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on Thursday, 06 December 2012. Posted in General
Recently we published the results for our Report for Double Blind Placebo Crossover Human Clinical Study of the Efficacy of the Ionic Balance Band in Improving Flexibility, Strength, Balance and Endurance in Healthy Subjects.
A member of the public raised this concern:
"The author of the study claims the following on their website "Your clinical trials will be customized for your product to provide optimal support for marketing claims". Not sure this is in the true spirit of serious unbiased scientific studies."
"In order for a study on a particular product to be done the testing must be customised, there is no point in testing a product for something it does not do. For example there is no point testing swimming goggles on dry land as the testing must be specific to the product claims such as if the goggles claim to be anti-mist, anti-leak and waterproof up to a certain depth then the testing must be customised to test these specific parameters. We customised our trial to test for our specific parameters of flexibility, strength, balance and endurance. This is just a pilot study as a pre-cursor to our full study which should be completed next year and will cover even more parameters. This 2nd study is being conducted by a British University. If you would like discuss anything please by all means give us a call on 0843 28 98 120. Thank you for your feedback."
The person was still unsure and replied:
"Thanks for the reply. I'm no scientist and have no experience conducting scientific trials so forgive my lack of knowledge on the matter. But can you honestly say you don't see a problem with Dr Tully carrying out "Clinical Trials to Support Marketing Claims"? Can a study be truly unbiased if the principle aim is to "support marketing claims"? Thanks for your time."
We reassured them by saying:
"No to be honest we don't see any problem with it. We have been very thorough when planning this research and it had to pass IRB (Institutional Review Board) approval before it could commence. We used standard peer review methodology to deconstruct the results and we obtained 2nd and 3d opinions on the validity of the data. The purpose of this study was not just to substantiate claims but to provide even more robust evidence and to improve the product. Thank you again for your feedback."
We take all customer feedback seriously and so asked a contact in the medical field to comment. This was their response:
"A company commissioning scientific research to support marketing claims is not without precedent. If one takes drug companies as an example, they not only commission the research into their new products, they actually also conduct the research themselves. The scientific papers which are the result of this research are specifically designed to be open to scrutiny and analysis, removing the risk of bias affecting the results. If you consider that Ionic Balance has outsourced the conduct of the study to an independent company, they have actually done more to reduce bias than the prevailing industry-wide standards suggest that they should."
We asked Dr Tully to comment:
"These are double blind placebo controlled studies, which are objective and unbiased. The customization is designed to test what the product actually does and the subject recruitment and testing is unbiased. Also, the study was analyzed for proper randomization of each group and for the learning effect of repeating tests, which was shown to not be involved in the positive results."