1. Lessons Learned: Recruiting And Enrollment in CAM Trials Suzanna M. Zick ND MPH, Elena Gillespie, Keith Aaronson MD MS, Martin Stevens MD University of Michigan Complementary and Alternative Medicine Research Center

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

6. Methods Identified three allopathic (APC) trials with the same patient population(s) Collected information on the(APC) trials –recruitment –enrollment –number of subjects who gave “no interest” as a reason for not wanting to be in the trial Compared the APC numbers to the CAM numbers

7. Herbal Therapy Vs. Energy Therapy

8. Hawthorn Project Congestive Heart Failure Randomized, Double- blind, placebo controlled Patients come for three visits over 6 months Take two herbal caplets/day

9. Reiki Project Diabetic Neuropathy Randomized, Double- blind, Placebo controlled Energy Treatment Patient receives twelve 1/2 hour treatments

10. Eligibility Criteria Hawthorn

11. 6-Minute Walk

12. Eligibility Criteria Reiki

13. HbA1c < 12%

14. Results

15. Results: Hawthorn 88% of eligible patients decided to participate 5% gave lack of interest as a reason for non- participation SOLVD and MERIT-HF Trials –54% of eligible patients decided to participate –11% gave lack of interest as a reason for non- participation

16. Results: Reiki 90 % of eligible patients decided to participate 1% gave lack of interest as a reason for non- participation Michigan Diabetic Research and Training Center –75% of eligible patients decided to participate –11% gave lack of interest

17. Reasons for Non-Participation Reiki Travel Distance and Time58% Frequency of Visits39% Religious Beliefs2%

18. Reasons for Non-Participation Hawthorn Travel Distance and Time75% Length of Visits18% Belief would affect current medication 1% Too Many Tests 1%

19. Conclusions Compared to trials using allopathic treatments in similar patient populations more patients choose to participate in CAM trials Fewer people gave no interest as a reason not to participate in CAM trials Different and unique reasons for non- participation

20. Future Directions/Research Why do patients choose to participate at higher rates in CAM trials? –Current popularity of CAM therapies –Perceptions of CAM as both safe and natural –Attention form individual caregivers

21. Future Directions/Research Finding ways to remove barriers to participation in CAM trials –Accurate identification and frequency of why patients do not participate –Devising strategies to minimize barriers to participation

22. “I have not failed I have just found 10,000 ways that won’t work” Thomas Alva Edison (1847-1931)