[The following is research from frequent commenter Vogel… I have cleaned up some of the formatting.]
I had a look at MonaVie’s latest publication that just came out this week. This is MonaVie’s worst study yet. My critical analysis follows; it is by no means all-encompassing of the many flaws.
Jensen GS, Ager DM, Redman KA, Mitzner MA, Benson KF, Schauss AG. Pain reduction and improvement in range of motion after daily consumption of an açai (Euterpe oleracea mart.) pulp-fortified polyphenolic-rich fruit and berry juice blend. J Med Food. 2011 Apr 6.
The article features the usual cast of MonaVie’s pseudo-scientific hacks; namely Alexander Schauss and Gitte Jensen. Their shenanigans have already been discussed in great depth on Lazyman and JuiceScam already. In a nutshell, both are skeezy lackeys of the supplement industry.
Schauss, holder of a mail-order PhD, has been in tight with MonaVie since the company’s inception. He conducted all of their bogus tainted research, heads the company’s “scientific advisory board”, is a frequent speaker at MonaVie distributor meetings, sells his books and CDs to Monavie distributors, and holds the patent to the freeze-dried acai that was allegedly used in Monavie (and which served as a fundamental part of Monavie’s advertising claims about the product’s uniqueness and “efficacy”). Schauss is also known for having previously peddled his own line of BS supplements (Feed My Brain) to treat autistic children.
Jensen is best known for her association with the Klamath Lake blue-green algae scam (shut down by the FDA), and for a previous MonaVie publication she coauthored with Schauss. She operates a tiny little insignificant research-for-hire organization (HolgerNIS) in Klamath Falls. You can find the information on StemTech here and here.
One of the other authors is David Marshall Ager, an obscure Klamath Falls chiropractor who operates out of a clinic (Cascade Chiropractic and Rehabilitation) so insignificant that it doesn’t even have its own website. This is his first scientific publication.
The remaining authors, who don’t have a PhD or MD degree among them, are underlings of Gitte Jensen and affiliated with HolgerNIS.
The Journal of Medicinal Food, a rag for the nutraceutical industry, is produced by the Korean Society of Food Science and Nutrition. It has an ISI impact factor of 1.39. For perspective, this compares to top-tier scientific journals in roughly the same way that a Suzuki Sidekick would compare to a shiny new Ferrari (e.g., top-tier journals have an IF of about 30, going as high as 50). Read more about Impact Factor on Wikipedia.
If it dawns on you to you ask why MonaVie would publish a study in an insignificant Asian nutraceutical journal, then you are asking the right question. There is no legitimate reason other than that they couldn’t get their crap study published anywhere that actually matters.
The Study Design and Methodology
This was an open-label study, meaning that it did not include any placebo group or blinding, and it was conducted in a mere 14 subjects who were not enrolled in a randomized fashion. On that basis, this would be considered by any expert as an extremely poorly designed study; so poor in fact that it would be completely incapable of generating any remotely reliable data. The results would be susceptible to bias and the study cohort was too small for definitive conclusions to be drawn. In contrast, a randomized placebo-controlled double-blinded clinical trial would have been an appropriate experimental design.
The authors state explicitly that they included 2 subjects that did not meet the study’s inclusion criteria. This is unheard of — simply unfathomable. Inclusion criteria exist for a reason and subjects should never be included who do not meet a study’s preset criteria. My mind boggles at the ineptitude of the investigators for violating their own rules of the study.
“The original plan was to involve 12 participants; however, during the initial recruitment and interview process 14 interested participants were identified. Because this study was performed with the intent of broadly exploring what pain conditions may benefit from consumption of MonaVie Active, we decided to enroll all 14 even though some did not meet the original inclusion criteria.” [Page 3]
Several of the endpoints used to measure outcomes (pain, range of motion, activities of daily living) were subjective (based on patient questionnaires) and, thus, easily influenced by the study’s poor design (i.e. lack of blinding and placebo control) and susceptible to the placebo effect and subject/researcher bias. One of the few non-subjective measures used (to assess antioxidant effects) was the CAP-e assay, which we have discussed here previously. It is an anomalous assay developed by one of Jensen’s underlings (Dana Honzel, while she was an undergraduate student at Santa Clara University) and has never been used or validated by any other researcher.
It would not be considered as an even remotely acceptable method of measurement by any bona fide researcher.
The investigators also implemented an inappropriate method for analyzing statistical significance. They used a t-test instead of a repeated measures analysis, such as one-way ANOVA, to measure the effect of multiple measurements over time.
The study does not contain the required Declaration of Helsinki statement indicating that it was conducted in accordance with internationally recognized standards for human medical experimentation, nor does it state that the study was approved by any independent review board or ethics committee. These are grave oversights.
The study involved blood draws, yet it does not appear that any of the authors are qualified to perform such procedures. Lastly, the article does not include any statement indicating that the subjects provided informed consent prior to participation in the study; this too is a grave oversight and it adds to the overall picture that this study was not conducted in accordance with standards for ethical research.
Because of the lack or blinding and placebo control, all results can be attributed solely to the placebo effect and investigator/subject bias.
The medical histories of the patients were not considered (probably attributable to the fact that no REAL doctor was involved in the study, and a chiropractor wouldn’t be qualified to assess their case histories). This oversight is ridiculous. No serious medical research study on joint pain would ever be undertaken without thorough medical exams and chart reviews to determine the diagnosis, etiology, and natural history of each patient’s condition. To make matters even worse, the subjects were not excluded from taking concurrent medications. Thus, all results could be attributable to such medication use rather than to Monavie.
The key results reported were improvements in activities of daily living (ADL), range-of-motion, and pain questionnaire scores; increased serum antioxidant status (measured by the unreliable CAP-e assay); and decreased lipid peroxidation (TBARs).
The only potentially reliable and semi-objective indicator of efficacy, the C-reactive protein assay (a surrogate marker of inflammation) was not significantly affected, and to make matters worse, the data were not shown at all (a ridiculous oversight). Equally ridiculous, is the fact that the lipid peroxidation data were not presented, despite the authors’ clam that there was a significant reduction in serum following consumption of Monavie for 12 weeks.
Averaged data for range of motion scores at each timepoint were not presented, making it impossible to verify the authors’ claims of a significant effect. Data for pain and CAP-e results were presented as percent change rather than raw values, again making verification impossible (this method is a common way of fudging and disguising bad data and small, clinically meaningless effects).
Pain scores were reduced from baseline by less than 10% at weeks 2 to 8, and by about 17% at week 12. The data throughout were highly variable (as evidenced by the very large error bars in Figure 4) and the differences from baseline could be just random noise (not to mention attributable to biasing factors, the placebo effect, concurrent medications, regression to the mean, or intentional data fudging).
The correlation graphs for TBARS and CRP in Figure 5 are basically meaningless. They are used to disguise the fact that the actual data TBAR and CRP data were not presented (a fundamental and inexcusable omission).
The study attempts to single out acai as the causative factor responsible for the alleged benefits seen in the study subjects, e.g.:
“Given the combined antioxidant, anti-inflammatory, and potentially antinociceptive properties of acai juice and pulp seen in vitro and in vivo, we sought to conduct a pilot study in humans with chronic pain and underlying inflammatory issues.” [Page 2]
“The test product for this study was MonaVie Active (MonaVie LLC, South Jordan, UT, USA), a fruit- and berry-based juice blend with a high level of polyphenolic compounds that exhibit strong antioxidant properties. These properties stem from the predominance of acai pulp in the formulation; pulp of this fruit has been shown to have high superoxide and peroxyl radical scavenging capacities in vitro.” [Page 2]
“Acai contains a range of polyphenols that protect cellular oxidative damage in vitro and provide anti-inflammatory signaling leading to reduced production of free radicals by inflammatory cells.” [Page 8]
However, the article’s discussion (page 8) states that grapes have been shown to have analgesic effects; and even though grape juice is a primary ingredient in Monavie, the authors fail to even remotely entertain the possibility that the alleged effects in this study would have been attributable to the grape juice rather than the acai in Monavie. Furthermore, the authors do not disclose that Monavie is made with significant vitamin and antioxidant fortification, nor do they consider the possibility that the juice’s alleged antioxidant effects could be attributable solely to the vitamin C that the juice is spiked with. Lastly, the do not discuss the possibility that the glucosamine added to Monavie Active could have been responsible for the improvements in patient-reported outcomes independently of any antioxidant effects (i.e. the purported benefits of glucosamine do not involve an oxidative/antioxidant mechanism).
The disclosure statement reveals that the study was funded by Monavie. Schauss declares that he is an unfunded member of the Monavie scientific advisory board. He fails to disclose that he has other relationships with the company, such as the licensing of his patent on Opti-Acai, speaking engagements, and profits from the sale of his CDs and book to Monavie distributors.
Originally posted 2011-05-04 10:42:33. Republished by Blog Post PromoterThe above article is intended to be accurate at the time of its original posting. MonaVie may change its pricing, product, or other policies at any time without notice.
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