Analysis of Claims and of an Experiment to Prove that Oxygen is Present in “Vitamin O”

ABSTRACT

Background: “Vitamin O” is being sold as an oxygen supplement. Direct analysis has shown that it contains no oxygen. A scientific study published on the manufacturer’s website claims to have demonstrated the presence of oxygen in the product indirectly, by demonstrating increases in blood oxygen in anemic subjects taking the product.

Objective and design: The study was analyzed for quality of evidence; flaws, errors, and inconsistencies were listed.

Results: Abnormalities in baseline blood gases were not explained.  No statistical analysis was done. Numerous errors and methodological flaws were present. Conclusions were illogical. The study failed to meet basic standards of scientific investigation.

Conclusion: The study failed  to prove that oxygen was present in “Vitamin O.”

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BACKGROUND

“Vitamin O” is the brand name for a product sold by R-Garden, Inc., and its sister company, Rose Creek Health Products.  It is one of several brands of a new generation of oxygen health supplements claimed to be better than the previously marketed ozone, hydrogen peroxide, and sodium chlorite preparations.  It purports to be an oxygen supplement produced from seawater by “electrical activation.” It contains distilled water, sodium chloride, and trace minerals. Laboratory analysis has failed to detect any oxygen in it.  On March 11,1999, the Federal Trade Commission (FTC) charged the Rose Creek company with making false statements.(1)  On May 1, 2000 the FTC reported a consent agreement with a fine of $375,000 for consumer redress. Under the agreement, the company may not:

1. Make any unsupported representation that “Vitamin O” or any substantially similar product prevents or is an effective treatment for life-threatening diseases, including but not limited to, cancer, cardiovascular disease and pulmonary disease.
2. Make any unsupported representation that the effectiveness of “Vitamin O” is established by medical or scientific research or studies.
3. Make any untrue representation about the health benefits, performance, efficacy or safety of any other food, drug, or dietary supplement.
4. Falsely state that any academic, scientific, or government organization, or any individual with medical or scientific training, uses, is affiliated with, or otherwise endorses or supports, the defendants’ products.
5. Deceptively represent that any user testimonial or endorsement of a product represents the typical or ordinary experience of members of the public who use the product.
6. Give its distributors any promotional or marketing materials prohibited by the order.
7. Permit its distributors to make any representations prohibited by the order.(2)

“Vitamin O” is still being marketed, although with disclaimers. The company’s direct mail advertising booklet consists of 141 testimonials claiming that “Vitamin O” improved or eliminated symptoms of asthma, canker sores, emphysema, easy bruising, Sjogren’s syndrome, sequelae of stroke, manic depression, tinnitus, bowel irregularity, angina pectoris, arthritis, herpes, diabetic foot ulcers, Candida yeast infections, arterial blockages, and many other conditions. A few testimonials from healthy people are included, claiming increased stamina, energy, improved breathing at high elevations, etc. There is a small print disclaimer at the bottom of each page that states,

These testimonials do not imply that similar results will happen with your use of our products. These testimonials are not intended to recommend any supplement as a drug, as a diagnosis for specific illnesses or conditions, nor as a product to eliminate diseases or other medical conditions or complications. We make no medical claims as to the benefits of any of our products to improve medical conditions.

The company’s website contains the text of a newspaper article by Stan Marks with an interview of John Heinerman.  PhD. The article quotes Dr.Heinerman as saying that it had not been possible to prove the presence of oxygen in the product directly because,  “there is no special equipment designed to measure oxygen over 40 parts per million (ppm).”(3) He also states that he did a randomized, double-blinded study that showed that  “Vitamin O” resulted in a higher level of arterial blood oxygen than did a placebo.  This study is unpublished, but is available free on request as a booklet entitled, “’Vitamin O’ Study 2002”. The company also sells the booklet as a “sales aid” for distributors in its multilevel marketing scheme, at a price of $2.50 for 10 or $25.00 for 100 copies.  The entire text under a different title is posted on the company’s website.(4)

OBJECTIVE

This study was examined for quality of evidence and to evaluate whether it proves its claim that oxygen is present  in “Vitamin O.” The booklet “Vitamin O Study 2002” was read and annotated, and each flaw, inconsistency, and misstatement listed.

DESCRIPTION OF STUDY

The study attempted to indirectly prove that there is oxygen in “Vitamin O” by measuring changes in partial pressure of oxygen in arterial blood (PaO₂ ) levels in subjects who took it. The study was funded by the manufacturer and carried out by Dr. Heinerman, a medical anthropologist who has written extensively on healing juices, folk remedies, herbs, vitamins, and anti-aging remedies. No collaborators were mentioned, although a footnote acknowledges  “various health professionals and scientists who rendered valuable assistance during the course of this study.”

The subjects were 60 Hutterites who were anemic but otherwise healthy.  The age range was from 9 to 83 years; half were female; half were already taking iron. They were randomized into 4 groups: Group A took the product plus an iron supplement, group B took the product without iron, group C took a placebo with iron, and group D took a placebo without iron. Blood gases were measured at the beginning and end of the study, which lasted 6 months, and a random sample of 6 subjects had blood drawn at the 3 month point. PaO₂ increased in both groups on “Vitamin O” (32.27% in those on iron, and 19.08% in those not on iron).  PaO₂ increased slightly in both groups on placebo (0.51% with iron, 1.91% without).  A rise in partial pressure of carbon dioxide in arterial blood (PaCO₂ ) was also seen. There were no crossover arms. There were no dropouts.

The following flaws were noted:

The report states that “Vitamin O” is produced through electrical activation with saline solution from the ocean; this is inconsistent with information on the web that it contains distilled or “deionized” water with sodium chloride and trace minerals (including iron).

The study attempts to prove indirectly that oxygen is present in the product because direct laboratory analysis had failed to demonstrate its presence. The website article states that  instruments cannot measure oxygen at  >40 ppm .  This is incorrect. If an instrument could measure up to 40 ppm, testing a solution containing 100 ppm would give the maximum reading of the instrument, 40 ppm. To illustrate by analogy: to say the device would not measure any oxygen at all equates to claiming that if a gallon of water were poured into a cup measure, the cup would remain empty.

Test subjects were anemic, defined as a “decrease” in hemoglobin (Hgb) or in the number of red blood cells; no information was given as to the type of anemia, how it was diagnosed, whether subjects were iron deficient, or how the “decrease” was quantitatively defined. In fact, no Hgb testing was done.

There is no indication whether subjects on and off iron were comparable.

The placebo was sterile saline “less than 5%” but the salinity of the product is not given for comparison. A placebo should be identical to the test product, except for the absence of the ingredient being tested.  A more appropriate placebo would be a version of the product that had not undergone electrical activation.

The study claims that older subjects responded better. There was no analysis, and a scatter graph based on the reported data does not support the claim (Figure 1). 

The study claims there was a general stabilization of PaO₂ after 3 months, based on interim testing of a random sample of 6 patients at 3 months compared to their results at the end of the 6-month study. Curiously, all 6 of these turned out to have the highest or second-highest changes in PaO₂  in their respective groups, suggesting that they were not randomly chosen, but somehow selected according to the results of the study before the results of the study were known.

The study states that this general stabilization by 3 months “could change if daily intake were temporarily discontinued.” This speculative statement was unsupported; : no observations were made of any subject temporarily discontinuing daily intake.

The study states, “No protocol and consent forms for the study were necessary,” explaining that all that was needed was the approval of the head minister of the Hutterite colony. This is unethical, as it denies autonomy and informed consent to the individual subjects.

The study states that many patients reported symptoms of anemia. The report does not state how many reported which symptoms, nor does it address whether symptoms abated with treatment. It does not compare symptoms of subjects who were taking iron with those who were not, nor does it compare symptoms of those who took the product and those who took placebo.

The “Results” (not  “Methodology”) section states that tests were done on Sundays, a day of rest, so that the PaO₂ would not rise due to physical activity. With activity, total oxygen consumption rises, but PaO₂ does not.

The report refers to “this randomized, double-blinded study,” but not until the “Results” section. Other than this casual reference, there is no other reference to blinding  in the report.

The only reference cited is another unpublished study by the author entitled “Electrically-Activated Oxygen ‘Vitamin O’ Supplementation Selectively Improves Energy Efficiency in Hutterites Demonstrating Classic Symptoms of Chronic Fatigue Syndrome,” This article is now available on the web.(5)  It contains statements to the effect that (1) the Antediluvians lived 1000 years because the oxygen in their food, water, and air was the same type that makes “Vitamin O” work; (2) oxygen is found on the sun in great abundance; (3) electrical activation knocks all the hydrogen molecules [sic] off water molecules leaving a “heavy water” consisting exclusively of O2 and O3. It highlights a statement of “Experimental Approach: The three key features of this approach in assessing the efficacy of natural man-made substance [sic] were employed here: randomization, blindedness, and measurement of predetermined outcomes.” In short, this second study contains obviously false statements as well as oxymoronic and senseless phrases such as natural man-made substance” and “predetermined outcomes.”  There is no attempt to measure significance of results by statistical methods.

The study gives a false explanation for the observed increases in PaCO₂, stating that as the body uses more oxygen, it produces CO₂ as a waste product which must be eliminated, “otherwise the blood pH acquires more acidity (below 7.0)”.  Actually, with normal pulmonary function, more total CO₂  is excreted through the lungs, but the PaCO₂  does not rise. Normal blood pH is 7.35-7.45. A blood pH below 7.0 is incompatible with life.

The study discusses a theory that “…as CO₂ residues slowly accumulate, rendering its blood supply more acidic,” the body develops changes of old age and disease because elevated CO₂ causes free radical production. This is false, and in any case free radical damage is treated with antioxidants, so oxygen supplementation would be contraindicated.

The study reports fewer “CO₂ discharges” in the placebo group but provides no numbers or analysis. Calculating changes in PaCO₂ from the reported data gives almost exactly the same average increase in PaCO₂  (5 mm and 4.93 mm Hg) for both groups on “Vitamin O” and exactly the same average decrease (-1.67 mm Hg) for both groups on the placebo. This seems statistically unlikely.

The study concludes that taking supplemental iron has a role in the body’s utilization of “Vitamin O.” This could be construed as recommending that nonanemic consumers should take iron supplements with the product. This would be bad advice, since excess iron consumption can cause adverse effects, such as life-threatening complications in people with hemochromatosis.

The study states that only additional oxygen in the blood could have caused the PaCO₂ to rise.  Even if this were true, it still would not show whether the oxygen came via the lungs or from the product.  In fact, it is false.  PaCO₂ can rise because of hypoventilation or acid-base disorders.

The study states that many subjects in group B (those taking “Vitamin O” without iron) had higher increases in Hgb than would have been expected. Not only does it not define what would have been expected, but no Hgb tests were done at any point in the study. Apparently the statement is based on the false assumption that Hgb must rise to account for a rise in PaO_2.

The study implies that anemic patients can stop taking their iron pills and take an oxygen supplement with dietary iron instead. This is potentially harmful advice: an anemic patient may require more iron than can be easily obtained by dietary means.

The study reports that there were unsolicited testimonials of “more energy and vitality” on the product but offers no documentation or numbers, and does not indicate whether there were any testimonials from the placebo groups.

All but 3 of the baseline PaO₂s were abnormal, ranging from 35-80 mm Hg with median of 58. (Normal is 75-100 mm Hg). The subject with the lowest PaO₂ was a 9 year old boy; only a serious disease would explain this. The PaO₂ should not be low in anemia, and these subjects were reported to be otherwise healthy. No explanation was given for those low values; in fact, no notice was taken of the phenomenon.

Almost two-thirds of the baseline PaCO₂s were above or below the normal range of 35-45 mm Hg, varying from 24-59 mm Hg.  A patient who is anemic but otherwise healthy would be expected to have a normal PaCO₂. This was not noticed or commented on.

After treatment, PaO₂ in some subjects went as high as 110mg Hg; it should not go over 100 mm Hg on room air. This was not noticed or explained.

Individual patients had puzzling combinations of test results. Low PaCO₂’s occur with pH’s that are high, low and normal. Normal PaCO₂’s occur with pH’s that are high, low and normal. High  PaCO₂’s occur with high and low pH’s.  These combinations cover the entire gamut of respiratory and metabolic acid-base disorders, and are unexpected in anemic but otherwise healthy subjects.

COMMENTS

If analyses in various labs did not detect oxygen in “Vitamin O,” it probably wasn’t there.

Any effects attributed to “Vitamin O” are probably due to placebo effects.

The hypothesis behind the use of oxygen supplements is not reasonable. Even if a small amount of oxygen were absorbed through the gastrointestinal mucosa, it would be insignificant in comparison with the amount inhaled with every breath. Only animals with gills are able to benefit from dissolved oxygen.

Even if the product administered oxygen, there is no evidence that supplemental oxygen would be expected to have any beneficial effect on the healthy human body.

If oxygen is required to treat disease, the only rational way to administer it is through the lungs as a gas.

It would not be reasonable to pursue further research in supplementation of oxygen in liquid form.

The company is essentially selling salt water at up to $10 an ounce.

Publication of this report on the company’s website is misleading, with the intent to convince scientifically naïve customers that the presence of oxygen in “Vitamin O” and its beneficial effect in the human body have been established by scientific study. This is a violation of the FTC consent agreement.(6)

By its own admission, the company is selling a product that laboratory analysis has proven not to contain the oxygen that it claims to contain.

CONCLUSIONS

This seriously flawed study fails to meet the most minimal requirements of a scientific experiment. It does not prove what it claims to prove: the presence of oxygen in “Vitamin O.”

If this study showed anything, it would be that anemic but otherwise healthy Hutterites have a very high incidence of puzzling blood gas abnormalities. There is no reason to think this actually occurs; more plausible explanations for the reported findings would include malfunctioning blood gas machines or fabrication of data by a medically naïve person.

REFERENCES

1. Federal Trade Commission Rose Creek Products, Inc. – Cmp. Available at: httpL//ftc.gov/os/1999/03/rosecreekcmp.htm. Accessed November 9, 2002.
2. Federal Trade Commission. Marketers of “Vitamin O” settle FTC charges of making false health claims; will pay $375,000 for consumer redress. Available at: http//www.ftc.gov/opa/2000/05/rosecreek2.htm. Accessed November 9, 2002.
3. Marks, S. Therapeutic “Vitamin O”? Vitamin O makes a real difference in people’s lives.  Available at: http://www.rosecreekvitamino.com/therapeutic.html. Accessed November 9, 2002.
4. Heinerman, J. Proving the existence of elemental oxygen in a liquid nutritional product (“Vitamin O”) through blood gas analyses of therapy/placebo-supplemented Hutterites. Available at: http://www.rosecreekvitamino.com/original_research2002.html. Accessed November 9, 2002.
5. Heinerman, J. Electrically-activated oxygen supplementation selectively improves energy efficiency in Hutterites demonstrating classic symptoms of chronic fatigue syndrome. Available at: http://www.rosecreekvitamino.com/chronic_fatigue.html. Accessed November 9, 2002.
6. Barrett, Stephen. FTC Attacks “ Stabilized Oxygen Claims”. http://www.quackwatch.org/04ConsumerEducation/News/vitamino.html  Accessed 10/08/02)

This article was originally published in the Scientific Review of Alternative Medicine.