A broad-spectrum micronutrient formula developed by a California HIV practitioner has been shown to significantly increase CD4 cell counts - by 25% over 12 weeks - when used as an adjunct therapy to HAART. However, treatment with the formula was not shown to result in significant improvements in peripheral neuropathy, which had been the primary point of the study, presented last week at the Eleventh Conference on Retroviruses and Opportunistic Infections in San Francisco.
Although this is the first randomised, double-blind, placebo-controlled study to show that vitamins, minerals and amino acids do appear to make a difference in CD4 counts, it must be noted that the study sample was small (n=40) and the micronutrient formula used in the study was especially manufactured without the fillers, binders or lubricants found in commercially-available supplements.
San Francisco general practitioner Dr. Jon Kaiser - who specialises in a holistic approach to treating HIV - designed a prospective, randomised, double-blind, placebo-controlled trial to study the effects of high-dose micronutrients in people with drug-induced peripheral neuropathy. The rationale behind the broad spectrum micronutrient formula (see below) was that a build up of free radicals by the use of the D-drugs (ddI, ddC, d4T) in the mitochondria may be the cause of mitochondrial toxicity, which can lead to symptomatic peripheral neuropathy.
The major components of the formula were, therefore, micronutrients known for their antioxidant effects, including alpha lipoic acid, NAC, acetyl l-carnitine, vitamins C and E, and selenium. The formula was manufactured especially for the trial and contained no substances usually found in commercially-manufactured supplements, which can inhibit absorption, bioavailability and/or tolerance in metabolically compromised people.
Broad-spectrum micronutrient formula
Multivitamin
Beta Carotene 20,000 i.u. Vitamin C 1,800 mg Vitamin D 400 i.u. Vitamin E 800 i.u. Vitamin B1 60 mg Vitamin B2 60 mg Vitamin B6 260 mg Niacinamide 60 mg Folic Acid 800 mcg Vitamin B12 2.5 mg Biotin 50 mcg Inositol 60 mg Pantothenic Acid 60 mg Potassium 99 mg Vitamin A 8,000 i.u.Multimineral
- Calcium 800 mg
Highly potent antioxidants
- Alpha lipoic acid 400 mg
Forty people with symptomatic peripheral neuropathy taking either stavudine (d4T) or didanosine (ddI) as part of a stable HAART regimen were randomly assigned to take either the high-dose micronutrients (n=18) or a packet of placebo pills twice a day for 12 weeks (n= 22). The two groups were essentially similar, except that the placebo group had a shorter duration of neuropathy symptoms (12.2 versus 21.4 months) and a higher CD4 count (467 vs 356 cells/mm3) than the micronutrient group.
After twelve weeks, although those on the micronutrients had a greater improvement in both neuropathy and quality of life scores compared with placebo (42% vs. 33%, and 29% vs 28%, respectively) these differences were not statistically significant, meaning the improvements could have occurred by chance.
Surprisingly, the mean absolute CD4 cell count improved significantly in those on micronutrients compared with placebo (+65 vs -6 cells/mm3; p <0.03). this represents a 26% increase in cd4 cells (not CD4 percentage, which was not reported) over 12 weeks.
Table linked from Integrative Health Consulting website
However, the clinical significance of this finding was also unreported, and with baseline levels of around 350 cells/mm3 in those on the supplement, an extra 65 CD4 cells is unlikely to have a substantial clinical impact. Additionally, no information was provided about the HAART regimens used by the study participants, other than that they were stable, nor was there any information provided on the diets or nutritional status of those in the study. There is, therefore, only an association with increased CD4 cell counts in the 18 people given this broad-spectrum micronutrient formula.
A non-significant (p=0.23) reduction in viral load was also seen in the micronutrient group. No difference was seen on any metabolic parameters, including insulin, cholesterol, triglycerides and ALT (liver function) levels.
Although two adverse events occurred, both in the micronutrient arm - bacterial pneumonia and cystic lithiasis - neither was judged to be related to the supplement treatment. Notably, there were no gastrointestinal side-effects noted in either arm.
Last year a Thai study showed for the first time that a much less potent multivitamin/mineral tablet, which cost around 60p a month, increased survival in those with CD4 counts below 200 and not on antiretrovirals. The Kaiser formula, on the other hand, costs $142.95 (£76) a month.
Further information on this website
Cheap multivitamin pill increases survival in those with low CD4 counts - news story
Vitamins and minerals - overview
Nutrition - - booklet in the award-winning information for HIV-positive people series (pdf file)
References
Kaiser J et al. Broad-spectrum micronutrient supplementation in HIV-infected patients with dideoxynucleoside-related peripheral neuropathy: a prospective, double-blind, placebo-controlled trial Eleventh Conference on Retroviruses and Opportunistic Infections, San Francisco, abstract 494, 2004.