• Title/Summary/Keyword: Quality of clinical trial

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Review of Studies on Fire Needle (화침에 대한 국내외 연구 경향 고찰)

  • Moon, Su-Jeong;Kong, Jae-Cheol;Jo, Dong-Chan;Kim, Esther;Song, Young-Sun;Lee, Jung-Han
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.4
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    • pp.67-76
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    • 2011
  • Objectives: The aim of this review was to investigate studies on fire needle and to propose for the better method of studies in the future. Methods: Studies related to fire needle were searched with electric database for this study, and 10 domestic and overseas databases were included. Results: 19 clinical studies were analyzed in terms of condition, time of heating, number and frequency of treatment, number of heating, safety procedure or device aid reports of adverse events. Also 3 review studies were summarized. The number of studies was increasing and the kind of diseases to treat with fire noodle were various. Especially musculoskeletal diseases like ligament lesion and lumbago were noticeable. Heating-after-insertion method was recently proposed but the use of term was confusing. The report of adverse events or safety procedure was rare. Also there was an effort to develop more convenient and safer device. Conclusions: High quality clinical trial en fire needle is needed especially to compare 2 methods, heating-after-insertion and heating-before-insertion. And studies need to report safety procedures and adverse events to evaluate the safety of fire needle therapy.

Clinical Research Using Salviae Miltiorrhizae Radix-Pharmacopuncture for Lumbar Herniated Intervertebral Disc: Analysis of Trends

  • Kim, Seon Woo;Park, Cheol Woo;Jo, Myeong Jae;Kim, Min Wook;Yu, Jae Hee;Hee, Jeon Seok;Jang, Seung Won;Kang, Do Young;Jeong, Hyun Jin
    • Journal of Acupuncture Research
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    • v.38 no.1
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    • pp.1-7
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    • 2021
  • This review of national and international randomized controlled trials of Salviae miltiorrhizae radix pharmacopuncture for lumbar herniated intervertebral discs was performed to assess its clinical efficacy. There were 5 online databases (PubMed, EMBASE, CNKI, NDSL, OASIS, and RISS) searched on June 1st, 2020. Studies were selected according to the inclusion and exclusion criteria and were reviewed by risk of bias assessment. This review included 14 Chinese studies. The sample sizes ranged from 50 to 100. The numbers of treatments ranged from 20 to 30, with most patients receiving 20 treatments. The longest treatment periods were 10-15 and 15-20 days, of which each accounted for 29% of the studies. The most frequently used evaluation indices were the Japanese Orthopedic Association and the Visual Analog Scale scoring method. The most frequently used acupoints were EX18 and BL25, which accounted for 31% of the total number of acupoints. In 50% of the studies, the pharmacopuncture injection volume was 2 mL. Acupuncture treatment was the most common control group. Eleven studies reported that the intervention group had significantly improved symptoms. However, most of the included studies were of low quality.

Comparative study of the efficacy and safety of Abexol (suspension versus tablets) in patients with gastrointestinal symptoms

  • Alfredo Hierro Gonzalez;Julio Cesar Fernandez Travieso;Yoandy Hernandez Casas;Susana Borges Gonzalez;Maria de los Angeles Camacho Morales;Elena Ferrer Batallie;Anaisa Roja Carralera;Yenney Reyes Nunez;Sarahi Mendoza Castano;Maytee Robaina Garcia;Diana Margarita Rey Kaba
    • The Korean journal of internal medicine
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    • v.39 no.1
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    • pp.57-67
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    • 2024
  • Background/Aims: Abexol is a mixture of primary aliphatic alcohols purified from beeswax (Apis mellifera), that produces anti-inflammatory, antioxidant and gastroprotective effects, as well as it is safe and well tolerated. To investigate and compare the efficacy and safety of Abexol (suspension versus tablets) in patients with gastrointestinal symptoms. Methods: Monocentric study, open-label, randomized design, with two parallel groups receiving Abexol tablets (150 mg/d) or Abexol suspension (75 mg/d) for 8 weeks. Primary efficacy variable (significant improvement in the total score of Gastrointestinal Symptom Rating Scale [GSRS]). Significant reduction in the intensity of the gastrointestinal-symptoms and the reduction in the consumption of antacids are considered secondary efficacy variable. Short form-36 (SF-36) quality of life questionnaire was evaluated as collateral variable. Data were analyzed as per intention to treat. Results: A significantly decrease in the overall score of the survey was observed with respect to the baseline level (p < 0.001) of 81.4% in the Abexol suspension group and 77.9% in the Abexol tablets group. At the end of the trial, most gastrointestinal-symptoms disappeared or reduced significantly. The frequency of consumption of neutralizing antacids was low. The significantly improvement in the perception of the state of health obtained in the Abexol is in correspondence with the improvement achieved in some of the components evaluate in the SF-36 questionnaire. Both treatments were safe and well tolerated. Conclusions: Abexol suspension showed efficacy and safety similar to Abexol tablets in patients with gastrointestinal symptoms, but using half the dose.

External Application of Herbal Medicines for Acne Vulgaris: A Systematic Review and Meta Analysis

  • Sung, Soo-Hyun;Choi, Gwang-Ho;Lee, Nam-Woo;Shin, Byung-Cheul
    • Journal of Pharmacopuncture
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    • v.23 no.1
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    • pp.8-17
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    • 2020
  • Aim of the study: The objective of this systematic review is to critically evaluate the evidence of the effectiveness and safety of external application of herbal medicines (EAHM) for acne vurgalis (AV). Methods: English, Chinese and Korean language databases were searched up to May 2018. Randomized clinical trials (RCTs) that reported the effects of EAHM for AV were included and analysed. Results: A total of 10 randomized trials with 656 AV patients were identified. A meta-analysis of two RCTs indicated that EAHM had a significant effect on improving primary outcome 'global assessment' compared with placebo (mean difference (MD) = -2.62, confidence interval (CI) = -4.84 to -0.40, p = 0.02). Furthermore, data extracted from two RCTs showed that EAHM significantly reduce primary outcome 'inflammatory lesion count of acne' (MD = -1.25, CI = -1.68 to -0.83, p < 0.00001) and 'non-inflammatory lesion count of acne' (MD = -1.32, CI = -1.75 to -0.90, p < 0.00001). No significant difference was observed between groups in secondary outcome 'sebum of skin' (MD = -0.21, CI = -0.53 to 0.11, p = 0.20) and 'patient-reported changes in symptom' (relative risk (RR) = 2.56, CI = 0.43 to 15.22, p = 0.30). No severe adverse events (AEs) were found and no treatment was stopped due to AEs of EAHM. Conclusions: EAHM seems to have affirmative effects, but quality of evidence, and non-standardized use of EAHM make our conclusion weak. Our suggestion is rigorously designed RCTs and standardization of EAHM are required in the future.

Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial

  • Nam, Tae-Hyun;Kang, Sung-Yoon;Lee, Sang Min;Kim, Tae-Bum;Lee, Sang Pyo
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.1
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    • pp.25-36
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    • 2022
  • Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods: In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results: Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion: The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.

The Effects of Uncooked Powdered Food on Nutrient Intake, Serum Lipid Level, Dietary Behavior and Health Index in Healthy Women (생식 제품의 섭취가 건강한 성인여성의 영양섭취상태, 식행동, 혈청지질농도 및 건강지표에 미치는 영향)

  • 박성혜;한종현
    • Journal of Nutrition and Health
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    • v.36 no.1
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    • pp.49-63
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    • 2003
  • The purpose of this study was to obtain the nutritional values and objective data of uncooked powdered food (UPF) in korea. We interviewed 27 healthy female subjects aged over 25 years living in the lksan area. We just replaced common breakfast and dinner of the subjects with UPF. Their dietary intake status was evaluated by 24-hour recall method. Their body compositions were measured using body fat analyzer. Also we conducted hematological and clinical analysis of blood. The intake of energy, lipid and protein has decreased as people started to take UPF, but the intake of vitamins and minerals has increased. The quality of meals has improved after taking UPF. Due to the energy loss by taking UPF, weight and body fat gradually lessened. Among the lost weight the percentage of the body fat was high and we judged that the process of losing weight was successful. It is hard to predict whether weight loss will occur to people who are already in shape or not, but if overweight and obesity people regularly take UPF instead of other food products, we assume that UPF will help lessening body fat. The most positive change among biochemical changes by taking UPF was decreasing of serum lipid contents. The concentrations of total cholesterol and LDL-cholesterol gradually decreased and decreased intently after 12weeks. Serum HDL-cholesterol gradually increased and serum triglyceride showed gradual decrement. When healthy adult women replaced two of three meals with UPF for 3months, we were able to see some useful changes like decrement of body fat and serum lipid control and during this 3month period, no significant nutritional problems occurred. Complete judgement on UPF may be difficult with these conclusions but if people take a nomal meal once and replenish iron from taking UPF twice a day, we assume that replacing UPF with regular meal not be a problem in nutritional status. If other experiments on the effects of UPF proceed, we believe that those experiments will be very helpful in judging the nutritional value of UPF. (Korean J Nutrition 36(1) : 49-63, 2003)

Interventions Using Technologies for Older Adults in Long-term Care Facilities: A Systematic Review (장기요양시설 거주 노인 대상 테크놀로지 활용 중재에 관한 체계적 문헌고찰)

  • Kim, Da Eun;Kim, Hyang;Hyun, Junghee;Lee, Hyojin;Sung, Hyehyun;Bae, Soyoung;Tak, Sunghee H;Park, Yeon-Hwan;Yoon, Ju Young
    • Research in Community and Public Health Nursing
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    • v.29 no.2
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    • pp.170-183
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    • 2018
  • Purpose: Although innovative interventions using technologies have been introduced in long-term care settings, available evidence is still anecdotal. The purpose of this study is to investigate and synthesize the outcomes of interventions using technologies delivered to nursing home residents. Methods: Published clinical trials were identified through PubMed, CINHAL, Cochrane and PsycINFO databases and manually hand-searching. Eligible studies were articles published between 1997-2016 in English or Korean with a randomized controlled trial or quasi-experimental design in which interventions using technologies were delivered to nursing home residents. Results: A total of 20 studies were selected for this review. Types of interventions using technologies were classified into the electronic documentation technology (n=1), the clinical decision support system (n=1), the safety technology (n=1), the health and wellness technology (n=10), and the social connectedness technology (n=7). Overall resident outcomes indicated that interventions using technologies improved behavioral symptoms and psycho-social outcomes, but mixed results were shown in the aspects of physical function, cognitive function, social relationship and quality of service. Conclusion: This review demonstrates that incorporating technologies into nursing home care have positive effects on residents' psycho-social outcomes and behavioral symptoms. To disseminate the effectiveness of interventions using technologies, further research is needed to determine what mechanisms underlying such relationships exist.

Reliability of joint angle during sit-to-stand movements in persons with stroke using portable gait analysis system based wearable sensors

  • An, Jung-Ae;Lee, Byoung-Hee
    • Physical Therapy Rehabilitation Science
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    • v.8 no.3
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    • pp.146-151
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    • 2019
  • Objective: The purpose of this study was to investigate the test-retest reliability and concurrent validity of the joint angle of the lower extremities during sit-to-stand movements with wearable sensors based on a portable gait analysis system (PGAS), and the results were compared with a analysis system (MAS) to predict the clinical potential of it. Design: Cross-sectional study. Methods: Sixteen persons with stroke (9 males, 7 females) participated in this study. All subjects had the MAS and designed PGS applied simultaneously and eight sensor units of designed PGAS were placed in a position to avoid overlap with the reflexive markers from MAS. The initial position of the subjects was 90º of hip, knee, and ankle joint flexion while sitting on a chair that was armless and backless. The height of the chair was adjusted to each individual. After each trial, the test administrator checked the quality of data from both systems that measured sit-to-stand for test-retest reliability and concurrent validity. Results: As a result, wearable sensor based designed PGAS and MAS demonstrated reasonable test-retest reliability for the assessment of joint angle in the lower extremities during sit-to-stand performance. The intra-class correlation coefficients (ICCs) for wearable sensor based designed PGAS showed an acceptable test-retest reliability, with ICCs ranging from 0.759 to 0.959. In contrast, the MAS showed good to excellent test-retest reliability, with ICCS ranging from 0.811 to 0.950. In concurrent validity, a significant positive relationship was observed between PGAS and MAS for variation of joint angle during sit-to-stand movements (p<0.01). A moderate to high relationship was found in the affected hip (r=0.665), unaffected hip (r=0.767), affected knee (r=0.876), unaffected knee (r=0.886), affected ankle (r=0.943) and unaffected ankle (r=0.823) respectively. Conclusions: The results of this study indicated that wearable sensor based designed PGAS showed acceptable test-retest reliability and concurrent validity in persons with stroke for sit-to-stand movements and wearable sensors based on developed PGAS may be a useful tool for clinical assessment of functional movement.

Safety and Efficacy of Bone Cement (Spinofill®) for Verte-broplasty in Patients with Osteoporotic Compression Fracture : A Preliminary Prospective Study

  • Park, Han Byeol;Son, Seong;Jung, Jong Myung;Lee, Sang Gu;Yoo, Byung Rhae
    • Journal of Korean Neurosurgical Society
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    • v.65 no.5
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    • pp.730-740
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    • 2022
  • Objective : Although several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill® (Injecta Inc., Gunpo, Korea), a new polymethyl methacrylate product. Methods : A prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the Visual analog scale (VAS), Korean-Oswestry disability index (K-ODI), and Odom's criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph. Results : The pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) 1 day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49%±21.97% to 80.07%±13.16%, p<0.001) and segmental kyphotic angle (from 11.46°±8.50° to 7.79°±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end. Conclusion : The overall outcomes of PVP using Spinofill® were as favorable as those of other conventionally used products.

A review of atopic dermatitis in traditional Chinese medicine

  • Lee, Sang-Chang;Lee, Young-Seob;Seong, Man-Jun;Choi, Mi-Sun;Kang, Suk-Hoon;Lee, Sheng-Ho;Kim, Jong-Hak;Kim, Min-San;Kwon, Dong-Yeul
    • Journal of Evidence-Based Herbal Medicine
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    • v.1 no.2
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    • pp.35-43
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    • 2008
  • Herbal medicines have an accurate effect on atopic dermatitis, and at the same time, they hardly have adverse reactions. However, herbal medicines are difficult to be quantitatively analyzed due to low-quality preparation and types. In addition, herbal medicines have raised many problems as they have not been standardized and their active components have not been analyzed. Patients with atopic dermatitis began to recognize the effectivity and safety of herbal medicines. Accordingly, standardization, biological analyses, animal experiments and clinical trials should be generally performed in order that herbal medicines may be recognized all over the world. A standard, which is to objectively judge the curative effect of atopic dermatitis, should be established as soon as possible. Case studies and RCTs (Randomized Controlled Trials) should be actively performed on the basis of rigid clinical trial design to the end that the curative effect of herbal medicines is recognized all the world over.

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