There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.

Why most published research findings are false

Complementary and alternative medicine are increasingly used to diagnose or treat allergic diseases, and numerous studies have reported benefits of this type of medicine. This article presents a review of the literature on risks of these methods. The potential sensitizing capacity of numerous herbal remedies may lead to allergic contact dermatitis and more rarely to IgE-mediated clinical symptoms. Mechanical injuries may be observed following acupuncture leading to pneumothorax, cardiac tamponade or spinal injury. Infectious complications after acupuncture include hepatitis and bacterial endocariditis. Organ toxicity has been observed associated with various herbal preparations involving the liver, kidneys, and the heart. Some herbs may have cancerogenic properties. Severe nutritional deficiencies can occur in infants and small children given strict alternative diets, resembling 'kwashiorkor'. Finally, among other miscellaneous adverse effects, adulteration with steroids, and herbal and drug interactions are discussed. The pattern of side-effects is similar to that observed by the use of conventional medicine. Therefore, caution may be justified using both conventional and unconventional methods. Only if the benefit is proven and the side-effects are established, should a given method be chosen.

Side-effects of complementary and alternative medicine

Do homeopathic medicines provoke adverse effects? A systematic review

A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos. The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy. Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38). Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

/pdf/randomised-placebo-controlled-trials-of-individualised-3cymu2pk37.pdf

Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis

Homeopathy is scientifically banned, both for lack of consistent empirical findings, but more so for lack of a sound theoretical model to explain its purported effects. This paper makes an attempt to introduce an explanatory idea based on a generalized version of quantum mechanics (QM), the weak quantum theory (WQT). WQT uses the algebraic formalism of QM proper, but drops some restrictions and definitions typical for QM. This results in a general axiomatic framework similar to QM, but more generalized and applicable to all possible systems. Most notably, WQT predicts entanglement, which in QM is known as Einstein-Podolsky-Rosen (EPR) correlatedness within quantum systems. According to WQT, this entanglement is not only tied to quantum systems, but is to be expected whenever a global and a local variable describing a system are complementary. This idea is used here to reconstruct homeopathy as an exemplification of generalized entanglement as predicted by WQT. It transpires that homeopathy uses two instances of generalized entanglement: one between the remedy and the original substance (potentiation principle) and one between the individual symptoms of a patient and the general symptoms of a remedy picture (similarity principle). By bringing these two elements together, double entanglement ensues, which is reminiscent of cryptographic and teleportation applications of entanglement in QM proper. Homeopathy could be a macroscopic analogue to quantum teleportation. This model is exemplified and some predictions are derived, which make it possible to test the model.

Entanglement model of homeopathy as an example of generalized entanglement predicted by weak quantum theory.

http://www.clubdelarazon.org/downloads/homeopatia45-95.pdf

A systematic review of the quality of homeopathic pathogenetic trials published from 1945 to 1995.

The relevance of teaching medical ethics to undergraduate medical students is recognized worldwide. Since 1969 all Brazilian medical schools must teach ethics to the undergraduate students. To assess the evolution of the teaching of deontology, medical ethics or bioethics over the last thirty years, a systematic review of Brazilian publications on this subject was performed. Three studies published in three different decades were identified, showing little progress in the number of disciplines exclusively dedicated to the teaching of medical ethics as well as in the number of teaching hours and faculty staff directly involved with medical ethics, most of them in connection with forensic medicine. Professional accountancy and confidentiality were the issues most explored in the courses, mainly by means of oral expositions and case discussions. Given the importance of educating future medical doctors in ethics, this matter should be taught during the entire course by skilled and clinically experienced medical doctors with additional knowledge in humanities. It should be taught in line with other ethical subjects in the academic institutions in order to prepare ethically competent doctors for practicing the art and science of medicine.

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Ensino da deontologia, ética médica e bioética nas escolas médicas Brasileiras: uma revisão sistemática

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. 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. 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. Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.

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Flávio Dantas

Papers

Do homeopathic medicines provoke adverse effects? A systematic review

A systematic review of the quality of homeopathic pathogenetic trials published from 1945 to 1995.

Ensino da deontologia, ética médica e bioética nas escolas médicas Brasileiras: uma revisão sistemática

Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study.

How can we get more reliable information from homoeopathic pathogenetic trials?: A critique of provings