Melinda A. Maggard, MD, MSHS; Lisa R. Shugarman, PhD; Marika Suttorp, MS; Margaret Maglione, MPP; Harvey J. Sugerman, MD; Edward H. Livingston, MD; Ninh T. Nguyen, MD; Zhaoping Li, MD, PhD; Walter A. Mojica, MD, MPH; Lara Hilton, BA; Shannon Rhodes, MFA; Sally C. Morton, PhD; Paul G. Shekelle, MD, PhD
Grant Support: By the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. At the time of this review, Dr. Maggard was a Veterans Affairs Robert Wood Johnson Clinical Scholar at the University of California, Los Angeles, and the West Los Angeles VA Medical Center.
Potential Financial Conflicts of Interest: Honoraria: H.J. Sugerman (Ethicon Endo-Surgery).
Requests for Single Reprints: Melinda A. Maggard, MD, MSHS, Department of Surgery, University of California, Los Angeles, Medical Center, CHS Room 72-215, 10833 Le Conte Avenue, Los Angeles, CA 90095; e-mail, email@example.com.
Current Author Addresses: Drs. Maggard, Li, Mojica, and Horton; Ms. Suttorp, Ms. Maglione, Ms. Solomon, Ms. Jungvig, and Ms. Rhodes: Department of Surgery, University of California, Los Angeles, Medical Center, CHS Room 72-215, 10833 Le Conte Avenue, Los Angeles, CA 90095.
Dr. Livingston: The University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75235-9156.
Dr. Nguyen: University of California, Irvine, Medical Center, 101 City Drive, Building 55, Orange, CA 92868.
Controversy exists regarding the effectiveness of surgery for weight loss and the resulting improvement in health-related outcomes.
To perform a meta-analysis of effectiveness and adverse events associated with surgical treatment of obesity.
MEDLINE, EMBASE, Cochrane Controlled Trials Register, and systematic reviews.
Randomized, controlled trials; observational studies; and case series reporting on surgical treatment of obesity.
Information about study design, procedure, population, comorbid conditions, and adverse events.
The authors assessed 147 studies. Of these, 89 contributed to the weight loss analysis, 134 contributed to the mortality analysis, and 128 contributed to the complications analysis. The authors identified 1 large, matched cohort analysis that reported greater weight loss with surgery than with medical treatment in individuals with an average body mass index (BMI) of 40 kg/m2 or greater. Surgery resulted in a weight loss of 20 to 30 kg, which was maintained for up to 10 years and was accompanied by improvements in some comorbid conditions. For BMIs of 35 to 39 kg/m2, data from case series strongly support superiority of surgery but cannot be considered conclusive. Gastric bypass procedures result in more weight loss than gastroplasty. Bariatric procedures in current use (gastric bypass, laparoscopic adjustable gastric band, vertical banded gastroplasty, and biliopancreatic diversion and switch) have been performed with an overall mortality rate of less than 1%. Adverse events occur in about 20% of cases. A laparoscopic approach results in fewer wound complications than an open approach.
Only a few controlled trials were available for analysis. Heterogeneity was seen among studies, and publication bias is possible.
Surgery is more effective than nonsurgical treatment for weight loss and control of some comorbid conditions in patients with a BMI of 40 kg/m2 or greater. More data are needed to determine the efficacy of surgery relative to nonsurgical therapy for less severely obese people. Procedures differ in efficacy and incidence of complications.
The effectiveness of surgical therapy in the treatment of obesity is unclear.
Many published studies of obesity surgery have significant limitations, and case series make up much of the evidence. Evidence is complicated by the heterogeneity of procedures studied. However, surgery can result in substantial amounts of weight loss (20 to 30 kg) for markedly obese individuals. One cohort study documented weight loss for 8 years with associated improvements in comorbid conditions, such as diabetes. Complications of surgery appear to occur in about 20% of patients.
Those considering surgical treatment for obesity should understand that, although patients who have surgery can lose substantial amounts of weight, the evidence base for these treatments is limited.
Table 1. Pooled Results for Controlled Trials of Weight Loss following Bariatric Surgery
Weight loss by procedure.
Table 2. Pooled Results for All Studies on Weight Loss following Bariatric Surgery
Table 3. Mortality Analysis for Surgical Procedures
Table 4. Pooled Results from All Studies for Postoperative Adverse Events by Bariatric Procedure
Table 5. Pooled Results from Controlled Trials of Postoperative Adverse Events following Bariatric Procedures
Appendix Table 1. Evidence Table for Controlled Trials of Surgical Treatment of Obesity
Appendix Table 2. Evidence Table for Case Series of Surgical Treatment of Obesity
Appendix Table 3. Postoperative Adverse Events by Bariatric Procedure in Controlled Trials
Appendix Table 4. Pooled Results for All Studies of Postoperative Adverse Events following Bariatric Procedures according to Operative Approach
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Harvey J Sugerman
Virginia Commonwealth University
April 22, 2005
To the editor:
We appreciate the attention Annals has given to the management of obesity, in the form of Clinical Guidelines, a Meta-Analysis with Editors' Notes, and a Summary for Patients [Ann Int Med 2005; 142(7)], although we have several concerns regarding the contents.
The American College of Physicians (ACP) Clinical Guidelines for Pharmacologic and Surgical Management of Obesity are inappropriately confining, potentially leading to denial of effective treatment for severely obese patients. The guidelines do not provide a balanced assessment of the relative long-term efficacy of non-surgical treatments such as diets, behavior modification, exercise, drugs or combinations of these modalities, in patients with body mass index (BMI) 35 kg/m or greater with serious co-morbidities. More than 95% of severely obese patients fail such treatments after less than two years, and, on average, have made more than 5 unsuccessful attempts prior to referral for bariatric surgery.
The Summary for Patients, regarding the benefits of a mean weight loss of 11 lbs during on-going non-surgical treatment (drugs, diets, etc), is misleading, if not disingenuous. Immediately after cessation of the 6-12 months of treatment, much of which is associated with alarmingly high drop-out rates, virtually 100% of patients return to their previous poor health. This rate of failure is extremely frustrating to both the patients and Primary Care physicians.
The Guidelines list of co-morbidities of obesity requiring treatment is remarkably incomplete; asthma, gastroesophageal reflux, liver disease, obesity hypoventilation, pseudotumor cerebri, stress incontinence, polycystic ovary syndrome and venostasis disease, among others, are all serious and limit the quality and even length of life. There are numerous consistent confirmatory case-series in peer-reviewed publications demonstrating the long-term efficacy of surgical treatment. Three large studies revealed mortality reduction compared to medically treated cohorts (1-3), yet the published algorithm in your Guidelines doesn't even mention a surgical treatment option!
Your "Editors* Notes", boldy displayed in "Meta-analysis: surgical treatment of obesity" (rather than on an editorial page), directly contradicts the preponderance of evidence regarding "..effectiveness of surgical therapy in the treatment of obesity..". One meta-analysis4 and several "evidence-based" reports [stman J et al.(5), Sauerland S et al.(6), Clegg et al.(7), including the Meta-Analysis by Maggard et al. presented in this very issue of Annals], although flawed, concur with the 1991 National Institutes of Health Consensus panel (9) affirming the effectiveness and safety of surgery for obesity. Evidence based medicine criteria for assessment of strength of evidence mandating randomized controlled or cohort studies, are inappropriate for evaluating invasive treatments such as operations which have robust physiological and behavioral effects, are difficult to reverse and may have more serious and variable side-effects than the drug studies for which the criteria were developed.
Ample data reveal the effect of surgeons' case volumes on outcome in most types of operations, including anti-obesity surgery.(3,9) The American Society for Bariatric Surgery, recognizing an increasing number of adverse outcomes in step with the increasing demand for this surgery, has created a bariatric surgery accreditation program to assure physicians and patients alike that a high quality of care is being provided. Severe obesity is extremely difficult to manage in primary care. However, overly restrictive, incomplete treatment guidelines, such as those just published, are a disservice to all parties.
Harvey J. Sugerman, MD President American Society for Bariatric Surgery Emeritus Professor of Surgery Virginia Commonwealth University Richmond, Virginia firstname.lastname@example.org
John G. Kral, MD, PhD Professor of Surgery and Medicine SUNY Downstate Medical Center Brooklyn, New York
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9.Courcoulas A, Schuchert M, Gatti G, Luketich J. The relationship of surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery 2003; 134:613-21. [PMID: 14605622]
President, American Society for Bariatric Surgery
Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, et al. Meta-Analysis: Surgical Treatment of Obesity. Ann Intern Med. 2005;142:547-559. doi: 10.7326/0003-4819-142-7-200504050-00013
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Published: Ann Intern Med. 2005;142(7):547-559.
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