Redox Therapy - Clinical Trials

Clinical Trials

Mayo-Moertel studies

While ascorbate treatments have been proposed by many professionals over a period of decades, it is not considered medically orthodox. This is mainly due to a series of studies conducted in the late 1970s in response to Linus Pauling's vitamin C claims for Ewan Cameron's cancer patients. Moertel et al. of the Mayo Clinic concluded that there was no statistically significant difference in survival rate between cancer patients briefly given 10 g daily oral doses of vitamin C, mostly before or after chemotherapy, and those given a placebo instead of oral vitamin C. Such was the reputation of the Mayo that Moertel's studies, using vastly different, more conventional chemotherapy protocols, became considered the definitive negation of vitamin C cancer treatment by many physicians for a generation.

Proponents of the treatment, however, point out that the Moertel results do not show that vitamin C is ineffective against cancer. They point out that the dose given was oral, not intravenous (uptake of vitamin C from oral dosage is very low), of short duration (averaging 72 days rather than lifelong, roughly 2 years more) stopped the vitamin C abruptly (generally bad) after which death rates rose, used a different oral form (dry AA caps vs neutralized AA-DHA-sorbitol solution) and that the Mayo patients died after stoppage of vitamin C usually on or after chemotherapy. The ascorbate monitoring was poor and compliance controls of outpatient treatment were flawed, despite Ewan Cameron's specific request to Moertel for better monitoring. Moertel (1985) tested only 6 of 49 placebo patients for a very high threshold of urinary residuals of ascorbate spillage, over 550 mg/day. This urinary threshold might roughly correspond to 2g-4g/day in healthy patients or about 8+g/day in less severe cancer cases vs ~0.06g/day intake (RDA then) assumed with a placebo. Still one of only six placebo "controls" measured higher than this threshold, belatedly dismissed as only a potential measurement interference. In one of Klenner's rare comments on cancer, intravenous administration of 17g/day ascorbate for 92 days yielded no measurable urinary residual in a severe cancer case. The Moertel (1985) tests were poorly analyzed in terms of radically changing test conditions (initial delays, brief vitamin C; abrupt stop & repeated chemo) and quality of life improvements.

Moertel's oral dosage - less than ten grams - is far lower than doses one would expect to be cytotoxic. Note that ten grams per day administered intravenously might well lead to increased expected lifetime according to proponents. Typical redox therapies today range from 20g to over 100g IV vitamin C daily initially, sometimes with nontoxic adjuvants (e.g. bindweed extract, alpha lipoic acid or the menaquinone-4 form of vitamin K₂). Oral adjuvant vitamin therapies are typically 12g to bowel tolerance (40g-200g) of vitamin C daily plus very high potency vitamins, special nutrients and mineral supplementation. Oral uptake of vitamin C may be increased through the use of liposomic preparations.

Other issues

Many physicians have also been under the impression that the work of Mark Levine at the National Institutes of Health which set the current US RDA for vitamin C showed that the blood becomes saturated with vitamin C at fairly low doses, and thus higher doses would just be excreted.

However, many have argued that these studies actually used the word 'saturated' in an incorrect and misleading way, and it has also been pointed out that they did not take the relatively short elimination half life of vitamin C in the body into account. In 2002, Drs. Michael J Gonzalez and Jorge R Miranda-Massari provided preliminary evidence that vitamin C can be used as effective tumor cell growth inhibitor. Later, Levine himself, in 2005, headed a study which concluded that vitamin C was toxic to cancer cells in vitro, and that it was an extremely promising treatment.

Michael J Gonzalez and Jorge R Miranda-Massari recently reviewed 25 years of ascorbate therapy indicating its potential as a future treatment.

Proponents and critics have yet to produce prospective, double blind, randomized controlled trials of high dose antioxidant formulas that decisively settle the efficacy claims.