| Should We Take Thyroid Medicine Away From the Elderly? | |
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by Mary J. Shomon
Results of a study have been published in the November/December 2000 issue of the Journal of the American Board of Family Practice, in which elderly residents of nursing homes who were on thyroid hormone had their doses cut, and ultimately, in some cases, had their medication withdrawn entirely. The study, titled, "Successful Withdrawal of Thyroid Hormone Therapy in Nursing Home Patients," was conducted by Patrick P. Coll, MB, BCh, Departments of Family Medicine and Medicine (Geriatrics), University of Connecticut Center on Aging, in Farmington, Connecticut.
The study's purpose was to find out whether thyroid hormone therapy in selected nursing home patients could be withdrawn without adverse effect. The research was based on the researcher's belief that "substantial numbers of patients might have had thyroid hormone therapy prescribed inappropriately and that thyroid hormone therapy in some can be discontinued without adverse effects or evidence of clinical hypothyroidism."
In the study, baseline TSH levels were measured, and if a patient had a level below 7, their thyroid hormone dosage was cut in half. A month later, if the TSH level was still less than 7, they discontinued thyroid hormone therapy entirely. A month later, they measured TSH, and if it was still below 7, they measured free thyroxine (T4), and if that level was normal, they kept the patient off thyroid hormone medicine, and measured the TSH a final time 2 months later.
The study reported that half the patients ultimately in the research group had their thyroid hormone therapy withdrawn.
According to researchers, "Patients were not monitored for a change in condition associated with the reduction or withdrawal of thyroid hormone therapy. Nursing staff and patients' attending physicians were notified that dose reductions were taking place for their patient, and they were asked to notify the investigators if a change in condition was noted."
At the same time, the study reports that "there were no reports during the study of any negative impact on the clinical status of the patients withdrawn. Reduction and discontinuation of thyroid hormone therapy are safe even for patients subsequently confirmed to be hypothyroid, as long as close attention is paid to follow-up measures of thyroid function. The study protocol might have been overly cautious; it would have been reasonable to discontinue thyroid hormone therapy in all patients with a normal baseline TSH level instead of the stepped reduction used here. "
The study references as justification some of the concerns of unnecessary use of thyroid hormone therapy, citing higher incidence of heart problems, possible increased risk of breast cancer, and the increased risk of osteoporosis. The study concludes by recommending that physicians with nursing home patients on thyroid hormone therapy should evaluate whether the patient is taking the medication for an appropriate indication.
This study presents many ethical and medical issues for consideration.
First, this study withdrew medication from people who were, by most measures, subclinically hypothyroid.
A cutoff level of 7 is, by all definitions, considered hypothyroid. In fact, by the most conventional criteria, a TSH that exceeds 4.0 to 5.5 -- depending on the lab's reference range -- is considered evidence of hypothyroidism. Some practitioners have long believed that TSH levels above 2.0 are in fact evidence of thyroid dysfunction, and that hypothyroidism symptoms, along with a TSH above 2, and in particular, elevated thyroid antibodies, are sufficient criteria for thyroid treatment. This theory has recently been embraced by the mainstream conventional endocrinology world, with the announcement of a major reversal at the American Association of Clinical Endocrinologists, who have announced that "Even though a TSH level between 3.0 and 5.0 uU/ml is in the normal range, it should be considered suspect since it may signal a case of evolving thyroid underactivity."
Second, this study cited as justifications three concerns that are by no means even proven, much less established, as risk factors of taking thyroid hormone replacement for subclinical hypothyroidism -- and in fact, are contrary to proven research.
For example, there is no clear evidence that proper treatment for subclinical hypothyroidism poses an increased risk of heart problems. In fact, in research published in the February, 2000 issue of the Annals of Internal Medicine, the opposite was found to be true. Researchers found that older women with subclinical hypothyroidism were almost twice as likely as women without this condition to have blockages in the aorta. They were also twice as likely to have had heart attacks. Hypothyroidism also increases the risk of elevated cholesterol and high triglycerides, both of which add to a patient's risk of heart attack and stroke.
The possible increased risk of breast cancer was also used as a justification. It's unclear where the researchers determined this to be justification for removing thyroid hormone, because there is no research definitively linking thyroid hormone replacement drugs to breast cancer risk, or even strongly suggesting it. Some researchers suggest that there is evidence that thyroid abnormalities may influence the progression of breast cancer. But other researchers strongly disagree, and have found contradictory evidence. The connection, if it exists, however, appears to be one that links autoimmune thyroid disease to increased breast cancer risk. There is also an increased risk of breast cancer among thyroid cancer patients who have received radioactive iodine. But when it comes to this study in quetion, there is no clear reason behind the theory that removing thyroid hormone from subclinically hypothyroid patients might reduce breast cancer risk.
The increased risk of osteoporosis was the third justification referenced. This is a very controversial theory, and one that has not been proven or agreed upon by experts. Many studies, in fact, refute this theory entirely. A study released in June, 2000, at the World Congress on Osteoporosis in Chicago, Illinois, found that taking thyroxine (i.e., Synthroid) does not increase the risk of osteoporosis. The research, presented by Dr. Martin Stenstrom of the University of Gothenburg in Sweden, studied more than 750 women who were taking prescribed thyroid medication for thyroid disease. Over an 18 month period, bone mineral density was measured, and compared to a control group who were not taking thyroid hormone. No differences were noted in bone mineral density between those taking the thyroid hormone, and the control group.
An October, 1998 study reported on in the Journal of Gynecological Endocrinology found that levothyroxine suppressive therapy, if carefully carried out and monitored, has no significant effect on bone mass. Gynecol Endocrinol 1998 Oct;12(5):333-7, "Bone mineral density in premenopausal women receiving levothyroxine suppressive therapy.").
The highly regarded Journal of Clinical Endocrinology and Metabolism found that even "suppressive," levothyroxine therapy -- prescribing medicine that lowers TSH levels to hyperthyroid levels below normal range -- if carefully carried out and monitored, has no significant effect on bone metabolism or bone mass. (
J Clin Endocrinol Metab 1994 Apr;78(4):818-23, "Carefully monitored levothyroxine suppressive therapy is not associated with bone loss in premenopausal women.")
A major thyroid-related journal, Thyroid, found that long-term levothyroxine therapy using suppressive doses has no significant adverse effects on bone.
(Thyroid, 1995 Feb;5(1):13-7, "Suppressive doses of thyroxine do not accelerate age-related bone loss in late postmenopausal women.")
Third, the study proclaimed that there was "no negative impact" to patients without allowing for the fact that many of the chronic symptoms of subclinical hypothyroidism appear over time.
In addition to contributing to a risk of heart disease, as discussed above, other proven risks associated with long-term subclinical hypothyroidism include:
Given that, as it stated in the writeup, "Patients were not monitored for a change in condition associated with the reduction or withdrawal of thyroid hormone therapy," how would these subtle signs of subclinical hypothyroidism be observed? And, while the report states, "there were no reports during the study of any negative impact on the clinical status of the patients withdrawn," in a study that lasted a total of four months, how could it be concluded that there is no negative impact on the status of the patients? Many symptoms of subclinical hypothyroidism require time to manifest themselves.
Fourth, the study's flawed conclusions may endanger nursing home patients whose physicians take the advice of the study and "evaluate whether the patient is taking the medication for an appropriate indication" according to the criteria and justifications presented by this researcher.
The questionable and medically unproven justifications for withdrawing thyroid hormone -- heart disease, breast cancer, and osteoporosis risk -- call into question the entire purpose of this study. Even then, before any conclusions can be drawn that removing elderly patients from thyroid hormone is safe -- much less justified -- patients who will be withdrawn from thyroid hormone would need to have baseline studies made of pychiatric function, depression, cholesterol and blood lipids, memory, cognitive function, and body weight, as well as qualitative assessments of energy levels and perceived fatigue. Followup studies after removal of thyroid hormone would then be carefully evaluated over time, looking for evidence of increasing clinical or subclinical depression, elevated blood lipids or cholesterol levels, reduced memory and cognitive function, increased body weight, and the patient's own assessment of energy levels. And this followup assessment would need to take place over time, ideally over at least one to two years, to assess subtle or slower changes that can result from longer-term subclinical hypothyroidism.
This study was poorly conceived and executed, and physicians who might consider using it to make patient care decisions would be well-advised to review the latest guidelines from the American Association of Clinical Endocrinology, as well as the recent research regarding the risks of subclinical hypothyroidism, before withdrawing what well may be a vitally necessary treatment from their elderly nursing home patients.
Contact the American Board of Family Practice to Express Your Concern About This Study
Email: general@abfp.org
John P. Geyman, M.D., Editor
Journal of the American Board of Family Practice
Department of Family Medicine
Box 354696
University of Washington
Seattle, WA 98195
Phone: (206) 685-3993
FAX: (206) 543-8911
Contact the Study's Author to Register Your Concern
If you have concerns about this study, contact the study's author:
Patrick P. Coll
Email Him Now: COLL@NSO1.UCHC.EDU
Mail:
MB, BCh, Center on Aging, MC-5215
University of Connecticut Health Center
Farmington, CT 06030-5215.
| Contact Mary Shomon by Phone! |
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