Recommendations regarding definitions and standards in healing research.
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Biomedical subjects
Publications and source records attributed to Wayne B Jonas.
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Religious and spiritual traditions from all cultures and times describe a spiritual or loving presence as a contributor to healing. In addition, there is a common belief that a special "presence" can exude from certain practitioners. Is it possible to measure a healing presence in an objective and reliable way? Most research on healing has focused on trying to prove spiritual and "energy" healing in comparative tests. However, if a measure of healing presence is to be sensitive and reliable, objective and real-time indicators of such a presence will be needed rather than comparative and statistical outcomes. This paper discusses what healers from various traditions have felt are the primary components of a healing presence, summarizes various attempts to measure healing, and describes two recently published approaches that have potential to provide such an objective and realtime indicator of a healing presence.
From December 1991 to December 1995, the National Cancer Institute (NCI) initiated phase II clinical trials of A10 and AS2-1 (antineoplastons) infusions in patients with diagnosed primary malignant brain tumors. Four years and more than a million dollars later, these studies were stopped before it was possible to determine the effectiveness of antineoplastons. Both NCI and Dr Burzynski, the developer of antineoplastons, accused one another of attempting to undermine the project. In an effort to determine why this study failed to be completed, the director of the National Institutes of Health Office of Alternative Medicine (OAM), who sponsored the study, commissioned a detailed analysis of the conflicts that led to the study's closure. The intent was to understand the social dynamics surrounding this failed study and to develop a method for managing and possibly preventing such failures in the future. This clinical trial was extremely complex and comprehensive. It involved hundreds of memoranda, letters, and telephone and fax correspondence among a wide number of parties over a 4-year period. All correspondence and other documents from the OAM as well as documentation from NCI were thoroughly examined. In addition, in-depth interviews with key individuals involved in the antineoplaston study were completed and incorporated into the analysis. At least 10 areas of conflict emerged from the analysis including issues around production, quality, and delivery of antineoplastons; commencement of the trial; the role of Dr Burzynski in the trial; types and combinations of cancers; choice of clinical investigators; need for communication; criteria for patient selection and treatment; and evaluation. Each of these issues clearly represented a difference of opinion between the 2 main parties around scientific protocols. Yet contention around these substantive, "scientific" disagreements reflected conflict in attunement (trust, power, and affiliation) between Dr Burzynski and NCI. This article summarizes the findings from this case study.
Homeopathy is a 200-year-old therapeutic system that uses small doses of various substances to stimulate autoregulatory and self-healing processes. Homeopathy selects substances by matching a patient's symptoms with symptoms produced by these substances in healthy individuals. Medicines are prepared by serial dilution and shaking, which proponents claim imprints information into water. Although many conventional physicians find such notions implausible, homeopathy had a prominent place in 19th-century health care and has recently undergone a worldwide revival. In the United States, patients who seek homeopathic care are more affluent and younger and more often seek treatment for subjective symptoms than those who seek conventional care. Homeopathic remedies were allowed by the 1939 Pure Food and Drug Act and are available over the counter. Some data--both from randomized, controlled trials and laboratory research--show effects from homeopathic remedies that contradict the contemporary rational basis of medicine. Three independent systematic reviews of placebo-controlled trials on homeopathy reported that its effects seem to be more than placebo, and one review found its effects consistent with placebo. There is also evidence from randomized, controlled trials that homeopathy may be effective for the treatment of influenza, allergies, postoperative ileus, and childhood diarrhea. Evidence suggests that homeopathy is ineffective for migraine, delayed-onset muscle soreness, and influenza prevention. There is a lack of conclusive evidence on the effectiveness of homeopathy for most conditions. Homeopathy deserves an open-minded opportunity to demonstrate its value by using evidence-based principles, but it should not be substituted for proven therapies.
Nonlinear responses to toxin exposure have been observed in multiple cell types and organisms across a wide array of phyla. High dose toxin exposures inhibit or kill biological systems, while low dose exposures can stimulate survival mechanisms. We examined the effects of low (10(-3), 10(-5), 10(-7), and 10(-9) M) and ultra-low (10(-25) and 10(-61) M) KCl and glutamate pretreatment (72 h) against glutamate toxicity in rat cerebellar neurons. Ultra-low dilutions (10(-31), 10(-61), and 10(-401)) of an Arnica montana mother tincture were also investigated for their neuroprotective potentials. Viability was significantly enhanced in neurons pretreated with either 10(-3) M glutamate (10.6%) or 10(-9) M KCl (6.3%). None of the toxins evaluated displayed significant toxicity at the concentrations indicated. The protective effect of glutamate is likely mediated through activation of N-methyl-D-aspartate receptors, whereas low dose KCl might confer neuroprotection through enhanced alteration of Na+/K+ receptor dynamics. This is the first time high dose glutamate tolerance has been shown along with low dose KCl, and is consistent with previous reports demonstrating tolerance induced by low dose toxin exposure.
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OBJECTIVE: To determine whether alterations in random events, as measured by a Random event generator (REG), occur in association with a bioenergy healing practice. DESIGN AND SETTING: Two REGs were set up and run in parallel: one in a bioenergy healer's office and another at a local library as a control. Two multiday sets of data were collected in each setting. A third set was collected in which a reduced amount of attention was placed on the REG by the healer. REG excursions were calculated and compared for (1) overall days in the library and bioenergy healer's office, (2) healing and nonhealing phases in the healing office, and (3) overall excursions during high(sets 1 and 2) and low attention (set 3) by the healer. RESULTS: The library REG produced excursions outside the 95% confidence interval (CI) on 35 of 61 days (58%), and the REG in the healing practice 47 of 51 days (92%) (mean difference, 34%; 95% CI, 18% to 49%; chi(2) = 16.3, 1 df, p < 0.0005). In the healer's office, 0.6496 excursions per segment for healing phases and 0.6548 excursions per segment for nonhealing phases were shown (t = -1.3, 6794 df, p = 0.182). A comparison with chance expectation derived from Monte Carlo runs showed significantly less mean excursions per segment (t = -7.8, 36625 df, p < 0.0005) for healing phases and no difference in nonhealing phases (t = -0.16, 6309 df, p = 0.872). There was no significant difference in excursions between the high- and low-attention situations in the healing practice. CONCLUSIONS: In the presence of a healer, an REG produced greater than chance excursions more often than a control REG in a library setting. The healing and nonhealing phases demonstrated inconsistent results. REG deviations were not influenced by the amount of attention directed toward the machine.
BACKGROUND: Previous studies have shown a positive treatment effect of individualized homeopathic treatment for acute childhood diarrhea, but sample sizes were small and results were just at or near the level of statistical significance. Because all three studies followed the same basic study design, the combined data from these three studies were analyzed to obtain greater statistical power. METHODS: Three double blind clinical trials of diarrhea in 242 children ages 6 months to 5 years were analyzed as 1 group. Children were randomized to receive either an individualized homeopathic medicine or placebo to be taken as a single 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. The duration of diarrhea was defined as the time until there were less than 3 unformed stools per day for 2 consecutive days. A metaanalysis of the effect-size difference of the three studies was also conducted. RESULTS: Combined analysis shows a duration of diarrhea of 3.3 days in the homeopathy group compared with 4.1 in the placebo group (P = 0.008). The metaanalysis shows a consistent effect-size difference of approximately 0.66 day (P = 0.008). CONCLUSIONS: The results from these studies confirm that individualized homeopathic treatment decreases the duration of acute childhood diarrhea and suggest that larger sample sizes be used in future homeopathic research to ensure adequate statistical power. Homeopathy should be considered for use as an adjunct to oral rehydration for this illness.
UNLABELLED: Immunoaugmentative therapy (IAT) is an unconventional therapy used by thousands of cancer patients that has not been systematically evaluated for safety and efficacy. The authors evaluated the toxicity and effects of this therapy in a series of consecutively treated cancer patients. METHODS: A sample of 46 consecutive patients treated at the Immune Therapy Clinic in Playas, Mexico, from April to December 1989 were evaluated for adverse reactions, tumor response, quality of life and immune status over 12 weeks of IAT treatment. Patients' blood was tested for HIV and hepatitis B antibody before and after treatment. Histological confirmation of cancer and staging was obtained in all patients, and the results of follow-up radiological examinations were judged in a blinded fashion by independent diagnostic radiologists. RESULTS: There were no signs of toxicity (SWOG criteria) and no HIV or hepatitis B conversion attributable to IAT. None of the 46 patients showed tumor regression. Forty patients (87%) had disease progression, and 25 (55%) died within 6 months from disease progression. Thirty-five patients (76%) noticed a decline in their quality of life during IAT. Thirty-eight patients (83%) opted to continue with the IAT treatment, despite its lack of effectiveness. CONCLUSIONS: No indication of toxicity or effectiveness was found in an uncontrolled, consecutively selected series of 46 cancer patients undergoing IAT treatment. In addition, the therapy did not appear to contribute to improved quality of life in most patients. This study does not justify its continued use.
We provide a new perspective with which to understand what for a half century has been known as the "placebo effect." We argue that, as currently used, the concept includes much that has nothing to do with placebos, confusing the most interesting and important aspects of the phenomenon. We propose a new way to understand those aspects of medical care, plus a broad range of additional human experiences, by focusing on the idea of "meaning," to which people, when they are sick, often respond. We review several of the many areas in medicine in which meaning affects illness or healing and introduce the idea of the "meaning response." We suggest that use of this formulation, rather than the fixation on inert placebos, will probably lead to far greater insight into how treatment works and perhaps to real improvements in human well-being.
Multiple cell types and organisms across a wide array of phyla and a variety of toxins demonstrate non-linear dose responses to low-level chemical exposures with high doses inhibiting cellular function and low doses stimulating function. We tested whether such non-linear responses to low and ultra-low dose N-methyl-D-aspartate (NMDA), 1-methyl-4-phenylpyridinium (MPP+) or cycloheximide moderated toxic glutamate exposure in cultured cerebellar granule cells. Neurons were incubated over 72 h with successive NMDA, MPP+ iodide or cycloheximide additions producing specified low (10(-5), 10(-7), 10(-9), 10(-11), and 10(-13) M) and ultra-low (10(-27),10(-29), 10(-63), and 10(-65) M) concentrations. Subsequently these neuronal cells were exposed to a 50% excitotoxic concentration of glutamate for 24 h. Neuronal viability was significantly reduced in neurons treated with micromolar (10(-5) M) cycloheximide whereas viability was enhanced in neurons treated with an ultra-low dose exposure of 10(-27) M cycloheximide. Neither NMDA nor MPP+ elicited harmful or protective responses. This is the first report demonstrating non-linear dose-response effects of cycloheximide in low and ultra-low concentration ranges.
BACKGROUND: External bioenergy (energy emitted from the body) can influence a variety of biological activities. It has been shown to enhance immunity, promote normal cell proliferation, increase tumor cell death, and accelerate bone fracture recovery. In this study, we investigated whether external bioenergy could alter intracellular calcium concentration ([Ca2+]i, an important factor in signal transduction) and regulate the cellular response to heat stress in cultured human lymphoid Jurkat T cells. METHODS: A practitioner emitted bioenergy toward tubes of cultured Jurkat cells for one 15-minute period. [Ca2+]i was measured spectrofluorometrically using the fluorescent probe indo-1. The heat shock protein 72 kd was detected using 35S-methionine prepulse and Western blot analysis. RESULTS: The resting [Ca2+]i in Jurkat T cells was 90+/-3 nM in the presence of external calcium. The removal of external calcium decreased the resting [Ca2+]i to 54+/-2 nM, indicating that Ca2+ entry from the external source is important for maintaining the basal level of [Ca2+]i. In the presence of external Ca2+, treatment of Jurkat T cells with external bioenergy for 15 minutes increased [Ca2+]i by 22+/-3%. [Ca2+]i remained elevated in these cells for 2 hours. Surprisingly, we also observed that [Ca2+]i increased by 11+/-1% if cells were simply placed in the area where external bioenergy had been used. This lingering effect of external bioenergy dissipated within 24 hours. Treatment with external bioenergy reduced cellular responses to heat stress and did not induce the production of heat shock protein 72 kd, which is known to provide cytoprotection. CONCLUSIONS: These results suggest that externally applied bioenergy can upregulate [Ca2+]i and downregulate the cellular response to stress. The association between the external bioenergy and increases in [Ca2+]i may be a good index for detecting presence of bioenergy.
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PURPOSE: To systematically review the quality of published experimental clinical and laboratory research involving hands-on healing and distance healing between 1955 and 2001. DATA SOURCES: Studies were identified through comprehensive literature searches on spiritual healing in MEDLINE, PSYCH LIT, EMBASE, CISCOM, and the Cochrane Library from their inceptions to December 2001. STUDY SELECTION: We selected published randomized, controlled trials of spiritual healing (hands-on healing and distance healing) done in clinical and laboratory settings, all of which had been peer reviewed. DATA EXTRACTION: Independent quality assessment of internal validity was conducted on all identified studies using the comprehensive Likelihood of Validity Evaluation scale. Clinical and laboratory studies were analyzed separately and then subdivided into hands-on healing or distance healing interventions. RESULTS: A total of 45 laboratory and 45 clinical studies published between 1956 and 2001 met the inclusion criteria. Of the clinical studies, 31 (70.5%) reported positive outcomes as did 28 (62%) of the laboratory studies; 4 (9%) of the clinical studies reported negative outcomes as did 15 (33%) of the laboratory studies. The mean percent overall internal validity for clinical studies was 69% (65% for hands-on healing and 75% for distance healing) and for laboratory studies 82% (82% for hands-on healing and 81% for distance healing). Major methodological problems of these studies included adequacy of blinding, dropped data in laboratory studies, reliability of outcome measures, rare use of power estimations and confidence intervals, and lack of independent replication. CONCLUSIONS: When laboratory studies were compared to clinical studies in the areas of hands-on healing and distance healing across the quality criteria for internal validity, distance healing studies scored better than hands-on healing studies, and laboratory studies fared better than clinical studies. Many studies of healing contained major problems that must be addressed in any future research.
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