A recently published study claims to have shown that a proprietary mixture of velvet bean and Chlorophytum borivilianum improves sleep quality. The journal, Integrative Medicine Insights, is online, peer-reviewed, PubMed indexed, open-access, and it charges authors $1848.00 to publish their article. It advertises editorial decisions in 3 weeks and publication in 2 weeks after acceptance. I can see two reasons why authors might be willing to pay that much for publication: to speed the process of getting important research results out to the public, or because their research is poor quality and they know it would be rejected by other journals.
The quality of this study is unfortunately typical of much of the research on alternative medicine.
Description of Study
The full text is available for download here. The title is “A Dietary Supplement Containing Chlorophytum Borivilianum and Velvet Bean Improves Sleep Quality in Men and Women.” They gave a proprietary supplement mixture to 18 young healthy subjects with self-reported impairment of sleep quality (defined as routine difficulty falling asleep, waking more than twice during the night, and awaking in the morning feeling tired) and had them fill out a questionnaire about sleep quality before and after the trial. They also measured heart rate, blood pressure, CBC, metabolic panel, and lipid panels.
A new product, Dream Water, is designed to help one relax, fall asleep and improve the quality of sleep using the all natural ingredients melatonin, GABA and 5-HTP (tryptophan). A single-dose 2.5 oz bottle retails for $2.99. They also offer a more dilute formulation in an 8 oz bottle. They suggest drinking half a bottle, keeping it at your bedside, and drinking more if you wake during the night. What dosage will you get from half a bottle? From a whole bottle? There’s no way to know. They offer a money back guarantee, free shipping, free samples, and lots of testimonials; but they refuse to disclose how much of what is in their product.
The DSHEA only permits structure and function claims like “supports prostate health,” but this product is clearly being promoted as a remedy for insomnia. The “Quack Miranda warning” is not displayed on the home page, but the “Dream Responsibly” page says “These statements have NOT been evaluated by the Food and Drug Administration. This product is NOT intended to diagnose, treat, prevent or cure any disease.”
Is it legal to sell this as a remedy for insomnia? I guess the legality depends on whether you define insomnia as a disease. Maybe they define it as an impairment in a function that needs supporting. Maybe they can get away with it. (more…)