Many antibiotic monographs cite the induction of vaginal infections as a possible side effect. Invariably, this is believed to be due to Candide albicans, and empirical therapy is given. However, recent studies raise the question of the extent to which yeast do infect the host after antibiotic use. A double-blind, randomized, placebo-controlled study was undertaken on female patients to determine how many yeast infections occurred following 10 days antibiotic use. In addition, the study was designed to examine whether oval use of probiotic lactobacilli can reduce the risk of vaginal infection. Twenty four patients diagnosed with respiratory, oval or throat infections received one of several types of antibiotic for 10 days, and two capsules containing 10$^{9}$ dried Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 from the day of commencement of antibiotic therapy for 21 days. The most commonly prescribed antibiotic was biaxin (clarithromycin). All but one patient had lactobacilli in the vagina upon entry to the study, and none developed yeast vaginitis or diarrhea during treatment or 20 days after completion of antibiotics. The mean Nugent score was higher in the placebo than the lactobacilli group (4.1 versus 2.4), and three cases of bacterial vaginosis arose (25 % incidence compared to 0% in the lactobacilli group) in the placebo group (2 receiving cefuroxime, 1 on biaxin). The study suggested that current antibiotic use is not necessarily associated with either diarrhea or yeast infection, as is often surmised. Nevertheless, daily use of probiotics was safe and could potentially reduce the risk of patients developing bacterial vaginosis after antibiotic use.
This study evaluated the weight reduction effect of Angook cereal mixture. The cereal mixture was prepared with barley, unpolished rice, corn, soybean, Garcinia cambogia, guar-gum, maltodextrin, glucomannan and a vitamin mixture. Eighteen female college students participated in this 8 weeks weight control program. All subjects were randomly assigned to the treatment and placebo groups. Mean energy intake of the treatment group was $1,356.4{\pm}79.9\;kcal$ (carbohydrate: 67.1%, protein: 18.7%, fat: 14.2%) and placebo group consumed $1,367.6{\pm}71.8\;kcal$ (carbohydrate: 64.2%, protein: 19.7%, fat: 16.1%) during program. The placebo group lost $3.9{\pm}0.8\;kg$ of body weight and the treatment group lost $5.9{\pm}0.7\;kg$ of body weight. There were significant differences in the decrease of total body weight, absolute fat mass, waist circumference (WC) and hip circumference (HC) between the two groups (p<0.05), however, the lean body mass was not significantly decreased in the treatment group compared to the placebo group. There were no differences in the changes in blood glucose, total-cholesterol, HDL-choloesterol, LDL-cholesterol and triglycerides between groups. These findings suggest that the intake of Angook cereal mixture may be beneficial for the reduction of the body weight, absolute fat mass, WC and HC.
Park, Jo-Eun;Song, Chan-Woo;Kim, Ki-Suk;Kim, Mee-Eun
Journal of Oral Medicine and Pain
/
제40권1호
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pp.10-16
/
2015
Purpose: Pilocarpine has the effects on improvement of salivary flow and subjective symptoms for xerostomic patients. Because of unwanted side effects following its systemic administration, topical pilocarpine has been paid attention as an alternative. This study aimed to investigate effects of pilocarpine solution as mouthwash on salivary flow and adverse effects compared to systemic administration of 5 mg pilocarpine tablet in healthy subjects. Methods: The study was a double blind, placebo-controlled, crossover clinical trial. Five milligrams pilocarpine tablets, 4 mL of 2% pilocarpine solution and placebo solution were given to 12 healthy volunteers (6 males and 6 females) in a predetermined order with wash-out period of at least two days and unstimulated whole saliva was collected before and after administration of each drug. Blood pressure and pulse rate was also measured and subjective effect and potential side effects were evaluated by a self-administrated questionnaire. Results: Systemic (5 mg tablet) and topical (2% solution) use of pilocarpine significantly increased salivary flow rate in healthy subjects compared to placebo (p<0.001). In both the pilocarpine solution and tablet groups, salivary flow rates at 120 minutes after administration remained increased. Subjective effect on salivation was the largest in the pilocarpine tablet group, followed by the pilocarpine solution group (p<0.05). There was no significant difference in blood pressure and pulse rate after administration of all three drugs. Fewer side effects reported in the pilocarpine solution group than in the tablet group. Conclusions: Two percents pilocarpine solution as mouthwash increases salivary flow rate, definitely superior to placebo solution and comparable to pilocarpine tablet, with fewer side effects in healthy subjects. It indicates a possibility of pilocarpine solution as a useful alternative of pilocarpine tablets for the xerostomic patients with systemic diseases.
Background; To explore the efficacy of aspartate as NAD regenerating agent for ethanol and acetaldehyde oxidation, we performed crossover challenge in two groups of volunteers by coadministration of various doses of aspartate, asparagine and ethanol. Methods; 18 healthy male volunteers were randomly divided into two groups. 6 volunteers of the first group were administered 5 gm monosodium aspartate(MSA), 5 gm asparagine or placebo with 100 ml of $40^{\circ}$ whiskey by the 3 way-crossover design, while 12 volunteers of the other group were administered placebo, 1, 2 or 5 bottles of $Aspar^(circledR)$ containing 1 gm of MSA per bottle with 100 ml of $40^{\circ}$ whiskey by the 4 way-crossover design. Ethanol(and acetaldehyde) concentrations in venous blood drawn at 0, 0.25, 0.5, 1, 2, 4, 8th hour after ethanol ingestion were analysed by gas chromatogaphy. Subjective symptoms, liver function tests and psychomotor function tests were also performed during the study periods. Result; Plasma concentration and AUC of acetaldehyde in asparagine and MSA trials on ethanol ingestion were significantly lower than those of placebo trial in the 1st group. Plasma ethanol concentration of 5 bottle $Aspar^(circledR)$ trial was significantly lower than that of placebo trial in the 2nd group. Improvement of subjective symptoms or psychomotor performance by the treatment was not statistically significant. Conclusion; Aspartate and asparagine may be prospective candidates for acceleration of ethanol metabolism and prevention of ethanol toxicity.
Bae, Hyoung Won;Kim, Ji Hyun;Kim, Sangah;Kim, Minkyo;Lee, Naeun;Hong, Samin;Seong, Gong Je;Kim, Chan Yun
Journal of Ginseng Research
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제39권1호
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pp.7-13
/
2015
Background: Many patients with glaucoma have difficulty using antiglaucoma eye drops because of dry eye symptom. In this prospective, randomized, double-blind, placebo-controlled study, we evaluated the effect of Korean Red Ginseng on dry eye syndrome in patients with glaucoma treated with antiglaucoma eye drops. Methods: Forty-nine participants were allocated to the Korean Red Ginseng (3 g/day; n = 24) or placebo (n = 25) groups for 8 weeks. Tear film stability, fluorescein corneal staining, conjunctival hyperemia, tear production, grade of meibomian gland dysfunction, and dry eye questionnaire (Ocular Surface Disease Index) were evaluated at baseline and on completion of the treatment. Results: Almost all patients displayed dry eye symptoms and signs at baseline. After the 8-week intervention, Korean Red Ginseng supplementation significantly improved the tear film stability and total Ocular Surface Disease Index score, as compared to placebo (p < 0.01). Conclusion: Korean Red Ginseng supplementation may provide an additional treatment option for dry eye and patients with glaucoma using antiglaucoma eye drops.
BACKGROUND/OBJECTIVES: The present study investigated the hypothesis that a highly pure linear ${\beta}$-1,3-glucan produced by Agrobacterium sp. R259 enhances human natural killer (NK) cell activity and suppresses pro-inflammatory cytokines. SUBJECTS/METHODS: In an eight-week, double-blind, randomized, placebo-controlled clinical trial, 83 healthy adults with white blood cell counts of $4,000-8,000cells/{\mu}L$ were participated and randomly assigned to take two capsules per day containing either 350 mg ${\beta}$-1,3-glucan or placebo. Six participants withdrew their study consent or were excluded due to NK cell activity levels outside the normal range. NK cell activity and serum levels of immunoglobulin G (IgG) and cytokines, such as interferon (IFN)-${\gamma}$, interleukin (IL)-2, IL-4, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-${\alpha}$ were measured. RESULTS: NK cell activity and the serum levels of IL-10 were significantly higher from baseline to week 8 in the ${\beta}$-glucan group compared with the placebo group (P = 0.048, P = 0.029). Consumption of ${\beta}$-1,3-glucan also significantly increased NK cell activity compared with placebo after adjusting for smoking and stress status (P = 0.009). In particular, the effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants with severe stress than in those experiencing mild stress. However, the administration ${\beta}$-1,3-glucan did not significantly modulate the levels of IFN-${\gamma}$, IL-2, IL-4, IL-6, IL-12, TNF-${\alpha}$ and IgG compared with the placebo. CONCLUSION: The results showed that supplementation with bacterial ${\beta}$-1,3-glucan significantly increased NK cell activity without causing any adverse effects. Additionally, the beneficial effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants experiencing severe stress.
Ostadrahimi, Alireza;Ziaei, Jamal Eivazi;Esfahani, Ali;Jafarabadi, Mohammad Asghari;Movassaghpourakbari, Aliakbar;Farrin, Nazila
Asian Pacific Journal of Cancer Prevention
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제15권14호
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pp.5733-5739
/
2014
Background: Breast cancer is the most common female malignancy in the world. Beta glucan can be a hematopoietic and an immune modulator agent in cancer patients. The aim of this trial was to determine the effect of beta glucan on white blood cell counts and serum levels of IL-4 and IL-12 in women with breast cancer undergoing chemotherapy. Materials and Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 30 women with breast carcinoma aged 28-65 years. The eligible participants were randomly assigned to intervention (n=15) or placebo (n=15) groups using a block randomization procedure with matching based on age, course of chemotherapy and menopause status. Patients in the intervention group received two 10-mg capsules of soluble 1-3, 1-6, D-beta glucan daily and the control group receiving placebo during 21 days, the interval between two courses of chemotherapy. White blood cells, neuthrophil, lymphocyte and monocyte counts as well as serum levels of IL-4 and IL-12 were measured at baseline and at the end of the study as primary outcomes of the study. Results: In both groups white blood cell counts decreased after 21 days of the intervention, however in the beta glucan group, WBC was less decreased non significantly than the placebo group. At the end of the study, the change in the serum level of IL-4 in the beta glucan group in comparison with the placebo group was statistically significant (p=0.001). The serum level of IL-12 in the beta glucan group statistically increased (p=0.03) and comparison between two groups at the end of the study was significant after adjusting for baseline values and covariates (p=0.007). Conclusions: The findings suggest that beta glucan can be useful as a complementary or adjuvant therapy and immunomodulary agent in breast cancer patients in combination with cancer therapies, but further studies are needed for confirmation.
Objectives : The present study was made to evaluate the clinical effectiveness of Saengmaeg-san (生脈散) extract to treat xerostomia in stroke patients. Methods : The study design was a double-blind randomized controlled trial. Subjects were stroke patients with xerostomia. They were allocated to either the Saengmaeg-san (n=12) or placebo group (n=12). Saengmaeg-san extract or a placebo in similar opaque capsules was given three times a day for a week. The improvement of xerostomia was measured by the xerostomia-evaluating questionnaire, developed by the school of dentistry in Seoul National University, before baseline and one week later. Eleven of the Saengmaeg-san group and ten of the placebo group finished the trial and were analyzed. Paired samples t-test and Mann-Whitney test were applied to statistical analysis. Results : On three of the six questions, the Saengmaeg-san group improved significantly. On two of the six questions, the Saengmaeg-san group improved significantly more than the placebo group. On the other questions, the Saengmaeg-san group improved more than the placebo group, although significance was not reached. Conclusions : These results demonstrate that Saengmaeg-san extract is effective for treating xerostomia in stroke patients, and further studies should be conducted to provide more valuable information.
BACKGROUND/OBJECTIVES: Soy isoflavones are expected to improve menopausal symptoms and osteoporosis in women. However, their efficacy is still inconclusive, and there was limited data for postmenopausal women in South Korea. We examined the effects of soy isoflavones on climacteric symptoms, bone biomarkers, and quality of life in Korean postmenopausal women. SUBJECTS/METHODS: A randomized, double-blind study design was used. Eighty-seven participants who had undergone natural menopause were randomly administered either 70 mg/day isoflavones (n = 43) or placebo (n = 41) for 12 weeks. We assessed the Kupperman index for climacteric symptoms and the menopause-specific quality of life (MENQOL) questionnaire for quality of the life. Biomarkers of bone metabolism were also measured in serum bone-specific alkaline phosphatase (BALP), osteocalcin (OC), N- and C-terminal cross-linking telopeptides of type Ι collagen (NTx, CTx), and urine-deoxypyridinolin (u-DPD). RESULTS: Scores of the Kupperman index were decreased in both the isoflavones group ($-7.0{\pm}15.8$, P = 0.0074) and placebo group ($-6.3{\pm}14.6$, P = 0.0064) during the intervention, but no significant difference was noted between the groups. Regarding the bone formation markers, the level of serum BALP increased by $6.3{\pm}4.1%$ (P = 0.004) and OC increased by $9.3{\pm}6.2%$ (P < 0.001), meanwhile those of the placebo were not changed. For the bone resorption markers, NTx, CTx, and u-DPD were not significantly different in either group. MENQOL was significant decreased in the isoflavone group ($-0.6{\pm}0.5$) and placebo group ($-0.6{\pm}0.4$), with a significant difference between groups (P = 0.0228). CONCLUSIONS: Our study suggests that 70 mg isoflavones supplement has beneficial effects on bone formation markers; however, it showed no benefit compared to the placebo on climacteric symptoms or quality of life.
Objective : Although chronic prostatitis/chronic pelvic pain syndrcme(CP/CPPS) is a common disease, there is no consensus on the etiology or pathology and treatment. This was a double-blinded, placebo-controlled, randomized clinical trial, investigating the therapeutic effects of the traditional Korean medicine, Bosingunyang-tang(BSGYT). Method : Participants who met US National Institutes of Health (NIH) consensus criteria for CP/CPPS were entered after applying inclusion/exclusion criteria. They were randomized to the BSGYT or placebo group. and treated three times a day for 6 weeks. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was used to estimate the clinical symptoms of CP/CPPS. Prostaglandin E2 and ${\beta}$-endorphin in prostatic fluid, collected by 2-glass pre-massage and post-massage test, were analyzed as factors associated with pain and inflammation. Result : The mean decrease in NIH-CPSI total score of the BSGYT group was 11.0 points, which is 5.7 points more than the placebo group. (Mann Whitney test P=0.038) Also the BSGYT group showed three times higher response rate than the placebo group in NIH-CPSI pain subscale score. (Fisher's exact test P=0.027) In those responders, prostaglandin E2 decreased significantly. (Wilcoxon's signed-ranks test P=0.037). No specific side effects were observed. Conclusion : After a 6-week treatment period, BSGYT improved clinical symptoms of CP/CPPS patients by decreasing PGE2 level in prostatic fluid.
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