Editorials
Management Options for Uterine Fibroid Tumors
See related article on page 1503.
The management options for uterine fibroid tumors have expanded greatly in the past 20 years. As Dr. Evans discusses in this issue of American Family Physician,1 there are few randomized trials to help generate level A evidence for appropriate counseling. Because of this lack of data, physicians defer to the lowest level of evidence: expert opinion and personal experience. This is probably why there is so much variation in treatment throughout the country. When considering these treatment choices, patients often must juggle expectations of treatment outcomes, quality of life, and preservation of fertility. Therefore, there is no best treatment plan.
Following the dictum of primum non nocere ("First, do no harm"), medical therapy is always the first-line option in management of symptomatic fibroid tumors. However, the use of hormonal therapies, including oral contraceptive pills, progesterones, and gonadotropin-releasing hormone agonists, has had conflicting results for some aspects of fibroid-related bleeding. In patients with symptoms persisting for more than three months, it is reasonable to try other therapies because further improvement is unlikely.
When considering other noninvasive treatment options, such as uterine artery embolization, it is important to carefully select your patients. There now are long-term follow-up data from the Fibroid Registry for Outcomes Data that may give patients some idea of treatment expectations. The overall success rate of uterine artery embolization is similar to that associated with the alternative treatment of myomectomy.2 Size and location of the tumor are important factors to consider when choosing a treatment. Submucosal fibroid tumors have a higher likelihood of necrosing and passing into the uterine cavity, which requires further surgical intervention (i.e., hysteroscopy or abdominal surgery), thus defeating the purpose of embolization. Fibroids larger than the equivalent of 20 weeks' gestational age, adenomyosis, and pedunculated subserosal fibroid tumors confer a higher chance of treatment failure and, if symptomatic, are best treated with other surgical options.
Another area of controversy is performing uterine artery embolization in patients who still desire fertility. Although there are more outcome-oriented case series for this treatment than for others, there are still insufficient data to recommend uterine artery embolization as a treatment option. This procedure is still considered investigational by the American College of Obstetricians and Gynecologists.3
Localizing submucosal fibroid tumors is best accomplished with magnetic resonance imaging; however, sonohysterography is more cost-effective. Fibroid tumors can then be classified as type 1, 2, or 3, depending on the extent of intracavitary involvement. This classification is useful in counseling about the likelihood of successful hysteroscopic resection. Patients with type 2 or 3 tumors are more likely to have incomplete resection or require a staged removal. If this risk is unacceptable to the patient, she may choose another treatment option.
Definitive surgery with hysterectomy improves most patients' symptoms with minimal effects on sexual function. Although supracervical hysterectomy has been suggested as a preferred option to total hysterectomy, removal of the cervix has been advocated because of purported benefits to sexual function, fewer operative complications, lower risk of future prolapse, and lower rates of postoperative morbidity and urinary dysfunction. However, a recent large randomized trial comparing the two types of hysterectomies did not show any benefit with either procedure in regards to these outcomes.4 Although limited conclusions can be drawn from the results of this study, it remains an ongoing debate whether to remove the cervix in hysterectomies for benign disease.
Options for hysterectomy include vaginal, abdominal, laparoscopy-assisted vaginal, laparoscopy-assisted supracervical, and complete laparoscopic hysterectomy. The approach recommended depends on many factors, such as size, concurrent ovarian pathology, prior surgeries, descent of uterus, and, most importantly, the expertise of the surgeon. Studies comparing all three approaches (i.e., vaginal, abdominal, and laparoscopic) suggest that the safest and most cost-effective approach is vaginal hysterectomy.5 This procedure is the most dependent on the expertise of the physician. Because residency training programs are now confined to 80-hour work weeks, and because less-invasive options are available, the rate of vaginal hysterectomies will continue to decline. Compared with abdominal hysterectomy, laparoscopy-assisted vaginal hysterectomy is marginally cost-effective and has faster recovery time, but it has slightly higher operative morbidity.5,6
The most difficult question about the treatment of fibroid tumors may be how to treat asymptomatic patients who are considering pregnancy. Although there are associated complications of pregnancy, including spontaneous abortions, preterm labor, growth restriction, and possible infertility if the tumor is blocking the fallopian tubes or impinging on the uterine cavity, most women do not experience any problems. The literature in infertile couples undergoing in vitro fertilization treatments suggests some improvement in implantation rates when fibroid tumors of a specific size and location are removed. However, it is difficult and possibly harmful to apply these data to a patient without infertility or a history of obstetric problems. Myomectomy can lead to hysterectomy, recurrence, adhesions, and tubal occlusion, all of which would have a negative impact on pregnancy rates.
Until there are better randomized trials comparing treatment options, physicians must carefully counsel patients and consider associated symptoms, individual expectations, and quality of life. In-depth counseling on the evidence for a specific treatment (or lack thereof) is an important consideration in the management of uterine fibroid tumors.
Address correspondence to John Buek, MD, at jdb36@georgetown.edu. Reprints are not available from the author.
Author disclosure: Nothing to disclose.
REFERENCES
1. Evans P. Uterine fibroid tumors: diagnosis and treatment. Am Fam Physician 2007;75:1503-8.
2. Broder MS, Goodwin S, Chen G, Tang LJ, Costantino MM, Nguyen MH, et al. Comparison of long-term outcomes of myomectomy and uterine artery embolization. Obstet Gynecol 2002;100(5 pt 1):864-8.
3. Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 293, February 2004. Uterine artery embolization. Obstet Gynecol 2004;103:403-4.
4. Kuppermann M, Summitt RL Jr, Varner RE, McNeeley SG, Goodman-Gruen D, Learman LA, et al., for the Total or Supracervical Hysterectomy Research Group. Sexual functioning after total compared with supracervical hysterectomy: a randomized trial. Obstet Gynecol 2005;105:1309-18.
5. Garry R, Fountain J, Mason S, Hawe J, Napp V, Abbott J, et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy [Published correction appears in BMJ 2004;328:494]. BMJ 2004;328:129.
6. Sculpher M, Manca A, Abbott J, Fountain J, Mason S, Garry R. Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial. BMJ 2004;328:134.
U.S. Statin Guidelines: Expensive but Not Necessarily Effective
See related Letter to the Editor on page 1447.
In 2000, the World Health Organization (WHO) ranked the overall performance of health care systems of its member nations.1 It considered responsiveness of the system, fairness of financial contribution, overall health goal attainment, per capita health care expenditure, and overall level of health. Overall, the United States ranked 37th-between Slovenia and Costa Rica. Although we ranked first in responsiveness to patients, we also led in per capita health care expenditure, spending 13.7 percent of our gross domestic product compared with 7.1 percent for Japan (the highest performer for overall health). Figure 1 compares the per capita expenditures of the 30 nations with the highest healthy life expectancies (i.e., the number of healthy years of life).1
Expenditures vs. Healthy Life Years
Figure 1. Medical expenditures and health. Selected data are for the 30 nations with the greatest healthy life expectancies.
Reprinted with permission from World Health Organization. The World Health Report 2000: Health Systems: Improving Performance. Geneva, Switzerland: World Health Organization, 2000.
The United States spends 50 to 100 percent more per person than most of our industrialized trading partners, yet we have worse overall health outcomes than most. Underscoring this point, Banks and colleagues demonstrated that at every socioeconomic stratum, British citizens are healthier than Americans.2 Although the WHO report can be criticized,3-6 a report card commissioned by the Commonwealth Fund similarly found room for improvement in the quality of care provided in the United States.7
A report by Manuel and colleagues gives us an opportunity to explore a few of the reasons why we spend so much and get so little benefit.8 This team compared six different guidelines on the use of statins to prevent death from coronary artery disease. If the most widely cited American guideline was applied to a hypothetical cohort of adults, we would treat twice as many patients as the most efficient guideline (from New Zealand) but mortality rates would not decrease.9 The efficiency of the American and international guidelines is summarized in Table 1.8 Although the American guideline saved a few more lives than the New Zealand guideline, it did so at great cost. If the least expensive statins cost $200 per year, the drug costs associated with the American guideline would be $198,000 to prevent one death, compared with $108,000 for the New Zealand guideline. This does not include the additional costs associated with subsequent office visits and other expenses for monitoring or managing side effects of treatment, all of which make the American guideline even more expensive. If we wish to understand why a major guideline can recommend treating so many more persons with so little additional benefit, we have to look at the process through which guidelines are developed.
|
Table 1. Effectiveness of Selected Lipid Management Guidelines |
||||
|
Guideline origin |
Adults tested |
Adults treated with statin (%) |
Coronary deaths averted in five years (per 100,000 adults) |
NNT for five years to prevent one coronary death |
|
Australia |
80.2 |
21.6 |
124 |
140 |
|
Canada |
82.3 |
20.2 |
108 |
154 |
|
Europe |
97.3 |
14.4 |
102 |
137 |
|
Great Britain |
73.4 |
23.6 |
124 |
139 |
|
New Zealand |
45.6 |
28.3 |
119 |
108 |
|
United States (treat only high-risk patients) |
100 |
16.4 |
104 |
158 |
|
United States (treat all patients recommended by NCEP panel) |
100 |
24.5 |
124 |
198 |
| NNT = number needed to treat; NCEP = National Cholesterol Education Program. Information from reference 8. |
||||
Clinical practice guidelines come in two broad types: consensus guidelines, which are typically based on the opinions of experts; and evidence-based guidelines, which are developed using an explicit process that first identifies the relevant research, then grades the quality of that research, extracting and summarizing the relevant data and identifying strategies that should lead to improved health outcomes. In both cases, however, the devil is in the details. Guidelines that are based on flawed research, that rely on surrogate disease-oriented end points (e.g., cholesterol levels) rather than clinically relevant patient-oriented end points (e.g., survival, symptom control, quality of life), that interpret the evidence inappropriately, or that are created by individuals or groups with substantial financial conflicts of interest are of questionable validity.10
The very low lipid thresholds recommended in the American guideline were based on extrapolation of data from studies that used different dosages of statins but did not explicitly study the effects of lowering cholesterol to specific target levels. Statins may have effects that prevent cardiovascular events independent of their lipid-lowering effects, and it may be that the dosage of statins is more important than lipid targets. Furthermore, the extraction of the research data lacked an explicit process, and the guideline became widely accepted before it was tested. Finally, the manner in which the guideline was developed created substantial concern at the time it was released. The panel that made the recommendations was composed largely of persons with a financial relationship with statin manufacturers. Interestingly, the acting director of the National Heart, Lung, and Blood Institute denied a public petition to convene a panel composed of persons without conflicts of interest to provide an independent review of the data.11,12 In fact, a subsequent independent analysis of the studies used to support the U.S. guideline concluded that the existing data do not support titrating lipid therapy to achieve specific lipid targets.13
Although guidelines from other countries may be more efficient, a common limitation of all guidelines, however they are created, is that few are tested to see if they actually work. Because guidelines affect the lives of millions of persons, we should make every effort to evaluate their impact in terms of resources and patient-oriented outcomes. This is rarely done, and analyses like that of Manuel and colleagues8 are valuable for that reason.
How, then, can family physicians determine if a guideline can be trusted? We suggest that the guideline development process itself must be explicit and transparent. The process must have a clearly defined purpose and target audience. Finally, and most importantly, the members of the development team should be free of financial conflicts of interest. In Table 2 we propose a set of criteria to evaluate guidelines. Despite our concerns about the National Cholesterol Education Program guideline,9 an excellent source of high-quality guidelines that include many of these elements can be found at the National Guideline Clearinghouse (http://www.guideline.gov). American physicians should be open to the likelihood that excellent guidelines may come from organizations outside the United States.
|
Table 2. Criteria for Evaluating Clinical Practice Guidelines |
|
The guideline should: Be critiqued in terms of its applicability to individual patients and local communities Be updated regularly Have a clearly defined purpose Identify the intended population (e.g., patients, practice settings, users) Undergo independent external review or formal testing for effectiveness Use explicit and systematic processes for identifying the relevant research, extracting the data, and grading the quality of the recommendations The guideline development panel members must be identified and their expertise specified The guideline development process must be free of financial conflicts of interest: No support from companies that stand to profit from its recommendations (including "educational contributions" to the sponsoring organization) No member of the panel should have financial relationships with companies that could profit from the recommendations (The claim that excluding individuals with such conflicts would leave us with no experts is untenable.) |
We do not suggest that consensus guidelines should be summarily rejected. But given the many threats to the validity of so many current guidelines, we must demand that there be evidence that a guideline is based on careful and unbiased analysis of clinically relevant data, and subjected to a critical evaluation of its own impact.
Address correspondence to Henry C. Barry, MD, MS, at henry.barry@ht.msu.edu. Reprints are not available from the authors.
Author disclosure: Dr. Barry is a paid consultant for Wiley InterScience.
REFERENCES
1. World Health Organization. The World Health Report 2000. Health Systems: Improving Performance. Geneva, Switzerland: World Health Organization, 2000.
2. Banks J, Marmot M, Oldfield Z, Smith JP. Disease and disadvantage in the United States and in England. JAMA 2006;295:2037-45.
3. Almeida C, Braveman P, Gold MR, Szwarcwald CL, Ribeiro JM, Miglionico A, et al. Methodological concerns and recommendations on policy consequences of the World Health Report 2000. Lancet 2001;357:1692-7.
4. Coyne JS, Hilsenrath P. The World Health Report 2000: can health care systems be compared using a single measure of performance? Am J Public Health 2002;92:30, 32-3.
5. Hyder AA. Misunderstanding the World Health Report 2000. Am J Public Health 2002;92:1054-5.
6. Navarro V. The World Health Report 2000: can health care systems be compared using a single measure of performance? Am J Public Health 2002;92:31, 33-4.
7. Schoen C, Davis K, How SK, Schoenbaum SC. U.S. health system performance: a national scorecard. Health Aff (Millwood) 2006;25:w457-75.
8. Manuel DG, Kwong K, Tanuseputro P, Lim J, Mustard CA, Anderson GM, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modelling study. BMJ 2006;332:1419.
9. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (adult treatment panel III): final report. NIH publication no. 02-5215. Bethesda, Md.: National Cholesterol Education Program, National Heart, Lung, and Blood Institute, National Institutes of Health, 2002.
10. Shaughnessy AF, Slawson DC, Bennett JH. Becoming an information master: a guidebook to the medical information jungle. J Fam Pract 1994;39:489-99.
11. Abramson J, Barnard RJ, Barry HC, Bezruchka S, Brody H, Brown DL, et al. Petition to the National Institutes of Health seeking an independent review panel to re-evaluate the National Cholesterol Education Program guidelines. September 23, 2004. Accessed March 13, 2007, at: http://cspinet.org/new/pdf/finalnihltr.pdf.
12. Alving B, for the U.S. Department of Health and Human Services. [Response to petition to the National Institutes of Health seeking an independent review panel to re-evaluate the National Cholesterol Education Program guidelines. September 23, 2004]. Accessed March 13, 2007, at: www.nhlbi.nih.gov/guidelines/cholesterol/response.pdf.
13. Hayward RA, Hofer TP, Vijan S. Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem. Ann Intern Med 2006;145:520-30.
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