• Title/Summary/Keyword: Placebo-controlled study

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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.

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.

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.

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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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
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    • v.40 no.12
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    • pp.1726-1733
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    • 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.

The Effect of Sa-am Acupuncture Treatment for Major Symptom of Hwa-byung : A Preliminary Study (화병의 핵심증상에 대한 사암침 치료의 효과 : 예비연구)

  • Lee, Sang-Ryong;Park, Yang-Chun;Hong, Kwon-Eui;Koo, Young-Sun;Jo, Jeong-Hyo;An, Joung-Jo;Kang, Wee-Chang;Kim, Jong-Woo;Choi, Sun-Mi;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.18 no.1
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    • pp.79-94
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    • 2007
  • Objective : The Purpose of this research is to examine the effect of Sa-am acupuncture treatment(Sim-seungkyuk) for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture in the treatment for major symptoms of Hwa-byung. likert scale(5 score) for major symptom of Hwa-byung was measured as the 1st evaluative instrument, and STAXI-K, STAI-K, BDI-K and HRV were also measured as the 2nd evaluative instrument at the before treatment and after treatment. Results : 26 volunteers participated in this study by dividing two groups, each 13 persons in trial group and control group at random. In comparison of likert scale for major symptoms, after treatment the total score of likert scale for major symptoms decreased significantly in both group than before treatment. And after treatment, the total score of trial group decreased less than those of control group in comparison between two groups. especially after 2 weeks from all treatment, there was significant difference between two groups. Conclusion : We considered that Shim-seungkyuk of Sa-am acupuncture treatment will be not recommended to treatment of Hwa-byung because this study could not prove effect of Shim-seungkyuk treatment for Hwa-hyung in spite of preliminary study. This study will be used to provide a fundamental data for development of clinical research as preliminary study of Hwa-byung.

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Evaluation of Therapeutic Effect of the Extract from Rhubarb (Rheum officinalis) in Dogs with Chronic Renal Failure (개의 만성 신부전에서 대황 추출물의 치료학적 효과의 평가)

  • Kim, Ye-Won;Hyun, Changbaig
    • Journal of Veterinary Clinics
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    • v.29 no.6
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    • pp.435-440
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    • 2012
  • This study was designed to evaluate the clinical efficacy and safety of Rhubarb extracts ($Rubenal^{(R)}$) in dogs with chronic renal failure (CRF). Client-owned 40 dogs with CRF graded International renal interest Society (IRIS) II-III were enrolled in this study. The dogs were equally allocated and blindly administered with $Rubenal^{(R)}$ or placebo. The following items were evaluated at day 0, 30, 90 and 180: body condition score (BCS), clinical score (appetite, polydipsia/polyuria, quality of life score), hemogram (WBC, RBC, PCV), serum biochemistry (ALT/AST, ALP, Creatinine/BUN, total protein, albumin), serum electrolyte (Na, K, Cl, Ca, P), systolic blood pressure, urinalysis (UPC, USG) and IRIS stage. In this study, we found that the $Rubenal^{(R)}$ preparation was well tolerated by dogs and induced no adverse effects. Statistically significant improvements were observed in clinical score (quality of life score by vet and clients), serum BUN and creatinine levels, serum phosphorus concentration, level of proteinuria, and the IRIS score of CRF in dogs after 6 month of treatment of $Rubenal^{(R)}$. Those findings suggested that the Rhubarb extracts can improve the clinical signs of CRF (i.e. azotemia, hypertension, proteinuria, hyperphosphoremia) and the quality of life (i.e. BCS, clinical score) and can retard the progression of CRF in dogs. Therefore the Rhubarb extracts can be a good supplementary drug for treating dogs with subclinical and clinical renal diseases. However, care should be taken for interpreting our result, because this study is not double-blinded controlled study but pilot study.