• Title/Summary/Keyword: Randomized controlled study

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A Clinical Analysis to Study Effectiveness of Korean Medicine for Medial Collateral Ligament Injury of the Knee (무릎 내측측부인대 손상의 한의학적 치료에 대한 국내외 임상연구 동향 분석)

  • Oh, Tae Young;Han, Si Hoon;Oh, Min Seok
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.17 no.1
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    • pp.35-46
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    • 2022
  • Objectives This study aimed to review clinical studies on traditional Korean medicine treatment for medial collateral ligament injury of the knee. Methods Clinical studies on Korean traditional medicine treatment of medial collateral ligament injury were conducted. We used five Korean online databases (OASIS, KISS, RISS, DBPia, and ScienceOn) and three foreign databases (PubMed, Cochrane Library, and CNKI). Out of 99 studies that were found, we excluded repeated articles, studies that were not related to Korean medicine, and those not relevant to the topic of the study. Results Ten randomized controlled trials and 20 case studies were selected. Eight traditional Korean medicine treatments, including acupuncture, herbal medicine, chuna, and herbal ointment, were used in these studies. The most commonly used treatment was found to be acupuncture. Conclusions Our study showed that traditional Korean medicine for medial collateral ligament injuries was effective. However, there were some limitations. Further clinical studies and randomized controlled clinical trials are needed for more evidence on Korean traditional medicine.

Intervention to Improve Menstrual Health Among Adolescent Girls Based on the Theory of Planned Behavior in Iran: A Cluster-randomized Controlled Trial

  • Fatemeh, Darabi;Mehdi, Yaseri
    • Journal of Preventive Medicine and Public Health
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    • v.55 no.6
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    • pp.595-603
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    • 2022
  • Objectives: Poor menstrual health may lead to school absenteeism and adverse health outcomes for adolescents. The purpose of this study was to determine the effect of pubertal and menstrual health education on health and preventive behaviors among Iranian secondary school girls. Methods: A quasi-experimental study was conducted to evaluate the effectiveness of a health intervention program. A total of 578 students (including intervention and control participants) in 12 schools in Tehran Province, Iran were included by multistage random sampling. The program comprised seven 2-hour educational sessions. After confirming the reliability and validity of a researcher-made questionnaire, that questionnaire was used to collect the required data, and the groups were followed up with after 6 months. Results: After the educational intervention, the mean scores of menstrual health-related knowledge and constructs of the theory of planned behavior were significantly higher in the intervention group than in the control group (p<0.001 for all dimensions). Conclusions: The results of this study emphasize the effectiveness of menstrual health interventions in schools. These findings should also encourage health policy-makers to take committed action to improve performance in schools.

Gwibi-tang for Renal Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (귀비탕이 신성빈혈에 미치는 효과에 대한 체계적 문헌 고찰 및 메타분석)

  • Mikyung Kim;Chang-ho Han
    • The Journal of Korean Medicine
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    • v.44 no.3
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    • pp.201-224
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    • 2023
  • Objectives: The purpose of this study was to evaluate the effect of Gwibi-tang (GBT) on renal anemia. Methods: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to investigate changes in anemia levels before and after oral administration of GBT in patients with renal anemia. Relevant literature published up to May 25, 2023, was searched in 10 academic electronic databases. Results: Data from 489 patients from 7 RCTs were obtained and analyzed. All participants were receiving erythropoietin-stimulating agent treatment, and most of them were under hemodialysis. Additional administration of GBT to the participants significantly increased the hemoglobin concentration (10.55 g/L, 95% CI 6.99 to 14.11) compared to the control group. Hematocrit, red blood cell count, serum ferritin concentration, transferrin saturation, and the total effective rate for anemia was also significantly higher in the GBT-treated group than in the control group. Conclusions: This study suggests that GBT may be considered to be a promising option for the effective management of patients with renal anemia under conventional treatment. However, the limitations of this study, including the quantitative and qualitative weakness of the RCTs, the lack of safety-related evidence, and the absence of long-term follow-up data, should be taken into account when interpreting the results of this study.

Comparing Compliance and Efficacy of Isocaloric Oral Nutritional Supplementation Using 1.5 kcal/mL or 1 kcal/mL Sip Feeds in Mildly to Moderately Malnourished Indonesian Children: A Randomized Controlled Trial

  • Devaera, Yoga;Syaharutsa, Danny Maesadatu;Jatmiko, Herwasto Kuncoroyakti;Sjarif, Damayanti Rusli
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.21 no.4
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    • pp.315-320
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    • 2018
  • Purpose: This study set out to evaluate the compliance to, and efficacy of oral supplementation, using a 1.5 kcal/mL or 1 kcal/mL sip feed, in children with mild to moderate malnutrition. Methods: This was a parallel, randomized, controlled open-label trial in children aged 3 to 6 years with a weight for height Z (WHZ) score <-1 and ${\geq}-3$, who were randomized to receive a total of 600 kcal/day from either a 1.5 kcal/mL or a 1.0 kcal/mL pediatric sip feed for 28 days. Assessments included daily study product intake, body weight, tolerance and dietary intake from solid food. Results: Of 110 children recruited, 98 ($mean{\pm}standard$ deviation of age $49{\pm}7months$) completed the study. Both sip feeds were well tolerated, with high compliance ($80{\pm}24%$ and $81{\pm}22%$ of prescribed volume in 1.5 kcal/mL and 1.0 kcal/mL groups respectively, p=0.79). Both study groups gained similar weight during the 28 days intervention period ($0.42{\pm}0.40kg$ in 1.5 kcal/mL group vs. $0.49{\pm}0.49kg$ in 1.0 kcal/mL group, p=0.43). There were no significant differences between the groups in weight gain and in the change in WHZ score over the intervention period. Dietary analysis at the end of the study did not show replacement of solid food by the oral nutritional supplements. Conclusion: In children with mild to moderate malnutrition, both 1.5 kcal/mL and 1 kcal/mL pediatric sip feeds had high compliance and were well tolerated, and were equally effective in promoting weight gain in the 28 days study period.

Effects of Psychosocial Interventions on Cortisol and Immune Parameters in Patients with Cancer: A Meta-analysis (암 환자에게 적용한 심리사회적 중재가 코티졸과 면역기능에 미친 효과: 메타분석)

  • Oh, Pok Ja;Jang, Eun-Su
    • Journal of Korean Academy of Nursing
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    • v.44 no.4
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    • pp.446-457
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    • 2014
  • Purpose: This study was done to evaluate the effects of psychosocial interventions on cortisol and immune response in adult patients with cancer. Methods: MEDLINE via PubMed, Cochrane Library CENTRAL, EMBASE, CINAHL and domestic electronic databases were searched. Twenty controlled trials (11 randomized and 9 non-randomized trials) met the inclusion criteria with a total of 862 participants. Methodological quality was assessed using the Cochrane's Risk of Bias for randomized studies and the Risk of Bias Assessment tool for non randomized studies. Data were analyzed using the RevMan 5.2.11 program of Cochrane library. Results: Overall, study quality was moderate to high. The weighted average effect size across studies was -0.32 (95% CI [-0.56, -0.07], p=.010, $I^2 $=45%) for cortisol concentration, -0.62 (95%CI [-0.96,-0.29], p<.001, $I^2 $=0%) for T lymphocyte (CD3) and -0.45 (95%CI [-0.74, -0.16], p=.003, $I^2 $=0%) for Th lymphocyte (CD4) numbers. Psychosocial interventions were not effective for Tc lymphocyte (CD4), NK cell, monocyte, and cytokine response. Conclusion: Although these results provide only small evidence of successful immune modulation, they support the conclusion that psychosocial interventions can assist cancer patients in reducing emotional distress and improving immune response.

Role of dexmedetomidine as adjuvant in postoperative sciatic popliteal and adductor canal analgesia in trauma patients: a randomized controlled trial

  • Ahuja, Vanita;Thapa, Deepak;Chander, Anjuman;Gombar, Satinder;Gupta, Ravi;Gupta, Sandeep
    • The Korean Journal of Pain
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    • v.33 no.2
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    • pp.166-175
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    • 2020
  • Background: The effect of dexmedetomidine as an adjuvant in the adductor canal block (ACB) and sciatic popliteal block (SPB) on the postoperative tramadol-sparing effect following spinal anesthesia has not been evaluated. Methods: In this randomized, placebo-controlled study, ninety patients undergoing below knee trauma surgery were randomized to either the control group, using ropivacaine in the ACB + SPB; the block Dex group, using dexmedetomidine + ropivacaine in the ACB + SPB; or the systemic Dex group, using ropivacaine in the ACB + SPB + intravenous dexmedetomidine. The primary outcome was a comparison of postoperative cumulative tramadol patient-controlled analgesia (PCA) consumption at 48 hours. Secondary outcomes included time to first PCA bolus, pain score, neurological assessment, sedation score, and adverse effects at 0, 5, 10, 15, and 60 minutes, as well as 4, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the block. Results: The mean ± standard deviation of cumulative tramadol consumption at 48 hours was 64.83 ± 51.17 mg in the control group and 41.33 ± 38.57 mg in the block Dex group (P = 0.008), using Mann-Whitney U-test. Time to first tramadol PCA bolus was earlier in the control group versus the block Dex group (P = 0.04). Other secondary outcomes were comparable. Conclusions: Postoperative tramadol consumption was reduced at 48 hours in patients receiving perineural or systemic dexmedetomidine with ACB and SPB in below knee trauma surgery.

Quality Assessment of Randomized Controlled Trials using Herbal Remedies in Korea (국내 한약 처방을 이용한 무작위 배정 임상연구논문의 질 평가)

  • Kim, Yun-Young;Yoo, Jong-Hyang;Lee, Su-Kyung;Lee, Si-Woo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.25 no.5
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    • pp.927-933
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    • 2011
  • This study aimed to evaluate the quality of herbal medicine-related RCT (Randomized controlled clinical trial) papers. 79 papers were searched from the domestic Hakjin paper list, and 16 papers of them were evaluated in terms of the Jadad Quality Assessment Scale and the adequacy of allocation concealment, and ethical validity. The evaluation results from Jadad Quality Assessment Scale showed that 15 papers showed high quality with the Jadad score of 3 points or higher, and none of the papers had a problem with randomization and double-blinding. The evaluation results from adequacy of allocation concealment showed that 3 of the papers were executed proper allocation concealment, and all of them had 5 points of Jadad score. IRB (Institutional Review Board) approval and written consent was investigated for the evaluation of ethical validity, and 12 papers had the IRB approval, and 14 papers had written consent. The papers published before 2005 were absent of IRB approval and written consent, and none of the papers had IRB approval number. From the above results, it is concluded that rigorous clinical research led high quality of research papers, and the ethical aspect of clinical researches are getting more important to protect the rights of research participants.

Effectiveness of Shortwave Therapy in Management of Knee Osteoarthritis : A Systematic Review and Meta-analysis of Randomized Controlled Trials (무릎 뼈관절염의 단파치료 효과 : 무작위임상시험의 메타분석과 체계적 고찰)

  • Lee, Jae-Hyoung;Cho, Hyuk-Shin;Song, In-Yong
    • The Journal of Korean Physical Therapy
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    • v.26 no.5
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    • pp.331-343
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    • 2014
  • Purpose: The purpose of this study is to assess the effectiveness of short-wave therapy (SWT) for treatment of knee osteoarthritis (OA) as compared to placebo and control, and to assess the question of whether the effects are related to the mode, dosage, and application method. Methods: We searched randomized, placebo-controlled trials using electronic databases. We also manually reviewed sources in order to identify additional relevant studies. Results: Eight studies (597 participants) with OA were included in the meta-analysis. Pulse SWT had a significant effect on pain relief compared with control treatment, while did not favour compared with the placebo group. Pulse SWT had a significant effect on functional improvement compared with control and placebo treatment. Continuous SWT had no effect on pain relief and functional improvement. Capacitive SWT a significant effect on pain relief, functional improvement, and muscle strength. Continuous and capacitive SWT had increased muscle strength significantly. We found no clinical significance of all outcomes except pain and functional improvement in pulsed SWT with low dose. There was no difference in adverse events. None of the participants experienced any serious adverse events. Conclusion: Low dose pulsed SWT provided a short-term clinical benefit for pain relief and functional improvement. Pulsed SWD with low and high dose had effects on pain and function. There seems to be a placebo effect. We found significant effects on pain and function in capacitive SWT. Despite some positive findings, this analysis lacked data on how effectiveness is affected by mode, dosage, and application method of SWT. Further well-designed clinical studies are required in order to confirm the effectiveness of SWT.

Therapeutic alternatives in painful diabetic neuropathy: a meta-analysis of randomized controlled trials

  • Vilar, Samuel;Castillo, Jose Manuel;Martinez, Pedro V. Munuera;Reina, Maria;Pabon, Manuel
    • The Korean Journal of Pain
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    • v.31 no.4
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    • pp.253-260
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    • 2018
  • Background: One of the most frequent problems caused by diabetes is the so called painful diabetic neuropathy. This condition can be treated through numerous types of therapy. The purpose of this study was to analyze, as a meta-analysis, different treatments used to alleviate painful diabetic neuropathy, with the aim of generating results that help making decisions when applying such treatments to tackle this pathology. Methods: A search was conducted in the main databases for Health Sciences, such as PUBMED, Web of Science (WOS), and IME biomedicina (Spanish Medical Reports in Biomedicine), to gather randomized controlled trials about treatments used for painful diabetic neuropathy. The analyzed studies were required to meet the inclusion criteria selected, especially those results related to pain intensity. Results: Nine randomized controlled trials were chosen. The meta-analysis shows significant positive effects for those treatments based on tapentadol [g: -1.333, 95% CI (-1.594; -1.072), P < 0.05], duloxetine [g: -1.622, 95 % CI (-1.650; -1.594), P < 0.05], pregabalin [g: -0.607, 95% CI (-0.980; -0.325), P < 0.05], and clonidine [g: -0.242, 95 % CI (-0.543; -0.058), P < 0.05]. Conclusions: This meta-analysis indicates the effectiveness of the treatments based on duloxetine, gabapentin and pregabalin, as well as other drugs, such as tapentadol and topic clonidine, whose use is better prescribed in more specific situations. The results provided can help increase the knowledge about the treatment of painful diabetic neuropathy and also in the making of clinical practice guidelines for healthcare professionals.

Review of Clinical Research on Effect of Traditional Chinese Medicine for Febrile Seizure (열성 경련에 대한 중의학 임상 연구 동향 - RCT를 중심으로 -)

  • Lee, Bo Ram;Lee, Eun Ju;Lee, Ji Hong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.78-96
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    • 2016
  • Objectives The purpose of this study is to provide clinical evidence of Korean medicine for febrile seizure by review of randomized controlled trials on the effect of TCM (traditional Chinese medicine) for febrile seizure. Methods We searched randomized controlled trials about TCM treatment of febrile seizure from the China National Knowledge Infrastructure (CNKI) (January 2008 to June 2016). The selected literatures were assessed by Jadad scale. Results 40 papers were selected from 160 studies. Analyses of selected studies indicated that the TCM treatment group has significantly higher cure rate for febrile seizure than first aid or western medicine group. The most commonly used herbs were Gardeniae Fructus (梔子), Uncariae Ramulus cum Uncis (鉤藤), Cornus Gazeliae (羚羊角), Margarita (珍珠), Scutellariae Radix (黃芩), Glycyrrhizae Radix (甘草). The most commonly used acupoints were GV26 (人中), LI4 (合谷), KI1 (湧泉), GV20 (百會). There were no serious adverse events reported from the TCM treatment group during the treatment period. Conclusions TCM has been shown as not only effective but also safe treatment on febrile seizure. This finding can be widely utilized in clinical practice and can form the basis for development of clinical practice guidelines in future.