A Skeptical Look at Respen-A and Its Promoters

Stephen Barrett, M.D.

In January 2018, Elaine DeLack, R.N., launched an Indiegogo crowdfunding campaign with a goal of raising $609,726 to enable Respen-A™ to be "manufactured and marketed as an over the counter treatment that is easily accessible to millions of children and families worldwide who are suffering the effects of autism!" [1] In response to a complaint, however, the site managers concluded that the campaign violated their terms of use and shut it down. The exact reason was not specified, but I suspect that it violated the policy on "prohibited claims."

Background History

Respen-A is administered via a disc that is applied to the skin in the morning and removed at bedtime daily [4]. The product was developed in 2009 by DeLack, who is the chief executive officer and founder of MedDEV Inc., and MedDEV-OTC Inc., of Stanwood, Washington. Company literature says that Respen-A is marketed through Neuro-Med, its homeopathic division. The MedDEV-OTC Web site describes the product as a "homeopathic topical treatment for the core symptoms of autism: impaired social interaction, impaired speech/language, impaired sensory/cognitive awareness, and restrictive health/physical behaviors." MedDEV, Inc., has obtained three patents, the most recent of which describes it this way:

A method for treatment of the symptoms of neurologic dysfunctions, including major depression, an autism spectrum disorder (ASD), and schizophrenia. The patient is administered an amount of a compound that increases the catalytic activity of MAO-A. The effective compound is preferably reserpine, administered in a dosage of less than about 0.03 mg per day. The reserpine may be administered topically or transdermally at a dosage in the range from about 0.002 mg per day to about 0.02 mg per day. In homeopathic use, the reserpine may be administered in the form of a homeopathic dilution, preferably as a 12 C homeopathic dilution of reserpine [2].

The Respen-A Web site states that the product is currently only available as a compounded prescription medication from three pharmacies and that the retail price is $82 for a 28-day supply.

DeLack is best known for her development and promotion of Prokarin (a/k/a/Procarin), a skin patch that she claimed would lessen the fatigue commonly associated with multiple sclerosis. The product, which was made by compounding pharmacists, contained histamine, caffeine, and other undisclosed ingredients and was sold for about $250 for a month's supply. In 2002, the National Multiple Society warned that Prokarin had been promoted for several years without sufficient evidence for its safety or effectiveness [3].

The Respen-A Web site states that more than 130 doctors have prescribed Respen-A to more than 900 patients with autism spectrum disorders, but its current prescriber list includes only 28 people (fourteen medical doctors, four osteopathic physicians, eight naturopaths, one acupuncturist, and one nurse practitioner). The most active of these has been Washington-based Kurt Woeller, D.O., who has promoted Respen-A in a book, at conferences, and through the Internet. Three of the listed physicians—Anju Usman, M.D., John A. Green, M.D., and Richard Menashe, M.D.—have been disciplined for various reasons by their state licensing boards.

Effectiveness Is Doubtful

There are two main ways to judge whether a product is effective. One is to examine the evidence cited to support it. The other is whether its use makes sense. Respen-A fails miserably on both counts.

Reserpine, a compound isolated from the dried root of Rauwolfia serpentina (Indian snakeroot) received FDA approval during the mid-1950s for treating high blood pressure and certain psychotic symptoms. However, its adverse effects and the development of more effective drugs soon led to its near-abandonment in medical practice. Respen-A's marketers claim (a) neurologic problems in autism can result from excess serotonin the the autistic brain, (b) the excess is caused by an inadequate level of an enzyme called monoamine oxidase, (c) the reserpine in Respen-A, by increasing the activity of monoamine oxidase, decreases serotonin in the brain, which helps correct impaired social inaction, impaired communication, and repetitive behaviors [4,5]. Although reserpine, serotonin, and monoamine oxidase have complex relationships to behavior, there is no significant evidence they are responsible for the symptoms displayed by people with autism.

Respen-A's marketers claim that its use is supported by reports by parents who submitted scores obtained with the Autism Research Institute's "Autism Treatment Evaluation Checklist." The Respen-A site displays a chart titled "Average Change in ATEC Score after One Month on Respen-A," which summarizes reports submitted online by parents. The scores improved, but no such study deserves the slightest credibility because (a) the data might not be representative because it is possible that parents who saw improvement might be more likely to report than those who did not, (b) there was no control group, and (c) there is no way to judge whether parent reports were accurate or reflected wishful thinking, or whether the alleged improvements lasted or were temporary. Moreover, the chart has been on the site without modification for nearly six years. If additional data have been gathered, why haven't they been posted?

Recently the company noted that Dr. Usman has reported that eight out of nine patients whom she had treated with Respen-A had improved their ATEC scores after 90 days of treatment [6]. Looking at the numbers, I see that two of the nine had worse total scores and two others "improved " by only 1 or 2 points, which I don't believe should be interpreted as clinical improvement. Moreover, as noted above, uncontrolled studies based on parental reports do not provide a sound basis for evaluating this treatment.

Most important, Respen-A—the "12C" homeopathic described on the product's Web site—cannot work. The Homeopathic Pharmacopeia of the United States requires that homeopathic rauwolfia preparations be manufactured by diluting a tincture made by dissolving a plant root in a 65% solution of alcohol in water [7]. A "12C" designation means that a sample of the tincture is diluted with 99 parts of water/alcohol and the process is repeated eleven times. (In other words, the end result would be one part of tincture in 1,000,000,000,000,000,000,000,000 parts of water/alcohol.) However, tthe laws of chemistry indicate that there is a limit to the dilution that can be made without losing the original substance altogether and, at 12C, there is virtually no chance that a single molecule of the original substance will remain [8]. I don't know whether the compound pharmacies are using rauwolfia root or the prescription drug as a source of reserpine, but it makes no practical difference. Respen-A is extremely unlikely to contain any of it. So even if reserpine could do all the wonderful things claimed by Respen-A's marketers, their ultradiluted product would not do them.

The Bottom Line

I see no reason to believe that Respen-A is effective against autistic symptoms.

References

  1. Respen-A: Homeopathic treatment for autism. Indiegogo Web site, accessed Jan 26, 2018.
  2. Method for treatment of neurological dysfunction. U.S. patent #9364474, granted June 14, 2016.
  3. Results of clinical trial of Prokarin to treat MS fatigue. National Multiple Sclerosis Research Bulletin, Jan 30, 2002.
  4. Respen-A homeopathic treatment for symptoms of impaired social inaction, impaired communication, and repetitive behaviors. Neuro-Med Power Point presentation, undated. Downloaded from Respen-A Web site Jan 31, 2018,
  5. DeLack E. Homeopathic topical disc for symptoms of impaired social interaction, impaired speech/language, impaired sensory/cognitive awareness, and restrictive health/physical behaviors. MedDEV product information, Jan 9, 2018.
  6. New study on respen-a in autism spectrum disorders shows respen-a to have a significant effect in treating the core symptoms. Respen-A Blog, Jan 8, 2018.
  7. Rauwolfia serpentina. Monograph No. 7622. Homeopathic Pharmacopeia of the United States, 1992.
  8. Barrett S. Homeopathy: The ultimate fake. Quackwatch, Aug 25, 2016.

This article was posted on February 1, 2018.

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