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1. Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)

Author

Teresa Sanz-Cuesta, Esperanza Escortell-Mayor, Isabel Cura-Gonzalez, Jesus Martin-Fernandez, Rosario Riesgo-Fuertes, Sofía Garrido-Elustondo, Jose Enrique Mariño-Suárez, Mar Álvarez-Villalba, Tomás Gómez-Gascón, Inmaculada González-García, Paloma González-Escobar, Concepción Vargas-Machuca Cabañero, Mar Noguerol-Álvarez, Francisca García de Blas-González, Raquel Baños-Morras, Concepción Díaz-Laso, Nuria Caballero-Ramírez, Alicia Herrero de-Dios, Rosa Fernández-García, Jesús Herrero-Hernández, Belen Pose-García, María Luisa Sevillano-Palmero, Carmen Mateo-Ruiz, Beatriz Medina-Bustillo, Monica Aguilar-Jiménez, Isabel Gutiérrez-Sánchez, Ángeles Fernández-Abad, José Antonio Granados-Garrido, Javier Martínez-Suberviola, Margarita Beltejar-Rodríguez, Carmen Coello-Alarcón, Susana Diez-Arjona, Ana Ballarín-González, Ignacio Iscar-Valenzuela, José Luis Quintana-Gómez, José Antonio González-Posada-Delgado, Enrique Revilla-Pascual, Esther Gómez-Suarez, Yolanda Fernández-Fernández, Fernanda Morales-Ortiz, Isabel Ferrer-Zapata, Esperanza Duralde-Rodríguez, Milagros Beamud-Lagos, Mª del Pilar Serrano-Simarro, Cristina Montero-García, María Domínguez-Paniagua, Sofía Causín-Serrano, Josefa San Vicente-Rodríguez, Germán Reviriego-Jaén, Margarita Camarero-Shelly, Rosa Gómez-del Forcallo, María Ángeles Miguel-Abanto, Lourdes Reyes-Martínez, Alejandro Rabanal-Basalo, Carolina Torrijos-Bravo, Pilar Gutiérrez-Valentín, Jorge Gómez-Ciriano, Susana Parra Román, Judit León-González, Mª José Nebril-Manzaneque, Juana Caro-Berzal, Alberto López-García-Franco, Sonia Redondo de-Pedro, Juan Carlos García-Álvarez, Elisa Viñuela-Beneitez, Marisa López-Martín, Nuria Sanz-López, Ana María Ibarra-Sánchez, Cecilio Gómez-Almodóvar, Javier Muñoz-Gutiérrez, Carmen Molins-Santos, Cristina Cassinello-Espinosa, Antonio Molina-Siguero, Rafael Sáez-Jiménez, Paloma Rodríguez-Almagro, Eva María Rey-Camacho, María Carmen Pérez-García, Antonio Redondo-Horcajo, Beatriz Pajuelo-Márquez, Encarnación Cidoncha-Calderón, Jesús Galindo Rubio, RosaAna Escriva Ferrairo, José Francisco Ávila-Tomas, Francisco De-Alba-Gómez, Mª Jesús Gómez-Martín, Alma María Fernández-Martínez, Rosa Feijoó-Fernández, José Vizcaíno-Sánchez-Rodrigo, Victoria Díaz-Puente, Felisa Núñez-Sáez, Luisa Asensio-Ruiz, Agustín Sánchez-Sánchez, Orlando Enríquez-Dueñas, Silvia Fidel-Jaimez, Rafael Ruiz-Morote-Aragón, Asunción Pacheco-Pascua, Belén Soriano-Hernández, Eva Álvarez-Carranza, Carmen Siguero-Pérez, Ana Morán-Escudero, María Martín-Martín, Francisco Vivas-Rubio, Rafael Pérez-Quero, Mª Isabel Manzano-Martín, César Redondo-Luciáñez, Nuria Tomás-García, Carlos Díaz-Gómez-Calcerrada, Julia Isabel Mogollo-García, Inés Melero-Redondo, Ricardo González-Gascón, María Carmen Álvarez-Orviz, María Veredas González-Márquez, Teresa SanClemente-Pastor, Amparo Corral-Rubio, Asunción Prieto-Orzanco, Cristina dela Cámara-Gonzalez, Mercedes Parrilla-Laso, Mercedes Canellas-Manrique, Maria Eloisa Rogero-Blanco, Paulino Cubero-González, Sara Sanchez-Barreiro, Mª Ángeles Aragoneses-Cañas, Ángela Auñón-Muelas, Olga Álvarez Montes, Petra María Cortes-Duran, Pilar Tardaguila-Lobato, Mar Escobar Gallegos, Antonia Pérez-de-Colosia-Zuil, Jaime Inneraraty-Martínez, María Jesús Bedoya-Frutos, María Teresa López-López, Nelly Álvarez-Fernández, Teresa Fontova-Cemeli, Josefa Marruedo-Mateo, Josefa Díaz-Serrano, Beatriz Pérez-Vallejo, Pilar Hombrados-Gonzalo, Marta Quintanilla-Santamaría, Yolanda González-Pascual, Luisa María Andrés-Arreaza, Soledad Escolar-Llamazares, Cristina Casado-Rodríguez, Luzdel Rey-Moya, Jesús Fernández-Valderrama, Alejandro Medrán-López, Julia Alonso-Arcas, Alejandra Rabanal-Carrera, Araceli Garrido-Barral, Milagros Velázquez-García, Azucena Sáez-Berlanga, Pilar Pérez-Egea, Pablo Astorga-Díaz, Carlos Casanova-García, Ana Isabel Román-Ruiz, Carmen Belinchón-Moya, Margarita Encinas-Sotillo, Virtudes Enguita-Pérez, Ester Valdés-Cruz, Consuelo Mayoral-López, Teresa Gijón-Seco, Francisca Martínez-Vallejo, Jesica Colorado-Valera, Ana Sosa-Alonso, Jeannet Sánchez-Yépez, Dolores Serrano-González, Beatriz López-Serrano, Inmaculada Santamaría-López, Paloma Morso-Peláez, Carolina López-Olmeda, Almudena García-Uceda-Sevilla, Mercedes delPilar Fernández-Girón, Leonor González-Galán, Mariano Rivera-Moreno, Luis Nistal Martín-de-Serranos, Mª Jesús López-Barroso, Margarita Torres-Parras, María Verdugo-Rosado, Mª Reyes Delgado-Pulpón, Elena Alcalá-Llorente, Sonsoles Muñoz-Moreno, Isabel Vaquero-Turiño, Ana María Sánchez-Sempere, FranciscoJavier Martínez-Sanz, Clementa Sanz-Sanchez, AnaMaría Arias-Esteso, Diego Martín-Acicoya, Pilar Kloppe-Villegas, Francisco Javier San-Andrés-Rebollo, Magdalena Canals-Aracil, Isabel García-Amor, Nieves Calvo-Arrabal, María Milagros Jimeno-Galán, Gloriade la Sierra-Ocaña, María Mercedes Araujo-Calvo, Julia Timoner-Aguilera, María Santos Santander-Gutiérrez, Alicia Mateo-Madurga, Ricardo Rodríguez-Barrientos, Milagros Rico-Blázquez, Juan Carlos Gil-Moreno, Mariel Morey-Montalvo, Amaya Azcoaga Lorenzo, Gloria Ariza-Cardiel, Elena Polentinos-Castro, Sonia Soto-Díaz, Mª Teresa Rodríguez-Monje, Susana Martín-Iglesias, Francisco Rodríguez-Salvanés, Marta García-Solano, Rocío González-González, María Vicente Herrero, Ramón Rodríguez-González, Irene Bretón-Lesmes, Martadel Alamo Camuñas, Anabel Sánchez Espadas, Marisa Serrano Olmeda, Mª Angeles Gálvez Múgica, University of St Andrews. School of Medicine, and University of St Andrews. Population and Behavioural Science Division

Subjects
medicine.medical_specialty, Primary health care, NDAS, injections intramuscular, Administration, Oral, administration oral, Quality of life, SDG 3 - Good Health and Well-being, Oral administration, RA0421, equivalence trial, Internal medicine, RA0421 Public health. Hygiene. Preventive Medicine, medicine, Humans, Vitamin B12, Adverse effect, Aged, Primary Health Care, business.industry, Bayes Theorem, Vitamin B 12 Deficiency, General Medicine, Patient preference, Clinical trial, Vitamin B 12, Equivalence Trial, Spain, Quality of Life, Medicine, business, General practice / Family practice, patient preference
Abstract

The trial was financed by Ministerio de Sanidad y Consumo Español through their call for independent clinical research, Orden Ministerial SAS/2377, 2010 (EC10-115, EC10-116, EC10-117, EC10-119, EC10-122); CAIBER—Spanish Clinical Research Network, Instituto de Salud Carlos III (ISCIII) (CAI08/010044); and Gerencia Asistencial de Atención Primaria de Madrid. This study is also supported by the Spanish Clinical Research Network (SCReN), funded by ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, project number PT13/0002/0007, within the National Research Program I+D+I 2013-2016 and co-funded with European Union ERDF funds (European Regional Development Fund). This project received a grant for the translation and publication of this article from the Foundation for Biomedical Research and Innovation in Primary Care (FIIBAP) Call 2017 for grants to promote research programs. Objectives To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. Design Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. Interventions The IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. Main outcomes Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. Results The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. Conclusions Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low. Publisher PDF

Published
2020

2. Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review

Author

Luciane Cruz Lopes, Mabel Fernandes Fiqueiró, Cristiane de Cássia Bergamaschi, Juliana Cama Ramacciato, Rogério Heládio Lopes Motta, Jimmy de Oliveira Araújo, Caio Chaves Guimaraes, and Natalia Karol de Andrade

Subjects
Research design, Adult, medicine.medical_specialty, Sedation, MEDLINE, Pain, Dentistry and Oral Medicine, CINAHL, Anxiety, 03 medical and health sciences, Benzodiazepines, administration oral, 0302 clinical medicine, Patient satisfaction, dental anxiety, Protocol, Medicine, Humans, Hypnotics and Sedatives, Anesthesia, 030212 general & internal medicine, Intensive care medicine, Protocol (science), dentistry, business.industry, conscious sedation, 030206 dentistry, General Medicine, Clinical trial, Systematic review, Patient Satisfaction, Research Design, medicine.symptom, business, Systematic Reviews as Topic, oral surgery
Abstract

Introduction The management of anxious patients undergoing dental procedures is still a challenge in clinical practice. Despite a wide variety of drugs for oral sedation in adult patients, there are relatively few systematic reviews that compare the effectiveness and safety of different drugs administered via this route. Thus, this study will evaluate the effectiveness and safety of oral sedation with benzodiazepines and other agents to patients undergoing dental surgical procedures. Method/design We will conduct a systematic review and, if appropriate, a meta-analysis of randomised controlled clinical trials that will evaluate the use of conscious sedation administered orally to adult patients undergoing oral surgery. The search will be conducted using electronic databases, such as the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), CINAHL (via Ovid), Lilacs (SciELO) and Capes database, without restriction of languages or date of publication. Primary outcomes include anxiety, sedation, treatment satisfaction, pain and adverse effects. Secondary outcomes include vital parameters (heart rate, respiratory rate and blood pressure) and patient cooperation during intervention. A team of reviewers will independently assess each citation for eligibility and in duplicates. For eligible studies, the same reviewers will perform data extraction, risk of bias assessment and determination of the overall quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation classification system. Ethics and dissemination The evidence gathered from this study should provide dental surgeons with knowledge on the effectiveness and safety of oral sedation in adults requiring dental surgical procedures. This in turn should contribute towards the decision-making process in dental practice, minimising the risks of anxiety and ineffective pain control in clinical procedures, as well as possible side effects. Ethics approval is not required in protocols for systematic reviews. The systematic review will be published in a peer-reviewed journal and presented at conferences. PROSPERO registration number CRD42017057142.

Published
2018

3. Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).

Author

Sanz-Cuesta T, Escortell-Mayor E, Cura-Gonzalez I, Martin-Fernandez J, Riesgo-Fuertes R, Garrido-Elustondo S, Mariño-Suárez JE, Álvarez-Villalba M, Gómez-Gascón T, González-García I, González-Escobar P, Vargas-Machuca Cabañero C, Noguerol-Álvarez M, García de Blas-González F, Baños-Morras R, Díaz-Laso C, Caballero-Ramírez N, Herrero de-Dios A, Fernández-García R, Herrero-Hernández J, Pose-García B, Sevillano-Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, and Aguilar-Jiménez M

Subjects
Administration, Oral, Aged, Bayes Theorem, Humans, Primary Health Care, Quality of Life, Spain, Vitamin B 12 therapeutic use, Vitamin B 12 Deficiency drug therapy
Abstract

Objectives: To compare the effectiveness of oral versus intramuscular (IM) vitamin B 12 (VB12) in patients aged ≥65 years with VB12 deficiency., Design: Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain)., Participants: 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm., Interventions: The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52., Main Outcomes: Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction., Results: The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B 12 levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B 12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route., Conclusions: Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low., Trial Registration Numbers: NCT01476007; EUDRACT (2010-024129-20)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2020
Full Text
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4. Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review.

Author

Araújo JO, Motta RHL, Bergamaschi CC, Guimarães CC, Ramacciato JC, de Andrade NK, Fiqueiró MF, and Lopes LC

Subjects
Adult, Anxiety etiology, Benzodiazepines therapeutic use, Humans, Pain etiology, Patient Satisfaction, Research Design, Systematic Reviews as Topic, Anesthesia methods, Anxiety prevention & control, Conscious Sedation methods, Dentistry methods, Hypnotics and Sedatives therapeutic use, Pain prevention & control
Abstract

Introduction: The management of anxious patients undergoing dental procedures is still a challenge in clinical practice. Despite a wide variety of drugs for oral sedation in adult patients, there are relatively few systematic reviews that compare the effectiveness and safety of different drugs administered via this route. Thus, this study will evaluate the effectiveness and safety of oral sedation with benzodiazepines and other agents to patients undergoing dental surgical procedures., Method/design: We will conduct a systematic review and, if appropriate, a meta-analysis of randomised controlled clinical trials that will evaluate the use of conscious sedation administered orally to adult patients undergoing oral surgery. The search will be conducted using electronic databases, such as the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), CINAHL (via Ovid), Lilacs (SciELO) and Capes database, without restriction of languages or date of publication. Primary outcomes include anxiety, sedation, treatment satisfaction, pain and adverse effects. Secondary outcomes include vital parameters (heart rate, respiratory rate and blood pressure) and patient cooperation during intervention. A team of reviewers will independently assess each citation for eligibility and in duplicates. For eligible studies, the same reviewers will perform data extraction, risk of bias assessment and determination of the overall quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation classification system., Ethics and Dissemination: The evidence gathered from this study should provide dental surgeons with knowledge on the effectiveness and safety of oral sedation in adults requiring dental surgical procedures. This in turn should contribute towards the decision-making process in dental practice, minimising the risks of anxiety and ineffective pain control in clinical procedures, as well as possible side effects. Ethics approval is not required in protocols for systematic reviews. The systematic review will be published in a peer-reviewed journal and presented at conferences., Prospero Registration Number: CRD42017057142., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2018
Full Text
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