• Title/Summary/Keyword: Randomized controlled study

Search Result 1,958, Processing Time 0.035 seconds

Clinical Application of Focused Ultrasound in Korean Medicine (집속초음파 치료의 한의 임상 활용에 대한 고찰)

  • Yoomin Choi;Maeum Lee;Nayeon Hur;Eunhee Lee;Hyugyong Choi;Hyung-Sik Seo;Eui-Hyoung Hwang;Insoo Jang
    • Korean Journal of Acupuncture
    • /
    • v.40 no.3
    • /
    • pp.79-89
    • /
    • 2023
  • Objectives : The purpose of this study is to investigate various application methods of focused ultrasound and apply them to clinical use in Korean medicine. Methods : Search was performed using the search engines of electronic databases, including PubMed, ScienceDirect, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure (CNKI), Wanfang Data, Japan Science Technology Information Aggregator, Electronic (J-STAGE) and Citation Information by NII (CiNii), from inception to July 2023 without language limitation. Inclusion criteria were clinical studies including randomized controlled trials (RCTs), and animal experimental studies related with focused ultrasound treatments for acupoints or meridian sinews. Results : Total 17 papers, 7 for RCT, 6 for in vivo animal studies, and other experimental studies, were finally selected. Indications used in studies were shoulder pain, back pain, chronic back pain, and degenerative knee arthritis. In experimental studies, studies on animal models of hypoxic ischemic brain damage and hyperlipidemia were also conducted. As for the acupoints, LR3, LI4, and ST36 were used in clinical studies and, in animal experimental studies, GV20, KI1, and ST36 were used. As for the dose, 4 studies below 3 W/cm2 and 3 studies in the range of 0.625 to 5 W/cm2 in clinical studies, and all studies did not exceed 5 W/cm2. In animal experimental studies, 0.5 W/cm2, 2 W/cm2, 7.5 WW/cm2, 15 W/cm2, 10~20 W/cm2 were used. In all three studies describing the penetration depth during irradiation, it was less than 1 cm. Conclusions : We suggest that focused ultrasound is an appropriate treatment tool for stimulating the acupoints to transfer heat energy. Future studies with rigorous and well-designed RCTs for various diseases will be required to ascertain the focused ultrasound stimulate acupoints or meridian sinews.

Herbal Medicine Treatment for Cold Urticaria: A Systematic Review and Meta-Analysis (한랭 두드러기에 대한 한약 치료: 체계적 문헌 고찰 및 메타분석)

  • Hae-Na Kim;Jeong-Hwa Oh;Hwa-Jung Yoon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
    • /
    • v.36 no.4
    • /
    • pp.122-144
    • /
    • 2023
  • Objectives : The purpose of this study is to evaluate the effects of herbal medicine treatment in patients with cold urticaria. Methods : We searched randomized controlled trials(RCTs) reporting the effects of herbal medicine for cold urticaria through domestic and international databases from their inception to September 2023. The results were summarized in tables. We assessed the risk of bias in included RCTs through Cochrane risk of bias tool and the data synthesis was conducted through RevMan version 5.4. Results : A total of 12 RCTs were included in this review and all trials compared herbal medicine alone treatment(treatment group) with western medicine alone treatment(control group). The total effective rate(TER) of treatment group was statistically higher than that of control group(RR: 1.49, 95% CI: 1.38 to 1.62, p<0.00001, I2=65%). On the other hand, when comparing except for 1 trial with different evaluation period, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.36, 95% CI: 1.26 to 1.47, p<0.00001, I2=0%). And when comparing 8 trials using the total symptom score(TSS) change index as an indicator of TER, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.38, 95% CI: 1.26 to 1.51, p<0.00001, I2=0%). The treatment group showed more statistically significant decrease compared to the control group in TSS(MD: -2.51, 95% CI: -2.63 to -2.40, p<0.00001, I2=99%). The relapse rate of treatment group was statistically lower than that of control group(RR: 0.19, 95% CI: 0.10 to 0.40, p<0.00001, I2=0%). Mild adverse events such as sleepiness, dizziness were reported in control group and gastric discomfort was reported in treatment group. In the risk of bias assessment, many cases were evaluated as 'Unclear risk'. Conclusions : This review found that herbal medicine alone treatment could more effective and safe than western medicine alone treatment for cold urticaria. But further well-designed researches are needed because of heterogeneity between trials and the quality of the included trials.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • The Journal of Korean Medicine
    • /
    • v.44 no.4
    • /
    • pp.104-120
    • /
    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

Effects of Ishige okamurae Extract Supplement on Blood Glucose and Antioxidant Systems in Type 2 Diabetic Patients (패 추출물이 제2형 당뇨병 환자의 혈당 및 항산화 체계에 미치는 영향)

  • Kang, Yeon-Ju;Kim, Hak-Ju;Han, Ji-Sook
    • Journal of the Korean Society of Food Science and Nutrition
    • /
    • v.40 no.12
    • /
    • pp.1726-1733
    • /
    • 2011
  • We performed a randomized placebo-controlled trial to determine whether or not Ishige okamurae extract supplements modulate blood glucose and antioxidant systems in type 2 diabetic patients. A total of 46 patients were randomized to either an Ishige okamurae extract group or a placebo group. The patients consumed either 1,600 mg of Ishige okamurae extract or cornstarch supplement per day for 10 weeks. The lifestyle factors and dietary intake of patients were not altered during the 10 week trial period. After 10 weeks, the fasting blood glucose level was slightly decreased in the Ishige okamurae extract group, but a significant decrease was not observed. Also, glycosylated hemoglobin was significantly (p<0.01) decreased. Especially, low-glycosylated hemoglobin ($7.12{\pm}0.38%$ to $6.56{\pm}0.53%$) was significantly decreased compared to high-glycosylated hemoglobin ($8.65{\pm}0.92%$ to $8.60{\pm}0.85%$) in that group. The superoxide dismutase, catalase, and glutathione peroxidase levels were increased in the Ishige okamurae extract group compared to the placebo group. The increase of these enzymes was associated with the decrease of MDA concentration in the Ishige okamurae extract group, but a significant decrease was not observed. The Ishige okamurae extract supplement showed no adverse effects on liver and kidney functions. Findings from this study suggest that an Ishige okamurae extract supplement can help blood glucose status in type 2 diabetic patients without adverse effects.

Effects of Laminaria Japonica Extract Supplement on Blood Glucose, Serum Lipids and Antioxidant Systems in Type ll Diabetic Patients (다시마추출물이 제2형 당뇨병 환자의 혈당, 지질 및 항산화 체계에 미치는 영향)

  • Park, Min-Jung;Ryu, Ho-Kyung;Han, Ji-Sook
    • Journal of the Korean Society of Food Science and Nutrition
    • /
    • v.36 no.11
    • /
    • pp.1391-1398
    • /
    • 2007
  • We performed a randomized double-blind placebo-controlled trial to determine whether Laminaria japonica extract (LJE) supplement modulates blood glucose, serum lipids and antioxidant systems in type II diabetic patients. We also measured critical parameters assessing safety in liver and kidney functions after LJE supplement. A total of 37 patients (18 males and 19 females) were randomized to either LJE group or placebo group. The treatment group received four 350 mg of LJE capsules (1.4 g, total) per day for 12 weeks. The placebo group received the same dose of cellulose capsules. Baseline characteristics regarding general life style and dietary intake pattern were similar between the two groups. There were no significant influences of LJE supplement except for waist circumference on anthropometric parameters. As the whole, 12 weeks of LJE supplement resulted in a little decrease in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c), but a significant decrease was not observed. Total cholesterol, LDL-cholesterol and triglyceride concentrations were significantly (p<0.05) lowered in LJE group. The antioxidant enzymes, glutathion peroxidase (GSH-px) and superoxide dismutase (SOD) levels were elevated in the LJE group (p<0.05) compared to the placebo. The increase of these enzymes was associated significantly with the decrease of MDA concentration (p<0.05). Furthermore, LJE supplement showed no adverse effects on the functions of liver and kidney. Findings from this study suggest that LJE supplement can help improve serum lipid status in type II diabetic subjects without adverse effects.

Clinical Efficacy of Clomiphene Citrate and Letrozole Combined with Gonadotropins for Superovulation in Patients with Clomiphene-Induced Thin Endometrium (클로미펜에 얇은 자궁내막을 보이는 환자에서 성선자극호르몬 병합 과배란유도시 클로미펜과 레트로졸의 임상적 효용성)

  • Lee, Eun-Joo;Park, Hyun-Jong;Yang, Hyo-In;Lee, Kyung-Eun;Seo, Seok-Kyo;Kim, Hye-Yeon;Cho, Si-Hyun;Choi, Young-Sik;Lee, Byung-Seok;Park, Ki-Hyun;Cho, Dong-Jae
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.36 no.2
    • /
    • pp.111-119
    • /
    • 2009
  • Objective: The aim of this study was to compare the clinical efficacy of clomiphene citrate (CC) and letrozole combined with gonadotropins for controlled ovarian stimulation (COS) in patients with CC-induced thin endometrium Methods: Fifty-one intrauterine insemination cycles performed in patients who previously had a thin endometrium (<8 mm) to ovulation induction using CC were included in this study. A CC 100 mg/day (CC+gonadotropin group, n=26) or letrozole 2.5 or 5 mg/day (letrozole+gonadotropin group, n=25) was administered on day 3~7 of the menstrual cycle, combined with gonadotropins at dose 75~150 IU every other day starting on day 5~7. We compared total dose of gonadotropin used, endometrial thickness, endometrial pattern, number of follicles ${\geq}14\;mm$ on hCG day, pregnancy rate and multiple pregnancy rate between the two groups, which were statistically analyzed using Mann-Whitney U test or Fisher's exact test, where appropriate. Results: There were no significant differences in clinical characteristics such as age, duration of infertility, number of previous IUI cycles, basal serum hormone levels and cause of infertility between the two groups. In both groups, the endometrium was significantly thicker than that of previous ovulation induction cycles using CC. No significant differences were found in the total dose of gonadotropin used, day of hCG administration, the rate of triple endometrium and pregnancy rate. The number of follicles ${\geq}14\;mm$ was significantly lower ($3.7{\pm}1.7$ vs. $2.8{\pm}1.7$, p=0.03) and the endometrium on hCG day was significantly thicker ($7.7{\pm}1.5$ vs. $9.1{\pm}1.7$, p=0.001) in letrozole+gonadotropin group compared to CC+gonadotropin group. Conclusion: The clomiphene citrate and letrozole combined with gonadotropins appear to avoid the undesirable effects on the endometrium frequently seen with CC for ovulation induction. However, in terms of adequate endometrial development or optimal follicular growth, letrozole may be more beneficial than CC for gonadotropin-combined COS in patients with CC-induced thin endometrium. Further prospective randomized controlled studies in a larger scale will be necessary to confirm our findings.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
    • /
    • v.33 no.2
    • /
    • pp.115-126
    • /
    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Efficacy of Statins on BMB or Fracture Risk in Postmenopausal Women (스타틴이 폐경기 여성의 골밀도 혹은 골절위험에 미치는 효과 -보고된 임상연구결과 분석을 중심으로-)

  • Bang, Joon-Seok
    • Korean Journal of Clinical Pharmacy
    • /
    • v.16 no.2
    • /
    • pp.86-91
    • /
    • 2006
  • There are 3 different hypotheses on how statins may affect bones, through promoting bone formation, inhibiting bone resorption or through anti-inflammatory effect. In the 3 cross-sectional studies above, one showed increase BMD at hip and spine, one showed increase BMD only at mid-forearm and one showed that the risk reduction in fractures is not explained by the changes in BMD however, all 3 studies showed a decrease in risk of fracture associated with statins. In the 2 prospective cohort studies, one showed the use of statins was not associated with BMD at any skeletal site or decreasing the risk of fracture, and the other showed statins except pravastatin decreased in risk of vertebrate fracture but not affecting lumbar spine BMD. All of case-control studies indicated reduction in fracture risk but did not provide any data regarding BMD. 2 of the randomized, controlled studies showed no significant reduction in fracture risk as well as statins' effects on BMD. Finally, one longitudinal study showed statin use reduced fracture risk and increased BMD. Among the conflicting results shown above, even when statin use was shown to increase BMD, it does not seem to account for the reduction in fracture risk. There may be different ways that statins affect bone other than those hypotheses proposed above. Many studies seem to agree that pravastatin does not have any effect on bone. Some studies suggested that the reason statins did not achieve clinically significant increases in BMD in some studies, is due to the low affinity of statins on bone; statins are designed to act in the liver therefore their effective concentration in extrahepatic tissue is low. The limitations to those studies discussed above. Many studies did not account for the change of lifestyle while subjects' were on statins. Increases in weight bearing exercise and changes in diet might affect BMD and thus reduce risk of fractures. Mental alertness and vision acuity might prevent falls from occurring; many statin-users in the studies were young so the risk of fractures from falls would be decreased. Almost all of the studies failed exclude patients with neurological problems. During study periods, many subjects may have been started on drugs for diseases that usually occur with aging which could cause drowsiness and lead to falls. The sample sizes used in some of the trials were small and the duration of treatment and follow up might not have been long enough to see clinically relevant results.

  • PDF

A Systematic Study of the Intervention Effect of Social Stories in Children with Sleep Disorders (수면장애 아동을 위한 사회적 이야기 중재 효과: 체계적 고찰)

  • Kim, Ji-Ho;Yoo, Eun-Young
    • The Journal of Korean Academy of Sensory Integration
    • /
    • v.21 no.2
    • /
    • pp.69-83
    • /
    • 2023
  • Objective : This study sought to systematically examine the intervention effect of social stories when applied in relation to children with sleep disorders. Methods : Studies available in the SCOPUS, ScienceDirect, PsycArticles, and PubMed databases that were published from 2001 to 2022 were searched. The keywords used for the search were as follows: ("social story" OR "social stories") AND ("sleep" OR "sleep disorders" OR "sleep wake disorder bedtimes" OR "sleep initiation and maintenance disorders" OR "sleep wake disorder" OR "sleep arousal disorders"). Based on the selection criteria, six experimental studies were selected and analyzed. Results : The selected studies were two randomized controlled trials, three individual trials, and one case study. The subjects were mostly children diagnosed with autism spectrum disorder who were school-aged or adolescent. The intervention types were often complex interventions, including social stories and other interventions, while the durations of the interventions varied from one day to more than 40 days. The interventions had a positive effect on the subjects' sleep quality, with night wakings, sleep onset delay, and sleep anxiety all being improved. As standardized assessment tools to evaluate the effectiveness of social stories, the Child Sleep Habits Questionnaire and the Child Behavior Checklist were used in two papers each, and were the most commonly used. As non-standardized assessment tools, each of the four papers used turbulence and sleep diaries as assessment tools. Conclusion : The effect of social story mediation can be divided into sleep quality and sleep-related behavior. In terms of sleep quality, studies showing improvements in night wakings, sleep onset delay, and sleep anxiety accounted for a large proportion of the sample. The detailed effect area of sleep quality showed a significant improvement after the interventions in most studies, and in all six studies analyzed in the present study, the continuation of the effect after the intervention was confirmed via follow-up tests. Thus, the findings of this study are expected to be helpful when applying social stories in children with sleep disorders in clinical practice due to presenting the intervention effects, outcome evaluation tools, and intervention periods in children with sleep disorders in prior investigations involving social stories.

Risk Factors Related to Uterine Leiomyoma in Korean Women - A Retrospective Study - (한국인 여성에서 자궁근종 발생에 관여하는 인자들에 대한 연구 - 후향적 연구 -)

  • Hong, D.G.;Chung, M.J.;Kim, B.S.;Lee, J.M.;Cho, Y.L.;Lee, T.H.;Chun, S.S.
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.33 no.3
    • /
    • pp.159-170
    • /
    • 2006
  • Objective: The purpose of this study is to find out risk factors related to uterine leiomyoma in Korean women and to compare with the results of previous western studies. Methods: A retrospective analysis was carried out. All the cases of uterine leiomyoma (n=244) were diagnosed surgically or sonographically between Jannuary 1998 and December 2004. Total of 269 controls not having uterine leiomyoma were collected from patients who visited Kyungpook national university hospital for routine gynecologic check-up or treatment of their gynecologic or obstetric diseases other than uterine leiomyoma. Data were collected through review of medical records and interviews and analyzed with $x^2$ and logistic regression model. Results: In multivariate analysis, patient's age (OR 1.070; 95% CI 1.041~1.099), number of artificial abortion (OR 1.182; 95% CI 1.018~1.374) and alcohol drinking (OR 1.865; 95% CI 1.231~2.824) had significantly positive correlation with uterine leiomyoma. The duration of lactation was the only factor which had negative correlation (OR 0.985; 95% CI 0.972~0.998). BMI, parity, age at menarche, the duration and interval of menstruation, caffeine consumption and marital status did not show any correlations. Conclusion: In this study, patient's age, number of artificial abortion, and alcohol drinking were the risk factors of uterine leiomyoma in Korean women and the result was similar to that of western studies. Though we couldn't find out the specific risk factors related to the development of uterine leiomyoma in this study, but it has a great meaning to be the first trial in Korean women. The role of information bias should be carefully evaluated and further multicentered, randomized, controlled prospective studies will be needed to know the possible risk factors among Korean women.