Looking for:
Prednisone and hashimotos disease |
Prednisone and hashimotos disease. Preoperative Steroids in Autoimmune Thyroid Disease
Cases Journal volume 2Article number: Cite this article. Metrics details. Hashimoto's Encephalopathy is an unusual condition associated with Hashimoto's Thyroiditis. This immune-mediated, steroid-dependent entity was first described thirty years ago.
In this case report, we discuss the importance of considering this diagnosis in the evaluation of confusion. The patient is a year-old African-American woman residing in United States, who was admitted to the hospital with a four-day history of mental status changes. There was no reported seizure activity. The patient's vital signs were stable on admission. On examination, the patient was awake, alert, oriented to place and time. Her neurological examination revealed agraphia and dyslexia.
Her speech showed lack of fluency and hesitation. Her complete blood count and electrolytes were within normal limits. The patient's brain CT scan did not reveal any significant findings. Her Magnetic Resonance Imaging only revealed mild chronic microangiopathy, which caused by "small vessel disease. Cerebral spinal fluid analysis was likewise did not reveal a cause for this patient's acute onset of confusion.
She was subsequently given mg of intravenous Methylprednisolone daily for 3 days. This three-day course of high-dose, intravenous steroids resulted complete resolution of the patient's symptoms. She was then discharged on an eleven-day course of oral prednisone 60 mg. Hashimoto's Encephalopathy should be considered in the differential diagnosis of an acute confusional state since it is responsive to steroid therapy and represents a readily reversible cause acute mental status changes.
Clues to this diagnosis include elevated antithyroid antibodies, abnormal Thyroid stimulating hormone values, and exclusion of other causes of acute mental status changes. Hashimoto's encephalopathy HE is a rare clinical syndrome that has been associated with elevated anti thyroid antibodies.
This immune-mediated, steroid-dependent entity was first described in [ 1 ]. It is more commonly seen in women. Since this condition can result in seizure activity and requires treatment beyond simple hormone replacement, it must be entertained in the differential diagnosis of mental status changes in a patient with hypothyroidism.
We present the case of one such patient who presented with an acute confusional state due to Hashimoto's encephalopathy. A year-old African-American woman residing in United States was admitted to the hospital with a four-day history of mental status changes complicated by left-sided weakness. Her family reported that she had been acting strange, including exhibiting aggressive behavior towards her niece. On interview, the patient reported that her family members were trying to hurt her.
This patient also reported auditory hallucinations, stating, "fire alarms were constantly going off in her house. She did not have any past psychiatric or seizure history. Review of systems was only notable for the issues already discussed. On examination, the patient was awake, alert, and oriented only to her name. Examination of heart, lungs and abdomen were within normal limits.
Thyroid examination was likewise within normal limits. Her neurological examination revealed disorientation to place and time, poor memory, agraphia, dyslexia, and an unusual form of aphasia where the patient was observed to be unable to read or write, but was able to spell words on request.
Her speech showed lack of fluency and marked hesitation. Her pupils were equal and reactive-to-light. Fundoscopic examination could not be successfully performed due to the presence of bilateral cataracts. Cranial nerve and sensory examination showed no abnormalities. Muscle strength and deep tendon reflexes were within normal limits.
Results of complete blood count testing were within normal limits. The patient's RPR was negative. Free T4 was not done due to the patient's refusal. Cerebral spinal fluid analysis was within normal limits. Likewise, the patient's electroencephalogram did not show any seizure activity or evidence of encephalopathy. Her magnetic resonance imaging revealed mild, chronic microangiopathy.
The patient was subsequently given mg of intravenous Methylprednisolone, repeated daily, for a total of 3 days. This three-day course of high-dose, intravenous steroids resulted in resolution of the patient's symptoms. She was then discharged on an eleven-day course of oral prednisone 60 mg, for a total of fourteen days of therapy. She has subsequently been followed in a community clinic in her home town.
To date, no recurrence of symptoms has been reported. Despite its eponym, Hashimoto's Encephalopathy HE [ 2 ] is only related to Hashimoto's Thyroiditis by the common presence of anti-thyroid antibodies.
Clinical manifestations most often consist of an acute to sub-acute onset of confusion associated with an alteration of consciousness, seizure activity, or myoclonus, and may include hallucinations and delusions. In reviewing the multitude of conditions that may lead to progressive mental status changes in an elderly patient, such conditions as metabolic derangements, autoimmune conditions, paraneoplastic encephalopathy, infection, psychiatric illness, and progressive neurologic conditions must be considered.
HE distinguishes itself through its rapid deterioration in mental status, lack of specific electrolyte or radiographic abnormalities, and specific response to immunosuppressive and immunomodulating agents. Although prion-related encephalopathies, such as Creutzfeldt-Jakob Disease CJDare considered in the differential diagnosis of HE, the rapid decline in mental status seen in HE distinguishes it from CJD, which causes a slower decline in functional status, and ultimately results in death [ 3 ].
The exact etiology for this neurological state is not known. As elevated immunoglobulin levels are usually seen in this condition, an inflammatory state has been conjectured to be pathologically responsible [ 4 ].
Given this condition's similarities to non-vasculitic, autoimmune, inflammatory meningoencephalopathies, it has been suggested that this condition's name should be changed to "Steroid Responsive Encephalopathy Associated with Autoimmune Thyroiditis," in order to better characterize what we know about the pathophysiology of this condition [ 5 ].
Over the last 40 years, the diagnosis of this condition has been hindered by a lack of universally agreed upon diagnostic features.
In response to this ambiguity, more clearly defined criteria have been delineated and include encephalopathy with neuropsychiatric features, seizure activity or focal neurologic deficits; presence of antithyroid antibodies; euthyroid status or mild hypothyroidism; no compelling evidence for a more likely etiology, and reversal of symptoms with steroid administration [ 6 ]. Laboratory evaluation is critical to making this diagnosis and will typically show an elevated serum level of anti-thyroperoxidase antibody or anti-thyroglobulin antibody.
These antibodies, though frequently present, are not felt to be pathogenic, but simply a marker for an underlying disease, possibly an inflammatory meningoencephalopathy.
Since cases of HE have been described in patients with a background metabolic milieu in the euthyroid, hyperthroid, and hypothyroid range, HE is felt not be related to thyroid disease.
Cerebrospinal fluid analysis CSF is abnormal in approximately 80 percent of patients, usually revealing an elevated CSF protein levels. Other CSF findings include lymphocytic pleocytosis as well as the presence of oligoclonal bands and immune complexes [ 78 ].
In the case of our patient, no such abnormalities were discerned. Nonspecific electroencephalographic EEG abnormalities are seen in 90 to 98 percent of patients with the most common finding being nonspecific slowing of background activity [ 9 ].
Again, in the case of our index patient, no diagnostic abnormalities were found. Magnetic resonance imaging in patients with Hashimoto's encephalopathy is usually normal. In some patients, particularly those with concomitant cerebral atrophy, T2 signal abnormalities of white matter are noted.
Recognizing that the acute confusional state seen in HE is not related to thyroid status and may exacerbate any mental status changes associated with severe hyperthyroidism or hypothyroidism, correction or near correction of thyroid function abnormalities is frequently required for the diagnosis of this condition.
This condition must be considered separate from confusion related to thyroid disease since the addition of immunomodulating agents will be required for its specific treatment. Despite the fact that corticosteroids are widely accepted as the standard treatment for HE, there is no consensus on indications for usage or pharmacologic dosing [ 10 ].
There appears to be not consensus on the optimal dose or duration of steroid therapy. One approach advocates a dose of oral Prednisone ranging from 50 to mg each day. Another approach recommends the use of high dose, intravenous Methylprednisone, although there are no studies comparing outcomes using the different administration and dosing strategies. In the case series described by Castillo et al. The three remaining patients received between ten to thirty days of oral Prednisone, ranging in doses from mg.
In the case of patients who cannot tolerate corticosteroids or who do not respond to corticosteroids, agents such as Azathioprine and Cyclophosphamide have been employed.
In other refractory cases, clinical improvement has been documented using either intravenous immunoglobulin or plasmapheresis [ 11 ]. Hashimoto's encephalopathy is an uncommon complication of thyroid disease, which is readily treatable with conventional modes of pharmacotherapy. As our case and the available literature show, a rapid reversible in the patient's confusion and neurologic debility can be affected after the initiation of therapy.
Furthermore, the literature maintains that this disease entity distinguishes itself from confusional states associated with thyroid hormone derangements by its response to steroids or other therapies for autoimmune disease. Our patient exhibited such a response. Thus, although this condition may be considered rare, its sensitivity to medical intervention necessitates that we consider it in our differential diagnosis for acute, and possibly long-term, confusional states; if we do not, we will miss a readily reversible cause for mental status changes.
Written informed consent was obtained from the patient for publication of this case report. A copy of the written consent is available for review by the Editor-in-Chief of this journal.
Arch Neurol. Article PubMed Google Scholar. J Neurol Sci. Article Google Scholar. J Neurol Neurosurg Psychiatry. CNS Drugs. Eur Neurol. J Clin Endocrinol Metab. Download references. You can also search for this author in PubMed Google Scholar. Correspondence to Pramil Cheriyath.
❿Preoperative Steroids in Autoimmune Thyroid Disease - Full Text View - localhost
Graves' disease and Hashimoto's thyroiditis are autoimmune conditions affecting the thyroid gland. Surgery to remove the thyroid gland in these patients may be complicated by the inflammatory nature of these diseases. Prednisone is a steroid medication used to decrease inflammation of the thyroid gland in other disease states such as sub-acute thyroiditis, but has not been used systematically to reduce inflammation in patients about to undergo surgery.
This is a pilot project that proposes to randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult.
This could potentially lead to better outcomes for these patients, as well as increased time to recovery and improved quality of life. This project proposes to administer short quality of life surveys at three time points, as well as draw additional labs to measure inflammation and antibody levels at times when patients will already be getting labs drawn for clinical purposes.
The purpose of this study is to generate preliminary data from which a larger, blinded, placebo-controlled trial could be designed. Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on:.
Update: Protocol amendment approved on Study team decided to omit the aim 'antibody-mediated cytokine levels' from the protocol and consent process as it became cost-prohibitive for processing and storage fees. Cytokine levels are not something typically collected or tracked in the course of clinical care, and may not be relevant.
Study can proceed without this aim and will not alter the main outcome measures of antibody levels and difficulty of the operation. This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid.
Any that were positive pre-op will be measured at each time point. Change in Antibody-mediated cytokine levels [ Time Frame: baseline weeks prior to surgery , up to 4 weeks Post Operative Day 1 , up to 6 weeks 2 weeks post-op , up to 30 weeks 6 months post-op ] Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex.
Change in Short Form Health Survey SF Score [ Time Frame: baseline weeks prior to surgery , up to 10 weeks 6 weeks post-op , up to 30 weeks 6 months post-op ] The SF is a item quality of life survey to understand how the participant feels and how well they are able to do their normal activities. It is scored on a scale of , with higher numbers indicating higher quality of life.
Change in Thyroid-specific quality of life patient-reported outcome measure for benign thyroid disorders ThyPRO Score [ Time Frame: baseline weeks prior to surgery , up to 10 weeks 6 weeks post-op , up to 30 weeks 6 months post-op ] The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life.
It is scored on a scale of with higher scores indicating worse quality of life. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. In the case series described by Castillo et al. The three remaining patients received between ten to thirty days of oral Prednisone, ranging in doses from mg.
In the case of patients who cannot tolerate corticosteroids or who do not respond to corticosteroids, agents such as Azathioprine and Cyclophosphamide have been employed. In other refractory cases, clinical improvement has been documented using either intravenous immunoglobulin or plasmapheresis [ 11 ]. Hashimoto's encephalopathy is an uncommon complication of thyroid disease, which is readily treatable with conventional modes of pharmacotherapy. As our case and the available literature show, a rapid reversible in the patient's confusion and neurologic debility can be affected after the initiation of therapy.
Furthermore, the literature maintains that this disease entity distinguishes itself from confusional states associated with thyroid hormone derangements by its response to steroids or other therapies for autoimmune disease. Our patient exhibited such a response. Thus, although this condition may be considered rare, its sensitivity to medical intervention necessitates that we consider it in our differential diagnosis for acute, and possibly long-term, confusional states; if we do not, we will miss a readily reversible cause for mental status changes.
Written informed consent was obtained from the patient for publication of this case report. A copy of the written consent is available for review by the Editor-in-Chief of this journal. Arch Neurol. Article PubMed Google Scholar. J Neurol Sci. Article Google Scholar. J Neurol Neurosurg Psychiatry. CNS Drugs. Eur Neurol. J Clin Endocrinol Metab. Download references. You can also search for this author in PubMed Google Scholar. Correspondence to Pramil Cheriyath. PC was the major contributor in writing the manuscript.
VN also contributed in writing the manuscript. SQ wrote the neurological part of the manuscript, AS wrote the endocrinology part of the manuscript. DF reviewed the manuscript making the important corrections. Reprints and Permissions. Cheriyath, P. Acute confusional state caused by Hashimoto's encephalopathy in a patient with hypothyroidism: a case report.
Cases Journal 2 , Download citation. Received : 29 January Accepted : 16 March Published : 19 June Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative.
Skip to main content. Search all BMC articles Search. Download PDF. Abstract Introduction Hashimoto's Encephalopathy is an unusual condition associated with Hashimoto's Thyroiditis. Case presentation The patient is a year-old African-American woman residing in United States, who was admitted to the hospital with a four-day history of mental status changes.
Conclusion Hashimoto's Encephalopathy should be considered in the differential diagnosis of an acute confusional state since it is responsive to steroid therapy and represents a readily reversible cause acute mental status changes. In some cases, as in our second patient a teacher , this may cause problems at work. To the best of our knowledge, this has not been previously published. Of note in the first patient was the strong association of autoimmune disease, suggesting potent immune activation.
Likewise of note in the second patient was the onset of pain after 8 years of hypothyroidism, which caused the condition to be initially mistaken for SAT. In conclusion, we provide a new therapeutic alternative for painful Hashimoto's thyroiditis, where to date surgery has been the only alternative when other management options fail. Tratamiento con glucocorticoides intratiroideos en la tiroiditis de Hashimoto dolorosa.
Resultado en 2 pacientes. Endocrinol Diabetes Nutr. Successful treatment of painful Hashimoto's thyroiditis with intrathyroidal ISSN: Previous article Next article. Issue 9. Pages November More article options. DOI: Successful treatment of painful Hashimoto's thyroiditis with intrathyroidal injection of glucocorticoid in two patients. Download PDF. Miguel Paja a ,. Corresponding author. This item has received. Article information.
Full Text. Figure 1. Pearce, A. Farwell, L. N Engl J Med, , pp. Rotondi, V. Capelli, P. Locantore, A. Pontecorvi, L. Painful Hashimoto's thyroiditis: myth or reality?. J Endocrinol Invest, 40 , pp. Kon, L. Painful Hashimoto's thyroiditis as an indication for thyroidectomy: clinical characteristics and outcome in seven patients. J Clin Endocrinol Metab, 88 , pp. Ohye, S. Fukata, S. Kubota, I. Sasaki, Y. Takamura, F. Matsuzuka, et al. Successful treatment for recurrent painful Hashimoto's thyroiditis by total thyroidectomy.
Thyroid, 15 , pp. Nagata, N.
❾-50%}Prednisone and hashimotos disease.
We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Preoperative Steroids in Autoimmune Thyroid Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : October 5, Study Description.
This pilot project will randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult. It will enroll 30 participants who will each be on study for up to 7 months. Detailed Description:. These specific aims are: Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on: Difficulty of surgery and rates of surgical complications Serum autoantibody levels Longitudinally assess the impact of surgical treatment on QoL in patients with autoimmune thyroid disease Update: Protocol amendment approved on Study team decided to omit the aim 'antibody-mediated cytokine levels' from the protocol and consent process as it became cost-prohibitive for processing and storage fees.
Drug Information available for: Prednisone. FDA Resources. Arms and Interventions. Outcome Measures. The total possible range of scores from , higher scores indicate increased difficulty in thyroid surgery. Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex.
The SF is a item quality of life survey to understand how the participant feels and how well they are able to do their normal activities.
The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life.
Eligibility Criteria. The patient was subsequently given mg of intravenous Methylprednisolone, repeated daily, for a total of 3 days. This three-day course of high-dose, intravenous steroids resulted in resolution of the patient's symptoms.
She was then discharged on an eleven-day course of oral prednisone 60 mg, for a total of fourteen days of therapy. She has subsequently been followed in a community clinic in her home town. To date, no recurrence of symptoms has been reported. Despite its eponym, Hashimoto's Encephalopathy HE [ 2 ] is only related to Hashimoto's Thyroiditis by the common presence of anti-thyroid antibodies. Clinical manifestations most often consist of an acute to sub-acute onset of confusion associated with an alteration of consciousness, seizure activity, or myoclonus, and may include hallucinations and delusions.
In reviewing the multitude of conditions that may lead to progressive mental status changes in an elderly patient, such conditions as metabolic derangements, autoimmune conditions, paraneoplastic encephalopathy, infection, psychiatric illness, and progressive neurologic conditions must be considered. HE distinguishes itself through its rapid deterioration in mental status, lack of specific electrolyte or radiographic abnormalities, and specific response to immunosuppressive and immunomodulating agents.
Although prion-related encephalopathies, such as Creutzfeldt-Jakob Disease CJD , are considered in the differential diagnosis of HE, the rapid decline in mental status seen in HE distinguishes it from CJD, which causes a slower decline in functional status, and ultimately results in death [ 3 ].
The exact etiology for this neurological state is not known. As elevated immunoglobulin levels are usually seen in this condition, an inflammatory state has been conjectured to be pathologically responsible [ 4 ]. Given this condition's similarities to non-vasculitic, autoimmune, inflammatory meningoencephalopathies, it has been suggested that this condition's name should be changed to "Steroid Responsive Encephalopathy Associated with Autoimmune Thyroiditis," in order to better characterize what we know about the pathophysiology of this condition [ 5 ].
Over the last 40 years, the diagnosis of this condition has been hindered by a lack of universally agreed upon diagnostic features.
In response to this ambiguity, more clearly defined criteria have been delineated and include encephalopathy with neuropsychiatric features, seizure activity or focal neurologic deficits; presence of antithyroid antibodies; euthyroid status or mild hypothyroidism; no compelling evidence for a more likely etiology, and reversal of symptoms with steroid administration [ 6 ].
Laboratory evaluation is critical to making this diagnosis and will typically show an elevated serum level of anti-thyroperoxidase antibody or anti-thyroglobulin antibody.
These antibodies, though frequently present, are not felt to be pathogenic, but simply a marker for an underlying disease, possibly an inflammatory meningoencephalopathy. Since cases of HE have been described in patients with a background metabolic milieu in the euthyroid, hyperthroid, and hypothyroid range, HE is felt not be related to thyroid disease.
Cerebrospinal fluid analysis CSF is abnormal in approximately 80 percent of patients, usually revealing an elevated CSF protein levels. Other CSF findings include lymphocytic pleocytosis as well as the presence of oligoclonal bands and immune complexes [ 7 , 8 ].
In the case of our patient, no such abnormalities were discerned. Nonspecific electroencephalographic EEG abnormalities are seen in 90 to 98 percent of patients with the most common finding being nonspecific slowing of background activity [ 9 ]. Again, in the case of our index patient, no diagnostic abnormalities were found. Magnetic resonance imaging in patients with Hashimoto's encephalopathy is usually normal.
In some patients, particularly those with concomitant cerebral atrophy, T2 signal abnormalities of white matter are noted. Recognizing that the acute confusional state seen in HE is not related to thyroid status and may exacerbate any mental status changes associated with severe hyperthyroidism or hypothyroidism, correction or near correction of thyroid function abnormalities is frequently required for the diagnosis of this condition.
This condition must be considered separate from confusion related to thyroid disease since the addition of immunomodulating agents will be required for its specific treatment. Despite the fact that corticosteroids are widely accepted as the standard treatment for HE, there is no consensus on indications for usage or pharmacologic dosing [ 10 ]. There appears to be not consensus on the optimal dose or duration of steroid therapy. One approach advocates a dose of oral Prednisone ranging from 50 to mg each day.
Another approach recommends the use of high dose, intravenous Methylprednisone, although there are no studies comparing outcomes using the different administration and dosing strategies. In the case series described by Castillo et al.
The three remaining patients received between ten to thirty days of oral Prednisone, ranging in doses from mg. In the case of patients who cannot tolerate corticosteroids or who do not respond to corticosteroids, agents such as Azathioprine and Cyclophosphamide have been employed. In other refractory cases, clinical improvement has been documented using either intravenous immunoglobulin or plasmapheresis [ 11 ].
Hashimoto's encephalopathy is an uncommon complication of thyroid disease, which is readily treatable with conventional modes of pharmacotherapy. As our case and the available literature show, a rapid reversible in the patient's confusion and neurologic debility can be affected after the initiation of therapy. Furthermore, the literature maintains that this disease entity distinguishes itself from confusional states associated with thyroid hormone derangements by its response to steroids or other therapies for autoimmune disease.
Our patient exhibited such a response. Thus, although this condition may be considered rare, its sensitivity to medical intervention necessitates that we consider it in our differential diagnosis for acute, and possibly long-term, confusional states; if we do not, we will miss a readily reversible cause for mental status changes. Written informed consent was obtained from the patient for publication of this case report.
A copy of the written consent is available for review by the Editor-in-Chief of this journal. Arch Neurol. Locantore, A. Pontecorvi, L.
Painful Hashimoto's thyroiditis: myth or reality?. J Endocrinol Invest, 40 , pp. Kon, L. Painful Hashimoto's thyroiditis as an indication for thyroidectomy: clinical characteristics and outcome in seven patients. J Clin Endocrinol Metab, 88 , pp. Ohye, S. Fukata, S. Kubota, I. Sasaki, Y. Takamura, F. Matsuzuka, et al. Successful treatment for recurrent painful Hashimoto's thyroiditis by total thyroidectomy. Thyroid, 15 , pp. Nagata, N.
Aoki, G. Treatment of thyroid diseases with intrathyroidal injection of glucocorticoid. Nihon Naibunpi Gakkai Zasshi, 50 , pp. Sanasam, D. Singh, N. Lyngdoh, P. Intrathyroid injection of triamcinolone acetonide in thyroid swelling disorders. Santosh, K. Prashanth, H. Manjunatha, K. Sumanth, K. Intrathyroid injection of steroid in benign thyroid swellings.
J Clin Diagn Res, 9 , pp. Vannucchi, I. Campi, D. Covelli, L. Forzenigo, P. Beck-Peccoz, M. Treatment of pretibial myxedema with dexamethazone injected subcutaneously by mesotherapy needles. Thyroid, 23 , pp. Mao, H. Li, Q. Li, D. Li, X. Xie, G. Yin, et al. J Clin Endocrinol Metab, 94 , pp. Mazza, F.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. Graves' disease and Hashimoto's thyroiditis are autoimmune conditions affecting the thyroid gland. Surgery to remove the thyroid gland in these patients may be complicated by the inflammatory nature of these diseases.
Prednisone is a steroid medication used to decrease inflammation of the thyroid gland in other disease states such as sub-acute thyroiditis, but has not been used systematically to reduce inflammation in patients about to undergo surgery. This is a pilot project that proposes to randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult.
This could potentially lead to better outcomes for these patients, as well as increased time to recovery and improved quality of life. This project proposes to administer short quality of life surveys at three time points, as well as draw additional labs to measure inflammation and antibody levels at times when patients will already be getting labs drawn for clinical purposes. The purpose of this study is to generate preliminary data from which a larger, blinded, placebo-controlled trial could be designed.
Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on:. Update: Protocol amendment approved on Study team decided to omit the aim 'antibody-mediated cytokine levels' from the protocol and consent process as it became cost-prohibitive for processing and storage fees.
Cytokine levels are not something typically collected or tracked in the course of clinical care, and may not be relevant. Study can proceed without this aim and will not alter the main outcome measures of antibody levels and difficulty of the operation.
This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid. Any that were positive pre-op will be measured at each time point. Change in Antibody-mediated cytokine levels [ Time Frame: baseline weeks prior to surgeryup to 4 weeks Post Operative Day 1up to 6 weeks 2 weeks post-opup to 30 weeks 6 months post-op ] Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex.
Change in Short Form Health Survey SF Score [ Time Frame: baseline weeks prior to surgeryup to 10 weeks 6 weeks post-opup to 30 weeks 6 months post-op ] The SF is a item quality of life survey to understand how the participant feels and how well they are able to do their normal activities. It is scored on a scale ofwith higher numbers indicating higher quality of life. Change in Thyroid-specific quality of life patient-reported outcome measure for benign thyroid disorders ThyPRO Score [ Time Frame: baseline weeks prior to surgeryup to 10 weeks 6 weeks post-opup to 30 weeks 6 months post-op ] The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life.
It is scored on a scale of with higher scores indicating worse quality of life. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think!
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms.
Save this study. Warning You have reached the maximum number of saved studies Preoperative Steroids in Autoimmune Thyroid Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Last Update Posted : October 5, Study Description. This pilot project will randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult.
It will enroll 30 participants who will each be on study for up to 7 months. Detailed Description:. These specific aims are: Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on: Difficulty of surgery and rates of surgical complications Serum autoantibody levels Longitudinally assess the impact of surgical treatment on QoL in patients with autoimmune thyroid disease Update: Protocol amendment approved on Study team decided to omit the aim 'antibody-mediated cytokine levels' from the protocol and consent process as it became cost-prohibitive for processing and storage fees.
Drug Information available for: Prednisone. FDA Resources. Arms and Interventions. Outcome Measures. The total possible range of scores fromhigher scores indicate increased difficulty in thyroid surgery.
Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex. The SF is a item quality of life survey to understand how the participant feels and how well they are able to do their normal activities. The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Participants will be invited to join the study after the decision has been made to proceed with thyroidectomy as the clinical treatment of their autoimmune thyroid disease. Patients on any immunosuppressive regiment such as organ transplant patients or patients treated for other autoimmune condition Pregnant patients.
Patients being treated for active infection. Any patient for whom the surgeon feels steroids would provide a clear benefit ie. Extremely high auto-antibody levels with a very large, inflamed thyroid gland will be treated according to the clinical judgement of the surgeon. If a surgeon feels steroids are indicated and prescribes them, the patient will not be eligible for the trial.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Autoimmune disease Graves' Disease Hashimoto's Thyroiditis. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Thyroid Diseases. Drug: Prednisone. Phase 4. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Active Comparator: Steroids Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care.
Drug: Prednisone used to reduce inflammation Other Name: steroid drug. September 9, Key Record Dates.
Typically the immune suppressant prednisone is a standard treatment for autoimmune disease, but it's too aggressive for Hashimoto's. How can Prednisone affect your thyroid and adrenal health? issues that go along with the thyroid such as Hashimoto's or Graves' disease. Prednisone is a steroid medication used to decrease inflammation of the thyroid gland in other disease states such as sub-acute thyroiditis, but has not been. Subacute thyroiditis (SAT) is the most common painful thyroid disease and is a common cause of thyrotoxicosis. Characteristics of SAT include the following. After two months of oral prednisone dosing tapered from 30mg/day, of goiters of different origins was described.6,7 In thyroid autoimmune disease. Cranial nerve and sensory examination showed no abnormalities. As our case and the available literature show, a rapid reversible in the patient's confusion and neurologic debility can be affected after the initiation of therapy. More article options.It is the best journal to keep up to date with endocrine pathophysiology both in the clinical and in the research field. It publishes the best original articles of large research institutions, as well as prestigious reviews. The Impact Factor measures the average number of citations received in a particular year by papers published in the journal during the two preceding years.
SRJ is a prestige metric based on the idea that not all citations are the same. SJR uses a similar algorithm as the Google page rank; it provides a quantitative and qualitative measure of the journal's impact.
SNIP measures contextual citation impact by wighting citations based on the total number of citations in a subject field. Thyroid pain usually corresponds to subacute thyroiditis SAT , characterized by markedly elevated inflammatory markers, moderate thyrotoxicosis, no isotopic uptake, and occasional systemic involvement.
This possibly viral disorder usually responds quickly and completely to oral corticosteroids. Hashimoto's thyroiditis is characterized by intraglandular lymphocytic infiltration resulting in hypothyroidism, and is sometimes preceded by a hyperfunctional phase.
Hyperesthesia of the thyroid gland in response to palpation is common in the early inflammatory stages of the disease, and in isolated cases is associated with limiting pain. This condition is referred to as painful Hashimoto's thyroiditis PHT. Such presentations are usually self-limiting and respond to oral corticosteroids. In some cases affected patients also respond to the start of thyroxine therapy. A relapse on corticosteroid treatment being reduced or a lack of response to therapy sometimes leads to the indication of surgery to solve the problem.
We present two patients with PTH who, after failed oral therapy, received intrathyroidal triamcinolone injections, with an excellent response. Both patients gave their explicit consent to the publication of the present communication. Case 1: A year-old woman with contact dermatitis to nickel and PABA was referred in January due to pain in the region of the thyroid gland. Her sister and father had autoimmune hypothyroidism. The patient had experienced a tenderness of variable intensity in the region during the previous 9 months and provided an ultrasound report indicating thyroiditis of right-side predominance, with patchy hypoechogenic zones in the gland parenchyma.
Firm and sensitive asymmetrical grade I goiter was palpated. The TSH concentration was 3. The patient showed progressive improvement, with long intervals between only minimum symptoms, until discomfort returned after 2 years despite adequate TSH levels 1. The symptoms improved one week after the injection, with no side effects, and after 6 months the patient was virtually asymptomatic, with normal TSH levels, the same replacement therapy dose, and diminished thyroid gland volume upon palpation.
Case 2: A year-old woman consulted in December coming from another center, due to increasing thyroid pain during the previous 6 months, with occasional ear pain and exacerbation when speaking.
She worked as a teacher. The patient had been diagnosed with primary autoimmune hypothyroidism 8 years earlier, and was receiving replacement therapy with l -thyroxine, with adequate control TSH: 0. Her daughter had eosinophilic esophagitis. The condition had been interpreted at her reference center as corresponding to SAT, despite ESR 3 mm in the first hour and a fine needle aspiration biopsy revealing lymphocyte infiltration. She had been treated with nonsteroidal antiinflammatory drugs and subsequently with prednisone tapered from 45 mg daily, with no improvement.
The patient had also received high-dose omeprazole due to the possibility of peptic reflux. She presented an ultrasound report reflecting marked hypoechogenicity and profuse panlobular vascularization. Treatment with intrathyroidal corticosteroids was proposed. We administered 40 mg of triamcinolone acetonide under ultrasound guidance and using the same technique as with the previous patient Fig.
The pain subsided markedly within a week, with residual discomfort whenever she forced her voice. At the patient's request, a second infiltration was performed after three months using the same technique, and another two injections were made 6 and 12 months after the first. All the injections were well tolerated. Following the third injection the patient reported complete relief. However, after 5 months the discomfort returned, though with milder intensity and affecting only the left lobe.
A fourth infiltration was therefore decided upon. After 5 months the patient remained asymptomatic and had returned to work. An atrophic thyroid gland was revealed at ultrasound. Thyroid gland ultrasound showing the right lobe with global hypoechogenicity and the 21G needle used for the intraglandular infiltration of triamcinolone.
The first reports of intraglandular corticosteroid administration date from , 5 and more than 30 years later its use in reducing the volume of goiters of different origins was described. The treatment of PHT is important because of its impact upon patient quality of life, since speech exacerbates the symptoms by displacing the gland.
In some cases, as in our second patient a teacher , this may cause problems at work. To the best of our knowledge, this has not been previously published. Of note in the first patient was the strong association of autoimmune disease, suggesting potent immune activation.
Likewise of note in the second patient was the onset of pain after 8 years of hypothyroidism, which caused the condition to be initially mistaken for SAT. In conclusion, we provide a new therapeutic alternative for painful Hashimoto's thyroiditis, where to date surgery has been the only alternative when other management options fail. Tratamiento con glucocorticoides intratiroideos en la tiroiditis de Hashimoto dolorosa.
Resultado en 2 pacientes. Endocrinol Diabetes Nutr. Successful treatment of painful Hashimoto's thyroiditis with intrathyroidal ISSN: Previous article Next article. Issue 9.
Pages November More article options. DOI: Successful treatment of painful Hashimoto's thyroiditis with intrathyroidal injection of glucocorticoid in two patients.
Download PDF. Miguel Paja a ,. Corresponding author. This item has received. Article information. Full Text. Figure 1. Pearce, A. Farwell, L. N Engl J Med, , pp.
Rotondi, V. Capelli, P. Locantore, A. Pontecorvi, L. Painful Hashimoto's thyroiditis: myth or reality?. J Endocrinol Invest, 40 , pp. Kon, L. Painful Hashimoto's thyroiditis as an indication for thyroidectomy: clinical characteristics and outcome in seven patients.
J Clin Endocrinol Metab, 88 , pp. Ohye, S. Fukata, S. Kubota, I. Sasaki, Y. Takamura, F. Matsuzuka, et al. Successful treatment for recurrent painful Hashimoto's thyroiditis by total thyroidectomy. Thyroid, 15 , pp. Nagata, N. Aoki, G. Treatment of thyroid diseases with intrathyroidal injection of glucocorticoid.
Nihon Naibunpi Gakkai Zasshi, 50 , pp. Sanasam, D. Singh, N. Lyngdoh, P. Intrathyroid injection of triamcinolone acetonide in thyroid swelling disorders. Santosh, K. Prashanth, H. Manjunatha, K.
Sumanth, K.
No comments:
Post a Comment