• 제목/요약/키워드: Controlled clinical trials, randomized

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산후 골반장기탈출증에 대한 한의학적 임상 연구 동향 (Review of Clinical Research of Korean Medicine on Postpartum Pelvic Organ Prolapse)

  • 박남경;황영식;김규태;박승혁;이진무;이창훈;장준복;황덕상
    • 대한한방부인과학회지
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    • 제33권4호
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    • pp.93-112
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    • 2020
  • Objectives: The purpose of this study is to review the clinical research trends of postpartum pelvic organ prolapse and to recognize the efficacy of Korean medicine intervention. Methods: Based on seven domestic and foreign databases, including Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (OASIS), Journal of Korean Obstetric and Gynecology, Cochrane Library Central, Pubmed, China National Knowledge Infrastructure (CNKI) and WangFang Med Online, we analyzed the clinical trials using Korean medicine intervention, which included acupuncture and herbal medicine. Data retrieval was carried out on May 18 to 20, 2020, and a total of 13 papers were included. Results: All papers were published in China and it contains nine randomized controlled trials, three clinical trials, and one case. The most frequently used intervention was herbal medicine, and Bupleuri Radix, Cimicifugae Rhizoma were used. The treatment group treated by Korean medicine intervention was more effective than the control group. Also, there were no significant side effects of Korean medicine. Conclusion: This study shows that Korean medicine can be effective and safe medical alternatives or options for pelvic organ prolapse patients. However, to laying the foundation of clinical guidelines and applying it to the real-world clinical scene, further follow-up research is needed.

폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer])

  • 한가진;조민지;박은주;성신;김성수;김관일;정희재;이범준;임정태
    • 대한한의학회지
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    • 제40권1호
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    • pp.153-173
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

  • Lee, Hyun-Jong;Seo, Jung-Chul;Park, Sung-Hoon;Kwak, Min-Ah;Shin, Im Hee;Min, Bo-Mi;Cho, Min-Su;Roh, Woon-Seok;Jung, Jin-Yong
    • 대한약침학회지
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    • 제18권1호
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    • pp.79-85
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    • 2015
  • Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

난소과자극증후군의 치료에 관한 한의 임상 연구 고찰 (Review for Clinical Studies of Oriental Medicine on the Treatment of Ovarian Hyperstimulation Syndrome)

  • 구수정;황덕상;이진무;이창훈;장준복
    • 대한한방부인과학회지
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    • 제33권3호
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    • pp.60-79
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    • 2020
  • Objectives: This review plans to assess the efficacy and effectiveness of oriental medicine for the treatment of Ovarian Hyperstimulation Syndrome (OHSS) through literature research and overview. Methods: Database searching was conducted to identify relevant randomized controlled trials (RCTs) on oriental medicine for the treatment of Ovarian Hyperstimulation Syndrome. Studies were searched from Journal of Korean Obstetrics and Gynecology, Korean Medical Database, Korean studies Information Service System, China National Knowledge Infrastructure, Cochrane library, PubMed and EmBase up to 21st May, 2020. Results: Seventeen studies were finally selected. Fifteen studies intervened with oral Chinese herb medicine, two studies intervened with acupuncture and moxibustion. Nine studies concluded that intervention with oriental medicine significantly relieved OHSS symptoms. Three studies reporting ovary diameter, four studies reporting abdominal circumference and other four studies reporting pelvic effusion showed significant reduction compared to control groups. Six studies showed significantly shorter duration for hospitalization in intervention groups. Only one study showed significantly higher pregnancy rate. Factors related with vascular permeability and blood cell coagulation were significantly lowered in intervention groups in general. Conclusions: From seventeen studies, oriental medicine relieved OHSS symptoms and showed treatment effectiveness. Further strictly designed studies and long-term observed studies are needed to establish evidences.

치매의 침치료에 대한 해외 RCT 연구 동향 - pubmed의 2000~2018년 검색을 통하여 - (Recent RCT Research on the Effects of Acupuncture on Dementia - Based on a PubMed Search of Literature Published from 2000 to 2018)

  • 김은지;최기훈;정희경;권오훈;박주헌;김상균
    • 대한한방내과학회지
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    • 제39권3호
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    • pp.338-349
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    • 2018
  • Objective: The purpose of this study is to investigate recent clinical studies on the effects of acupuncture on dementia. Method: We searched RCTs (randomized controlled trials) using the database PubMed (2000-2018). Clinical RCT studies of acupuncture used to treat dementia in humans were included. Nine randomized controlled trials were included. Results: Various acupoints such as Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24) were used to treat symptoms. The studies reported a decrease in evaluation criteria, such as the Mini Mental State Examination (MMSE) and activities of daily living (ADL), for measuring cognitive ability. The acupuncture process, the results for outcome measure, and the effectiveness of studies were analyzed. We then assessed "risk of bias." Conclusions: Through this review, we found that acupuncture is applicable for the treatment of dementia. This can be used for future study.

고혈압에 대한 한약 이수 처방 효과에 대한 체계적 문헌 고찰 및 메타분석 (The Effect of Korean Herbal Medicine that Function by Inducing Diuresis for Hypertension: Systematic Review and Meta-Analysis of Randomized Controlled Trials)

  • 강자연;강기완;정민정;김홍준;장인수
    • 대한한방내과학회지
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    • 제38권6호
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    • pp.902-916
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    • 2017
  • Objectives: The aim of this study was to review the clinical research on antihypertensive effects of Korean herbal medicines that function by inducing diuresis. Methods: Literature searches were performed using PubMed, Cochrane, CNKI, Wanfang, Cinii, Oasis, KISS, NDSL, RISS, DBPia, with the keywords "利水", "利尿", "高血壓", "hypertension", and "lishui." The search range included only randomized controlled trials that verified the effects of Korean herbal medicine interventions on hypertension. The selected studies were assessed by risk of bias (RoB). Results: 26 reports were selected from a total of 532 identified. For these reports, meta-analysis was performed using Revman 5.3. From this analysis, it was observed that the combined treatment of Korean medicine and antihypertensive drugs had a significantly higher total effective rate (TER) and improvement in systolic blood pressure (SBP) and diastolic blood pressure (DBP) than did the use of a single antihypertensive drug. The risk ratio of TER for lowering blood pressure was 1.25. The mean differences of SBP, DBP were -19.63 mm Hg (95% confidential interval (CI), -22.45 mm Hg, -16.80 mm Hg, p<0.00001), and -5.39 mm Hg (95% CI, -7.36 mm Hg, -3.42 mm Hg, p<0.00001) respectively. The use of Korean medicine only did not improve blood pressure, as compared to the use of an antihypertensive drug. Most of items of RoB were unclear, and the methodological quality was low. Conclusions: The combination of antihypertensive drugs and Korean medical treatment can effectively improve SBP, DBP, and TER. This finding could be widely utilized in clinical practice in Korean medicine.

편타성 손상으로 인해 발생된 경부통의 한의학적 치료에 대한 국내 연구 동향 (The Domestic Trends of Korean Medical Treatments for Neck Pain Caused by Whiplash Injury)

  • 정성현;이현호;이기언;최지훈;김동후;이종하
    • 한방재활의학과학회지
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    • 제27권4호
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    • pp.11-19
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    • 2017
  • Objectives We attempted to investigate the trends of Korean Medical treatments for neck pain caused by whiplash injury by analyzing domestic clinical studies. Methods We searched for studies listed on Korean electronic databases (KTKP, OASIS, RISS, KMbase, NDSL, KCI, and National Assembly Library). Clinical studies were chosen according to the inclusion criteria. Subsequently, we compared and analyzed the data. Results The search yielded 35 studies, of which there were 12 randomized controlled trials (RCTs), 15 non-randomized controlled trials (NRCTs), 6 case reports, and 2 before-after studies. Among these, 54.7% of participants were in the acute stage of the damage period. Pharmacopuncture was used the most in main treatment methods. Only 14.3% of studies mentioned approval by an institutional review board (IRB) and only 8.6% of studies considered side effects. Conclusions There is some evidence that Korean Medical treatment is effective for neck pain caused by whiplash injury. Since all studies, however, were exposed to the risk of bias. Therefore, future studies of a higher quality are required.

뇌졸중 편마비 환자의 견관절 통증에 대한 추나요법의 효과: 체계적 문헌고찰 및 메타분석 (The Effect of Chuna Manual Therapy for Shoulder Pain in Hemiplegic Patients after Stroke: A Systematic Review and Meta-Analysis)

  • 오은미;이은정
    • 한방재활의학과학회지
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    • 제30권3호
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    • pp.89-101
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    • 2020
  • Objectives The purpose of this study is to assess the effectiveness of Chuna manual therapy for shoulder pain in hemiplegic patients after stroke. Methods For a systematic review and meta-analysis, we set a key question in accordance with participants, intervention, comparison, outcome, study design (PICO-SD). we searched for clinical studies that conducted chuna manual therapy for shoulder pain in hemiplegic patients after stroke 7 databases until September 2019. Only randomized controlled trials were chosen. Results Total 14 randomized controlled trials were chosen for systematic review and meta-analysis. 9 studies used efficacy rate as evaluation tool, and 8 used visual analogue scale. Pressure method (壓力型) was used in 11 studies, followed by osteopathy method (整骨型) and wave motion method (波動型) in 9 studies. Chuna manual therapy showed statistically significant pain reduction effect. Through meta analysis, Chuna manual therapy showed significant pain reducing effect except the study with Chuna manual therapy and electroacupuncture compared to electroacupuncture only. Conclusion As a result, Chuna manual therapy showed statistically significant effect in pain reduction. However, almost studies were evaluated in a state of having probable high risk of bias. This suggests that it requires attention to make an interpretation in this study. Furthermore, more clinical research need to be accomplished in the future.

손목 통증의 수기 치료에 대한 체계적 문헌 고찰과 메타분석 (Manual Therapy for Wrist Pain: A Systematic Review and Meta-analysis)

  • 이예지;전천후;김효빈;전주현;김은석;김진엽;최강민;김영일
    • 척추신경추나의학회지
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    • 제15권1호
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    • pp.75-87
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    • 2020
  • Objectives : This study aimed to evaluate the effectiveness of manual therapy for wrist pain. Methods : We searched electronic databases (PubMed, Embase, Cochrane, CAJ, KISS, RISS, NDSL, OASIS, and KMBASE) for randomized controlled trials for manual therapy as a treatment for wrist pain. Results : A total of 9 randomized controlled trials were selected and meta-analysis was conducted on 6 studies. Three studies with different design of the intervention/control group were excluded from the meta-analysis. A high risk of bias was observed for both performance bias and detection bias. Conclusions : Our systematic review verified the clinical effect of manual therapy on wrist pain. Based on the results of this study, it is expected that clinical studies on wrist diseases and high-level follow-up studies will be conducted.

조현병 및 조현정동장애 환자에서 항정신병약물에 의한 체중증가에 미치는 메트포르민의 영향: 체계적 문헌고찰 및 메타분석 (The Effect of Metformin on Antipsychotic-induced Weight Gain in Patients with Schizophrenia or Schizoaffective Disorder: A Systematic Review and Meta-analysis of Randomized Placebo-Controlled Trials)

  • 신혜연;천부순
    • 한국임상약학회지
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    • 제28권3호
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    • pp.204-215
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    • 2018
  • Background: In this systematic review and meta-analysis, the effect of metformin on weight loss was assessed to determine whether metformin should be recommended for the prevention or treatment of weight gain in patients receiving antipsychotic medication for the treatment of schizophrenia or schizoaffective disorder. Methods: The PubMed, Embase, and Cochrane Library databases were searched for all published randomized controlled trials (RCTs) from inception to June 2018. In addition, the references of relevant articles were also examined. Using Review Manager 5, the pooled estimates of the weighted mean difference (WMD) of the changes in body weight and body mass index (BMI) and the corresponding 95 % confidence intervals (CIs) were calculated. Results: The meta-analysis included 15 RCTs. The pooled analysis showed that compared with placebo, metformin led to significant reductions in body weight (WMD: -2.09, 95% CI: -2.59, -1.60; p<0.00001) and BMI (WMD: -0.90, 95% CI: -1.08, -0.72; p<0.00001). The effect of metformin on weight loss was greater in patients receiving olanzapine than in patients receiving clozapine (body weight, WMD: -2.39, 95% CI: -3.76, -1.02; p=0.0006 for olanzapine; -1.99, 95% C: -3.47, -0.51; p=0.009 for clozapine; BMI, WMD: -1.15, 95% CI: -1.74, -0.57, p=0.0001 for olanzapine; WMD: 0.76, 95% CI: -1.23, -0.28; p=0.002 for clozapine). Conclusion: Metformin can be recommended to manage olanzapine-induced weight gain in patients with schizophrenia or schizoaffective disorder. The magnitude of the reductionss in body weight and BMI implieds that the use of metformin to attenuate olanzapine-induced weight gain can minimize the risk of coronary heart disease.