Wednesday, August 16, 2006

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.

1 comment:

Hadijah said...

I conducted a year of case studies in New Zealand on PTSD recovery using acupuncture as the primary modality. Most of the participants came from domestic violence and/or sexual abuse histories. I conducted it as an observational study using the Hopkins symptoms checklist as a measure of improvement. The diagnostic protocol I developed was based on the Three Treasures(Jing, Shen and Qi) as a differentiation macrotemplate over the organ disharmonies and I used concepts of Shen disharmony as presented by a teacher at the Nanjing Neuropsychiatric institute for point protocols. I have an unpublished thesis on the topic. I believe that as acupuncturists we have to obtain more training on conducting research, but we need to creatively define it by our own terms. The research that is being done sort of misses the mark...and it is , of course, difficult to find funding. Most medical research is funded through pharmaceutical monies and directed by Medical doctors. We have to get really creative to find alternative funding sources, and find the courage to develop our own research designs appropriate to concepts in our field. As in psychiatry and psychology the basic outcome we aim for is the subjective report that the patient feels better, is more functional and displays higher coping mechanisms, even virtues and creative capacities. I would love to see us create an ad hoc think tank to deal with each of these elements: the definition of the problem, the identification of goals of the research, the location of funding sources appropriate for our field and the power to design our own research projects. Guess what??..the pharmaceutical monies are never going to flow our way..because our success reduces the consumption of their products.....................................Submitted by Hadijah Vanada, Licensed acupuncturist in the state of Florida