• Title/Summary/Keyword: Clinical trial center

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The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention

  • Pil Sang Song;Seok-Woo Seong;Ji-Yeon Kim;Soo Yeon An;Mi Joo Kim;Kye Taek Ahn;Seon-Ah Jin;Jin-Ok Jeong;Jeong Hoon Yang;Joo-Yong Hahn;Hyeon-Cheol Gwon;Woo Jin Jang;Hyuck Jun Yoon;Jang-Whan Bae;Woong Gil Choi;Young Bin Song
    • Korean Circulation Journal
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    • v.54 no.4
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    • pp.189-200
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    • 2024
  • Background and Objectives: Concerns remain that early aspirin cessation may be associated with potential harm in subsets at high risk of ischemic events. This study aimed to assess the effects of P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) vs. prolonged DAPT (12-month or longer) based on the ischemic risk stratification, the CHADS-P2A2RC, after percutaneous coronary intervention (PCI). Methods: This was a sub-study of the SMART-CHOICE trial. The effect of the randomized antiplatelet strategies was assessed across 3 CHADS-P2A2RC risk score categories. The primary outcome was a major adverse cardiac and cerebral event (MACCE), a composite of all-cause death, myocardial infarction, or stroke. Results: Up to 3 years, the high CHADS-P2A2RC risk score group had the highest incidence of MACCE (105 [12.1%], adjusted hazard ratio [HR], 2.927; 95% confidence interval [CI], 1.358-6.309; p=0.006) followed by moderate-risk (40 [1.4%], adjusted HR, 1.786; 95% CI, 0.868-3.674; p=0.115) and low-risk (9 [0.5%], reference). In secondary analyses, P2Y12 inhibitor monotherapy reduced the Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding without increasing the risk of MACCE as compared with prolonged DAPT across the 3 CHADS-P2A2RC risk strata without significant interaction term (interaction p for MACCE=0.705 and interaction p for BARC types 2, 3, or 5 bleeding=0.055). Conclusions: The CHADS-P2A2RC risk score is valuable in discriminating high-ischemic-risk patients. Even in such patients with a high risk of ischemic events, P2Y12 inhibitor monotherapy was associated with a lower incidence of bleeding without increased risk of ischemic events compared with prolonged DAPT.

Concurrent Chemoradiotherapy in Locally Advanced Carcinoma of The Uterine Cervix : A Phase I/II Prospective Study (국소적으로 진행된 자궁경부암의 방사선치료와 복합 항암화학요법의 동시치료 결과)

  • Kang One Chul;Choi Eun Kyung;Chung Weon Kuu;Kim Jong Hoon;Chang Hyesook;Kim Yong Man;Kim Young Tak;Nam Joo Hyun;Mok Jung-Eun;Lee Moo-Song
    • Radiation Oncology Journal
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    • v.16 no.3
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    • pp.311-323
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    • 1998
  • Purpose : Prospective, single arm, Phase I/II clinical trial was performed to assess the efficacy and toxicity of the concurrent chemotherapy and definitive radiotherapy (RT) in patients with previously untreated locally advanced carcinoma of the uterine cervix. Methods and Materials : From Mar 1992 to January 1997, a total of 73 patients with advanced cervical carcinoma were entered on the protocol but 5 patients were excluded in analysis because of patients' refusal of treatment. Their ages ranged from 31 to 77 years, median 58 years. The International Federation of Gynecology and Obstetrics (FIGO) stage distribution was as follows: IIB 46, IIIA 2, IIIB 15 and IVA 5. RT consisted of external beam irradiation to 4,140-5,040 cGy/23-28 fractions plus high dose rate intracavitary treatments to deliver a dose of 30-35 Gy to point A in 6-7 fractions. During the intracavitary treatments parametrial boost was delivered for point B dose of 60 Gy in stage IIB and 65 Gy in stage IIIB. Two cycles of concurrent 5-fluorouracil and cisplatin (FP) chemotherapy (5-fluorouracil 1,000 mg/$m^2$/day continuous infusion for 4 days, day 1-4, 29-32 and cisplatin 20 mg/$m^2$/day intravenous bolus for 3 days day 1-3, 29-31) administered starting on day 1 of RT. Results : The median follow-up was 24 months (range 4-68+). Sixty-four patients were evaluable for survival rate in this protocol: The 5-year actuarial and disease-free survival rate were 52$\%$ and 64$\%$, respectively. The 5-rear actuarial survival for stage IIB and III+IVA patients were 58$\%$ and 36$\%$, respectively The 5-year disease-free survival rate for stage IIB and III+IVA patients were 71$\%$ and 40$\%$, respectively. Of the 68 patients evaluated for patterns of failure, overall recurrence rate was 27.9$\%$ (19/68) : local failure in 5.9$\%$ (4/68), distant metastasis in 10.3$\%$ (7/68) and both in 11.8$\%$ (8/68). Of the 64 patients evaluated for response at one month after the completion of treatment the complete response rate was 78$\%$ (50/64). Concurrent chemoradiation appear to be a well-tolerated regimen but there were two treatment-related deaths. Conclusion : Concurrent chemotherapy of FP with high-dose definitive RT in locally advanced carcinoma of the uterine cervix is feasible and effective with acceptable toxicities. This chemoradiation regimen may offer a modest survival benefit for advanced stage. Further follow-up of these patients will evaluate the impact of this regimen on the long-term local control and their survival.

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A Delphi Study For Treatment Standardization of Coldness in hands and Feet (수족냉증 치료 표준화를 위한 델파이 연구)

  • Sun, Seung-Ho;Go, Ho-Yeon;Ko, Seungwoo;Cho, Yoon-Young;Shin, Ji-Hye;Kim, Tae-Hoon;Choi, Dong-Jun;Lee, Jin-Moo;Jang, Jun-Bok;Jung, Ki-Yong;Song, Yun-Kyung;Go, Seong-Gyu;Choi, You-Kyung;Lim, Eun-Mee;Park, Jong-Hyeong;Jeon, Chan-Yong
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.3
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    • pp.131-140
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    • 2015
  • Objective : The purpose of this study is to figure out the treatment of coldness in hands and Feet by using Delphi survey. Method : This study was approved by institutional review boards at Kyung Hee University. Self recording type delphi survey were sent by e-mail to 55 Korean medicine specialists (19 gynecologist, 36 internal medical doctors) who treat coldness in hands and Feet. And replies were analyzed. As this study is cross sectional study, simple descriptive analysis was applied. Results & Conclusion : Herbal medicine, acupuncture and moxibustion were mainly applied and extract (granule), pharmacopuncture, bee venom pharmacopuncture and cupping therapy were also added case by case. Treatment was done twice a weak for 4 months. Cupping therapy was done at GB21 and SI11. Bee venom pharmacopuncture and Kidney yang deficiency pharmacopuncture were applied at ST36, GB21, CV4 and LR3. As extract (granule) Ijungtang, Dangguisayeokgaosuyusaenggangtang and Dangguisayeoktang were mainly used and as herbal medicine formula Palmijihwangwon, Bojungikgitang, Ijungtang, Danggwisayeok-gaosuyusaenggangtang and Danggwisayeoktang were mainly prescribed. Comprehensive treatment of acupuncture, moxibustion and herbal medicine was considered to have more effective and more rapid result than single treatment of herbal medicine have.

Nutrikinetic study of fermented soybean paste (Cheonggukjang) isoflavones according to the Sasang typology

  • Kim, Min Jung;Lee, Da-Hye;Ahn, Jiyun;Jang, Young-Jin;Ha, Tae-Youl;Do, Eunju;Jung, Chang Hwa
    • Nutrition Research and Practice
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    • v.14 no.2
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    • pp.102-108
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    • 2020
  • BACKGROUND/OBJECTIVES: In Oriental medicine, certain foods may be beneficial or detrimental based on an individual's constitution; however, the scientific basis for this theory is insufficient. The purpose of this study was to investigate the effect of body constitution, based on the Sasang type of Korean traditional medical classification system, on the bioavailability of soy isoflavones of Cheonggukjang, a quick-fermented soybean paste. SUBJECTS/METHODS: A pilot study was conducted on 48 healthy Korean men to evaluate the bioavailability of isoflavone after ingestion of food based on constitution types classified by the Sasang typology. The participants were classified into the Taeeumin (TE; n = 15), Soyangin (SY; n = 15), and Soeumin (SE; n = 18) groups. Each participant ingested 50 g of Cheonggukjang per 60 kg body weight. Thereafter, blood was collected, and the soy isoflavone metabolites were analyzed by ultra-performance liquid chromatography/quadrupole time-of-flight mass spectrometry. Ntrikinetic analysis of individual isoflavone-derived metabolites was performed. RESULTS: Our nutrikinetic analysis identified 21 metabolites derived from isoflavones in the blood samples from 48 healthy Korean men (age range, 21-29 years). Significant differences were observed in the time to maximum concentration (Tmax) and elimination half-life (t1/2) for nine metabolites among the three groups. The Tmax and t1/2 of the nine metabolites were higher in the SE group than in the other groups. Moreover, the absorption rates, as determined by the area under the plasma-level curve (AUC) values of intact isoflavone, were 5.3 and 9.4 times higher in the TE group than in the SY and SE groups, respectively. Additionally, the highest AUC values for phase I and II metabolites were observed in the TE group. CONCLUSIONS: These findings indicate that isoflavone bioavailability, following Cheonggukjang insgestion, is high in individuals with the TE constitution, and relatively lower in those with the SE and SY constitutions.

The Pyramid of Injury: Estimation of the Scale of Adolescent Injuries According to Severity

  • Han, Hyejin;Park, Bomi;Park, Bohyun;Park, Namsoo;Park, Ju Ok;Ahn, Ki Ok;Tak, Yang Ju;Lee, Hye Ah;Park, Hyesook
    • Journal of Preventive Medicine and Public Health
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    • v.51 no.3
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    • pp.163-168
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    • 2018
  • Objectives: Due to their developmental characteristics, adolescents have a higher probability than other age groups of experiencing injuries caused by accidents, violence, and intentional self-harm. The severity and characteristics of injuries vary by the intentionality and mechanism of injury; therefore, there is a need for a national-level estimate of the scale and the severity of injuries in adolescents that takes these factors into account. Methods: By using data from the Emergency Department-based Injury In-depth Surveillance Data, National Emergency Department Information System, the Korean National Hospital Discharge In-depth Injury Survey, and cause of death statistics, we calculated the emergency department (ED) visit rate, hospitalization rate, and death rate of injuries per 100 000 adolescents for each injury mechanism. The calculated rates were used to generate the injury pyramid ratio (ratio of death rate to hospitalization rate to ED visit rate) to visualize the scale and the severity of the injury. Results: The mortality rate in adolescents due to injury was 10/100 000; the corresponding rates for hospitalization and ED visits were 1623 and 4923, respectively, resulting in an injury pyramid ratio with the general pyramid form, with a 1:162:492 ratio of deaths to hospitalizations to ED visits. The mortality rate due to suicide/intentional self-harm was 5/100 000, while 35 were hospitalized for this reason and 74 made ED visits. The pyramid ratio of 1:7:15 for intentional self-harm/suicide showed a steep pyramidal form, indicating considerable lethality. The mortality rate due to motor vehicle collisions (MVCs) was 3/100 000; 586 were hospitalized for this reason, while 1023 made ED visits. The pyramid ratio of 1:195:341 for MVCs showed a gradual pyramid form, indicating that the lethality was low and the scale of injury was high. Conclusions: The main categories of injuries in adolescents were visualized in pyramid form, contributing to an understanding of the scale of each injury by mechanism in terms of levels of death, hospitalization, and ED visits. These findings will be helpful for understanding how to prioritize injuries in adolescents.

Effect of Arthritis and Comorbid Chronic Conditions on Health-related Quality of Life in Korean Elderly (우리나라 노인에서 관절염과 동반 만성질환에 의한 건강관련 삶의 질 감소 효과)

  • No, Ji-Young;Kim, Soon-Young;Kweon, In-Sun;Nam, Hae-Sung
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.15 no.6
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    • pp.3751-3758
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    • 2014
  • This study was designed to evaluate the effects of arthritis and comorbid chronic conditions on the health-related quality of life (HRQoL) in the Korean older population. The study subjects were 2,708 Korean adults aged 65 and older from the $3^{rd}$ Korea National Health and Nutrition Examination Surveys data: 1,357 persons with a single chronic condition, such as arthritis, herniations of the intervertebral disc, osteoporosis, asthma, peptic ulcers, stroke, or cataract; 886 persons with arthritis and a second chronic condition described above; and 465 persons with no chronic condition. An analysis of covariance was performed to compare the EQ-5D index among the groups. The effects of arthritis, second chronic condition and their interactions were analyzed by multiple linear regression analysis. The results are as follows. Compared to men with arthritis only, men with stroke only, stroke and arthritis, or cataract and arthritis had a lower age adjusted EQ-5D index. Women with a stroke only, asthma only, cataract only, osteoporosis and arthritis, peptic ulcer and arthritis, stroke and arthritis, or cataract and arthritis had a lower age adjusted EQ-5D index than women with arthritis only. Arthritis and comorbid conditions had additive effects on the HRQol in both genders except for arthritis and stroke in women. In conclusion, comorbid chronic medical conditions in older people with arthritis may reduce the HRQoL in an additive manner.

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

  • Shin, Dong-Seong;Carroll, Christopher P.;Elghareeb, Mohammed;Hoh, Brian L.;Kim, Bum-Tae
    • Journal of Korean Neurosurgical Society
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    • v.63 no.2
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    • pp.137-152
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    • 2020
  • In spite of the developing endovascular era, large (15-25 mm) and giant (>25 mm) wide-neck cerebral aneurysms remained technically challenging. Intracranial flow-diverting stents (FDS) were developed to address these challenges by targeting aneurysm hemodynamics to promote aneurysm occlusion. In 2011, the first FDS approved for use in the United States market. Shortly thereafter, the Pipeline of Uncoilable or Failed Aneurysms (PUFS) study was published demonstrating high efficacy and a similar complication profile to other intracranial stents. The initial FDA instructions for use (IFU) limited its use to patients 22 years old or older with wide-necked large or giant aneurysms of the internal carotid artery (ICA) from the petrous segment to superior hypophyseal artery/ophthalmic segment. Expanded IFU was tested in the Prospective Study on Embolization of Intracranial Aneurysms with PipelineTM Embolization Device (PREMIER) trial. With further post-approval clinical data, the United States FDA expanded the IFU to include patients with small or medium, wide-necked saccular or fusiform aneurysms from the petrous ICA to the ICA terminus. However, IFU is more restrictive in South Korea than in United States. Several systematic reviews and meta-analyses have sought to evaluate the overall efficacy of FDS for the treatment of cerebral aneurysms and consistently identify FDS as an effective technique for the treatment of aneurysms broadly with complication rates similar to other traditional techniques. A growing body of literature has demonstrated high efficacy of FDS for small aneurysms; distal artery aneurysms; non-saccular aneurysms posterior circulation aneurysms and complication rates similar to traditional techniques. In the short interval since the Pipeline Embolization Device was first introduced, FDS has been firmly entrenched as a powerful tool in the endovascular armamentarium. As new FDS are developed, established FDS are refined, and delivery systems are improved the uses for FDS will only expand further. Researchers continue to work to optimize the mechanical characteristics of the FDS themselves, aiming to optimize deploy ability and efficacy. With expanded use for small to medium aneurysms and posterior circulation aneurysms, FDS technology is firmly entrenched as a powerful tool to treat challenging aneurysms, both primarily and as an adjunct to coil embolization. With the aforementioned advances, the ease of FDS deployment will improve and complication rates will be further minimized. This will only further establish FDS deployment as a key strategy in the treatment of cerebral aneurysms.

Combined effects of dietary zinc at 3 years of age and obesity at 7 years of age on the serum uric acid levels of Korean children

  • Lee, Sung Hee;Lee, Hye Ah;Park, Eun Ae;Cho, Su Jin;Oh, Se Young;Park, Bohyun;Park, Hyesook
    • Nutrition Research and Practice
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    • v.14 no.4
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    • pp.365-373
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    • 2020
  • BACKGROUND/OBJECTIVES: To assess the longitudinal associations of the antioxidant capacity of zinc and body mass index (BMI) with serum uric acid (SUA) in South Korean children. SUBJECTS/METHODS: Using follow-up data from the Ewha Birth and Growth Cohort, we included subjects who were seen at 3 and 7 years of age (n = 183; 90 boys, 93 girls). Daily zinc intake and BMI were assessed at 3 and 7 years of age. SUA measured at 7 years was used as the outcome variable. Using a general linear model, the effects of dietary zinc intake and BMI on SUA were assessed. We also assessed the combined effect of early dietary zinc intake and BMI on SUA in children. RESULTS: The dietary zinc intake at 3 years of age was negatively correlated (ρ = -0.18, P = 0.04), whereas the BMI at 7 years of age was positively correlated (r = 0.18, P = 0.01), with the SUA level at 7 years of age. The dietary zinc intake level at 3 years of age and the BMI level at 7 years of age were, together, significantly related to SUA in children at 7 years of age. SUA was lower in group 1 (normal-weight, high-zinc group) than in the other two groups (group 2: normal-weight, low-zinc and overweight, high-zinc group; and group 3: overweight, low-zinc group). Our results demonstrate the combined effect of zinc intake and BMI on SUA. The combined association remained significant in both the crude and adjusted models (P < 0.01). CONCLUSIONS: SUA was related to combined BMI and dietary zinc intake, and increased zinc intake and normal body weight had a beneficial effect on reducing SUA in children.

The Change of Blood Pressure according to the Number of Measurements and the Number of Visits (측정 횟수 및 방문 횟수에 따른 혈압 변화)

  • Park, Ji-Eun;Lee, Min-Hee;Ryu, Yeon-Hee;Liu, Yan;Jung, Hee-Jung;Hong, Sang-Hoon;Lee, Seung-Deok;Kim, Nam-Kwen;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
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    • v.18 no.3
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    • pp.111-118
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    • 2012
  • Objective : The aim of this study was to investigate the number of measurements and visits for blood pressure measurement. We also analyzed the change of blood pressure based on the measurement method and measurement interval. Methods : Data of three clinical trials evaluating the effect of acupuncture, moxibustion, and qigong for pre and mild essential hypertension were used. Blood pressure was measured 3 times each visit with 1 or 5 minutes interval, and it was checked until $3^{rd}$ visit. Two trials used sphygmomanometer and another one trial used automatic device for blood pressure measurement. Results : The mean difference between $1^{st}$ and $2^{nd}$, and $2^{nd}$ and $3^{rd}$ measurement were significant in systolic (p<0.001) and diastolic blood pressure (p<0.001). However, in automated measurement or measuring with 1 minute interval, the difference between $2^{nd}$ and $3^{rd}$ was not significant. The mean of $1^{st}$ and $2^{nd}$ measurements was also significantly different from the mean of all three measurements in both systolic (p<0.001) and diastolic blood pressure (p<0.001). While the difference between each visit was not significant in diastolic blood pressure, the systolic blood pressure difference was significant between $1^{st}$ and $2^{nd}$ visit in automated and manual measurement. Conclusion : The mean of two measurements and three measurements were significantly different. The change of blood pressure was different according to the method and interval of blood pressure measurement.

Effect of Pretreatment with Lactobacillus delbrueckii and Streptococcus thermophillus on Tailored Triple Therapy for Helicobacter pylori Eradication: A Prospective Randomized Controlled Clinical Trial

  • Tongtawee, Taweesak;Dechsukhum, Chavaboon;Leeanansaksiri, Wilairat;Kaewpitoon, Soraya;Kaewpitoon, Natthawut;Loyd, Ryan A;Matrakool, Likit;Panpimanmas, Sukij
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.12
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    • pp.4885-4890
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    • 2015
  • Background: Helicobacter pylori plays an important role in gastric cancer and typical eradication regimens are no longer effective in many countries, including Thailand. The aim of our study was to compare the effect of Lactobacillus delbrueckii and Streptococcus thermophillus on tailored triple therapy for Helicobacter pylori eradication. Materials and Methods: This prospective single-center study was conducted in Thailand. Helicobacter pylori associated gastritis patients were randomized to 2 groups: group 1 (n=100) was tailored triple therapy with placebo (esomeprazole 20 mg bid, clarithromycin 500 mg bid or metronidazole 400 mg tid if clarithromycin resistance and amoxicillin 1000 mg bid), and group 2 was tailored triple therapy plus pretreatment with probiotic containing yogurt. Successful eradication was defined as both negative histology and negative rapid urease test at four weeks after treatment. Results: A total of 200 infected patients were enrolled. PP analysis involved 194 patients: 96 in the tailored triple therapy with placebo group (group 1) and 98 the in tailored triple therapy plus pretreatment with probiotic containing yogurt group (group 2). Successful eradication was observed in 170 (87.6%) patients; by PP analysis, the eradication rate was significantly higher in group 2 (P = 0.04, 95%CI; 0.02-0.13) than in group 1. ITT analysis also showed that the value was significantly higher in the tailored triple threapy plus pretreatment with probiotic containing yogurt group (group 2) (89/100; 89%) than in the tailored triple therapy with placebo group (group 1) (P= 0.01, 95%CI; 0.04-0.15). In terms of adverse events, there was no significant difference between the two groups. Conclusions: Pretreatment with probiotic containing yogurt can improve Helicobacter pylori eradication rates with tailored triple therapy. Adding probiotics does not reduce adverse effects of the medication.