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For Peer Review Only BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-005267 on 23 July 2014. Downloaded from Brazilian medicinal plants to treat respiratory disease: systematic review and meta-analyses - Study Protocol ForJournal: peerBMJ Open review only Manuscript ID: bmjopen-2014-005267 Article Type: Protocol Date Submitted by the Author: 17-Mar-2014 Complete List of Authors: Lopes, Luciane; UNISO, Pharmacie Science; University of Sorocaba, Pharmaceutical Science Silva, Maria Carolina; University of Sorocaba, Pharmaceutical Science Motta, Cristiane; University of Sorocaba, Pharmaceutical Science Quirós, Antonio; Universidad de Córdoba, Biología Celular, Fisiología e Inmunología. Facultad de Medicina Biavatti, Maique; Federal University of Florianopolis, Pharmaceutical Department de Oliveira, Jardel; Secretaria Municipal de Saúde, Médico de Família e Comunidade, Especialista em Saúde da Família, Geriatria e Gerontologia Guyatt, Gordon; McMaster Unviersity, Department of Clinical Epidemiology and Biostatistics <b>Primary Subject http://bmjopen.bmj.com/ Complementary medicine Heading</b>: Pharmacology and therapeutics, Respiratory medicine, Complementary Secondary Subject Heading: medicine COMPLEMENTARY MEDICINE, RESPIRATORY MEDICINE (see Thoracic Keywords: Medicine), THERAPEUTICS, Herbal medicine < THERAPEUTICS on September 27, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 22 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-005267 on 23 July 2014. Downloaded from 1 2 3 Brazilian medicinal plants to treat respiratory disease: 4 5 systematic review and meta-analyses- Study Protocol 6 7 Luciane C Lopes 8 Pharmaceutical Sciences Post graduate Course, University of Sorocaba, UNISO , SP, Brazil. 9 [email protected] 10 11 Maria Carolina O. Silva 12 Pharmaceutical Sciences Post graduate Course, University of Sorocaba, UNISO, SP, Brazil 13 [email protected] 14 15 Cristiane BergamashiFor Mottapeer review only 16 Pharmaceutical Sciences Post graduate Course, University of Sorocaba, UNISO, SP, Brazil 17 [email protected] 18 19 Antonio Macho Quirós 20 21 Biología Celular, Fisiología e Inmunología. Facultad de Medicina, Universidad de Córdoba, Spain 22 [email protected] 23 24 Maique Weber Biavatti 25 Pharmaceutical Department, Federal University of Florianopolis, SC, Brazil 26 [email protected] 27 28 Jardel Corrêa de Oliveira 29 Médico de Família e Comunidade, Especialista em Saúde da Família, Geriatria e Gerontologia, 30 Secretaria Municipal de Saúde, Florianópolis, SC, Brasil 31 32 [email protected] 33 http://bmjopen.bmj.com/ 34 Gordon Guyatt 35 Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada. 36 [email protected] 37 38 Contact information for the corresponding author: Luciane Cruz Lopes, [email protected] 39 40 Rua Gomes Carneiro, 570 apto 141, Postal code: 13400-530 Piracicaba, SP, Brazil. 41 on September 27, 2021 by guest. Protected copyright. 42 Telephone: 55 19 978-18441 43 Fax: 55 15 21017074 44 45 46 Financial support: This project is funded from a grant by CAPES Research Programme 47 (grant) and is Support Program Graduate Education Institutions Private - PROSUP - 48 CAPES / UNISO 49 No conflict of interest 50 Word count: 3381 Figures: 0; tables: 0; references: 52 51 Additional file: 1 52 Keywords: Common cold, upper respiratory disease, Cough, Systematic review, 53 54 Meta-analysis, Brazilian medicinal plants 55 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 22 BMJ Open: first published as 10.1136/bmjopen-2014-005267 on 23 July 2014. Downloaded from 1 2 3 ABSTRACT 4 5 Introduction: Respiratory illness, often associated with cough, is frequent. In Brazil, 6 7 herbal medicines are often recommended as a first-line treatment for respiratory illness. 8 9 There exists uncertainty regarding the effectiveness of these treatments. No systematic 10 review has evaluated Brazilian medicinal plants to treat the common cold, lower and 11 12 upper respiratory tract infection and associated cough. 13 14 15 MethodsFor and analysis: peer We will conductreview a systematic reviewonly and if appropriate a 16 series of meta-analyses evaluating the safety and effectiveness of Brazilian medicinal 17 18 plants for the common cold and upper respiratory tract infection and associated cough. 19 20 We will acquire eligible randomized controlled trials and observational studies in adult 21 or pediatric patients with such illness treated by any form of Brazilian herbal compared 22 23 with placebo, no treatment, or an alternative therapy through a systematic search of 24 25 CINAHL, EMBASE, MEDLINE, AMED, Web of Science, Ovid Health star, Cochrane 26 Library, Pubmed and Scielo and the Cochrane Central Registry of Controlled Trials. 27 28 Teams of reviewers will, independently and in duplicate, screen titles and abstracts and 29 30 complete full text reviews to determine eligibility, and subsequently perform data 31 abstraction and assess risk of bias of eligible trials. When appropriate, we will conduct 32 33 meta-analyses to establish the effect of all reported therapies on patient-important http://bmjopen.bmj.com/ 34 35 outcomes. 36 37 38 Discussion: Our review will be the first to evaluate all Brazilian medicinal plants to 39 treat the common cold, upper respiratory tract infection and associated cough and 40 41 establish best estimates of the safety and effectiveness of treatments. Our review will on September 27, 2021 by guest. Protected copyright. 42 43 facilitate evidence-based management of patients in primary care and identify key areas 44 for future research. 45 46 47 Ethics and Dissemination: The systematic review will be published in a peer- 48 49 reviewed journal. Brief reports of review findings will be disseminated directly to 50 appropriate audiences via email and other modes of communication. The review will 51 52 guide healthcare practice and policy in Brazil. 53 54 Register Protocol: Prospero CRD42014007057 55 56 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 22 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-005267 on 23 July 2014. Downloaded from 1 2 3 4 ARTICLE FOCUS: 5 Will a systematic review of Brazilian medicinal plants to treat the common cold, lower 6 and upper respiratory tract infection and associated cough reveal effectiveness of these 7 8 agents? 9 10 Do Brazilian medicinal plants lead to symptom improvement and cough control in 11 common cold, lower and upper respiratory tract infection in patients? 12 13 14 15 For peer review only 16 KEY MESSAGE: 17 This study will investigate the effects of all marketed Brazilian medicinal plants 18 indicated to use in respiratory disease: Ananas comosus, Echinacea purpurea Moench, 19 20 Eucalyptus globules, Glycyrrhiza glabra L., Hedera helix L., Malva sylvestris L., 21 22 Mentha spp* (M. piperita or M. villosa), Mikania spp* (M. glomerata or M. laevigata), 23 Pelargonium sidoides D.C., Petasites hybridus L., Pimpinella anisum L., Polygala 24 25 senega L., Psychotria ipecacuanha (Brot.) Stokes, Sambucus nigra L. 26 27 28 Outcomes of interest will include time to resolution of clinical symptoms and/or signs 29 (where clinical symptoms and signs include cough, sputum production or activity 30 31 limitations). Also of interest will be severity of symptoms prior to resolution. Other 32 important outcomes will include hospitalization rates and duration of hospital stay, and 33 http://bmjopen.bmj.com/ 34 days receiving antibiotics 35 36 37 38 STRENGTHS AND LIMITATIONS OF THIS STUDY 39 This will be the first systematic review to assess specifically the Brazilian medicinal 40 plants to treat the common cold, lower and upper respiratory tract infection and 41 on September 27, 2021 by guest. Protected copyright. 42 associated cough. The methods of the review are state-of-art, including explicit 43 eligibility criteria, a comprehensive search, independent duplicate assessment of 44 eligibility, and use of the GRADE approach to assessing confidence in estimates of 45 effect including independent duplicate assessment of risk of bias, precision, consistency, 46 47 directness and publication bias. We will make separate ratings for bodies of evidence 48 from randomized trials and bodies of evidence from observational studies. 49 50 Our results are likely to be limited by limitations in the primary studies include non- 51 randomized studies and randomized trials with a high risk of bias. Eligible studies will 52 53 differ substantially in study design and outcome measures. 54 55 56 57 INTRODUCTION 58 59 60 3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 22 BMJ Open: first published as 10.1136/bmjopen-2014-005267 on 23 July 2014. Downloaded from 1 2 3 Respiratory illness is common and important 4 5 Respiratory illness, including the common cold and upper respiratory tract infection 6 7 (URTI), and associated cough, are frequent[1] and a major cause of morbidity, 8 9 especially in children and the elderly [2]. Although in most cases benign, respiratory 10 illness results in many consultations to primary care [3 4]. 11 12 13 Acute URTIs are the most common reason for people to seek medical care in the United 14 States [5] and at least one billion colds occur there per year, with a frequency of two to 15 For peer review only 16 six colds per person [6]. Symptoms of the common cold typically include a runny nose, 17 18 congestion, sneezing, weakened sense of taste and smell, scratchy throat and cough. 19 These start developing in the first three days following infection. Infants and young 20 21 children are more likely than adults and teens to also develop fever. Symptoms usually 22 23 abate within seven to 10 days but some colds last longer, especially in children, the 24 elderly and those with generally poor health [7]. The most common symptom of 25 26 respiratory tract infection, cough, is also the most common symptom presenting to 27 28 general practitioners [5 8].
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