• 제목/요약/키워드: Placebo-controlled

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The Therapeutic Efficacy of Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis (항암화학요법 유발 말초신경병증에 대한 한약의 치료 효과: 체계적 문헌고찰 및 메타 분석)

  • Kim, Eun Hye;Yoon, Jee-hyun;Lee, Jee Young;Yoon, Seong Woo
    • Journal of Korean Traditional Oncology
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    • v.25 no.2
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    • pp.23-36
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    • 2020
  • Objective: This study was aimed to report the therapeutic effects of herbal medicine on chemotherapy-induced peripheral neuropathy (CIPN). Methods: The prior studies were searched from the databases included PubMed, Cochrane Library, EMBASE, CNKi, CiNii, KISS, NDSL, KMBASE, and OASIS until September 2020. The main search keywords were chemotherapy, peripheral neuropathy, and herbal medicine, and only randomized controlled trials that analyzed the therapeutic efficacy of herbal medicine were included. The Cochrane's Risk of Bias was used for assessment of the risk of bias and the Review Manager 5.3 program was used for meta-analysis. Meta-analyses were grouped by the administration routes of herbal medicines (oral administration or topical use). Results: Nine studies with a total of 563 participants were included. Compared with usual care, the effective rate was higher in oral administrated herbal medicine (RR 1.67, 95% CI 1.25 to 2.23; p<0.001, I2=31%). In addition, topical herbal medicine showed an significantly higher effective rate than placebo (RR 2.20, 95% CI 1.52 to 3.18; p<0.001, I2=0%) and usual care (RR 2.24, 95% CI 1.74 to 2.89; p<0.001, I2=66%). There was no severe adverse effect in all participants. Conclusions: Herbal medicine appears to improve neuropathy caused by chemotherapy in cancer patients more than conventional therapy of CIPN. However, as there is heterogeneity between the included studies and a lack of blinding, further well-designed researches are more needed.

Efficacy of Portable Low Power Laser Therapy on Pain and Functions in Chronic Low Back Pain (만성 요통 환자에서의 휴대용 저출력 레이저 치료기의 통증 및 기능 효과)

  • Cho, Yeon Wook;Kim, Tae Hee;Lim, Oh Kyung;Lee, Ju Kang;Park, Ki Deok
    • Clinical Pain
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    • v.19 no.1
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    • pp.1-7
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    • 2020
  • Objective: A prospective, assessor-blinded, randomized controlled trial was conducted in patients with chronic low back pain to evaluate the efficacy of portable low power laser therapy (LPLT) and the effect when combined with exercise therapy on pain and functions. Method: 60 patients were recruited and 56 patients, excluding 4 dropouts, were randomly allocated to the LPLT group (Group 1: 19 patients), placebo laser therapy with exercise group (Group 2: 18 patients), and LPLT with exercise group (Group 3: 19 patients). Laser therapy and exercise was performed five times a week for 4 weeks. Visual analogue scale (VAS), Schober test, lumbar range of motion (ROM) measures (flexion, extension and lateral flexion), Oswestry Disability index (ODI) were measured at baseline, at 4 weeks after intervention, and at 6 weeks after 2 weeks of no intervention. Results: Statistically significant improvements were noted in all group by time interaction with respect to all outcome parameters (p<0.05). All parameters in each group improved not only in the period of treatment (4 weeks), but also in the final evaluation (6 weeks) 2 weeks after the end of treatment. Post-hoc analysis showed statistically significant difference between the LPLT with exercise group and the other groups in all outcome parameters except for the ODI at 4 weeks and at 6 weeks. Conclusion: Portable LPLT is effective treatment in reducing pain and improving lumbar ROM and with exercise is more effective than laser or exercise monotherapy for the chronic low back pain patients.

Three Case Reports on Patients with Facial Asymmetry Treated Using Korean Medicine Mainly Using Cervical Chuna Manipulation Treatment and Functional Cerebrospinal Technique (경추 추나 및 기능적 뇌척주요법(FCST) 등의 한의학적 치료로 개선된 안면비대칭 환자 3례 증례보고)

  • Jumi Lee;Eunwoo Kim;Yunhyung Jo;Jeongmin Shin;Hye In Jeong;Kyeong Han Kim
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.17 no.2
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    • pp.81-89
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    • 2022
  • Objectives This report aimed to investigate the possibility of correcting facial asymmetry using cervical Chuna manipulation treatment and functional cerebrospinal technique and introduce meaningful additional improvement of systemic symptoms of non-surgical Korean medicine treatments through three case studies. Methods Three patients with facial asymmetry were treated using Korean medicine treatments. The effects of the treatments were all measured using photographs, lateral cephalograms, and whole-body radiogram and Likert scale. Results After Korean medicine treatment, there were significant correction effects of asymmetry in photography, cephalography, and whole-body radiogram and meaningful score of Likert scale. Conclusions This study suggested that Korean medicine treatments may be effective in facial asymmetry. Improving muscular asymmetry, including soft tissue asymmetry and functional asymmetry, has meaningful effects on maintaining an overall balance of the body. Facial asymmetry should be treated by making an alignment of the whole body and there should be further well-designed, randomized, and placebo-controlled trials to verify these results.

The Effect of Ankle Balance Taping on Gait and Balance in Stroke Patients

  • Kyoung-Won Kim;Ki Bum Jung;Dong-Ho Kim;Yongwoo Lee
    • Physical Therapy Rehabilitation Science
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    • v.12 no.2
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    • pp.123-129
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    • 2023
  • Objective: Kinesio tape has been applied to the ankle to improve balance and gait. Stroke patients show abnormal gait patterns due to foot drop. This study aimed to determine the effects of ankle balance taping which to support the ankle joint on balance and gait in patients with chronic stroke. Design: A randomized controlled trial. Methods: Twenty-four chronic stroke patients were selected and randomized into experimental group (n=12) and control group (n=12). The experimental group applied kinesio taping three times a week for three weeks, and the control group applied placebo taping for the same amount of time. To evaluate the effectiveness of the treatment, the subjects' walking ability, static balance, and dynamic balance were assessed before and after the experiment. Gait speed and spatiotemporal gait ability were measured to examine walking ability, postural sway velocity and velocity moment for static balance, and Timed-Up and Go test and Berg Balance Scale were conducted to check dynamic balance. Results: The experimental group showed a significant increase in walking ability, static balance, and dynamic balance in the within-group pre-post difference (p<0.05). In the between-group comparison, the experimental group had a significant difference in walking ability than the control group (p<0.05). Conclusions: Ankle balance taping can help improve gait, and this study can be used as a basis for future studies of ankle balance taping.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Effect of Mulberry Leaf Extract Supplement on Blood Glucose, Glycated Hemoglobin and Serum Lipids in Type II Diabetic Patients (상엽추출물이 제2형 당뇨병 환자의 혈당, 당화혈색소 및 혈청지질에 미치는 영향)

  • Yang, Jung-Hwa;Han, Ji-Sook
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.35 no.5
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    • pp.549-556
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    • 2006
  • The purpose of this study was to assess the effects of mulberry leaf extract supplement on blood glucose, glycated hemoglobin ($HbA_{1C}$) and serum lipids in type II diabetic patients, and also to assess safety in liver function after mulberry leaf extract supplement. The study was a randomized placebo-controlled trial and total 23 type II diabetic patients were divided into a MLE group taking 1,000 mg mulberry leaf extract supplement per day as experimental group and a placebo group taking 1,000 mg cellulose Powder supplement per day for 12 weeks. After 2 weeks of wash-out period, fasting blood glucose, $HbA_{1C}$, serum lipid levels and liver function test were analyzed before and after treatment of 12 weeks. The general baseline characteristics, nutrient intake and life style factors of study subjects were similar between two groups during intervention. The concentrations of fasting blood glucose and $HbA_{1C}$ (p<0.05) decreased significantly after mulberry leaf extract supplement in MLE group, while there were no changes found in placebo group. We also found it showed that mulberry leaf extract supplement for 12 weeks decreased significantly (p<0.05) the fasting blood glucose in poor fasting blood glucose group and $HbA_{1C}$ concentration in poor $HbA_{1C}$ group. The concentrations of LDL-cholesterol (p<0.05) and triglyceride (p<0.01) decreased significantly in MLE group after 12 weeks of taking the supplement, while there were no changes found in placebo group. The mulberry leaf extract supplement for 12 weeks didn't show hepatotoxicity. These results suggested that mulberry leaf extract supplement could be effective in improving fasting blood glucose and $HbA_{1C}$ levels in the diabetic patients, specially having high concentrations of fasting blood glucose and $HbA_{1C}$ among type II diabetic patients.

Antihypertensive Effect and Safety Evaluation of Vegetable Drink with Peptides Derived from Sardine Protein Hydrolysates on Mild Hypertensive, High-normal and Normal Blood Pressure Subjects (정어리 단백질 유래 펩티드를 배합한 야채 과일 음료의 경증 고혈압자, 정상고치(高値)혈압자 및 정상혈압자에 대한 강압효과와 안전성의 평가)

  • Kawasaki, Terukazu;Chen, Jian-Jun;Fukushima, Yoichi;Kegai, Kaori;Seki, Eiji;Osajima, Katsuhiro;Itoh, Kazue;Matsui, Toshiro;Matsumoro, Kiyoshi
    • Proceedings of the Korean Society of Food Hygiene and Safety Conference
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    • 2004.11a
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    • pp.59-70
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    • 2004
  • A randomized double-blind placebo-controlled study was conducted on 63 subjects to determine the antihypertensive effect of a vegetable drink in which sardine protein hydrolysates containing a dipeptide, Valyl-Tyrosine (VY), were incorporated. The subjects, consisting of people with mild hypertension, high-normal blood pressure and normal blood pressure, were randomly divided into test (male/female=25.6, average age 50.1${\pm}$10.4 years old) and control groups (26/6, 49.0${\pm}$5.0). Each subjects in the test group was given 195g of the vegetable drink containing 0.5g of sardine peptides (sardine protein hydrolysates) with 0.4 mg of VY (test drink) once a day for 13 weeks in a row, and subjects in the control group were given the same amount of the vegetable drink without sardine peptides (control drink) in the same manner. In the test group, 40 subjects with mild hypertension of high-normal blood pressure (130 mmHg${\leq}$systolic blood pressure (SBP)<160 mmHg and/or 80 mmHg${\leq}$diastolic blood the start of the test to 134.4${\pm}$11.1 mmHg during the first week of the test period, after which similar values were seen throughout the test period (13 weeks). Compared to the control group, the difference in SBP from vaseline was statistically significant in the test group throughout the intake period. DBP also decreased significantly from 88.0${\pm}$7.9 mmHg at baseline to 83.5${\pm}$8.6 mmHg after 13 weeks. In the control group, SBP and DBP were 140.8${\pm}$8.4 mmHg and 90.5${\pm}$6.6 mmHg respectively at the start of the test, and neither decreased during the test period. In subjects with normal blood pressure, neither those in the test group nor those in the control group showed a significant change in SBP and DBP during the test period. An excessive ingestion test was performed on 25 subjects with hypertension, mild hypertension, high-normal blood pressure, and normal blood pressure by giving 585g (3 times the recommended amount of intake) of the test drink for 14 days in a row. As a result, a significant decrease of blood pressure was observed in the hypertension, mild hypertension and high-normal blood pressure groups, but no excessive decline in blood pressure or any side-effects were associated with any subjects during the test period. In the groups with normal blood pressure, the excessive ingestion of the test drink did not affect blood pressure. In these two studies, physical check-ups and biochemical analyses of blood and urine were also conducted in all subjects, and no abnormalities were observed. These results suggest that the test drink containing sardine protein hydrolysates exhibited the antihypertensive effect in only the subjects with mild hypertension or high-normal blood pressure. No adverse effects were observed in either hypertensive of normotensive subjects.

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Persisting Effects of Acupuncture Method for Chronic Tension-type Headache;A Randomized Controlled Trial (만성 긴장성 두통 환자의 침치료 지속효과에 대한 임상연구)

  • Kwak, Byung-Min;Kim, Min-Jeong;Kim, Yeon-Mi;Lee, Jae-Min;Park, Yang-Chun;Jo, Jeong-Hyo;Jeong, In-Choel;Kang, Wee-Chang;Lee, Sang-Bong;Choi, Sun-Mi;Hong, Kwon-Eui
    • Journal of Acupuncture Research
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    • v.25 no.2
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    • pp.165-177
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    • 2008
  • Objectives : Headache is one of the most common symptom in primary medical care. The purpose of this research is to examine persisting effects of acupuncture treatment for CTTH. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture method for the treatment of chronic tension-type headache. Volunteers who satisfied the requirements were enrolled in study. Evaluation of CTTH was measured by VAS, and Headache Disability Inventory(HDI), Six point Likert Scale, Algometer score(Rt, Lt) before and after treatments. Results : 32 subjects finished study. There were no difference between two group on age, sex, weight, height, blood pressure, pulse, respiratory rate, differentiation of symptoms, surmise of treatment. In change of VAS, after treatment decreased than before treatment in two group, but there were no statistical significance compared with two group and time. In change of HDI(Total score, Emotional score, Functional score) and Six point Likert scale, after treatment decreased than before treatment in two group, but there were no statistical significance compared with two group and time. In change of two sides Algometer score, after treatment increased than before treatment in two group, and Lt algometer score was statistical significance compared with two group(p<0.001). And both sides Algometer score, threr were statistical significance compared with time. Conclusions : Acupuncture treatment has persisting effects that improve the symptoms and decrease the temporal muscle tenderness in patient with chronic tension-type headache.

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A Systematic Review and Meta-analysis of Acupuncture Trials in Republic of Korea that Used Sham Acupuncture as a Control Group (거짓침을 대조군으로 사용한 국내 침 임상시험에 대한 체계적 고찰과 메타분석)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Tae-Hun;Lee, Seung-Hoon;Kim, Joo-Hee;Baek, Seung-Min;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.28 no.6
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    • pp.1-17
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    • 2011
  • Objectives : This study aimed to review randomized controlled trials of acupuncture performed in South Korea that used sham acupuncture as a control group. Methods : The following databases were searched through the end of September 2011: Koreanstudies information service system (KISS), Korean medical database (KMbase), national discovery OR science leaders (NDSL), oriental medicine advance searching integrated system (OASIS), and research information service system (RISS). The following search terms were used: acupuncture AND (sham or placebo). The reference lists of searched articles and Korea institute of oriental medicine (KIOM) reports(2005~2009) were identified. The following data were extracted: year/first author, disease, number of participants, blinding, intervention, outcome, and result. Where appropriate, we performed meta-analysis. The methodological quality was assessed according to the Jadad scale and 'risk of bias' by Cochrane Handbook procedure. Results : Twenty-nine studies were included in this review. In eighteen studies, penetrating sham controls were used as the control intervention, whereas the remaining eleven studies adopted non-penetrating sham controls such as the Park Sham Device or blunt auricular acupuncture. Nine studies showed statistically significant difference in outcomes. Twelve studies concerning insomnia after stroke, chronic tension-type headache, idiopathic Parkinson's disease, Hwa-Byung, and smoking cessation were included in meta-analysis. A meta-analysis of insomnia after stroke only found significant difference(MD -4.31, 95% Cl -6.19 to -2.42, $p$<0.00001). In general, all of the studies showed low methodological quality(Jadad score: mean 2.1). Risk of bias by Cochrane Handbook procedure varied. Conclusions : The results of this study could not suggest conclusive evidence that acupuncture is more effective than sham acupuncture in several diseases. In the future, more studies with rigorous acupuncture trials using sham controls should be conducted.

Effect of Acupuncture Treatment for Functional Dyspepsia;A Randomized Controlled Trial (기능성 소화불량증에 대한 침치료의 효과;무작위배정 대조군 연구)

  • Park, Yang-Chun;Jo, Jeong-Hyo;Son, Chang-Gyu;Hong, Kwon-Eui;Jeong, In-Cheol;Kang, Wee-Chang;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.24 no.1
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    • pp.1-12
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    • 2007
  • Objectives : Functional dyspepsia is a prevalent disease. It impedes subjective quality of life. The purpose of this research is to examine the effect of acupuncture treatment for functional dyspepsia. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture for the treatment of functional dyspepsia. Volunteers who satisfied the requirements were enrolled in study. Severity of dyspepsia was measured by Nepean Dyspepsia Index(NDI) and Functional Dyspepsia Quality fo Life(FD-QOL) before and after treatments. Results : 68 subjects finished study. There were not difference between two groups on age, sex, weight, height, severity of dyspepsia, subtype, Byeonjeung, surmise of treatment. After treatment total key symptoms score, improve rate of key symptoms were decreased than before treatment in active acupuncture group, but there were no statistical significance compared with sham acupuncture group. After treatment "pressure in upper abdomen" and " cramps in upper abdomen" were more decreased in active acupuncture group compared with sham acupuncture group(p=0.001, p=0.014). After treatment total symptom score and QOL of NDI were decreased than before treatment in active acupuncture group, but there were no statistical significance compared with sham acupuncture group. After treatment eating status of FD-QOL in active acupuncture group was significantly increased than sham acupuncture group(p=0.008). After treatment liveliness status of FD-QOL and total score of FDQOL in active acupuncture group was increased than sham acupuncture group though statistically insignificant(p=0.095, p=0.077). Conclusion : Acupuncture treatment is effective to improve the symptoms and quality of life in patients with functional dyspepsia.

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