• 제목/요약/키워드: Randomized controlled study

검색결과 2,016건 처리시간 0.033초

월경전증후군에 대한 침 치료의 효과 : 체계적 문헌고찰과 메타분석 (Acupuncture for Premenstrual Syndrome: A Systematic Review and Meta-analysis)

  • 김안나;김영은;이은희;손미주
    • 대한한방부인과학회지
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    • 제36권3호
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    • pp.154-172
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    • 2023
  • Objectives: This study aimed to assess the clinical evidence supporting the use of acupuncture (AC) for premenstrual syndrome (PMS). Methods: We searched randomized controlled trials (RCTs) that used AC for PMS in 9 databases (PubMed, EMBASE, Cochrane Library, CINAHL, CNKI, CiNii, SCIENCE ON, KoreaMed, OASIS) from their inception to July 2022. Results: We identified 1,168 studies, of which 15 RCTs met the inclusion criteria. The risk of bias in the included studies was relatively unclear or high. Meta-analysis of 3 RCTs showed that the AC group had a significantly higher effective rate than the Medroxyprogesterone group (RR 1.48, 95% CI (1.23, 1.78), p<0.0001). Meta-analysis of 2 RCTs showed that there was no statistically significant difference between the AC group and the Sham AC group in the effective rate (RR 4.72, 95% CI (0.88, 25.36), p=0.07). In a review of individual studies, the AC group was more effective than the control group in terms of the effective rate, symptom scale, quality of life, adverse events, and recurrence rate. Conclusions: The AC group was more effective than general treatments groups such as sham AC, western medicine, and dietary supplements, and there were no serious adverse events. However, the evidence on the effectiveness and safety of acupuncture for PMS was inconclusive due to the small number of included studies and low quality. Therefore, systematic reviews based on more rigorously designed randomized clinical trials are needed in the future to properly evaluate the effect of AC on PMS.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on Acupuncture for Improving Post-Operative Cognitive Dysfunction (POCD) and Chemotherapy-Related Cognitive Impairment (CRCI)

  • Kim, Ju-Young;Cho, Han-Byul;Kim, Man-Gi;Koo, Byung-Su;Kim, Geun-Woo
    • 동의신경정신과학회지
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    • 제33권1호
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    • pp.49-78
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    • 2022
  • Objectives: This study was conducted to evaluate the efficacy of Korean Medicine Therapy (KMT) for the treatment of Chemotherapy-induced Cognitive Impairment (CICI) through systematic review and meta-analysis of randomized controlled trials (RCTs) as proceeding research to further research the efficacy of KMT for CICI patients. Methods: We conducted a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines (PRISMA). The RCTs on the efficacy of KMT for treatment of CICI were searched by structured search strategies in MEDLINE, EMBASE, Cochrane library, CAJD, KISS, NDSL, KoreaMed, and OASIS. The searched RCTs were screened by inclusion and exclusion criteria. We evaluated the quality of the method in the included studies using the Jadad score and Cochran ROB tool. The efficacy outcomes were the Visual Analogue Scale (VAS) and the Clinical total Effective Rate (CER) of CICI. They were analyzed using mean difference for continuous variable or Relative Risk (RR) for Dichotomous variable in the random-effect model. The RevMan 5.3 program was used for meta-analysis. Results: We included 19 RCTs, including 653 participants, in the systematic review and meta-analysis. There were favorable results for the KMT group after the intervention compared with the pharmacotherapy group, physiotherapy group, and combined treatment group. KMT group showed improvement using CER and VAS compared with exercises, but their heterogeneities were slightly significant. KMT was more effective compared to the Rehabilitation program in CER and the subgroup analysis results showed that KMT had a significant difference compared to other therapies in VAS, to Medication therapy in CER. Conclusions: KMT presented reasonable evidence on improving the Clinical total Effective Rate and Visual Analogue Scale in CICI patients. However, further evaluation in future research is required.

뇌혈관 조영술에 대한 동영상 교육 프로그램이 환자결과에 미치는 효과: 무작위대조군 전후 실험 설계 (Effects of a Video-based Education Program for Cerebral Angiography on Patients' Outcomes: A Randomized Controlled Trial)

  • 탁성현;황지인
    • 한국의료질향상학회지
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    • 제30권1호
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    • pp.76-87
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    • 2024
  • Purpose: We investigated the effects of a video-based education program for cerebral angiography on patients' state anxiety, uncertainty, nursing care satisfaction, and complications. Methods: The randomized experimental study included patients who underwent cerebral angiography at a university hospital in Bucheon, Gyeonggi-do between January 2023 and August 2023. Patients were assigned to the experimental group (n=50) and the control group (n=48). The program included video- and pamphlet-based education. The intervention included video-based education provided to the experimental group and conventional pamphlet-based education provided to the control group. Data were obtained pre-, post-, and 2-7 days post-intervention. Data were analyzed using the x2-test and the repeated measures analysis of variance test with the SPSS software, version 28.0. Results: The experimental group showed lower levels of state anxiety (x2=4.316, p=.038) and uncertainty (x2=3.974, p=.046) than the control group. However, we observed no significant intergroup differences in satisfaction with nursing care and complication rates. Conclusion: The results suggest that a video-based education program for cerebral angiography can effectively reduce state anxiety and uncertainty in patients undergoing cerebral angiography. Video-aided educational interventions can improve the quality of nursing care with regard to reducing state anxiety and uncertainty in patients who undergo cerebral angiography.

CONSORT-CHM 2017 지침에 근거한 대한한의학회지 및 회원학회지에 투고된 경구투여 한약 중재를 활용한 무작위 배정 비교 임상 연구(RCT)의 양적, 질적 평가 연구 (Orally Administered Korean Herbal Medicine Medications of Randomized Controlled Trials Published in the Journal of Korean Medicine and Related Journals: A Narrative Analysis using CONSORT-CHM 2017)

  • 문세훈;조정호;최승관; 한윤희;우현준;전병현;하원배;이정한
    • 대한한방내과학회지
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    • 제44권6호
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    • pp.1212-1242
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    • 2023
  • Objectives: This study aims to explore the current usage status of orally administered Korean herbal medicine in randomized controlled trials (RCTs) published in the Journal of Korean Medicine and member journals using the CONSORT-Chinese Herbal Medicine Formulas 2017 (CONSORT-CHM 2017) checklist. Methods: We searched the OASIS, RISS, and KMBASE archives as well as the websites of the Journal of Korean Medicine and 45 member journals to identify RCTs that used herbal interventions. Two independent researchers searched and categorized the RCTs and performed a quantitative evaluation by journal, study design, and target disease, as well as qualitative evaluation of the literature using CONSORT-CHM 2017. Results: After the search, 66 articles were selected. The quantitative evaluation resulted in 13 articles (19.6%) that were published in the Journal of Korean Medicine and 12 articles (18.1%) in the Journal of Internal Korean Medicine. In terms of study design, 62 articles (93.9%) were parallel, 4 articles (6%) were crossover, and 2-arm parallel study designs were the most common in 45 articles (68.2%). In terms of the study participants, physiological characteristics and mechanisms in healthy individuals were the most common in 21 studies (31.8%) and obesity in 9 studies (13.6%). In terms of assessing completeness in the CONSORT-CHM 2017 items, 29 articles were rated high, 31 were rated moderate, and 6 were rated low. Items 4a, 6a, and 7a had low reporting rates (≤ 30%), while items 2a, 2b, and 12a were completely reported in all studies. Conclusion: Future RCTs using orally administered Korean herbal medicine need to be reported completely, and the CONSORT-CHM 2017 checklist can be a helpful tool for this purpose.

Exploring Study Designs for Evaluation of Interventions Aimed to Reduce Occupational Diseases and Injuries

  • van der Molen, Henk F.;Stocks, Susan J.;Frings-Dresen, Monique H.W.
    • Safety and Health at Work
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    • 제7권1호
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    • pp.83-85
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    • 2016
  • Effective interventions to reduce work-related exposures are available for many types of work-related diseases or injuries. However, knowledge of the impact of these interventions on injury or disease outcomes is scarce due to practical and methodological reasons. Study designs are considered for the evaluation of occupational health interventions on occupational disease or injury. Latency and frequency of occurrence of the health outcomes are two important features when designing an evaluation study with occupational disease or occupational injury as an outcome measure. Controlled evaluation studies-giving strong indications for an intervention effect-seem more suitable for more frequently occurring injuries or diseases. Uncontrolled evaluation time or case series studies are an option for evaluating less frequently occurring injuries or diseases. Interrupted time series offer alternatives to experimental randomized controlled trials to give an insight into the effectiveness of preventive actions in the work setting to decision and policy makers.

암성통증에 대한 SBVP 효과 - 무작위대조시험, 이중맹검 (The Effect of Sweet Bee Venom Pharmacopuncture(SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study)

  • 유화승;김정선
    • 대한약침학회지
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    • 제11권1호
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    • pp.21-29
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    • 2008
  • Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구 (Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study)

  • 공한미;전승아;정연중;김주란;이정희;이현종;박정아;김재수
    • Korean Journal of Acupuncture
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    • 제37권1호
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.

일차성 두통의 약침 치료에 대한 임상연구 동향 (A Review of Clinical Research Trends in the Treatment of Primary Headache Disorders with Pharmacopuncture)

  • 신희연;이상화;김하리;김정화;양승보;조승연;박정미;고창남;박성욱
    • 대한한방내과학회지
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    • 제39권6호
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    • pp.1191-1205
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    • 2018
  • Objectives: This study was performed to review clinical research trends in the treatment of primary headache disorders with pharmacopuncture. Methods: We searched clinical studies on primary headache disorders treated with pharmacopuncture in four electronic databases including OASIS, RISS, CNKI, and Pubmed. The selected studies were analyzed with regard to study design, subject, intervention, evaluation, and result. Results: Five randomized controlled trials, one non-randomized controlled trial, one before-and-after study, and six case series were selected. Most of the studies showed that pharmacopuncture treatment was significantly effective in treating primary headache disorders; however, the quality of the randomized controlled trials was low. Conclusions: According to this study, pharmacopuncture could be a useful treatment option for primary headache disorders. Based on these results, further studies on the effectiveness and safety of pharmacopuncture for primary headache disorders should be performed in the near future.

Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial

  • Zhang, Li;Chen, Xiaoyun;Cheng, Yanqi;Chen, Qilong;Tan, Hongsheng;Son, Dongwook;Chang, Dongpill;Bian, Zhaoxiang;Fang, Hong;Xu, Hongxi
    • Journal of Ginseng Research
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    • 제43권4호
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    • pp.676-683
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    • 2019
  • Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.

20대 성인 흡연자의 조깅운동이 심장호흡기능에 미치는 영향 (Influence of Smokers's Jogging Exercises on Cardiopulmonary Function of Normal Adults in Their Twenties)

  • 이삼철
    • 대한물리치료과학회지
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    • 제23권1호
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    • pp.9-17
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    • 2016
  • Background and Purpose : Effects of smokers's jogging exercises on oxygen uptake, ventilation, heart rate, and vital-capacity of normal adults have not been studied in details on. In this study, people that had completed the established jogging exercises was selected for the study. We could examine the effects of imposed jogging in smokers who might be considered by an experienced physical therapist to be well practiced and proficient in this exercises. Subjects and Methods : A total number of 24 young healthy subjects participated in a randomized crossover controlled study and completed the study. The subjects of this study were divided into jogging and controlled groups which were composed 14 people respectively. The members of exercise group had jogging exercises 50 minutes a day, five times a week, for 5 weeks in same conditions, otherwise controlled group did not. Results : The results of this study were as follows. The jogging group demonstrated significant increases in cardiopulmonary function, vital-capacity and exercise capacity, compared with control group, which demonstrated no change in baseline measurements of 5 weeks. Conclusion : Jogging exercises can increase cardiopulmonary function in people after they have undergone successful PA. These results suggested that it was improved on cardiopulmonary function and lung capacity, since jogging exercise had. The results of this study could be applied for valuable criterion cardiopulmonary function. It is necessary to selects in various groups of the purpose of enhancing confidence in of this research.

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