• Title/Summary/Keyword: randomized clinical controlled trial

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

  • Sin, Dae Chul;Song, Ho Sueb
    • Journal of Acupuncture Research
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    • v.33 no.2
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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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    • v.42 no.3
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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
    • The korean journal of orthodontics
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    • v.48 no.6
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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.

Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial) (월경곤란증의 자하거 약침효과에 관한 연구)

  • Kim, Su-Min;Jang, Sun-Hee;Kim, Cheol-Hong;Youn, Hyoun-Min;Song, Choon-Ho;Ahn, Chang-Beohm;Jang, Kyung-Jeon
    • Journal of Pharmacopuncture
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    • v.11 no.3
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    • pp.123-131
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    • 2008
  • Objective: This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods: 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain) and MSSL(Menstrual Symptom Severity List) questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25) and a Normal Saline(N/S) treatment group(Control group, n=24). The two groups were injected on the $CV_4,\;S_{36},\;Sp_9$ and $Sp_6$ acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results: As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05), and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions: The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

Effects of Electroacupuncture on the Muscle Cramps of Liver Cirrhosis Patients: A Randomized Controlled Study (간경변 환자의 근경련에 대한 전침 치료의 효과 무작위 대조군 연구)

  • Lee, Chang-hyeong;Kim, Byung-seok;Kim, Kyung-soon;Kwak, Min-a;Kim, Seung-mo
    • The Journal of Internal Korean Medicine
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    • v.39 no.4
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    • pp.511-519
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    • 2018
  • Objectives: The purpose of this clinical trial was to examine the efficacy and safety of electroacupuncture on liver cirrhosis patients suffering from muscle cramps. Methods: Fourteen patients with liver cirrhosis who experienced muscle cramps at least once a week, regardless of cramp location, were enrolled and randomly allocated to an experimental group (n=12) or a control group (n=12). The experimental patients were treated with electroacupuncture at an electrical stimulation frequency of 100 Hz three times a week for four weeks (12 times in total). Muscle cramps were evaluated by a questionnaire that probed subjective symptoms. We analyzed the frequency of muscle cramps 3 times (at screening, 14 th visit, 15 th visit) during 8 weeks. Results: The number of patients with cramps occurring 'more than once a week' was reduced and the proportion of patients decreased in response to electroacupuncture. The number of patients with cramps occurring 'less than once every two weeks' increased and the proportion of patients also increased in response to eletroacupunture. Conclusions: The results of this study suggest that electroacupuncture treatment will be beneficial for improving muscle cramps in patients with liver cirrhosis. Electroacupuncture is considered a safe and efficacious treatment for patients with liver cirrhosis who complain of muscle cramps.

Differential Effects of Two Individual Acupuncture Points (BL62, KI6) on Heart Rate Variability in Healthy Volunteers : A Randomized, Single-Blind, Self-Controlled Trial (건강한 지원자에서 두 경혈(신맥, 조해)이 심박변이도에 미치는 영향의 차이 : 무작위, 단일 맹검, 자기 대조군 임상시험)

  • Lee, Ji-Hye;Choi, Young-Joon;Shin, Byung-Chul;Koo, Sung-Tae
    • Korean Journal of Acupuncture
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    • v.27 no.4
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    • pp.85-97
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    • 2010
  • 목적 : 이 연구는 서로 다른 두 경혈이 심박변이도에 미치는 영향을 비교하고, 자율신경계에 미치는 영향을 평가하기 위해 수행하였다. 재료 및 방법 : 13명의 지원자가 3개의 세션에 균등하게 무작위 배정되었다. 각 세션에서 지원자들은 신맥(BL62), 조해(KI6), 또는 비경혈에 각각 침처치를 받았다. 10분간 휴식을 한 후에 자침 전, 유침기간, 발침 후 기간에 5분 동안 심박변이도 측정을 하였다. 유침기간에는 2분 간격을 두고 2회 심박변이도를 측정하였다. 결과 : 신맥에 자침한 군에서는 자침후 기간에 total power(TP)와 standard deviation N-N interval(SDNN)이 유의하게 증가하였다. 유침기간 중 첫 5분 동안의 TP와 SDNN은 자침전 값과 유의한 차이가 없었으며 유침기간 중 마지막 5분 동안에는 다소 증가하는 경향은 있었지만 통계적인 유의성은 없었다. 반면에 조해와 비경혈에 자침한 군에서는 TP와 SDNN에 유의한 변화가 관찰되지 않았다. 발침 후에 신맥자침군에서는 조해와 비경혈 자극군과 비교해서 TP가 유의하게 변화하였다. 그러나 SDNN은 발침 후에 세 군 사이에 유의한 차이가 없었다. 결론 : 이 실험 결과는 조해와 비교했을 때 신맥에 자침한 경우 심장 기능 및 자율신경계와 관련이 있는 대체적인 활성이 증가한다는 것을 보여주었다. 이 결과는 신맥 자침이 자율신경계와 관계되어 있는 심장의 기능에 미치는 영향을 통해서 경혈의 특이성을 관찰할 수 있음을 의미한다.

Antihypertensive effect of Meridian Tai Ji exercise treatment in hypertension patients (고혈압 환자에서 경락도인태극권의 혈압강하 효과)

  • Shin, Mi-Suk;Han, Chang-Hyun;Kang, Kyung-Won;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
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    • v.14 no.1
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    • pp.67-72
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    • 2008
  • Objectives : The purpose of the study was to determine the effects of a 4 weeks Meridian Tai Ji exercise treatment on blood pressure reducing in hypertensive patients. Methods : We measured the blood pressure of 3 patients who were visited in the Gwacheon Health center from 21th November 2007 to 17th December 2007. Eligible participants had systolic blood pressure ${\geq}$ 120 mmHg or diastolic blood pressure ${\geq}$ 80 mmHg with antihypertensive drug. Blood pressure measurements were after the patient had been in rest for at least 10 minute. Twelve sessions of Meridian Tai Ji exercise treatment over 4 weeks were performed in the patients. Blood pressure were measured twice before and after each session. Results : After 4 weeks, blood pressure reduction was observed in the treatment patients, with an average decline of systolic blood pressure up to 5.67 mmHg and diastolic blood pressure up to 0.17 mmHg. But, it was not statistically significant. Blood pressure increased between measurements taken before and after an Meridian Tai Ji exercise treatment session, although individual responses were quite variable. No significant difference was found in the immediate effect. Conclusion : Twelve sessions of Meridian Tai Ji exercise treatment do not seem to control hypertension. Further research is required to determine whether Meridian Tai Ji exercise treatment can enhance clinical management of hypertension if it is used in combination with more enrolled participants, over longer periods, or randomized controlled trial.

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Efficacy of the Probiotic Probiotical Confirmed in Acute Gastroenteritis

  • Kluijfhout, Sandra;Trieu, Thanh-Van;Vandenplas, Yvan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.5
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    • pp.464-471
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    • 2020
  • Purpose: Some probiotic strains reduce the duration of acute diarrhea. Because of strain and product specificity, each product needs to be supported by clinical data. This study aimed to test the efficacy of the synbiotic food supplement Probiotical (Streptococcus thermophilus, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium infantis, fructo-oligosaccharides) in children with acute gastroenteritis of likely infectious origin. The primary endpoint was the number of children with normal stool consistency during the treatment duration. Methods: A total of 46 children (aged 3.6 months to 12 years) with acute gastroenteritis that started less than 48 hours prior to their visit at a hospital-based emergency department were included in this prospective, randomized, placebo-controlled trial. All children were treated with oral rehydration solution and placebo (n=20) or the test product (n=26). Results: Significantly more children had a normal stool consistency on days 1 and 2 in the probiotic group: 5 children (20%) on day 1 in the probiotic group compared with none in the placebo group (p=0.046). On day 2, 11 children in the probiotic group (46%) and 3 (16%) in the placebo group (p=0.024) had a normal stool consistency. The mean duration of diarrhea was shorter in the probiotic group compared with that in the placebo group (3.04±1.36 vs. 4.20±1.34 days) (p=0.018). Conclusion: The test product was shown to normalize stool consistency significantly more rapidly than the placebo. These data confirm the findings from a previous study in a larger group of children performed in a primary healthcare setting.

The effect of Hominis Placenta Pharmacopuncture on Leg spasticity of stroke patients (A Pilot study, Double blind, Randomized, Controlled Clinical Trial) (중풍 환자의 하지 경직에 대한 자하거 약침의 효과 연구)

  • Noh, Ju-Hwan;Park, Jung-Ah;Youn, Hyoun-Min;Jang, Kyung-Jeon;Song, Choon-Ho;Ahn, Chang-Beohm;Kim, Cheol-Hong
    • Journal of Pharmacopuncture
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    • v.12 no.4
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    • pp.97-110
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    • 2009
  • Objective : The purpose of this study is to determine the effect of Hominis Placenta Pharmacopuncture(HPP) on lower limb spasticity control in stroke patients. Methods : Twenty stroke patients with Leg spasticity were randomly divided into two groups, a Distilled water Pharmacopuncture(group I) and a HPP(group II). The number of Pharmacopuncture was 5 times a week and acupuncture treatment was 3 times a week for 3 weeks. Modified Ashworth Scale(MAS), H-reflex/M-response ratio(H/M ratio), Berg Balance Scale(BBS) and Time Up & Go(TUG) were used for evaluation of spasticity control before experiment, after 1 week, 2 weeks, 3 weeks. Results : Group I showed significant improvement(p$<$.05) in BBS but no significant improvement in MAS, H/M ratio, and TUG. Group II showed significant improvement(p$<$.05) in MAS, BBS, and TUG, but no significant improvement in H/M ratio. The results showed significant difference in TUG, but no significant difference in MAS, H/M ratio and BBS between 2 groups. Conclusion : These results showed that HPP might decrease lower limb spasticity and increase leg motor function in stroke patients. Further studies will be required to examine more cases in the long period for the effect on lower limb in spasticity by HPP.

Effects of Sweet Bee Venom and Bee Venom on the Heart Rate Variability (Sweet Bee Venom과 Bee Venom이 심박변이도(HRV)에 미치는 영향)

  • Yook, Tae-Han;Yu, Jung-Suk;Jung, Han-Sung
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.41-54
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    • 2008
  • Objective : In this study, we investigated the effects of Sweet Bee Venom(SBV) and Bee Venom(BV) at a acupoint, HT7(Shinmun) on the Heart Rate Variability(HRV) in the healthy man. And we tried to observe how Sweet Bee Venom and Bee Venom affects on the balance of the autonomic nervous system. Methods : We investigated on 22 heathy volunteers consisted of 10 subjects in SBV group and 12 subjects in BV group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 22 subjects of each group were injected SBV and BV at HT7(Shinmun). And we measured HRV by QECG-3:LXC3203 (LAXTHA Inc. Korea) on 7 times : before and after injection per 5minutes during 30minutes. Results : 1. After SBV injection, Mean-RR was significantly high from 0 to 10 minutes, Mean-HRV was significantly low from to 10 minutes, SDNN was significantly high after 25minutes, Complexity was significantly high from 5 to 10 minutes and RMSSD was significantly high from 5 to 10minutes. 2. Complexity of SBV Group significantly decreased from 20 to 25minutes, RMSSD of SBV Group significantly increased from 10 to 15minute and from $20{\sim}25$minutes, SDSD of SBV Group significantly increased from 10 to 15 minute and from $20{\sim}25$minutes compared with that of BV group. 3. After SBV injection, Ln(VLF) was significantly from 25 to 30minutes. Conclusions : The results suggest that SBV in heathy adult man tend to activate the autonomic nervous system compared to BV within normal range.