Lessons Learned: Recruiting and Enrollment in CAM Trials

Purpose: To compare and contrast the unique aspects of recruiting and enrollment of patients in complementary and alternative medicine (CAM) trials compared to allopathic trials.

Methods: Analysis of the number of patients screened and recruited in two contrasting alternative medicine trials. Additionally, analysis of why patients chose not to participate in CAM trials.

Results: In a trial examining the use of an herbal product for individuals with congestive heart failure (CHF) roughly 73 to 88 % of eligible patients decided to particpate in the trial and only 5 percent of all patients screened gave lack of consent as a reason for non-participation. In contrast, two recent trials (SOLVD & MERIT-HF) of patients with symptomatic CHF had lower rates of eligible patients agreeing to participate (46 to 63 %) and at least 11 percent of all patients screened gave lack of consent as a reason for non-participation. More dramatically, in a study assessing the effectiveness of a bioenergy technique in the management of chronic pain, approximately 70 to 96 % of eligible patients decided to participate in the trial compared to only 10 percent of eligible patients in similar populations conducted at the same tertiary care facility.
In the bioenergy trial, thirty three % of patients refused participation due to the distance and travel time involved, making it the primary reason for refusal. The frequency and length of visits involved in the application of a manual technique was the next most frequently stated reason for non-participation (33%). A small percent of patients (<2%) refused on the basis of their religious beliefs.

Conclusions: Compared to trials using allopathic treatments more eligible patients chose to participate in trials testing CAM therapies. In addition, CAM that consists of manual techniques has unique obstacles differing from the study of herbal, nutritional, or homeopathic therapies. These obstacles such as frequent treatments are the primary reasons for patient refusal. Further research about why patients chose to participate in CAM trials, including personal attention from a caregiver, popularity of CAM, and perception of the safety of CAM therapies deserve further study.