• Title/Summary/Keyword: randomized clinical trial

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The Efficacy of Low-dose Aspirin Therapy for Controlled Ovarian Hyperstimulation in IVF-ET (체외수정시술 환자의 과배란유도시 저용량 아스피린 투여의 효용성에 관한 연구)

  • Lee, Eun-Sil;Lee, Sang-Hoon
    • Clinical and Experimental Reproductive Medicine
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    • v.28 no.3
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    • pp.225-233
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    • 2001
  • Objective : To evaluate the efficacy of low-dose aspirin on IVF outcome and endometrium in patients undergoing IVF-ET. Materials and Methods : From February, 2001 to Jun, 2001, 60 infertile patients were randomly divided into study group (28 cycles) and control group (32 cycles). The study group received a daily oral dose of 25 mg of aspirin for at least 2 weeks from first visiting day. Controlled ovarian hyperstimulation was initiated in all patients with the GnRH agonist starting in the midluteal phase of the previous cycle. Results: There were no significant differences in age of the patients, basal serum E2, LH, FSH level and endometrial thickness among two groups. There were no statistically significant differences between the study group and the control group respectively in dosage ($26.5{\pm}4.8$ vs $26.2{\pm}5.3$ amples) and duration ($10.4{\pm}4.2$ vs $9.8{\pm}5.3$ days) of gonadotropin administration, serum E2 level on the hCG administration day ($1823{\pm}342$ vs $1854{\pm}543$), LH ($14.5{\pm}2.7$ vs $14.8{\pm}3.1$), FSH ($16.7{\pm}3.4$ vs $18.3{\pm}4.7$), the number of follicles > 15 mm ($13.2{\pm}6.3$ vs $12.8{\pm}5.9$), the number of oocytes retrieved ($9.2{\pm}2.4$ vs $8.4{\pm}1.7$), the number of embryos transferred ($4.7{\pm}2.0$ vs $4.7{\pm}2.0$), fertilization rate (68.4% vs 64.5%), implantation rate (21.3% vs 17.6%), and clinical pregnancy rate (28.4% vs 26.2%). The endometrial thickness and the percentage of endometrial trilaminar pattern on hCG day were significantly higher in study group than control group ($12.9{\pm}3.7mm$ vs $10.4{\pm}2.8mm$, 78.3% vs 64.5%). Conclusion: Many reports suggest that low-dose aspirin improve ovarian response, implantation rate, fertilization rate, implantation rate, and pregnancy rate by increasing the blood flow, but we couldn't prove the significant effect of low-dose aspirin on the IVF outcome except on endometrium. This may be affected by dose of aspirin, duration, and number of patients studied. This trial is small, so our results highlight the need for a large randomized controlled trial to identify the effect of low-dose as pirin on IVF-ET outcome.

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Effect of Sa-am Acupuncture Treatment on the Dysmenorrhea(Pillot Study, Single Blind, Randomized, Sham Acupuncture, Controlled Clinical Trial) (월경통에 사암침치료 효과에 대한 임상연구)

  • Lee, In-Sun;Youn, Hyoun-Min;Jung, Kyoung-Keun;Kim, Soo-Min;Min, Young-Kwang;Kim, Cheol-Hong;Park, Sung-Hwan;Park, Ji-Eun;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.24 no.3
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    • pp.63-79
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    • 2007
  • Objectives : Korean traditional acupuncture Theory, Sa-am's 5 phases acupuncture method was originated in 1644-1742, in the middle of the Cho Sun dynasty. This study was to verify the effect of Sa-am Acupuncture Treatment on dysmenorrhea of Women. Methods : The subjects were 49 volunteers who were suffering for dysmenorrhea, employed using Measure of Menstrual Pain (MMP) questionnaire. Subjects were divided into two groups including Sa-am acupuncture treatment group(n=23) and minimal acupuncture treatment group(n=26). They had agreed to take part in tIris experiment, with didn't take any anodyne drugs. In the acupuncture group, subjects were stimulated at $GB_{41}$, $SI_3$, $GL_{66}$, $SI_2$(Small intestine jung-guk) and $SP_6$. In the control group, subjects were needled at $L_{10}$, $S_{40}$, $P_5$, $G_{40}$ points have any effect on dysmenorrhea. A total of 5 acupuncture sessions were performed for each patient depending on the individual menstruation cycle. The MMP score by using 7 questions and the Menstrual Symptom Severity List(MSSL-D) were measured before and after menstruation cycle. Collected data were analyzed as frequency, percentage, paired t-test, independent t-test using SPSS 10.0 WIN Program. Results : Acupuncture treatment produced a significant improvement on dysmenorrhea in two groups, but a statistically significant difference was not shown in the acupuncture group compare to control group. Conclusions : Based on the above results, it was verified that Acupuncture Treatment was effective in decreasing the symptom of Dysmenorrhea.

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Comparison of the Effects between Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture on Carpal Tunnel Syndrome (Randomized, Controlled Clinical Trial) (수근관증후군에 대한 Sweet봉약침과 오공약침의 효과 비교)

  • Ku, Ji-Young;Lee, Kyoung-Hee;Cho, Sung-Woo;Lee, Sang-Chan;Youn, Hyoun-Min;Jang, Kyung-Jeon;Song, Choon-Ho;Ahn, Chang-Beohm;Kim, Cheol-Hong
    • Journal of Pharmacopuncture
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    • v.13 no.4
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    • pp.75-89
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    • 2010
  • Objectives : The purpose of this study is to compare the effects of Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture on Carpal Tunnel Syndrome. Methods : From February to September 2010, the number of patients with Carpal Tunnel Syndrome who volunteered for this clinical study was 16 and 7 out of 16 patients complained both hands. Total 23 cases of hands were randomly divided by 2 groups. We injected Sweet Bee Venom Pharmacopuncture on PC7(Daereung) twice a week for 4weeks for experimental group(n=11), and Scolopendrid Pharmacopuncture with the same methods for control group(n=12). One case was dropped out due to itchiness of allergic response in the experimental group. Improvement of the symptoms was evaluated by Visual Analogue Scale, Pain Rating Scale, Tinel's sign, Phalen's sign and Nerve Conduction Velocity. Nerve Conduction Velocity was checked at baseline and the end of the trial and others were checked at baseline, after 2 and 4 weeks. Results : Both groups showed significant improvement in Visual Analogue Scale, Pain Rating Scale, but no significant difference between two groups. Only the control group showed significant reduction of the 'poitive response' in the Tinel's sign and Phalen's sign. However, no groups improved in Nerve Conduction Velocity. Conclusions : These results showed that Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture could decrease the symptoms of Carpal Tunnel Syndrome. Further studies will be required to examine more cases for the long period and use more various concentration and amount pharmacopuncture for the effect on Carpal Tunnel Syndrome.

Addition of 2 mg dexamethasone to improve the anesthetic efficacy of 2% lidocaine with 1:80,000 epinephrine administered for inferior alveolar nerve block to patients with symptomatic irreversible pulpitis in the mandibular molars: a randomized double-blind clinical trial

  • Aggarwal, Vivek;Ahmad, Tanveer;Singla, Mamta;Gupta, Alpa;Saatchi, Masoud;Hasija, Mukesh;Meena, Babita;Kumar, Umesh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.4
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    • pp.305-314
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    • 2022
  • Introduction: This clinical trial aimed to evaluate the anesthetic effect of the addition of 2 mg (4 mg/ml) of dexamethasone to 2% lidocaine (plain or with 1:80,000 epinephrine). The solutions were injected for a primary inferior alveolar nerve block (IANB) to provide mandibular anesthesia for the endodontic treatment of mandibular molars with symptomatic irreversible pulpitis. Methods: In a double-blinded setup, 124 patients randomly received either of the following injections: 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, or plain 2% lidocaine mixed with 2 mg dexamethasone, which were injected as a primary IANB. Ten minutes after injection, patients with profound lip numbness underwent electric and thermal pulp sensibility tests. Patients who responded positively to the tests were categorized as "failed" anesthesia and received supplemental anesthesia. The remaining patients underwent endodontic treatment using a rubber dam. Anesthetic success was defined as "no pain or faint/weak/mild pain" during endodontic access preparation and instrumentation (HP visual analog scale score < 55 mm). The effect of the anesthetic solutions on the maximum change in heart rate was also evaluated. The Pearson chi-square test at 5% and 1% significance was used to analyze anesthetic success rates. Results: The 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, and plain 2% lidocaine mixed with 2 mg dexamethasone groups had anesthetic success rates of 34%, 59%, and 29%, respectively. The addition of dexamethasone resulted in significantly better results (P < 0.001, 𝛘2 = 9.07, df = 2). Conclusions: The addition of dexamethasone to 2% lidocaine with epinephrine, administered as an IANB, can improve the anesthetic success rates during the endodontic management of symptomatic mandibular molars with irreversible pulpitis.

Efficacy and Safety of Miniscalpel Acupuncture in Knee Degenerative Osteoarthritis Patients: A Study Protocol for a Randomized Controlled Pilot Trial (퇴행성 슬관절염 환자에 대한 도침요법의 효능 및 안전성 연구: 임상예비연구)

  • Jun, Seungah;Park, Mu Seob;Oh, Se Jung;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Hwangbo, Min;Lee, Hyun-Jong;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.33 no.2
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    • pp.67-74
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    • 2016
  • Objectives : The Knee degenerative osteoarthritis patients are not satisfied with the conventional therapies of KDOA, which results in the use of alternative therapies. The miniscalpel acupuncture is effective in treating chronic soft tissue, releasing contractures. However, there is little scientific evidence supporting the use of miniscalpel acupuncture in knee degenerative osteoarthritis. This study was designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis patients. Methods : We describe the protocol for a randomized controlled pilot clinical trial of 5 weeks duration. Twenty patients will be recruited and randomly allocated to two treatment groups: miniscalpel acupuncture treatment(experimental group); and acupuncture and electro-acupuncture treatment(control group). Miniscalpel acupuncture will be performed once with a 1-week interval for 3 weeks. Electro-acupuncture will be administered twice per week for a period of 3 weeks. The primary outcomes will be measured by visual analogue scale and range of motion. The secondary outcomes will be short-form McGill Pain Questionnaire and Western Ontario and McMaster Universities Osteoarthritis Index. Both primary and secondary outcomes will be measured at baseline and at 1, 2, 3 and 5 weeks(i.e. 2 weeks after treatment completion). Conclusions : This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis.

Effects of Simulation-Based Training on the Clinical Competence and Confidence of Nursing Students in Intravenous Injection Performance and the Satisfaction of Clients (시뮬레이션 기반 정맥주사 교육이 간호학생의 임상수행능력과 수행자신감 및 대상자 만족도에 미치는 효과)

  • Jeong, Hyeon-Cheol;Choi, Na-Young;Kim, Mi-Seon;Jeon, Mi-Yang
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.13 no.6
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    • pp.2600-2606
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    • 2012
  • Purpose: This study was conducted to examine the effect of simulation-based training on the clinical competence and confidence of nursing students in intravenous injection performance and the satisfaction of clients. Methods: This study employed a randomized control posttest non-synchronized design. The participants were 90 second-year nursing students(31 multimedia group, 28 IV model group, 31 IV computerized systems group) of S-University in Seoul, Korea. Each group was given 30 minutes for five trial injections, then the students performed intravenous injections on the back of hands of the clients, and the results were measured. Results: There were significant differences in competence of clinical performance among the three groups showed no significant differences in confidence before and after intravenous injections. While there was no significant difference in the satisfaction of clients among the three groups, there were significant differences in the satisfaction of clients resulting from the success or failure of intravenous injections(p=<.001). Conclusion: This study shows that simulation-base training contributes to the enhancement of competence and confidence of nursing students in clinical performance. It would be helpful to use various simulation-based training media as another choice of education in different fields.

An Analysis of Domestic Medicine Study Tendency on Obesity -Focused on The Korean Journal of Obesity- (비만에 대한 국내 의학계의 최근 연구 동향 분석 -대한비만학회지를 중심으로-)

  • Kim, Doo Hee;Shin, Woo Suk;Kim, Dong Hwan;Jeong, Yeon Jae;Im, Han Bit;Park, Won Hyung;Cha, Yun Yeop
    • Journal of Korean Medicine for Obesity Research
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    • v.13 no.1
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    • pp.1-9
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    • 2013
  • Objectives: This study was performed to analyze the recent trend of the studies about obesity in medicine and to provide background for futher studies. Methods: All of the article were selected in "The Korean Journal of Obesity". Search were conducted through "http://kosso.or.kr" with the search word "obesity". Collected articles were classified into clinical study, experimental study, literary study, case report. Results: One hundred eighty four studies were included and analyzed in terms of study design, subject, intervention, period, obesity index and so on. The numbers of clinical studies, literary studies, experimental studies, case reports were respectively 143 (77.7%), 26 (14.1%), 2 (1.1%) and 7 (3.8%). In clinical studies, observational studies were 112 (78.3%) and intervention studies were 31 (21.7%). And most of sample sizes were more than 100 and less than 499. Body mass index, waist circumstance, body fat percent were major criteria of clinical study. Most of the subjects on obesity were about relation with another disease or experimental results and diagnosis. According to classification by the kinds of intervention, diet, exercise, drug, behavior were respectively 22, 18, 8, and 8. More than fourty percent of intervention studies were studied for 12 weeks. Conclusions: To improve the quality of Korean Medicine study for obesity, we need to recruiting big sample size and activate randomized clinical trial.

The effectiveness of sealing technique on in-office bleaching (전문가 미백시 sealing technique의 효율성에 관한 연구)

  • Lee, Yoon;Kwon, So-Ran;Park, Jeong-Won
    • Restorative Dentistry and Endodontics
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    • v.33 no.5
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    • pp.463-471
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    • 2008
  • This study investigated the clinical effectiveness and safety of sealed bleaching compared to conventional in-office bleaching using a randomized clinical trial of split arch design. Ten participants received a chairside bleaching treatment on the upper anterior teeth, and each side was randomly designated as sealed or control side. A mixture of Brite powder (PacDent, Walnut, USA), 3% hydrogen peroxide and carbamide peroxide (KoolWhite, PacDent, Walnut, USA) were used as bleaching agent. The control side was unwrapped and the experimental side was covered with a linear low density polyethylene (LLDPE) wrap for sealed bleaching. The bleaching gel was light activated for 1 hour. The tooth shades were evaluated before treatment, after treatment, and at one week check up by means of a visual shade (VS) assessment using a value oriented shade guide and a computer assisted shade assessment using a spectrophotometer (SP). The data were analyzed by paired t-test. In the control and sealed groups, the visual shade scores after bleaching treatment and at check up showed statistically significant difference from the preoperative shade scores (p<.05). The shade scores of the sealed group were significantly lighter than the control immediately after bleaching and at the check-up appointment (p<0.05). Compared to prebleaching status, the ${\Delta}E$ values at post bleaching condition were $4.35{\pm}1.38\;and\;5.08{\pm}1.34$ for the control and sealed groups, respectively. The ${\Delta}E$ values at check up were $3.73{\pm}1.95\;and\;4.38{\pm}2.08$ for the control and sealed groups. ${\Delta}E$ values were greater for the sealed group both after bleaching (p<.05) and at check up (p<.05). In conclusion, both ${\Delta}E$ and shade score changes were greater for the sealed bleaching group than the conventional bleaching group, effectively demonstrating the improvement of effectiveness through sealing.

Review on Clinical Studies of Traditional Herbal Medicine and Acupuncture Treatments for Colorectal Cancer Patients (대장암 환자의 한약 및 침치료에 대한 국내외 임상연구 결과에 대한 고찰 - Pubmed를 중심으로)

  • Kang, Yun Hwan;Hong, Mi-na;Han, Chang Woo;Choi, Jun Yong;Park, Seong Ha;Kim, So Yeon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.30 no.4
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    • pp.219-228
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    • 2016
  • The aim of this study was to collect and analyze the clinical studies of traditional herbal medicine and acupuncture treatments for colorectal cancer patients searched in Pubmed and Cochrane library in English. We collected the clinical studies, including randomized controlled trial, case control study and cohort study, in the PubMed and Cochrane library using keywords 'Colorectal Cancer', 'Korean Medicine', 'Traditional Chinese Medicine', 'Kampo' and 'Acupuncture'. Then we analyzed them according to the objective of the therapy, i.e. improving therapy prognosis, reducing chemotherapy's adverse event and reducing operational adverse event. In case RCT, we evaluate the quality of the study with jadad scale. Total 18 studies were selected. There were 3 studies about improving therapy prognosis, 6 studies about reducing chemotherapy's adverse event and 9 studies about reducing operational adverse event. Traditional medicine might improve therapy prognosis in terms of the survival rate, relapse/metastasis rate, quality of life and immune function. The specific herbal formula, 'Goshajinkigan' might not be successful about reducing chemotherapy's adverse event, peripheral neurotoxicity. 'Hangeshanshinto' might reduce the duration of oral mucositis but it is not clear to reduce the incidence of that. 'PHY906' might reduce the incidence of diarrhea. Acupuncture might reduce operational adverse event such as gastrointestinal dysfunction and pain. And 'Daikenchuto' might not be successful in reducing operational adverse event, gastrointestinal dysfunction. Further studies are needed to clarify the efficacy of traditional herbal medicine and acupuncture for colorectal cancer patients.

A Literature Review of the East-West Medical Combined Treatment (한양방 병용치료에 대한 문헌고찰)

  • Kim, Chang-Seok;Kim, Sang-Kyun;Kim, Young-Eun;Kim, Chul;Yea, Sang-Jun;Jang, Hyun-Chul;Song, Mi-Young
    • Korean Journal of Oriental Medicine
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    • v.18 no.2
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    • pp.101-116
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    • 2012
  • Objectives : This study aims to analyze the papers of the east-west medical combined treatment and suggest the research direction. Methods : 183 research papers were collected by using 25 keywords including combination(in korean words, 병용), collaborative practice(in korean words, 협진) in Korean Medical Database(KMbase) and Oriental Medicine Advanced Searching Integrated System(OASIS). We analysed the type of studies, the kind of diseases, the treatment method, the kind of herbs and drugs in frequent use, and the result of research. Results : Among the analysed 183 papers, clinical studies are 89 cases and experimental studies are 94. 5 cases of clinical studies are Randomized Controlled Trial(RCT). The cancer(50 papers) and diseases of the circulatory system(25 papers) occupied mostly in treatment studies. Because Combined treatment was actively progressed in oriental medicine, treatment was mainly applied the combined oriental medical treatment with herbs and western drugs. In herbal medicine, Mahwangyounpae-tang(麻黃潤肺湯) and Eunkyo-San(銀翹散) were frequently used in the papers. In western drugs, Cyclophosphamide, Cisplatin, and Mitomycin C were frequently used in the papers. 154 papers introduced the treatment effect, 14 papers announced the safety, and 4 papers mentioned the side effect. Conclusions : We suggested several future research direction as follows. Clinical studies based on experiment studies must be more activated and many RCT shoud be shown. Experimental group in clinical studies should be clearly separated to confirm the treatment method is effective or isn't effective. Studies about the side effect must be expanded, and every study should be confirmed both the treatment effect and safety.