• Title/Summary/Keyword: Randomized clinical trial

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화병의 한의학적 치료에 대한 연구동향 (Current Trends in Intervention Studies of Hwabyung in Korean Medicine)

  • 서효원;최은지;김상호;김동희;김락형;김종우;이재혁;임재환;최우진;정선용
    • 동의신경정신과학회지
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    • 제27권4호
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    • pp.261-274
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    • 2016
  • Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.

교합면 삭제(occlusal reduction)를 이용한 수동적 정출 (passive eruption)이 치주조직에 미치는 영향 (Clinical Evaluation of Passive Eruption Using Occlusal Reduction on Periodontium)

  • 김유진;최점일;김성조;이주연
    • 구강회복응용과학지
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    • 제28권1호
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    • pp.15-25
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    • 2012
  • 치주치료에 있어 교합치료의 타당성은 오래전부터 연구되어오고 있으나 아직도 논란이 많은 부분이다. 그 중에서도, 교합삭제를 이용한 수동적 정출(passive eruption)의 치료 효과에 대한 연구는 아직 보고된 바가 많지 않다. 본 연구의 목표는 교합삭제를 이용한 수동적 정출이 치주부착수준, 치주낭깊이 등의 치주임상지표들에 미치는 효과를 평가하는 것이다. 본 연구는 부산대학교 치과병원 치주과에서 중등도 치주염으로 치료받은 환자 중, 연구대상조건을 만족하는 16명의 환자, 40개의 치아를 대상으로 하였다. 연구 시작 단계에서 임의로 분류한 실험군과 대조군 치아 모두 임상적, 방사선적 검사를 시행하였다. 치석제거술과 치근활택술, 구강 위생 교육을 포함한 초기치료를 시행하고 4주 후 임상적, 방사선적 검사를 재실시하였다. 이 때 실험군은 교합면 삭제를 이용한 수동적 정출을 시행하고 대조군은 아무런 처치를 하지 않았다. 그 후 6개월 이후 임상적, 방사선적 검사를 재실시하였다. 그 결과 1)연구시작 단계와 비교 시, 초기치료에 의해 임상지표를 통한 치주조직의 염증상태가 개선되었으며, 2)실험군에서 치주낭깊이, 치아동요도, 치조골 소실 감소와 각화치은 폭경 증가가 더 큰 것으로 나타났다 (p<0.05). 이 결과로 볼 때, 초기치료와 함께 교합조정을 이용한 수동적 정출술이 치주치료에 도움을 줄 수 있을 것으로 사료된다.

Thinning and drilling laser-assisted hatching in thawed embryo transfer: A randomized controlled trial

  • Le, Minh Tam;Nguyen, Thi Tam An;Nguyen, Thi Thai Thanh;Nguyen, Van Trung;Le, Dinh Duong;Nguyen, Vu Quoc Huy;Cao, Ngoc Thanh;Aints, Alar;Salumets, Andres
    • Clinical and Experimental Reproductive Medicine
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    • 제45권3호
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    • pp.129-134
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    • 2018
  • Objective: In frozen and thawed embryos, the zona pellucida (ZP) can be damaged due to hardening. Laser-assisted hatching (LAH) of embryos can increase the pregnancy rate. This study compared thinning and drilling of the ZP before frozen embryo transfer (FET). Methods: Patients were randomly allocated into two groups for LAH using thinning or drilling on day 2 after thawing. Twenty-five percent of the ZP circumference and 50% of the ZP thickness was removed in the thinning group, and a hole $40{\mu}m$ in diameter was made in the drilling group. Results: A total of 171 in vitro fertilization/intracytoplasmic sperm injection FET cycles, including 85 cycles with drilling LAH and 86 cycles with thinning LAH, were carried out. The thinning group had a similar ${\beta}$-human chorionic gonadotropin-positive rate (38.4% vs. 29.4%), implantation rate (16.5% vs. 14.4%), clinical pregnancy rate (36.0% vs. 25.9%), miscarriage rate (5.8% vs. 2.4%), ongoing pregnancy rate (30.2% vs. 23.5%), and multiple pregnancy rate (7.0% vs. 10.6%) to the drilling LAH group. There were no significant differences in pregnancy outcomes between subgroups defined based on age (older or younger than 35 years) or ZP thickness (greater or less than $17{\mu}m$) according to the LAH method. Conclusion: The present study demonstrated that partial ZP thinning or drilling resulted in similar outcomes in implantation and pregnancy rates using thawed embryos, irrespective of women's age or ZP thickness.

임신 중 벨 마비 한방치료에 대한 국내외 증례 연구 고찰 (A Review of Clinical Research Trends on Korean Medicine Treatment for Bell's Palsy during Pregnancy)

  • 김효정;안영태;현지수;최소연;김백준;이윤재
    • 대한한방부인과학회지
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    • 제37권3호
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    • pp.1-19
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    • 2024
  • Objectives: The purpose of this study is to analysis the clinical study trends on Korean Medicine treatment for Bell's palsy during pregnancy. Methods: Key words such as 'facial palsy', 'Bell's palsy, 'Korean medicine', 'herbal medicine', 'acupuncture', 'pregnancy' were searched through the 'RISS', 'OASIS', 'KISS', 'PubMed' and 'CNKI' databases. Results: Ten clinical studies with 107 patients were selected, and 1 randomized controlled trial and 9 case reports were included as the target studies. In the 9 case reports, the gestational age at the onset of facial palsy was most common in the third trimester (29-42 weeks) in 38 cases (56.7%). The most commonly used Korean medicine interventions were acupuncture, with the most frequently used acupoints being ST4, ST2, ST6, BL2, TE23, LI20, GB1, GB14, SI18, and CV24. The herbal medicine treatment most commonly utilized was Geumgwedanggwi-san (金匱當歸散), which is related to the principles of clearing heat, nourishing blood, and stabilizing the fetus (淸熱養血安胎). Among the 65 participants evaluated using the House-Brackmann facial nerve grading system, 81.5% showed complete recovery to grade 1, while 6% remained at grade 4 with no effect, indicating the efficacy of Korean medicine treatment for facial palsy during pregnancy. All the selected studies reported no abnormalities in the mothers or fetal growth, and all participants who had the reported delivery had full-term childbirth. Conclusions: The effect on Korean Medicine treatment for Bell's palsy during pregnancy had mostly positive results. However, further large, well-designed clinical trials are needed to establish the foundation of Korean Medicine treatment for Bell's palsy during pregnancy.

순차적 냉·온 요법이 척추 수술 후 통증과 통증 조절 만족도, 안위, 주관적 반응에 미치는 효과 (Effects of Sequential Application of Superficial Cold and Heat on Pain, Patient Satisfaction with Pain Control, Comfort Level and Subjective Response after Spine Surgery)

  • 김정희;임승철;노성우;이순진;고영미;김여옥;신용순
    • 기본간호학회지
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    • 제23권2호
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    • pp.184-193
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    • 2016
  • Purpose: The aims of the current study were to evaluate the effects of superficial cold and heat after spine surgery on pain, satisfaction with pain control and comfort level, and to identify subjective responses and adverse effects. Methods: A prospective, single-blind, randomized controlled trial was utilized. The intervention group (n=36) received superficial cooling until the wound drain was removed and thereafter followed by superficial heating until discharge, while the control group (n=34) received only superficial cooling until wound drain was removed. Data were collected from August 4 to November 11 2014. Results: There was significant difference in pain according to time within groups (F=71.87, p<.001). However, we found no difference in pain between groups. The intervention group reported higher patient satisfaction with pain control (4 vs 3, z=-2.83, p=.005) and higher comfort level (5 vs 4, z=-4.12, p<.001) than the control group. Conclusion: Results indicate that sequential application of superficial cold and heat is a useful method in clinical practice for management of pain after spine surgery.

침구와 약침에 대한 중개연구 현황 (Current situation of Translational research on Acupuncture, Moxibustion and Pharmacopuncture)

  • 신대철;송호섭
    • Journal of Acupuncture Research
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    • 제33권2호
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    • pp.109-116
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    • 2016
  • Objectives : Our primary objective lies in understanding the current landscape of translational research on acupuncture, moxibustion and pharmacopuncture. Methods : We searched our own selection of keywords of acupuncture, moxibustion and pharmacopuncture and translational research from three overseas databases (Pubmed, Scopus, Medicine) and four domestic databases (DBpia, KISS, Riss4u, Korea Med). Results : We have chosen 41 articles in total-40 articles on acupunture, 6 article on moxibustion(5 articles were duplicated in use in each category). Origin-wise, 48.8 %/24.8 %/17.0 % of our articles pool came from USA/China/Korea, respectively. UK, Austria, Thailand and Italy contributed the rest of our article pool. For those articles written in USA and China, review articles were the most common type. For the US articles, all 10 review articles were non-systematic reviews, while, for China's contribution, one out of 4 review articles were systematic review. Type-wise, our research pool's breakdown is as follows ; 17 review articles, 11 experimental research, 2 randomized controlled trials(RCT), 1 clinical trial, 4 conference reports, 1 letter, 1 study protocol and 4 uncategorized. Topic-wise, brain-neurology was most frequently referred with 8 articles, followed by parkinson's disease (3 articles) and epilepsy (2 articles). Conclusion : 1. In terms of research submission articles, Korea appears to be lacking translational research on acupuncture, moxibustion and pharmacopuncture, compared to USA and China, in our view. 2. Unlike the cases of USA and China, most of Korean translational research is limited to doing a T1 level of translational research. In order to bring bench-to-bedside to light. we believe, there should be more studies, and thereby a certain level of activation, to the T2 level of translational research in Korea. 3. Further, in our view there should be more efforts to improve article quality at the T1 level of translational research, which eventually becomes the fundamentals of the next level of research (i.e. T2 research), as well as to increase the number of research submissions, going forward.

Dose- and Time-Related Effects of Pilocarpine Mouthwash on Salivation

  • Song, Je-Il;Park, Jo-Eun;Kim, Hye-Kyoung;Kim, Mee-Eun;Kim, Ki-Suk
    • Journal of Oral Medicine and Pain
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    • 제42권3호
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    • pp.72-80
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    • 2017
  • Purpose: Pilocarpine as a salivation stimulant in pill form has mostly been used to relieve oral dryness for xerostomic patients but its use may often be limited due to variable side effects from systemic absorption. Therefore, the purpose of this study was to investigate the effects of pilocarpine mouthwash on salivation according to the variable concentration and duration for healthy volunteers. Related adverse effects and subjective assessment on its effects on salivation were also examined. Methods: This study was performed as placebo-controlled, double-blind, randomized clinical trial. Thirty healthy volunteers (male=23, mean age=22.2 years) were randomly allocated to 6 groups with the different concentration of pilocarpine mouthwash (placebo, 0.1%, 0.5%, 1.0%, 1.5%, and 2.0%). The whole experiment consisted of 3 sessions according to the duration of mouthwash, i.e., 1, 3, and 5 minutes with the mean wash-out period ${\geq}2$ days between the sessions. Unstimulated whole saliva was collected before and after gargling with a mouthwash. Results: Salivation of the higher concentration groups ${\geq}1%$ significantly increased than those of lower concentration group. The application period of mouthwash did not cause any changes of salivary flow rate at the higher concentrations ${\geq}1.0%$. The lower concentrations of 0.5% and 0.1% had no effects on salivation even after 5-minute mouthwash. There was no significant difference between blood pressure and pulse rate before and after use of mouthwash. Conclusions: From the results of the current study, pilocarpine mouthwash with at least 1.0% concentration more than a minute might be clinically effective in salivation without any serious side effects. Dose of mouthwash rather than duration seems to be a critical factor to salivation.

Comparison of clinical and histological characteristics of orthodontic tooth movement into recent and healed extraction sites combined with corticotomy in rats

  • Samruajbenjakun, Bancha;Kanokpongsak, Kaviya;Leethanakul, Chidchanok
    • 대한치과교정학회지
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    • 제48권6호
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    • pp.405-411
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    • 2018
  • Objective: This study was performed to investigate the rate of tooth movement and histological characteristics of extraction sockets those were subjected to corticotomy. Methods: A split-mouth randomized controlled trial experiment was designed. Thirty-two adult, male Wistar rats were divided into 2 groups: healing extraction socket (H) and recent extraction socket (R); these groups were randomly classified into 4 subgroups (0/7/21/60 days). The first maxillary molar was extracted on 1 side and 2 months were allowed for complete bone healing; then, the corresponding molar was extracted on the other side and surgical intervention was performed at the mid-alveolar point of the first maxillary molar. Ten grams of continuous force was applied. The outcomes measured were rate of tooth movement, percentage of periodontal space and histological evaluation. The rate of tooth movement was calculated as the measured distance divided by the duration of molar movement. Histomorphometric evaluations were performed on the second and third maxillary molars. The Wilcoxon signed rank test was used to compare differences between the two groups. Results: There were no significant differences in the rates of tooth movement between H and R groups at any of the 4 time points. The histological appearance and percentage of periodontal space between the R and H groups also demonstrated no significant differences. Conclusions: The rates of orthodontic tooth movement into recent and healed socket sites did not differ between the groups. Histological analysis of tooth movement revealed regional acceleration during every time period.

기온 변화는 폐경후 안면홍조의 침 치료 효과에 영향을 미치는가? (Can Ambient Temperature Change Affect the Efficacy of Acupuncture on the Postmenopausal Hot Flash?)

  • 노진주;안홍엽;김동일
    • 대한한방부인과학회지
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    • 제20권4호
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    • pp.123-131
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    • 2007
  • Purpose: To find the correlation between ambient temperature change and the efficacy of acupuncture on the postmenopausal hot flash. Methods: 52 patients entered a randomized clinical trial which was to verify the efficacy of acupuncture on postmenopausal hot flash. Participants were treated with optimal/minimal acupuncture in the course of 13 weeks. 34 of 52 visited for the temperature-rising period(Group 1), while 18 of 52 for the temperature-falling period(Group 2), 100mm hot flash VAS and average temperature were taken 18 times from each person. Linear mixed effects model was used to find the correlation between temperature and hot flash VAS score(p-value<0.05). Group1/2, optimal/minimal acupuncture, age, age of menarche, height, weight, percent body fat, BMI, waist-hip ratio, past history of hysterectomy and HRT were also examined. Results: Period of treatment had influence on the hot flash VAS. As time went by, hot flash decreased(p<.0000). Participants who underwent minimal acupuncture showed higher hot flash VAS(p=0.0479) and as waist-hip ratio rose, hot flash increased(p<.0000). As the temperature rose, hot flash VAS score became lower(p=0.0143) and it was because 34 of 52 participants were treated for the temperature-rising period. Group 1/2 had no interrelation with hot flash(p=0.5741). Conclusion: Hot flash diminished as participants were treated with acupuncture, independently of whether the ambient temperature rises or falls.

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인삼약침과 산조인약침이 정상인의 심박 변이도에 미치는 영향 (The Effects of Panax Ginseng Radix Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on the Heart Rate Variability)

  • 설현;송범용;육태한
    • Journal of Acupuncture Research
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    • 제26권5호
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    • pp.19-28
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    • 2009
  • Objectives : We tried to investigate the effects of Panax Ginseng Radix pharmacopuncture and Zizyphi Spinosi Semen pharmacopuncture on human body with the Heart Rate Variability (HRV) in adult man. As well as we tried to investigate how safe Panax Ginseng Radix and Zizyphi Spinosi Semen pharmacopuncture on the the human being. Methods : We investigated on 44 healthy volunteers consisted of 16 subjects in Panax Ginseng Radix pharmacopuncture group, 13 subjects in Zizyphi Spinosi Semen pharmacopuncture group and 15 subjects in Normal Saline. We ruled out subjects who wasn't stable by rest, with in the limit of normal heart beat(60-120cycle/min). Study form was a randomized, clinical trial. Each group was injected Panax Ginseng Radix pharmacopuncture, Zizyphi Spinosi Semen pharmacopuncture and Normal Saline $0.2m{\ell}$ at $GB_{21}$(Kyonjong). We measured HRV on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 13.0 for windows was used to analyze the data by the paired t-test(in the group) and Anova test(among the groups) were used to verify the result. Results : 1. After Panax Ginseng Radix pharmacopuncture injection, SDNN was significantly high, pNN50 was significantly low, Ln(TP) was significantly high, Ln(VLF) was significantly high, Ln(LF) was significantly high at 30 minutes. 2. After Zizyphi Spinosi Semen pharmacopuncture injection, Complexity was significantly low, Ln(VLF) was significantly high at 30 minutes. 3. HRV-index made a significant difference between the Zizyphi Spinosi Semen pharmacopuncture and normal saline at 5 minutes(p=0.02). 4. There wasn's any pain the injected region and whole body, rubefaction, uredo, nausea, vomiting, colic, headache, dizziness within 24 hours. Measured data and mean value of Mean-HRV was within normal range. Conclusions : The results suggested that and Panax Ginseng Radix pharmacopuncture in healthy adult man tended to activate the vagus nervous system within normal range.

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