Background: The demand for the use of human universal energy (HUE) as a form of complementary alternative medicine (CAM) for cancer treatment is increasing, but scientific evidence of its efficacy is lacking.
Aims: The aims of this first randomized study of external beam radiotherapy (EBRT) + HUE versus EBRT + sham HUE in subjects with early breast cancer were to (1) document the changes in health related quality of life (HRQoL) during EBRT and immediately 1 mo after completion of radiation treatment within each subject group and to (2) compare the differences in HRQoL between the 2 groups of subjects.
Method: Eligible subjects were randomized to either HUE (n = 16) or sham-HUE (n = 16). HRQoL measurements were taken in each patient group before starting treatment, during week 3 of EBRT, immediately after completing treatment, as well as 1 mo after EBRT. These results were evaluated using the validated functional assessment of cancer therapy-breast cancer (FACT-B) HRQoL instrument consisting of the FACT-G and breast cancer specific subscales and trial outcome index (TOI) summary scores. Changes in the scores relevant to both groups were compared using a Mann-Whitney U test. The effect of the HUE treatment was quantified by analysis of covariance (ANCOVA) models. All statistical analysis was done at a 95% confidence interval and the differences were considered significant if P ≤ .05.
Results: The tests associated with FACT-G, social wellbeing, and emotional well-being scores returned insignificant P value > .05. The test associated with physical well-being and FWB returned significant P value ≤ .05, but the (adjusted) quantified influence of the HUE treatment on these scores was less than the clinically significant threshold of 5 points, and the FWB clinically significant threshold of greater than 2.9 points. The test associated with FACT-B, breast cancer specific (BCS), and TOI scores returned significant or close to significant P value, α ≤ .05, and the (adjusted) quantified influence of HUE treatment on these scores is more than the accepted thresholds (5 points for BCS and 10 points for FACT-B and TOI) for clinical difference.
Conclusion: Although some results, such as P values for Mann-Whitney U tests and coefficients of HUE treatment in initial ANCOVA models showed promising and positive effects of HUE treatment on the subject, further research with a larger sample size is necessary to confidently conclude whether HUE treatment has significant positive influence on subject HRQoL.