1.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
2.Evaluation of Adherence to Guideline for Heart Failure with Reduced Ejection Fraction in Heart Failure with Preserved Ejection Fraction and with or without Atrial Fibrillation
Min-Soo AHN ; Byung-Su YOO ; Jung-Woo SON ; Young Jun PARK ; Hae-Young LEE ; Eun-Seok JEON ; Seok-Min KANG ; Dong-Ju CHOI ; Kye Hun KIM ; Myeong-Chan CHO ; Seong Yoon KIM ; Dae Ryong KANG ; Tae-Hwa GO
Journal of Korean Medical Science 2021;36(40):e252-
Background:
This study evaluated the relationship between guideline adherence for heart failure (HF) with reduced ejection fraction (HFrEF) at discharge and relevant clinical outcomes in patients with acute HF with preserved ejection fraction (HFpEF) with or without atrial fibrillation (AF).
Methods:
We analyzed Korean Acute Heart Failure Registry data for 707 patients with HFpEF with documented AF and 687 without AF. Guideline adherence was defined as good or poor according to the prescription of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and mineralocorticoid receptor antagonists. Anticoagulation adherence was also incorporated for the AF group.
Results:
Among patients with normal sinus rhythm, those with poor guideline adherence had a reduced prevalence of comorbidities and favorable clinical characteristics when compared with those with good guideline adherence. Using inverse probability of treatment weighting (IPTW) to address the bias of nonrandom treatment assignment, good adherence was associated with a poor 60-day composite endpoint in the multivariable Cox model (weighted hazard ratio [wHR], 1.74; 95% confidence interval [CI], 1.01–3.00; P = 0.045). For patients with AF, baseline clinical characteristics were similar according to the degree of adherence. The IPTW-adjusted analysis indicated that good adherence was significantly associated with the 60-day composite endpoint (wHR, 0.47; 95% CI, 0.27–0.79; P = 0.005). In the analysis excluding warfarin, good adherence was associated with 60-day rehospitalization (wHR, 0.60; 95% CI, 0.37–0.98; P = 0.040), 1-year re-hospitalization (wHR, 0.67; 95% CI, 0.48–0.93; P = 0.018), and the composite endpoint (wHR, 0.77; 95% CI, 0.59–0.99; P = 0.041).
Conclusion
Our findings indicate that good adherence to guidelines for HFrEF is associated with a better 60-day composite endpoint in patients with HFpEF with AF.
3.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
4.Evaluation of Adherence to Guideline for Heart Failure with Reduced Ejection Fraction in Heart Failure with Preserved Ejection Fraction and with or without Atrial Fibrillation
Min-Soo AHN ; Byung-Su YOO ; Jung-Woo SON ; Young Jun PARK ; Hae-Young LEE ; Eun-Seok JEON ; Seok-Min KANG ; Dong-Ju CHOI ; Kye Hun KIM ; Myeong-Chan CHO ; Seong Yoon KIM ; Dae Ryong KANG ; Tae-Hwa GO
Journal of Korean Medical Science 2021;36(40):e252-
Background:
This study evaluated the relationship between guideline adherence for heart failure (HF) with reduced ejection fraction (HFrEF) at discharge and relevant clinical outcomes in patients with acute HF with preserved ejection fraction (HFpEF) with or without atrial fibrillation (AF).
Methods:
We analyzed Korean Acute Heart Failure Registry data for 707 patients with HFpEF with documented AF and 687 without AF. Guideline adherence was defined as good or poor according to the prescription of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and mineralocorticoid receptor antagonists. Anticoagulation adherence was also incorporated for the AF group.
Results:
Among patients with normal sinus rhythm, those with poor guideline adherence had a reduced prevalence of comorbidities and favorable clinical characteristics when compared with those with good guideline adherence. Using inverse probability of treatment weighting (IPTW) to address the bias of nonrandom treatment assignment, good adherence was associated with a poor 60-day composite endpoint in the multivariable Cox model (weighted hazard ratio [wHR], 1.74; 95% confidence interval [CI], 1.01–3.00; P = 0.045). For patients with AF, baseline clinical characteristics were similar according to the degree of adherence. The IPTW-adjusted analysis indicated that good adherence was significantly associated with the 60-day composite endpoint (wHR, 0.47; 95% CI, 0.27–0.79; P = 0.005). In the analysis excluding warfarin, good adherence was associated with 60-day rehospitalization (wHR, 0.60; 95% CI, 0.37–0.98; P = 0.040), 1-year re-hospitalization (wHR, 0.67; 95% CI, 0.48–0.93; P = 0.018), and the composite endpoint (wHR, 0.77; 95% CI, 0.59–0.99; P = 0.041).
Conclusion
Our findings indicate that good adherence to guidelines for HFrEF is associated with a better 60-day composite endpoint in patients with HFpEF with AF.
5.Accuracy of the 24-hour diet recall method to determine energy intake in elderly women compared with the doubly labeled water method
Kye-Wol PARK ; Na-Young GO ; Ji-Hye JEON ; Didace NDAHIMANA ; Kazuko ISHIKAWA-TAKATA ; Jong hoon PARK ; Eun-Kyung KIM
Journal of Nutrition and Health 2020;53(5):476-487
Purpose:
This study evaluated the accuracy of the 24-hour diet recall method for estimating energy intakes in elderly women using the doubly labeled water (DLW) method.
Methods:
The subjects were 23 elderly women with a mean age of 70.3 ± 3.3 years and body mass index (BMI) of 23.9 ± 2.8 kg/m 2 . The total energy expenditure (TEEDLW ) was determined by using the DLW and used to validate the 24-hour diet recall method. The total energy intake (TEI) was calculated from the 24-hour diet recall method for three days.
Results:
TEI (1,489.6 ± 211.1 kcal/day) was significantly lower than TEEDLW (2,023.5 ± 234.9 kcal/day) and was largely under-reported by −533.9 ± 228.0 kcal/day (−25.9%). The accurate prediction rate of elderly women in this study was 8.7%. The Bland-Altman plot, which was used to evaluate the TEI and the TEEDLW , showed that the agreement between them was negatively skewed, ranging from −980.8 kcal/day to −86.9 kcal/day.
Conclusion
This study showed that the energy intake of elderly women was underreported.Strategies to increase the accuracy of the 24-hour diet recall methods in the elderly women should be studied through analysis of factors that affect underreporting rate. Further studies will be needed to assess the validity of the 24-hour diet recall method in other population groups.
6.A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy: Results of the Korean South West Oncolog.
So Yeon JEON ; Hye Sook HAN ; Woo Kyun BAE ; Moo Rim PARK ; Hyeok SHIM ; Sang Cheol LEE ; Se Il GO ; Hwan Jung YUN ; Yong Jin IM ; Eun Kee SONG
Cancer Research and Treatment 2019;51(1):90-97
PURPOSE: Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC. MATERIALS AND METHODS: We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting. The primary end point was complete response for the acute phase (0-24 hours after chemotherapy). The secondary end points were complete response for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant nausea (visual analogue scale ≥ 25 mm), use ofrescue medications, and effect on QOL. RESULTS: Fifty-six patients were randomized to the olanzapine (n=29) and placebo (n=27) groups. Complete response rates were not significantly different between the olanzapine and placebo groups in the acute (96.5% vs. 88.0%, p=0.326), delayed (69.0% vs. 48.0%, p=0.118), and overall phases (69.0% vs. 48.0%, p=0.118). However, the percentage of patients with significant nausea (17.2% vs. 44.0%, p=0.032) and the use of rescue medications (0.03±0.19 vs. 1.88±2.88, p=0.002) were lower in the olanzapine group than in the placebo. Furthermore, the olanzapine group demonstrated better QOL (p=0.015). CONCLUSION: Olanzapine combined with palonosetron and dexamethasone significantly improved QOL and vomiting control among previously untreated patients receiving MEC, although the efficacy was limited to the reduction of the frequency of CINV.
Antiemetics
;
Dexamethasone
;
Drug Therapy*
;
Humans
;
Nausea*
;
Quality of Life
;
Vomiting*
7.Accuracy of 24-hour Diet Recalls for Estimating Energy Intake in Elderly Men using the Doubly Labeled Water Method
Ji Hye JEON ; Na Young GO ; Mo Ran LEE ; Didace NDAHIMANA ; Eun Kyung KIM
Korean Journal of Community Nutrition 2018;23(6):516-524
OBJECTIVES: This study assessed the accuracy of the 24-hour diet recall method for estimating the energy intake of elderly men using the doubly labeled water as a reference method. METHODS: Seventeen subjects (mean age 72.5 ± 3.9 years), who maintained the same body weight during the two weeks study period, were included in this study. Three 24-hour diet recalls (two weekdays and one weekend) were obtained over a 14 day period to estimate the mean energy intake. The total energy expenditure was measured over the same 14 days using the doubly labeled water method. The total energy intake and total energy expenditure were compared by paired t-test. RESULTS: The total energy intake from the 24-hour diet recalls method was 2536.7 ± 350.6 kcal/day, and the total energy expenditure from the doubly labeled water method was 2659.8 ± 306.8 kcal/day. The total energy intake was slightly under-reported by −123.2 ± 260.8 kcal/day (−4.4%). On the other hand, no significant difference was observed between the total energy intake and total energy expenditure of the subjects (p=0.069). The percentage of accurate predictions was 64.7%. The correlation between the total energy intake and total energy expenditure was statistically significant (r=0.697, p < 0.005). CONCLUSIONS: The present study supports the use of the 24-hour diet recall method to estimate the mean energy intake in elderly men group. More studies are needed to assess the validity of 24-hour diet recall method in other population groups, including elderly women, adults and children.
Adult
;
Aged
;
Body Weight
;
Child
;
Diet
;
Energy Intake
;
Energy Metabolism
;
Female
;
Hand
;
Humans
;
Male
;
Methods
;
Population Groups
;
Water
8.Accuracy of 24-hour Diet Recalls for Estimating Energy Intake in Elderly Men using the Doubly Labeled Water Method
Ji Hye JEON ; Na Young GO ; Mo Ran LEE ; Didace NDAHIMANA ; Eun Kyung KIM
Korean Journal of Community Nutrition 2018;23(6):516-524
OBJECTIVES: This study assessed the accuracy of the 24-hour diet recall method for estimating the energy intake of elderly men using the doubly labeled water as a reference method. METHODS: Seventeen subjects (mean age 72.5 ± 3.9 years), who maintained the same body weight during the two weeks study period, were included in this study. Three 24-hour diet recalls (two weekdays and one weekend) were obtained over a 14 day period to estimate the mean energy intake. The total energy expenditure was measured over the same 14 days using the doubly labeled water method. The total energy intake and total energy expenditure were compared by paired t-test. RESULTS: The total energy intake from the 24-hour diet recalls method was 2536.7 ± 350.6 kcal/day, and the total energy expenditure from the doubly labeled water method was 2659.8 ± 306.8 kcal/day. The total energy intake was slightly under-reported by −123.2 ± 260.8 kcal/day (−4.4%). On the other hand, no significant difference was observed between the total energy intake and total energy expenditure of the subjects (p=0.069). The percentage of accurate predictions was 64.7%. The correlation between the total energy intake and total energy expenditure was statistically significant (r=0.697, p < 0.005). CONCLUSIONS: The present study supports the use of the 24-hour diet recall method to estimate the mean energy intake in elderly men group. More studies are needed to assess the validity of 24-hour diet recall method in other population groups, including elderly women, adults and children.
Adult
;
Aged
;
Body Weight
;
Child
;
Diet
;
Energy Intake
;
Energy Metabolism
;
Female
;
Hand
;
Humans
;
Male
;
Methods
;
Population Groups
;
Water
9.The Influence of Iron Deficiency on Helicobacter pylori Eradication.
Sung Eun KIM ; Moo In PARK ; Seun Ja PARK ; Won MOON ; Jae Hyun KIM ; Kyoungwon JUNG ; Kwang Il SEO ; Seong Kyeong LIM ; Jin Kyu JUNG ; Hyeon Jin KIM ; Go Eun YEO ; Sung Chan JEON ; Duk Song CHO ; You Jin HAN
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2016;16(2):82-87
BACKGROUND/AIMS: Helicobacter pylori is a distinctive pathogen that lives in the gastric mucosa and is a well known risk factor of gastric adenocarcinoma. Iron deficiency aggravates the development of H. pylori-induced premalignant and malignant lesions in a cagA-dependent manner, enhancing H. pylori virulence. The aim of this study was to identify the relationship between iron deficiency and H. pylori eradication rates. MATERIALS AND METHODS: Participants who received 7 days of first-line triple therapy with serum iron level measured in parallel were retrospectively investigated between 2005 and 2014. H. pylori eradication was confirmed by the rapid urease test or 13C-urea breath test at least 4 weeks after completion of triple therapy. Iron deficiency was defined as either a serum iron level less than 50 µg/dL or a serum ferritin level less than 12 ng/mL. RESULTS: A total of 194 patients received 7 days of first-line triple therapy along with parallel serum iron level measurements over the 10-year period. The mean average age was 53.3 years (range, 21~86 years), and 135 patients (69.6%) were male. The overall H. pylori eradication rate was 83.5%. Proportions of eradication success with ferritin level less than 12 ng/mL and iron less than 50 µg/dL were 90.5% and 88.6%, respectively. However, there was no statistical difference in eradication rates according to iron deficiency. CONCLUSIONS: Iron deficiency might not be related with H. pylori eradication rates in this study. Further large-scale studies are needed to confirm this result.
Adenocarcinoma
;
Breath Tests
;
Disease Eradication
;
Ferritins
;
Gastric Mucosa
;
Helicobacter pylori*
;
Helicobacter*
;
Humans
;
Iron*
;
Male
;
Retrospective Studies
;
Risk Factors
;
Urease
;
Virulence
10.Effects of anti-obesity drugs, phentermine and mahuang, on the behavioral patterns in Sprague-Dawley rat model.
Ryeo Eun GO ; Kyung A HWANG ; Seung Hee KIM ; Min Young LEE ; Cho Won KIM ; So Ye JEON ; Yun Bae KIM ; Kyung Chul CHOI
Laboratory Animal Research 2014;30(2):73-78
According to WHO global estimates from 2008, more than 1.4 billion adults were overweight and among them, over 200 million men and 300 million women were obese. Although the main treatment modalities for overweight and obese individuals remain dieting and physical exercise, the synthetic anti-obesity medications have been increasingly used due to their perceived convenience. Generally, anti-obesity medications are classified as appetite suppressants or fat absorption blockers. In the present study, we examined the adverse side-effects in respect of behavior changes of phentermine and Ephedra sinica (mahuang) that are anti-obesity drugs currently distributed to domestic consumers. Phentermine is mainly classified as an anorexing agent and mahuang a thermogenic agent. Because phentermine and mahuang are considered to display effectiveness through the regulation of nerve system, their potential influences of on behavioral changes were examined employing animal experiments. From the results of experiments testing locomotor activity through the use of treadmill, rota-rod, and open field system, phentermine and mahuang were commonly revealed to induce behavioral changes of rats by reducing a motor ability, an ability to cope with an external stimulus, and a sense of balance or by augmenting wariness or excitement. These adverse effects of phenternime and mahuang in behavioral changes need to be identified in humans and anti-obesity medications such as phentermine and mahuang should be prescribed for only obesity where it is anticipated that the benefits of the treatment outweigh their potential risks.
Absorption
;
Adult
;
Animal Experimentation
;
Animals
;
Anti-Obesity Agents*
;
Appetite Depressants
;
Diet
;
Diethylpropion
;
Ephedra sinica
;
Exercise
;
Female
;
Humans
;
Male
;
Models, Animal*
;
Motor Activity
;
Obesity
;
Overweight
;
Phentermine*
;
Rats
;
Rats, Sprague-Dawley*

Result Analysis
Print
Save
E-mail