• 제목/요약/키워드: Placebo-controlled study

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The Effects of Acupuncture Treatment on the Autonomic Nervous Systems of Hwa-byung Patients' Insomnia (화병환자의 불면증 침치료가 인체의 자율신경계에 미치는 영향)

  • Bae, Dal-Bit;Lyu, So-Jung;Lee, Go-Eun;Lee, Seung-Jae;Kang, Hyung-Won;Lyu, Yeoung-Su
    • Journal of Oriental Neuropsychiatry
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    • v.25 no.3
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    • pp.235-242
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    • 2014
  • Objectives: The purpose of this research is to examine effects of acupuncture treatment on the autonomic nervous systems of Hwa-byung patients with insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors, and analysts were unaware of which individuals were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. Eighteen subjects were placed into a trial group and 19 subjects into a control group using a randomization table. The trial group was treated with bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI (Insomnia Severity Scale) was measured as the first evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by ANS (BVP/HR, respiration rate, peripheral temperature, skin conductance, EMG). Results: In the BVP/HR, statistically significant decreases were found in those from the trial group compared to those of the control group. Skin conductance was found to be significantly increased in the trial group, as compared to the control group. However, there were no significant differences between the groups with respect to peripheral temperature, respiration rate, and EMG. Conclusions: The results suggest that acupuncture treatment is effective in the treatment of hwa-byung patients who suffer from insomnia due to their autonomic nervous systems.

EVALUATION OF EFFICACY AND SAFETY OF MINOCLINE STRIP ON CHRONIC MARGINAL PERIODONTITIS (미노클린 첨부제의 만성 변연성 치주염의 치료효과에 대한 유효성과 안전성의 평가)

  • Shin, Hyung-Shik;Han, Kyung-Yoon;Chung, Jong-Pyung
    • Journal of Periodontal and Implant Science
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    • v.24 no.3
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    • pp.493-502
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    • 1994
  • The benefits in using controlled delivery approaches include improved pharmacokinetic response, greater ability to localize the drung adjacent to the disease, and more control of local concentration at a lower total dosage. The purpose of this study was to evaluate the efficacy and safety of Minocline strip on chronic marginal periodontitis. Minocline Strip was applied in the periodontal pocket of 94 patients with a clinically diagnosed as a chronic marginal periodontitis, 4 sites for each patients with a 5mm probing pocket depth were selected in split mouth design and were divided into two group, ie., placebo group ($C_1$, $C_2$) and experimental group ($E_1$, $E_2$). Supragingival scaling and oral hygiene instruction were performed 1 week before experiment. Minocline Strip was applied on day 0 and 7, weekly, Clinical and microbiological tests were performed on day 0, 7, 14, 28 and 42. The results were as follows ; 1. Minocline Strip showed significant improvement on Chronic Marginal Periodontitis in 77 patients (82.0%) and improvement rate was more than 66.7% of all investigational items. 2. Only 6 patients complained mild pruritis during the early therapy but not needed discontinuence of the therapy. 3. The availability of Minocline Strip was 72 patients (76.6%) synthetically evaluating efficacy and safety. In conclusion, Minocline Strip appears to be effective and safe for the treatment of Chronic Marginal Periodontitis.

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External Application of Herbal Medicines for Acne Vulgaris: A Systematic Review and Meta Analysis

  • Sung, Soo-Hyun;Choi, Gwang-Ho;Lee, Nam-Woo;Shin, Byung-Cheul
    • Journal of Pharmacopuncture
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    • v.23 no.1
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    • pp.8-17
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    • 2020
  • Aim of the study: The objective of this systematic review is to critically evaluate the evidence of the effectiveness and safety of external application of herbal medicines (EAHM) for acne vurgalis (AV). Methods: English, Chinese and Korean language databases were searched up to May 2018. Randomized clinical trials (RCTs) that reported the effects of EAHM for AV were included and analysed. Results: A total of 10 randomized trials with 656 AV patients were identified. A meta-analysis of two RCTs indicated that EAHM had a significant effect on improving primary outcome 'global assessment' compared with placebo (mean difference (MD) = -2.62, confidence interval (CI) = -4.84 to -0.40, p = 0.02). Furthermore, data extracted from two RCTs showed that EAHM significantly reduce primary outcome 'inflammatory lesion count of acne' (MD = -1.25, CI = -1.68 to -0.83, p < 0.00001) and 'non-inflammatory lesion count of acne' (MD = -1.32, CI = -1.75 to -0.90, p < 0.00001). No significant difference was observed between groups in secondary outcome 'sebum of skin' (MD = -0.21, CI = -0.53 to 0.11, p = 0.20) and 'patient-reported changes in symptom' (relative risk (RR) = 2.56, CI = 0.43 to 15.22, p = 0.30). No severe adverse events (AEs) were found and no treatment was stopped due to AEs of EAHM. Conclusions: EAHM seems to have affirmative effects, but quality of evidence, and non-standardized use of EAHM make our conclusion weak. Our suggestion is rigorously designed RCTs and standardization of EAHM are required in the future.

Evaluation the Effects of Short Term Intake Avena sativa Extracts on Blood Glucose and Cholesterol Level (단기간 귀리 추출물 섭취의 혈당 및 콜레스테롤 저하 효과 평가)

  • Kim, Hana;Lee, Insoo;Shin, Kyungsook;Yoon, Soonkyu;Lee, Buhyung;Yoon, Seungkyu;Choi, Jinwoo;Suh, In Bum
    • The Journal of the Korea Contents Association
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    • v.15 no.3
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    • pp.272-279
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    • 2015
  • Recently, studies about various natural extracts to help control blood glucose has been in progress. Avena sativa is well known to have various physilogical effects. Especially, ${\beta}$-glucan has effect about lowering blood glucose level and prevent cardiovascular dz and adult dz related to obesity. In this study we evaluated the effect of Down and control (BM pharmaceutical) which is consist of commercialized Avena sativa fextracts on blood glucose and cholesterol, 6weeks, randomized, double-blind, placebo-controlled trials. The results show not significantly different in all blood index test group from control group, but in glycated albumin decreased 50.33% for test group, decreased 37.91% for control group, in triglyceride decreased 7.51% for test group, increased 3.98 for control group and we can observed Avena sativa has blood glucose and triglyceride lowering effect in some.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer] (위암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Gajin;Seong, Sin;Kim, Sungsu;Kim, Jinsung;Park, Jae-Woo
    • The Journal of Korean Medicine
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    • v.38 no.3
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    • pp.124-142
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    • 2017
  • Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

Systemic review : The study on alternative medicine for allergic rhinitis in Entrez Pubmed (알레르기 비염의 대체의학적 치료에 관한 최근 논문경향 분석 - Entrez Pubmed 위주)

  • Kim, Ja-Hye;Shin, Sang-Ho;Kim, Mi-Bo;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.20 no.1 s.32
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    • pp.239-249
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    • 2007
  • Background : Allergic rhinitis is the most frequently occuring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Objective & Methods : We referred to the information through Entrex Pubmed from 2004 to 2007 January about alternative medicine for allergic rhinitis, 9 treatises. Results : About 9 treatises, 2 treatises were for the acupuncture treatment, I treatise was for the acupuncture and chinese herbal medicine, 2 treatises were for the single substance(butterbur, soy sauce ingredients), 1 treatise was for the homeopathic preparation, 1 treatise was for the ayur-veda herbal treatment, 1 treatise was for the ultraviolet light phototherapy, 1 treatise was for the systematic review of alternative medicine. Except 2 treatises for the acupuncture treatment, 6 treatises used the double-blind, randomized, placebo-controlled methods. As a result, we found 5 treatises that treat group had more improvement than control group, 3 treatises that treat group had no difference control group on effect significantly. 1 review article exhibited the most of alternative medical literatures were inadequate methodologically and therapeutic efficacy alternative treatment for allergic rhinitis was not supported by currently available evidence. Conclusion : We found that treatises about the alternative medicine for allergic rhinitis were more and more published. We were supposed that many internal treatises were published adequately by methodology to prove Korean medical treatment effects for allergic rhinitis.

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[ $\b{S}afety\;\b{A}nd\;\b{E}fficacy$ ] of $\b{K}orean$ red ginseng Intervention (SAEKI) Trial: Rationale, Design, and Expected Findings

  • Sievenpiper John L;Buono Marco Di;Stavro P. Mark;Jenkins Alexandra L;Nam Ki Yeul;Choi Melody;Naeem Asima;Leiter Lawrence A;Sung Mi-Kyung;Vuksan Vladimir
    • Proceedings of the Ginseng society Conference
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    • 2002.10a
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    • pp.424-455
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    • 2002
  • Diabetes mellitus is reaching epidemic proportions worldwide. The insufficiency of medication to cope with this burden has coincided with a dramatic rise in the prevalence of use of complementary and alternative therapies, especially herbal treatments. This surge in demand presents a challenge to prove the safety and efficacy of these treatments in diabetes. Korean red ginseng (steam treated Panax ginseng C.A. Meyer) is a strong candidate to succeed. It has been shown to possess a multitude of hypoglycemic effects and improve metabolic disturbances related to diabetes in in vitro and animal models. Data in humans is also emerging to support these benefits. Whether these results can be replicated in a rigorous clinical testing program is unclear. We therefore investigated the antidiabetic effects of Korean red ginseng in a series of 2 acute and 1 longterm randomized, double-blinded, placebo-controlled clinical trials. This paper provides the rationale for this program of study, expanding on the problem of diabetes, its management, and the possible role for Korean red ginseng. It then describes the design and expected findings.

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Evaluation of efficacy of Valsalva maneuver for attenuating propofol injection pain: a prospective, randomized, single blind, placebo controlled study

  • Kumar, Sanjay;Khuba, Sandeep;Agarwal, Anil;Gautam, Sujeet;Yadav, Madhulika;Dixit, Aanchal
    • Korean Journal of Anesthesiology
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    • v.71 no.6
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    • pp.453-458
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    • 2018
  • Background: Pain on injection is a limitation with propofol use. The effect of the Valsalva maneuver on pain during propofol injection has not been studied. This maneuver reduces pain through the sinoaortic baroreceptor reflex arc and by distraction. We aimed to assess the efficacy of the Valsalva maneuver in reducing pain during propofol injection. Methods: Eighty American Society of Anesthesiologists class I adult patients undergoing general anesthesia were enrolled and divided into two groups of 40 each. Group I (Valsalva) patients blew into a sphygmomanometer tube raising the mercury column up to 30 mmHg for 20 seconds, while Group II (Control) patients did not. Anesthesia was induced with 1% propofol immediately afterwards. Pain was assessed on a 10-point visual analog scale (VAS), where 0 represented no pain, and 10, the worst imaginable pain, and a 4-point withdrawal response score, where 0 represented no pain, and 3, the worst imaginable pain. Scores were presented as median (interquartile range). Results: We analyzed the data of 70 patients. The incidence of pain was significantly lower in the Valsalva than in the control group (53% vs. 78%, P = 0.029). The withdrawal response score was significantly lower in the Valsalva group (1.00 [0.00-1.00] vs. 2.00 [2.00-3.00], P < 0.001). The VAS score was significantly lower in the Valsalva group (1.00 [0.00-4.00] vs. 7.00 [6.25-8.00], P < 0.001). Conclusions: A prior Valsalva maneuver is effective in attenuating injection pain due to propofol; it is advantageous in being a non-pharmacological, safe, easy, and time-effective technique.

Evaluation of the Effectiveness and Safety of Zanthoxylum piperitum Leaf Extract against Mild Degenerative Osteoarthritis of Knee: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (경증의 퇴행성 슬관절염에 대한 초피나무잎 추출물의 유효성 및 안전성 평가: 무작위 배정, 이중맹검, 위약대조 임상연구)

  • Jeong, Ji-Hong;Lee, Soo-Hwan;Yoon, Hong-Ryoul;Kim, Soon-Joong
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.167-191
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    • 2021
  • Objectives Degenerative osteoarthritis of knee is a disease with an increasing number of patients worldwide and its general treatments have some side effects. Methods 102 subjects were classified into test group 1, test group 2, and control group, and clinical trial products were taken for 12 weeks. The effectiveness was evaluated with changes in visual analogue scale, Korean-Western Ontario and McMaster Universities Osteoarthritis Index, inducible nitric oxide synthase, and cyclooxygenase-2. Results Both test group 1 and test group 2 were effective in reducing the pain of degenerative osteoarthritis of knee, and only test group 2 was effective in improving the ability to perform daily activities. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this study indicate that Zanthoxylum piperitum leaf extract has effectiveness and safety against mild degenerative osteoarthritis of knee.

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.