Non-specific Factors Come to the Fore in Study of Biofield Therapy

Abstract & Commentary

By Dónal P. O'Mathùna, PhD. Dr. O'Mathùna is Senior Lecturer in Ethics, Decision- Making & Evidence, School of Nursing, Dublin City University, Ireland; he reports no financial relationship to this field of study.

Synopsis: This blinded, randomized, controlled trial found that a biofield therapy and a mock treatment did not differ in their effectiveness in relieving cancer-related fatigue, although they both were significantly better than control. The biofield therapy did lead to significantly greater cortisol variability, which is associated with fatigue.

Source: Jain S, et al. Complementary medicine for fatigue and cortisol variability in breast cancer survivors: A randomized controlled trial. Cancer epub 5 August 2011; DOI: 10.1002/cncr.26345

Cancer-related fatigue is one of the most common and bothersome side effects of cancer and cancer treatment. One third of cancer patients experience significant fatigue 5-10 years after treatment.1 The cause of this fatigue is unclear, but in breast cancer patients it is associated with decreased diurnal cortisol variability. The precise mechanism involved here is not known. Few effective treatments are available for cancer-related fatigue. Many breast cancer patients pursue complementary and alternative medicine (CAM), among these therapies are a group called biofield therapies. According to the National Center for Complementary and Alternative Medicine (NCCAM), biofield therapies "are intended to affect energy fields that purportedly surround and penetrate the human body. The existence of such fields has not yet been scientifically proven."2 These include Therapeutic Touch, Reiki, and Qigong. While training is available in each, variations are commonly introduced, such as with the therapy examined in this study.

Few high-quality studies have examined the effectiveness of biofield therapies in cancer patients. Jain and colleagues designed a three-arm, double-blinded study to test the effectiveness of a hands-on energy healing technique called "energy chelation." The technique's description makes it appear very similar to Reiki, with the practitioner's hands positioned over different parts of the recipient's body. Each position was held for 5-7 minutes with the whole session lasting 45-60 minutes. During this time, the practitioner focused her intention on bringing healing to the patient.

A mock healing technique was developed for scientists who were skeptical of energy healing. Volunteers were trained in the hand positions, but kept their intention focused on their own research activities. They were also trained to answer common questions about energy healing to maintain patient blinding. To account for therapist bias, participants were asked to guess which treatment they received. No significant differences were found between the two groups receiving either intervention. The third group was a waiting-list control group.

Patients were females who had completed breast cancer treatment 1 month to 10 years earlier. Only those with scores > 50 on the RAND SF-36 vigor-fatigue subscale were included. A power analysis established that 65 subjects were needed to detect a small effect size. To account for attrition, the plan was to recruit 80 subjects and randomly assign 30 to each of the intervention groups and 20 to the waiting-list control. In the end, 76 were recruited with 27 receiving biofield therapy, 30 receiving the mock treatment, and 19 in the control. The interventions were given for 4 weeks, with two 1-hour sessions each week.

The primary outcome measured was cancer-related fatigue using the validated Multidimensional Fatigue Symptom Inventory-short form. Secondary outcomes were cortisol variability, depression, and quality of life (QOL). An exploratory aim was to investigate the influence of prior beliefs about energy healing and spirituality on outcomes.

Significant reductions in fatigue scores were found for the biofield therapy group (P < 0.0005) and the mock treatment group (P < 0.02) compared to control. However, the two intervention groups did not differ significantly (P = 0.12). For the secondary outcomes, significantly greater increased variability occurred in cortisol levels between biofield therapy and control (P = 0.004) and between biofield therapy and mock treatment (P = 0.039). This finding was relied on by the study authors to suggest that the impact of the biofield therapy was not simply due to factors of human touch and presence. No significant differences were found for depression and QOL scores. However, those subjects who believed they received biofield therapy (whether they did or not) showed significantly greater increases in QOL than those subjects who believed they did not receive biofield therapy (P = 0.004). Belief did not impact fatigue or cortisol outcomes.

The authors concluded: "Overall, our results suggest that biofield healing may be a promising intervention for ameliorating cancer-related fatigue, and that it warrants further study. Effects of biofield healing on fatigue may in part be because of nonspecific factors such as touch and rest, but not belief."

Commentary

This randomized controlled trial was designed and reported well. Details about power calculations, randomization, patient attrition, and other factors listed in the CONSORT statement were provided. The subjects were blinded, and when asked which intervention they thought they received, each group gave similar answers. All other research personnel were blinded to the nature of the intervention given each subject. The authors are to be commended for conducting a high-quality study. However, a few comments must still be made.

Although standard methods were used in the study design, some justification for examining "energy chelation" therapy was needed. A search of PubMed and the NCCAM databases revealed no other references to this therapy. Given the acknowledgment by the study authors that few high-quality studies have been conducted on any biofield therapy, further investigation of biofield therapies which already have been assessed, like Reiki or Therapeutic Touch, would have been preferable. At the very least, justification for using this obscure therapy was warranted.

The authors used the popularity of CAM in general to justify their study, but NCCAM notes that biofield therapies are not very popular. They cite a study that found that about 0.5% of adults have used biofield therapies.2 Jain and colleagues claimed that biofield therapies are "often used by breast cancer patients." Yet the study they themselves cite found that 2% of breast cancer patients in Portland, Oregon, used energy healing.3

In spite of this, the only significant problem with this study lies with the implications the authors draw from their results. As quoted above, they made generalized comments about biofield therapies for cancer-related fatigue, even though they investigated one specific therapy. In addition, their results support the importance of nonspecific factors, not the energy-related factors. The excellent design of their study allowed the energy and practitioner intention factors to be distinguished from the presence and touch of the practitioner and the patient getting rest. Since the biofield therapy and mock therapy groups did not differ significantly in fatigue scores, the implication is that energy chelation is not the beneficial variable. Rather, allowing patients to relax for an hour in the presence of someone who touches them in specific ways brings significant relief from cancer-related fatigue. The significant difference found in cortisol slope is intriguing, although much remains to be understood about the relevance of this for clinical symptoms.

The lack of significant differences in primary outcomes suggests that specific training in energy manipulation may not be needed. While biofield therapies will continue to be investigated, touch and presence should be examined for their own value, not just factors to be controlled against. Such investigations would be challenging to design. However, in these days of scarce resources, it would be helpful to explore the impact of friends or family members carrying out a touch routine at home. It could be that the health care setting used in this study is a necessary factor. If not, a finding that touching someone at home for an hour twice a week brings significant benefit would help many patients.

References

1. Bower JE, et al. Fatigue in long-term breast carcinoma survivors: A longitudinal investigation. Cancer 2006;106:751-758.

2. NCCAM. What is complementary and alternative medicine? Available at: http://nccam.nih.gov/health/whatiscam/. Accessed Sept. 8, 2011.

3. Henderson JW, Donatelle RJ. Complementary and alternative medicine use by women after completion of allopathic treatment for breast cancer. Altern Ther Health Med 2004;10:52-57.