Optimizing Reports of Biofield Therapy Research

April 15, 2024
Richard Hammerschlag, Meredith Sprengel, Ann L. Baldwin

What are Biofield Therapies? 

Biofield Therapies, a major sub-group of integrative healthcare practices involving energy healing, have their origins in widely diverse cultures. Reiki and Johrei were developed in Japan, External Qigong in China, and Yakson Touch in Korea, in each case from long-standing systems of Traditional East Asian Medicine.  Pranic Healing is based in the Ayurvedic medicine of South India, while Spiritist Passe originated in Brazil. Therapeutic Touch and Healing Touch each developed within the Nursing profession in the United States. 

Despite their differing origins, these and numerous other similar practices have much in common: Practitioners use their hands, with or without physical contact, combined with their intention to treat areas of ‘energetic imbalance’; treatment sessions are conducted with practitioners either in close proximity to or at a considerable distance from their client/patient.

The terms Biofield and Biofield Therapy were introduced at a 1992 meeting, hosted by the National Institutes of Health to recommend research priorities for its newly-formed Office of Alternative Medicine. Biofield Therapies were described as interventions mediated via an unspecified ‘energy field’ generated within the body but extending past the body surface. The term was proposed in hopes it would be acceptable to the broad group of practices as well as to the wider healthcare and scientific communities. 

Rising acceptance of Biofield Therapy as a healthcare option

Collectively, many Biofield Therapies are increasingly accepted as integrative healthcare options in the West. They are offered in private practice for numerous disorders or for symptom management within the scope of non-emergency primary care. They are also accessible in many major medical centers, as adjunctive treatment to conventional care for conditions ranging from pre-operative anxiety, to pain management, to cancer-related symptoms.

As with any form of healthcare intervention, Biofield Therapies have undergone testing within the framework of formal clinical trials to assess their safety and effectiveness. Results of these trials form the ‘evidence base’ upon which hospital decision-makers decide whether to offer Biofield Therapies for in-patient integrative care. While clinical trial results are an integral aspect of this top-down decision-making process, research on effectiveness of Biofield Therapies for a wide range of health conditions also helps to drive bottom-up acceptance and usage of these treatments. This is especially true as patients become more adept at using the internet to research information about complementary forms of treatment. Biofield practitioners and hospital professionals report that clients sometimes bring down-loaded copies of research to their clinic appointments.

Why are guidelines needed for reporting clinical trials of Biofield Therapies? 

Safety and effectiveness evaluation of a particular type of healthcare intervention is commonly based on not just a few carefully selected clinical trials but on results from a Systematic Review. In this approach, a comprehensive search of the scientific literature is made to gather and assess the results of all the trials that have tested the intervention for a condition of interest. But, when these valuable reviews are performed, it is often mentioned that clear conclusions were difficult to draw since published trials often failed to describe key aspects of how the treatment was performed. For example, a Systematic Review evaluated only those Biofield Therapy trials in which the treatment was delivered with the practitioner’s hands off the patient’s body. When seeking trials to include in the review it was found that the position of the practitioner’s hands (whether on or off the patient’s body) was not mentioned in several published trials.

The general problem of inconsistent or incomplete reporting of experimental details was first addressed in 1996 by a group of biomedical researchers, statisticians and journal editors, resulting in a published document, CONsolidated Standards Of Reporting Trials, known by its acronym, CONSORT. These guidelines, consisting of a checklist of items with explanations and published examples of good reporting, have been updated several times with a third revision to be published later this year. Since CONSORT is aimed primarily at improving the reporting of biomedical trials, clinical researchers from other disciplines have adapted the guidelines to include specific items related to their types of interventions. In the complementary healthcare field, reporting guidelines have been created that focus on acupuncture, homeopathy, herbal medicine and yoga. All such reporting guidelines are accessible on the EQUATOR (Enhancing the QUAlity and Transparency Of Health Research) website. 

How we created guidelines for reporting trials of Biofield Therapies

BiFi REGs (Biofield: Reporting Evidence Guidelines) was designed largely by following the procedures used for CONSORT and related guidance documents. A core group (RH, MS, AB) compiled an initial list of items that we felt would be essential to enable other researchers to replicate a published trial. The list was formatted to allow an international group of Biofield Therapy researchers, following the recognized Delphi process, to rate each item on an increasing scale of 1-5, and offer modifications to the wording. Respondents were also encouraged to suggest additional items. Responses were collated and items receiving a mean score of at least 4 were re-worded where needed and sent out for a second round of ratings.

The revised list was reviewed during two Zoom meetings of participants including four editors-in-chief of journals that have published many Biofield Therapy clinical trials, and representatives from organizations of complementary, integrative and allopathic medicine. Following the Zoom sessions, the core group made final edits to the BiFi REGs checklist, provided explanations for each item and added exemplars of reporting from the published literature on Biofield Therapy trials. 

Highlights from BiFi REGs

The primary focus of our reporting guidelines is a set of 15 items related to the Biofield Therapy as well as the control or comparison procedure performed in each trial. As examples from the list, authors are asked to describe whether the Biofield Therapy protocol was structured (predetermined) or individualized to the patient, whether communication between practitioner and patient was allowed or constrained, and, if the Biofield Therapy was performed remotely, was the patient aware of when treatment was delivered. Another of the 15 items asks for the criteria used to select the practitioners. All items are described in the text and presented in a Table. 

Items relevant to the reporting of all other generally accepted aspects of clinical trial design and performance, such as recruitment and randomization of patients, outcome measures, results and statistical analysis, and discussion of limitations of the trial, are included in a second Table that lists the 2010 CONSORT guidelines.

Clearly, BiFi REGs seeks to enhance reporting of the many known variables that contribute to the outcomes of Biofield Therapy trials. Our article also includes a brief discussion of several little understood, under-researched variables that may confound trial results and their interpretation. Examples include the often debated ‘energy in the room’ and the need to calibrate the quality of practitioner delivery as well as the degree of practitioner/patient rapport (sometimes referred to as ‘therapeutic alliance’).  

What BiFi REGs can achieve

Adoption of these reporting guidelines has the potential to facilitate the work of a broad range of stakeholders who share the desire to increase the acceptance of Biofield Therapies as a contemporary healthcare option.

Researchers will be reminded of the information they should include when preparing results of their clinical trials for publication. Completeness of reporting, in turn, will enhance attempts of other researchers to replicate the published trial protocol. It will also facilitate the inter-trial comparisons necessary to perform a Systematic Review of Biofield Therapy trials and to draw more robust conclusions from such reviews.  Guidelines for reporting can also suggest ideas to improve the design of future trials.

Practitioners will benefit from receiving more complete information about safety and effectiveness of Biofield Therapies to pass on to potential clients and to other healthcare providers who are sources of referrals.

Health Policy decision-makers will be better able to make evidence-based assessments and recommendations regarding inclusion of Biofield Therapies in hospitals and other community-based healthcare settings.

Healthcare consumers will benefit as improved reporting helps to provide more definitive evaluations of Biofield Therapy clinical trial results.

And last, of major importance to Biofield Therapy research, Funders of Integrative Medicine research may be encouraged by the improved quality of reporting of Biofield Therapy trials to consider financial support of much-needed larger, and potentially more definitive trials of these complementary healthcare practices.

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