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Diagnosis and Management of Infantile Hemangioma
Comparative Effectiveness Reviews, No. 168
Investigators: Sivakumar Chinnadurai, MD, MPH, Kristen Snyder, MD, Nila Sathe, MA, MLIS, Chris Fonnesbeck, PhD, Anna Morad, MD, Frances E Likis, DrPH, NP, CNM, Tanya Surawicz, MPH, Genevieve Ness, PharmD, Cathy Ficzere, PharmD, and Melissa L McPheeters, PhD, MPH.
Author Information and AffiliationsStructured Abstract
Objectives:
To systematically review evidence addressing the diagnosis and management of infantile hemangiomas (IH).
Data sources:
Multiple databases from 1982 to June 2015.
Review methods:
We included comparative studies of interventions, case series addressing harms, and any study to address contextual questions. Two investigators independently screened studies and rated study quality. We extracted and summarized data qualitatively and quantitatively via network meta-analysis, which provides a relative ranking of anticipated effects among treatments. We also assessed strength of the evidence (SOE).
Results:
Among 148 unique studies, 42 addressed effectiveness outcomes (6 good, 22 fair, and 14 poor quality), and 144 studies reported harms (14 good, 3 fair, and 127 poor quality). Two small studies reported differing findings for the sensitivity of ultrasound and effectiveness of imaging modalities. Studies of steroids assessed different agents; treated children typically had improvement in lesion size. Steroid harms frequently included Cushingoid facies, irritability/mood changes, and growth retardation. Beta-blockers typically demonstrated significantly greater effects on reducing lesion size than did control or other active comparators. In network meta-analysis, oral propranolol had the largest mean estimate of expected clearance (95%; 95% Bayesian credible interval [BCI]: 88% to 99%) relative to oral corticosteroids (43%, 95% BCI: 21%–66%) and control (6%, 95% BCI: 1%–11%). Beta-blocker harms included hypotension, hypoglycemia, bradycardia, sleep disturbances, and cold extremities. Surgical intervention studies primarily addressed variations of pulse dye laser (PDL) to manage IH size. Most studies reported a higher success rate with longer-pulse PDL compared to observation, with differing magnitude of effect. Laser treatment harms included hypopigmentation and scarring. No studies explicitly evaluated treatments following failure of beta-blockers or corticosteroids. Literature addressing contextual questions suggested that referral indications include large size; segmental type; risk for complications including bleeding, ulceration, and pain; involvement of critical structures; risk factors for occult lesions (numerous cutaneous lesions, beard distribution); and potential for psychosocial concerns in some cases. Multiple case series reported associations between multiple cutaneous lesions and airway or hepatic IH and facial lesions in a beard distribution and airway IH.
Conclusions:
Our review for contextual questions described a range of indications for referral and suggested support for a higher index of suspicion of extracutaneous IH in children with multiple cutaneous lesions or facial lesions in a beard distribution. Corticosteroids demonstrated moderate effectiveness at reducing IH size/volume (moderate SOE for improvement in IH with oral steroids compared with observation/placebo; low SOE for intralesional steroids versus observation/placebo; moderate SOE for association with clinically important harms). Propranolol had high SOE for effects on reducing lesion size compared with observation/placebo. Clearance of IH was greater in propranolol arms compared with placebo/observation and active comparators in most studies. Meta-analysis indicated high mean rates of IH clearance with oral propranolol (95%, 95% BCI: 88%–99%) and moderate rates for steroids (43% to 58%, with wide BCI; moderate SOE for effects of propranolol compared with steroids). Beta-blockers and steroids also may cause clinically important harms (moderate SOE for association of oral propranolol with harms). Laser studies generally found PDL more effective than other lasers, but effects remain unclear (insufficient to low SOE for effects of laser types on IH clearance; moderate SOE for association of PDL with skin pigmentation changes; low SOE for association with pain). Data were inadequate to address the role of imaging in guiding treatment (insufficient SOE).
Contents
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- CQ1 Natural History of Untreated IH and Adverse Outcomes of Untreated IH
- CQ2 Evidence for Association of Cutaneous IH and Occult IH
- Results of Literature Searches for Key Questions
- Key Question 1 Effectiveness and Harms of Imaging Modalities
- Key Question 2 Effectiveness and Harms of Corticosteroids or Beta-Blockers
- Key Question 3 Effectiveness and Harms of Drugs Administered After the Failure of Corticosteroids or Beta-Blockers
- Key Question 4 Effectiveness and Harms of Surgical Interventions
- Discussion
- Conclusions
- References
- Abbreviations and Acronyms Used in This Report
- Appendix A Search Strategies
- Appendix B Screening and Quality Assessment Forms
- Appendix C Excluded Studies
- Appendix D Methods for Network Meta-Analysis
- Appendix E Study Design Classification Algorithm
- Appendix F Quality/Risk of Bias Ratings
- Appendix G Applicability Tables
- Appendix H Harms Reported in Package Insert Data and Other Sources
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2010-0009-I, Prepared by: Vanderbilt Evidence-based Practice Center, Nashville, TN
Suggested citation:
Chinnadurai S, Snyder K, Sathe N, Fonnesbeck C, Morad A, Likis FE, Surawicz T, Ness G, Ficzere C, McPheeters ML. Diagnosis and Management of Infantile Hemangioma. Comparative Effectiveness Review No. 168. (Prepared by the Vanderbilt University Evidence-based Practice Center under Contract No. 290-2010-0009-I.) AHRQ Publication No.16-EHC002-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Vanderbilt Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00009-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.
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