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Thyroid UK Study
Update January 2012

The Thyroid UK study has been going on for a long time now due to difficulties that have arisen.  We thought we would let you have a recap along with details of the problems we have had since we first started the study.

The incidence of the overt form (full blown hypothyroidism) thyroid disease is 2% women, 0.2% men.  The incidence of Sub-clinical hypothyroidism is 6-8% women, 3% men.  The incidence of pregnant women who develop hypothyroidism is 2.5%.

However, Thyroid UK believes that the incidence is much higher due to undiagnosed hypothyroidism.

The tests to diagnose hypothyroidism are:

    • TSH  (Thyroid Stimulating Hormone)
    •  Free T4  (thyroxine)
    •  Free T3
    •  Thyroid antibodies – Anti Thyroid Peroxidase
    •  Antibody (TPO)/Antithyroglobulin Antibody
    •  (TgAb)/ Thyroid Stimulating Immunoglobulin (TSIAb)

However, not all these tests are routinely done. Many doctors only do the TSH test which often misses people with Hashimoto’s Disease until they become very ill.

The Pharmaceutical Journal stated, “…. large numbers of thyroid function tests are carried out because patients describe vague non-specific symptoms. Doctors are frequently faced with decisions on the management of patients who have little or no clinical signs of thyroid dysfunction, but have abnormal tests.”  (The Pharmaceutical Journal Vol. 265 No 7109 p240-244)

We know from our telephone helpline that these patients are often put onto levothyroxine and become ill. We also know that doctors also have many patients with symptoms of hypothyroidism but normal test results. Thyroid UK feels that this is an indication that the TSH test alone is not sufficient.

Our study came about because in 2004, money was collected by the friends and family of Andrew Bull who died from a heart condition. The family felt that he had had undiagnosed thyroid disease for many years leading to his heart condition. After discussions, it was decided to use this money for a study into thyroid blood tests.

We put a report in our newsletter telling our members that we wanted to do a study and Jane Evans, an ME patient, contacted Lyn Mynott and offered to help – before she became ill she had been a study co-ordinator in the NHS.

A Study Working Group was then set up and we did a literature search to see what other studies had been done. 

We found that some research had been done in Belgium using urine tests to diagnose thyroid disease, both of them concluding that urine tests were better than serum.

We had our first Working Group Meeting in February 2005 where we discussed things such as which tests we wanted to study – blood, urine and saliva tests; how many patients and controls we would need, which signs and symptoms to use; how we would write the protocol and who would contact the ethics committee and how we would pay for the study.

We then started doing the preliminary things needed such as putting a report in our newsletter and on our website asking for donations; discuss the protocol and the statistics with Dr John Lowe and contacting the testing laboratories to see if they were interested in helping us.  We also organised an initial meeting with the Ethics Committee

At the second Working Group Meeting we made some decisions such as which testing labs to use; how and where we would assess the participants etc. A lot of the other work was carried out by phone, letter and email.

Once this was all done we had an Ethics Committee Review. The Ethics Committee disagreed with our statistics and wanted us to change the patient group for testing and the symptom profile but this would have meant a fundamental change to the protocol and we felt that this would affect the results of the research.

We wrote a letter explaining our point of view, giving evidence regarding the symptoms and we were very pleased to hear a couple of days later that we had been given ethics approval.

The next step was to find volunteers to be participants in the study and to explain briefly what would happen if they were participants so we wrote a report in our newsletter. We also told our members that we would be fundraising for the study.

Unfortunately, we then had a major problem.  The saliva test machine broke down and wasn’t going to be replaced.  This meant we had to change the protocol, taking out all references to the saliva test and re-submit it to the Ethics Committee for approval. We had to stop testing until the protocol had been approved but, thankfully, the Ethics Committee approved the amendments to the protocol and so we were able to continue with the study.

Jane Evans co-ordinated the study for us. For the study we needed to recruit 25 patients and 25 controls (fit and healthy people with no signs or symptoms of hypothyroidism).

We used 13 underactive thyroid symptoms, ranging from cold intolerance to headaches to constipation to muscle aches and pains and the volunteers were asked to score these symptoms:    

    • Cold intolerance                                         
    • Constipation/sluggish bowel                                           
    • Difficulties with memory/concentration              
    • Dry skin                                                                    
    • Fatigue                                                                     
    • Hair loss (from head, body and/or face)                        
    • Headaches                                                                          
    • Low mood/depression                                          
    • Muscle aches and pains                                      
    • Unexplained weight gain                                      
    • Numbness/tingling in hands/arms                    
    • Menstrual problems/infertility/loss of libido/impotency  
    • Slow speech/movement/thought       

We asked the participants to score the symptoms they had had over the previous month:  0 if they never experienced them; 1 if they sometimes had them; 2 if they often had them and 3 if they had them constantly.
The signs we used were:

    • A low waking temperature i.e. The Basal temperature
    • Slow or irregular pulse
    • Loss of the outer third of eyebrow
    • Puffy face or fluid retention
    • Swollen tongue
    • Slow or absent Achilles reflex
    • Cold extremities

These were either present or absent as assessed by the study co-ordinator. Again these are signs you would associate with an underactive thyroid.

Our inclusion criteria were very strict. The patients had to score over 26, have a resting HR below 65bpm, a basal temperature below 36.6ºC and have at least 2 other signs.

The controls had to score below 6, have a resting HR above 65bpm and a basal temperature above 36.6ºC.

These were chosen to clearly distinguish the two groups and were strictly adhered to.

So far 25 patients and 7 controls have completed the study.

Finding the patient group was not a problem. Most came through our website or they contacted the office. Some were recruited from a local ME support group.

However the control group was an entirely different matter!!! First we started recruiting from Jane Evans’ friends and family, then Adult Education Centres, local gyms and leisure centres.

When this did not produce enough controls, even though some sites were visited twice, local retailers were approached.

This resulted in a total of 210 people volunteering to be a control and give us some of their blood and urine.

All 210 volunteers were telephoned to screen out those who did not meet our strict inclusion criteria and 87 of these were seen to carry out a full assessment, but only 7 met all the criteria.

What were the reasons the other 80 were rejected?

18 people still scored too high on the symptom profile, despite what they had said on the telephone phone; 6 people had low resting heart rates and were very fit, one lady cycled everywhere; 7 withdrew for family reasons; the majority, 49, were rejected because their basal temperature was too low.

Finding healthy people, with low basal temperatures, has also been a problem Dr John Lowe encountered in his studies so he agreed to look at our temperature results.

The controls had met all our criteria except the temperature. He found that the average temperature for the patient group was 36.0ºC and the average for the control groups was 36.2ºC. The difference in these averages was statistically significant.

The Barnes Basal Temperature Test was first proposed by Dr. Barnes in 1942 in America and it was published over here in The Lancet in 1945. Doctors and other practitioners have used the temperature of 36.6ºC as a diagnostic tool and a means of monitoring patient progress ever since.  It is therefore important that we inform them of our findings.

We intend to do this with Dr Lowe, at a future date.

We are still looking for more volunteers so that the statistics we carry out at the end of the study will have some meaning. We need healthy people with no history of any kind of thyroid disease – if you have been tested for thyroid disease then probably you would not make a good control.
So if you know anyone, who would fit our inclusion criteria for the control group, would you please ask them to contact Thyroid UK on 01255 820407 or use our admin Contact Us form.

We are hoping that the results of the study will show that the urine test is as good as or better than the blood test and that it will bring about a change in practise in respect of thyroid testing. Patients could have a choice of tests - urine testing is non invasive, especially for the needle phobic patient and older children; the urine test can be done at home allowing the patient to be much more involved in their diagnosis and treatment. We also hope to encourage similar research.

It’s taken a long time to run this study but we hope to finish it next year so watch out for our final report.