The British Tinnitus Association (BTA) joined AllTrials saying:
The BTA is the only national charity dedicated to supporting the 10% of the UK adult population who experience tinnitus. We are a world leader in providing support and advice about tinnitus, giving accurate, reliable and authoritative information. If we are to retain our confidence in the advice we produce, we need to ensure that all relevant information is available. As a major supporter of tinnitus research, we also recognise the need to ensure that patients and clinicians alike have confidence in the results of clinical trials.
The BTA is trying to uncover the results of a clinical trial on a possible treatment for tinnitus. An early clinical trial on the treatment showed promising results and a follow up trial, RESET2, sponsored by Nottingham University Hospitals NHS Trust, was completed in February 2014.
The Trust and the trial researchers decided in August that the results would not be published because changes in the trial protocol meant the results could not be considered scientifically valid. The BTA submitted a Freedom of Information request to the Trust to find out more about how the decision was made and was given the End of Study Report in response. According to the report, which included the trial’s methodology and the changes in the protocol, there was not a significant difference in the results for patients who received the treatment versus the placebo. The BTA hopes that full disclosure of the trial results, with any necessary caveats, could be used by researchers to design better trials on the treatment in the future.
Nic Wray, Communications Manager, BTA:
We are very disappointed that the trial results have not been published. The non-publication has had a devastating impact on the tinnitus community – and not just the fact that these long anticipated actual results have been withheld. The opportunity to elevate tinnitus research to a new level, where double-blind RCT’s are possible/feasible has been massively set back. Without this trial as a comparator, we have lost the opportunity to robustly evaluate potential treatments to the highest standard.
Tinnitus is a very common condition, for which there is no cure. It is experienced by 10% of the UK adult population, and in around 10% of those with the condition, severely affects their quality of life, so you can imagine the numbers of people this decision to not publish impacts.