Dynamiclear

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It also has the effect, intended or not, of making criticism and quotation of site material more difficult.
 
It also has the effect, intended or not, of making criticism and quotation of site material more difficult.
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== External links ==
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*[http://www.dynamiclear.com/ Dymaniclear's official webshite]
  
 
==Footnotes==
 
==Footnotes==
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{{reflist|2|90%}}
 
{{reflist|2|90%}}
  

Revision as of 02:26, 26 August 2010

Against allopathy

Alternative medicine

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Alternative articles

Dynamiclear is a herbal treatment for herpes simplex (cold sore) infections which claims the ability to clear up outbreaks quicker and more effectively than leading pharmaceutical treatments (such as Aciclovir). It shows a concerning number of signs of being made entirely from woo.

Contents

Site discrepancies

The Dynamiclear website and the claims therein 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.

Ingredients

The ingredients listed on their site have changed overtime. The site in July 2007[1] offered no specific ingredients in their product though listing several other products and their ingredients also available on for purchase.

The ingredients listed on the site changed 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 to the site:[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 2 tablets per day (1.25g).

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 2-6g 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 they claim is copper sulfate, which they even contacted us as 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 on a petri dish.[8] Many promising cures that work in vitro fail as soon as you begin 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 in 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 is 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 whether it really works at all.

Clinical trials

Dynamiclear is different to other herbal remedies on the market in that instead of simply claiming it is "scientifically proven", it actually boasts of success in clinical trials.[9] In fact, the manufacturers claim a successful phase III drug trials. All of these claims seem to originate from the same clinical trail 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 effect 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 with out these steps in between 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.

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 series question of the independence of the study. While it was conducted by Apothecaries Clinical Research, which appears to be a legitimate clinical research group, the fact is that 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[11]. 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, and it is the stage where efficacy of the drugs is established, and the stage where regulatory bodies can approve a drug for treatment of diseases and symptoms. By claiming a successful phase III study Dynamiclear gains all this reputation, but in reality, even the company who performed the research did now 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 self admiting the product's inability to provide proven results:

The statements made on this website have not been evaluated by the FDA (U.S. Food & 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)

Site anomalies

Search engine manipulation

A quick Google search for Dynamiclear scamimg throws a number of results with the two search terms in the title worded such that they are investigating the probability of the treatment being a scam. On closer investigation, it seems they are purposefully created pages which deliberately use the terms "dynamiclear" and "scam" while going on to either praise the treatment (often just through testimonials) or simply give a description of it.[12][13][14][15][16] 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, but most of the sites have a disclaimer to the effect that they receive commission from the products they are promoting[17] showing they have a financial interest in promoting the product.

Another interesting point to note is that since Dynamiclear discovered this page and protested against it[18] one of the pages references changed from "Dynamiclear Reviews Will Reveal the Scam"[6] to just "Dynamiclear Reviews"[1]img. Why did the site owner change the page title after this page drew attention to it?

So while they may not be responsible for the content they do seem to benefit from its existence and may have some editorial control over it .

Site locking

About the same time the ingredients were changed, the main site webmaster added code to the page to avoid right-clicking and text highlighting:

<body oncontextmenu="return false;" ondragstart="return false;" onselectstart="return false;">

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.

It also has the effect, intended or not, of making criticism and quotation of site material more difficult.


External links

Footnotes

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