Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

Highlights Guidelines have been created to improve the reporting of clinical trials of biofield therapies, e.g. External Qigong, Healing Touch, Reiki, and Therapeutic Touch. Appropriate use of these guidelines is likely to strengthen the evidence base for biofield therapies as well as increase their usage as stand-alone practices and as complementary therapies within mainstream healthcare.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, eg, External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONsolidated Standards of Reporting Trials (CONSORT) 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Evaluation of a Distance Reiki Program for Frontline Healthcare Workers' Health-Related Quality of Life During the COVID-19 Pandemic.

Background: Reiki is a biofield therapy which is based on the explanatory model that the fields of energy and information of living systems can be influenced to promote relaxation and stimulate a healing response. Objective: To conduct a pragmatic within-subject pilot trial of a remote Reiki program for frontline healthcare workers' health-related symptoms during the COVID-19 pandemic. Methods: Healthcare professionals in the UK (eg, physicians, nurses, and paramedics) were eligible to sign up for a distance Reiki program and were also invited to participate in the research study. Eight Reiki practitioners simultaneously gave each participant Reiki remotely for 20 minutes on 4 consecutive days. Feasibility of the research was assessed, including recruitment, data completeness, acceptability and intervention fidelity, and preliminary evaluation of changes in outcome measures. Participants' stress, anxiety, pain, wellbeing, and sleep quality were evaluated with 7-point numerical rating scales. Measures were completed when signing up to receive Reiki (pre) and following the final Reiki session (post). Pre and post data were analyzed using Wilcoxon signed ranks tests. Results: Seventy-nine healthcare professionals signed up to receive Reiki and took the baseline measures. Of those, 40 completed post-measures after the 4-day intervention and were therefore included in the pre-post analysis. Most participants were female (97.5%), and the mean age was 43.9 years old (standard deviations = 11.2). The study was feasible to conduct, with satisfactory recruitment, data completeness, acceptability, and fidelity. Wilcoxon signed ranks tests revealed statistically significant decreases in stress (M = -2.33; P < .001), anxiety (M = -2.79; P < .001) and pain (M = -.79; P < .001), and significant increases in wellbeing (M = -1.79; P < .001) and sleep quality (M = -1.33; P = .019). Conclusions: The Reiki program was feasible and was associated with decreased stress, anxiety and pain, and increased wellbeing and sleep quality in frontline healthcare workers impacted by the COVID-19 pandemic.

An Evaluation of the Subjective Experience of Receiving Reiki: Qualitative Results from a Pragmatic Effectiveness Study.

Objectives: The main purpose of this study was to evaluate the subjective experience of Reiki in a large sample. Design: The study design was a single-arm pragmatic effectiveness trial with qualitative questions completed post-Reiki session. Setting: The study took place at private Reiki practices across the United States. Subjects: A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners invited each of their Reiki clients to complete a survey before and after the Reiki session. Of the N = 1575 Reiki sessions recorded, N = 1284 qualitative responses were completed (82% of total) and included in the analysis. Interventions: Trained and experienced Reiki masters conducted Reiki sessions in person, with each session lasting between 45 and 90 min. Outcome measures: Participants were asked to describe their experience during the Reiki session. Results: Qualitative analysis revealed eight major themes: (1) deep relaxation and calm (68%), (2) body sensations/somatic experiences (53%), (3) emotions (29%), (4) spiritual or symbolic significance (18%), (5) changes in symptoms (17%), (6) changes in perception (11%), (7) sleep and drowsiness (10%), and (8) changes to breathing (4%). Significantly more males reported feeling relaxed and experiencing time perception changes, whereas more females reported body sensations, emotions, visual perceptions, and spiritual significance. Conclusions: The findings from this study suggest that Reiki can elicit the relaxation response and alter emotions and perception in such a way as to facilitate a transformative subjective healing experience. Future work will analyze these themes as they relate to changes in symptoms and compare the experience of Reiki with other biofield therapies.

A Large-Scale Effectiveness Trial of Reiki for Physical and Psychological Health.

Objectives: The main purpose of this study was to measure the effect of a single session of Reiki on physical and psychological health in a large nonclinical sample. Design: The study design was a single arm effectiveness trial with measures at pre-and postintervention. Settings: The study took place at private Reiki practices across the United States. Subjects: Reiki practitioners were recruited from an online mailing list to participate in the study with their Reiki clients. A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners were instructed to give a flyer to each of their Reiki clients that contained information about the study and invited the client to complete a survey before and after their Reiki session. Interventions: Trained and certified Reiki Masters conducted the Reiki sessions in person, with each session lasting between 45 and 90 min. Outcome measures: The well-validated 20-item Positive and Negative Affect Schedule was used to assess affect, and brief, single-item self-report measures were used to assess a wide range of physical and psychological variables immediately before (pre) and after (post) the Reiki session. Results: A total of N = 1411 Reiki sessions were conducted and included in the analysis. Statistically significant improvements were observed for all outcome measures, including positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (all p-values <0.001). Conclusions: The results from this large-scale multisite effectiveness trial suggest that a single session of Reiki improves multiple variables related to physical and psychological health.

An Integrative Review of Scientific Evidence for Reconnective Healing.

BACKGROUND: Biofield therapies offer a novel, non-invasive approach to treating chronic diseases based on assessing and adjusting an individual's physiological and emotional responses through their bio-energetic field. Reconnective Healing™ (RH) is defined as: "…not just energy healing, but instead a more comprehensive spectrum of healing composed of energy, light, and information." OBJECTIVES: Several biofield therapies, such as Reiki, Therapeutic Touch and Johrei, have already been reviewed in the literature but RH has received little attention even though it is taught and practiced worldwide. This review provides a critical assessment of RH as a healing modality. METHODS: Scientific research articles published in peer-reviewed journals addressing RH were identified using relevant databases and archives. Information was extracted from each article that met selection criteria for evaluation of quality of reporting and design. This review summarizes and critically evaluates the five currently published peer-reviewed research papers involving RH and assesses whether RH provides consistent physiological outcomes between the studies. RESULTS: These results, taken together, suggest: (i) exposure of a healer or healee to RH, either directly or indirectly, amplifies their degree of autonomic arousal and energy, (ii) RH can reduce pain and improve range of motion in people with shoulder limitations, and (iii) when individuals experience RH as a group, their autonomic nervous systems simultaneously show sudden similar responses consistent with the idea that RH is mitigated by entrainment of biofields. CONCLUSIONS: Since these studies are extremely varied in design it is not possible at this point to reach conclusions about the general effectiveness of RH. More clinical and physiological research performed on different populations under a range of conditions is needed in order to support this healthcare approach.

The Touchstone Process: an ongoing critical evaluation of reiki in the scientific literature.

BACKGROUND: Reiki is used by a growing number of people but little is known about the scientific basis for its use. PURPOSE: The Touchstone Process was developed as an ongoing process to systematically analyze published, peer-reviewed studies of Reiki, the results being made accessible to the public online. METHOD: Thirteen scientifically qualified experts in the field of Reiki were assembled into 3 teams to retrieve, evaluate, and summarize articles using standardized, piloted evaluation forms. RESULTS: Summaries of 26 Reiki articles, including strengths and weaknesses, were posted on a newly developed Web site (www.centerforreikiresearch.org), together with an overall summary of the status of Reiki research and guidelines for future research: The Touchstone Process determined that only 12 articles were based on a robust experimental design and utilized well-established outcome parameters. Of these articles, 2 provided no support, 5 provided some support, and 5 demonstrated strong evidence for the use of Reiki as a healing modality. CONCLUSION: There is a need for further high-quality studies in this area.

Effect of noise on microvascular integrity in laboratory rats.

Housing rats in an environment with high personnel activity increases microvascular leakiness to albumin in the mesenteric microcirculation and causes mast cell degranulation. In this study, rats were exposed to daily 15-min episodes of 90-dB SPL noise to determine whether similar effects occurred and whether vitamin E with a-lipoic acid or Traumeel (a homeopathic anti-inflammatory-analgesic) reduced these effects. Groups of rats fed a control diet (1000 IU/kg vitamin E) only, the control diet with Traumeel, or a diet with 10,000 IU/kg vitamin E and 1.65 g/kg lipoic acid were exposed to daily noise for 3 to 5 wk; a fourth group of rats, fed control diet, was housed with no excess noise. The rats were anesthetized, the superior mesenteric artery cannulated, and a portion of the microvasculature perfused for 1 min with fluoroscein isothiocyanate-albumin before fixing for microscopy. All groups exposed to excess noise had significantly more leaks per venule length and greater leak area per venule length than did the quiet group. However, the number and area of leaks in the rats that received Traumeel or vitamin E were significantly smaller than those in rats exposed to noise only. In addition, mast cell degranulation was significantly lower in rats given Traumeel. Thus exposure of rats to excessive noise produces structural damage in the mesenteric microvasculature that is significantly reduced by dietary supplements.

Personal interaction with a Reiki practitioner decreases noise-induced microvascular damage in an animal model.

OBJECTIVE: To determine whether Reiki, a process of transmission of healing energy, can significantly reduce microvascular leakage caused by exposure to excessive noise using an animal model. RATIONALE: Reiki is beginning to be used in hospitals to accelerate recovery. Despite many anecdotes describing Reiki's success, few scientific studies are reported and none of those use animals. Animal models have the advantage over human subjects in that they provide well-controlled, easily interpretable experiments. The use of noise is relevant to hospital patients because of the excessive ambient noise in hospitals in the United Kingdom and United States. Loud noise can lead to several nonauditory disorders in humans and animals that impair recovery. In the rat, stress from noise damages the mesenteric microvasculature, leading to leakage of plasma into the surrounding tissue. DESIGN: One group of four rats simultaneously received daily noise and Reiki, while two other groups received "sham" Reiki or noise alone. A fourth group did not receive noise or additional treatment. The experiment was performed three times to test for reproducibility. OUTCOME MEASURES: Average number and area of microvascular leaks to fluorescent albumin per unit length of venule. RESULTS: In all three experiments, Reiki significantly reduced the outcome measures compared to the other noise groups (sham Reiki and noise alone) (p < 0.01). CONCLUSIONS: Application of Reiki significantly reduces noise-induced microvascular leakage in an animal model. Whether or not these effects are caused by Reiki itself, or the relaxing effect of the Reiki practitioner, this procedure could be useful for minimizing effects of environmental stress on research animals and hospital patients.

Selenium reduces hemoglobin-induced epithelial damage to intestinal mucosa.

Modified hemoglobins are being considered as possible "blood substitutes." Experiments were performed to determine whether diaspirin cross-linked hemoglobin (DBBF-Hb) produces epithelial damage and whether this is reduced by selenium (Se). Anesthetized Sprague-Dawley rats, half of which received 2 x 10(-6) g/ml Se, daily for 3 weeks, in their drinking water, were injected with a 5 ml bolus of 10 mg/ml DBBF-Hb. Control animals received saline (5 animals per group). After 30 minutes, the intestine was perfusion-fixed for light and electron microscopy. Eighty villi per rat were assigned an epithelial integrity index (E.I.), ranging from 1 (intact) to 3 (some cell-cell and cell-basement membrane separation). In non-Se rats, E.I. was significantly compromised by DBBF-Hb, compared to HBS-BSA (2.47+/-0.57 (SD) vs. 1.36+/-0.49, p<0.001). In Se rats, neither injection with DBBF-Hb or HBS-BSA caused epithelial damage (1.03+/-0.17 vs. 1.07+/-0.26). Mast cell degranulation per villus (MCD) was measured in 60 villi per rat. In non-Se rats, MCD was significantly greater after DBBF-Hb than after HBS-BSA injection (1.83+/-1.42 vs. 0.2+/-0.4). Supplementary Se did not reduce this effect. In fact, MCD was significantly increased in both sets of rats compared to their non-Se counterparts (3.27+/-2.40 and 1.48+/-1.70 for DBBF-Hb and HBS-BSA, respectively). Since mast cell mediators damage cells, Se must protect the mucosal epithelium in some way.