Efficacy of Raloxifene Hydrochloride for the Prevention of Health Care Problems in Patients Who Undergo Surgery for Endometrial Cancer: A Multicenter Randomized Clinical Trial

2015 ◽  
Vol 25 (2) ◽  
pp. 288-295 ◽  
Author(s):  
Koji Nakamura ◽  
Kenjiro Sawada ◽  
Michiyo Sugiyama ◽  
Seiji Mabuchi ◽  
Takeshi Hisamatsu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Endometrial Cancer ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Lipid Profile ◽  
Bone Metabolism ◽  
Randomized Clinical Trial ◽  
Group 2 ◽  
Raloxifene Hydrochloride ◽  
Group 1

ObjectiveRemoval of the ovaries is common during surgery for endometrial cancer. However, because loss of the ovaries can cause several health problems in patients, strategies for the prevention of such problems need to be established. Hence, we decided to conduct a multicenter randomized clinical trial to assess the effect of raloxifene on bone mineral density (BMD), bone metabolism, and the lipid profile of patients who had undergone surgery for patients with endometrial cancer.Materials and MethodsPatients with endometrial cancer were enrolled after treatment. The participants were randomized into 2 groups: group 1 included 39 women who received alfacalcidol (1 μg/d) alone and group 2 included 37 women who received alfacalcidol and the test drug, raloxifene hydrochloride, at a dose of 60 mg/d. The BMD of lumbar spine and femoral neck, serum bone markers, as well as lipid profile parameters were evaluated at enrollment as well as 6, 12, and 24 months after the enrollment. The primary efficacy end point was the percentage change from baseline to 24 months in lumbar spine (L2-L4) and femoral neck BMD.ResultsSixty-four women completed the 24-month study. At 24 months, the lumbar and femoral neck BMDs were significantly increased in group 2 compared with group 1 (3.5% vs −0.8% and 2.3% vs −2.8%, respectively). In group 2, low-density lipoprotein-cholesterol levels were significantly reduced by 13.6% and serum N-terminal telopeptide of type I collagen as well as bone-specific alkaline phosphatase values were significantly reduced by 16.7% and 25.7%, respectively. The patients who received adjuvant therapy for endometrial cancer showed a significantly higher response to raloxifene (5.8% vs 1.9%). Recurrence was detected in 2 (2.6%) patients in group 1. No severe adverse events were noted in any patient during the study period.ConclusionsRaloxifene exerts positive effects on BMD, bone metabolism, and lipid profile parameters and could provide an improved therapeutic option for patients with endometrial cancer.

scholarly journals Comparison of the effect on postoperative pain between instrumentation with and without connected electronic apex locator: a randomized clinical trial

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 868
Author(s):  
Khoa Van Pham ◽  
Cuong Hoang
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Randomized Clinical Trial ◽  
Root Canal ◽  
Single Visit ◽  
Significant Difference ◽  
Group 2 ◽  
Root Canal Instrumentation ◽  
Electronic Apex Locator ◽  
Group 1

Background: The aim of the present study was to evaluate the postoperative pain between root canal instrumentation with unconnected electronic apex locator and instrumentation with connected electronic apex locator. Methods: Forty-two patients were randomly divided into two groups (n=21). Group 1 was treated using the traditional endodontic motor with unconnected electronic apex locator (EAL) and group 2 was treated using the endodontic motor with connected EAL. All teeth were treated in single-visit endodontic therapy. Postoperative pain levels at 6, 24, 48, 72 h and 1 week were recorded by patients. The data were collected and analyzed using the χ2, and Mann-Whitney U tests with significance at 0.05. Results: Postoperative pain levels were significantly reduced by half at 6 hours in both experimental groups; however, no significant differences were found in postoperative pain levels between the two groups at all considered times. The postoperative pain levels using a percussion test were reduced on day 7 in both groups, and there was no significant difference in this variable between two groups. Conclusions: Both groups have a similar effect on reduction of the postoperative pain for endodontic patients undergoing root canal.

scholarly journals The Effectiveness of Herbal Mixture Supplements with and without Clomiphene Citrate in Comparison to Clomiphene Citrate on Serum Antioxidants and Glycemic Biomarkers in Women with Polycystic Ovary Syndrome Willing to Be Pregnant: A Randomized Clinical Trial

Biomolecules ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. 215 ◽  
Author(s):  
Nava Ainehchi ◽  
Arash Khaki ◽  
Azizeh Farshbaf-Khalili ◽  
Mohamad Hammadeh ◽  
Elaheh Ouladsahebmadarek
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovary Syndrome ◽  
Randomized Clinical Trial ◽  
Polycystic Ovary ◽  
Clomiphene Citrate ◽  
Ovary Syndrome ◽  
Herbal Mixture ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

This paper aimed to evaluate the effect of herbal mixture (Mentha spicata, Zingiber officinale, Cinnamomum zeylanicum, and Citrus sinensis) only and along with clomiphene citrate (CC) compared to CC on serum antioxidants, glycemic status, menstrual regulation, and rate of pregnancy. This single-blind randomized clinical trial was carried out on 60 infertile participants with polycystic ovary syndrome (PCOS) willing to be pregnant. They were randomly allocated into group 1 (n = 20) who received routine dose of CC pills (50–150 mg) for three menstrual cycles from the fifth day of menstruation for five days; group 2 (n = 20) who consumed herbal mixture daily (700 mg); and group 3 (n = 20) who used up herbal mixture along with CC for 3 months. Catalase (CAT), glutathione peroxidase (GPx), superoxide dismutase (SOD), malondialdehyde (MDA), fasting blood sugar (FBS), insulin, and homeostatic model assessment for insulin resistance (HOMA-IR) were measured in their blood samples. No statistically significant differences were observed between the three groups in terms of socio-demographic characteristics. After intervention, however, the levels of CAT in group 2 (adjusted mean difference (aMD): = 9.0; confidence interval (CI) 95% = 1.1–16.9) and group 3 (aMD = 12.2; CI 95% = 4.5–19.9), GPx in group 2 (aMD = 986.1; CI 95% = 141.1–1831.1) and group 3 (aMD = 1781.2; CI 95% = 960.7–2601.8), and SOD in group 2 (aMD = 55.1; CI 95% = 26.0–84.2) increased. While FBS in group 3 (aMD = −8.7; CI 95% = −14.7 to −2.7), insulin in group 2 (aMD = −5.6; CI 95% = −10.8 to −0.4), and HOMA-IR in group 2 (aMD = −1.3; CI 95% = −2.4 to −0.2) significantly decreased compared to the group 1. To summarize, herbal mixture supplements along with CC have beneficial effects on serum antioxidant levels, as well as glycemic biomarkers of infertile PCOS, menstrual regulation, and pregnancy rate.

scholarly journals Efficacy of estriol in inhibiting epithelial proliferation in mammary fibroadenoma: randomized clinical trial

2007 ◽  
Vol 125 (6) ◽  
pp. 343-350 ◽  
Author(s):  
Rodrigo Augusto Fernandes Estevão ◽  
Edmund Chada Baracat ◽  
Ângela Flávia Logullo ◽  
Celina Tizuko Fujiyama Oshima ◽  
Afonso Celso Pinto Nazário
Keyword(s):  
Clinical Trial ◽  
Oral Contraceptive ◽  
Randomized Clinical Trial ◽  
Ethinyl Estradiol ◽  
Study Groups ◽  
Reproductive Age ◽  
Double Blind ◽  
Ki 67 ◽  
Group 2 ◽  
Group 1

CONTEXT AND OBJECTIVE: Mammary fibroadenoma is a disease that affects a large number of women of reproductive age. The aim of this study was to evaluate the proliferative activity of mammary fibroadenoma through expression of Ki-67 and c-myc antigens, following administration of oral contraceptive with or without estriol. DESIGN AND SETTING: Placebo-controlled double-blind randomized clinical trial in the Mastology Sector of the Department of Gynecology, Universidade Federal de São Paulo. METHODS: Thirty-three fibroadenoma patients were studied. Ten women (group 1) took an oral contraceptive constituted by levonorgestrel and ethinyl estradiol together with placebo manufactured in the same capsule for four consecutive cycles with a seven-day interval between them. The other 23 patients (group 2) took the same oral contraceptive together with estriol, which was put into the same capsule and used in the same way as among the group 1 patients. After four cycles, the nodules were surgically removed and sent for immunohistochemical analysis of Ki-67 and c-myc expression. RESULTS: The Ki-67 and c-myc analysis did not reveal any significant differences between the study groups. The values were 9.16 and 10.54 for group 1 and 10.86 and 17.03 for group 2, respectively. There was a tendency towards higher expression of antigens in group 2. CONCLUSION: Our results showed that there was no significant statistical difference in Ki-67 and c-myc expression between our study groups, but only a tendency towards higher expression among users of oral contraceptives containing estriol.

scholarly journals Effects of Two Different Modes of Task Practice during Lower Limb Constraint-Induced Movement Therapy in People with Stroke: A Randomized Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9 ◽  
Author(s):  
Auwal Abdullahi ◽  
Naima Umar Aliyu ◽  
Ushotanefe Useh ◽  
Muhammad Aliyu Abba ◽  
Mukadas Oyeniran Akindele ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Lower Limb ◽  
Knee Extensor ◽  
Constraint Induced Movement Therapy ◽  
Formula Group ◽  
Task Practice ◽  
Group 2 ◽  
Normal Rank ◽  
Group 1

Background. Constraint-induced movement therapy (CIMT) is used for the rehabilitation of motor function after stroke. Objectives. The aim of this study was to compare the effects of lower limb CIMT that uses number of repetition of tasks with the one that uses number of hours of practice. Method. The study was a randomized clinical trial approved by the Ethics Committee of Kano State Ministry of Health. Fifty-eight people with stroke participated in the study. Groups 1 and 2 performed daily 600 repetitions and 3 hours of task practice, respectively, 5 times weekly for 4 weeks. Motor impairment (primary outcome), balance, functional mobility, knee extensor spasticity, walking speed and endurance, and exertion before and after commencement of activities were assessed at baseline and postintervention. The data was analyzed using Friedmann and Mann-Whitney U tests. Result. The results showed that there was only significant difference ( p < 0.05 ) in knee extensor spasticity (group 1 ( median = 0 0 , mean   rank = 27.50 ); group 2 ( median = 0 0 , mean   rank = 31.64 )), exertion before commencement of activities (group 1 ( median = 0 0.5 , mean   rank = 21.90 ); group 2 ( median = 1 0.5 , mean   rank = 37.64 )), and exertion after commencement of activities (group 1 ( median = 1 1 , mean   rank = 20.07 ); group 2 ( median = 1 0 , mean   rank = 39.61 ) postintervention in favour of the experimental group (group 1)). Conclusion. The group 1 protocol is more effective at improving outcomes after stroke.

scholarly journals Comparative Evaluation of Effect of Nano-hydroxyapatite and 8% Arginine Containing Toothpastes in Managing Dentin Hypersensitivity: Double Blind Randomized Clinical Trial

2017 ◽  
Vol 60 (3) ◽  
pp. 114-119 ◽  
Author(s):  
Suresh Anand ◽  
Fathima Rejula ◽  
Joseph V G Sam ◽  
Ramakrishnan Christaline ◽  
Mali G Nair ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Electrical Stimulus ◽  
Tooth Surface ◽  
Dentin Hypersensitivity ◽  
Double Blind ◽  
Vas Score ◽  
Group 2 ◽  
Group 1

Purpose: This double blind randomized clinical trial was conducted with the purpose of evaluating the effects of Nano-hydroxyapatite toothpaste as compared to 8% Arginine containing toothpaste in the management of Dentin hypersensitivity (DH). Method and materials: Patients (30 in each group) suffering from DH and eliciting a VAS score higher than 2 in air blast and tactile test were randomly allocated (block randomization) into either a group 1 (arginine toothpaste) or group 2 (nHA toothpaste). The primary outcome evaluated was the reduction of DH as measured by the electrical stimulus reading on the digital pulp tester. Current required for eliciting a VAS score of 2 was recorded before application of dentifrice. 1 cm of toothpaste was then expressed on the tooth surface for two minutes in each group and rinsed off. The electrical stimulus required to elicit a VAS score of 2 was recorded after 5 minutes, 1 week and 4 weeks. Results: The desensitizing paste containing arginine provided a statistically significant reduction in DH and so did the paste containing nHA. Mean increase in amperage value (reduction in DH) was higher for nHA based than the arginine containing dentifrice. This difference was not statistically significant showing that both toothpastes are equally effective. Conclusions: The findings of the present study encourage the use of Nano-hydroxyapatite and arginine containing dentifrice as an effective desensitizing agent providing relief from symptoms 5 minutes after application and after 1 and 4 weeks.

Management of Aphthous Ulceration with Topical Quercetin: A Randomized Clinical Trial

2010 ◽  
Vol 11 (4) ◽  
pp. 9-16 ◽  
Author(s):  
Ahmed Abd El-Meguid Mostafa Hamdy ◽  
Mohamed Abd El-Moneam Ibrahem
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Topical Application ◽  
Size Difference ◽  
Control Group ◽  
Ulcer Size ◽  
Aphthous Ulcers ◽  
Aphthous Ulceration ◽  
Group 2 ◽  
Group 1

Abstract Aim Recurrent aphthous ulceration is the most commonly known oral mucosal disease. Quercetin is a useful therapeutic agent for the treatment of colitis and gastric ulcer. The objective of this study was to determine the effect of topical application of quercetin in the treatment of minor aphthous ulcers. Methods and Materials Forty male patients with no known pathology of the oral mucosa other than minor aphthous ulcers were enrolled in this study. Patients were randomly divided into two groups, each consisting of 20 patients. Group 1 (control group) patients used a benzydamine hydrochloride mouthwash three times daily. Group 2 patients placed two to three dabs of quercetin three times daily directly on their ulcers. Clinical evaluation of patients included assessment of ulcer size, pain measure, and interviews regarding the topical application of quercetin in terms of consistency, taste, local tolerability, and ease of application. Results The topical application of quercetin cream to minor mouth ulcers relieved pain and produced complete healing in seven of the Group 2 patients (35 percent) in 2–4 days, 18 patients (90 percent) in 4–7 days, and 20 patients (100 percent) in 7–10 days. When comparing the mean ulcer size after 10 days, lesions in the Group 2 patients were smaller than those in Group 1, and the size difference between the two groups was significantly different (p<0.004). Also, 90 percent of patients responded that they appreciated the ease of application when using the topical quercetin, and they did not object to its consistency or taste. Conclusion Quercetin is a safe, well-tolerated, and highly effective promising new, adjunctive treatment for healing common aphthous ulcers. Clinical Significance Although aphthous ulcers typically resolve on their own in one to two weeks, the daily topical application of quercetin may be useful in accelerating the healing process of minor aphthous ulcers. Citation Hamdy AAEM, Ibrahem MAE. Management of Aphthous Ulceration with Topical Quercetin: A Randomized Clinical Trial. J Contemp Dent Pract [Internet]. 2010 July; 11(4):009-016. Available from: http://www.thejcdp. com/journal/view/volume11-issue4-hamdy

scholarly journals Paracetamol versus Paracetamol Plus Ondansetron on Acute Postoperative Pain

2021 ◽  
Vol 07 (04) ◽  
pp. e314-e318
Author(s):  
Mohamad Aryafar ◽  
Mahnaz Narimani Zamanabadi ◽  
Kourosh Farazmehr ◽  
Giti Dehghanmanshadi ◽  
Sepideh Davoodinejad ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Randomized Clinical Trial ◽  
Pain Severity ◽  
Comparative Efficacy ◽  
University Hospitals ◽  
Acute Postoperative Pain ◽  
Group 2 ◽  
Analgesic Use ◽  
Group 1

AbstractThis study was performed to determine the comparative efficacy of paracetamol alone versus paracetamol plus ondansetron on acute postoperative pain after abdominal surgeries in Azad University hospitals in 2017 and 2019. In this randomized clinical trial, 62 consecutive patients under abdominal surgeries, were randomly divided into two groups, group 1 patient who received paracetamol alone 1 gram and group 2 patient who received paracetamol 1 gram plus 4 mg ondansetron and the pain severities were determined and compared between groups at recovery and after 4 and 24 hours. The results of this study revealed that there were no statistically significant differences between two groups for the postoperative pain severity and analgesic use (p> 0.05). It may be concluded that addition of ondansetron to paracetamol would not result in further postoperative pain reduction and additive use of this drug is not recommended.

scholarly journals Effects of sacred music on the spiritual well-being of bereaved relatives: a randomized clinical trial

2017 ◽  
Vol 51 (0) ◽  
Author(s):  
Vladimir Araujo da Silva ◽  
Rita de Cássia Frederico Silva ◽  
Nubia Carla Ferreira Cabau ◽  
Eliseth Ribeiro Leão ◽  
Maria Júlia Paes da Silva
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Sacred Music ◽  
Family Members ◽  
Well Being ◽  
Control Group ◽  
Spiritual Well Being ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract OBJECTIVE To evaluate the effects of instrumental sacred music and sacred music with vocals on the spiritual well-being of bereaved relatives. METHOD This is a randomized clinical trial carried out with family members bereaving the death of loved ones to cancer. Participants were allocated into three groups: Group 1 (control), Group 2 (experimental using sacred music with vocals) or Group 3 (experimental using instrumental sacred music). Spiritual well-being was assessed through the Spiritual Well-Being Scale. RESULTS Sixty-nine (69) family members participated. Mean scores before and after the intervention indicated high levels of spiritual well-being (106.4 and 105.5 in Group 1; 103.2 and 105.2 in Group 2; 107.4 and 108.7 in Group 3) and religious well-being (57.9 and 56.9 in Group 1; 56.3 and 56.4 in Group 2; 57.4 and 58.1 in Group 3), and moderate levels of existential well-being (48.5 and 48.6 in Group 1; 46.9 and 48.9 in Group 2; 49.9 and 50.7 in Group 3), with the exception of Group 3 which presented a high level of existential well-being after the intervention. CONCLUSION The results show that there were no statistically significant differences in the spiritual well-being scores between the experimental groups and the control group. We evidence the need for further studies that use music therapy as a Nursing intervention for bereaved families. Brazilian Registry of Clinical Trials: RBR-2wtwjz.

scholarly journals AB0910 SARCOPENIA AND BONE MINERAL DENSITY IN MEN WITH CORONARY HEART DISEASE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1757.2-1757
Author(s):  
T. Raskina ◽  
I. Grigoreva ◽  
J. Averkieva ◽  
A. Kokov ◽  
V. Masenko
Keyword(s):  
Bone Mineral Density ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Muscle Mass ◽  
Bone Mineral ◽  
Mineral Density ◽  
Group 3 ◽  
Group 2

Objectives:To examine bone mineral density (BMD) in men with coronary heart disease (CHD), depending on the state of the muscle mass, strength and function.Methods:79 men aged over 50 years with verified CHD were examined (mean age 63 (57; 66) years).The BMD and T-criterion (standart deviation, SD) of the femoral neck and lumbar spine (L1-L4) were evaluated using dual-energy x-ray absorptiometry (DXA) on the Lunar Prodigy Primo bone densitometer (USA). The following reference intervals were used: normal BMD values (T-criterion ≥-1), osteopenia (OPe) (T-criterion from -1 to -2.5), and osteoporosis (OP) (T-criterion <-2.5).To assess muscle mass, the total area (cm2) of the lumbar muscles of the axial section at the level of the 3rd lumbar vertebra (L3) was determined using multispiral computed tomography on a 64-slice computer tomograph “Somatom Sensation 64” (Siemens AG Medical Solution, Germany). The ratio of the obtained index of the area of skeletal muscle to the square of the patient’s growth index determined the “ skeletalmuscular index L3” (SMI). The media considered the threshold value to be 52.4 cm2/m2.Results:The femoral neck BMD in the examined patients was 0.96 (0.89; 1.03) g/cm2, which corresponds to -0.50 (-1.00; 0) SD according to the T-criterion, in the lumbar spine -1.23 (1.11; 1.32) g/cm2and 0.4 (-0.50; 1.20) SD according to the T-criterion.In accordance with the recommendations of the European working group on sarcopenia in Older people (EWGSOP, 2010, 2018), the patients were divided into 3 groups: 31 patients without sarcopenia (group 1), 21 patients with isolated muscle loss (presarcopenia) (group 2) and 27 patients with sarcopenia (group 3).BMD in the femoral neck in the group of patients without sarcopenia was 0.96 (0.72; 1.26) g/cm2, which corresponds to -0.50 (-0.8; 0.2) SD according to the T-criterion, in the lumbar spine – 1.19 (1.10; 1.275) g/cm2and 0.1 (-0.6; 0.8) SD according to the T-criterion. BMD in the femoral neck in the group of patients with presarcopenia (group 2) – 0.995 (0.94; 1.04) g/cm2and -0.3 (-0.70; 0) SD according to the T-criterion, in the lumbar spine – 1.32 (1.24; 1.40) g/cm2and 1.20 (0.50; 1.90) SD according to the T-criterion. In patients with established sarcopenia (group 3), the following indicators of BMD and T-criterion were recorded: 0.95 (0.845; 0.98) g/cm2and -0.60 (-1.40; -0.40) SD and 1.23 (0.085; 1.31) g/cm2and 0.4 (-0.8; 1.1) SD in the femoral neck and lumbar spine, respectively.A comparative analysis of the results of the DXA found that patients with sarcopenia had a significant decrease in the BMD and T-criterion in the femoral neck compared to patients with presarcopenia (p=0.039 and p=0.040, respectively). There were no differences between the groups of patients without sarcopenia and with sarcopenia and presarcopenia (p>0.05).It was found that patients with sarcopenia had significantly lower BMD and T-criterion in the lumbar spine compared to patients with presarcopenia (p=0.017 and p=0.0165, respectively). The values of the BMD and T-criterion in the groups of patients without sarcopenia and with presarcopenia and sarcopenia in the lumbar spine were comparable (p>0.05).Conclusion:The presence of sarcopenia is associated with loss of BMD in the femoral neck and in the lumbar spine. The results obtained confirm the high probability of common pathogenetic links between OP and sarcopenia.Disclosure of Interests:None declared

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