Shamini Jain

Relation of nocturnal blood pressure dipping to cellular adhesion, inflammation and hemostasis.

Background Subjects who fail to dip their nocturnal blood pressure (BP) are at substantially increased risk for cardiovascular diseases. The pathogenetic mechanisms of this relationship have not been elucidated. We investigated whether non-dipping would relate to procoagulant and proinflammatory activity. Design Study participants were 76 unmedicated normotensive and hypertensive subjects (44 male, 32 female; 41 white, 35 black; mean age, 36 ± 8 years) who underwent 24-h outpatient ambulatory BP monitoring. Based on whether their average nocturnal systolic BP relative to their average daytime systolic BP declined by less than 10%, 34 subjects were categorized as non-dippers. D-dimer, plasminogen activator inhibitor-1, von Willebrand factor, soluble intercellular adhesion molecule-1, and interleukin-6 were measured in plasma. Results Multivariate analyses showed that D-dimer (median/interquartile range, 242/162–419 ng/ml versus 175/132–254 ng/ml; P = 0.041), plasminogen activator inhibitor-1 (36/19–61 ng/ml versus 17/6–44 ng/ml; P = 0.010), von Willebrand factor (122/91–179% versus 92/66–110%; P = 0.001), and soluble intercellular adhesion molecule-1(227/187–291 ng/ml versus 206/185–247 ng/ml; P = 0.044) were all higher in non-dippers than in dippers. Adjustment for gender, ethnicity, age, body mass index, smoking status, hypertension status, and social class revealed independent effects of non-dipping. Non-dippers continued to have higher D-dimer (P = 0.030) and von Willebrand factor (P = 0.034) than dippers. A similar trend not reaching statistical significance emerged for soluble intercellular adhesion molecule-1 (P = 0.055). In contrast, dipping status had no effect on interleukin-6. Conclusion Nocturnal BP non-dipping is associated with elevated levels of molecules related to endothelial dysfunction and atherosclerosis. The finding provides one possible mechanism linking non-dipping with cardiovascular disease.

Healing Touch With Guided Imagery for PTSD in Returning Active Duty Military: A Randomized Controlled Trial

Post-traumatic stress disorder (PTSD) remains a significant problem in returning military and warrants swift and effective treatment. We conducted a randomized controlled trial to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery [HT+GI]) reduced PTSD symptoms as compared to treatment as usual (TAU) returning combat-exposed active duty military with significant PTSD symptoms. Active duty military (n = 123) were randomized to 6 sessions (within 3 weeks) of HT+GI vs. TAU. The primary outcome was PTSD symptoms; secondary outcomes were depression, quality of life, and hostility. Repeated measures analysis of covariance with intent-to-treat analyses revealed statistically and clinically significant reduction in PTSD symptoms (p < 0.0005, Cohens d = 0.85) as well as depression (p < 0.0005, Cohens d = 0.70) for HT+GI vs. TAU. HT+GI also showed significant improvements in mental quality of life (p = 0.002, Cohens d = 0.58) and cynicism (p = 0.001, Cohens d = 0.49) vs. TAU. Participation in a complementary medicine intervention resulted in a clinically significant reduction in PTSD and related symptoms in a returning, combat-exposed active duty military population. Further investigation of GT and biofield therapy approaches for mitigating PTSD in military populations is warranted.

Complementary medicine for fatigue and cortisol variability in breast cancer survivors: a randomized controlled trial.

Fatigue is a chief complaint in cancer patients, and warrants effective treatment. Biofield therapies are complementary medicine approaches used by cancer populations. There is little information about their efficacy.

Pilot Randomized Study of a Gratitude Journaling Intervention on Heart Rate Variability and Inflammatory Biomarkers in Patients With Stage B Heart Failure.

Objective Stage B, asymptomatic heart failure (HF) presents a therapeutic window for attenuating disease progression and development of HF symptoms, and improving quality of life. Gratitude, the practice of appreciating positive life features, is highly related to quality of life, leading to development of promising clinical interventions. However, few gratitude studies have investigated objective measures of physical health; most relied on self-report measures. We conducted a pilot study in Stage B HF patients to examine whether gratitude journaling improved biomarkers related to HF prognosis. Methods Patients (n = 70; mean [standard deviation] age = 66.2 [7.6] years) were randomized to an 8-week gratitude journaling intervention or treatment as usual. Baseline (T1) assessments included the six-item Gratitude Questionnaire, resting heart rate variability (HRV), and an inflammatory biomarker index. At T2 (midintervention), the six-item Gratitude Questionnaire was measured. At T3 (postintervention), T1 measures were repeated but also included a gratitude journaling task. Results The gratitude intervention was associated with improved trait gratitude scores (F = 6.0, p = .017, &eegr;2 = 0.10), reduced inflammatory biomarker index score over time (F = 9.7, p = .004, &eegr;2 = 0.21), and increased parasympathetic HRV responses during the gratitude journaling task (F = 4.2, p = .036, &eegr;2 = 0.15), compared with treatment as usual. However, there were no resting preintervention to postintervention group differences in HRV (p values > .10). Conclusions Gratitude journaling may improve biomarkers related to HF morbidity, such as reduced inflammation; large-scale studies with active control conditions are needed to confirm these findings. Trial Registration: Clinicaltrials.gov identifier: NCT01615094

Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations

Biofield therapies are noninvasive therapies in which the practitioner explicitly works with a clients biofield (interacting fields of energy and information that surround living systems) to stimulate healing responses in patients. While the practice of biofield therapies has existed in Eastern and Western cultures for thousands of years, empirical research on the effectiveness of biofield therapies is still relatively nascent. In this article, we provide a summary of the state of the evidence for biofield therapies for a number of different clinical conditions. We note specific methodological issues for research in biofield therapies that need to be addressed (including practitioner-based, outcomes-based, and research design considerations), as well as provide a list of suggested next steps for biofield researchers to consider.

Integrative Nanomedicine: Treating Cancer With Nanoscale Natural Products

Finding safer and more effective treatments for specific cancers remains a significant challenge for integrative clinicians and researchers worldwide. One emerging strategy is the use of nanostructured forms of drugs, vaccines, traditional animal venoms, herbs, and nutraceutical agents in cancer treatment. The recent discovery of nanoparticles in traditional homeopathic medicines adds another point of convergence between modern nanomedicine and alternative interventional strategies. A way in which homeopathic remedies could initiate anticancer effects includes cell-to-cell signaling actions of both exogenous and endogenous (exosome) nanoparticles. The result can be a cascade of modulatory biological events with antiproliferative and pro-apoptotic effects. The Banerji Protocols reflect a multigenerational clinical system developed by homeopathic physicians in India who have treated thousands of patients with cancer. A number of homeopathic remedy sources from the Banerji Protocols (eg, Calcarea phosphorica; Carcinosin—tumor-derived breast cancer tissue prepared homeopathically) overlap those already under study in nonhomeopathic nanoparticle and nanovesicle tumor exosome cancer vaccine research. Past research on antineoplastic effects of nano forms of botanical extracts such as Phytolacca, Gelsemium, Hydrastis, Thuja, and Ruta as well as on homeopathic remedy potencies made from the same types of source materials suggests other important overlaps. The replicated finding of silica, silicon, and nano-silica release from agitation of liquids in glassware adds a proven nonspecific activator and amplifier of immunological effects. Taken together, the nanoparticulate research data and the Banerji Protocols for homeopathic remedies in cancer suggest a way forward for generating advances in cancer treatment with natural product–derived nanomedicines.

Rapid Evidence Assessment of the Literature (REAL©): streamlining the systematic review process and creating utility for evidence-based health care

BackgroundSystematic reviews (SRs) are widely recognized as the best means of synthesizing clinical research. However, traditional approaches can be costly and time-consuming and can be subject to selection and judgment bias. It can also be difficult to interpret the results of a SR in a meaningful way in order to make research recommendations, clinical or policy decisions, or practice guidelines. Samueli Institute has developed the Rapid Evidence Assessment of the Literature (REAL) SR process to address these issues. REAL provides up-to-date, rigorous, high quality SR information on health care practices, products, or programs in a streamlined, efficient and reliable manner. This process is a component of the Scientific Evaluation and Review of Claims in Health Care (SEaRCH™) program developed by Samueli Institute, which aims at answering the question of “What works?” in health care.Methods/designThe REAL process (1) tailors a standardized search strategy to a specific and relevant research question developed with various stakeholders to survey the available literature; (2) evaluates the quantity and quality of the literature using structured tools and rulebooks to ensure objectivity, reliability and reproducibility of reviewer ratings in an independent fashion and; (3) obtains formalized, balanced input from trained subject matter experts on the implications of the evidence for future research and current practice.ResultsOnline tools and quality assurance processes are utilized for each step of the review to ensure a rapid, rigorous, reliable, transparent and reproducible SR process.ConclusionsThe REAL is a rapid SR process developed to streamline and aid in the rigorous and reliable evaluation and review of claims in health care in order to make evidence-based, informed decisions, and has been used by a variety of organizations aiming to gain insight into “what works” in health care. Using the REAL system allows for the facilitation of recommendations on appropriate next steps in policy, funding, and research and for making clinical and field decisions in a timely, transparent, and cost-effective manner.

SEaRCH™ expert panel process: streamlining the link between evidence and practice

AbstractBackgroundWith rising health care costs and the diversity of scientific and clinical information available to health care providers it is essential to have methodologies that synthesize and distill the quality of information and make it practical to clinicians, patients and policy makers. Too often research synthesis results in the statement that “more and better research is needed” or the conclusions are slanted toward the biases of one type of stakeholder. Such conclusions are discouraging to clinicians and patients who need better guidance on the decisions they make every day.MethodExpert panels are one method for offering valuable insight into the scientific evidence and what experts believe about its application to a given clinical situation. However, with improper management their conclusions can end up being biased or even wrong. There are several types of expert panels, but two that have been extensively involved in bringing evidence to bear on clinical practice are consensus panels, and appropriateness panels. These types of panels are utilized by organizations such as the National Institutes of Health, the Institute of Medicine, RAND, and other organizations to provide clinical guidance. However, there is a need for a more cost effective and efficient approach in conducting these panels. In this paper we describe both types of expert panels and ways to adapt those models to form part of Samueli Institute’s Scientific Evaluation and Research of Claims in Health Care (SEaRCH™) program.DiscussionExpert Panels provide evidence-based information to guide research, practice and health care decision making. The panel process used in SEaRCH seeks to customize, synthesize and streamline these methods. By making the process transparent the panel process informs decisions about clinical appropriateness and research agenda decisions.

Ethnicity, social class and hostility: effects on in vivo β-adrenergic receptor responsiveness

Little is known about the potential influences of social and psychosocial variables in accounting for ethnic differences in the beta-adrenergic receptor. We examined the effects of ethnicity, social class, and other variables on an in vivo marker of beta-adrenergic receptor responsiveness (Chronotropic 25 Dose, CD(25)) for 224 African-Americans and Caucasian-Americans. Social class was determined using the clinician-rated Hollingshead two-factor index. The Cook-Medley hostility and Buss-Durkee assaultiveness subscales were administered to a subset of subjects. Results indicated that African-Americans had decreased beta-receptor responsiveness compared to Caucasian-Americans after controlling for social class, age, and smoking (P=0.001). Secondary analysis for a subset of subjects revealed significant hostility x ethnicity interactions, such that hostility predicted decreased beta-receptor responsiveness for Caucasian-Americans (P=0.004), but not for African-Americans. Thus, decreased beta-adrenergic receptor responsiveness in African-Americans does not appear to be due to differences in current social class, age, or smoking status, nor to higher reports of hostility.

Biofield Science and Healing: History, Terminology, and Concepts.

Biofield science is an emerging field of study that aims to provide a scientific foundation for understanding the complex homeodynamic regulation of living systems. By furthering our scientific knowledge of the biofield, we arrive at a better understanding of the foundations of biology as well as the phenomena that have been described as “energy medicine.” Energy medicine, the application of extremely low-level signals to the body, including energy healer interventions and bio-electromagnetic device-based therapies, is incomprehensible from the dominant biomedical paradigm of “life as chemistry.” The biofield or biological field, a complex organizing energy field engaged in the generation, maintenance, and regulation of biological homeodynamics, is a useful concept that provides the rudiments of a scientific foundation for energy medicine and thereby advances the research and practice of it. An overview on the biofield is presented in this paper, with a focus on the history of the concept, related terminology, key scientific concepts, and the value of the biofield perspective for informing future research.