 dealt with biologically-based therapies, seven involved manipulative and body-based methods, and two energy therapies. Eighty-nine percent of studies used a PRO as a primary endpoint and 59% documented PRO missing data. Although 84% of the studies used a validated PRO questionnaire, only 37% stated an a priori hypothesis and 20% addressed clinical significance of the outcomes. Overall, 64% of the studies analyzed exhibited a number of methodological drawbacks. Conclusions: To facilitate the interpretation of results from such CAM RCTs, investigators are encouraged to pay greater attention to key methodological issues as identified in this study. (C) 2006 Elsevier Inc. All rights reserved

Subregional Nigral Neurodegeneration in Parkinson's Disease Using Multisite Longitudinal MRI

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