• Title/Summary/Keyword: Standardized patients

Search Result 853, Processing Time 0.028 seconds

갱년기 안면홍조에 대한 침 임상시험 방법론 연구 (A Study on the Methodology of Acupuncture Clinical Trial on the Postmenopausal and Perimenopausal Hot Flashes)

  • 노진주;김동일
    • 대한한방부인과학회지
    • /
    • 제21권4호
    • /
    • pp.193-206
    • /
    • 2008
  • Purpose: In spite of many arguments on the result of WHI (Women's Health Initiative) study, no one can deny the necessity for researches on the alternative treatment to HRT (hormone replacement therapy). In this study, the author wanted to investigate the method of precedent acupuncture RCTs (randomized controlled trials) to make out the appropriate acupuncture study design on postmenopausal and perimenopausal hot flashes in Korea. Methods: Precedent studies were investigated using Pubmed search and key-words "acupuncture and hot flash", "acupuncture and menopause", "acupuncture and vasomotor", limited to RCT, from 2000 to 2008 April. Results: As a result. 10 studies were searched. In the hereafter studies, multi-center clinical trials which consist of population group of postmenopausal and perimenopausal women that would be pre-stratified and more than 50 patients per treatment arm seem adequate. Sham control study can make out the proper consequence because many people are get used to acupuncture in Korea. Flexible choice of acupoints addressed an individual's symptoms using standardized algorithm is recommended. Treatment consist of 4 weeks' observation, 11 acupuncture sessions during 7 weeks, follow-up of 3 months or more after treatment and hot flash score as a primary outcome measure seem appropriate. After all, higher level of description according to global standard must be obtained in the study report and publishing. Conclusion: The researchers should develope the methodology of acupuncture clinical trial on the postmenopausal and perimenopausal hot flashes.

  • PDF

Subcutaneous progesterone versus vaginal progesterone for luteal phase support in in vitro fertilization: A retrospective analysis from daily clinical practice

  • Schutt, Marcel;Nguyen, The Duy;Kalff-Suske, Martha;Wagner, Uwe;Macharey, Georg;Ziller, Volker
    • Clinical and Experimental Reproductive Medicine
    • /
    • 제48권3호
    • /
    • pp.262-267
    • /
    • 2021
  • Objective: Progesterone application for luteal phase support is a well-established concept in in vitro fertilization (IVF) treatment. Water-soluble subcutaneous progesterone injections have shown pregnancy rates equivalent to those observed in patients receiving vaginal administration in randomized controlled trials. Our study aimed to investigate whether the results from those pivotal trials could be reproduced in daily clinical practice in an unselected patient population. Methods: In this retrospective cohort study in non-standardized daily clinical practice, we compared 273 IVF cycles from 195 women undergoing IVF at our center for luteal phase support with vaginal administration of 200 mg of micronized progesterone three times daily or subcutaneous injection of 25 mg of progesterone per day. Results: Various patient characteristics including age, weight, height, number of oocytes, and body mass index were similar between both groups. We observed no significant differences in the clinical pregnancy rate (CPR) per treatment cycle between the subcutaneous (39.9%) and vaginal group (36.5%) (p=0.630). Covariate analysis showed significant correlations of the number of transferred embryos and the total dosage of stimulation medication with the CPR. However, after adjustment of the CPR for these covariates using a regression model, no significant difference was observed between the two groups (odds ratio, 0.956; 95% confidence interval, 0.512-1.786; p=0.888). Conclusion: In agreement with randomized controlled trials in study populations with strict selection criteria, our study determined that subcutaneous progesterone was equally effective as vaginally applied progesterone in daily clinical practice in an unselected patient population.

합병증을 동반하지 않은 2형 당뇨병 환자에 대한 황련해독탕의 혈당 강하 효과에 대한 유효성과 안전성 : 체계적 문헌 고찰과 메타분석 (Efficacy and Safety of the Antidiabetic effect of Hwangryunhaedok-tang for Type 2 Diabetes Mellitus Patients without Complications: A Systematic Review and Meta-Analysis)

  • 백지수;신선미;신동국;조충식
    • 대한한방내과학회지
    • /
    • 제42권4호
    • /
    • pp.605-621
    • /
    • 2021
  • Objectives: The purpose of this review is to assess the efficacy and safety of Hwangryunhaedok-tang for type 2 diabetes without complications by systemic review and meta-analysis of randomized controlled trials (RCTs). Methods: We searched the following up to March 31. 2021: PubMed, EMBASE, The Cochrane Library, CNKI, CiNii, KISS, KMBASE, OASIS, ScienceON. Data extraction and assessment of Cochrane's risk of bias (RoB) tool were performed by two independent authors, and if there was disagreement between two researchers, it was resolved through the intervention of a third researcher. Results: A total of seven trials are included in this systemic review. The treatment group (Hwangryunhaedok-tang plus conventional treatment) showed more statistically significant effects than did the control group (conventional treatment only) in fasting plasma glucose level, 2-hour postprandial plasma glucose level, glycated hemoglobin A1c, fasting insulin level, and HOMA-IR. There was no significant difference between the treatment group (Hwangryunhaedok-tang alone) and the control group (metformin alone). Conclusion: Hwangryunhaedok-tang might have efficacy and safety in controlling blood sugar level and improving insulin-resistance. However, the number of studies included in the meta-analysis was insufficient, and the Hwangryunhaedok-tang used in the included studies was not standardized. Also, the quality of the involved studies was generally low. Therefore, further studies are needed to determine the efficacy and safety of Hwangryunhaedok-tang treatment for type 2 diabetes mellitus.

합병증을 동반하지 않은 2형 당뇨병 환자에 대한 백호가인삼탕과 혈당강하제 병행치료의 혈당 강하 효과 및 안전성 연구 : 체계적 문헌 고찰과 메타분석 (A Study on the Hypoglycemic Effect and Safety of Combined-Therapy of Baekhogainsam-tang and Hypoglycemic Agent for Type 2 Diabetes Mellitus Patients without Complications: A Systematic Review and Meta-Analysis)

  • 신재익;백지수;신선미;조충식
    • 대한한방내과학회지
    • /
    • 제42권4호
    • /
    • pp.672-686
    • /
    • 2021
  • Objectives: The purpose of this study is to assess the efficacy and safety of Baekhogainsam-tang for type 2 diabetes without complications by systemic review and meta-analysis of randomized controlled trials (RCTs). Methods: For a systematic review and meta-analysis, we set a key question in accordance with PICOT-SD. We searched the following up to March 31. 2021: PubMed, EMBASE, The Cochrane Library, CNKI, CiNii, KISS, KMBASE, OASIS, and ScienceON. A meta-analysis was conducted by synthesizing the results, including fasting plasma glucose level, postprandial 2-hour plasma glucose level, and Glycated Hemoglobin (HbA1c). Results: A total of five trials are included in this systemic review. The treatment group (Baekhogainsam-tang plus conventional treatment) showed more statistically significant effect than did the control group (conventional treatment only) in fasting plasma glucose level, postprandial 2-hour plasma glucose level, and glycated hemoglobin (HbA1c). Conclusions: Baekhogainsam-tang showed statistically significant effects in hypoglycemic effect and in improving insulin resistance. However, the number of studies included in the meta-analysis was insufficient, and the BIT used in the included studies was not standardized. This topic requires further attention and more clinical research.

External apical root resorption 6 months after initiation of orthodontic treatment: A randomized clinical trial comparing fixed appliances and orthodontic aligners

  • Toyokawa-Sperandio, Katia Cristina;Conti, Ana Claudia de Castro Ferreira;Fernandes, Thais Maria Freire;de Almeida-Pedrin, Renata Rodrigues;de Almeida, Marcio Rodrigues;Oltramari, Paula Vanessa Pedron
    • 대한치과교정학회지
    • /
    • 제51권5호
    • /
    • pp.329-336
    • /
    • 2021
  • Objective: To compare the magnitude of external apical root resorption (EARR) 6 months after starting orthodontic treatment using orthodontic aligners (OAs) and fixed appliances (FAs). Methods: This parallel randomized clinical trial included 40 patients randomized into two groups: OA group (n = 20, 160 incisors) and FA group (n = 20, 160 incisors). For evaluation of the tooth length, periapical radiographs and standardized linear measurements of the maxillary and mandibular incisors were acquired before (T0) and 6 months after treatment initiation (T1). EARR was calculated through the difference in length between the two time points (T1-T0). Statistical comparisons were performed by means of using t-tests, chi-squared test and covariance analysis (a = 5%). Results: Rounding of the root apex was observed in both groups; the resorption involved 2.88% of the root length, so 97.12% of the tooth length remained intact. Intragroup comparisons between the two time points revealed a significant difference, with (T1-T0) ranging from -0.52 to -0.88 mm in the FA group and from -0.52 to -0.85 mm in the OA group. In the intergroup comparisons, only tooth #21 presented a statistically significant difference (OA: -0.52 ± 0.57 mm, FA: -0.86 ± 0.60 mm); however, the overall differences between groups were not clinically relevant, ranging from 0.03 to 0.35 mm. Conclusions: OA and FA treatment resulted in a similar degree of EARR in the maxillary and mandibular incisors at 6 months after treatment initiation. However, the amount of resorption was small and does not impair tooth longevity.

동측 반맹과 안면실인증을 호소하는 뇌경색 환자 한방복합치료 1례 (A Case of Combined Korean Medicine Treatment for Homonymous Hemianopia and Prosopagnosia after Ischemic Stroke)

  • 김근영;박호정;이유진;조기호;문상관;정우상;권승원;진철
    • 대한중풍순환신경학회지
    • /
    • 제22권1호
    • /
    • pp.21-30
    • /
    • 2021
  • ■ Background Patients with posterior cerebral artery infarction could complain of visual field defects or prosopagnosia that does not recognize a person's face. However, there has been no standardized treatment for these symptoms. ■ Case report A 57-year-old male patient complained homonymous hemianopia and prosopagnosia after posterior cerebral artery infarction. After combined Korean medicine treatment for 49 days, subjective visual field was improved and the discomfort associated with visual field defect and the disability of recognizing people was decreased. Evaluations were took place by assessing visual field using Automated Perimetry and Confrontation visual field exam. Discomfort caused by visual field defects or prosopagnosia was evaluated by visual analog scale. The patient was treated with acupuncture, moxibustion, and herbal medications. ■ Conclusion The present case report suggests that combined Korean medicine treatment might be effective to resolution of homonymous hemianopia and prosopagnosia after stroke.

비부비동염과 혈압의 상관관계 (Relationship between Chronic Rhinosinusitis and Blood Pressure)

  • 서윤태;김덕수;길부관;신승헌;예미경
    • 임상이비인후과
    • /
    • 제29권2호
    • /
    • pp.182-189
    • /
    • 2018
  • Background and Objectives : There were few literatures about the relationship between upper airway disorders and cardiovascular risk factors such as hypertension, although an association between impaired lower respiratory function and cardiovascular alterations was often reported. Our purpose was to assess the relationships between chronic sinusitis and hypertension. Materials and Methods : Three hundred subjects with bilateral chronic sinusitis who underwent functional endoscopic sinus surgery between 2015and 2017 were evaluated. Six hundred forty subjects without any nasal diseases were enrolled as a control group. Blood pressure and body mass index (BMI) were measured using a standardized method, and subjects were asked about current use of any antihypertensive medication, history of diabetes, smoking and alcohol drinking habits.Sinusitis group was assessed by nasal endoscopic examination, paranasal sinus CT scan and allergy test. Results : Average systolic and diastolic blood pressures were statistically significantly higher in subjects with sinusitis than control group. Chronic rhinosinusitis was associated with a 1.415-fold (95% confidence interval 1.053-1.930) increased hazard of hypertension after multivariate adjustment. Conclusions : These results suggest that sinusitis is associated with high blood pressure. Therefore patients with sinusitis may need special attention for blood pressure control. Further studies need to be performed to elucidate the pathogenesis behind such associations.

The Preventive Effects of Standardized Extract of Zataria multiflora and Carvacrol on Acetaminophen-Induced Hepatotoxicity in Rat - Zataria multiflora and Carvacrol and Hepatotoxicity -

  • Mohebbati, Reza;Paseban, Maryam;Beheshti, Farimah;Soukhtanloo, Mohammad;Shafei, Mohammad Naser;Rakhshandeh, Hasan;Rad, Abolfazl Khajavi
    • 대한약침학회지
    • /
    • 제21권4호
    • /
    • pp.249-257
    • /
    • 2018
  • Objectives: The hepatotoxicity induced by Acetaminophen (AAP) mostly mediated by effect on oxidative stress parameters. The Zataria multiflora (Z.M) is an herbal medicine with well-known antioxidant effect. The aim of this study is investigation of preventive effects of Z.M and Carvacrol (CAR) on AAP-induced hepatotoxicity in rats. Methods: Rats were randomly divided into four groups including: 1) Control, 2) Acetaminophen (AAP), 3) and 4) CAR. The saline, Z.M (200 mg/kg) and CAR (20 mg/kg) were administrated orally for 6 days, after that AAP (600 mg/kg) was administrated in the $7^{th}$ day. Blood sampling was performed on the first and last days. Also, the liver tissue was removed for evaluation of Malondyaldehide (MDA), Thiol content, Superoxide dismutase (SOD) and Catalase (CAT). Total Protein (tPro), Glutamic Oxaloacetic Transaminase (GOT), Glutamic Pyruvic Transaminase (GPT) and Alkaline Phosphatase (ALP) in liver tissue were evaluated. The changes (${\Delta}$) of enzymes activities were presented. Results: The ${\Delta}GOT$, ${\Delta}GPT$ and ${\Delta}ALP$ in CAR group significantly decreased compared to AAP group (P < 0.01 to P < 0.001) and ${\Delta}GPT$ in Z.M group was significantly reduced in comparison with AAP group (P < 0.05). Also, MDA, Thiol, SOD and CAT levels in treated groups were attenuated compared to AAP group (P < 0.05 to P < 0.001). Conclusion: Z.M and CAR have a powerful hepatoprotective effect. CAR is more effective than Z.M. Based on the results. Z.M and CAR could be potent supplementary agents against hepatotoxicity of AAP in patients.

Measurement of Uncertainty Using Standardized Protocol of Hand Grip Strength Measurement in Patients with Sarcopenia

  • Ha, Yong-Chan;Yoo, Jun-Il;Park, Young-Jin;Lee, Chang Han;Park, Ki-Soo
    • 대한골대사학회지
    • /
    • 제25권4호
    • /
    • pp.243-249
    • /
    • 2018
  • Background: The aim of this study was to determine the accuracy and error range of hand grip strength measurement using various methods. Methods: Methods used for measurement of hand grip strength in 34 epidemiologic studies on sarcopenia were analyzed. Maximum grip strength was measured in a sitting position with the elbow flexed at 90 degrees, the shoulder in 0 degrees flexion, and the wrist in neutral position (0 degrees). Maximum grip strength in standing position was measured with the shoulder in 180 degrees flexion, the elbow fully extended, and the wrist in neutral position (0 degrees). Three measurements were taken on each side at 30 sec intervals. The uncertainty of measurement was calculated. Results: The combined uncertainty in sitting position on the right and left sides was 1.14% and 0.38%, respectively, and the combined uncertainty in standing position on the right and left sides was 0.35 and 1.20, respectively. The expanded uncertainty in sitting position on the right and left sides was 2.28 and 0.79, respectively, and the expanded uncertainty in standing position on the right and left sides was 0.71 and 2.41, respectively (k=2). Conclusions: Uncertainty of hand grip strength measurement was identified in this study, and a significant difference was observed between measurement. For more precise diagnosis of sarcopenia, dynamometers need to be corrected to overcome uncertainty.

고령 환자에서 위암 발병 감소를 위해 헬리코박터 제균 치료를 해야 하는가? (Do We Have to Treat Helicobacter pylori for Elderly Patients to Prevent Gastric Cancer?)

  • 박선영
    • 대한상부위장관⦁헬리코박터학회지
    • /
    • 제18권3호
    • /
    • pp.215-216
    • /
    • 2018
  • 위암의 발병률이 감소하고 있기는 하지만 전 세계적으로 여전히 연 100만 명 이상이 새롭게 위암으로 진단되고 있으며, 앞으로 향후 몇십 년 동안은 인구의 고령화로 인하여 위암에 대한 사회적 경제적 부담이 줄어들지 않을 것으로 추측된다. 최근 메타분석에서 Helicobacter pylori 제균 치료가 위암발병을 33~47% 감소시킨다고 보고하였으나, 중국에서 시행된 무작위 대조 연구에서는 제균 치료가 위암의 전구 병변 감소에 도움이 되지 않았다고 보고하고 있어 위축성 위염이나 장상피화생을 동반한 경우 제균 치료가 위암 예방에 큰 도움이 되지 않을 수 있음을 제시하고 있다. 그렇다면 위축성 위염이 있는 경우가 많은 고령 환자에서는 과연 헬리코박터 제균 치료가 도움이 될 것인가? 저자들은 빅데이터 분석을 통해 헬리코박터 제균 치료가 위암 발병에 미치는 영향을 성별과 연령에 따라 분석하였다. 2003년부터 2012년까지 'Hospital Authority'에 등록된 clarithromycin 포함 3제 요법을 받은 환자들에서의 위암 발생률과 2003년부터 2013년까지 'Hong Kong Cancer Registry'에 등록된 성별과 연령이 일치된 대조군에서의 위암기대 발생률(expected incidence)을 비교하였다. 3제 요법을 받은 73,237명의 환자들을 확인하였을 때, 평균 7.6년의 추적기간 중 200명(0.27%)에서 위암이 발생하였다. 연령에 따라 40세 미만, 40~59세, 60세 이상의 그룹으로 나누어 각각 위암발생률을 대조군과 비교한 결과 60세 이상 환자군에서만 standardized incidence ratio (SIR)가 0.82로 감소하였다. 치료 성공여부에 따라 위암 발생률을 분석하였을 때, 제균 치료에 성공한 60세 이상 군에서 SIR이 0.78로 감소하였으나 재 치료를 받은 40~59세 군에서는 SIR이 2.43으로 증가하였다. 제균 치료시점이 위암 발생률에 미치는 영향으로는 제균 치료 후 10년 미만에서의 위암 발생률에는 큰 영향이 없었으나 10년 이상 경과한 경우 60세 이상 군과 40~59세 군에서의 위암 발병률이 대조군의 위암 예측 발병률보다 낮았다.