Letters to the Editor
When Should Pregnant Women with Diabetes Receive Insulin?
To the editor: When should a pregnant woman who has diabetes receive insulin? Rightly or wrongly, the administration of insulin in pregnant women is perceived as increasing the risk to the mother and fetus enough to necessitate referral from the family practice, which often results in increasingly aggressive management. A review of bylaws at four major hospitals indicated that the administration of insulin required the involvement of an obstetrician documented in the chart before delivery. This consultation has become increasingly difficult to obtain because obstetricians often avoid involvement with high-risk cases other than their own.
Examples of aggressive management have included recommendations for insulin at two-hour postprandial glucose levels of 120 mg per dL (6.7 mmol per L). In Tennessee, recommendations vary, but few consultants have recommended the administration of insulin at these levels. An article1 in American Family Physician on gestational diabetes cited limited studies claiming to reduce the frequency of macrosomia, which is an indirect measure of a rare event (such as shoulder dystocia or brachial plexus injury with permanent paralysis of an arm). This leads to the heuristic fallacy of managing each case with the strategy of catastrophic expectations. This advice is not compatible with community medical practice, which usually does not require insulin for the successful management of gestational diabetes mellitus.
Several patients were referred to perinatology for prescription of insulin to achieve "tight control” of blood glucose levels. Follow-up revealed that the consultants managed these cases with diet and surveillance similar to what previously had been used in the family physicians' office. The source data2 were reviewed starting with the Cochrane database.
We are concerned that the following statement from the article1 may be misinterpreted as a standard of care: "Therefore, insulin therapy traditionally has been started when capillary blood glucose levels exceed 105 mg per dL (5.8 mmol per L) in the fasting state and 120 mg per dL…two hours after meals. These cutoff values are derived from guidelines for managing insulin in pregnant women who have type 1 diabetes.”1 The authors1 suggest that insulin might be started at even lower levels. While this may lower the blood glucose level, it is premature to mandate insulin on the basis of indirect measures taken from a different disease. Gestational diabetes is not the equivalent of ketosis-prone type 1 diabetes or women who were receiving insulin before becoming pregnant. The more stable condition of gestational diabetes is appropriately managed in a more conservative fashion with a latitude of practice styles.3
In our community and many others, the prescription of insulin raises the patient up into a risk category that literally prohibits continuing care by the family physician. For our uninsured patients, premature referral has been a financial disaster. In the hands of the family physician, close surveillance with ultrasonography in the third trimester appears to work just as well in avoiding the complications of macrosomia. Other maternal and fetal morbidities are extremely rare, and insulin does not prevent them. A guideline should not be elevated to a standard before its time.
REFERENCES
1. Turok DK, Ratcliffe SD, Baxley EG. Management of gestational diabetes mellitus. Am Fam Physician 2003;68:1767-72.
2. U.S. Preventive Services Task Force (USPSTF). Screening for gestational diabetes mellitus: recommendations and rationale. Am Fam Physician 2003;68:331-5.
3. Naylor CD, Sermer M, Chen E, Sykora K. Cesarean delivery in relation to birth weight and gestational glucose tolerance: pathophysiology or practice style? Toronto Trihospital Gestational Diabetes Investigators. JAMA 1996;275:1165-70.
In reply: I appreciate the comments from Dr. Rodney and colleagues regarding my article1 on gestational diabetes mellitus in American Family Physician. I guarantee you that the authors of our article1 understand the nature of the difficulties you face in obtaining obstetric consultation when working with an underserved population. The authors1 have decades of experience providing obstetric care to underserved populations. It was certainly not our intention to refer a greater number of patients for consultation.
A central theme of the article1 is that much of the "routine care” for patients with gestational diabetes mellitus is based on imperfect and possibly misapplied data. This article represents one groups' view on this subject, and it is possible to find many other sources that vary in their opinions. As stated in the article,1 this is a controversial issue. The lack of agreement among many expert bodies reflects this.
Given the wide variance in practice, there appear to be several options for family physicians:
(1) Don't screen for gestational diabetes mellitus. The U.S. Preventive Services Task Force assigns screening an "I” rating, meaning that the evidence is insufficient to recommend for or against. The argument is that this screening test does not have data to demonstrate a reduction in adverse outcomes.
(2) Develop a community standard for the initiation of insulin in patients with gestational diabetes mellitus. There is some leeway here, and the physician may agree with the obstetricians in your community about who actually needs insulin. This may provide an option for those obstetricians who may not want to consult on your patients.
(3) Use glyburide instead of insulin. Do the hospital protocols call for referral with glyburide? The American College of Obstetricians and Gynecologists do not recommended the use of glyburide, but it is used widely in clinical practice.
As physicians who provide care to the underserved, we certainly appreciate the issues raised by Dr. Rodney and colleagues.
REFERENCE
1. Turok DK, Ratcliffe SD, Baxley EG. Management of gestational diabetes mellitus. Am Fam Physician 2003;68:1767-72.
Contact Information Needed for Manufacturers of Diaphragms
to the editor: I found Dr. Allen's article, "Diaphragm Fitting,”1 in the January 1, 2004, issue of American Family Physician helpful and informative. However, I would have appreciated specific details on how to contact the manufacturers for fitting diaphragms, as I have been unable to do so.
REFERENCE
1. Allen RE. Diaphragm fitting. Am Fam Physician 2004; 69:97-100.
In reply: I sympathize with Dr. Pagnotta's attempt to obtain diaphragm fitting rings. The marketing of diaphragms certainly is not the major emphasis of the pharmaceutical companies that produce them. My own fitting set is very old and was passed down from a retired gynecologist. But I do have several recommendations.
Most physicians who fit diaphragms will invest in a variety of sizes to keep in the office. The actual diaphragm may be easier to use than a fitting ring and can be demonstrated to patients who are interested. Diaphragms can be sterilized between patients according to instructions in the package insert. It is recommended that physicians have diaphragms in a size range of 60 to 90 mm (a total of seven diaphragms); these sizes will fit most women. The fitting diaphragm can then be sold to the patient and the clinic stock replenished, or the patient can be sent to the pharmacy to order the correct size.
Milex manufactures the Wide-Seal silicone diaphragm and offers a "free fitting set with order of 12 diaphragms” on their Web site (http://www.milexproducts.com). The Milex sales representative who visits my office with a supply of pessaries also has been helpful with diaphragm information.
Latex diaphragms are available from several online pharmacies, including Westons Internet Home Health and Medical Equipment (http://www.westons.com), or your local pharmacy can order a variety of diaphragms for use in fitting. Ortho-McNeil makes latex diaphragms, and I recommend contacting one of their sales representatives. Ortho-McNeil did not respond to my e-mails or telephone calls when I asked about complimentary fitting rings or diaphragm sets. The contact number for Ortho-McNeil is 800-682-6532, and they can be found on the Web at http://www.ortho-mcneil.com.
Aspirin Use for Prevention of CHD: An FP's Story
to the editor: On December 8, 2003, I had the honor of testifying before the U.S. Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee in Washington, D.C. This adventure started with an editorial I wrote for the May 15, 2002, issue of American Family Physician.1 The third U.S. Preventive Services Task Force (USPSTF) found good evidence that the benefit of low-dose (81 mg) daily aspirin therapy in persons at high risk (10-year risk of at least 6 percent) for coronary heart disease (CHD) outweighs any potential harm.2 The USPSTF recommended that we discuss the benefits and harms of aspirin chemoprophylaxis with our at-risk patients, and this recommendation was subsequently endorsed by the American Heart Association (AHA) and the American Diabetes Association (ADA).
Nearly 18 months later I was contacted by the Bayer Health Care Organization, inviting me to participate in the FDA Advisory Committee meeting. When I asked them why they were contacting me, their reply was that they had read the AFP editorial1 and wanted a family physician to testify on the importance of primary prevention of CHD.
Over-the-counter drug labeling supplies information to consumers so they can safely self-medicate, while professional drug labeling provides advice to health care professionals on the safe and effective use of the drug. Currently, the approved professional labeling regarding cardiovascular indications for aspirin use includes suspected acute myocardial infarction (MI), prevention of recurrent MI, and unstable and chronic stable angina. Based on results of recent studies,3,4 Bayer submitted a Citizen's Petition requesting the FDA's approval for expanded cardiovascular indications and labeling for the use of a daily aspirin regimen (75 to 325 mg) in persons at high risk for CHD.
The day-long meeting with the FDA Advisory Committee was inspirational and humbling. Data were presented, analyzed, subanalyzed, and debated. I was part of a group who testified during the Open Public Hearing, which was then followed by a heated discussion by the advisory committee. The debate centered on the risk-benefit ratio of aspirin use. Despite studies totaling nearly 55,000 subjects, women and minorities were under-represented, and it was unclear exactly how many were in a low-risk CHD category compared with a moderate-risk category. While there was a 27 percent decrease in nonfatal MIs, the data were less clear with silent and fatal MIs. Although the committee ultimately voted against approval of the request, the reasons given for their votes were enlightening-many who voted "no” took daily aspirin themselves for prophylaxis! The proceedings from this committee can be found online at http://www.fda.gov/ohrms/dockets/ac/cder03.html#CardiovascularRenal.
So, where does that leave family physicians? We have three major organizations (USPSTF, AHA, and ADA) recommending low-dose aspirin for primary prevention in persons at moderate to high risk for CHD, while the FDA notes that further studies need to be performed. Because these studies will probably not be performed, we are left to what we do best-talk to our patients. For patients who are at increased risk, we can talk to them about modifying their risk factors while discussing the risks and benefits of low-dose aspirin to arrive at a mutual decision. We then need to keep alert for further studies that may help resolve this dilemma.
REFERENCES
1. Miser WF. An aspirin a day keeps the MI away (for some). Am Fam Physician 2002;65:2000, 2003.
2. U.S. Preventive Services Task Force. Aspirin for the primary prevention of cardiovascular events: recommendations and rationale. Am Fam Physician 2002;65:2107-10.
3. Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324:71-86.
4. Eidelman RS, Hebert PR, Weisman SM, Hennekens CH. An update on aspirin in the primary prevention of cardiovascular disease. Arch Intern Med 2003;163:2006-10.
The quiz answer block in the November 15, 2004, issue (page 2028) gave an incorrect answer to question 5 of the "Clinical Quiz” (page 1854). The correct answer to question 5 is D, rather than C. The quiz answer block has been corrected online, and the question is reprinted below.
- Q5. Which one of the following is the mainstay in symptomatic relief in an acute relapse of multiple sclerosis?
A. Physical therapy until symptoms resolve.-
B. Amitriptyline (Elavil).
-
C. Intrathecal baclofen (Lioresal).
-
D. Corticosteroids.
-
E. Amantadine (Symmetrel).
|
Copyright © 2005 by the American
Academy of Family Physicians. |
