• Title/Summary/Keyword: randomized clinical

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Evaluation of the effects of Hangover-releasing agent containing freeze-dried mature silkworm larval powder (SMSP) on alcohol metabolism and hangover improvement (숙잠 함유 복합물의 알코올 대사 및 숙취개선 효능평가)

  • Woo, Miseon;Cha, Ji Hyeon;Kim, Yonghwan;Kang, Hee-Taik;Kim, Hyeondok;Cho, Kyong Won;Park, Sung Sun;Lee, Jong Hun
    • Korean Journal of Food Science and Technology
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    • v.53 no.1
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    • pp.72-77
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    • 2021
  • Silkworms have traditionally been used to produce silk and textiles. However, steamed and freeze-dried mature silkworm larval powder (SMSP) contain large amounts of amino acids, vitamins, and essential minerals. In this study, we investigated the potential of SMSP as a hangover-relieving agent. Thirty individuals who met the selection criteria and exclusion criteria were included in the study and subsequently underwent a double-blind, randomized, placebo-controlled, cross-design human application test. Importantly, the test product containing SMSP (CKDHC) was proven to alleviate hangovers through a significant reduction in the plasma concentration of acetaldehyde in the context of an alcohol-induced hangover model. In particular, from 0.5 h after SMSP intake, the blood acetaldehyde concentration (mg/L), area under the time curve (AUC; indicating the degree of bioabsorption of blood acetaldehyde), and the highest blood acetaldehyde concentration (Cmax) were reduced. Altogether, these results suggest that the test product (CKDHC) exhibits an accelerated hangover-relieving effect.

Effect of Korea red ginseng on nonalcoholic fatty liver disease: an association of gut microbiota with liver function

  • Hong, Ji Taek;Lee, Min-Jung;Yoon, Sang Jun;Shin, Seok Pyo;Bang, Chang Seok;Baik, Gwang Ho;Kim, Dong Joon;Youn, Gi Soo;Shin, Min Jea;Ham, Young Lim;Suk, Ki Tae;Kim, Bong-Soo
    • Journal of Ginseng Research
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    • v.45 no.2
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    • pp.316-324
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    • 2021
  • Background: Korea Red Ginseng (KRG) has been used as remedies with hepato-protective effects in liver-related condition. Microbiota related gut-liver axis plays key roles in the pathogenesis of chronic liver disease. We evaluated the effect of KRG on gut-liver axis in patients with nonalcoholic statohepatitis by the modulation of gut-microbiota. Methods: A total of 94 patients (KRG: 45 and placebo: 49) were prospectively randomized to receive KRG (2,000 mg/day, ginsenoside Rg1+Rb1+Rg3 4.5mg/g) or placebo during 30 days. Liver function test, cytokeraton 18, and fatigue score were measured. Gut microbiota was analyzed by MiSeq systems based on 16S rRNA genes. Results: In KRG group, the mean levels (before vs. after) of aspartate aminotransferase (53 ± 19 vs. 45 ± 23 IU/L), alanine aminotransferase (75 ± 40 vs. 64 ± 39 IU/L) and fatigue score (33 ± 13 vs. 26 ± 13) were improved (p < 0.05). In placebo group, only fatigue score (34 ± 13 vs. 31 ± 15) was ameliorated (p < 0.05). The changes of phyla were not statistically significant on both groups. In KRG group, increased abundance of Lactobacillus was related with improved alanine aminotransferase level and increased abundance of Clostridium and Intestinibacter was associated with no improvement after KRG supplementation. In placebo group, increased abundance of Lachnospiraceae could be related with aggravation of liver enzyme (p < 0.05). Conclusion: KRG effectively improved liver enzymes and fatigue score by modulating gut-microbiota in patients with fatty liver disease. Further studies are needed to understand the mechanism of improvement of nonalcoholic steatohepatitis. ClnicalTrials.gov: NCT03945123 (www.ClinicalTrials.gov).

The efficacy of ultrasound-guided erector spinae plane block after mastectomy and immediate breast reconstruction with a tissue expander: a randomized clinical trial

  • Park, Sukhee;Park, Joohyun;Choi, Ji Won;Bang, Yu Jeong;Oh, Eun Jung;Park, Jiyeon;Hong, Kwan Young;Sim, Woo Seog
    • The Korean Journal of Pain
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    • v.34 no.1
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    • pp.106-113
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    • 2021
  • Background: We aimed to investigate the analgesic efficacy of an erector spinae plane block (ESPB) in immediate breast reconstruction (IBR) with a tissue expander. Methods: Adult women undergoing IBR with a tissue expander after mastectomy were randomly assigned to either intravenous patient-controlled analgesia (IV-PCA) alone (group P) or IV-PCA plus ESPB (group E). The primary outcome was the total amount of opioid consumption during 24 hours postoperatively between the two groups. Secondary outcomes were patient satisfaction, pain score at rest and on shoulder movement using numerical rating scale, incidences of postoperative nausea and vomiting (PONV), and a short form of the brief pain inventory (BPI-SF) at 3 and 6 months after surgery between the groups. Results: Fifty eight patients completed the study. At 24 hours postoperatively, total opioid consumption was significantly less in group E than in group P (285.0 ± 92.0, 95% confidence interval [CI]: 250.1 to 320.0 vs. 223.2 ± 83.4, 95% CI: 191.5 to 254.9, P = 0.005). Intraoperative and cumulative PCA fentanyl consumption at 3, 6, 9, and 24 hours were also less in group E than in group P (P = 0.004, P = 0.048, P = 0.020, P = 0.036, and P < 0.001, respectively). Patient satisfaction was higher in group E (6.9 ± 1.8 vs. 7.8 ± 1.4, P = 0.042). The incidences of PONV was similar. Conclusions: The ESPB decreased postoperative opioid consumption and increased patient satisfaction without significant complications after IBR with a tissue expander after mastectomy.

Effects of Manual Therapy on Musculoskeletal Diseases : A Meta-Analysis (근육뼈대계 질환에 대한 도수치료의 효과: 메타분석)

  • Lee, Jeong-Woo;Gong, Gwang-Sik;Kim, Dong-Yeon;Koh, Un
    • Journal of The Korean Society of Integrative Medicine
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    • v.9 no.1
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    • pp.203-217
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    • 2021
  • Purpose: The purpose of this meta-analysis was to examine the high-level evidence of the effects of manual therapy on musculoskeletal diseases. Methods: Domestic databases were searched for studies that conducted clinical trials associated with manual therapy on chronic musculoskeletal diseases. A total of 591 studies published between 2005 and 2018 were identified, with 18 studies satisfying the inclusion data. The studies were classified according to patient, intervention, comparison, and outcome (PICO). The search outcomes were items associated with pain and physical function. The 18 studies included in the study were evaluated by using the R meta-analysis (version 4.0). The quality of 18 randomized control trials was evaluated by using the Cochrane risk of bias (ROB). The effect sizes were computed as the corrected standardized mean difference (SMD). Subgroup and meta-regression analyses were also used. Egger's regression test was carried out in order to analyze the publication bias. Cumulative meta-analysis and sensitivity analysis were also conducted in order to analyze the data error. Results: The following factors showed the large effect size of manual therapy on chronic musculoskeletal diseases: pain (Hedges's g = 2.66; 95% CI = 1.47 ~ 3.85), and physical function (Hedges's g = 2.15; 95% CI: 1.22 ~ 3.08). The subgroup analysis only showed a statistical difference in the type of manual therapy (pain) and outcome (physical function). No statistically significant difference was found in the meta-regression analysis. Publication bias was found in the data, but the results of the trim-and-fill method showed that such bias did not largely affect the obtained data. Furthermore, there were no data errors in the cumulative meta-analysis and sensitivity analysis. Conclusion: This study provides evidence for the effectiveness of manual therapy on chronic musculoskeletal diseases in pain and physical function. Subgroup analysis suggests that only the type of manual therapy for pain and the type of outcome for physical function differed in effect size.

Case Report of the Pityriasis Rosea Patient with Pruritus Treated by Korean Medicine Treatment alone (소양감이 동반된 장미색 비강진 환자의 한방단독치료 보고)

  • Lee, Kyoungeun;Kim, Jungpil;Jeong, Seonhyung;Ahn, Joon;Jeong, Hyein;Kim, Kyounghan;Jang, Insoo;Choi, Yoomin;Oh, Yongtaek
    • Herbal Formula Science
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    • v.30 no.1
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    • pp.27-36
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    • 2022
  • Objective : The purpose of this study is to present a case report with the adult patient who needed active treatment of pityriasis rosea with severe pruritus, and did not respond to steroid treatment in the preceding month. Methods : The subject is an adult patient with pityriasis rosea over the age of 40 without any other diseases. We administered Korean medicine treatment with Bangpungtongseong-san (防⾵通聖散) and acupuncture. The effects of the treatment were evaluated via scales including Pruritus score, Pityriasis Rosea Severity Score (PRSS), and picture. Results : After the treatment Pruritus score/PRSS index of the case changed from 8/20 to 0/0. No other severe adverse reactions were reported. No more recurrence or pruritus was confirmed in follow-up. Conclusions : Korean medicine treatment with Bangpungtongseong-san showed marked improvement in pruritus and skin symptoms of pityriasis rosea in need of active care. With the lack of existing clinical reports of pityriasis rosea, we found that Korean medicine treatment could be an effective way, and it is expected that Bangpungtongseong-san could be administered to pityriasis rosea patients. Randomized-controlled trial for further evaluation will be needed in the future.

Efficacy of Different Number of XELOX or SOX Chemotherapy Cycles After D2 Resection for Stage III Gastric Cancer

  • Yu, Yuanyuan;Zhang, Zicheng;Meng, Qianhao;Wang, Ke;Li, Qingwei;Ma, Yue;Yao, Yuanfei;Sun, Jie;Wang, Guangyu
    • Journal of Gastric Cancer
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    • v.22 no.2
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    • pp.107-119
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    • 2022
  • Purpose: We aimed to explore whether the prognosis of patients treated with capecitabine and oxaliplatin (XELOX) or S-1 and oxaliplatin (SOX) regimens who received fewer cycles of chemotherapy after D2 radical resection for gastric cancer (GC) would be non-inferior to that of patients who received the standard number of cycles of chemotherapy. Materials and Methods: Data on patients who received XELOX or SOX chemotherapy after undergoing D2 radical resection at Harbin Medical University Cancer Hospital between January 2011 and May 2016 were collected. Results: In patients who received 4, 6, and 8 cycles of chemotherapy, the 5-year overall survival (OS) rates were 59.4%, 64.8%, and 62.7%, respectively. Compared to patients who received 4 cycles of chemotherapy, those who received 6 cycles (hazard ratio [HR], 0.882; 95% confidence interval [CI], 0.599-1.299; P=0.52) or 8 cycles (HR, 0.882; 95% CI, 0.533-1.458; P=0.62) of chemotherapy did not exhibit significantly prolonged OS. The 3-year disease-free survival (DFS) rate of patients who received 4, 6, and 8 cycles of chemotherapy was 62.1%, 67.2%, and 60.8%, respectively. Compared to patients who received 4 cycles of chemotherapy, those who received 6 cycles (HR, 0.835; 95% CI, 0.572-1.221; P=0.35) or 8 cycles (HR, 0.972; 95% CI, 0.606-1.558; P=0.91) of chemotherapy did not show significantly prolonged DFS. However, the 3-year DFS and 5-year OS rates of patients who received 6 cycles of chemotherapy appeared to be superior to those of patients who received 4 and 8 cycles of chemotherapy. Conclusions: For patients with stage III GC, 4 to 6 cycles of XELOX or SOX chemotherapy may be a favorable option. This study provides a rationale for further randomized clinical trials.

Anesthetic efficacy of supplemental buccal infiltration versus intraligamentary injection in mandibular first and second molars with irreversible pulpitis: a prospective randomized clinical trial

  • Zargar, Nazanin;Shojaeian, Shiva;Vatankhah, Mohammadreza;Heidaryan, Shirin;Ashraf, Hengameh;Baghban, Alireza Akbarzadeh;Dianat, Omid
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.339-348
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    • 2022
  • Background: To compare the anesthetic efficacy of supplemental buccal infiltration (BI) (1.7 ml) versus intraligamentary (IL) injection containing 0.4 ml of 4% articaine with 1:100.000 epinephrine after an inferior alveolar nerve block (IANB) with 1.7 ml 2% lidocaine in the first and second mandibular molars diagnosed with irreversible pulpitis (IP). Methods: One hundred subjects diagnosed with IP of either the mandibular first (n = 50) or second molars (n = 50) and failed profound anesthesia following an IANB were selected. They randomly received either the IL or BI techniques of anesthesia. Pain scores on a 170 mm Heft-Parker visual analog scale were recorded initially, before, and during supplemental injections. Furthermore, pulse rate was measured before and after each supplemental injection. During the access cavity preparation and initial filing, no or mild pain was assumed to indicate anesthetic success. The chi-square test, Mann-Whitney U test, and independent samples t-test were used for the analyses. Results: The overall success rates were 80% in the IL group and 74% in the BI group, with no significant difference (P = 0.63). In the first molars, there was no significant difference between the two techniques (P = 0.088). In the second molars, IL injection resulted in a significantly higher success rate (P = 0.017) than BI. IL injection was statistically more successful (P = 0.034) in the second molars (92%) than in the first molars (68%). However, BI was significantly more successful (P = 0.047) in the first molars (88%) than in the second molars (64%). The mean pulse rate increase was significantly higher in the IL group than in the BI group (P < 0.001). Conclusions: Both the IL and BI techniques were advantageous when used as supplemental injections. However, more favorable outcomes were observed when the second molars received IL injection and the first molars received BI.

Long-Term Outcomes of Preoperative Atrial Fibrillation in Cardiac Surgery

  • Kim, Hyo-Hyun;Kim, Ji-Hong;Lee, Sak;Joo, Hyun-Chel;Youn, Young-Nam;Yoo, Kyung-Jong;Lee, Seung Hyun
    • Journal of Chest Surgery
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    • v.55 no.5
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    • pp.378-387
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    • 2022
  • Background: Atrial fibrillation (Afib) is a marker of increased cardiovascular morbidity and mortality. Owing to the increased prevalence of Afib in patients undergoing cardiac surgery, assessing the effect of Afib on postsurgical outcomes is important. We aimed to analyze the effect of preoperative Afib on clinical outcomes in patients undergoing cardiac surgery using a large surgical database. Methods: This retrospective cohort study was based on the national health claims database established by the National Health Insurance Service of the Republic of Korea from 2009 to 2015. Diagnosis and procedure codes were used to identify diseases according to the International Statistical Classification of Diseases, 10th revision. Results: We included 1,037 patients (0.1%) who had undergone cardiac surgery from a randomized 1,000,000-patient cohort, and 15 patients (1.5%) treated with isolated surgical Afib ablation were excluded. Of these 1,022 patients, 412 (39.7%), 303 (29.2%), and 92 (9.0%) underwent coronary artery bypass, heart valve surgery, and Cox-maze surgery, respectively. Preoperative Afib was associated with higher patient mortality (p=0.028), regardless of the surgical procedure. Patients with preoperative Afib (n=190, 18.6%) experienced a higher cumulative risk of overall mortality (hazard ratio [HR], 1.435; 95% confidence interval [CI], 1.263-2.107; p=0.034). Subgroup analysis revealed a reduced risk of overall mortality with Cox-maze surgery in Afib patients (HR, 0.500; 95% CI, 0.266-0.938; p=0.031). Postoperative cerebral ischemia or hemorrhage events were not related to Afib. Conclusion: Preoperative Afib was independently associated with worse long-term postoperative outcomes after cardiac surgery. Concomitant Cox-maze surgery may improve the survival rate.

Systematic Review on the Patient Safety Education for the Improvement of Patient Safety Competency of Nursing Students (간호학생의 환자안전역량 향상을 위한 환자안전교육에 관한 체계적 문헌고찰)

  • Seo, Eun-Ju;Seo, Young-Sun;Hong, Eun-Hee
    • Journal of Korea Entertainment Industry Association
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    • v.14 no.5
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    • pp.255-266
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    • 2020
  • This study conducted a systematic literature review on nursing students to find out the types and composition of patient safety-related education programs. The research was conducted systematically using PRISMA. The patient was a nursing college student, and the intervention was patient safety education. The outcome was either numerical or descriptive reports of the results measured using the tool. The types of research were carried out including randomized design, quasi-experimental design, one-group design, survey and qualitative research. The paper was searched through Medline, Embases, CINAHL, DBpia, Riss and KISS. A total of 2,468 papers were searched in the search results, and nine papers were used for analysis as a result of extracting data according to PICO. The characteristics of patient safety education of nursing college students were classified according to the teaching method, period, result variables and measurement tools. As a result, patient safety education consisted of a variety of subjects, and was being taught through lectures, clinical practice, laboratories, and simulations. The period of education also varied. The resulting variables were mainly checked for knowledge, attitude, and skill, and the tools used to measure them varied. Patient safety education for nursing college students was conducted through various topics, methods and periods at home and abroad. Therefore, continuous research is needed to establish consistent and integrated patient safety education in educational institutions and working institutions to produce nursing personnel with patient safety capabilities.

Programmed-release intraosseus anesthesia as an alternative to lower alveolar nerve block in lower third molar extraction: a randomized clinical trial

  • Pol, Renato;Ruggiero, Tiziana;Bezzi, Marta;Camisassa, Davide;Carossa, Stefano
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.3
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    • pp.217-226
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    • 2022
  • Background: Intraosseous anesthesia is the process by which an anesthetic solution, after penetration of the cortical bone, is directly injected into the spongiosa of the alveolar bone supporting the tooth. This study aimed to compare the effectiveness of the traditional inferior alveolar nerve block (IANB) and computerized intraosseous anesthesia in the surgical extraction of impacted lower third molars, compare their side effects systemically by monitoring heart rate, and assess patients' a posteriori preference of one technique over the other. Methods: Thirty-nine patients with bilaterally impacted third molars participated in this study. Each patient in the sample was both a case and control, where the conventional technique was randomly assigned to one side (group 1) and the alternative method to the contralateral side (group 2). Results: The traditional technique was faster in execution than anesthesia delivered via electronic syringe, which took 3 min to be administered. However, it was necessary to wait for an average of 6 ± 4 min from the execution to achieve the onset of IANB, while the latency of intraosseous anesthesia was zero. Vincent's sign and lingual nerve anesthesia occurred in 100% of cases in group 1. In group 2, Vincent's sign was recorded in 13% of cases and lingual anesthesia in four cases. The average duration of the perceived anesthetic effect was 192 ± 68 min in group 1 and 127 ± 75 min in group 2 (P < 0.001). The difference between the heart rate of group 1 and group 2 was statistically significant. During infiltration in group 1, heartbeat frequency increased by 5 ± 13 beats per minute, while in group 2, it increased by 22 ± 10 beats per minute (P < 0.001). No postoperative complications were reported for either technique. Patients showed a preference of 67% for the alternative technique and 20% for the traditional, and 13% of patients were indifferent. Conclusion: The results identified intraosseous anesthesia as a valid alternative to conventional anesthesia in impacted lower third molar extraction.