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Biomedical subjects

W B Jonas

Publications and source records attributed to W B Jonas.

At least 19 recordsLinked to original sources

Rapid induction of protective tolerance to potential terrorist agents: a systematic review of low- and ultra-low dose research.

OBJECTIVE: To systematically review the literature on the ability of low-dose (LD) and ultra-low-dose (ULD) toxin exposure to prevent and treat biological and chemical threats. METHODS: Laboratory research articles on protection or treatment from LD or ULD exposure for the 13 high-risk chemical and biological warfare threats were collected and systematically evaluated for quantity and scientific quality using pre-defined methodological criteria. RESULTS: Over 2600 articles were screened. Only five studies met the inclusion criteria examining stimulation and protective effects of LD- or ULD-exposures to the 13 pre-identified biological and chemical agents. The quality evaluation (QE) of these studies was above average with a mean QE score of 70.6% of maximum. Two articles of fair to good quality reported both protective and treatment efficacy from exposure of animals or humans to LD- and ULD-exposures to toxins of risk in biochemical warfare. CONCLUSION: There is little research on agents of biological and chemical warfare investigating the possible use of LD- and ULD-toxins for protection and treatment. The existing literature is generally of good quality and indicates that rapid induction of protective tolerance is a feasible but under-investigated approach to bioterrorist or biowarfare defense. In our opinion, further research into the role of induced protection with LD- and ULD-toxic agents is needed.

Biological Warfare↗

A systematic review of the quality of homeopathic clinical trials.

BACKGROUND: While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature. METHODS: In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945-1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95. RESULTS: 59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years. CONCLUSIONS: Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods.

Clinical Trials as Topic↗

Advising patients on the use of complementary and alternative medicine.

Complementary and alternative medicine (CAM) is an area of great public interest and activity, both nationally and worldwide. Many alternative medical practices have existed for hundreds, even thousands of years. Patients and professionals are turning to CAM for a variety of reasons. Most have tried conventional medicine for a particular (usually chronic) medical condition and have found the results inadequate. Some are concerned over the side effects of conventional therapies. Some are seeking out a more "holistic" orientation in health care where they can address body, mind, and spirit. A continuing challenge will be how to address CAM services that are based on time, practitioner-patient interactions, and self-care, using modern standards of evidence, education, licensing, and reimbursement. For most CAM therapies, there is insufficient research to say definitively that it works and CAM research is especially limited in the area of cancer. Given that situation, the questions (but not answers) facing the medical practitioner are clear-cut. Should the practitioner await the definitive results of formal Phase III randomized clinical trials, or should the practitioner rely on limited data, seeking out evidence that makes physiological sense and small trials that seem to offer some benefit to the patient? When and at what point do you discourage, permit, or recommend an available alternative therapy? The answers are not simple. There may be differences of opinion and values among the patient, the practitioner, and the organizations that pay for a therapy. CAM areas should be approached with every patient who enters the office recognizing that there are precautions to consider when patients are using, or plan to use, such therapies. This paper presents a broad survey of what complementary and alternative medicine is from the perspectives of both the public as user and the conventional medical practitioner, as well as provides examples of issues pertinent to understanding and evaluating research in CAM. The past is back and the future will involve integration of modern and ancient ways.

Attitude of Health Personnel↗

A survey of medical students' opinions about complementary and alternative medicine.

OBJECTIVE: We wished to determine third-year medical students' opinions and knowledge related to complementary and alternative medicine (CAM) in a school with no formal or elective course on the subject. STUDY DESIGN: A questionnaire was offered to third-year medical students during their 8-week rotation on obstetrics and gynecology. RESULTS: Most students had been exposed to CAM therapies, knew that the majority of the American public was using CAM, believed that some CAM interventions were useful, and did not believe CAM therapies were a threat to public health. Most students had insufficient knowledge or understanding of the safety or lack of it for 10 of the more common CAM modalities. Most respondents thought these interventions were useful, but would not refer the patient nor dissuade her from using them. There were no significant differences in responses between men and women or related to the time in the year of the clerkship. CONCLUSION: Medical students in this school self-identified an interest about the clinical usefulness of 10 CAM modalities, but did not have sufficient knowledge about the safety for 10 of the more common CAM modalities. Including CAM topics in the medical school curriculum would better prepare physicians to respond to patient inquiries about CAM and thereby to fulfill their role as patient advocates.

Adult↗

The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture.

BACKGROUND: To investigate the methodological quality of randomized controlled trials in three areas of complementary medicine. METHODS: The methodological quality of 207 randomized trials collected for five previously published systematic reviews on homeopathy, herbal medicine (Hypericum for depression, Echinacea for common cold), and acupuncture (for asthma and chronic headache) was assessed using a validated scale (the Jadad scale) and single quality items. RESULTS: While the methodological quality of the trials was highly variable, the majority had important shortcomings in reporting and/or methodology. Major problems in most trials were the description of allocation concealment and the reporting of drop-outs and withdrawals. There were relevant differences in single quality components between the different complementary therapies: For example, acupuncture trials reported adequate allocation concealment less often (6% versus 32% of homeopathy and 26% of herb trials), and trials on herbal extracts had better summary scores (mean score 3.12 versus 2.33 for homeopathy and 2.19 for acupuncture trials). Larger trials published more recently in journals listed in Medline and in English language scored significantly higher than trials not meeting these criteria. CONCLUSION: Trials of complementary therapies often have relevant methodological weaknesses. The type of weaknesses varies considerably across interventions.

Acupuncture Therapy↗

Fever, cancer incidence and spontaneous remissions.

OBJECTIVE: Accumulating evidence exists for (1) an inverse correlation between the incidence of infectious diseases and cancer risk and (2) an inverse correlation between febrile infections and remissions of malignancies. This review is part of an effort of the Office of Alternative Medicine at the National Institutes of Health to examine this evidence. METHODS: A review of the literature to a key word search was undertaken, using the following key words: fever, infectious diseases, neoplasm, cancer incidence and spontaneous remission. RESULTS: The data reviewed in this article support earlier observations on the topic, i.e. that the occurrence of fever in childhood or adulthood may protect against the later onset of malignant disease and that spontaneous remissions are often preceded by feverish infections. CONCLUSION: Pyrogenic substances and the more recent use of whole-body hyperthermia to mimic the physiologic response to fever have successfully been administered in palliative and curative treatment protocols for metastatic cancer. Further research in this area is warranted.

Communicable Diseases↗

Homeopathy and rheumatic disease.

Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide.

Arthritis, Rheumatoid↗

Toward a research agenda on placebo.

The placebo effect is about healing. The human healing process can be substantially influenced in actual medical practice by appropriate kinds of caring, communication, and patient empowerment. The creation of "meaning" and of "representations" by physicians and their patients can have dramatic effects on patients for good or ill. These effects are potentially as important in procedures such as surgery or chiropractic as they are in medicine generally. Placebo processes can substantially affect the overall response to health care and its cost, yet very little research specifically explores these phenomena. An explicit research agenda should be developed to investigate the influences of belief, context, and meaning in medicine. Such a research agenda would have significant beneficial scientific and policy consequences. In addition, it would enhance our understanding of those healing processes that underlie most if not all of medicine.

Humans↗

Homeopathic treatment of acute childhood diarrhea: results from a clinical trial in Nepal.

OBJECTIVE: To investigate whether the finding in a previous study that homeopathic medicines decrease the duration of acute diarrhea in children could be replicated in a different study population. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Private, charitable health clinic in Kathmandu, Nepal. SUBJECTS: A consecutive sample of 126 children, 6 months to 5 years of age, who presented during April through June, 1994, with more than three unformed stools in the previous 24 hours. INTERVENTION: Children received either an individualized homeopathic medicine or placebo, to be taken one dose after each unformed stool for 5 days. Parents recorded daily stools on diary cards, and health workers made home visits daily to monitor children. OUTCOME MEASURES: Predefined measures were based on the previous study: (1) duration of diarrhea, defined as the time until there were fewer than three unformed stools per day, for two consecutive days, and (2) Average number of stools per day for each group. RESULTS: Of the 126 children initially enrolled, 116 completed treatment. The mean number of stools per day over the entire 5-day treatment period was 3.2 for the treatment group and 4.5 for the placebo group (P = 0.023). A Kaplan-Meier survival analysis of the duration of diarrhea, which included data from all patient visits, showed an 18.4% greater probability that a child would be free of diarrhea by day 5 under homeopathic treatment (P = 0.036). CONCLUSIONS: These results are consistent with the finding from the previous study that individualized homeopathic treatment decreases the duration of diarrhea and number of stools in children with acute childhood diarrhea.

Acute Disease↗

Impact of study quality on outcome in placebo-controlled trials of homeopathy.

We investigated the influence of indicators of methodological quality on study outcome in a set of 89 placebo-controlled clinical trials of homoeopathy in three different ways: (1) The results of studies meeting single criteria (explicit statement of random allocation, allocation concealment, double-blinding, completeness of follow-up) of methodological quality were compared with those of studies not meeting the criteria in univariate and multivariate analyses; (2) The results of studies scoring above and below predefined scores in two quality assessment scales were compared; (3) Primary studies were consecutively entered into a cumulative meta-analysis according to the summary scores derived from the quality assessment scales. All analyses were performed using meta-regression methods. Studies that were explicitly randomized and were double-blind as well as studies scoring above the cut-points yielded significantly less positive results than studies not meeting the criteria. In the cumulative meta-analyses, there was a trend for increasing effect sizes when more studies with lower-quality scores were added. However, there was no linear relationship between quality scores and study outcome. We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results. Because summarizing disparate study features into a single score is problematic, meta-regression methods simultaneously investigating the influence of single study features seem the best method for investigating the impact of study quality on outcome.

Analysis of Variance↗

Do homeopathic nosodes protect against infection? An experimental test.

CONTEXT: For centuries, homeopathic practitioners have claimed that serially agitated dilutions of infectious agents (called "nosodes") are effective in the prevention of infectious disease. However, no rigorous tests of this claim have been performed. OBJECTIVE: To test whether a nosode of Francisella tularensis-infected tissue could protect from subsequent challenge with this pathogen in vivo. DESIGN: Experimental laboratory test. SETTING: A P3 containment laboratory at an infectious disease research facility. PARTICIPANTS: 142 male C3H/HeN specific, pathogen-free mice. INTERVENTION: Six levels of a nosode prepared from tularemia-infected tissue were produced. All exposures were below the lowest level at which a classical vaccination response was expected. The nosode and dilutent control solutions were administered orally (.03 mL, 3 times per week) for 1 month before and after challenge. Animals were challenged with a potentially lethal dose (LD50 or LD75) of F tularensis, then evaluated for time of death and total mortality. MAIN OUTCOME MEASURES: Mortality and time to death. RESULTS: In a series of 15 trials (n = 142), the tularemia nosode consistently produced increased mean times to death. All but 2 of 15 trials showed reduced time to death in the nosode group and decreased mortality compared with controls. Protection rates averaged 22% over controls compared to 100% protection by standard vaccination. CONCLUSIONS: This study found partial protection from a nosode of tularemia in dilutions below those expected to have protective effects, but not as great as those produced by standard vaccination. If homeopathic nosodes can induce protection from infectious agents for which vaccination is currently unavailable, they may provide an interim method of reducing morbidity or mortality from such agents.

Administration, Oral↗