• Title/Summary/Keyword: randomized clinical trial

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Ultrasound guidance versus the blind method for intrauterine catheter insemination: A randomized controlled trial

  • Mubarak, Sarah;Yusoff, Noor Haliza;Adnan, Tassha Hilda
    • Clinical and Experimental Reproductive Medicine
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    • v.46 no.2
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    • pp.87-94
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    • 2019
  • Objective: The primary objective of this study was to compare clinical pregnancy rates in intrauterine insemination (IUI) treatment cycles with transabdominal ultrasound guidance during intrauterine catheter insemination (US-IUI) versus the "blind method" IUI without ultrasound guidance (BM-IUI). The secondary objective was to compare whether US-IUI had better patient tolerability and whether US-IUI made the insemination procedure easier for the clinician to perform compared to BM-IUI. Methods: This was a randomized controlled trial done at the Reproductive Medicine Unit of General Hospital Kuala Lumpur, Malaysia. We included women aged between 25 and 40 years who underwent an IUI treatment cycle with follicle-stimulating hormone injections for controlled ovarian stimulation. Results: A total of 130 patients were recruited for our study. The US-IUI group had 70 patients and the BM-IUI group had 60 patients. The clinical pregnancy rate was 10% in both groups (p> 0.995) and there were no significant difference between the groups for patient tolerability assessed by scores on a pain visual analog scale (p= 0.175) or level of difficulty for the clinician (p> 0.995). The multivariate analysis further showed no significant increase in the clinical pregnancy rate (adjusted odds ratio, 1.07; 95% confidence interval, 0.85-1.34; p= 0.558) in the US-IUI group compared to the BM-IUI group even after adjusting for potential covariates. Conclusion: The conventional blind method for intrauterine catheter insemination is recommended for patients undergoing IUI treatment. The use of ultrasound during the insemination procedure increased the need for trained personnel to perform ultrasonography and increased the cost, but added no extra benefits for patients or clinicians.

Analysis of the current status of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance (건강보험 급여 한약제제 56종 처방의 계량적 문헌 근거 현황 분석)

  • Chul Kim;Hyeun-kyoo Shin
    • The Journal of Korean Medicine
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    • v.44 no.3
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    • pp.189-200
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    • 2023
  • Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future. Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure. Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration. Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

Current Status of Institutional Review Boards and Approvals of Clinical Research in Oriental Medical Hospitals in Korea: A Survey (국내 한방병원의 IRB 및 임상시험 실태조사)

  • Jung, Hee-Jung;Park, Ji-Eun;Choi, Snu-Mi
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.122-129
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    • 2010
  • Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

The effects of Sa-am Acupuncture Simpojeongkyeok Treatment on Hwa-byung : Randomized, patient-assessor blind, placebo-controlled acupuncture, pilot clinical trial (화병에 대한 사암침 심포정격의 치료 효과 : 환자-평가자 눈가림, 무작위배정 대조군 임상시험)

  • Choi, Woo-Jin;Lee, Seung-Gi;Son, In-Bong;Sun, Seung-Ho
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.2
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    • pp.1-13
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    • 2011
  • Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial (화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험)

  • Lee, Go-Eun;Kim, Nam-Kwon;Kim, Hang-Yi;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.1
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    • pp.31-48
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    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

Effects of Cordyceps militaris supplementation on the immune response and upper respiratory infection in healthy adults: a randomized, double-blind, placebo-controlled study (건강한 성인을 대상으로 면역증강 및 상기도 감염 예방에 대한 동충하초주정추출물의 유효성 평가 : 이중맹검 플라세보 대조 연구)

  • Jung, Su Jin;Hwang, Ji Hyun;Oh, Mi Ra;Chae, Soo Wan
    • Journal of Nutrition and Health
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    • v.52 no.3
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    • pp.258-267
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    • 2019
  • Purpose: Upper respiratory tract infections are major causes of the common cold throughout the world. Cordyceps militaris (C. militaris) is a well-known functional food for its anti-fatigue and immunomodulating activities. On the other hand, there are no reports on the protective effect against upper respiratory tract infections (URI). This study was a 12 week randomized, double-blind, and placebo-controlled trial in healthy volunteers. Methods: A total of 100 subjects 20 ~ 70 years of age with a history of at least two colds in the year were enrolled in the study. The participants were required to record any adverse events and rate any cold-related incidents in a diary during the investigation period. The efficacy end point was the symptoms and incidence of URI, and changes in cytokines, IgA and natural killer (NK) cell activity. Results: The Cordyceps militaris group over 12 weeks showed no significant impact on the incidence and symptomatology of URI compared to the placebo group. On the other hand, the experimental group showed significantly higher NK cell activity (p = 0.047) and IgA level (p = 0.035) compared to the placebo group. The NK-cell activity and IgA level were increased significantly by Cordyceps militaris over 12 weeks. Conclusion: The results suggest the possible beneficial immunomodulating effects, but the protective effects on URI could not be demonstrated under these conditions. Additional research will be needed to determine the efficacy and mechanisms of Cordyceps militaris function.

Clinical Usefulness of Gastric Residual Volume as An Indicator to Provide Approximately Enteral Nutrition for Patients in Intensive Care Units: A Systematic Literature Review (중환자의 경관영양 공급 지표로서 위 잔여량의 임상적 효용성: 체계적 문헌고찰)

  • Kim, Hyunjung;Chang, Sun Ju
    • Journal of Korean Biological Nursing Science
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    • v.16 no.4
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    • pp.267-275
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    • 2014
  • Purpose: The practice of enteral nutrition with gastric residual volumes (GRVs) as a clinical indicator is poorly standardized in intensive care units. This study aims to summarize the results from studies that evaluated the clinical outcomes related to the GRVs. Methods: This systematic review study analyzed 11 studies consisting of four randomized controlled trials, one non-randomized controlled trial, and six observational studies. Results: No consistent relationship between GRV thresholds and clinical outcomes was observed. Higher GRVs were not consistently correlated with clinical outcomes such as higher gastrointestinal complications, aspiration pneumonia, or mortality. Higher GRVs significantly generate complications more often. Findings show that a single GRV more than 200 mL or two consecutive GRVs more than 150 mL should raise concern about negative consequences. Conclusion: Critical care nurses need to monitor GRVs closely during their practice of enteral nutrition. For critically ill patients receiving enteral nutrition, a GRV threshold of 200 ml would be a desirable limit to provide safe and adequate nutrition with a conservative approach.

Recent Clinical Research on Effect of Acupuncture for Autism Spectrum Disorder (자폐스펙트럼장애의 침치료에 대한 최근 임상 연구 동향 - RCT 중심으로 -)

  • Lee, Ji Na;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.29 no.4
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    • pp.119-126
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    • 2015
  • Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for Autism Spectrum Disorder in other countries. We have analyzed the studies on effect of acupuncture for Autism Spectrum Disorder within randomized controlled trail (RCT) for 6years (from 2010 to 2015). Methods The search database includes Medline, Embase, Cochrane library and CNKI (China National Knowledge Infrastructure). To narrow the search, the following key search terms were used: 'autism or ASD or Asperger's Syndrome or pervasive developmental disorder, acupuncture'. The search was limited to the publication date from 2010 to 2015. 7 control studies in Medlin, Embase, Cochrane library and 5 control studies in CNKI were selected for analysis. Results and Conclusions 1. The acupuncture and rehabiliation treatment is more effective than only acupuncture treatment. Especially, Retention of needling is helpful. 2. It is necessary to set up standard scale in assessment of ASD patients and serum arginine-vasopressin (AVP) can be substitution. 3. Head acupuncture and tongue acupuncture is effective for ASD.

Randomized Clinical Controlled Trials of a Herb Remedies in Korea - Systematic Review (한약을 이용한 한국에서의 무작위 임상시험 개괄적 검토)

  • Oh, Rai-Young;Seol, In-Chan;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.4
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    • pp.1-8
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    • 2010
  • Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients (한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰)

  • Park, Bong-Ky;Wang, Jing-Hua;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.5
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.