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Micronutrient supplementation shows promise in placebo-controlled Trial.

A small (40-patient) randomized trial in patients on HAART with peripheral neuropathy showed a statistically significant increase in CD4 (T-cell) counts over 12 weeks.(1) Neuropathy, the primary focus of this trial, also decreased--but it decreased almost as much in the placebo group, so the difference was not statistically significant. Viral load also decreased, but again not to a statistically significant degree. The possibility of nutritional treatment to reduce neuropathy deserves further investigation, however, because statistical proof could easily have been missed in this small trial.

This study was designed by Jon D. Kaiser, M.D., and others. Dr. Kaiser, the author or Healing HIV: How to Rebuild Your Immune System (HealthFirst Press, 1999), is well known for combining mainstream HIV treatment with nutritional supplements, acupuncture, and other complementary approaches. All the volunteers in this trial were on stable HAART regimens that included d4T and/or ddI, drugs that can cause neuropathy. HIV infection itself can also cause neuropathy.

The nutritional supplement was formulated based on Dr. Kaiser's HIV treatment experience, and contains 33 vitamins, minerals, and antioxidants. The list was published on the poster at the Retroviruses conference, and is available online.(2) The supplement itself is also available through the Web site (the "high-dose" formulation is the one used in this trial). Of note, there were no gastrointestinal side effects reported during the trial.

Due to the luck of the draw in the randomization for this small trial, the volunteers in the micronutrient group had a lower baseline CD4 count (356 vs. 467) and a longer duration of neuropathy (21.4 months vs. 12.2). In addition, three in the micronutrient group had diabetes.(3) Some trial designs randomize among matched pairs to prevent this kind of accidental bias, but that was not done in this case. These differences (all to the detriment of the micronutrient group), plus the small size of the trial and the difficulty of treating long-standing neuropathy, made it unlikely that this trial could show a statistically significant neuropathy improvement, even if a benefit did exist.

The trial was conducted at four U.S. research sites--one of them Philadelphia FIGHT, where AIDS Treatment News is located. During the trial we heard from staff that patients seemed to be doing well. The trial was blinded at the time, and no one knew who was getting the placebo.

This is one of the few nutritional studies that has been presented at the Retroviruses conference, which is heavily oriented toward basic science.

Note: A much less expensive formula of 21 micronutrients was shown to reduce death in a trial in Thailand, among volunteers with a CD4 count less than 200 who were unable to obtain HAART.(4) Its cost in Thailand was about U.S. $1.00 per month.

References

(l) J Kaiser, J Ondercin, G Santos, G Leoung, S Brown, M Mass, and M Baum. Broad-spectrum micronutrient supplementation in HIV-infected patients with dideoxynucleoside-related peripheral neuropathy: A prospective, double-blind, placebo controlled trial, 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, February 8-11, 2004 [abstract 494].

(2) http://www.integrativehealthconsulting.com

(3) Personal communication from Dr. Kaiser.

(4) S Jiamton, J Pepin, R Suttent, and others. A randomized trial of the impact of multiple micronutrient supplementation on mortality among HIV-infected individuals living in Bangkok. AIDS. Volume 17, pages 2461-2469, 2003. The formula (which may less applicable to other regions because of differences in prevailing nutrition and deficiencies) is available online at:

http://www.aidsmap.com/news/newsdisplay2.asp?newsId=2412 Note that all the doses are listed by weight--not always the numbers U.S. readers are familiar with.
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Author:James, John S.
Publication:AIDS Treatment News
Geographic Code:1USA
Date:Feb 27, 2004
Words:601
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