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 (PaO) 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).