What is The Thyroid UK Research Study About?
There is controversy within the medical profession about treating patients who present with the symptoms of hypothyroidism, but whose blood tests fall within the reference range.
Members of the medical profession are reluctant to prescribe thyroxine (T4) for such patients. There are also a number of patients who are on thyroxine treatment, but who still feel unwell despite the blood test results falling within the reference range. Doctors are reluctant to increase the dose further because of concerns about bone density and the effect on the heart due to the supposed over stimulation with thyroxine.
Some patients are found to have subclinical hypothyroidism (serum thyrotrophin (TSH) is raised with normal free T4 (fT4) and no symptoms reported) by virtue of their blood tests alone and again there is controversy over whether to treat them.
The standard test for thyroid function in the UK is blood TSH and, in some areas, fT4 tests are performed as well. It has been suggested in recent years that there could be some refinement to this thinking and that it is the effect of the thyroid hormones on the peripheral tissues that is the ultimate test, especially since some patients have problems with T4 to triiodothyronine (T3) conversion. It has also been suggested that surgery and certain drugs may interfere with peripheral metabolism of the thyroid hormones and thus the interpretation of the serum tests.
Blood serum TSH tests for thyroid function were introduced in the 1970's and are now considered to be the "gold" standard, with all new tests being compared to these for accuracy, rather than to the symptoms, although some are questioning the validity of the TSH test . It is therefore important to have a test that is sensitive, reliable and correlates with the symptoms presented by the patient, whether it is to diagnose hypothyroidism or to monitor a patient's progress.
Chan & Landon, (1972), Chan et al., (1972), Orden et al., (1998) and Baisier et al., (2000) suggest a reliable correlation of clinical status can be found by testing 24hr urine samples, with free T3 (fT3) correlating well with presenting symptoms. In Belgium, 24hr urine tests have been used to assess thyroid function for 18 years.
Gotovtseva and Korot'ko, (2002) have suggested there is a high correlation between serum levels of thyroid hormones and those found in saliva. Thyroid saliva tests have recently become available, via a clinic in the UK, for assessing thyroid function, although they have been available since 1999 in the USA for research purposes.
No research has been published on the relative merits of testing and comparing individuals' urine, saliva and blood samples and then correlating them with presenting signs and symptoms. Thyroid UK aims to redress that omission by conducting a study entitled "Comparison of Urine, Saliva and Blood Tests for Thyroid Function and Their Correlation with Presenting Symptoms."
Two groups of 25 will be recruited. The first will be volunteers who present with hypothyroid symptoms but are, as yet, untreated. The second group will be randomly selected volunteers who are asymptomatic and healthy.
Thyroid UK need £10,000 to conduct the study and we will therefore be organising different fundraising activities, such as the 3 Peaks Challenge and the Masquerade Ball, to ensure that the study is finalised. Please help us in our venture!
Progress Update January 2012
The Thyroid UK Study has been going on for a long time now, due to difficulties that have arisen.
This update is presented as a recap, along with details of the problems we have had since we first started the study. Please click here to read it
1st May 2010 - Thyroid UK Study in it's Last Stages
Thyroid UK has almost finished testing people for their study, Comparison Of Urine AndBlood Tests For Thyroid Function And Their Correlation With Presenting Symptoms.
We are in the process of finding the last few "controls" to test – people without thyroid symptoms – and once these have been tested, we can continue writing up the results.
This means that we no longer require any patients for our study and we would like to thank you for your support in this venture.
We hope that the study will be finished by the Autumn, possibly earlier and as soon as it is finished we will start disseminating the results, hopefully to journals, magazines, newspapers and, of course, on our website.
8th June 2009
We have nearly finished testing all the patients who are taking part in our study! 23 have completed the study and two are going through the process at the moment. We have a waiting list in case these two do not fit the criteria so we do not need any more patients. Thank you so much for supporting us in this venture!
We are now recruiting controls for the study (people who do not have symptoms of hypothyroidism). Two controls have completed the study and we are recruiting controls from adult education centres.
We will start collating the information from the patients' results soon and as soon as the controls have been tested, this information will be added. Dr John Lowe has been helping us a great deal with how to input the results into a database.
Once all the information is collated, the study will be written up and, again, Dr Lowe will be helping us with this.
As soon as we have more information, we will let you know!
31st December 2008
Our study has taken a bit longer than we had hoped. The reason for this was partly due to the health problems of Jane Evans, who is co-ordinating the testing of the patients and controls for us. However, the main reason was that the saliva test machine broke down and saliva tests were therefore unavailable. We had to re-submit our Protocol to the Ethics Committee, taking out any mention of saliva testing, before we could continue.
Unfortunately we did lose a few people because they wanted to get tested as soon as possible. We are a few short of the 25 needed for the patient group (patients with symptoms of an underactive thyroid but who have not started any treatment). If you decide to take part you will be given an information sheet to keep and asked to sign a consent form. You are free to withdraw at anytime and without having to give a reason.
If you agree to take part in this research you will be asked to fill in a symptom profile and you will be assessed for signs of hypothyroidism. You will then be asked to take your temperature on waking for three consecutive mornings and you will be contacted for the results. If your results fit our strict criteria, you will be selected and asked to collect your urine over a 24 hour period. You will also be asked to bring the urine sample to the Genova Diagnostics Laboratory, where some of your blood will be taken by a qualified professional and a sample of your saliva will be collected. All samples will then be analysed for the level of your thyroid hormones. All information which is collected about you during the course of this research will be kept strictly confidential. Any information about you will have your name and address removed so that you cannot be recognized from it. Your GP will be informed that you have agreed to take part in this study, if you give your permission.
To take part in the study you should either live in the Surrey or London area and/or be prepared to travel to Surrey (reasonable travelling expenses will be paid.)
If you would be interested in taking part, please contact us.
We have contacted local Adult Education Centres to obtain controls (people without any signs and symptoms of hypothyroidism) and have recruited 5 people so far. Dr John Lowe has offered to do the statistical analysis for us, and we are very happy about this!
I would like to thank all those who have helped us with the study - we couldn't
have done it without you. We will keep everyone updated!
22nd February 2008
We have now recruited enough patients for our study and the testing process is the next stage. Some tests have already been done but more are being organized.
Once this is done, we will need to recruit control subjects – people who have no symptoms of hypothyroidism.
We would like to say a big THANK YOU to all those who have participated in this study so far and we will keep you updated on this website.
£10,404.43 raised - We've reached our target!
29th October 2007
A special THANK YOU to Bentalls Shopping Centre, Heybridge, Essex, and a huge THANK YOU to everyone else who donated money or time to help us raise this fantastic amount.
We have started recruiting patients and will soon be recruiting control subjects. We are waiting for some statistical information and as soon as this is received, we'll be starting the actual testing. Watch this space!
Ethics Approval Received for the Study!
I am extremely pleased to tell you all that Thyroid UK has now received ethics approval for our study entitled, "Comparison of Urine, Saliva and Blood Tests for Thyroid Function and their Correlation with Presenting Symptoms" from the London-Surrey Borders Research Ethics Committee! The approval is given provided that we comply with certain conditions one being that we should start the research within 12 months.
We informed the ethics committee that our aim was,
"No research has been published on the relative merits of testing and comparing individuals' urine, saliva and blood samples and then correlating them with presenting signs and symptoms. This study aims to redress that omission."
For the study, we require two groups of volunteers. One group will consist of "normal" (healthy) controls and the other of patients with symptoms of an underactive thyroid but who have not started any treatment. We will be recruiting soon. If you decide to take part you will be given an information sheet to keep and asked to sign a consent form. You are free to withdraw at any time and without having to give a reason.
If you agree to take part in this research you will be asked to fill in a symptom profile and you will be assessed for signs of hypothyroidism. You will then be asked to take your temperature on waking for three consecutive mornings and you will be contacted for the results. If your results fit our strict criteria you will be selected for either the patient group or the control group. You will be asked to provide a collection of your urine over a 24 hour period. You will also be asked to bring the urine sample to the IWDL Laboratory, where some of your blood will be taken by a qualified professional and a sample of your saliva will be collected. All samples will then be analysed for the level of your thyroid hormones. All information which is collected about you during the course of this research will be kept strictly confidential. Any information about you will have your name and address removed so that you cannot be recognized from it. Your GP will be informed that you have agreed to take part in this study, if you give your permission.
To take part in the study you should either live in the Surrey or London area and/or be prepared to travel to Dr Barry Durrant-Peatfield's clinic in Crawley, Surrey and to travel to IWDL in New Malden, Surrey. (Reasonable travelling expenses will be paid.)
If you are interested in being a volunteer, please contact me on 01255 820407 (permanent message machine).
We are very excited about this study and although we haven't got enough money to complete it, we can make a start at the end of the summer. We really feel that this study will help those suffering from undiagnosed thyroid disease now and in the future.
Progress report - May 2007
Our Study, which we have entitled "Comparison of Urine, Saliva and Blood Tests for Thyroid Function and their Correlation with Presenting Symptoms", has been before the ethics committee.
This committee ensures research is conducted in a proper and ethical manner, and that participants in each study are correctly treated by the research team.
There has been a hold up in the procedure as the ethics committee suggested we change our protocol slightly. They want us to group the subjects by the TSH test, which is what we were trying to avoid. They have also requested more information regarding the symptoms profile we have chosen. We have had some help from an endocrinologist with regard to finding a suitable symptom questionnaire and we must now discuss with the ethics committee which one to use. Once this has been agreed, we hope to be able to make a start.