Abstract
18566 Background: To determine whether the impact of “laying on of hands” on well being of patients with advanced cancer is more efficient when performed by a person with “healing powers” as compared to an actor. Methods: A total of 80 patients was registered to participate in a randomized, single-blind phase III trial to evaluate the difference in efficacy of “laying on of hands” by either a “healer” or a sham person (actor). Both arms were designed to consist of a total of 40 patients, divided into 5 groups including 8 patients each. Each patient should receive treatment for 5 minutes, 3 times a week. A “Well-being scale” was used to measure differences in treatment outcomes. The primary and secondary endpoint evaluated the difference in the total sum score of the “Well-being scale” between the two arms on day 10 or day 5, respectively. Results: The first run was unblinded by the “healer”. Hence, only the second run was available for comparison. There was no significant difference in sum-score values between the “healer” and the actor (p = 0.34) with regard to the primary endpoint or the secondary endpoint (p = 0.94). After the second run, the “healer” quit and a major protocol violation occurred. Despite this major obstacle, the study was completed by the actor as a descriptive, explorative study. There was a significant decrease in total sum score values after each single treatment (day 1, 3 and 5, p < 0.0001, respectively) for all patients. In addition, a significant improvement in symptoms could be found on day 5 (p < 0.001) after treatment and day 10 (p = 0.0002) as compared to day 1 before treatment. Conclusions: “Laying on of hands” resulted in a significant improvement of cancer or cancer-therapy associated symptoms. The magnitude of improvement obtained was similar when “treatment” was provided by a self declared “healer” or an actor, although the comparison was hampered by protocol vialotions by the “healer”. No significant financial relationships to disclose.
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