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Biofield therapies: helpful or full of hype? A best evidence synthesis.

ABSTRACT: BACKGROUND: Biofield therapies (such as Reiki, therapeutic touch, and healing touch) are complementary medicine modalities that remain controversial and are utilized by a significant number of patients, with little information regarding their efficacy. PURPOSE: This systematic review examines 66 clinical studies with a variety of biofield therapies in different patient populations. METHOD: We conducted a quality assessment as well as a best evidence synthesis approach to examine evidence for biofield therapies in relevant outcomes for different clinical populations. RESULTS: Studies overall are of medium quality, and generally meet minimum standards for validity of inferences. Biofield therapies show strong evidence for reducing pain intensity in pain populations, and moderate evidence for reducing pain intensity hospitalized and cancer populations. There is moderate evidence for decreasing negative behavioral symptoms in dementia and moderate evidence for decreasing anxiety for hospitalized populations. There is equivocal evidence for biofield therapies' effects on fatigue and quality of life for cancer patients, as well as for comprehensive pain outcomes and affect in pain patients, and for decreasing anxiety in cardiovascular patients. CONCLUSION: There is a need for further high-quality studies in this area. Implications and future research directions are discussed.

SUBMITTER: Jain S

PROVIDER: S-EPMC2816237 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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Biofield therapies: helpful or full of hype? A best evidence synthesis.

Jain Shamini S Mills Paul J PJ

International journal of behavioral medicine 20100301 1

<h4>Background</h4>Biofield therapies (such as Reiki, therapeutic touch, and healing touch) are complementary medicine modalities that remain controversial and are utilized by a significant number of patients, with little information regarding their efficacy.<h4>Purpose</h4>This systematic review examines 66 clinical studies with a variety of biofield therapies in different patient populations.<h4>Method</h4>We conducted a quality assessment as well as a best evidence synthesis approach to exami ...[more]

PMID: 19856109

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Project description:BackgroundIntra-articular injections of hyaluronic acid (HA), the United States Food and Drug Administration approved treatment and widely utilized to delay or reserve the progression of the osteoarthritis (OA) involves. However, this treatment has shown controversial results through various clinical practice guidelines and meta-analysis evaluations, warrants more advanced researches on its safety and effectiveness.MethodsA novel strategy of integrating medical informatics and bioinformatics was utilized. An updated meta-analysis of 16 randomized controlled trials (RCTs) out of 1820 articles was conducted, in combination with a high throughput body-wide-organ-transcriptomic (BOT) RNA-sequencing (RNA-seq) and in vitro and vivo experiments to evaluate the effect of HA at local and systemic levels, revealing the underlying mechanism.ResultsA sensitivity analysis was performed restricting to high quality RCTs, no significant effect of HA treatment was found on pain relief and functional improvement. Descriptive analysis of RNA-seq using Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway analysis revealed biological process related to innate immune responses and apoptosis; BOT analysis revealed differential gene expressions (DEGs) in cartilage, lymph node, spleen, kidney, and liver, with immune cell proliferation in immune-related organs. In vitro, HA-coated plates were shown to induce macrophage responses; in vivo histological images revealed knee joint, liver, and kidney with damaged/abnormal morphologies, while immune cell proliferation was observed in the lymph node and spleen and it was found that there was no significant difference in the treatment effect for OA animal model.ConclusionConclusively, integration of meta-analysis with bioinformatics analysis exhibited that HA induces inflammatory responses both locally and systematically and not benefit for OA treatment, thus limiting the regeneration and leading to some organ-specific pathogenesis. The strategy and findings will be of important for guiding future long-term clinical studies.The translational potential of this articleThis study illustrated that the administered HA activated both systemic and local pro-inflammatory immune responses, possibly limiting its efficacy. This novel unique strategy proposed in this study can be utilized and adapted for future meta-analysis and bioinformatics study.

Project description:BACKGROUND: Postmarket surveillance of the comparative safety and efficacy of orphan therapeutics is challenging, particularly when multiple therapeutics are licensed for the same orphan indication. To make best use of product-specific registry data collected to fulfill regulatory requirements, we propose the creation of a distributed electronic health data network among registries. Such a network could support sequential statistical analyses designed to detect early warnings of excess risks. We use a simulated example to explore the circumstances under which a distributed network may prove advantageous. METHODS: We perform sample size calculations for sequential and non-sequential statistical studies aimed at comparing the incidence of hepatotoxicity following initiation of two newly licensed therapies for homozygous familial hypercholesterolemia. We calculate the sample size savings ratio, or the proportion of sample size saved if one conducted a sequential study as compared to a non-sequential study. Then, using models to describe the adoption and utilization of these therapies, we simulate when these sample sizes are attainable in calendar years. We then calculate the analytic calendar time savings ratio, analogous to the sample size savings ratio. We repeat these analyses for numerous scenarios. KEY RESULTS: Sequential analyses detect effect sizes earlier or at the same time as non-sequential analyses. The most substantial potential savings occur when the market share is more imbalanced (i.e., 90% for therapy A) and the effect size is closest to the null hypothesis. However, due to low exposure prevalence, these savings are difficult to realize within the 30-year time frame of this simulation for scenarios in which the outcome of interest occurs at or more frequently than one event/100 person-years. CONCLUSIONS: We illustrate a process to assess whether sequential statistical analyses of registry data performed via distributed networks may prove a worthwhile infrastructure investment for pharmacovigilance.

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Biofield therapies: helpful or full of hype? A best evidence synthesis.

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Biofield therapies: helpful or full of hype? A best evidence synthesis.

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