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Randomized double blinded controlled studies

Tulay Sagkal Midilli, Nazmiye Ciray Gunduzoglu
This study was conducted to determine the effects of Reiki on pain and vital signs when applied for 15 minutes to the incision area of the body after cesarean section surgery. The study was single-blinded, randomized, and double-controlled (Reiki, sham Reiki, and control groups). Forty-five patients, equalized by age and number of births, were randomly assigned to the Reiki, sham Reiki, and control groups. The treatment, which was applied to the patients in these 3 groups, was applied for 15 minutes to the incision area of body in the first 24 and 48 hours after the operation within 4 to 8 hours of the application of standard analgesics...
November 2016: Holistic Nursing Practice
J Y Park, K H Kim
OBJECTIVES: The purpose of this clinical trial was to evaluate the effectiveness of a natural extract from Schisandra chinensis for relief of various menopausal symptoms. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted from January 1, 2014 until January 13, 2015. We recruited women between the ages of 40 and 70 years who complained of menopausal symptoms measured by the Kupperman Index (KI). Patients were randomly assigned to treatment with either an extract from Schisandra chinensis (BMO-30) or placebo...
October 20, 2016: Climacteric: the Journal of the International Menopause Society
José-Francisco Rocha, Éric Sicard, Nicolas Fauchoux, Amílcar Falcão, Ana Santos, Ana I Loureiro, Roberto Pinto, Maria João Bonifácio, Teresa Nunes, Luís Almeida, Patrício Soares-da-Silva
AIMS: To compare the levodopa/carbidopa (LC) and levodopa/benserazide (LB) pharmacokinetic profiles following repeated doses of opicapone (OPC) administered apart from levodopa. METHODS: Two randomized, double blind, sex-balanced, placebo-controlled studies in 4 groups of 12 or 18 healthy subjects each. In each group, enrolled subjects received a once-daily morning (5, 15 and 30 mg) or evening (5, 15 and 50 mg) administration of OPC or placebo for up to 28 days...
October 20, 2016: British Journal of Clinical Pharmacology
M García-Gargallo, M Zurlohe, E Montero, B Alonso, J Serrano, M Sanz, D Herrera
OBJECTIVE: To compare the effect of two newly formulated chlorhexidine (CHX) and cetylpyridinium chloride (CPC) mouthrinses after scaling and root planing (SRP) in terms of clinical, microbiological, patient-based variables and adverse events, with a positive control with the same active components, already marketed and tested. METHODS: A pilot, randomized clinical trial, double-blind, parallel design with 1-month follow-up was conducted. Chronic periodontitis patients requiring non-surgical periodontal therapy were enrolled and randomly assigned to: (i) SRP and test-1 (new reformulation: 0...
October 20, 2016: International Journal of Dental Hygiene
Francisco J Tinahones, Baptist Gallwitz, Matias Nordaby, Sophia Götz, Mario Maldonado-Lutomirsky, Hans J Woerle, Uli C Broedl
AIM: To evaluate the efficacy and safety of linagliptin versus placebo as add-on to empagliflozin and metformin in patients with type 2 diabetes. MATERIALS AND METHODS: Patients with inadequate glycaemic control despite stable-dose metformin received open-label empagliflozin 10 mg (study 1) or 25 mg (study 2) as add-on therapy for 16 weeks. Subsequently, those with HbA1c ≥7.0 and ≤10.5% (>53 and ≤91 mmol/mol) (N = 482) were randomized to 24 weeks' double-blind, double-dummy treatment with linagliptin 5 mg or placebo in study 1, or linagliptin 5 mg or placebo in study 2; all patients continued treatment with metformin and empagliflozin 10 mg (study 1) or metformin and empagliflozin 25 mg (study 2)...
October 20, 2016: Diabetes, Obesity & Metabolism
Chien-Ying Lee, Hung-Che Shih, Min-Chien Yu, Ming-Yung Lee, Ya-Lan Chang, Ya-Yun Lai, Yi-Ching Lee, Yu-Hsiang Kuan, Chun-Che Lin
OBJECTIVE: To investigate whether three strains of probiotics, L. acidophilus, L. rhamnosus, and L. sporogenes, had significant inhibitive effects on Helicobacter pylori (H. pylori). METHODS: This is a 4-week, randomly assigned, parallel-group, doubled-blind, and placebo-controlled study. Fifty patients with a positive H. pylori infection urea breath test (ΔUBT) result > 10% and without ulcer symptoms were randomized into a treatment group and a placebo group by a computer generated allocation sheet with 1:1...
October 19, 2016: Chinese Journal of Integrative Medicine
Shobhit Srivastava, Anil K Saksena, Sanjay Khattri, Santosh Kumar, Raghubendra Singh Dagur
BACKGROUND AND PURPOSE: Curcuma longa L. (CL), an Indian herb, has been used to treat many disorders because of its wide spectrum of pharmacological activities. It has been shown to exhibit anti-oxidant and anti-inflammatory properties, and is being used as herbal remedy since ancient times. Osteoarthritis of knee (KOA) is a chronic painful disorder in which prolong use of non-steroidal anti-inflammatory drugs (NSAIDs) or steroids may result into many serious side effects; hence, there is a need to develop herbal drugs, having good analgesia without side effects...
October 19, 2016: Inflammopharmacology
Karla Zanolla Dias de Souza, Fabiene Bernardes Castro Vale, Selmo Geber
OBJECTIVE: The objective of this study was to evaluate the efficacy of Tribulus terrestris for the treatment of hypoactive sexual desire disorder in postmenopausal women and evaluate its effect on the serum levels of testosterone. METHODS: We performed a prospective randomized, double-blinded, placebo-controlled study, during 18 months. A total of 45 healthy sexually active postmenopausal women reporting diminished libido were selected to participate in the study and were randomly assigned to receive 750 mg/d of T terrestris or placebo for 120 days...
October 10, 2016: Menopause: the Journal of the North American Menopause Society
James A Simon, Tatiana Gaines, Katherine D LaGuardia
OBJECTIVE: Assess effects of once-daily, extended-release oxybutynin chloride on frequency and severity of vasomotor symptoms in healthy, postmenopausal symptomatic women. METHODS: A 12-week, multicenter, double-blind, placebo-controlled, phase 2 clinical trial randomized naturally postmenopausal women experiencing at least seven moderate-to-severe vasomotor symptoms daily to oxybutynin 15 mg once daily (n = 73) or placebo (n = 75). Co-primary outcomes were the change from baseline to week 12 in the frequency and severity of moderate-to-severe vasomotor symptoms...
October 10, 2016: Menopause: the Journal of the North American Menopause Society
Ana Rosa Cunha, Jenifer D'El-Rei, Fernanda Medeiros, Bianca Umbelino, Wille Oigman, Rhian M Touyz, Mario F Neves
BACKGROUND: Epidemiological studies demonstrate an inverse association between serum magnesium and incidence of cardiovascular disease. Diuretics commonly cause hypomagneseamia. METHOD: We evaluated effects of magnesium supplementation on blood pressure (BP) and vascular function in thiazide-treated hypertensive women in a randomized, double-blind, clinical trial. Hypertensive women (40-65 years) on hydrochlorothiazide and mean 24-h BP at least 130/80 mmHg were divided into placebo and supplementation (magnesium chelate 600 mg/day) groups...
October 18, 2016: Journal of Hypertension
V E Radzinskii, I V Kuznetsova, Y B Uspenskaya, N B Repina, Y K Gusak, O M Zubova, D I Burchakov, A A Osmakova
Peri- and postmenopausal women commonly suffer from climacteric symptoms. We evaluated the effectiveness and safety of dietary supplement Amberen to relieve vasomotor and psychosomatic symptoms during the course of a 3-month, randomized, double-blind, placebo-controlled study. General clinical assessment, evaluation using the Greene climacteric test and Spielberger-Hanin test, determination of plasma levels of gonadotropins, estradiol, leptin and apolipoproteins were used to evaluate 42-60-year-old women with vasomotor and psychosomatic menopausal symptoms...
October 2016: Gynecological Endocrinology
Sergio Amaro, Carlos Laredo, Arturo Renú, Laura Llull, Salvatore Rudilosso, Víctor Obach, Xabier Urra, Anna M Planas, Ángel Chamorro
BACKGROUND AND PURPOSE: Identification of neuroprotective therapies in acute ischemic stroke is imperative. We report a predefined analysis of the URICO-ICTUS trial (Efficacy Study of Combined Treatment With Uric Acid and r-tPA in Acute Ischemic Stroke) assessing the efficacy of uric acid (UA) compared with placebo to prevent early ischemic worsening (EIW) and the relevance of collateral circulation. METHODS: URICO-ICTUS was a double-blind, placebo-controlled, phase 2b trial where a total of 411 patients treated with alteplase within 4...
October 6, 2016: Stroke; a Journal of Cerebral Circulation
Sadegh Feizollahzadeh, Reza Ghiasvand, Abbas Rezaei, Hossein Khanahmad, Akram Sadeghi, Mitra Hariri
Probiotic therapies are going to be an effective alternative therapeutic strategy in the treatment and management of diabetes. The mechanism behind the essential effects of probiotic therapies in diabetic patients was not fully understood. The objective of this study was to evaluate the effects of probiotic soy milk containing Lactobacillus planetarum A7 on inflammation, lipid profile, fasting blood glucose, and serum adiponectin among patients with type 2 diabetes mellitus. Forty patients with type 2 diabetes, at the age of 35-68 years old, were assigned to two groups in this randomized, double-blind, controlled clinical trial...
October 18, 2016: Probiotics and Antimicrobial Proteins
John S Mason, Michael Crowell, Jeffery Dolbeer, Jamie Morris, Aspen Terry, Shane Koppenhaver, Donald Lee Goss
BACKGROUND: Recently, dry needling has emerged as a popular treatment for muscular pain and impairments. While there are numerous studies detailing the benefits of dry needling for pain, few studies exist examining the effects on soft tissue mobility. PURPOSE: The purpose of this study was to determine if the addition of hamstring dry needling to a standard stretching program results in greater improvements in hamstring flexibility compared to sham dry needling and stretching in subjects with atraumatic knee pain...
October 2016: International Journal of Sports Physical Therapy
Nasrin Rafieian, Hamidreza Abdolsamadi, Aliakbar Moghadamnia, Mina Jazayeri, Mohammadali Seif-Rabiee, Mina Salmanzadeh, Shahrbanoo Radi
BACKGROUND: Recurrent aphthous stomatitis (RAS) is the most common painful ulcers of oral mucosal which can cause many sufferings. Treatment of RAS often includes administration of corticosteroids, analgesics and regulators of the immune system. However, considering the side effects of these medications, even their topical application must be done with caution. Alum is used in traditional medicine for treatment of oral ulcers without significant side effect. This study sought to assess the effect of topical application of alum on aphthous ulcers...
2016: Caspian Journal of Internal Medicine
Sharon B Wigal, Tim Wigal, Ann Childress, Graeme A E Donnelly, Joseph L Reiz
OBJECTIVE: The aim of this study is to assess the onset and duration of efficacy of multilayer-release methylphenidate (PRC-063) over 16 hr compared with placebo in adults with ADHD using the simulated adult workplace environment. METHOD: After dose-optimization with PRC-063, participants entered a double-blind, placebo-controlled, crossover phase. Primary outcome measure was the Permanent Product Measure of Performance (PERMP) total score measured pre-dose and from 1 to 16 hr post-dose...
October 17, 2016: Journal of Attention Disorders
Laura M Gault, Robert A Lenz, Craig W Ritchie, Andreas Meier, Ahmed A Othman, Qi Tang, Scott Berry, Yili Pritchett, Weining Z Robieson
BACKGROUND: Results from a phase 2a study indicated that treatment with the novel α7 nicotinic acetylcholine receptor agonist ABT-126 25 mg once daily (QD) was associated with a trend for improvement in cognition in subjects with mild-to-moderate Alzheimer's dementia (AD). A phase 2b program was designed to evaluate a broader dose range of ABT-126 as monotherapy in subjects with mild-to-moderate AD. The program consisted of a double-blind, placebo and active controlled study of ABT-126 (dose range 25-75 mg) and an open-label extension study (75 mg)...
October 18, 2016: Alzheimer's Research & Therapy
Teruki Aizawa, Ayaka Yamamoto, Tomoya Ueno
Theaflavins are reddish-colored polyphenols in black tea. To test the efficacy of theaflavin administration on body fat and muscle, we performed a randomized, double-blind, placebo-controlled study and investigated the effect of theaflavins administration on the body composition using of healthy subjects. In this study, 30 male and female Japanese were enrolled and participants were randomly allocated to receive placebo, theaflavin (50 or 100 mg/day), or catechin (400 mg/ml) for 10 weeks. The effects were evaluated using body weight, body fat percentage, subcutaneous fat percentage, and skeletal muscle percentage...
October 19, 2016: Bioscience, Biotechnology, and Biochemistry
Terence A Ketter, Suresh Durgam, Ronald Landbloom, Mary Mackle, Xiao Wu, Maju Mathews
BACKGROUND: Asenapine (ASN) is approved in the United States as monotherapy and adjunctive therapy (to lithium or valproate) in adults with bipolar mania, and as monotherapy in pediatric patients with bipolar mania. This is the first long-term study evaluating safety and tolerability of ASN fixed doses in this population. METHODS: After completing a 3-week, randomized, placebo (PBO)-controlled acute trial, patients could enroll in this 26-week, fixed-dose (5 or 10mg twice daily), double-blind extension study...
October 14, 2016: Journal of Affective Disorders
Sui Cheung Man, Xian-Bin Li, Huai-Hai Wang, Hai-Ning Yuan, Hua-Ning Wang, Rui-Guo Zhang, Qing-Rong Tan, Hei Kiu Wong, Grainne M McAlonan, Chuan-Yue Wang, Zhang-Jin Zhang
OBJECTIVES: An herbal preparation called peony-glycyrrhiza decoction (PGD) may have the potential in reducing antipsychotic-related hyperprolactinemia (hyperPRL). This double-blind, randomized placebo-controlled study aimed to reevaluate the efficacy of PGD against antipsychotic-related hyperPRL. METHODS: Ninety-nine schizophrenic women who were under antipsychotic therapy and had symptomatic hyperPRL were randomly assigned to additional treatment with placebo (n = 50) or PGD (n = 49, 45 g/d) for 16 weeks...
October 13, 2016: Journal of Clinical Psychopharmacology
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