(BQ) Part 1 book Evidence-Based dermatology presents the following contents: The concept of evidence-based dermatology, the critical appraisal toolbox, the evidence (common inflammatory skin diseases, skin cancer, moles, and actinic keratoses).
Evidence-based Dermatology Third edition Dedication We, the editors, dedicate this book to our patients who have helped us to understand what it is really like to have a skin disease, and who have helped us to identify the questions that matter to them Evidence-based dermatology starts with patients and ends with patients If we lose our compassion for patients, we become a sounding brass or a tinkling cymbal Evidence-based Dermatology Third Edition Edited by Hywel C Williams DSc, FRCP Centre of Evidence Based Dermatology University of Nottingham, Nottingham, UK ASSOCIATE EDITORS Michael Bigby MD Department of Dermatology Harvard Medical School and Beth Israel Deaconess Medical Center Boston, MA, USA Andrew Herxheimer MB, FRCP UK Cochrane Centre Oxford, UK Luigi Naldi MD Centro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia Department of Dermatology Ospedali Riuniti Bergamo, Italy Berthold Rzany MD, ScM RZANY & HUND Privatpraxis für Dermatologie und Ästhetische Medizin Berlin, Germany Robert P Dellavalle MD, PhD, MSPH Department of Dermatology University of Colorado Denver Aurora, USA Yuping Ran Department of Dermatovenereology West China Hospital Sichuan University Chengdu, P R China Masutaka Furue Department of Dermatology Graduate School of Medical Sciences Kyushu University, 3-1-1, Maidashi, Higashi-ku Fukuoka, Japan This edition first published 2014, © 2003 BMJ Publishing Group, 2008, 2014 by John Wiley & Sons, Ltd BMJ Books is an imprint of BMJ Publishing Group Limited, used under licence by John Wiley & Sons Registered office: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial offices: 9600 Garsington Road, Oxford, OX4 2DQ, UK The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK 111 River Street, Hoboken, NJ 07030-5774, USA For details of our global editorial offices, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/wiley-blackwell The right of the author to be identified as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988 All rights reserved No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher Designations used by companies to distinguish their products are often claimed as trademarks All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners The publisher is not associated with any product or vendor mentioned in this book It is sold on the understanding that the publisher is not engaged in rendering professional services If professional advice or other expert assistance is required, the services of a competent professional should be sought The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method, diagnosis, or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom Library of Congress Cataloging-in-Publication Data Evidence-based dermatology (Williams) Evidence-based dermatology / edited by Hywel C Williams ; associate editors, Michael Bigby [and six others] – Third edition p ; cm Includes bibliographical references and index ISBN 978-1-118-35767-5 (cloth) I. Williams, Hywel C., editor of compilation. II. Bigby, Michael E., editor of compilation. III. Title [DNLM: 1. Skin Diseases. 2. Evidence-Based Medicine WR 140] RL71 616.5–dc23 2013049542 A catalogue record for this book is available from the British Library Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic books Cover image: © iStock/AnnettVauteck Set in 9/11 pt MinionPro-Regular by Toppan Best-set Premedia Limited 1 2014 Contents Contributors, viii Foreword, xii Preface, xiv About the companion website, xv PART I The concept of evidence-based dermatology Andrew Herxheimer, editor The field and its boundaries, Luigi Naldi 2 The rationale for evidence-based dermatology, Hywel C Williams and Michael Bigby 3 The role of patient and public involvement in evidence-based dermatology, 12 Carron Layfield, Amanda Roberts, Jason Simons, Colette O’Sullivan, Anjna Rani, and Kim Thomas What makes a good case series?, 54 Joerg Albrecht and Michael Bigby What makes a good prevalence survey?, 58 Hywel C Williams Critical appraisal of pharmacoeconomic studies, 62 Rajini K Murthy, Laura K DeLong, and Suephy C Chen Comparative effectiveness research: what it is and how to assess its quality, 66 Junko Takeshita and Joel M Gelfand Outcome measures, 71 Alain Dupuy, Emilie Sbidian, and Sylvie Bastuji-Garin Where does qualitative research fit into evidence-based dermatology?, 75 Ray Jobling and Luigi Naldi Applying the evidence back to the patient, 79 Hywel C Williams 4 The Cochrane Skin Group, 17 Finola Delamere, Liz Doney, Laura Prescott, and Shirley Manknell PART III The evidence PART II The critical appraisal toolbox SECTION 1: Common inflammatory skin diseases Luigi Naldi, editor Michael Bigby, editor Acne vulgaris, 87 Formulating well-built clinical questions, 25 Michael Bigby and Berthold Rzany Finding the best evidence, 27 Michael Bigby and Rosamaria Corona The hierarchy of evidence, 30 Michael Bigby Appraising systematic reviews and meta-analyses, 33 Michael Bigby and Hywel C Williams How to critically appraise a randomized controlled trial, 39 Hywel C Williams Michael Romano and Robert P Dellavalle Papulopustular rosacea, 106 Alfredo Rebora and Francesco Drago Perioral dermatitis, 112 Vincenzo Bettoli, Stefania Zauli, and Annarosa Virgili 2 Hand eczema, 117 Wietske A Christoffers, Marie-Louise Anna Schuttelaar, and Pieter-Jan Coenraads The primary prevention of atopic dermatitis, 127 Joanne R Chalmers, Sam F Bremmer, and Eric L Simpson Assessing and explaining the evidence on harms of medical Atopic eczema, 136 1 How to evaluate diagnostic tests, 50 Seborrheic dermatitis, 169 interventions, 46 Luigi Naldi Joerg Albrecht and Michael Bigby Kim Thomas, Carolyn Charman, Helen Nankervis, Jane Ravenscroft, and Hywel C Williams Mauro Picardo and Norma Cameli v vi Contents Treatment of psoriasis, 175 Leprosy, 407 Lichen planus, 200 Cutaneous leishmaniasis, 421 Acute urticaria, 206 Scabies, 432 Chronic urticaria, 210 Head lice, 441 Alexander Nast, Phyllis Spuls, and Tamar Nijsten Laurence Le Cleach and Olivier Chosidow Torsten Schäfer Karsten Weller and Marcus Maurer SECTION 2: Skin cancer, moles, and actinic keratoses Robert Dellavalle, editor Primary prevention of skin cancer, 223 Monika Janda and Adèle C Green Treatment of cutaneous melanoma, 231 Mary Ann N Johnson and April W Armstrong Treatment of squamous cell carcinoma, 241 Louise Lansbury, William Perkins, and Fiona Bath-Hextall 3 Basal cell carcinoma, 250 Fiona Bath-Hextall and William Perkins Primary cutaneous T-cell lymphoma, 264 Fiona Child and Sean Whittaker Actinic keratosis and Bowen’s disease, 283 Sasha N Jenkins, Maren Speck, and Suephy C Chen Kaposi sarcoma, 303 Whitney A High Melanocytic nevi, 313 Varun Shahi and Jerry D Brewer SECTION 3: Infective skin diseases, exanthems, and infestations Masutaka Furue and Yuping Ran, editors Local treatments for cutaneous warts, 320 Juping Chen and Yan Wu Molluscum contagiosum, 329 Minh L Lam Impetigo, 337 Sander Koning, Renske van der Sande, Lisette W.A van Suijlekom-Smit, and Johannes C van der Wouden Athlete’s foot, 341 Inajara Rotta, Michel F Otuki, and Cassyano J Correr Pityriasis versicolor, 345 Nancy Habib and Michael Bigby Onychomycosis, 349 Aditya K Gupta, Elizabeth A Cooper, Maryse Paquet, and Fiona Simpson 4 Tinea capitis, 364 Urbà González Saumya Panda Urbà González, Armando Ruiz-Baqués, and Jorge Alvar Ian F Burgess Ian F Burgess and Ciara S Casey Insect bites and stings, 451 Belen Lardizabal Dofitas SECTION 4: Disorders of pigmentation Hywel C Williams, editor Vitiligo, 464 Juan Jorge Manriquez and Sergio M Niklitschek 5 Melasma, 470 Asad Salim, Ratna Rajaratnam, and Eva Soos Domanne SECTION 5: Common ailments with significant cosmetic impact Berthold Rzany, editor Male and female androgenetic alopecia, 486 Hans Wolff and Kathrin Giehl Alopecia areata, 490 Rod Sinclair Evidence-based treatment of hirsutism, 498 Ulrike Blume-Peytavi and Natalie Garcia-Bartels Focal hyperhidrosis, 504 Kave Shams and Berthold Rzany Dermal fillers, 512 Stephanie Ogden and Tamara Griffiths Reducing mimic wrinkles and folds with botulinum toxin A, 516 Berthold Rzany SECTION 6: Other important skin disorders Michael Bigby, editor Cutaneous lupus erythematosus, 523 Susan Jessop and David Whitelaw Dermatomyositis, 531 Ruth Ann Vleugels, David F Fiorentino, and Jeffrey P Callen Acquired subepidermal bullous diseases, 545 Gudula Kirtschig, Vanessa Venning, Nonhlanhla P Khumalo, and Fenella Wojnarowska Pemphigus, 552 Linda K Martin, Brian R Sperber, Dedee F Murrell, and Victoria P Werth 6 Cutaneous sarcoidosis, 561 Misha Rosenbach and Joseph C English III Deep fungal infections, 371 Erythema multiforme, 575 Streptococcal cellulitis/erysipelas of the lower leg, 378 Stevens–Johnson syndrome and toxic epidermal necrolysis, Roderick J Hay Vinod E Nambudiri and Michael Bigby Exanthematic reactions, 388 Sandra R Knowles and Neil H Shear Herpes simplex, 396 Vera Mahler Pierre-Dominique Ghislain and Jean-Claude Roujeau 578 Jean-Claude Roujeau, Pierre-Dominique Ghislain, and Laurence Valleyrie-Allanore Polymorphic light eruption, 586 Robert S Dawe Contents vii Infantile hemangiomas, 590 PART IV The future of evidence-based dermatology Pruritus, 595 Luigi Naldi, editor Hossain Shahidullah Elke Weisshaar and Gil Yosipovitch Vulval lichen sclerosus, erosive lichen planus, and vulvodynia, 615 Rosalind C Simpson, Ruth Murphy, and David Nunns Venous ulcers, 624 Jonathan Kantor, David J Margolis, and Douglas J Pugliese Other skin diseases for which trials exist, 632 Sinéad Langan and Hywel C Williams Where we go from here?, 637 Hywel C Williams Subject Index, 644 Contributors Joerg Albrecht Department of Medicine and Division of Dermatology, John Stroger Hospital of Cook County, Chicago, IL, USA Ciara S Casey Insect Research & Design Limited, Cambridge, UK Sir Iain Chalmers Robert S Dawe Department of Dermatology, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK Finola Delamere Leishmaniasis Clinical Program, Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland Founding Director of the UK Cochrane Centre and Editor of the James Lind Initiative, James Lind Initiative, Summertown Pavilion, Middle Way, Oxford, UK April W Armstrong Joanne R Chalmers Robert P Dellavalle Sylvie Bastuji-Garin Carolyn Charman Laura K DeLong Juping Chen Belen Lardizabal Dofitas Jorge Alvar Department of Dermatology, University of Colorado, Denver Health System, Denver, CO, USA Université Paris Est (UPEC), LIC, EA4393, 94010 Créteil, France; AP-HP, hôpital Henri Mondor, Service de Santé Publique, 94010 Créteil, France Fiona Bath-Hextall Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK Vincenzo Bettoli Department of Clinical and Experimental Medicine, Section of Dermatology, University of Ferrara, Arcispedale S.Anna, Ferrara, Italy Michael Bigby Department of Dermatology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA Ulrike Blume-Peytavi Department of Dermatology and Allergy, CharitéUniversitätsmedizin Berlin, Berlin, Germany Sam F Bremmer Department of Dermatology, Oregon Health & Science University, Portland, OR, USA Jerry D Brewer Department of Dermatology, Mayo Clinic, Rochester, MN, USA Ian F Burgess Insect Research & Development Limited, Cambridge, UK Jeffrey P Callen Division of Dermatology, University of Louisville School of Medicine, Louisville, KY, USA Norma Cameli Laboratory of Cutaneous Physiopathology, San Gallicano Dermatological Institute (IRCCS), Elio Chianesi, Rome, Italy viii Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK Department of Dermatology, Second Clinical Medical College of Yangzhou University, Yangzhou, China Suephy C Chen Department of Dermatology, Emory University School of Medicine, Atlanta, GA, USA Fiona Child St John’s Institute of Dermatology, Guy’s and St Thomas NHS Foundation Trust, London, UK Olivier Chosidow Department of Dermatology, Groupe Hospitalier Henri Mondor, Créteil, France; Satellite of the Cochrane Skin Group, Créteil, France; Université Paris Est Créteil Val de Marne, Créteil, France; INSERM, Centre d’Investigation Clinique 006, APHP, Créteil, France Wietske A Christoffers Department of Dermatology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands Pieter-Jan Coenraads Department of Dermatology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands Elizabeth A Cooper Mediprobe Research Inc, London, Ontario, Canada Rosamaria Corona Wolters Kluwer Health, Waltham, MA, USA Cassyano J Correr Pharmacy Department, Federal University of Paraná, Curitiba, Paraná, Brazil Cochrane Skin Group, Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK Department of Dermatology, University of Colorado Denver, Aurora, CO, USA Department of Dermatology, Emory University School of Medicine, Atlanta, GA, USA Department of Dermatology, St Luke’s Medical Center, E Rodriguez Blvd., Quezon City, Philippines; University of the Philippines College of Medicine & Philippine General Hospital, Metro Manila, Philippines Liz Doney Cochrane Skin Group, Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK Francesco Drago Clinica Dermatologica, Department of Health, University of Genoa, Genoa, Italy Alain Dupuy Dermatology Department and Pharmacoepidemiology Unit, Rennes-1 University, University Hospital, Rennes, France Joseph C English III Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA David F Fiorentino Department of Dermatology, Stanford University School of Medicine, Stanford, CA, USA Natalie Garcia-Bartels Department of Dermatology and Allergy, CharitéUniversitätsmedizin Berlin, Berlin, Germany Joel M Gelfand Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA Kaposi sarcoma 305 • Iatrogenic KS among transplant recipients has been estimated at 8.8 per 100 000 person-years in the USA, with most cases occurring in the first years after transplantation, and the risk of KS increases steadily with recipient age (P = 0.001) [20] Etiology An infective etiology for KS was long suspected, but a milestone in understanding came in 1994, when Chang et al identified sequences of HHV8 DNA, within tumor material [3] Since that time, the virus has been detected in virtually all KS specimens, regardless of subtype, but has been absent from uninvolved skin The viral genome encodes proteins that are homologous with human oncoproteins and have the potential to induce cellular proliferation and inhibit apoptosis The presence of HHV8 appears requisite to development of KS, but the role of other permissive cofactors, such as immunosuppression, other cytokines, and HIV, is still being investigated and debated As a malignancy, it was long presumed that KS was caused by the clonal expansion of a single endothelial cell, but recent evidence may suggest otherwise For example, the cell of origin is still unproven, and expression of multiple immunohistochemical markers among KS cells, including factor VIIIa, smooth muscle actin, CD68, and CD14, as well as lymphatic markers, such as D2-40, in addition to common vascular markers of CD31 and CD34, may also be interpreted to suggest the origin is a pluripotent mesenchymal progenitor cell [21,22] Similarly, data from a series of patients with multiple lesions of KS showed that nearly 80% of the tumors were polyclonal in nature, engendering speculation that “metastatic” KS may not be truly metastatic (in the strict sense), but may be multifocal, arising independently at various sites [23] Diagnosis/histology The diagnosis of KS is typically made based upon clinical suspicion, and then confirmed with a biopsy and histopathologic analysis While the fundamental qualities of a malignant spindle cell neoplasm are common to all forms KS, clinical circumstances, as well as the temporal course of the lesion, will clearly impact the histologic findings in cutaneous disease [24] (a) • Patch stage. The earliest phase in the evolution of typical cutaneous KS, patch stage disease, also presents the greatest degree of diagnostic difficulty owing to the subtle nature of the findings Often, the dermis only appears only slightly hypercellular, with subtle and slit-like or jagged vascular spaces present upon close inspection The protrusion of newly formed rudimentary vascular structures into the lumen of larger vascular channels results in a “promontory sign.” Proliferating vessels may dissect the collagen, and often there are a varied number of extravasated erythrocytes and hemosiderin-laden macropahges Background inflammatory cells, mostly lymphocytes and plasma cells, may be present • Plaque stage. This is accompanied by greater cellularity and perhaps even extension of neoplastic process into the subcutis Atypical spindled cells are arranged in haphazard fascicles Mitotic figures may be present, and extracellular perioic acid Schiff-positive hyaline globules, thought to represent fragmented and decaying erythrocytes, may be noted [25] Dissecting vascular channels with central erythrocytes exist in the dermis, and an inflammatory infiltrate rich in plasma cells is common • Nodular stage. Nodular disease usually results in marked dermal expansion of atypical spindled cells arranged in fascicles (Figure 36.5) These spindled cells are monomorphic and atypical in appearance Mitotic activity among the cells is not uncommon Hyaline globules, also seen in plaque-stage disease, are typically rather numerous in nodular KS At the periphery of nodular lesions there are often dilated and congested vascular spaces Other recognized and described variants of KS, beyond the scope of this discussion, but more germane to a text on dermaotpathology, include hyperkeratotic, keloidal, micronodular, pyogenic granuloma-like, ecchymotic, and intravascular forms [24] Immunohistochemical stains that may prove useful in confirming a histologic assessment of KS include use of antibodies directed at the alleged endothelial/lymphatic origin of the spindled cells, such as CD31 (platelet/endothelial cell adhesion molecule, PECAM1), CD34 (a hematopoietic progenitor cell surface protein), D2-40 (podoplanin, a cell surface marker of lymphatic endothelium), and FLI1 (Friend leukemia virus integration 1, a member of the ETS family of DNA-binding transcription factors) A recent (b) Figure 36.5 Histologic and immunohistochemical analysis of nodular KS: (a) stained with H&E, shows atypical spindled cells and extravasated erythrocytes and pink hyaline globules (arrow) (b) stained with an immunohistochemical marker for HHV8, shows strong and aberrant positivity among the atypical spindled cells (arrow) 306 The evidence investigation of these four antibodies (CD31, CD34, D2-40, and FLI1) strongly and diffusely stained tumor cells in 75%, 92%, 67%, and 92% of AIDS-related cases, and 58%, 92%, 67%, and 75% of non-AIDS-related cases, respectively [26] Additionally, a commercially available monoclonal antibody directed against HHV8, for use on formalin-fixed, paraffin-embedded tissue, has been available since 2004 One such clone, directed against the virus latencyassociated nuclear antigen of HHV8, has demonstrated high sensitivity and specificity for all clinical subtypes and tumor stages of KS, and is of great utility, especially in subtle patch-stage disease [27] Prognosis The prognosis for KS varies depending upon the clinical subtype, the extent of tumor and/or organ involvement, and the overall general medical condition of the patient • Classic KS usually follows a rather indolent course that spans years or decades Complications include venous stasis, lymphedema, and verrocous and/or hyperkeratotic qualities to the epidermis overlying KS lesions Admittedly, many of these conditions, to one degree or another, are not unexpected upon the lower legs of elderly persons with circulatory issues (even absent KS) It is widely held that persons with classic KS often die “with the disease,” rather than “of the disease.” • Epidemic (AIDS-related) KS may be a disseminated and fulminant disease The tumor extent (T), immune status (I), and severity of systemic illness (S) are all expected prognostic determinants To this end, in the pre-HAART era, a TIS staging classification was proposed and prospectively validated (Table 36.1) [28] Even in the HAART era, only minor alterations of these prognostic factors are proposed For example, CD4 count of