• Title/Summary/Keyword: Randomized controlled trials

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Comparison Different Methods of Intraoperative and Intraperitoneal Chemotherapy for Patients with Gastric Cancer: A Meta-analysis

  • Huang, Jin-Yu;Xu, Ying-Ying;Sun, Zhe;Zhu, Zhi;Song, Yong-Xi;Guo, Peng-Tao;You, Yi;Xu, Hui-Mian
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4379-4385
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    • 2012
  • Purpose: To investigate the efficacy and safety of intraperitoneal chemotherapy (IPC) for patients with gastric cancer and to compare effects between different regimens of IPC. Method: Randomized controlled trials comparing the effects of surgery plus intraperitoneal chemotherapy with surgery alone or comparing the efficacy between different regimens of intraperitoneal chemotherapy were searched for in Medline, Embase, Pubmed, the Cochrane Library and the Chinese BioMedical Disc and so on by two independent reviewers. After quality assessment and data extraction, data were pooled for meta-analysis using RevMan5.16 software. Tests of interaction were used to test for differences of effects among subgroups grouped according to different IPC regimens. Results: Fifteen RCTs with a total of 1713 patients with gastric cancer were included for quality assessment and data extraction. Ten studies were judged to be of fair quality and entered into meta-analysis. Hyperthermic intraoperative intraperitoneal chemotherapy (HR=0.60, P<0.01), hyperthermic intraoperative intraperitoneal chemotherapy plus postoperative intraperitoneal chemotherapy (HR=0.47, P<0.01) and normothermic intraoperative intraperitoneal chemotherapy (HR=0.70, P=0.01) were associated with a significant improvement in overall survival. Tests of interaction showed that hyperthermia and additional postoperative intraperitoneal chemotherapy did not impact on its effect. Further analysis revealed that intraperitoneal chemotherapy remarkably decrease the rate of postoperative hepatic metastasis by 73% (OR=0.27, 95% CI=0.12 to 0.67, P<0.01). However, intraperitoneal chemotherapy increased risks of marrow depression (OR=5.74, P<0.01), fever (OR=3.67, P=0.02) and intra-abdominal abscess (OR=3.57, P<0.01). Conclusion: The present meta-analysis demonstrates that hyperthermic intraoperative intraperitoneal chemotherapy and normothermic intraoperative intraperitoneal chemotherapy should be recommended to treat patients with gastric cancer because of improvement in overall survival. However, it is noteworthy that intraperitoneal chemotherapy can increase the risks of marrow depression, intra-abdominal abscesses, and fever.

Efficacy and Toxicity of Anti-VEGF Agents in Patients with Castration-Resistant Prostate Cancer: a Meta-analysis of Prospective Clinical Studies

  • Qi, Wei-Xiang;Fu, Shen;Zhang, Qing;Guo, Xiao-Mao
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.19
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    • pp.8177-8182
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    • 2014
  • Background: Blocking angiogenesis by targeting vascular endothelial growth factor (VEGF) signaling pathway to inhibit tumor growth has proven to be successful in treating a variety of different metastatic tumor types, including kidney, colon, ovarian, and lung cancers, but its role in castration-resistant prostate cancer (CRPC) is still unknown. We here aimed to determine the efficacy and toxicities of anti-VEGF agents in patients with CRPC. Materials and Methods: The databases of PubMed, Web of Science and abstracts presented at the American Society of Clinical Oncology up to March 31, 2014 were searched for relevant articles. Pooled estimates of the objective response rate (ORR) and prostate-specific antigen (PSA) response rate (decline ${\geq}50%$) were calculated using the Comprehensive Meta-Analysis (version 2.2.064) software. Median weighted progression-free survival (PFS) and overall survival (OS) time for anti-VEGF monotherapy and anti-VEGF-based doublets were compared by two-sided Student's t test. Results: A total of 3,841 patients from 19 prospective studies (4 randomized controlled trials and 15 prospective nonrandomized cohort studies) were included for analysis. The pooled ORR was 12.4% with a higher response rate of 26.4% (95%CI, 13.6-44.9%) for anti-VEGF-based combinations vs. 6.7% (95%CI, 3.5-12.7%) for anti-VEGF alone (p=0.004). Similarly, the pooled PSA response rate was 32.4% with a higher PSA response rate of 52.8% (95%CI: 40.2-65.1%) for anti-VEGF-based combinations vs. 7.3% (95%CI, 3.6-14.2%) for anti-VEGF alone (p<0.001). Median PFS and OS were 6.9 and 22.1 months with weighted median PFS of 5.6 vs. 6.9 months (p<0.001) and weighted median OS of 13.1 vs. 22.1 months (p<0.001) for anti-VEGF monotherapy vs. anti-VEGF-based doublets. Conclusions: With available evidence, this pooled analysis indicates that anti-VEGF monotherapy has a modest effect in patients with CRPC, and clinical benefits gained from anti-VEGF-based doublets appear greater than anti-VEGF monotherapy.

Review of Clinical Research Literatures on Effect of Traditional Chinese Medicine for Pediatric Night Crying (야제 (夜啼)의 한의학 치료에 대한 최신 중의학 임상 연구 동향 -2000년대 이후 발표된 임상 연구 논문을 중심으로-)

  • Kim, Sang Min;Lee, Jin Yong;Lee, Sun Haeng;Doh, Tae Yun
    • The Journal of Pediatrics of Korean Medicine
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    • v.32 no.3
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    • pp.100-118
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    • 2018
  • Objectives The purpose of this study is to analyze some of the TCM (traditional Chinese medicine) clinical research literatures about pediatric night crying in order to learn clinical application of Korean medicine treatment for pediatric night crying. Methods We searched clinical trial literatures about TCM treatment of pediatric night crying from the CNKI (China National Knowledge Infrastructure) (January 2000 to June 2018). We analyzed the literature in regards to the treatment methods and the results. Results Among the 459 searched studies, 13 randomized controlled trials and 41 case studies were selected and analyzed. In most of the studies, the effectiveness of TCM in treating patients was significantly high, so we confirmed the effectiveness of TCM on pediatric night crying. The most commonly used pattern differentiations (辨證) were Spirit damage due to fright and fear (驚恐傷神), Spleen deficiency and cold (脾虛寒) and Heart fire heat (心火熱). Methods of treatment include herbal medicines (internal medicine and external application), massage therapy (Tuina methods), acupuncture and other treatments (bloodletting). The most commonly used herb medicines were Cicadidae Periostracum (蟬?), Poria Cocos (茯?), Glycyrrhizae Radix (甘草), Uncariae Ramulus et Uncus (釣鉤藤), Junci Medulla (燈心草), Fossilia Ossis Mastodi (龍骨), Atractylodis Rhizoma Alba (白朮), Cinnabaris (朱砂), and Coptidis Rhizoma (黃連). The most commonly used massage methods were Clearing Liver Channel (淸肝經), Clearing Heart Channel (淸心經), Kneading $Xi{\check{a}}oti{\bar{a}}nx{\bar{i}}n$ (?小天心), Supplementing Spleen Channel (補脾經), Clearing $Ti{\bar{a}}nh{\acute{e}}shu{\check{i}}$ (淸天河水), and Rubbing Abdomen (摩腹). Conclusions Based on the results of clinical studies from China, the use of Korean medicine for the treatment of pediatric night crying has been shown to be effective in relieving symptoms. Based on the results of this study, it is possible to widen the scope of Korean medicine by additionally reviewing clinical and experimental studies on pediatric night crying.

A Systematic Review on clinical studies of Korean medicine for smoking cessation - Focusing on study design (한의약 금연 임상연구의 체계적 고찰 - 연구 설계를 중심으로)

  • Park, Yu Lee;Jang, Soobin;Sung, Hyun Kyung;Kweon, Seung Uk;Sung, Joo Won;Yang, Jaehyung;Park, Bongkyu;Ko, Seong-Gyu;Park, Sunju
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.3
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    • pp.115-129
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    • 2015
  • Objective : This study aims to review clinical studies evaluating effectiveness of Korean medicine for smoking cessation. It also aims to critically analyze study design of the studies and suggest strategies for future clinical studies on smoking cessation. Method : Only domestic databases such as RISS, KISS, DBPIA, NDSL, and OASIS were searched from August to November 2011 for clinical studies on smoking cessation. There was no limitation on study design, period, and language. The studies were qualitatively analyzed focusing on study design including participants, intervention, and outcome measurements. Results : Out of 537 studies searched, 27 studies were included in the analysis. 56% of the studies were observational studies, 33% were quasi-experimental studies, and 11% were randomized controlled studies. 44% and 32% of the studies were conducted at educational institutions and hospitals, respectively. The average number of the participants were 182, which ranged from 15 to 1,056. Most of the participants were male. Intervention used were mostly auricular acupuncture, and the most frequently used acupoints were Lung, Shinmun, Endocrine, Pharynx & Larynx, and Inner nose. The average length of treatment period was four weeks, and the treatment was provided twice per week. The outcomes were measured at the end of the treatment and only 26% of the studies conducted follow-up measurements. 26% of the studies utilized questionnaires of which validity was evaluated and only 15% used objective measurements such as exhaled Carbon monoxide and Cotinine test. Conclusion : Though many clinical studies on effectiveness of Korean medicine for smoking cessation were conducted, there are still debates on quality of evidence. Recently, guidelines have been developed for clinical trials evaluating effectiveness of smoking cessation program. Thus, in the future, clinical studies should be developed based on these guidelines and designed to improve validity and reliability.

Analysis of Studies on Guibi-tang(Guipitang) for Fundamental Establishment of Evidence Based Medicine(EBM) (EBM 기반구축을 위한 귀비탕(歸脾湯) 연구 문헌 분석)

  • Kim, Jung-Hoon;Lee, Jun-Kyoung;Ha, Hye-Kyoung;Seo, Chang-Seob;Lee, Mi-Young;Lee, Ho-Young;Jung, Da-Young;Lee, Nam-Hun;Lee, Jin-Ah;Huang, Dae-Sun;Shin, Hyun-Kyoo
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.3
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    • pp.205-216
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    • 2009
  • Objectives : To establish the fundaments for EBM of Traditional Korean Medicine, the papers on Guibi-tang(Guipitang) which were frequently used in medical institutions of Traditional Korean Medicine were analyzed through researching domestic and international literatures. Methods : The papers were classified by the year of publishment, by experimental methods, by laboratory animals used in biological experiment and by the kinds of studies on biological efficacy. Results : Of total 39 papers were registered in domestic journals. Since 1980, publishments of papers have continuously increased. The papers on biological studies were 34 volumes, clinical studies were 5 volumes. Biological studies mainly showed the effects of anti-stress, anti-oxidant, hemostasis, anti-osteoporosis, gastroprotection, reproductive ability, brain cell activity, radioprotection. And clinical studies showed improvements of fearful throbbing, memory and orientation, insomnia, vericose vein, schizophrenia. Conclusions : Guibi-tang(Guipitang) could be used to fortify the spleen, nourish the heart and then control the blood. However biological studies need to be conducted in accordance with clinical study and further clinical studies on randomized controlled trials should be proceeded.

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Criteria for diet pattern and meal management to improve cognitive function: A systematic review (체계적 문헌 고찰을 통한 인지기능 개선에 도움을 주는 식사 관리에 대한 연구)

  • Park, Young-Sook;Lee, Hyun-Jung;Choi, Kui-Jeong;Xu, Lin;Nam, Ye-Rim;Kim, Yoon-Ha;Kim, Min-Ji;Shin, Weon-Sun
    • Korean Journal of Food Science and Technology
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    • v.52 no.5
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    • pp.450-458
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    • 2020
  • The purpose of this study was to conduct a systematic review of the current published research related to improvement in cognitive function. A systematic search was performed in three bibliographic databases (PubMed, Cochrane Library, and EMBASE) using "dementia", "memory", "food", "diet", and "nutrition" as keywords. Meal management intervention, including Dietary Approaches to Stop Hypertension (DASH) diet, Mediterranean (Med) diet, Diet Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, and other studies, was also included in the analysis. Through extensive screening, 21 articles, out of 2101 papers retrieved, were used for the final systematic review. The methodological quality of the randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias tool. These articles recommended vegetables, fruits, whole grains, olive oil, fish, berries, nuts, and beans. In conclusion, this study suggests the potential use of meal management to improve cognitive function.

The Heterogeneity of T2NO Glottic Carcinoma Treated by Irradiation (T2NO 병기 성문암의 방사선치료-예후인자 분석)

  • Lee Hyung Sik;Moon Sun Rock;Ahn Ki Jung;Chung Eun Ji;Suh Chang Ok;Kim Gwi Eon;Loh John J K
    • Radiation Oncology Journal
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    • v.8 no.2
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    • pp.199-205
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    • 1990
  • During a ten-year period from 1978 through 1987, 44 patients with T2NOMO glottic cancer were treated with radical radiation therapy at the Yonsei University Medical Center. Forty-two patients had a minimum follow-up of 3 years, and $81\%$ had at least five years of follow-up. Patients were staged according to the AJCC system. Forty-two patients have been analyzed in detail with respect to two variables: the status of vocal cord mobility and the degree of local extension of the disease. Five-year local recurrence free survival rates were as follows: All 42 patients, $53.3\%$ patients with normal vocal cord mobility (n =18), $69.1\%$ versus patients with impaired vocal cord mobility (n=24), $43.4\%$(p<0.05); patients with subglottic extension (n=15), $36.7$ versus patients without subglottic extension (n=29), $61.9\%$ (p<0.05). The most favorable Prognostic group included the patients with normal mobility without subglottic extension (n=14), $83.1\%$. On the basis of this analysis, we confirmed the presence of heterogeneity in T2NOMO glottic cancer This study indicates that further randomized controlled trials are warranted to evaluate.

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Evaluation of Pregnancy and Thyroid Function (임신과 갑상선 기능의 평가)

  • Park, Chang-Eun
    • Korean Journal of Clinical Laboratory Science
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    • v.50 no.1
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    • pp.1-10
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    • 2018
  • During early pregnancy, before the development of a functioning thyroid gland, thyroid stimulating hormone (TSH) is a very sensitive marker of thyroid dysfunction during pregnancy. Normal values have been modified during gestation with a downward shift. The fetus is influenced by the TSH supplied by the mother. TSH and free thyroxine (FT4) concentrations vary during pregnancy and conventional units can vary between laboratories. A downward shift of the TSH reference range occurs during pregnancy, with a decrease in both the lower and upper limits of maternal TSH, relative to the typical non-pregnant TSH reference range. Each laboratory produces its own reference TSH and FT4 concentrations because there are many different assays that yield different results in pregnancy. Therefore, automated immunoassays used for serum FT4 analysis are still used widely, but the important considerations discussed above must be noted. The use of population-based, trimester-specific reference ranges remains the best way to handle this issue The slight downward shift in the upper reference range of TSH occurring in the latter first trimester (7~12 weeks) of pregnancy, typically not observed prior to 7 weeks. Their use indicates high or low levels in a quantitative manner independent of the reference ranges. These data highlight the importance of calculating population-based pregnancy-specific thyroid parameter reference intervals. A precision medicine initiative in this area will require the collection and analysis of a large number of genetic, biological, psychosocial, and environmental variables in large cohorts of individuals. Large prospective randomized controlled trials will be needed to resolve these controversies.

Development of a Guidelines of the Herbal Medicine Treatment for Gastric Cancer on the Use of Systemic Review and Delphi Technique (체계적 문헌 고찰과 델파이 기법을 활용한 위암의 한약 치료에 관한 한의표준임상진료 지침 개발)

  • Song, Si Yeon;Ban, Kyung-tae;Ha, Su-jeung;Park, So-jung;Lee, Yeon-weol;Cho, Chong-kwan;Cho, Seung-Hun;Yoo, Hwa-Seung
    • Journal of Korean Traditional Oncology
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    • v.23 no.1
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    • pp.1-14
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    • 2018
  • Objectives: This study was conducted towards developing guidelines of herbal medicine treatment for gastric cancer. Methods: We performed a systematic review and meta-analysis designed to investigate the efficacy of herbal medicine treatment for gastric cancer on four cancer questions; survival rate, metastasis, immune function, and quality of life. Based on the findings, we utilized a two-round delphi process with panel of 22 experts for their level of agreement. Results: Combined therapy group, herbal medicine treated with chemotherapy, was significantly higher in the 1-year survival rate (RR=1.27, 95% CI: 1.14 to 1.40, P=0.005, $I^2=71%$) and 3-years survival rate (RR=1.41, 95% CI: 1.16 to 1.71, P=0.91, $I^2=0%$) than chemotherapy group. The suppression of metastasis was higher in the combined therapy group (RR=0.62, 95% CI: 0.45 to 0.84, P=0.09, $I^2=54%$). The immunology function was higher in the combined therapy group compared with the chemotherapy group (MD=16.43, 95% CI: 13.25 to 29.61, P<0.001, $I^2=99%$). The quality of life score was higher in the combined therapy group compared with the chemotherapy group (RR=1.55, 95% CI: 1.21 to 2.00, P<0.66, $I^2=0%$). Conclusions: Among the Randomized controlled trials (RCT) included, the levels of survival rates, suppression of metastasis, immune function, and quality of life of the group treated with chemotherapy were lower compared to those treated with herbal medicine in addition to chemotherapy.

Early gonadotropin-releasing hormone antagonist start improves follicular synchronization and pregnancy outcome as compared to the conventional antagonist protocol

  • Park, Chan Woo;Hwang, Yu Im;Koo, Hwa Seon;Kang, Inn Soo;Yang, Kwang Moon;Song, In Ok
    • Clinical and Experimental Reproductive Medicine
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    • v.41 no.4
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    • pp.158-164
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    • 2014
  • Objective: To assess whether an early GnRH antagonist start leads to better follicular synchronization and an improved clinical pregnancy rate (CPR). Methods: A retrospective cohort study. A total of 218 infertile women who underwent IVF between January 2011 and February 2013. The initial cohort (Cohort I) that underwent IVF between January 2011 and March 2012 included a total of 68 attempted IVF cycles. Thirty-four cycles were treated with the conventional GnRH antagonist protocol, and 34 cycles with an early GnRH antagonist start protocol. The second cohort (Cohort II) that underwent IVF between June 2012 and February 2013 included a total of 150 embryo-transfer (ET) cycles. Forty-three cycles were treated with the conventional GnRH antagonist protocol, 34 cycles with the modified early GnRH antagonist start protocol using highly purified human menopause gonadotropin and an addition of GnRH agonist to the luteal phase support, and 73 cycles with the GnRH agonist long protocol. Results: The analysis of Cohort I showed that the number of mature oocytes retrieved was significantly higher in the early GnRH antagonist start cycles than in the conventional antagonist cycles (11.9 vs. 8.2, p=0.04). The analysis of Cohort II revealed higher but non-significant CPR/ET in the modified early GnRH antagonist start cycles (41.2%) than in the conventional antagonist cycles (30.2%), which was comparable to that of the GnRH agonist long protocol cycles (39.7%). Conclusion: The modified early antagonist start protocol may improve the mature oocyte yield, possibly via enhanced follicular synchronization, while resulting in superior CPR as compared to the conventional antagonist protocol, which needs to be studied further in prospective randomized controlled trials.