Noh, Yoo-Hun;Lee, Ji Won;Park, Jiae;Lee, Sang Hyung;Lee, Jun Young;Kim, Sung-Su;Park, Kwang-Kyun;Kim, Tae Jin;Myung, Soon-Chul;Jeong, Yoonhwa
Journal of the Korean Society of Food Science and Nutrition
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v.45
no.6
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pp.903-910
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2016
In this study, the expression level of estrogen receptor in an ovariectomized rat model was effectively enhanced by MS-10, Cirsium japonicum and Thymus vulgaris extract complex, in a reversible manner. MS-10 plays a positive role in enhancing estrogen activity at low concentrations, leading to improved women's health. In order to determine whether or not MS-10 improves menopausal symptoms clinically, a randomized, double-blinded, and placebo-controlled clinical study was carried out on 62 middle-aged women treated with 500 mg of MS-10 or placebo daily for 12 weeks. Clinical menopausal symptoms were evaluated by Kupperman's index (KI) detecting various menopausal symptoms, including hot flushes, parenthesis, insomnia, nervousness, melancholia, dizziness, fatigue, rheumatic pain, palpitations, formication, and headaches. Total KI score decreased significantly by about 18% upon ingestion of MS-10. Colpoxerosis, a main symptom of menopause, was significantly reduced by about 21% upon ingestion of MS-10 in contrast to placebo. In addition, reduction of insulin-like growth factor-1 with age was improved by over 10% upon ingestion of MS-10, whereas there were no significant difference with placebo. No side effects appeared after treatment with MS-10. Thus, MS-10 can be suggested as a plausible natural substance for improving women's health.
Objectives: This study aimed to evaluate the change in weight and heart rate associated with the use of phentermine through meta-analysis based on the published literatures. Methods: Eight electronic databases, PubMed, EMBASE, Cochrane library, and five domestic databases were used to search the literature. Randomized controlled trials that evaluated the change in weight and heart rate with the use of phentermine compared with placebo were included in this study. The fixed-effect model weighted by the Mantel-Haenszel method was used in the meta-analysis, and the random-effects model was used when heterogeneity was present. Results: We included 12 studies comprising 677 patients. The change in weight observed with the use of phentermine (SMD = -1.37, 95% CI: -1.55, -1.19) was statistically significant compared with that observed with placebo. As per the subgroup analysis results, the change in weight by publication year, country, phentermine dosage, follow-up check was not heterogeneous. The change in heart rate observed with the use of phentermine (SMD = 0.64, 95% CI: 0.35, 0.92) was significant compared with that observed with placebo. Conclusions: Weight loss and increased heart rate were confirmed in phentermine compared with placebo.
Ulcerative colitis (UC) is characterized by a life-long chronic course with remissions and exacerbations. Use of biological therapies may reduce or delay the surgical procedures in patients with UC. The aim of this study was to determine the impact of infliximab (IFX) use on the rate of remission, surgical interventions, and the effect on quality of life in patients with moderate to severe UC. Literature was searched for studies that investigated the efficacy of IFX on the rate of remission, colectomy and quality of life (QoL) between January 1990 and June 2012 at MEDLINE, January 1988 and June 2012 at EMbase and others. Eleven trials were included in the meta-analysis; divided into placebo controlled 8 trials and intravenous corticosteroid controlled group 3 trials. In comparison to placebo control groups, patients who received IFX had an odds ratio (OR) of 3.712 (95% CI: 2.714, 5.079) for the short-term clinical remission, and 3.053 (95% CI: 2.044, 4.559) for the rate of long-term remission. In colectomy rate and quality of life (QoL), odds ratio were 0.566(95% CI: 0.387, 0.827) and 0.658 (0.505, 0.811) respectively. Any adverse reactions including infections, infusion reaction, rash and arthralgia were equivalent in both groups. Compared with intravenous corticosteroid controlled group, patients who received IFX had lower remission rate with short-term odds ratio 0.227 (95% CI: 0.033, 1.556) and long-term odds ratio 1.054 (95% CI: 0.317, 3.502) respectively. However, statistical significance was not showed with both two analyses. The higher adverse drug reaction (ADR) rates were occurred in the corticosteroid controlled groups. 73.3% of patients treated corticosteroid reported Cushing-like syndrome with moon face. In conclusion, IFX does increase remission rate and decrease the rate of colectomy in patients with UC without elevating any adverse reactions significantly. IFX also improves QoL in moderate to severe UC patients. It would not exceed the efficacy of intravenous corticosteroid, whereas intravenous corticosteroid also reported high rate of adverse reactions.
Objectives : This study was performed to investigate the efficacy and safety of the Mulberry Extract Complex in a placebo-controlled randomized clinical trial and animal study on degenerative arthritis. Methods : Animal study: Mulberry Extract Complex is composed of extracts of mulberry (Morus alba L.) fruit, mulberry leaves and black beans (Glycine max (L.) Merr.). To evaluate the serum level of interleukin-2, interferon-$\gamma$, and prostaglandin E2, an animal model of degenerative arthritis induced by monosodium iodoacetate was employed. Clinical study: The efficacy index (VAS, K-WOMAC) was compared among patients with symptoms of degenerative arthritis before and after Mulberry Extract Complex ingestion as well as the one in groups. Evaluations of the improvement by the subjects and by doctor assessment were also performed. Results : Animal study: Mulberry Extract Complex reduced the serum level of interferon-$\gamma$ and prostaglandin E2 in an animal model with degenerative arthritis. Clinical study: The VAS change showed statistical significance in the experimental groups after 4 weeks (PP set) and 8 weeks (ITT set) of ingestion. When the K-WOMAC was analyzed using a modified ITT set to determine the effectiveness, statistically significant results were obtained in the fields of pain & symptom within the Mulberry Extract Complex group as well as between the Mulberry Extract Complex and placebo groups after 8 weeks of ingestion. Results from the improvement evaluation by subjects and the assessment of improvement by doctors showed statistical significance in the experimental groups (PP set) after 8 weeks. Conclusions : Mulberry Extract Complex could be useful for the improvement of various symptoms of degenerative arthritis based on its anti-inflammatory activity and its reduction of VAS and K-WOMAC pain scores.
Arcabose is a competitive inhibitor of the intestinal ${\alpha}$-glucosidases and reduces the postprandial digestion and absorption of carbohydrate and disaccharides. Due to its negligible oral absorption, measuring drug concentration in the plasma is impractical. Thus, the common pharmacokinetic study is not available to determine the bioequivalence of the generic acarbose preparations. The aim of this study is the establishment of pharmacodynamic assessment method for the bioequivalence test of the generic acarbose preparations. Placebo-controlled cross-over ($3{\times}3$) clinical study was conducted in 23 healthy volunteers. Volunteers received a single oral dose of placebo, reference drug ($Glucoby^{(R)}$ 100 mg, Lot # D043) or test drug ($Glucoby^{(R)}$ 100 mg, Lot # E005) just before breakfast, then blood samples for evaluation of serum glucose and insulin levels were taken during for 4 hours. $C_{max},\;AUC_{0-2},\;AUC_{0-4},\;{\Delta}C_{max},\;{\Delta}AUC_{0-2}\;and\;{\Delta}AUC_{0-4}$ of the postprandial plasma glucose level significantly decreased when a single dose of acarbose 100 mg preparations was administered. However, any significant difference was not detected between the groups taken the reference drug and the test drug. These results proposed that the pharmacodynamic protocols of this study is suitable to use for bioequivalence test of acarbose preparations. On the basis of the results of this study and the data of literature on this subject, the standard protocols of bioequivalence study of acarbose preparation are proposed.
Park, Jae-Woo;Yoon, Seong-Woo;Kim, Jin-Sung;Ryu, Bong-Ha
Journal of Acupuncture Research
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v.25
no.5
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pp.127-137
/
2008
Objectives : These days, herbal acupuncture therapy is widely applied to many diseases and symptoms by Korean medical doctors in Korea. The aim of this study was to demonstrate the effect of Carthami-Semen herbal acupuncture(CSHA) on chronic constipation. Methods : This single-blind placebo-controlled randomized parellel study enrolled 24 adults with chronic constipation. After one week's run-in period, they were randomly assigned to receive CSHA therapy, or placebo therapy for 4 weeks by 2 times per week. After completing 4 week's therapy, 2 week's follow-up period was continued. During study, defecation frequency, consistency and ease of evacuation were checked before study, every week and follow-up periods. Also, the VAS of constipation, quality of life(QoL) and heart rate variability(HRV : low frequency, high frequency) were checked 3 times totally. Finally, 21 subjects completed the protocol and 20 subjects were analyzed.(1 subject is excluded for analysis because of not following the protocol.) Results : In CSHA group, defecation frequency(continued after 1 week), consistency and ease of evacuation(at 1 week after and follow-up) were increased significantly. The VAS of constipation in CSHA group was significantly decreased. There was no significant change at QoL and HRV. Conclusions : CSHA therapy was effective in treating adults with chronic constipation. Study that have larger case number and longer follow up will be needed in the future.
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.
Objectives The purpose of this study is to review the effectivenss of Neurofeedback Therapy in children with Attention Deficit/Hyperactivity Disorders Methods 16 randomized controlled trials (RCT) of Neurofeedback Treatment in ADHD from 2009 to 2019 in PubMed were reviewed and analyzed their methods of assessment, treatment, results and adverse effect. Results In 16 RCT, the most frequently used diagnostic tool in ADHD was DSM-IV. Most of the studies reported Neurofeedback Treatment isn't superior than placebo or medication group but still effective in ADHD. In 6 out of the 16 studies, there were no adverse effect reported. Conclusion Most of the studies have shown neurofeedback treatment was effective in ADHD symptoms. More clinical studies are needed to prove the effectiveness of neurofeedback in ADHD.
Many studies show that the bone loss in postmenopausal women is closely related with status of vitamin K. The purpose of this study is to observe the effects of the vitamin K supplements on the carboxylation of serum osteocalcin in postmenopausal women. Twenty-four healthy postmenopausal women were recruited for the double-blind controlled study. Before and after daily administration of 1.0mg of phylloquinone for one month, the levels of serum vitamin K, osteocalcin, undercarboxylated osteocalcin were measured. Daily intake of vitamin K was also calculated. After the 4-weeks of supplements of 1.0mg/day of vitamin K, there were no significant differences for the levels of serum vitamin K, osteocalcin, and ucOC between the experimental and placebo groups. In this study, it was not found that the supplements of vitamin K to the postmenopausal women had any positive effects on.
Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.
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