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1.
J Int Soc Sports Nutr ; 18(1): 60, 2021 Sep 09.
Artículo en Inglés | MEDLINE | ID: mdl-34503541

RESUMEN

BACKGROUND: Numerous studies have demonstrated the efficacy of creatine supplementation for improvements in exercise performance. Few studies, however, have examined the effects of phosphocreatine supplementation on exercise performance. Furthermore, while polyphenols have antioxidant and anti-inflammatory properties, little is known regarding the influence of polyphenol supplementation on muscular strength, power, and endurance. Thus, the purpose of the present study was to compare the effects of 28 days of supplementation with phosphocreatine disodium salts plus blueberry extract (PCDSB), creatine monohydrate (CM), and placebo on measures of muscular strength, power, and endurance. METHODS: Thirty-three men were randomly assigned to consume either PCDSB, CM, or placebo for 28 days. Peak torque (PT), average power (AP), and percent decline for peak torque (PT%) and average power (AP%) were assessed from a fatigue test consisting of 50 maximal, unilateral, isokinetic leg extensions at 180°·s- 1 before and after the 28 days of supplementation. Individual responses were assessed to examine the proportion of subjects that exceeded a minimal important difference (MID). RESULTS: The results demonstrated significant (p < 0.05) improvements in PT for the PCDSB and CM groups from pre- (99.90 ± 22.47 N·m and 99.95 ± 22.50 N·m, respectively) to post-supplementation (119.22 ± 29.87 N·m and 111.97 ± 24.50 N·m, respectively), but no significant (p = 0.112) change for the placebo group. The PCDSB and CM groups also exhibited significant improvements in AP from pre- (140.18 ± 32.08 W and 143.42 ± 33.84 W, respectively) to post-supplementation (170.12 ± 42.68 W and 159.78 ± 31.20 W, respectively), but no significant (p = 0.279) change for the placebo group. A significantly (p < 0.05) greater proportion of subjects in the PCDSB group exceeded the MID for PT compared to the placebo group, but there were no significant (p > 0.05) differences in the proportion of subjects exceeding the MID between the CM and placebo groups or between the CM and PCDSB groups. CONCLUSIONS: These findings indicated that for the group mean responses, 28 days of supplementation with both PCDSB and CM resulted in increases in PT and AP. The PCDSB, however, may have an advantage over CM when compared to the placebo group for the proportion of individuals that respond favorably to supplementation with meaningful increases in muscular strength.


Asunto(s)
Fuerza Muscular/efectos de los fármacos , Músculo Esquelético/efectos de los fármacos , Fosfocreatina/farmacología , Resistencia Física/efectos de los fármacos , Extractos Vegetales/farmacología , Arándanos Azules (Planta)/química , Creatina , Suplementos Dietéticos , Método Doble Ciego , Humanos , Masculino , Torque , Adulto Joven
2.
Am J Gastroenterol ; 116(9): 1929-1937, 2021 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-34465695

RESUMEN

INTRODUCTION: Linaclotide improves abdominal pain and constipation in patients with constipation-predominant irritable bowel syndrome (IBS-C). Patients report additional bothersome abdominal symptoms of bloating and discomfort. The intention of this study was to evaluate linaclotide's efficacy in relieving IBS-C-related abdominal symptoms (bloating, discomfort, and pain) using a novel multi-item Abdominal Score (AS). METHODS: Patients with IBS-C with abdominal pain ≥3 (0-10 scale) were randomized to linaclotide 290 µg or placebo daily for 12 weeks. The AS, derived from the Diary for IBS Symptoms-Constipation, is the average of abdominal bloating, discomfort, and pain at their worst (0 = none, 10 = worst possible). The primary end point was overall change from baseline (CFB) in AS. Secondary end points included CFB in 12-week AS evaluated using cumulative distribution function and 6-week/12-week AS responder (AS improvement ≥2 points for ≥6-week/12-week). RESULTS: Overall, 614 patients (mean age 46.7 years; 81% female) were randomized. All prespecified end points showed significant benefit of linaclotide vs placebo. The mean overall CFB AS reduction for linaclotide was -1.9 vs -1.2 for placebo (P < 0.0001); the 6-week/12-week AS responder rate was 40.5% for linaclotide vs 23.4% for placebo (odds ratio = 2.2 [95% confidence interval, 1.55-3.12; P < 0.0001]). Diarrhea was the most common treatment-emergent adverse event (linaclotide = 4.6%, placebo = 1.6%). DISCUSSION: Linaclotide significantly reduced multiple abdominal symptoms important to patients with IBS-C (bloating, discomfort, and pain) compared with placebo, as measured by a novel multi-item AS. The AS, derived from the Diary for IBS Symptoms-Constipation, should be considered for use in future IBS-C clinical studies to measure clinically meaningful improvements beyond traditional end points.


Asunto(s)
Dolor Abdominal/tratamiento farmacológico , Estreñimiento/tratamiento farmacológico , Fármacos Gastrointestinales/uso terapéutico , Agonistas de la Guanilato Ciclasa C/uso terapéutico , Péptidos/uso terapéutico , Adulto , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
3.
Isr Med Assoc J ; 23(9): 563-568, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34472231

RESUMEN

BACKGROUND: Infants born very prematurely have functionally and structurally immature gastrointestinal tracts. OBJECTIVES: To assess the safety and tolerability of administration of enteral recombinant human (rh) insulin on formula fed preterm infants and to assess whether enteral administration of rh-insulin enhances gastrointestinal tract maturation by reducing the time to reach full enteral feeding. METHODS: A phase 2, multicenter, double-blind, placebo-controlled, randomized study was conducted. Premature infants (26-33 weeks gestation) were randomized 1:1 to receive insulin 400 µU/ml mixed with enteral feeding or placebo added to their formula. The primary efficacy outcome measure was the number of days required to achieve full enteral feeding. Safety outcomes included adverse events and blood glucose levels. RESULTS: The study consisted of 33 infants randomized for the safety population and 31 for efficacy analysis. The mean time to full enteral feeding was 6.37 days (95% confidence interval [95%CI] 4.59-8.15) in the enteral rh-insulin treatment group (n=16) and 8.00 days (95%CI 6.20-9.80) in the placebo group (n=15), which represents a statistically significant reduction of 1.63 days (95%CI 0.29-2.97; P = 0.023). There was no difference in blood glucose levels between the groups and none of the participants experienced hypoglycemia. Adverse events occurred in 9/17 (53%) infants in the enteral rh-insulin group and 12/16 (75%) in the placebo group. CONCLUSIONS: Our trial demonstrated that administration of enteral rh-insulin as supplement to enteral nutrition significantly reduced time to achieve full enteral feeding in preterm infants with a gestational age of 26-33 weeks.


Asunto(s)
Nutrición Enteral/estadística & datos numéricos , Hipoglucemiantes/administración & dosificación , Recien Nacido Prematuro , Insulina/administración & dosificación , Glucemia/efectos de los fármacos , Método Doble Ciego , Femenino , Edad Gestacional , Humanos , Hipoglucemiantes/efectos adversos , Recién Nacido , Insulina/efectos adversos , Masculino , Factores de Tiempo
4.
Shanghai Kou Qiang Yi Xue ; 30(3): 312-315, 2021 Jun.
Artículo en Chino | MEDLINE | ID: mdl-34476452

RESUMEN

PURPOSE: To investigate the effect of toothpaste containing emulsifier 30 and sodium lauryl sulfate surfactant on the integrity of oral epithelium. METHODS: Sixty individuals equally divided into 2 groups by random number table methods. Group A received toothpaste containing emulsifier 30, while group B received fluoride toothpaste containing sodium lauryl sulfate (SLS) surfactant. The exfoliation of oral soft tissue was evaluated before, 30 minutes and 4 days after the test. The fluoride concentration in plaque and saliva was compared between the two groups. The data were processed with SPSS 22.0 software package. RESULTS: The scores of oral soft tissue exfoliation at 30 min and 4 d after the test were increased significantly (P<0.05). The scores of subgingival, supragingival, oral apex and oral soft tissue exfoliation of group A at 30 min after using the paste were significantly lower than those 4 days after using the paste(P<0.05), while no significant change was observed in the score of oral soft tissue exfoliation at the dorsal tongue(P>0.05). The total scores of subgingival, supragingival, dorsal tongue, ventral tongue and oral soft tissue exfoliation in group B 30 min after using the paste were significantly higher than those at 4 d after use, and the score of oral soft tissue exfoliation at oral apex was significantly lower than that at 4 d after use (P<0.05).The total scores of subgingival, supragingival, dorsal tongue, ventral tongue and oral soft tissue exfoliation in group B at 30 min after using the paste were significantly higher than those of group A, while the score of oral soft tissue exfoliation at oral apex was significantly lower than that of group A(P<0.05).The total scores of subgingival, supragingival, ventral tongue and oral soft tissue exfoliation in group B at 4 d after using the paste were significantly higher than those of group A(P<0.05). The scores of oral soft tissue exfoliation at oral apex and dorsal tongue at 4 d after use had no significant difference between the two groups (P>0.05). The fluoride concentration in plaque and saliva was increased significantly in both groups after test(P<0.05). CONCLUSIONS: Both fluoride toothpaste containing emulsifier 30 and SLS surfactant cause a certain degree of oral soft tissue exfoliation. In comparison, fluoride toothpaste containing emulsifier 30 has less oral soft tissue damage; moreover, the two fluoride toothpastes can effectively inhibit acid production of plaque bacteria and prevent occurrence of caries.


Asunto(s)
Tensoactivos , Pastas de Dientes , Método Doble Ciego , Epitelio , Fluoruros , Humanos , Dodecil Sulfato de Sodio , Fluoruro de Sodio
5.
Trials ; 22(1): 585, 2021 Sep 03.
Artículo en Inglés | MEDLINE | ID: mdl-34479619

RESUMEN

BACKGROUND: Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. METHODS: This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. DISCUSSION: The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. TRIAL REGISTRATION: ClinicalTrials.gov NCT04210973 . Registered on December 26, 2019.


Asunto(s)
Trastorno Depresivo Mayor , Adulto , China , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/tratamiento farmacológico , Método Doble Ciego , Humanos , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
6.
Medicine (Baltimore) ; 100(36): e27086, 2021 Sep 10.
Artículo en Inglés | MEDLINE | ID: mdl-34516497

RESUMEN

BACKGROUND: Knee osteoarthritis (KOA) is a chronic degenerative joint disease, which is the most common type of osteoarthritis. The clinical manifestations are pain, swelling, and dysfunction of the knee joint, which seriously reduces the quality of life of patients and causes a huge social burden. At present, western medicine mainly focuses on symptomatic treatment, such as anti-inflammatory and pain relief, joint cavity injection, joint replacement, etc. The curative effect has certain limitations. Xianling Gubao capsule has some advantages in the treatment of KOA, but it lacks high-quality clinical research to verify it. Therefore, the purpose of this study is to evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. METHODS: A randomized, double-blind, double-simulation, parallel controlled trial design was used to study the efficacy and safety of Xianling Gubao capsules in the treatment of KOA. The patients were randomly divided into a treatment group and the control group according to 1:1. The treatment group: Xianling Gubao capsule + glucosamine hydrochloride capsule simulation agent treatment; the control group: glucosamine hydrochloride capsule + Xianling Gubao capsule simulation agent treatment. Both groups received standard treatment for 8 weeks and followed up for 30 days. And at the same time, pay attention to its efficacy and safety indicators. Observation indicators include: the western Ontario and McMaster universities osteoarthritis index, hospital for special surgery knee score, liver and kidney function, adverse reactions, etc. Data analysis was performed using SPSS 25.0 software. DISCUSSION: This study will evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. The results of this experiment will provide evidence support for Xianling Gubao capsule in the treatment of KOA. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/ERM9C.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Osteoartritis de la Rodilla/tratamiento farmacológico , Administración Oral , Método Doble Ciego , Medicamentos Herbarios Chinos/administración & dosificación , Humanos , Fitoterapia , Ensayos Clínicos Controlados Aleatorios como Asunto
7.
Medicine (Baltimore) ; 100(35): e26873, 2021 Sep 03.
Artículo en Inglés | MEDLINE | ID: mdl-34477120

RESUMEN

ABSTRACT: Meloxicam is commonly administrated to control postoperative pain in orthopedic surgery, while its efficacy in total knee arthroplasty (TKA) is not clear. Therefore, this study aimed to explore the postoperative analgesic effect and tolerance of meloxicam in knee osteoarthritis (OA) patients undergoing TKA.Totally, 128 knee OA patients scheduled for TKA were enrolled in this randomized, controlled, double-blind study, then randomized into meloxicam group (N = 65) and control group (N = 63) as 1:1 ratio. Patients took meloxicam or placebo from 4 hours (h) to 72 h after TKA. Patients were followed up at 6 h, 12 h, day (D)1, D2, D3, D7, month (M)1, and M3.Pain visual analog scale score at rest was decreased in meloxicam group at 12 h, D1 and D3 compared to control group; pain visual analog scale score at flexion was reduced in meloxicam group at 6 h, 12 h, D1, D2, and D3 compared to control group. Additional and total consumption of patient-controlled analgesia were both attenuated in meloxicam group compared to control group. Furthermore, patient satisfaction score was higher on D1, D2, D3 in meloxicam group compared to control group. However, no difference of hospital for special surgery knee score score at M1 or M3 was found between the 2 groups. Moreover, the occurrence of adverse events was similar between the 2 groups.Meloxicam displays good effect on controlling postoperative pain and improving patient satisfaction, while does not affect long-term knee function recovery or safety profile in knee OA patients undergoing TKA.


Asunto(s)
Meloxicam/normas , Osteoartritis de la Rodilla/tratamiento farmacológico , Anciano , Antiinflamatorios no Esteroideos/normas , Antiinflamatorios no Esteroideos/uso terapéutico , Artroplastia de Reemplazo de Rodilla/métodos , Artroplastia de Reemplazo de Rodilla/estadística & datos numéricos , Distribución de Chi-Cuadrado , Método Doble Ciego , Femenino , Humanos , Masculino , Meloxicam/uso terapéutico , Persona de Mediana Edad , Manejo del Dolor/métodos , Manejo del Dolor/estadística & datos numéricos , Dimensión del Dolor/métodos , Recuperación de la Función
8.
J Refract Surg ; 37(9): 582-589, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34506240

RESUMEN

PURPOSE: To compare the efficacy of oral codeine plus acetaminophen versus oxycodone plus acetaminophen for severe pain control following photorefractive keratectomy (PRK). METHODS: This single-center trial randomized 200 patients to receive codeine 30 mg/acetaminophen 325 mg (codeine group) or oxycodone 5 mg/acetaminophen 325 mg (oxycodone group)every 4 hours as needed for severe pain for 4 days following PRK. Patients recorded postoperative pain, tablet consumption, and tetracaine use. Patients were monitored at postoperative 1 day, 1 week, and 1, 3, and 6 months for visual acuity and follow-up. Study outcomes were mean postoperative pain, treatment and tetracaine use, and visual acuity. RESULTS: Analysis of 197 patients who completed the trial (97 codeine group and 100 oxycodone group) showed mean pain scores were lower in the codeine group throughout the intervention period. Mean pain scores were higher in the oxycodone group than the codeine group on postoperative days 2 and 4 (P = .017 and P = .034, respectively). The oxycodone group consumed more tablets than the codeine group, with a difference on postoperative day 2 (P = .019), and used a greater number of tetracaine drops (P = .015). Repeated measures analysis of variance showed significant improvement in visual acuity in both groups with no difference in visual outcomes (P = .81). CONCLUSIONS: Codeine/acetaminophen is as effective and safe as oxycodone/acetaminophen for pain control following PRK, with no clinical difference in overall pain control and long-term visual outcomes. This implies that treating postoperative pain after PRK with a Schedule III opioid (codeine) is effective and potentially decreases the risk of misuse by a higher regulated Schedule II opioid (oxycodone), lowering the potential for abuse and dependence. [J Refract Surg. 2021;37(9):582-589.].


Asunto(s)
Oxicodona , Queratectomía Fotorrefractiva , Codeína , Método Doble Ciego , Humanos , Dimensión del Dolor , Dolor Postoperatorio/tratamiento farmacológico , Estudios Prospectivos
9.
BMC Psychiatry ; 21(1): 439, 2021 09 06.
Artículo en Inglés | MEDLINE | ID: mdl-34488701

RESUMEN

BACKGROUND: In people with intellectual disability (ID) and challenging behaviour, antipsychotics (AP) are often used off-label and for a long period. Despite a lack of evidence for efficacy for challenging behaviour and concerns about common and clinically relevant side effects, complete withdrawal often fails. We postulate three possible hypotheses for withdrawal failure: 1. Influence of subjective interpretation of behavioural symptoms by caregivers and family; 2. Beneficial effects from AP treatment on undiagnosed psychiatric illness, through improvement in sleep or a direct effect on behaviour; and 3. Misinterpretation of withdrawal symptoms as a recurrence of challenging behaviour. METHODS: To investigate our hypotheses, we have designed a multicentre double-blind, placebo-controlled randomised trial in which AP (pipamperone or risperidone) are withdrawn. In the withdrawal group, the AP dose is reduced by 25% every 4 weeks and in the control group the dose remains unaltered. Behaviour, sleep, psychiatric disorders, withdrawal symptoms and side effects will be measured and compared between the two groups. If drop-out from the protocol is similar in both groups (non-inferiority), the first hypothesis will be supported. If drop-out is higher in the withdrawal group and an increase is seen in psychiatric disorders, sleep problems and/or behavioural problems compared to the control group, this suggests effectiveness of AP, and indications for AP use should be reconsidered. If drop-out is higher in the withdrawal group and withdrawal symptoms and side effects are more common in the withdrawal group compared to the control group, this supports the hypothesis that withdrawal symptoms contribute to withdrawal failure. DISCUSSION: In order to develop AP withdrawal guidelines for people with ID, we need to understand why withdrawal of AP is not successful in the majority of people with ID and challenging behaviour. With this study, we will bridge the gap between the lack of available evidence on AP use and withdrawal on the one hand and the international policy drive to reduce prescription of AP in people with ID and challenging behaviour on the other hand. TRIAL REGISTRATION: This trial is registered in the Netherlands Trial Register (NTR 7232) on October 6, 2018 ( www.trialregister.nl ).


Asunto(s)
Antipsicóticos , Discapacidad Intelectual , Adulto , Antipsicóticos/uso terapéutico , Síntomas Conductuales , Método Doble Ciego , Humanos , Discapacidad Intelectual/complicaciones , Discapacidad Intelectual/tratamiento farmacológico , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Risperidona/uso terapéutico
10.
Trials ; 22(1): 595, 2021 Sep 06.
Artículo en Inglés | MEDLINE | ID: mdl-34488845

RESUMEN

BACKGROUND: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. METHODS: A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. DISCUSSION: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. TRIAL REGISTRATION: ClinicalTrials.gov NCT04466007 . Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.


Asunto(s)
COVID-19 , Diabetes Mellitus Tipo 2 , Trasplante de Células Madre Hematopoyéticas , Células Madre Mesenquimatosas , Noma , Tejido Adiposo , Animales , Ensayos Clínicos Fase II como Asunto , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Método Doble Ciego , Humanos , Isquemia/diagnóstico , Isquemia/terapia , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , SARS-CoV-2 , Resultado del Tratamiento
11.
JNMA J Nepal Med Assoc ; 59(236): 365-368, 2021 Apr 30.
Artículo en Inglés | MEDLINE | ID: mdl-34508534

RESUMEN

INTRODUCTION: Propofol is the most frequently used anaesthetic agent. Despite various anaesthetic benefits, propofol is not without side effects, pain on injection being the most common adverse effect. This study aimed to find the grade of pain reduced due to the injection of propofol after administration of lidocaine. METHODS: A descriptive cross-sectional study was conducted from March 2015 to August 2015 in the operating theatre in a tertiary care hospital after taking ethical clearance with an ethical clearance from the Institutional Review Committee. A total of 64 participants fulfilling all inclusion criteria of both gender, age ranged from 16-65 years of American Society of Anesthesiologists physical status I and II ready for elective surgery under general anaesthesia with propofol pretreated with 60mg lidocaine with venous occlusion for one minute were observed. The pain was graded by the four-point scale (0=none, 1=mild, 2=moderate, 3=severe). Haemodynamic variables were measured until just before intubation. RESULTS: In patients pretreated with lidocaine, no pain 56 (87.5%), mild pain 8 (12.5%) and moderate pain 0 (0%) were observed. CONCLUSIONS: The grade of pain during injection of propofol was reduced in more than three-fourth of the patients after administration of pre-anaesthetic drug-like lidocaine.


Asunto(s)
Propofol , Adolescente , Adulto , Anciano , Anestésicos Intravenosos/efectos adversos , Anestésicos Locales , Estudios Transversales , Método Doble Ciego , Humanos , Lidocaína , Persona de Mediana Edad , Dolor/tratamiento farmacológico , Dolor/etiología , Dolor/prevención & control , Propofol/efectos adversos , Centros de Atención Terciaria , Adulto Joven
12.
BMJ ; 374: n1448, 2021 06 30.
Artículo en Inglés | MEDLINE | ID: mdl-34526307

RESUMEN

OBJECTIVE: To determine whether dietary interventions that increase n-3 fatty acids with and without reduction in n-6 linoleic acid can alter circulating lipid mediators implicated in headache pathogenesis, and decrease headache in adults with migraine. DESIGN: Three arm, parallel group, randomized, modified double blind, controlled trial. SETTING: Ambulatory, academic medical center in the United States over 16 weeks. PARTICIPANTS: 182 participants (88% women, mean age 38 years) with migraines on 5-20 days per month (67% met criteria for chronic migraine). INTERVENTIONS: Three diets designed with eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and linoleic acid altered as controlled variables: H3 diet (n=61)-increase EPA+DHA to 1.5 g/day and maintain linoleic acid at around 7% of energy; H3-L6 diet (n=61)-increase n-3 EPA+DHA to 1.5 g/day and decrease linoleic acid to ≤1.8% of energy; control diet (n=60)-maintain EPA+DHA at <150 mg/day and linoleic acid at around 7% of energy. All participants received foods accounting for two thirds of daily food energy and continued usual care. MAIN OUTCOME MEASURES: The primary endpoints (week 16) were the antinociceptive mediator 17-hydroxydocosahexaenoic acid (17-HDHA) in blood and the headache impact test (HIT-6), a six item questionnaire assessing headache impact on quality of life. Headache frequency was assessed daily with an electronic diary. RESULTS: In intention-to-treat analyses (n=182), the H3-L6 and H3 diets increased circulating 17-HDHA (log ng/mL) compared with the control diet (baseline-adjusted mean difference 0.6, 95% confidence interval 0.2 to 0.9; 0.7, 0.4 to 1.1, respectively). The observed improvement in HIT-6 scores in the H3-L6 and H3 groups was not statistically significant (-1.6, -4.2 to 1.0, and -1.5, -4.2 to 1.2, respectively). Compared with the control diet, the H3-L6 and H3 diets decreased total headache hours per day (-1.7, -2.5 to -0.9, and -1.3, -2.1 to -0.5, respectively), moderate to severe headache hours per day (-0.8, -1.2 to -0.4, and -0.7, -1.1 to -0.3, respectively), and headache days per month (-4.0, -5.2 to -2.7, and -2.0, -3.3 to -0.7, respectively). The H3-L6 diet decreased headache days per month more than the H3 diet (-2.0, -3.2 to -0.8), suggesting additional benefit from lowering dietary linoleic acid. The H3-L6 and H3 diets altered n-3 and n-6 fatty acids and several of their nociceptive oxylipin derivatives in plasma, serum, erythrocytes or immune cells, but did not alter classic headache mediators calcitonin gene related peptide and prostaglandin E2. CONCLUSIONS: The H3-L6 and H3 interventions altered bioactive mediators implicated in headache pathogenesis and decreased frequency and severity of headaches, but did not significantly improve quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT02012790.


Asunto(s)
Ácidos Grasos Omega-3/administración & dosificación , Ácidos Grasos Omega-6/administración & dosificación , Trastornos Migrañosos/dietoterapia , Adulto , Ácidos Docosahexaenoicos/sangre , Método Doble Ciego , Ácidos Grasos Omega-3/metabolismo , Ácidos Grasos Omega-6/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Nocicepción , Autoinforme , Índice de Severidad de la Enfermedad
13.
J Headache Pain ; 22(1): 110, 2021 Sep 18.
Artículo en Inglés | MEDLINE | ID: mdl-34537006

RESUMEN

BACKGROUND: These subgroup analyses of a Phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of erenumab 70 mg in Japanese migraine patients with/without prior preventive treatment failure(s) ("failed-yes" and "failed-no" subgroups) and with/without concomitant preventive treatment ("concomitant preventive-yes" and "concomitant preventive-no" subgroups). METHODS: Overall, 261 patients were randomized; 130 and 131 patients to erenumab 70 mg and placebo, respectively. Subgroup analyses evaluated the change from baseline to Months 4-6 in mean monthly migraine days (MMD) (primary endpoint), achievement of a ≥50% reduction in mean MMD, and change from baseline in mean monthly acute migraine-specific medication (MSM) treatment days. Treatment-emergent adverse events were also evaluated. RESULTS: Of the 261 patients randomized, 117 (44.8%) and 92 (35.3%) patients were in the failed-yes and concomitant preventive-yes subgroups, respectively. Erenumab 70 mg demonstrated consistent efficacy across all subgroups, with greater reductions from baseline in mean MMD versus placebo at Months 4-6 (treatment difference versus placebo [95% CI], failed-yes: - 1.9 [- 3.3, - 0.4]; failed-no: - 1.4 [- 2.6, - 0.3]; concomitant preventive-yes: - 1.7 [- 3.3, 0.0]; concomitant preventive-no: - 1.6 [- 2.6, - 0.5]). Similar results were seen for achievement of ≥50% reduction in mean MMD and change from baseline in mean monthly acute MSM treatment days. The safety profile of erenumab 70 mg was similar across subgroups, and similar to placebo in each subgroup. CONCLUSION: Erenumab was associated with clinically relevant improvements in all efficacy endpoints and was well tolerated across all subgroups of Japanese migraine patients with/without prior preventive treatment failure(s) and with/without concomitant preventive treatment. TRIAL REGISTRATION: Clinicaltrials.gov . NCT03812224. Registered January 23, 2019.


Asunto(s)
Trastornos Migrañosos , Minorías Sexuales y de Género , Anticuerpos Monoclonales Humanizados , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina , Método Doble Ciego , Homosexualidad Masculina , Humanos , Japón , Masculino , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/prevención & control , Insuficiencia del Tratamiento , Resultado del Tratamiento
14.
J Headache Pain ; 22(1): 111, 2021 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-34544359

RESUMEN

BACKGROUND: Calcitonin gene-related peptide (CGRP) (receptor) antibodies (erenumab, fremanezumab and galcanezumab) are increasingly used in prophylactic treatment of migraine. In the approval studies, severely affected patients with migraine and chronic daily headache without any headache free days were excluded. Thus, less is known about the effectiveness of CGRP antibody treatment in this cohort. METHODS: Clinical routine data of 32 patients with migraine and daily headache were analysed after three months of treatment with a CGRP antibody (16 erenumab, 7 galcanezumab, 9 fremanezumab), including changes of monthly headache days (MHD) monthly migraine days (MMD) and monthly acute medication intake (AMD) as well as migraine characteristics. Statistical analysis was performed with the Wilcoxon-Test. Migraine characteristics were analysed descriptively. RESULTS: The number of MHD was significantly reduced (mean reduction (standard error), p-value): (-4.2 (1.3), p = 0.009) as well as MMD (-4.3 (1.6), p = 0.033). Four patients (13 %) reached a 50 % reduction regarding MHD and 8 patients (25 %) regarding MMD, migraine duration and intensity improved under therapy. CONCLUSIONS: Despite the low responder rate, CGRP antibodies can be effective at least in a few cases of severely affected patients with drug resistant migraine and chronic daily headache. TRIAL REGISTRATION: Retrospective registered.


Asunto(s)
Trastornos Migrañosos , Preparaciones Farmacéuticas , Calcitonina , Péptido Relacionado con Gen de Calcitonina , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina , Método Doble Ciego , Humanos , Trastornos Migrañosos/tratamiento farmacológico , Estudios Retrospectivos , Resultado del Tratamiento
15.
Trials ; 22(1): 643, 2021 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-34544463

RESUMEN

BACKGROUND: Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a Phase I clinical trial. Here, we present the protocol for a Phase IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients. METHODS: This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of 7 days, ensued by a follow-up period of another 21 days. DISCUSSION: The patients to be included in this trial will be severely sick and in need of mechanical ventilation. The amount of data to be collected upon screening and during the course of the intervention phase is substantial and the potential timeframe for inclusion of any given patient is short. However, when prepared properly, adherence to this protocol will make for the acquisition of reliable data. Particular diligence needs to be exercised with respect to informed consent, because eligible patients will most likely be comatose and/or deeply sedated at the time of inclusion. TRIAL REGISTRATION: This trial was prospectively registered with the EU Clinical trials register (clinicaltrialsregister.eu). EudraCT Number: 2017-003855-47 .


Asunto(s)
COVID-19 , Edema Pulmonar , Síndrome de Dificultad Respiratoria , Método Doble Ciego , Edema , Humanos , Péptidos Cíclicos , Permeabilidad , Edema Pulmonar/diagnóstico , Edema Pulmonar/tratamiento farmacológico , Síndrome de Dificultad Respiratoria/diagnóstico , Síndrome de Dificultad Respiratoria/tratamiento farmacológico , SARS-CoV-2 , Resultado del Tratamiento
16.
Trials ; 22(1): 642, 2021 Sep 20.
Artículo en Inglés | MEDLINE | ID: mdl-34544470

RESUMEN

BACKGROUND: Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of choice although almost half of the resected patients get recurrence in the liver. METHODS: The ASAC trial is a Scandinavian, multicentre, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose aspirin (acetylsalicylic acid (ASA)) can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo, for a period of 3 years or until disease recurrence. The patients will be recruited at all major hepatobiliary surgical units in Norway, Sweden and Denmark and have follow-up according to standard of care and the National Guidelines. DISCUSSION: The ASAC trial will be the first clinical interventional trial to assess the potential beneficial role of ASA in recurrence of CRCLM and survival. ASA is an inexpensive, well-tolerated and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRCLM if the study shows a beneficial effect. We will also determine the effect of ASA as adjuvant treatment on Health-Related Quality of Life and the cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03326791 . Registered on 31 October 2017.


Asunto(s)
Neoplasias Colorrectales , Neoplasias Hepáticas , Aspirina/efectos adversos , Neoplasias Colorrectales/prevención & control , Método Doble Ciego , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/prevención & control , Estudios Multicéntricos como Asunto , Recurrencia Local de Neoplasia/prevención & control , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Prevención Secundaria
17.
N Engl J Med ; 385(11): 982-995, 2021 09 09.
Artículo en Inglés | MEDLINE | ID: mdl-34496174

RESUMEN

BACKGROUND: Universal provision of iron supplements (drops or syrup) or multiple micronutrient powders to young children in low-to-middle-income countries where anemia is prevalent is recommended by the World Health Organization and widely implemented. The functional benefits and safety of these interventions are unclear. METHODS: We conducted a three-group, double-blind, double-dummy, individually randomized, placebo-controlled trial to assess the immediate and medium-term benefits and risks of 3 months of daily supplementation with iron syrup or iron-containing multiple micronutrient powders, as compared with placebo, in 8-month-old children in rural Bangladesh. The primary outcome was cognitive development, as assessed by the cognitive composite score on the Bayley Scales of Infant and Toddler Development, third edition, immediately after completion of the assigned 3-month regimen; scores range from 55 to 145, with higher scores indicating better cognitive performance. Secondary outcomes included the cognitive composite score at 9 months after completion of the assigned regimen; behavioral, language, and motor development, as well as growth and hematologic markers, immediately after completion and at 9 months after completion; and safety. RESULTS: We randomly assigned 3300 infants to receive iron syrup (1101 infants), multiple micronutrient powders (1099), or placebo (1100) daily. After completion of the assigned 3-month regimen, no apparent effect on the cognitive composite score was observed with iron syrup as compared with placebo (mean between-group difference in change in score from baseline, -0.30 points; 95% confidence interval [CI], -1.08 to 0.48) or with multiple micronutrient powders as compared with placebo (mean between-group difference in change in score from baseline, 0.23 points; 95% CI, -0.55 to 1.00). No apparent effect on any other developmental or growth outcome was observed immediately after completion of the assigned regimen or at 9 months after completion. At 9 months after completion of the assigned regimen, the prevalences of anemia, iron deficiency, and iron deficiency anemia increased in all three trial groups but remained lower among the children who received iron syrup or multiple micronutrient powders than among those who received placebo. The risk of serious adverse events and incidence of symptoms of infection were similar in the three trial groups. CONCLUSIONS: In this trial involving infants in Bangladesh, 3 months of daily supplementation with iron syrup or multiple micronutrient powders did not appear to have an effect on child development or other functional outcomes as compared with placebo. (Funded by the National Health and Medical Research Council of Australia; BRISC Australian New Zealand Clinical Trials Registry number, ACTRN12617000660381.).


Asunto(s)
Anemia Ferropénica/tratamiento farmacológico , Desarrollo Infantil/efectos de los fármacos , Suplementos Dietéticos , Micronutrientes/uso terapéutico , Anemia Ferropénica/prevención & control , Bangladesh , Cognición/efectos de los fármacos , Método Doble Ciego , Femenino , Hemoglobinas/análisis , Humanos , Lactante , Desarrollo del Lenguaje , Masculino , Población Rural
18.
BMJ Open ; 11(9): e047099, 2021 09 02.
Artículo en Inglés | MEDLINE | ID: mdl-34475155

RESUMEN

INTRODUCTION: Experimental and clinical data demonstrate that skin diseases like psoriasis are affected by psychological factors and can be modulated by interventions other than conventional drug therapy. The expectation of patients towards the benefit of a forthcoming treatment as well as treatment pre-experiences have been demonstrated as crucial factors mediating placebo responses in inflammatory skin diseases. However, it is unknown whether and to what extent treatment outcomes of psoriasis patients under therapy with monoclonal antibodies like secukinumab can be experimentally modulated at subjective and physiological levels by modifying the expectation of patients via verbal instruction or prior experience. METHODS AND ANALYSIS: Treatment expectations will be modulated in patients with moderate-to-severe psoriasis undergoing treatment with the anti-interleukin-17A monoclonal antibody secukinumab. Patients with a Psoriasis Area and Severity Index (PASI) >12 will be randomly allocated to one of three groups (N=40 each). As a standard schedule, patients in the pharmacological control group (group 1) will be treated weekly with 300 mg secukinumab, while patients in groups 2 and 3 will receive only 75 mg secukinumab (75% dose reduction) during all treatment weeks. In addition to the injections, patients in group 3 will ingest a novel tasting drink, with a cover story explaining that previous studies showed additional beneficial effects of this combination (drug and drink). Patients will be assessed and treated at nine visits over a 16-week period, during which the severity of pain and itch symptoms, skin lesions and quality of life will be analysed with standardised questionnaires and the PASI. ETHICS AND DISSEMINATION: This study was approved by the Ethics committee of the Medical Faculty of the University Duisburg-Essen. Study outcomes will be published in peer-reviewed scientific journals.


Asunto(s)
Psoriasis , Calidad de Vida , Método Doble Ciego , Humanos , Motivación , Dolor/tratamiento farmacológico , Psoriasis/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
19.
BMJ Open ; 11(9): e047142, 2021 09 02.
Artículo en Inglés | MEDLINE | ID: mdl-34475156

RESUMEN

INTRODUCTION: For over more than a decade, low-dose amitriptyline and mirtazapine are prescribed off-label for insomnia. However, placebo-controlled evidence on these antidepressants for insomnia is still lacking. Therefore, the present trial aims to assess the effectiveness of low-dose amitriptyline (10-20 mg/day) and mirtazapine (7.5-15 mg/day) in patients with insomnia disorder with difficulty maintaining sleep or early-morning awakening problems in general practice. METHODS AND ANALYSIS: The Drug REdiscovery: low-dose Amitriptyline and Mirtazapine for INsomnia disorder in General practice (DREAMING) study is a randomised, double-blind, placebo-controlled trial in about 50 general practices. Adults (18-85 years) with insomnia disorder (Diagnostic and Statistical Manual of Mental Disorders-5) who ask their general practitioner (GP) for sleep medication when non-pharmacological treatment is deemed not effective, are eligible. EXCLUSION CRITERIA: isolated sleep initiation problem, contraindications for or drug-drug interactions with either amitriptyline or mirtazapine. Participants (n=156) will be randomly assigned to three parallel treatment groups of 16-week treatment with either amitriptyline (one or two tablets of 10 mg/day) or mirtazapine (one or two tablets of 7.5 mg/day) or placebo (one or two tablets) alongside usual GP care. All participants start and end with single dose, but dose can be doubled following GP consultation in week 3. Questionnaire assessments will be conducted at baseline, week 6, 12, 20 and 52. The primary study outcome is self-reported insomnia severity at 6 weeks, measured with the Insomnia Severity Index (ISI) in an intention to treat analysis. Secondary outcomes include subjective sleep quality quantified by sleep indices, daytime functioning and symptoms, safety and treatment evaluation and other sleep care consumption. ETHICS AND DISSEMINATION: The Medical Ethics Committee of the VU Medical Centre Amsterdam approved this trial. The results of this trial will be published in peer-reviewed scientific journals and presented at relevant academic conferences and to key stakeholders. TRIAL REGISTRATION NUMBER: NTR7449.


Asunto(s)
Medicina General , Trastornos del Inicio y del Mantenimiento del Sueño , Adulto , Amitriptilina , Antidepresivos/uso terapéutico , Método Doble Ciego , Humanos , Mirtazapina , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Resultado del Tratamiento
20.
N Engl J Med ; 385(7): 595-608, 2021 08 12.
Artículo en Inglés | MEDLINE | ID: mdl-34379922

RESUMEN

BACKGROUND: Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. METHODS: We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. RESULTS: The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. CONCLUSIONS: CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).


Asunto(s)
Infecciones por VIH/prevención & control , Inhibidores de Integrasa VIH/administración & dosificación , Profilaxis Pre-Exposición , Piridonas/administración & dosificación , Tenofovir/uso terapéutico , Administración Oral , Adulto , Anciano , Fármacos Anti-VIH/uso terapéutico , Preparaciones de Acción Retardada/administración & dosificación , Método Doble Ciego , Esquema de Medicación , Resistencia a Medicamentos/genética , Femenino , Inhibidores de Integrasa VIH/efectos adversos , Homosexualidad Masculina , Humanos , Inyecciones Intramusculares/efectos adversos , Análisis de Intención de Tratar , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Piridonas/efectos adversos , Personas Transgénero , Adulto Joven
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