“A nutritional formula . . . may help slow CD4 cell decline and reduce immune activation” [Liz Highleyman, reporting on “Reduced CD4+ T cell decline and immune activation by NR100157, a specific multi-targeted nutritional intervention, in HIV-1 positive adults not on antiretroviral therapy (BITE)” by J. Lange et al., presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, 12-15 September 2009; Abstract H-1230b].
“Pedro Cahn and colleagues with the international BITE study aimed to determine whether a combination nutritional formula could reduce CD4 cells loss in people on ART. The randomized controlled trial was designed to include 800 HIV positive participants in Argentina, Australia, Brazil, Italy, the Netherlands, Thailand, the U.K., and the U.S. Half were randomly assigned to take the nutritional formula, known as NR100157, for 1 year, while the other half received a control product containing the same amount of calories and protein, but without the active ingredients. NR100157 contains several components that individually have demonstrated beneficial effects on immune function in previous studies: Prebiotic oligosaccharides: chains of simple sugars that help maintain healthy flora, or balance of bacteria in the gut; N-acetyl cysteine: a modified amino acid that helps maintain the body’s supply of glutathione, a key antioxidant; Bovine colostrum: nutrient- and antibody-rich fluid produced prior to milk; Omega-3 long-chain polyunsaturated fatty acids: molecules shown to improve the integrity of the gut, which prevents bacteria from leaking out and triggering systemic immune activation; Micronutrients including vitamins and minerals.
The study was stopped early after a planned interim analysis showed significant immunological benefit in the NR100157 arm and no notable safety concerns. . . .
Participants in the NR100157 arm lost significantly fewer CD4 cells per year than those in the control arm (-28 vs -68 cells/mm3, respectively; expected loss for untreated people with HIV 50-70 cells/mm3 annually). There were no significant differences between the 2 arms with regard to CD4 percentage, CD8 cell count, or CD4/CD8 ratio. Plasma viral load remained stable, and similar, in both groups” [emphases added].
1. Maintaining healthy gut flora benefits immune function: that’s what Tony Lance discussed in his intestinal dysbiosis hypothesis, including the aspect of gut leakage, systemic immune activation, and potentially testing “HIV-positive” [“What really caused AIDS: Slicing through the Gordian Knot”, 20 February 2008].
2. The “viral load” was stable while CD4 counts varied: in other words, once again, changes in CD4 counts do not correlate with “viral load” [Rodriguez et al., JAMA, 296 (2006) 1498-1506].
3. HIV/AIDS mainstreamers are much more critical of clinical trials of alternative remedies than they are of mainstream endeavors. When mainstreamers publish at “statistical significance” of p<0.05 — wrong once in 20 times —, that’s good; but when an alternative treatment is significant at p=0.03 — wrong only once in 33 times — that’s cause for HAART enthusiasts and HIV/AIDS believers to be “stunned” that anyone would accept it (“Gut-shielding mix slows CD4 drop in people not taking antiretrovirals”) :
“The data and safety monitoring board (DSMB) recommended stopping BITE early because of a significant difference in CD4 decline between groups and lack of safety concerns. An intention-to-treat analysis at 52 weeks showed a significantly slower annual average CD4-cell drop in the NR100157 group, 28 versus 68 cells/mm(3) with placebo (P = 0.030). . . . In a question-and-answer session after Argentina’s Pedro Cahn presented these findings, Harvard’s Daniel Kuritzkes claimed to be ‘stunned’ that the DSMB would stop the trial of an apparently safe agent when the statistical difference between treatment arms reached only 0.03. He also questioned the investigators’ decision to take the DSMB’s advice. Kuritzkes felt stopping a trial at such a low level of significance leaves open the possibility of bias toward a positive finding” [emphases added].
I suppose Kuritzkes would have been even more astonished that researchers stopped trials of circumcision early on the basis of the usual “95% confidence interval” — i.e., wrong once in 20 times; or that they were ecstatic over the first apparent success of a vaccine trial after many failures, even though one would have expected such an APPARENT success sooner or later at that usual “p<0.05”, “wrong once every 20 times”, criterion.
To be quite clear:
I agree that a single clinical trial is inconclusive, no matter what level of statistical significance may be reached.
I agree that p=0.03 is not in itself a particularly convincing result; still less so, of course, are all the mainstream trials that accept the weaker p<0.05; not to speak of the statistical ignorance that allows researchers at the Centers for Disease Control and Prevention and elsewhere to confuse correlation with causation and to say such things as “nonsignificantly lower” [“Abuses of statistics in HIV/AIDS research”, 14 September 2009].
My point here is just that alternative treatments are criticized while even worse examples of mainstream contentions are given free passes or even praised.