• Title/Summary/Keyword: Randomized controlled trials

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Platelet Rich Plasma Injection: Evidence Based Analysis (혈소판 풍부 혈장 주사 요법: 근거 중심의 분석)

  • Oh, Joo Han;Chung, Seok Won
    • The Journal of Korean Orthopaedic Ultrasound Society
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    • v.4 no.2
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    • pp.111-122
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    • 2011
  • Platelet rich plasma (PRP) has been widely used nowadays for several common orthopaedic-related sports medicine conditions with the theoretical basis that PRP supplies numerous autologous growth factors from concentrated platelets needed to promote the healing process of injured tissue. Even though there are many basic sciences, animal studies and some clinical studies regarding PRP injections for musculoskeletal injuries which suggested good results, it is difficult to compare these various studies due to marked methodological differences such as PRP preparation method, the timing, volume and number of injection, and the outcome measurement tool. In addition, many studies have no control groups or a limited sample size, and there are few prospective randomized controlled trials assessing the efficacy of PRP injections. Therefore, well designed high-quality randomized studies are required to confirm the preliminary results until now and provide scientific evidence to support its use, and the paucity of scientific clinical evidence suggest that the administration of PRP on humans for musculoskeletal injuries should be performed with caution.

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Efficacy and Adverse Events of Bangpungtongseong-san(Bofutsusho-san) and Bangkihwangki-tang(Boiogiot-tang) by Oriental Obesity Pattern Identification on Obese Subjects : Randomized, Double Blind, Placebo-controlled Trial (비만 환자에서 한방 비만 변증에 따른 방풍통성산과 방기황기탕의 치료효과 및 부작용 비교 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Lee, Myeong-Jong;Kim, Ho-Jun;Hong, Sun-woo;Lee, Dong-Ki;Yoo, Jae-Wook;Choi, Sun-Mi;Moon, Jin-Seok;Lim, Chi-Yeon;Lee, Jung-bok
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.2
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    • pp.265-278
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    • 2011
  • Objectives : This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods : 166 subjects(body mass index ${\geq}25kg/m^2$) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results : The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) > stagnation of the liver qi(肝鬱) > yang deficiency(陽虛) > spleen deficiency(脾虛) > phlegm(痰飮) > blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions : Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.12-24
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    • 2024
  • The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01-0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97-5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

Efficacy of ketamine in the treatment of migraines and other unspecified primary headache disorders compared to placebo and other interventions: a systematic review

  • Chah, Neysan;Jones, Mike;Milord, Steve;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.413-429
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    • 2021
  • Background: Migraine headaches are the second leading cause of disability worldwide and are responsible for significant morbidity, reduction in the quality of life, and loss of productivity on a global scale. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of ketamine on migraines and other primary headache disorders compared to placebo and other active interventions, such as midazolam, metoclopramide/diphenhydramine, and prochlorperazine/diphenhydramine. Methods: An electronic search of databases published up to February 2021, including Medline via PubMed, EMBASE, Web of Science, and Cochrane Library, a hand search of the bibliographies of the included studies, as well as literature and systematic reviews found through the search was conducted to identify randomized controlled trials (RCTs) investigating ketamine in the treatment of migraine/headache disorders compared to the placebo. The authors assessed the risk of bias according to the Cochrane Handbook guidelines. Results: The initial search strategy yielded 398 unduplicated references, which were independently assessed by three review authors. After evaluation, this number was reduced to five RCTs (two unclear risk of bias and three high risk of bias). The total number of patients in all the studies was 193. Due to the high risk of bias, small sample size, heterogeneity of the outcomes reported, and heterogeneity of the comparison groups, the quality of the evidence was very low. One RCT reported that intranasal ketamine was superior to intranasal midazolam in improving the aura attack severity, but not duration, while another reported that intranasal ketamine was not superior to metoclopramide and diphenhydramine in reducing the headache severity. In one trial, subcutaneous ketamine was superior to saline in migraine severity reduction; however, intravenous (I.V.) ketamine was inferior to I.V. prochlorperazine and diphenhydramine in another study. Conclusion: Further double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.

Effects for kangaroo care: systematic review & meta analysis (캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석)

  • Lim, Junghee;Kim, Gaeun;Shin, Yeonghee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.599-610
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    • 2016
  • This paper reports the results of a systematic review (SR) and meta-analysis research to compare the effect of Kangaroo care, targeting mothers and premature infants. A randomized clinical trial study was performed until February 2015. The domestic literature contained the non-randomized clinical trial research without restriction according to the level of the study design. A search of the Ovid-Medline, CINAHL, PubMed and KoreaMed, the National Library of KOREA, the National Assembly Library, NDSL, KISS and RISS. Through the KMbase we searched and combined the main term ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((kangaroo OR kangaroo OR kangaroo) AND (care OR nursing care OR management OR skin contact)) was made; these were all combined with a keywords search through the selection process. They were excluded in the final 25 studies (n=3051). A methodology checklist for randomized controlled trials (RCTs) designed by SIGN (Scottish Intercollegiate Guidelines Network) was utilized to assess the risk of bias. The overall risk of bias was regarded as low. In 16 studies that were evaluated as a grade of "++", 9 studies were evaluated as a grade of "+". As a result of meta-analysis, kangaroo care regarding the effects of premature mortality, severe infection/sepsis had an insignificant effect. Hyperthermia incidence, growth and development (height and weight), mother-infant attachment, hypothermia incidence, length of hospital days, breast feeding rate, sleeping, anxiety, confidence, and gratification of mothering role were considered significant. In satisfaction of the role performance, depression and stress presented contradictory research results for individual studies showing overall significant difference. This study has some limitations due to the few RCTs comparing kangaroo care in the country. Therefore, further RCTs comparing kangaroo care should be conducted.

Polymorphisms of tumor necrosis factor-alpha promotor gene in Kawasaki disease and relation to the risk of coronary artery lesion (가와사키병에서의 TNF-alpha 유전자의 다형성 및 관상동맥 합병증과의 연관성)

  • Kim, Se-hwa;Yun, Jang-won;Lee, Young-hyuk;Cheon, Eun-jung
    • Clinical and Experimental Pediatrics
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    • v.52 no.4
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    • pp.476-480
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    • 2009
  • Purpose : The purpose of this study was to investigate the polymorphisms of the TNF-alpha promotor gene, its susceptibility to Kawasaki disease (KD) and to assess whether the TNF-alpha promotor gene polymorphism was related the risk of coronary artery lesions (CALs). Methods : From January 2003 to January 2007, 51 children (30 boys and 21 girls) with KD and 48 children forming an age-matched control group were studied. DNA from the peripheral blood of all the children was sampled, and the DNA polymorphisms of the 5' flanking regions of the TNF-alpha promoter gene at position -308 [guanine (G) to adenine (A)] were determined by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Then, the relationship between KD and the TNF-alpha promotor gene polymorphisms was evaluated. Results : The A allele frequency of the -308 site of the TNF-alpha promotor gene was 17.6% (9/51) for children with KD and 6.8% (3/48) for the control group children, but this result was not statistically significant. Twenty-four patients experienced CALs within 60 days after the onset of symptoms. KD children with TNF-alpha -308 A allele had lower frequencies of CALs (12.5% versus 22.2%, P>0.05). Conclusion : The DNA polymorphism of the -308 site TNF-alpha gene was not associated with susceptibility to KD and a risk of CALs. Multicenter, large-scale randomized controlled trials are needed for further study.

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.