The Woes of Research Grant Money

If one were to believe the bevy of solicitous e-mails, one would surmise that to get a grant, you just need to fill out a few pieces of paperwork and send it off to various organizations that some internet company provides you for the low cost of $59.99. For the past two years, we have been trying to get funding though the government to continue the research started by Dr. Hollifield and Nityamo Lian concerning an acupuncture treatment protocol for PTSD, and the going is rough and frustrating.

We have applied for grants to "further research in several sites with several practitioners of each discipline is needed to confirm these results," but when the concerns on the part of the grant investigators are addressed and answered by our team, the investigators come up with additional concerns. The latest: To sham, or not to sham - that is the question.

A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert.

J Altern Complement Med. 2006 Apr;12(3):303-10.
Birch S.Stichting (Foundation) for the Study of Traditional East Asian Medicine (STEAM), Amsterdam, The Netherlands. sjbirch@gmail.com

Researchers examining the efficacy of medical procedures make assumptions about the nature of placebo. From these assumptions they select the sham interventions to be used in their trials. However, placebo is not well defined. A number of definitions are contradictory and sometimes misleading. This leads to problems in sham-controlled studies of medical procedures and difficulties interpreting their results. The author explores some of the contradictory definitions of placebo and assumptions and consequences of these. Principal among these is the assumption that the placebo is inert when it is not, which introduces bias against the tested medical procedures and devices. To illustrate the problem, the author examines the use of sham procedures in clinical trials of the medical procedures surgery and acupuncture in which the sham was assumed to be inert but was not. Trials of surgery and acupuncture should be re-examined in light of this.

More to come on this in the future. In the meantime, here is the abstract from the Journal of Alternative and Complementary Medicine on the protocol that was used in New Mexico (you need sign-on to access the full article - it has the specifics on the treatment points). If you would like to see some JAMA abstracts of acupuncture research fortunate enough to get funding, check out http://jama.ama-assn.org/cgi/search?fulltext=acupuncture or the Society for Acupuncture research http://www.acupunctureresearch.org/


Journal of Alternative and Complementary Medicine
Developing a Traditional Chinese Medicine Diagnostic Structure for Post-Traumatic Stress Disorder
Jan 2006, Vol. 12, No. 1: 45-57
Nityamo Sinclair-Lian, D.O.M. (N.M.)
University of New Mexico, Department of Family and Community Medicine, Albuquerque, NM.
Behavioral Health Research Center of the Southwest, Albuquerque, NM.
Michael Hollifield, M.D.
University of Louisville, Department of Psychiatry and Behavioral Sciences, Louisville, KY.
Margaret Menache, Ph.D.
University of New Mexico, Department of Family and Community Medicine, Albuquerque, NM.
Teddy Warner, Ph.D.
University of New Mexico, Department of Family and Community Medicine, Albuquerque, NM.
Jenna Viscaya, D.O.M. (N.M.)
International Institute of Chinese Medicine, Sante Fe, NM.
Richard Hammerschlag, Ph.D.
Oregon College of Oriental Medicine, Portland, OR.

Background: Post-traumatic stress disorder (PTSD) is a common, disabling condition with many diverse symptoms including anxiety, depression, insomnia, and body pain. These symptoms are likely to be helped by treatment with Traditional Chinese Medicine (TCM); however, PTSD is not yet a recognized disorder (bing ming) in Chinese medicine. In preparation for a phase II clinical trial comparing TCM and cognitive behavioral therapy (CBT) treatment of PTSD symptoms, a TCM diagnostic pattern framework for persons who meet the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) definition of PTSD was sought.

Methods: Three approaches were used to identify the most likely TCM pattern differentiations for PTSD: an English-language TCM textbook review on the conditions "depression," "anxiety," and "insomnia"; a survey of 20 experienced practitioners of TCM; and TCM assessments of 21 individuals affected by PTSD. Two TCM practitioners synthesized the information into a list of pattern differentiations.

Results: The most likely pattern differentiations for PTSD were Heart Shen disturbance caused by Heat, Fire, or a constitutional deficiency; Liver Qi stagnation; and Kidney deficiency. Secondary patterns identified were outcomes of long-term Liver Qi stagnation—Liver overacting on Spleen/Stomach, Liver Fire, Phlegm Fire, Phlegm-Damp, and Heart Fire—and constitutional deficiencies in the Heart, Kidney, and Spleen organ systems.

Conclusions: The use of extant literature, expert knowledge, and clinical TCM diagnoses contributed to the development of a TCM diagnostic structure for PTSD. The results can inform the clinical practice of TCM. The method can be used to guide research design involving different diagnostic systems.