• Title/Summary/Keyword: double blind

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Health-Related Quality of Life of Breast Cancer Patients in iran: Pooled Analysis using Generalized Estimating Equations

  • Kiadaliri, Aliasghar Ahmad;Bastani, Peivand;ibrahimipour, Hossein
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.3
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    • pp.941-944
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    • 2012
  • Objective: The aim of current study was to evaluate the changes of health-related quality of life (HRQoL) and its clinical, demographic and socioeconomic determinants during chemotherapy and 4 months follow-up in women with breast cancer using a repeated measures framework. Methods and Materials: A double blind cohort study was performed in 100 breast cancer patients given fluorouracil, doxorubicin and cyclophosphamide (FAC) or docetaxel, doxorubicin, cyclophosphamide (TAC) in south of Iran. HRQoL was assessed at baseline, end of chemotherapy and four months thereafter using the QLQ-C30 questionnaire from European Organization for Research and Treatment of Cancer (EORTC). Generalized estimating equations (GEE) was applied for statistical analysis. Results: The mean of age at baseline was $48.5{\pm}10.6$. 70% and 14% of patients were married and smokers, respectively, and 20% suffered from another disease besides breast cancer. The results of GEE showed that after control for baseline scores, the HRQoL significantly improved over time. Although, the patients in FAC group had higher scores than the TAC group, the differences also diminished over time. Smoking, marital status and having child affected some scales of HRQoL. None of other variables were significantly related to HRQoL. Conclusion: Although patients in TAC groups had lower level of HRQoL over 8 months follow up, they experienced faster improvement than the FAC group. This implies that in long-term, improvements in TAC group are higher than FAC. Having children was positively correlated with HRQoL. Generally, there were no demographic and socio-economic differences in HRQoL in these patients between the chemotherapeutic regimens.

Randomized Double-Blind Placebo-Controlled Trial of Propolis for Oral Mucositis in Patients Receiving Chemotherapy for Head and Neck Cancer

  • Akhavan-Karbassi, Mohammad Hasan;Yazdi, Mohammad Forat;Ahadian, Hakimeh;Sadr-Abad, Maryam Jalili
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.7
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    • pp.3611-3614
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    • 2016
  • Background: Propolis based preparations have a wide range of applications in various specialties of dentistry. The aim of this clinical trial was to test the efficacy of propolis as a mouthwash in the reduction of chemotherapy induced oral mucositis (OM) in a single center. Materials and Methods: In this randomised, controlled study patients undergoing chemotherapy were included consecutively and randomised to an experimental group receiving propolis mouthwash (n = 20) and a control group receiving diluted water (n=20). Oral mucositis, erythema and eating and drink ability were assessed at baseline and after 3 and 7 days using the World Health Organization (WHO) scale and the oral mucositis assessment scale (OMAS). Results: There were significant differences in OM, wound and erythema in propolis group compared to placebo, but no significant difference in eating and drink ability. However, it was interesting that 65% of the patients in the propolis group were completely healed at day 7 of the trial. No significant adverse events were reported by the patients. Conclusions: This study found that oral care with propolis as mouthwash for patients undergoing chemotherapy is an effective intervention to improve oral health. Our findings shouldlencourage health practitioners to apply propolis mouth rinse for the oral care of patients under chemotherapy.

Effect of 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol on Immune Functions in Healthy Adults in a Randomized Controlled Trial

  • Hwang, Hee-Jin;Sohn, Ki-Young;Han, Yong-Hae;Chong, Saeho;Yoon, Sun Young;Kim, Young-Jun;Jeong, Jinseoun;Kim, Sang-Hwan;Kim, Jae Wha
    • IMMUNE NETWORK
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    • v.15 no.3
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    • pp.150-160
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    • 2015
  • We previously reported that 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (PLAG) accelerates hematopoiesis and has an improving effect on animal disease models such as sepsis and asthma. The effects of PLAG supplementation on immune modulation were assessed in healthy men and women. The objective was to evaluate the effects of PLAG supplementation on immune regulatory functions such as activities of immune cells and cytokine production. A randomized double blind placebo-controlled trial was conducted. Seventy-five participants were assigned to one of two groups; all participants had an appropriate number of white blood cells on the testing day. The PLAG group (n=27) received oral PLAG supplements and the control group (n=22) received oral soybean oil supplements. IL-4 and IL-6 production by peripheral blood mononuclear cells (PBMC) were lower (p<0.001 and p<0.001, respectively) with PLAG than with soybean oil. However, the production of IL-2 and IFN-$\gamma$ by PBMC was unaltered with PLAG supplementation. The B cell proliferation decreased significantly in the PLAG group compared to the soybean oil control (p<0.05). The intake of PLAG in healthy adults for 4 weeks was deemed safe. These data suggest that PLAG has an immunomodulatory function that inhibits the excessive immune activity of immunological disorders such as atopic and autoimmune diseases. PLAG could improve the condition of these diseases safely as a health food supplement.

Efficacy of Electroacupuncture using an Insulated Needle in Adults with Abdominal Obesity: A Pilot Study

  • Oh, Seo Young;Lee, Hyun;Yun, Gee Won;Kang, Jae Hui
    • Journal of Acupuncture Research
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    • v.34 no.2
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    • pp.49-59
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    • 2017
  • Objectives : This study evaluated the efficacy of electroacupuncture therapy using an insulated needle in adults with abdominal obesity. Methods : This study was a randomized, double-blind, parallel-designed pilot trial. Sixteen participants eligible according to the inclusion and exclusion criteria were randomly divided into an insulated needle group and a control group. Insulated or common needles were inserted at acupoints located on the abdomen (CV12, CV6, ST25, ST27, SP15) and were electrically stimulated for 30 minutes (16 Hz, within tolerable strength). A total of 10 sessions of treatment were performed twice per week for 5 weeks. All participants were requested to maintain their usual diet and lifestyle. The outcome measures were waist circumference (WC), waist-to-hip ratio (WHR), and abdominal computed tomography (CT) of the total fat area (TFA), subcutaneous fat area (SFA), and visceral fat area (VFA). Results : A total of 12 participants divided into the insulated needle group (n = 5) and the control group (n = 7; common needle) were treated for 10 sessions and analyzed per-protocol (PP). WC decreased significantly after 10 sessions in both groups. The WC, TFA, SFA, and VFA of abdominal CT in the insulated needle group decreased more than in the control group; however, there were no significant differences in any parameter between the insulated needle group and the control group. Patients in the insulated needle group were more strongly stimulated with electrical stimulation than patients in the control group. Conclusion : Electroacupuncture using insulated needles in adults with abdominal obesity might be a more effective treatment than common needles. Additional studies are required to compensate for the limitations of this pilot study and to verify the results and efficacy.

The supplementation effects of peanut sprout on reduction of abdominal fat and health indices in overweight and obese women

  • Ha, Ae Wha;Kim, Woo Kyoung;Kim, Jung Hwan;Kang, Nam E
    • Nutrition Research and Practice
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    • v.9 no.3
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    • pp.249-255
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    • 2015
  • BACKGROUD/OBJECTIVES: This study was conducted in order to investigate the effect of peanut sprout extracts (PSE) on health indices in overweight and obese women (BMI $${\geq_-}23kg/m^2$$). SUBJECTS/METHODS: Subjects were divided into three groups by double-blind randomized trial; the Placebo group (n = 15) and the Low PSE group (2.6 g PSE/day, n = 15), and the High PSE group (5.8 g PSE/day, n = 15). Subjects consumed 12 capsules per day, three times a day, 30 min before meals, for 4 weeks. Anthropometric data, blood biochemical variables, and dietary intake were evaluated before and after the experiments. RESULTS: In the Low and High PSE group, the waist circumference showed a significant decrease between pre- and post-test. In the Low PSE group, the reduction of systolic blood pressure between pre- and post-test was statistically significant. Serum LDL or triglyceride levels in both Low and High PSE groups were significantly decreased, and serum alanine transaminase and aspartate transaminase were significantly decreased only in the Low PSE group. The parameters regarding erythrocyte and leucocyte counts showed no significant differences between pre- and post-test among groups, which suggested the safety of intake of peanut sprouts as a dietary supplement. CONCLUSIONS: This study indicates that PSE supplementation improves abdominal obesity and overall health indices. Therefore, an appropriate amount of peanut sprouts may be a plausible effective agent for obesity and obesity related health problems in obese women.

Whitening Effect of the Extracts from Juglans mandshurica (가래나무 추출물의 미백효과)

  • Lee, Gye-Won;Lee, Ju-Yeon;Cho, Young-Ho
    • KSBB Journal
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    • v.25 no.1
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    • pp.18-24
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    • 2010
  • Juglans mandshurica belongs to the family Juglandaceae is known to contain a wide range of pharmacological activities including anti-cancer, anti-inflammation, astringent, and anti-human immunodeficiency virus-type 1 (HIV-1). Melanogenesis refers to the biosynthesis of melanin pigment in melanocytes. In this study, to investigate the whitening activity of the extracts from Juglans mandshurica, we measured effects on a tyrosinase activity, a melanogenesis, and a tyrosinase synthesis in the B16/BL6 melanoma cells and an antioxidant activity. The extracts significantly scavenged a 1,1-diphenyl-2-picrylhydrazyl (DPPH) and a superoxide anion radicals in a dose-dependent manner with a $SC_{50}$ value of $20\;{\mu}g/mL$ and $25\;{\mu}g/mL$, respectively. Also, the tyrosinase activity and melanogenesis were significantly inhibited by the extracts. Furthermore, the synthesis of tyrosinase protein was significantly decreased by the extracts in enzyme-linked immunosorbent assay. Double blind study on the clinical efficacy of a cream containing 2% of the extracts showed that the extracts have a significant skin whitening effect. Therefore, this study demonstrates that the extracts from Juglans mandshurica may be useful as a potential agent for skin whitening.

The Efficacy and Safety of Beef Tallow Extract Including Cis-9-cetylmyristoleate in Patients with Osteoarthritis - As an Adjuvant Pharmacological Treatment -

  • Lee, Sang-Hoon;Kim, June-Hyuk;Cho, Whan-Seong;Seo, Sung-Wook;Kim, Sung-Kyu;Oh, Joo-Han
    • Preventive Nutrition and Food Science
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    • v.10 no.3
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    • pp.285-289
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    • 2005
  • In this double-blind, placebo-controlled trial, we assessed the efficacy and safety of beef tallow extract (BTE) including Cis-9-cetylmyristoleate in patients with arthritis. Between May and December 2003, we selected 80 patients (n=80) who showed/manifested arthritic symptoms and whose radiological findings were suggestive of arthritis, and randomly assigned them to placebo-controlled (n=40) and treatment group (n=40). The placebo (corn starch 350 mg) and BTE (208 mg) were orally administered to placebo-controlled and treatment group three times a day, respectively. We assessed the efficacy and safety based on the visual analogue scale (V AS) and modified knee society knee scores (MKSKS) at baseline and endpoint, respectively. To assess the safety, we monitored the adverse effects noted in liver, kidney, cardiovascular and gastrointestinal system for 3 weeks. Then, we performed not only a questionnaire study but also laboratory tests (e.g., liver function test, kidney function test, urinalysis, electrocardiography [EKG], complete blood cell counts [CBC] and chest X-ray). For statistical analysis, Student (-test and paired (-test were done using SPSS■ Version 11.0. Statistical significance was set at p < 0.05. The scores between V AS and MKSKS showed statistical significance (p < 0.05) with an improvement of $69.2\%$ (27/39) and $3.8\%$ (21/39) of treatment-group patients, respectively. Abnormal laboratory findings were noted in neither placebo-controlled nor treatment group. In conclusion, our results indicate that the administration of BTE was a safe and effective treatment regimen for patients with arthritis. In addition, the efficacy of BTE was more remarkable in alleviating the symptoms rather than improving the function.

Oral food challenges in children

  • Yum, Hye-Yung;Yang, Hyeon-Jong;Kim, Kyung-Won;Song, Tae-Won;Kim, Woo-Kyung;Kim, Jung-Hee;Ahn, Kang-Mo;Kim, Hyun-Hee;Lee, Soo-Young;Pyun, Bok-Yang
    • Clinical and Experimental Pediatrics
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    • v.54 no.1
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    • pp.6-10
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    • 2011
  • Many patients assume that allergic reactions against foods are responsible for triggering or worsening their allergic symptoms. Therefore, it is important to identify patients who would benefit from an elimination diet, while avoiding unnecessary dietary restrictions. The diagnosis of food allergy depends on the thorough review of the patients's medical history, results of supplemented trials of dietary elimination, and in vivo and in vitro tests for measuring specific IgE levels. However, in some cases the reliability of such procedures is suboptimal. Oral food challenges are procedures employed for making an accurate diagnosis of immediate and occasionally delayed adverse reactions to foods. The timing and type of the challenge, preparation of patients, foods to be tested, and dosing schedule should be determined on the basis of the patient's history, age, and experience. Although double-blind, placebo-controlled food challenges(DBPCFC) are used to establish definitively if a food is the cause of adverse reactions, they are time-consuming, expensive and troublesome for physician and patients. In practice, An open challenge controlled by trained personnel is sufficient especially in infants and young children. The interpretation of the results and follow-up after a challenge are also important. Since theses challenges are relatively safe and informative, controlled oral food challenges could become the measure of choice in children.

Effect of Supplementation of Zinc, Glutamine, Fiber, and Prebiotics in Presumed Healthy Indonesian Children Aged 1-3 Years

  • Kadim, Muzal;Hegar, Badriul;Bardosono, Saptawati;Timan, Ina S;Gunardi, Hartono;Prasetyo, Dwi;Firmansyah, Agus;Vandenplas, Yvan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.4
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    • pp.388-396
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    • 2020
  • Purpose: Impaired intestinal mucosal integrity may affect the gastrointestinal function, especially in relation to nutrition, absorption, and barrier function. The purpose of this study was to measure the prevalence of impaired intestinal mucosal integrity in presumed healthy children aged 1-3 years and assess the effects of zinc, glutamine, fiber, and prebiotic supplementation in them. Methods: A cross-sectional study was conducted in 200 children aged 1-3 years in Pasar Minggu, South Jakarta, Indonesia. A randomized double-blind parallel group method clinical trial was then performed to assess the effects of zinc, glutamine, fiber, and prebiotic supplementation. Results: Elevated calprotectin was found in 91/200 subjects (45.5%) at the onset of the study. After 10 months, 144 subjects completed the study: 72 subjects received the trial formula, whereas the other 72 received the standard formula. A transitory decrease in fecal calprotectin (FC) was observed after 6 months in the subgroup with normal FC levels, who were fed the test formula (p=0.012). Conclusion: The prevalence of impaired intestinal mucosal integrity in this group of Indonesian children aged 1-3 years was high. Supplementation with zinc, glutamine, fiber, and prebiotics during 6 months reduced FC only in those who had low levels at baseline but not in those with impaired integrity.

Nasal Carriage of 200 Patients with Nasal Bone Fracture in Korea

  • Lee, Jun Wook;Kim, Young Joon;Kim, Hoon;Nam, Sang Hyun;Shin, Bo Moon;Choi, Young Woong
    • Archives of Plastic Surgery
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    • v.40 no.5
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    • pp.536-541
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    • 2013
  • Background Pathogens in the nasal cavity during nasal surgery could lead to a systemic infectious condition, such as bacteremia, nosocomial infection, or toxic shock syndrome. However, there is no research about the prevalence of nasal carriage in patients with nasal bone fracture. Methods This was a prospective, double-blind, randomized study about the rate of nasal carriage in 200 patients with nasal bone fracture in Korea. Nasal secretions were taken from both the middle nasal meatus and colonized. All analyses were carried out using SPSS software. Results Pathogens were identified in 178 of the 200 cases. Coagulase-negative staphylococci (CNS) were the most cultured bacteria in 127 (66.84%) of the 190 total patients after excluding 10 cases of contaminated samples, and methicillin-resistant coagulase-negative staphylococci (MRCNS) were found in 48 (25.26%). Staphylococcus aureus was the second most identified pathogen, found in 36 (18.95%), followed by 7 cases (3.68%) of methicillin-resistant Staphylococcus aureus (MRSA). The prevalence rate of MRSA in the females was higher than that in the males (RR=4.70; 95% CI, 1.09-20.18), but other demographic factors had no effect on the prevalence rate of MRSA and MRCNS. Conclusions The prevalence rate of these pathogens in patients with nasal bone fracture in Korea was similar to other reports. However, few studies have addressed the prevalence rate of CNS and MRCNS in accordance with risk factors or the change in prevalence according to specific prophylaxis against infectious complications. Additional research is needed on the potential connections between clinical factors and microbiological data.