Silver-level articleDynamiclear

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Dynamiclear is an herbal product which is allegedly a treatment for herpes simplex (cold sore) infections. The manufacturer claims it has the ability to clear up outbreaks more quickly and more effectively than leading pharmaceutical treatments (such as Acyclovir). The marketing and evidence used to support the efficacy of Dynamiclear shares many characteristics with pseudoscience.

Contents

[edit] Site discrepancies

The Dynamiclear website, and, more importantly, the claims it makes, have changed significantly and repeatedly over the span of three years, making it difficult to assess the actual claims. Comparisons between revisions are explained in the relevant sections below.

[edit] Ingredients

The ingredients listed on their site have changed over time. In July 2007,[1] they listed no specific ingredients for the product, although there were several other products with their ingredients listed.

The ingredients were added in October 2007, specifically listing:[2]

  • "A sulphate based solution which contains copper as a trace metal in an aqueous, odorless herbal base"
  • St John's Wort

Currently, more ingredients have been added:[3][4]

  • Hypericum perforatum (St John's Wort)
  • Calendula officinalis (Marigold)
  • Cupric sulfate pentahydrate (copper sulfate)
  • Vegetable Derived Glycerol
  • Aloe vera barbadensis
  • Naturally Sourced Vitamin E

All versions state that they also recommend "Combined Lysine Formula",[5] which is a preparation containing 625mg per capsule of lysine, the dose being stated as two tablets per day (1.25g).

[edit] Claims of efficacy

Advertisement on hubpages.com for Dynamiclear. Note the clear implication of medical use.

It is important to note that lysine is not an active ingredient in Dynamiclear but is also recommended as part of the treatment. This is interesting because lysine is the only ingredient listed that has been shown to be statistically effective against herpes simplex outbreaks in clinical trials with people, and even then, doses of between two and six grams per day are required to keep the virus at bay,[6] if it even helps at all.

The site claims that several active ingredients have been shown to be effective against herpes and other microbial infections.[7] One of the primary ones is copper sulfate, which they even contacted us to claim is one of the main active ingredients shown to be effective in "clinical trials." The paper they cite is an in vitro study that used large concentrations of copper sulfate on HSV in a petri dish.[8] Many promising cures that work in vitro fail in animal or human testing. The copper sulfate work cited is from 1997, and only marginal follow up work has been done on it, mostly advocating the use of copper sulfate on clothing as a potential anti-microbial. No in vivo work has been done to show that copper sulfate in the concentrations listed have any effect on HSV infections in humans.

The same issue appears with every other ingredient they claim is backed by scientific studies. At best there are one or two in vitro studies showing "promise", but none of this work has gone on to actually test what concentrations would work in humans, how it should be used, or even whether it really works at all.

[edit] Clinical trials

Dynamiclear is different from other herbal remedies on the market in that instead of simply claiming it is "scientifically proven", it actually boasts of successes in clinical trials.[9] In fact, the manufacturers makes claims about successful Phase III drug trials. All of these claims seem to originate from the same clinical trial which was performed in India.[10]

It is an open question on why an Australian-based company would opt to pay for clinical research in India, but regardless there are many concerns with the study methodology and its choice of labeling. The first major issue is in referring to it as a Phase III trial at all. Phase III trials are the last stage in drug development, which follows a line of extensive in vitro testing on dosage and effect, animal testing, and limited human testing to see if it is effective in vivo and at what dosage and administration procedures. There is no evidence that any of these studies were ever conducted. A major Phase III trial without these preparatory steps would be a serious ethical breach, but the study cited does not appear to be a full Phase III test regardless of what they label it. A Phase III test usually involves upwards of 3000 people. The cited study has just over 100. In reality this study, regardless of its methodological flaws, is at best an early Phase II clinical trial. Not that this stops Dynamiclear reps from claiming that it has "completed Phase I, II and III comprehensive Clinical Trials (scientific double blind studies)"[11]

Now on to the methodological flaws. The basic procedure is outlined as follows:


Test product, dose and mode of administration:
Investigational Product (IP):

  • Dynamiclear - Single Dose Topical Application;
  1. Cotton swab was immersed in water and lightly squeezed out to remove most of its water,
  2. 2-4 drops of IP (depending upon the affected area) was transferred to the cotton swab (enough to saturate it).
  3. The cotton swab was then applied to the location of active condition making sure the entire lesion was swabbed thoroughly with Dynamiclear.
  • Comparator Product:

Five times daily application; "Leading Brand Name" cream was applied on to the affected area.


So we can instantly see several problems with the protocol:

  1. The method does not appear to be blinded, either to the patient or the tester. Furthermore, the application method is completely different (cotton swab vs cream application) as well as the dosing interval (once daily vs 5 times a day) meaning that even if it was double blind, both the patient and the tester could ascertain what each patient has been given
  2. No placebo. For a proper clinical trial of a treatment, the test preparation containing the active ingredient(s) should be tested against the exact same test preparation without the active ingredient(s). This test used "Leading Brand Name cream" (presumably acyclovir, although unhelpfully they don't appear to have stated this).
  3. There is a serious question of the independence of the study. While it was conducted by Apothecaries Clinical Research, which appears to be a legitimate clinical research group, it violates several of the basic standards for good clinical practice in India (poor protocol, no Phase I or II trials).

These issues were presented to Apothecaries Clinical Research, a major global clinical research organization, to see if they stand by this work as a legitimate Phase III trial. While standing by the work ACR stated that this research was a "proof of concept" and therefore was not bound by the normal standards of clinical research[12]. The phrase "proof of concept" is a code word in medical research for very early stage studies, mostly looking at basic safety of the drug, and using population sizes in line with those used in this study.

This means that the group who performed the research for Dynamiclear viewed it as, at best, an early Phase II study. Phase III is the gold standard for pharmacological research. It is the stage where efficacy of the drugs is established, and the stage after which regulatory bodies may approve a drug for treatment of diseases and symptoms. By claiming a successful Phase III study, Dynamiclear asserts this reputation, but in reality, even the company that performed the research did not view it as a true Phase III. Labeling it as such appears extremely disingenuous.

In addition, to show the product's lack of efficacy, the site sports a standard Quack Miranda Warning in an attempt to legally indemnify themselves against litigation by admitting the product's inability to provide proven results:

The statements made on this website have not been evaluated by the FDA (U.S. Food and Drug Administration) and our products are not intended to diagnose, prevent, treat, cure or mitigate any disease. If a condition persists, please contact your physician.
—Dynamiclear website's footnote (emphasis added)

Nevertheless, Dynamiclear like to frequently point out that their product is registered with both the FDA and the TGA (the Australian Therapeutic Goods Administration)[13]. It should be noted that approval by either agency does not prove efficacy, only safety. One could just as easily make parsley paste and have it listed with the FDA and TGA as a cold sore remedy.

[edit] Site anomalies

[edit] Search engine manipulation

A Google search for Dynamiclear scam returns many results. Most of them are purposely created pages which deliberately use the terms and then praise the treatment (often just through testimonials) or simply give a description of it.[14][15][16][17] This is a classic internet method of diverting traffic away from critical reviews of a product to pages which praise the product complete with a link back to the site.

There is no evidence that suggests that these pages were created by Dynamiclear themselves, and most of the sites have a disclaimer to the effect that they receive commissions from the products they are promoting.[18]

Another interesting point to note is that since Dynamiclear discovered this page and protested against it[19] one of the pages referenced changed its title from "Dynamiclear Reviews Will Reveal the Scam"[7] to just "Dynamiclear Reviews"[1]img.

[edit] Site locking

Around the same time the ingredients were changed, the main site webmaster tweaked its code to prevent right-clicking and highlighting text. Dynamiclear has claimed that this locking is to prevent competitors from stealing their content, though it would not prevent someone from merely copying from the page source. However, it does have the effect, intended or not, of making criticism and quotation of site material slightly more difficult.

[edit] External links

[edit] Footnotes

  1. Active ingredients as of July 2007img
  2. Active ingredients as of October 2007img
  3. Current ingredients listimg
  4. Expanded ingredients listimg
  5. Combined Lysine Formulaimg
  6. [2]img
  7. [3]img
  8. Sagripanti, J., Routson, L., Bonifacino, A., & Lytle, C. (1997). Mechanism of copper-mediated inactivation of herpes simplex virus. Antimicrobial agents and chemotherapy, 41(4), 812.
  9. Homepage - "Demonstrated to have a significant success rate in Clinical Trials."img
  10. Clinical Trial Summary
  11. [4]img
  12. Excerpts of e-mails from Apothecaries Clinical Research
  13. Dynamiclear's listing in the ARTG Database
  14. Dynamiclear Product Report and Reviewimg
  15. "Dynamiclear Reviews Will Reveal The Scam"img (Has since been deleted)
  16. "Dynamiclear Reviews: Does Dynamiclear works or is it a Scam?"img
  17. [5]img
  18. [6] - At the bottom: "MerchantBuster.com has affiliate relationships with trusted stores and merchants mentioned on this website. If you buy any product from the links on this website, we may receive compensation from the provider of the products or services."
  19. Comments about Dynamiclear contacting RationalWiki
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