ࡱ>  bjbj )Gcc VVVjjj84<j_pA{L3e]*h p020183810The diagnoisis and management of primary hypothyroidism. Royal College College of Physicians. http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf Accessed on 06/09/2018.Generic3810The diagnoisis and management of primary hypothyroidism. Royal College College of Physicians. http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf Accessed on 06/09/2018.2018armour thyroidNot in File33(1) The Royal College of Physicians (RCP), the British Thyroid Association (BTA) and the European Thyroid Association (ETA) recommend that synthetic levothyroxine (tetra-iodothyronine, or T4) monotherapy is the standard treatment for hypothyroidism, due to the robust evidence supporting its use.  ADDIN REFMGR.CITE  ADDIN EN.CITE.DATA (1-3) Levothyroxine has a long half-life (1 week), giving relatively stable blood levels with minimal daily fluctuations in T4 (4). It is converted into liothyronine (T3) in the body and so a preparation of levothyroxine should provide T3 in an appropriate concentration.  ADDIN REFMGR.CITE Cooper19893719Thyroid hormone treatment: new insights into an old therapy.Journal3719Thyroid hormone treatment: new insights into an old therapy.Cooper,D.S.1989armour thyroidIn File26942695Journal of the American Medical Association26118Journal of the American Medical Association1(4). Liothyronine has a quicker onset (a few hours) and shorter duration of action (half-life is about 24 hours) than levothyroxine.  ADDIN REFMGR.CITE  ADDIN EN.CITE.DATA (2;5-8) Desiccated thyroid extracts (DTE), such as Armour Thyroid, NP Thyroid and Nature-Throid, are natural preparations derived from porcine (pig) thyroid glands. One grain of thyroid contains 38 micrograms (mcg) levothyroxine and 9mcg liothyronine per 65mg of the labelled amount of thyroid  ADDIN REFMGR.CITE 20183807Armour thyroid (thyroid tablets, USP). Allergan, Inc. Content updated: June 2018. http://www.allergan.com/assets/pdf/armourthyroid_pi Accessed on 05/09/2018.Generic3807Armour thyroid (thyroid tablets, USP). Allergan, Inc. Content updated: June 2018. http://www.allergan.com/assets/pdf/armourthyroid_pi Accessed on 05/09/2018.2018armour thyroidNot in File3320183805NP Thyroid (thyroid tablets, USP). Acella Pharmaceuticals, LLC. https://npthyroid.com/wp-content/uploads/2018/06/NP-Thyroid-Web-PI-6-27-18C-FPO1.pdf . Accessed 05/09/2018Generic3805NP Thyroid (thyroid tablets, USP). Acella Pharmaceuticals, LLC. https://npthyroid.com/wp-content/uploads/2018/06/NP-Thyroid-Web-PI-6-27-18C-FPO1.pdf . Accessed 05/09/20182018armour thyroidNot in File3320183806Nature-Throid (thyroid USP) tablets. RLC Labs. https://getrealthyroid.com/assets/docs/Nature-Throid-Prescribing-Information.pdf Accessed 05/09/18Generic3806Nature-Throid (thyroid USP) tablets. RLC Labs. https://getrealthyroid.com/assets/docs/Nature-Throid-Prescribing-Information.pdf Accessed 05/09/182018armour thyroidNot in File33(5-7), but this can be variable between batches.  ADDIN REFMGR.CITE Wiersinga20123801ETA Guidelines: The use of L-T4 + L-T3 in the treatment of hypothyroidismJournal3801ETA Guidelines: The use of L-T4 + L-T3 in the treatment of hypothyroidismWiersinga,W.MDuntas,LFadeye,V2012armour thyroidNot in File5571European Thyroid Journal1European Thyroid Journal1(3) Pigs have 2-3 times more T3 (relative to T4) than humans so a consistent effect cannot be guaranteed with DTE products.  ADDIN REFMGR.CITE 20183808Q&As to accompany to the 2015 BTA statement on the management of hypothyroidism. http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf Accessed 05/09/2018.Generic3808Q&As to accompany to the 2015 BTA statement on the management of hypothyroidism. http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf Accessed 05/09/2018.2018armour thyroidNot in File33(9) DTE products are not licensed in the UK and can cost the NHS twenty times more than a prescription of levothyroxine with no obvious benefit.  ADDIN REFMGR.CITE 20183808Q&As to accompany to the 2015 BTA statement on the management of hypothyroidism. http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf Accessed 05/09/2018.Generic3808Q&As to accompany to the 2015 BTA statement on the management of hypothyroidism. http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf Accessed 05/09/2018.2018armour thyroidNot in File33(9) While they are available in the US,  ADDIN REFMGR.CITE 20183807Armour thyroid (thyroid tablets, USP). Allergan, Inc. Content updated: June 2018. http://www.allergan.com/assets/pdf/armourthyroid_pi Accessed on 05/09/2018.Generic3807Armour thyroid (thyroid tablets, USP). Allergan, Inc. Content updated: June 2018. http://www.allergan.com/assets/pdf/armourthyroid_pi Accessed on 05/09/2018.2018armour thyroidNot in File3320183805NP Thyroid (thyroid tablets, USP). Acella Pharmaceuticals, LLC. https://npthyroid.com/wp-content/uploads/2018/06/NP-Thyroid-Web-PI-6-27-18C-FPO1.pdf . Accessed 05/09/2018Generic3805NP Thyroid (thyroid tablets, USP). Acella Pharmaceuticals, LLC. https://npthyroid.com/wp-content/uploads/2018/06/NP-Thyroid-Web-PI-6-27-18C-FPO1.pdf . Accessed 05/09/20182018armour thyroidNot in File3320183806Nature-Throid (thyroid USP) tablets. RLC Labs. https://getrealthyroid.com/assets/docs/Nature-Throid-Prescribing-Information.pdf Accessed 05/09/18Generic3806Nature-Throid (thyroid USP) tablets. RLC Labs. https://getrealthyroid.com/assets/docs/Nature-Throid-Prescribing-Information.pdf Accessed 05/09/182018armour thyroidNot in File33(5-7) they have not been approved by the US FDA as licensed drugs and have therefore not undergone rigorous clinical trials evaluating safety and efficacy. The RCP, the BTA and the ETA all state routine use of natural thyroid extracts is not generally recommended as they are inconsistent with normal physiology, have not been unequivocally proven to be of any benefit to patients and may be harmful in the long term. There is some concern that symptoms of hyperthyroidism can occur with high T3 levels post-dose, due to the shorter half-life of natural thyroid extracts. Furthermore, as the dose cannot be adjusted easily in the combination product, patients are likely to be receiving higher doses, particularly of T3, leading to a risk of osteoporosis and arrhythmia, in addition to unknown risks from long term use.  ADDIN REFMGR.CITE  ADDIN EN.CITE.DATA (1-3;9) A recently published NHS England document Items which should not be routinely prescribed in primary care advises against the use of liothyronine (including Armour Thyroid) except under exceptional circumstances when levothyroxine has failed and use is supported by a consultant NHS endocrinologist.  ADDIN REFMGR.CITE 20183809Items which should not routinely be prescribed in primary care: Guidance for CCGs. NHS England. https://www.england.nhs.uk/wp-content/uploads/2017/11/items-which-should-not-be-routinely-precscribed-in-pc-ccg-guidance.pdf Accessed 05/09/2018.Generic3809Items which should not routinely be prescribed in primary care: Guidance for CCGs. NHS England. https://www.england.nhs.uk/wp-content/uploads/2017/11/items-which-should-not-be-routinely-precscribed-in-pc-ccg-guidance.pdf Accessed 05/09/2018.2018armour thyroidNot in File33(10) Subsequently the  HYPERLINK "https://www.sps.nhs.uk/articles/rmoc-guidance-prescribing-of-liothyronine/" Regional Medicines Optimisation Committee (RMOC) published guidance which advised against the use of combination products containing DTE (e.g. Armour Thyroid) and gave further guidance to prescribers around exceptional circumstances, criteria and responsibilities for liothyronine prescribing.  ADDIN REFMGR.CITE 20183813Guidance - Prescribing of Liothyronine. Regional Medicines Optimisation Committee (RMOC). November 2018. https://www.sps.nhs.uk/wp-content/uploads/2018/11/RMOC-Liothyronine-Guidance-v2.0-final-1.pdf Accessed 09/11/2018.Generic3813Guidance - Prescribing of Liothyronine. Regional Medicines Optimisation Committee (RMOC). November 2018. https://www.sps.nhs.uk/wp-content/uploads/2018/11/RMOC-Liothyronine-Guidance-v2.0-final-1.pdf Accessed 09/11/2018.2018armour thyroidIn File33(11) This Q&A summarises the published clinical evidence for DTE products. Answer Few robust studies of desiccated thyroid have been carried out in the last 10 years. Most data are pre-1980 and many studies date from the 1950s to 1970s. These tend to be uncontrolled, open-label studies which compared desiccated thyroid with levothyroxine, not in terms of efficacy and safety but comparative potency, onset and duration of action, and effects on serum lipids; these have not been included in this Q&A.  ADDIN REFMGR.CITE  ADDIN EN.CITE.DATA (12-15) It is not clear whether studies comparing levothyroxine alone with levothyroxine/T3 combination can be extrapolated to desiccated thyroid. These studies have not been reviewed because they do not provide information supporting the clinical effectiveness of natural DTE. Randomised, double-blind trial There is only one randomised, prospective, double-blind study comparing the effectiveness of DTE with levothyroxine (n=70).  ADDIN REFMGR.CITE Hoang20133674Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study.Journal3674Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study.Hoang,T.D.Olsen,C.H.Mai,V.Q.Clyde,P.W.2013armour thyroidIn File19821990J.Clin.Endocrinol.Metab.985Journal of Clinical Endocrinology and MetabolismJ.Clin.Endocrinol.Metab.1(16) Patients with primary hypothyroidism on a stable dose of levothyroxine were randomised to treatment with either DTE or levothyroxine in identical appearing capsules. Each grain (65mg) of DTE (as Armour Thyroid) provided 38mcg levothyroxine and 9mcg liothyronine. The initial desiccated thyroid dose was based on the conversion: 1mg DTE = 1.667mcg levothyroxine. After 6 weeks of study medication, thyroid stimulating hormone (TSH) levels were checked and medication adjusted to maintain TSH between 0.5 and 3.0microIU/mL. Once the TSH was within range, medication was continued for at least another 12 weeks. Patients were then crossed over to the other treatment arm for 16 weeks, with TSH checked at 6 weeks as during the first treatment period. The primary outcome measures were the changes from baseline to endpoint of a number of assessments, including the Thyroid Symptom Questionnaire (TSQ), the quality of life General Health Questionnaire (GHQ)-12, the Wechsler memory scale (WMS-IV) and the Beck Depression Inventory (BDI). The WMS-IV included the auditory memory index (AMI) and the visual working memory index (VWMI). Subgroup analyses were carried out on patients who preferred desiccated thyroid or levothyroxine or who had no preference. A sample size of 67 was required to provide 80% power to detect a difference of 8 points on the TSQ. Primary outcome measures. Overall, the patients showed no difference in symptom scores, general health questionnaires or neuropsychological testing. During the DTE treatment period, there was a trend towards greater improvements in GHQ-12, TSQ and AMI and there was a reduction of 2.86lb in weight (p<0.001) compared to the levothyroxine treatment period. No study patient had a TSH level outside of the reference range. No adverse events were reported with any of the treatments; both were tolerated equally well. Patients had higher T3 serum levels during the DTE treatment period but no cardiovascular adverse events occurred. Patient preference. At the end of the study, 34 patients (49%) preferred DTE treatment, 13 (19%) preferred levothyroxine and 23 (33%) had no preference. The higher preference for DTE therapy was due to an average of 4lb weight loss during the DTE treatment compared with levothyroxine (p<0.001), (note that on average, these patients were 16lbs heavier at baseline than those patients who preferred levothyroxine), and improvements in subjective symptoms such as concentration, memory, sleep, decision-making capability, happiness and energy levels. Patients preferring DTE therapy did better on their neuropsychological measures compared with baseline [TSQ, GHQ-12 WMS-IV and BDI], while those preferring levothyroxine did better only on the WMS-IV. Predictors of preference for DTE. The best predictor for clinical preference for DTE was a lower TSQ score at endpoint. Patients with lower VWMI values on DTE were also more likely to favour DTE. Doses. The mean levothyroxine dose during the study was 119.2mcg and the mean DTE dose was 80.6mg. For the patients who preferred DTE treatment, their general well-being and thyroid symptoms were better controlled than with levothyroxine. It is possible that DTE may provide subtle improvements for some patients. The study is limited by its small size, low sensitivity of some of the neuropsychological tests and biochemical measures, no genetic testing for deiodinase polymorphisms and the lack of a washout period, although this may not have been deemed appropriate. Studies with a longer duration are required to clarify the efficacy and safety of DTE. Switching from desiccated thyroid to levothyroxine Thyroid hormone levels were compared in 40 patients who had their therapy switched from desiccated thyroid to levothyroxine and clinical benefits were assessed. ADDIN REFMGR.CITE Jackson19783667Why does anyone still use desiccated thyroxine USP?Journal3667Why does anyone still use desiccated thyroxine USP?Jackson,I.M.Cobb,W.E.1978armour thyroidIn File284Am.J.Med.197864American Journal of MedicineAm.J.Med.1(8) Seventeen patients had been treated for hypothyroidism and 23 patients received thyroid as medical therapy for thyroid gland suppression. The most common desiccated thyroid doses were 120mg-180mg per day (in 35/40 patients), which were switched to 150mcg to 200mcg levothyroxine daily. Serum thyroid hormone levels were measured while the patients were taking desiccated thyroid, and then at least 6 weeks after changing to levothyroxine. The mean T3 levels with desiccated thyroid were significantly higher than with levothyroxine: 289ng/dL vs. 176ng/dL, p<0.0005 [normal range, 70-180ng/dL]. The mean T4 level was significantly lower with desiccated thyroid than with levothyroxine: 7.4mcg/dL vs. 11.6mcg/dL, p<0.01 [normal range, 5-13mcg/dL]. When treated with desiccated thyroid, most patients (36/38) had T3 levels above the normal range and 39/40 had T4 levels in the low normal or normal range; raised T4 level was seen in a pregnant patient. One patient had a T3 level of 540ng/dL 3 hours post-dose, falling to 240ng/dL at 24 hours; supraphysiological levels of T3 have also been reported in a case series of 21 patients experiencing nervousness, palpitations and tremor post-dose. ADDIN REFMGR.CITE Lev-Ran19833677Part-of-the-day hypertriiodothryoninemia caused by desiccated thyroid.Journal3677Part-of-the-day hypertriiodothryoninemia caused by desiccated thyroid.Lev-Ran,A.1983armour thyroidIn File27902791Journal of the American Medical Association25020Journal of the American Medical Association1(17) When treated with levothyroxine, 17/40 patients had elevated T3 levels (two of the 17 patients had previously been taking 60mg desiccated thyroid) and 8/40 had raised T4 levels; three of the raised T3 and one of the raised T4 could be accounted for by pregnancy and all of the raised levels occurred in patients taking 200mcg, which may have been too high a dose. What this study showed is that symptoms of hyperthyroidism may occur following a daily dose of 120-180mg desiccated thyroid. Abnormally high T3 concentrations, measured 2-5 hours post-dose were seen in 90% of patients taking 90mg-180mg desiccated thyroid; while most tolerated this well, six patients had symptoms of hyperthyroidism and benefited from switching to levothyroxine. Raised T3 levels may be hazardous in some patients, especially those with cardiac disease. Changing to levothyroxine resulted in lower T3 and higher T4 levels, resembling those seen in normal subjects. One American resource suggests that clinicians use the following conversion factor: 1 grain (60mg) is equivalent to 100mcg T4. For a patient who is taking one and a half grains (90mg) of desiccated thyroid, an equivalent T4 dose ranges from 112-150mcg, with some clinicians preferring the higher 150mcg dose and slowly tapering the dose if the TSH measured six weeks after switching remains below the reference range. ADDIN REFMGR.CITE 20183811UpToDate. Treatment of primary hypothyroidism in adults. Wolters Kluwer N.V. www.uptodate.com Accessed 06/09/2018.Generic3811UpToDate. Treatment of primary hypothyroidism in adults. Wolters Kluwer N.V. www.uptodate.com Accessed 06/09/2018.2018armour thyroidNot in File33(18) Retrospective, practice-based reviews Three retrospective practice based reviews assessing the symptomatic effects of switching from levothyroxine to a desiccated thyroid treatment were identified. In the first, published in 1997, the records of 89 patients with hypothyroidism treated with levothyroxine but still symptomatic were compared with those of 832 untreated hypothyroid patients. ADDIN REFMGR.CITE Baisier20013673Thyroid insufficiency. Is thyroxine the only valuable drug?Journal3673Thyroid insufficiency. Is thyroxine the only valuable drug?Baisier,W.V.Hertoghe,J.Eeckhaut,W.2001armour thyroidIn File159166J Nutr Environ Med11J Nutr Environ Med1(19) Forty of the previously treated patients and 278 of the untreated patients were followed-up after treatment with natural desiccated thyroid. The investigators monitored eight main symptoms, (constipation, headache, muscle cramps, depression, Achilles, rheumatoid, cold, fatigue), scored as 0=no symptoms and 2=full-blown symptoms, giving a maximum score of 16. In the levothyroxine-treated patients prior to switching to desiccated thyroid (n=40), the prevalence of symptoms was comparable to that of the main group of untreated patients, with a mean symptom score of 10.7. The mean 24-hour urine free T3* level was 797.5pmol. The mean levothyroxine dose was 99.7mcg, given for a mean 33.2 months; most patients were taking between 76-100mcg/day. After switching to desiccated thyroid treatment, the mean symptom score fell from 10.7 to 3.6 and the mean 24-hour urine T3 rose from 767 to 1990pmol. Mean desiccated thyroid dose was 233mg, given for a mean 26.9 months. For the previously untreated patients, the mean symptom score fell from 10.1 to 3.6 and the 24-hour urine T3 rose from 752 to 1900pmol. The mean desiccated thyroid dose was 200mg, given for a mean 23 months. The investigators acknowledge that levothyroxine treatment can adequately treat patients with hypothyroidism. They also state that reliance on serum tests (TSH and free T4) than on clinical signs and 24-hour urine free T3 may lead to an insufficient dose of thyroid hormone to obtain satisfactory results. But, the investigators did not appear to consider the possibility that the 89 patients still symptomatic on levothyroxine may have simply required a dose increase to control their symptoms, but instead switched them to desiccated thyroid. For all patients, the 24-hour urine free T3 levels were low but were within the reference range. The study is limited by its retrospective nature, lack of control group and lack of titration of levothyroxine to control symptoms. * A 24-hour urine free T3 measured below the reference range indicates functional hypothyroidism. Free T3 measures the biologically active fraction of total T3, the majority of which is bound by protein carriers and is therefore inactive. The normal range is 592 1850pmol/24 hours. Another retrospective review (described as a retrospective observational study) was published in 2014. ADDIN REFMGR.CITE Pepper20143803Conversion to Armour Thyroid from Levothyroxine improved patient satisfaction in the treatment of hypothyroidism.Journal3803Conversion to Armour Thyroid from Levothyroxine improved patient satisfaction in the treatment of hypothyroidism.Pepper,G.MCasanova-Romero,P.Y2014armour thyroidNot in File1055Journal of Endocrinology, Diabetes and Obesity23Journal of Endocrinology, Diabetes and Obesity1(20) It investigated the observed preference for Armour Thyroid over levothyroxine in a subgroup of patients with hypothyroidism who reported dissatisfaction with levothyroxine monotherapy. Of the 450 patients treated at a single outpatient endocrinology practice over 3 months, 154 patients (34%, average age 53 years) self-reported failure of levothyroxine monotherapy. Despite having normal thyroid hormone levels, they reported persistent fatigue, cold intolerance, constipation, myalgia and unexplained weight gain. They were switched from levothyroxine (average dose prior to switch not documented) to Armour Thyroid (mean dose post switch 92.3 +/- 28.6mg), excluding those with thyroid cancer or nodular thyroid therapy. It is not clear from the manuscript whether the dose of levothyroxine was optimised prior to switching. After at least 4 weeks on Armour Thyroid, patients were asked to compare Armour Thyroid and levothyroxine using a 5 point patient Satisfaction Rating Scale (=SRS, where 1 means that Armour Thyroid is definitely worse than levothyroxine and 5 means that Armour Thyroid is definitely better than levothyroxine). Of the 154 patients switched, 78% scored >3 and they were classed as responders. Thirty three patients (21%) scored d"3; they were classed as non-responders. The average mean SRS scores for responders vs. non responders was 4.79 vs. 2.70, p<0.001. TSH levels checked after the switch did not differ to levels taken before the switch (1.30 vs. 1.34 mIU/L, p=ns). T3 levels, however, increased after the switch (1.18 vs. 1.50 pmol/L, p<0.003) and the T4:T3 ratio was lowered when patients were switched (4.70 vs. 8.45, p<0.001). Despite this, reported patient satisfaction and biochemistry did not correlate and there was no significant change in average weight after switching (75.9kg vs. 74.4kg). No adverse reactions were reported. This study suggests that in patients already dissatisfied with their hypothyroid symptom management with levothyroxine despite being biochemically euthyroid, switching to Armour Thyroid increases their level of perceived satisfaction. Larger, prospective studies with a suitable control group are needed to clarify whether Armour Thyroid has a role in the management of hypothyroidism. There were several limitations. Although a relatively high proportion of patients (78%) reported satisfaction with the switch from levothyroxine to Armour Thyroid, this is the expected result of a selection bias for patients already dissatisfied with levothyroxine treatment. The study did not involve any blinding which would have compounded this bias. The study was relatively small and of short duration and the five point SRS scale used is not a validated scale. Furthermore, the paper is published in an open access journal and there are small discrepancies between the numerical results published in the abstract and the main text. Given the discrepancies and noting that such journals often charge authors a fee for publication, there is concern about whether the manuscript of the study was adequately peer reviewed prior to publication. ADDIN REFMGR.CITE Pepper20143803Conversion to Armour Thyroid from Levothyroxine improved patient satisfaction in the treatment of hypothyroidism.Journal3803Conversion to Armour Thyroid from Levothyroxine improved patient satisfaction in the treatment of hypothyroidism.Pepper,G.MCasanova-Romero,P.Y2014armour thyroidNot in File1055Journal of Endocrinology, Diabetes and Obesity23Journal of Endocrinology, Diabetes and Obesity1Butler20133804The dark side of publishing.Journal3804The dark side of publishing.Butler,D2013armour thyroidNot in File433435Nature495Nature1(20;21) The most recent retrospective review was published in 2018. ADDIN REFMGR.CITE Tariq20183812Effects of long-term combination LT4 and LT3 therapy for improving hypothyroidism and overall quality of life.Journal3812Effects of long-term combination LT4 and LT3 therapy for improving hypothyroidism and overall quality of life.Tariq,AWert,YCheriyath,P2018armour thyroidNot in File363369South.Med.J.1116Southern Medical JournalSouth.Med.J.1(22) It investigated the clinical and biochemical effects of the addition of T3 therapy to the standard T4 in hypothyroid patients by use of DTE or levothyroxine/T3 combination. Of the 2400 patients treated at a single endocrinology clinic, 100 patients complained of signs and symptoms of hypothyroidism despite optimal TSH levels (and continued to have low T3), and were switched to either DTE (n= 57) or levothyroxine/T3 combination with a ratio of 4:1 (n=37). Dosage adjustments were made to achieve physiological and therapeutic T3 levels along with symptom relief. The mean follow-up duration was 27 months (range 1111 months).The average dose of DTE was 30 mg, and for this population, the average TSH remained normal in 96.5% of patients (P < 0.05), and T4 remained normal in 96.5% of patients (P=1). Average T3 levels remained normal in 93.6% of patients vs. 74.5% prior to the switch in therapy (P < 0.005), and 4.3% of patients had T3 levels below range compared to 21.3% prior to the switch in therapy. None of the patients with low TSH or high T4 and T3 were hospitalised for adverse effects or arrhythmias. Fifty-one patients receiving DTE participated in the Medical Outcomes Study Short Form-20 questionnaire (SF-20) to evaluate daily symptoms of hypothyroidism; 92% of patients answered feeling excellent, very good, or good when questioned about self-health and 86.8% reported feeling calm and peaceful, and 88.2% reported being a happy person. The authors suggest in this subset population, symptoms of hypothyroidism improved significantly as well as quality of life, with no increase in hyperthyroidism. There are several limitations to these conclusions, including the retrospective nature, lack of comparison with T4 monotherapy and the fact that the SF-20 questionnaire was not conducted before the switch in therapy for comparison. In addition, the studied population had optimal TSH levels but continued to have low T3, however, according to the BTA, the clinical significance of low T3 levels is unknown.  ADDIN REFMGR.CITE Okosieme20153802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Journal3802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Okosieme,OGilbert,JAbraham,P2015armour thyroidNot in File110Clinical Endocrinology0Clinical Endocrinology1(2) Summary Desiccated thyroid extract (DTE) is derived from porcine (pig) thyroid gland. One grain contains 38mcg levothyroxine (T4) and 9mcg liothyronine (T3) per 65mg of the labelled amount of thyroid. Prescribers and patients should be aware that the amount of thyroid hormone in the thyroid gland can vary from animal to animal and between batches of product so a consistent effect cannot be guaranteed with desiccated thyroid extract products. Products such as Armour Thyroid, which contain thyroid extract, are not licensed in the UK. These products are available more widely in the US but they have not been approved by the US FDA as licensed drugs and have therefore not undergone rigorous clinical trials evaluating safety and efficacy. The FDA has urged companies who market unapproved drug products, including thyroid products, to carry out such studies and submit applications for their approval as new drugs. The Royal College of Physicians, the British Thyroid Association and the European Thyroid Association all recommend that, for the vast majority of patients, levothyroxine alone is used in the treatment of hypothyroidism for underactivity of the thyroid gland. Routine use of thyroid extracts including Armour Thyroid is not recommended because this is inconsistent with normal physiology, they have not been unequivocally proven to be of any benefit to patients and they may be harmful in the long term. Most liothyronine (80%) is generated from the de-iodination of circulating T4, so a preparation of levothyroxine should provide T3 in a physiological and appropriate concentration. The NHS England document Items which should not be routinely prescribed in primary care advise against the use of liothyronine (including Armour Thyroid) except under exceptional circumstances when levothyroxine has failed and use is supported by a consultant NHS endocrinologist. The Regional Medicines Optimisation Committee (RMOC) gives further guidance to prescribers around exceptional circumstances, criteria and responsibilities for liothyronine prescribing. Overall, there is a lack of good quality evidence to support the use of desiccated thyroid. Studies vary in design, size, duration and outcomes. There is only one small randomised, controlled, crossover trial which has compared the efficacy of desiccated thyroid with levothyroxine. There was no difference in general health and all patients had TSH levels within range. Patients who preferred desiccated thyroid (49%) tended to have greater weight loss and improvement in subjective symptoms such as concentration, memory and energy. Three retrospective practice-based review found the use of desiccated thyroid improved symptoms in patients who were previously uncontrolled on levothyroxine. However, for two of the studies dose titration of levothyroxine had not been carried out prior to switching to desiccated thyroid for optimal symptom control and patients studied were already dissatisfied with their levothyroxine which would have led to selection bias. There is limited information regarding adverse events. Product information for desiccated thyroid products state that adverse reactions, other than those indicative of hyperthyroidism because of therapeutic overdosage, are rare. In a small study in which 40 patients had their treatment switched to levothyroxine from desiccated thyroid (90-180mg), abnormally high liothyronine concentrations were seen in 90% of patients with six patients developing symptoms of hyperthyroidism (nervousness, palpitations and tremor post-dose) and benefited from switching to levothyroxine. Abnormally high liothyronine levels were also seen in a smaller (n=21) case series. Some patients do request treatment with desiccated thyroid, such as Armour Thyroid because they do not feel as well when treated with levothyroxine, but there is a lack of robust evidence supporting the clinical effectiveness of desiccated thyroid. Limitations This Q&A focuses solely on the use of desiccated thyroid for the treatment of hypothyroidism, not euthyroid hypometabolism. This Q&A focuses on evidence that shows clinical effectiveness and safety of Armour Thyroid compared with that of levothyroxine. There may be articles that were not found via the three databases searched (Embase, Medline and AMED). This may be because either the journal is not included in the 3,500+ journals indexed by these databases, or that the article was published prior to 1950 and as such, that practice may be considered obsolete. References  ADDIN REFMGR.REFLIST  (1) The diagnoisis and management of primary hypothyroidism. Royal College College of Physicians.  HYPERLINK "http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf" http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf Accessed on 06/09/2018. (2) Okosieme O, Gilbert J, Abraham P. Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee. Clinical Endocrinology 2015; 0:1-10. (3) Wiersinga WM, Duntas L, Fadeye V. ETA Guidelines: The use of L-T4 + L-T3 in the treatment of hypothyroidism. European Thyroid Journal 2012; 1:55-71. (4) Cooper DS. Thyroid hormone treatment: new insights into an old therapy. Journal of the American Medical Association 1989; 261(18):2694-2695. (5) Armour thyroid (thyroid tablets, USP). Allergan, Inc. Content updated: June 2018.  HYPERLINK "http://www.allergan.com/assets/pdf/armourthyroid_pi" http://www.allergan.com/assets/pdf/armourthyroid_pi Accessed on 05/09/2018. (6) NP Thyroid (thyroid tablets, USP). Acella Pharmaceuticals, LLC. https://npthyroid.com/wp-content/uploads/2018/06/NP-Thyroid-Web-PI-6-27-18C-FPO1.pdf . Accessed 05/09/2018 (7) Nature-Throid (thyroid USP) tablets. RLC Labs. https://getrealthyroid.com/assets/docs/Nature-Throid-Prescribing-Information.pdf Accessed 05/09/18 (8) Jackson IM, Cobb WE. Why does anyone still use desiccated thyroxine USP? Am J Med 1978; 1978(64):-284. (9) Q&As to accompany to the 2015 BTA statement on the management of hypothyroidism.  HYPERLINK "http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf" http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf Accessed 05/09/2018. (10) Items which should not routinely be prescribed in primary care: Guidance for CCGs. NHS England. https:// HYPERLINK "http://www.england.nhs.uk/wp-content/uploads/2017/11/items-which-should-not-be-routinely-precscribed-in-pc-ccg-guidance.pdf" www.england.nhs.uk/wp-content/uploads/2017/11/items-which-should-not-be-routinely-precscribed-in-pc-ccg-guidance.pdf Accessed 05/09/2018. (11) Guidance - Prescribing of Liothyronine. Regional Medicines Optimisation Committee (RMOC). November 2018. https:// HYPERLINK "http://www.sps.nhs.uk/wp-content/uploads/2018/11/RMOC-Liothyronine-Guidance-v2.0-final-1.pdf" www.sps.nhs.uk/wp-content/uploads/2018/11/RMOC-Liothyronine-Guidance-v2.0-final-1.pdf Accessed 09/11/2018. (12) Sawin CT, Hershman JM, Fernandez-Garcia R et al. A comparison of thyroxine and desiccated thyroid in patients with primary hypothyrodism. Metabolism 1978; 27(10):1518-1525. (13) Singh SP, Feldman EB, Carter AC. Desiccated thryoid and levothyroxine in hypothyroidism. N Y State J Med 1972; May:1045-1048. (14) Sturnick MI, Lesses MF. A comparison of the effect of desiccated thyroid and sodium levothyroxine on the serum protein-bound iodine. N Engl J Med 1961; 264(12):608-609. (15) McGavack TH, Reckendorf HK. Therapeutic activity of desiccated thyroid substance, sodium L-thyroxine and D,L-triiodothyronine. A comparative study. Am J Med 1956; May:774-777. (16) Hoang TD, Olsen CH, Mai VQ et al. Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study. J Clin Endocrinol Metab 2013; 98(5):1982-1990. (17) Lev-Ran A. Part-of-the-day hypertriiodothryoninemia caused by desiccated thyroid. Journal of the American Medical Association 1983; 250(20):2790-2791. (18) UpToDate. Treatment of primary hypothyroidism in adults. Wolters Kluwer N.V.  HYPERLINK "http://www.uptodate.com" www.uptodate.com Accessed 06/09/2018. (19) Baisier WV, Hertoghe J, Eeckhaut W. Thyroid insufficiency. Is thyroxine the only valuable drug? J Nutr Environ Med 2001; 11:159-166. (20) Pepper GM, Casanova-Romero PY. Conversion to Armour Thyroid from Levothyroxine improved patient satisfaction in the treatment of hypothyroidism. Journal of Endocrinology, Diabetes and Obesity 2014; 2(3):1055. (21) Butler D. The dark side of publishing. Nature 2013; 495:433-435. (22) Tariq A, Wert Y, Cheriyath P. Effects of long-term combination LT4 and LT3 therapy for improving hypothyroidism and overall quality of life. South Med J 2018; 111(6):363-369.  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Royal College College of Physicians. http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf Accessed on 06/09/2018.Generic3810The diagnoisis and management of primary hypothyroidism. Royal College College of Physicians. http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf Accessed on 06/09/2018.2018armour thyroidNot in File33Okosieme20153802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Journal3802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Okosieme,OGilbert,JAbraham,P2015armour thyroidNot in File110Clinical Endocrinology0Clinical Endocrinology1Wiersinga20123801ETA Guidelines: The use of L-T4 + L-T3 in the treatment of hypothyroidismJournal3801ETA Guidelines: The use of L-T4 + L-T3 in the treatment of hypothyroidismWiersinga,W.MDuntas,LFadeye,V2012armour thyroidNot in File5571European Thyroid Journal1European Thyroid Journal1D20183807Armour thyroid (thyroid tablets, USP). Allergan, Inc. Content updated: June 2018. http://www.allergan.com/assets/pdf/armourthyroid_pi Accessed on 05/09/2018.Generic3807Armour thyroid (thyroid tablets, USP). Allergan, Inc. Content updated: June 2018. http://www.allergan.com/assets/pdf/armourthyroid_pi Accessed on 05/09/2018.2018armour thyroidNot in File3320183805NP Thyroid (thyroid tablets, USP). Acella Pharmaceuticals, LLC. https://npthyroid.com/wp-content/uploads/2018/06/NP-Thyroid-Web-PI-6-27-18C-FPO1.pdf . Accessed 05/09/2018Generic3805NP Thyroid (thyroid tablets, USP). Acella Pharmaceuticals, LLC. https://npthyroid.com/wp-content/uploads/2018/06/NP-Thyroid-Web-PI-6-27-18C-FPO1.pdf . Accessed 05/09/20182018armour thyroidNot in File3320183806Nature-Throid (thyroid USP) tablets. RLC Labs. https://getrealthyroid.com/assets/docs/Nature-Throid-Prescribing-Information.pdf Accessed 05/09/18Generic3806Nature-Throid (thyroid USP) tablets. RLC Labs. https://getrealthyroid.com/assets/docs/Nature-Throid-Prescribing-Information.pdf Accessed 05/09/182018armour thyroidNot in File33Jackson19783667Why does anyone still use desiccated thyroxine USP?Journal3667Why does anyone still use desiccated thyroxine USP?Jackson,I.M.Cobb,W.E.1978armour thyroidIn File284Am.J.Med.197864American Journal of MedicineAm.J.Med.1Okosieme20153802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Journal3802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Okosieme,OGilbert,JAbraham,P2015armour thyroidNot in File110Clinical Endocrinology0Clinical Endocrinology1< D20183808Q&As to accompany to the 2015 BTA statement on the management of hypothyroidism. http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf Accessed 05/09/2018.Generic3808Q&As to accompany to the 2015 BTA statement on the management of hypothyroidism. http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdf Accessed 05/09/2018.2018armour thyroidNot in File3320183810The diagnoisis and management of primary hypothyroidism. Royal College College of Physicians. http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf Accessed on 06/09/2018.Generic3810The diagnoisis and management of primary hypothyroidism. Royal College College of Physicians. http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdf Accessed on 06/09/2018.2018armour thyroidNot in File33Okosieme20153802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Journal3802Management of primary hypothyroidism: statement by the British Thyroid Association Executive Committee.Okosieme,OGilbert,JAbraham,P2015armour thyroidNot in File110Clinical Endocrinology0Clinical Endocrinology1Wiersinga20123801ETA Guidelines: The use of L-T4 + L-T3 in the treatment of hypothyroidismJournal3801ETA Guidelines: The use of L-T4 + L-T3 in the treatment of hypothyroidismWiersinga,W.MDuntas,LFadeye,V2012armour thyroidNot in File5571European Thyroid Journal1European Thyroid Journal1DyK yK https://www.sps.nhs.uk/articles/rmoc-guidance-prescribing-of-liothyronine/yX;H,]ą'c`DSawin19783720A comparison of thyroxine and desiccated thyroid in patients with primary hypothyrodism.Journal3720A comparison of thyroxine and desiccated thyroid in patients with primary hypothyrodism.Sawin,C.T.Hershman,J.M.Fernandez-Garcia,R.Ghazvinian,S.1978armour thyroidIn File15181525Metabolism2710Metabolism1Singh19723721Desiccated thryoid and levothyroxine in hypothyroidism.Journal3721Desiccated thryoid and levothyroxine in hypothyroidism.Singh,S.P.Feldman,E.B.Carter,A.C.1972armour thyroidIn File10451048N.Y.State J.Med.MayNew York State Journal of MedicineN.Y.State J.Med.1Sturnick1961946A comparison of the effect of desiccated thyroid and sodium levothyroxine on the serum protein-bound iodine.Journal946A comparison of the effect of desiccated thyroid and sodium levothyroxine on the serum protein-bound iodine.Sturnick,M.I.Lesses,M.F.1961armour thyroidIn File608609N.Engl.J.Med.26412New England Journal of MedicineN.Engl.J.Med.1McGavack19563722Therapeutic activity of desiccated thyroid substance, sodium L-thyroxine and D,L-triiodothyronine. A comparative study.Journal3722Therapeutic activity of desiccated thyroid substance, sodium L-thyroxine and D,L-triiodothyronine. A comparative study.McGavack,T.H.Reckendorf,H.K.1956armour thyroidIn File774777Am.J.Med.MayAmerican Journal of MedicineAm.J.Med.1DyK yK http://www.thyroiduk.org.uk/tuk/guidelines/RCP_statement_20111.pdfyX;H,]ą'cDyK yK http://www.allergan.com/assets/pdf/armourthyroid_piyX;H,]ą'c3DyK yK http://www.btf-thyroid.org/images/documents/FAQ_for_BTA_Hypothyroidism_Statement.pdfyX;H,]ą'cDyK yK http://www.england.nhs.uk/wp-content/uploads/2017/11/items-which-should-not-be-routinely-precscribed-in-pc-ccg-guidance.pdfyX;H,]ą'cCDyK yK http://www.sps.nhs.uk/wp-content/uploads/2018/11/RMOC-Liothyronine-Guidance-v2.0-final-1.pdfyX;H,]ą'cDyK yK Jhttp://www.uptodate.com/yX;H,]ą'c^" 666666666vvvvvvvvv666>66666666666666666666666666666666666666666666666hH6666666666666666666666666666666666666666666666666666666666666666662 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~_HmH nH sH tH D`D NormalCJOJQJ_HmH sH tH X@X  Heading 1$ & F h<@& 5CJKHT@T  Heading 2$ & F<@& 5CJV@V  Heading 3$ & F<@&  56CJP@P  Heading 4$ & F<@& CJHH  Heading 5 & F<@& nT@T  Heading 6 & F<@&  6OJQJL@L  Heading 7 & F<@& CJP@P  Heading 8 & F<@& 6CJR @R  Heading 9 & F<@&  56CJDA`D Default Paragraph FontViV 0 Table Normal :V 44 la (k ( 0No List 8 @8 Footer  9r CJ<@< Header  9r 6CJDB@D  Body TextB*CJmH phsH .)@!.  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