• Title/Summary/Keyword: Randomized response

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Review of Randomized Controlled Trials of Oriental Medicine for Recurrent Vulvovaginal Candidiasis (재발성 칸디다성 외음질염의 한약치료 효과에 관한 무작위 대조 연구 문헌고찰)

  • Chae, Min-Soo;Park, Seung-Hyeok;Hwang, Deok-Sang;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bock
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.2
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    • pp.29-43
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    • 2020
  • Objectives: The purpose of this study is to review and evaluate the effectiveness of oriental medicine per oral for recurrent vulvovaginal candidiasis (RVVC). Methods: We searched articles from Korean journal databases including Journal of Korean Obstetrics and Gynecology, Korean studies Information Service Studies, and Chinese National Knowledge Infrastructure, Cochrane Library, PubMed. Searched keywords were "재발성 칸디다성 외음질염", "recurrent vulvovaginal candidiasis", "㚆发性外阴阴道假丝酵母菌病", "中藥". Results: 10 randomized controlled trials with 700 patients were identified and reviewed. 8 studies compared combination of oriental medicine and anti-fungal agent with anti-fungal agent, and 6 of them reported that treatment group (TG) showed statistically higher total effective rate or cure rate and lower recurrence rate. One study compared oriental medicine and anti-fungal agent and TG showed statistically higher total effective rate and lower recurrence rate after 1 month. One study compared combination of oriental medicine and lacto bacillus capsule with lacto bacillus capsule, and TG showed statistically higher total effective rate and lower positive fungul test rate after 6 months. No severe adverse response was reported. Conclusions: Our review found that oriental medicine per oral is effective for alleviating symptoms, lowering recurrence rate and positive fungal test in RVVC patients. We recommend standardized randomized controlled trial guideline should be made to obtain stronger evidence and well designed trials with larger sample sizes are needed.

The Clinical Effect of Bosingunyang-tang on Chronic Non-bacterial Prostatitis/Chronic Pelvic Pain Syndrome : Randomized Double-blind, Placebo-controlled Clinical Trial

  • Song, Moon-Koo;Kang, Ji-Suck;Kang, Cheol-Ho;Ahn, Young-Min;Ahn, Se-Young;Doo, Ho-Kyung;Lee, Byung-Cheol
    • The Journal of Internal Korean Medicine
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    • v.29 no.3
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    • pp.800-809
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    • 2008
  • Objective : Although chronic prostatitis/chronic pelvic pain syndrcme(CP/CPPS) is a common disease, there is no consensus on the etiology or pathology and treatment. This was a double-blinded, placebo-controlled, randomized clinical trial, investigating the therapeutic effects of the traditional Korean medicine, Bosingunyang-tang(BSGYT). Method : Participants who met US National Institutes of Health (NIH) consensus criteria for CP/CPPS were entered after applying inclusion/exclusion criteria. They were randomized to the BSGYT or placebo group. and treated three times a day for 6 weeks. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was used to estimate the clinical symptoms of CP/CPPS. Prostaglandin E2 and ${\beta}$-endorphin in prostatic fluid, collected by 2-glass pre-massage and post-massage test, were analyzed as factors associated with pain and inflammation. Result : The mean decrease in NIH-CPSI total score of the BSGYT group was 11.0 points, which is 5.7 points more than the placebo group. (Mann Whitney test P=0.038) Also the BSGYT group showed three times higher response rate than the placebo group in NIH-CPSI pain subscale score. (Fisher's exact test P=0.027) In those responders, prostaglandin E2 decreased significantly. (Wilcoxon's signed-ranks test P=0.037). No specific side effects were observed. Conclusion : After a 6-week treatment period, BSGYT improved clinical symptoms of CP/CPPS patients by decreasing PGE2 level in prostatic fluid.

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Meta-analysis of Six Randomized Control Trials of Chemotherapy Plus Anti-HER Monoclonal Antibody for Advanced Gastric and Gastroesophageal Cancer

  • Luo, Huai-Qing;Han, Li;Jiang, Yan
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.13
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    • pp.5343-5348
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    • 2014
  • Background: A meta-analysis was performed to examine the benefit/risk ratio for the addition of anti- HER MoAbs to chemotherapy in patients with advanced gastric and gastroesophageal cancer from six randomized phase II/III trials. Materials and Methods: We searched relative trials from Pubmed, EMBASE, Cochrane library databases, China National Knowledge Infrastructure databases, Google Scholar and the NIH ClinicalTrials. Primary outcomes were overall response rate (ORR), progression-free survival (PFS), overall survival (OS). Secondary outcomes were toxicities. All analyses were performed using STATA 12.0. Results: This meta-analysis included six randomized controlled trials (RCTs) with 2, 297 patients and we demonstrated that the anti-HER MoAbs arm did have a positive effect on ORR in the anti-HER MoAbs arm (OR 1.28, 95% CI 1.00-1.64, p=0.01). There was an increasing benefit regarding OS (HR 0.74, 95% CI 0.60-0.88, p<0.05) and PFS (HR 0.72, 95% CI 0.60-0.84, p<0.05) in the anti-HER2 subgroup, but a reduction of OS (HR 1.11, 95% CI 0.87-1.36, p<0.05) and PFS (HR 1.13, 95% CI 0.98 -1.28, P<0.05) in anti-EGFR subgroup. Some grade 3-4 toxicity had a significantly higher incidence in the anti-HER MoAbs arm. There was no significant publication bias for all endpoints. Conclusions: The addition of trstuzumab MoAb to chemotherapy for gastric and gastroesophageal cancer significantly improved outcome of OS and PFS endpoints, while other MoAbs led to no improvement in results. Some adverse events were increased in anti-HER MoAbs arm compared with the control.

Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial

  • Dong-Ju Choi;Jin Joo Park;Minjae Yoon;Sung-Ji Park;Sang-Ho Jo;Eung Ju Kim;Soo-Joong Kim;Sungyoung Lee
    • Korean Circulation Journal
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    • v.52 no.10
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    • pp.785-794
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    • 2022
  • Background and Objectives: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess BP accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feed-back algorithm (SMBP-App) for tailored recommendations. In this study, we aim to evaluate whether SMBP-App is superior to SMBP alone in terms of BP reduction and drug adherence improvement in patients with hypertension. Methods: Self-Monitoring of blood pressure and Feed-back using APP in Treatment of UnconTrolled Hypertension (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. Patients with uncomplicated essential hypertension will be randomly assigned to the SMBP-App (90 patients) and SMBP alone (90 patients) groups. In the SMBP group, the patients will perform home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients will receive additional recommendations from the application in response to the obtained BP value. Follow-up visits will be scheduled at 12 and 24 weeks after randomization. The primary endpoint of the study is the mean home systolic BP. The secondary endpoints include the drug adherence, the home diastolic BP, home and office BP. Conclusions: SMART-BP is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App. If we can confirm its efficacy, SMBP-App may be scaled-up to improve the treatment of hypertension.

Clinical Effects of Preoperative treated-Methylprednisolone in Pediatric Cardiac Surgery with Cardiopulmonary Bypass

  • Choi Seok-Cheol;Kim Yang-Weon;Jang Jung Hoon
    • Biomedical Science Letters
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    • v.11 no.3
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    • pp.407-416
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    • 2005
  • Cardiopulmonary bypass (CPB) for cardiac surgery induces the production and release of numerous chemotactic substances and cytokines, ensuing systemic inflammatory response that causes postoperative major organ dysfunctions. We performed a randomized, prospective study to investigate clinical effects of preoperative treated-methylprednisolone for preventing inflammation in pediatric cardiac surgery with CPB. Thirty pediatric patients scheduled for elective cardiac surgery were randomized to either control(n=15) or steroid group (n=15, 10 mg/kg of methylprednisolone). Arterial blood samples were taken before and after the operations for measuring total leukocyte (T-WBC) and differential counts, platelet counts, interleukin-6 (IL-6), myeloperoxidase (MPO), neuron specific enolase (NSE), troponin-I (TNI), aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine levels. Postoperative parameters such as pulmonary index (PI, $PaO_2/FiO_2$), 24 hrs and total bleeding volumes, mechanical ventilating (MVP) and intensive care unit (ICU)-staying periods, and hospitalization were assessed. T-WBC, neutrophil fraction, IL-6, MPO, NSE, TNI, AST and creatinine levels, bleeding volumes, PI, and MVP at the postoperative periods were lower or shorter in steroid group than in control group (P<0.05). These findings indicated that preoperative administration of methylprednisolone attenuated CPB-induced inflammatory reactions, contributing to postoperative recovery of patients underwent cardiac surgery.

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Comparative randomized study of propofol target-controlled infusion versus sevoflurane anesthesia for third molar extraction

  • Chung, Patrick K;Dhanrajani, Parmanand
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.18 no.3
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    • pp.169-175
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    • 2018
  • Background: The objective of this study was to compare hemodynamic and recovery characteristics of total intravenous anesthesia using propofol target-controlled infusion (TCI) versus sevoflurane for extraction of four third molar teeth. Methods: One hundred patients undergoing extraction of four third molar teeth under general anesthesia were randomized to one of two groups. Group 1 received propofol TCI-oxygen for induction and propofol TCI-oxygen-air for maintenance. Group II received a propofol bolus of 2 mg/kg for induction and sevoflurane-oxygen-air for maintenance. Heart rate, mean arterial pressure (MAP), operating time, time to emergence, nausea and vomiting, and sedation and pain scores were measured in each group. Results: Demographic data, including age, gender, weight, and height, were not significantly different between the two groups. The MAP was significantly higher after intubation (P = 0.007) and injection of anesthesia (P = 0.004) in the propofol group than in the sevoflurane group, with significant reflex bradycardia (P = 0.028). The mean time to emergence from anesthesia using propofol was 25 s shorter than that of sevoflurane (P = 0.02). Postoperatively, the propofol group was less sedated than the sevoflurane group at 30 min (0.02 versus 0.12), but this difference was not significant (P = 0.065). Conclusion: Both propofol TCI and sevoflurane are good alternatives for induction and maintenance of anesthesia for short day-case surgery. However, propofol TCI does not blunt the hemodynamic response to sudden, severe stimuli as strongly as sevoflurane, and this limitation may be a cause for concern in patients with cardiac comorbidities.

Research Trends of the Acupuncture Treatment for Pelvic Inflammatory Disease (골반염의 침치료에 대한 최신 연구 동향)

  • Kang, Nu-Ri;Hwang, Deok-Sang;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bock
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.1
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    • pp.76-85
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    • 2020
  • Objectives: The purpose of this review is to overview the studies of acupuncture treatment for pelvic inflammatory disease. Methods: In order to investigate the effect of acupuncture treatment for pelvic inflammatory disease, we searched relevant studies in Pubmed, Cochrane, Oasis, Korean studies Information Service System up to March 2019. After searching studies, we analyzed selected studies. Results: Five studies were included in this review. There were 1 randomized controlled studies and 4 before and after studies. The outcome measurement of pelvic inflammatory disease was divided into effective rate, physical examination, response, hematological parameter, pain. The acupuncture treatment was effective in improving pelvic inflammatory disease. Conclusions: This study shows that acupuncture treatment is one of effective treatment methods for pelvic inflammatory disease. Further large randomized placebo controlled trials will be needed.

The effectiveness and safety of cupping therapy for stroke survivors: A systematic review and meta-analysis of randomized controlled trials

  • Kim, Mikyung;Han, Chang-ho
    • The Journal of Korean Medicine
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    • v.42 no.4
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    • pp.75-101
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    • 2021
  • Objectives: ncluding stroke. The aim of this study was to systematically review the clinical evidence of CT for stroke. Methods: To identify randomized controlled trials (RCTs) reporting the effectiveness and/or safety of CT, seven databases including PubMed, EMBASE, and Cochrane Library were searched for articles published from January 2000 to February 2021 without language restrictions. Meta-analysis was performed using Review Manager 5.4 software and the results were presented as mean difference (MD) or standard mean difference (SMD) for continuous variables and odds ratio (OR) for diverse variables with 95% confidence intervals (CIs). Assessment of the methodological quality of the eligible trials was conducted using the Cochrane Collaboration tool for risk of bias in RCTs. Results: Twenty-two RCTs with 1653 participants were included in the final analysis. CT provided additional benefit in improving upper limb motor function (Fugl-Meyer assessment for upper limb motor function, MD 6.91, 95% CI 4.64 to 1.67, P<0.00001) and spasticity (response rate, OR 3.28, 95% CI 1.31 to 8.22, P=0.08) in stroke survivors receiving conventional medical treatment. These findings were supported with a moderate level of evidence. CT did not significantly increase the occurrence of adverse events. Conclusions: This study demonstrated the potential of CT to be beneficial in managing a variety of complications in stroke survivors. However, to compensate for the shortcomings of the existing evidence, rigorously designed large-scale RCTs are warranted in the future.

The impact of caudally administrated tramadol on immune response and analgesic efficacy for pediatric patients: a comparative randomized clinical trial

  • Sayed, Jehan Ahmed;Elshafy, Sayed Kaoud Abd;Kamel, Emad Zareif;Riad, Mohamed Amir Fathy;Mahmoud, Amal Ahmed;Khalaf, Ghada Shalaby
    • The Korean Journal of Pain
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    • v.31 no.3
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    • pp.206-214
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    • 2018
  • Background: Immune responses appear to be affected by anesthetics and analgesics. We investigated the effects of caudal tramadol on the postoperative immune response and pain management in pediatric patients. Methods: Sixty ASA-I pediatric patients aged 3-10 years undergoing lower abdominal surgery. Patients were randomly assigned either to a caudal bupivacaine (0.25%) group (group B), or a group that received caudal tramadol (1 mg/kg) added to the bupivacaine (0.25%) (group T). Both were diluted in a 0.9% NaCl solution to a total volume of 1ml/ kg. The systemic immune response was measured by collecting blood samples preoperatively, at the end of anesthesia, and at 24 and 72 hours postoperatively, and studied for interleukin IL-6, C-reactive proteins (CRP) cortisol levels, and leucocytes with its differential count. Postoperative pain was assessed along with sedation scales. Results: Postoperative production of IL-6 was significantly higher in group B at the end of anesthesia, than at the $24^{th}$ hour, and at the $72^{nd}$ hour in group B and group T, respectively. The immune response showed leukocytosis with increased percentages of neutrophil and monocytes, and a decreased lymphocyte response rate within both groups with no significant differences between the groups. Cortisol and CRP were significantly higher in group B. Conclusions: Adding tramadol to a caudal bupivacaine block can attenuate the pro-inflammatory cytokine response, Cortisol, and CRP in children undergoing lower abdominal surgery.

Immune Responses in Broiler Chicks Fed Propolis Extraction Residue-supplemented Diets

  • Eyng, C.;Murakami, A.E.;Santos, T.C.;Silveira, T.G.V.;Pedroso, R.B.;Lourenco, D.A.L.
    • Asian-Australasian Journal of Animal Sciences
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    • v.28 no.1
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    • pp.135-142
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    • 2015
  • This study was conducted to evaluate the effect of inclusion of propolis extraction residue in the feed of broilers from 1 to 21 d of age on phagocytic activity of macrophages, cutaneous basophil hypersensitivity response to phytohemagglutinin, antibody production against Newcastle disease, lymphoid organ weight and hematological profile and to determine the optimal level of inclusion. 120 chicks, reared in metabolism cages until 21 days of age, were distributed in a completely randomized design, with five treatments (0%, 1%, 2%, 3%, and 4% of propolis residue) and six replications. The relative weight of thymus and monocyte percentage were affected by propolis residue, with a quadratic response (p<0.05) and lowest values estimated at 2.38% and 2.49%, respectively. Changes in relative weight of cloacal bursa and spleen, percentage of lymphocyte, heterophil, basophil, eosinophil, and heterophil:lymphocyte ratio, antibody production against Newcastle disease, phagocytic activity of macrophages and the average number of phagocytosed erythrocytes were not observed. The nitric oxide production with regard to positive control (macrophages+erythrocytes) decreased linearly (p<0.05) with increased doses of propolis residue. The remaining variables of nitric oxide production (negative control - macrophages, and difference between the controls) were not affected by propolis residue. The cutaneous basophil hypersensitivity response to phytohemagglutinin as determined by the increase in interdigital skin thickness exhibited a quadratic response (p<0.05), which predicted a lower reaction response at a dose of 2.60% of propolis residue and highest reaction response after 43.05 hours of phytohemagglutinin injection. The inclusion of 1% to 4% of propolis extraction residue in broiler diets from 1 to 21 days of age was not able to improve the immune parameters, despite the modest changes in the relative weight in thymus, blood monocyte percentage, nitric oxide concentration, and interdigital reaction to phytohemagglutinin.