Lessons Learned: Recruiting And Enrollment in CAM Trials

Suzanna M. Zick ND MPH, Elena Gillespie, Keith Aaronson MD MS,

Martin Stevens MDUniversity of Michigan Complementary

and Alternative Medicine Research Center

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.

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

Herbal Therapy Vs. Energy Therapy

Hawthorn Project

• Congestive Heart Failure

• Randomized, Double-blind, placebo controlled

• Patients come for three visits over 6 months

• Take two herbal caplets/day

Reiki Project

• Diabetic Neuropathy• Randomized, Double-

blind, Placebo controlled

• Energy Treatment• Patient receives twelve

1/2 hour treatments

Eligibility CriteriaHawthorn

6-Minute Walk

Eligibility CriteriaReiki

HbA1c < 12%

Results

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

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

Reasons for Non-Participation Reiki

• Travel Distance and Time 58%

• Frequency of Visits 39%

• Religious Beliefs 2%

Reasons for Non-Participation Hawthorn

• Travel Distance and Time 75%

• Length of Visits 18%

• Belief would affect

• current medication 1%

• Too Many Tests 1%

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

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

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

“I have not failed I have just found 10,000 ways that won’t

work”Thomas Alva Edison (1847-1931)