What Matters

Medical knowledge about clinical indications for medications is transferred to new generations of clinicians frequently without the caveat that the indication is, by the way, “off label."

Off-label use is the practice of prescribing pharmaceuticals for: 1) an unapproved indication; 2) in an unapproved age group; 3) using an unapproved dose; or 4) using an unapproved form of administration. Likely not many of us have recently reviewed the package insert for trazodone, for example, to find out that insomnia is not a Food and Drug Administration–approved indication. But what else do we do?

A fascinating piece of work was published recently that pulls back the curtain on off-label prescribing patterns for certain medications (Arch. Intern. Med. Published online April 16, 2012. doi:10.1001/archinternmed.2012.340).

The study evaluated prescribing practices – including off-label uses – in a Canadian primary care network covering 113 primary care clinicians who wrote 253,347 electronic prescriptions for 50,823 patients. Overall, 11% of medications were prescribed for off-label uses, of which 79% lacked scientific evidence of efficacy. Older drugs and those with fewer approved indications had higher rates of off-label use.

The top 10 clinical indications treated with off-label drugs and the most frequent off-label drugs used for them included the following: 1) benign paroxysmal positional vertigo – betahistine (not available in U.S.); 2) nocturnal leg pain – quinine; 3) neurogenic pain – gabapentin; 4) chronic pain – nortriptyline; 5) fibromyalgia – cyclobenzaprine; 6) arrhythmia – metoprolol; 7) generalized anxiety disorder – citalopram; 8) insomnia – oxazepam; 9) bipolar disorder – lamotrigine; and 10) diabetic neuropathy – gabapentin.

Antimigraine, lipid-lowering agents and antidiabetic medications had the lowest rates of off-label use. Patients who had more medical problems were less likely to receive off-label medications probably because, as the authors point out, clinicians might feel they had less room to “experiment” with a medication.

Keep in mind that this study looked at indications approved by Health Canada, which may differ from indications approved by the Food and Drug Administration in the United States. Health Canada can approve generic drugs for the Canadian market 5 years earlier than the FDA can in the United States, and drugs may not be approved at the same time in the two countries.

Clinical “tricks of the trade” are handed down through generations of physicians. As practicing clinicians, we need to seek out and remind ourselves of the evidence base supporting the use of the medications we prescribe. Prescribing ineffective pharmacotherapeutics to our trusting patients will take the magic out of what we do.

Dr. Ebbert is a professor of medicine and a primary care clinician at the Mayo Clinic in Rochester, Minn. He does not promote the off-label use of medications. The opinions expressed are solely those of the author. E-mail him at ebbert.jon@mayo.edu.

Medical knowledge about clinical indications for medications is transferred to new generations of clinicians frequently without the caveat that the indication is, by the way, “off label."

Off-label use is the practice of prescribing pharmaceuticals for: 1) an unapproved indication; 2) in an unapproved age group; 3) using an unapproved dose; or 4) using an unapproved form of administration. Likely not many of us have recently reviewed the package insert for trazodone, for example, to find out that insomnia is not a Food and Drug Administration–approved indication. But what else do we do?

A fascinating piece of work was published recently that pulls back the curtain on off-label prescribing patterns for certain medications (Arch. Intern. Med. Published online April 16, 2012. doi:10.1001/archinternmed.2012.340).

The study evaluated prescribing practices – including off-label uses – in a Canadian primary care network covering 113 primary care clinicians who wrote 253,347 electronic prescriptions for 50,823 patients. Overall, 11% of medications were prescribed for off-label uses, of which 79% lacked scientific evidence of efficacy. Older drugs and those with fewer approved indications had higher rates of off-label use.

The top 10 clinical indications treated with off-label drugs and the most frequent off-label drugs used for them included the following: 1) benign paroxysmal positional vertigo – betahistine (not available in U.S.); 2) nocturnal leg pain – quinine; 3) neurogenic pain – gabapentin; 4) chronic pain – nortriptyline; 5) fibromyalgia – cyclobenzaprine; 6) arrhythmia – metoprolol; 7) generalized anxiety disorder – citalopram; 8) insomnia – oxazepam; 9) bipolar disorder – lamotrigine; and 10) diabetic neuropathy – gabapentin.

Antimigraine, lipid-lowering agents and antidiabetic medications had the lowest rates of off-label use. Patients who had more medical problems were less likely to receive off-label medications probably because, as the authors point out, clinicians might feel they had less room to “experiment” with a medication.

Keep in mind that this study looked at indications approved by Health Canada, which may differ from indications approved by the Food and Drug Administration in the United States. Health Canada can approve generic drugs for the Canadian market 5 years earlier than the FDA can in the United States, and drugs may not be approved at the same time in the two countries.

Clinical “tricks of the trade” are handed down through generations of physicians. As practicing clinicians, we need to seek out and remind ourselves of the evidence base supporting the use of the medications we prescribe. Prescribing ineffective pharmacotherapeutics to our trusting patients will take the magic out of what we do.

Dr. Ebbert is a professor of medicine and a primary care clinician at the Mayo Clinic in Rochester, Minn. He does not promote the off-label use of medications. The opinions expressed are solely those of the author. E-mail him at ebbert.jon@mayo.edu.

Medical knowledge about clinical indications for medications is transferred to new generations of clinicians frequently without the caveat that the indication is, by the way, “off label."

Off-label use is the practice of prescribing pharmaceuticals for: 1) an unapproved indication; 2) in an unapproved age group; 3) using an unapproved dose; or 4) using an unapproved form of administration. Likely not many of us have recently reviewed the package insert for trazodone, for example, to find out that insomnia is not a Food and Drug Administration–approved indication. But what else do we do?

A fascinating piece of work was published recently that pulls back the curtain on off-label prescribing patterns for certain medications (Arch. Intern. Med. Published online April 16, 2012. doi:10.1001/archinternmed.2012.340).

The study evaluated prescribing practices – including off-label uses – in a Canadian primary care network covering 113 primary care clinicians who wrote 253,347 electronic prescriptions for 50,823 patients. Overall, 11% of medications were prescribed for off-label uses, of which 79% lacked scientific evidence of efficacy. Older drugs and those with fewer approved indications had higher rates of off-label use.

The top 10 clinical indications treated with off-label drugs and the most frequent off-label drugs used for them included the following: 1) benign paroxysmal positional vertigo – betahistine (not available in U.S.); 2) nocturnal leg pain – quinine; 3) neurogenic pain – gabapentin; 4) chronic pain – nortriptyline; 5) fibromyalgia – cyclobenzaprine; 6) arrhythmia – metoprolol; 7) generalized anxiety disorder – citalopram; 8) insomnia – oxazepam; 9) bipolar disorder – lamotrigine; and 10) diabetic neuropathy – gabapentin.

Antimigraine, lipid-lowering agents and antidiabetic medications had the lowest rates of off-label use. Patients who had more medical problems were less likely to receive off-label medications probably because, as the authors point out, clinicians might feel they had less room to “experiment” with a medication.

Keep in mind that this study looked at indications approved by Health Canada, which may differ from indications approved by the Food and Drug Administration in the United States. Health Canada can approve generic drugs for the Canadian market 5 years earlier than the FDA can in the United States, and drugs may not be approved at the same time in the two countries.

Clinical “tricks of the trade” are handed down through generations of physicians. As practicing clinicians, we need to seek out and remind ourselves of the evidence base supporting the use of the medications we prescribe. Prescribing ineffective pharmacotherapeutics to our trusting patients will take the magic out of what we do.

Dr. Ebbert is a professor of medicine and a primary care clinician at the Mayo Clinic in Rochester, Minn. He does not promote the off-label use of medications. The opinions expressed are solely those of the author. E-mail him at ebbert.jon@mayo.edu.

Last week, JAMA released a theme issue devoted to comparative effectiveness research (CER).

In contrast to traditional randomized clinical trials comparing an active intervention to a control condition (or placebo), CER compares existing interventions to each other to determine relative harms and benefits. CER research frequently includes patient preferences and patient-centered perspectives, and models have been developed to engage patients every step of the way. CER data are maturing and attracting enormous attention thanks to staggering sums of money provided through the American Recovery and Reinvestment Act in 2009 and the Patient Protection and Affordable Care Act of 2010. One of the CER studies published last week evaluated long-term outcomes after open vs. endovascular repair of an abdominal aortic aneurysm (JAMA. 2012;307:1621-28).

The study was a retrospective analysis of patients at least 65 years in the Medicare database who underwent repair of a nonruptured AAA. Open repair was conducted on 703 patients and endovascular repair was conducted on 3,826. After statistical adjustment for relevant potential confounders, a higher risk was observed for both all-cause mortality (hazard ratio [HR], 1.24 [95% CI, 1.05-1.47]; P=.01) and AAA-related mortality (HR, 4.37 [95% CI, 2.51-7.66]; P<.001) after open compared with endovascular repair. Hospital length of stay was 6.5 days longer and incisional repair was higher with open repair. One-year readmission, repeat AAA repair, and leg amputation did not differ between the two approaches.

This study has immediate implications for clinical counseling and referrals of patients who we were following and are now referring for large AAA’s. While the study’s retrospective analysis design may not be at the top of the evidence-based hierarchy, it’s a good example of how CER often yields the "best available evidence" for our clinical questions. Practicing clinicians will be well-served familiarizing ourselves with CER research if, for no other reason, than the following: funding agencies and health care insurers are paying attention. Cost-effective treatment approaches will likely receive preferential or exclusive reimbursement. This will undoubtedly have a stunning and transformative effect on the complexion of our practices.

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. The opinions expressed are solely those of the author. He reports having no relevant conflicts of interest. To contact him, send an e-mail to ebbert.jon@mayo.edu.

Last week, JAMA released a theme issue devoted to comparative effectiveness research (CER).

In contrast to traditional randomized clinical trials comparing an active intervention to a control condition (or placebo), CER compares existing interventions to each other to determine relative harms and benefits. CER research frequently includes patient preferences and patient-centered perspectives, and models have been developed to engage patients every step of the way. CER data are maturing and attracting enormous attention thanks to staggering sums of money provided through the American Recovery and Reinvestment Act in 2009 and the Patient Protection and Affordable Care Act of 2010. One of the CER studies published last week evaluated long-term outcomes after open vs. endovascular repair of an abdominal aortic aneurysm (JAMA. 2012;307:1621-28).

The study was a retrospective analysis of patients at least 65 years in the Medicare database who underwent repair of a nonruptured AAA. Open repair was conducted on 703 patients and endovascular repair was conducted on 3,826. After statistical adjustment for relevant potential confounders, a higher risk was observed for both all-cause mortality (hazard ratio [HR], 1.24 [95% CI, 1.05-1.47]; P=.01) and AAA-related mortality (HR, 4.37 [95% CI, 2.51-7.66]; P<.001) after open compared with endovascular repair. Hospital length of stay was 6.5 days longer and incisional repair was higher with open repair. One-year readmission, repeat AAA repair, and leg amputation did not differ between the two approaches.

This study has immediate implications for clinical counseling and referrals of patients who we were following and are now referring for large AAA’s. While the study’s retrospective analysis design may not be at the top of the evidence-based hierarchy, it’s a good example of how CER often yields the "best available evidence" for our clinical questions. Practicing clinicians will be well-served familiarizing ourselves with CER research if, for no other reason, than the following: funding agencies and health care insurers are paying attention. Cost-effective treatment approaches will likely receive preferential or exclusive reimbursement. This will undoubtedly have a stunning and transformative effect on the complexion of our practices.

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. The opinions expressed are solely those of the author. He reports having no relevant conflicts of interest. To contact him, send an e-mail to ebbert.jon@mayo.edu.

Last week, JAMA released a theme issue devoted to comparative effectiveness research (CER).

In contrast to traditional randomized clinical trials comparing an active intervention to a control condition (or placebo), CER compares existing interventions to each other to determine relative harms and benefits. CER research frequently includes patient preferences and patient-centered perspectives, and models have been developed to engage patients every step of the way. CER data are maturing and attracting enormous attention thanks to staggering sums of money provided through the American Recovery and Reinvestment Act in 2009 and the Patient Protection and Affordable Care Act of 2010. One of the CER studies published last week evaluated long-term outcomes after open vs. endovascular repair of an abdominal aortic aneurysm (JAMA. 2012;307:1621-28).

The study was a retrospective analysis of patients at least 65 years in the Medicare database who underwent repair of a nonruptured AAA. Open repair was conducted on 703 patients and endovascular repair was conducted on 3,826. After statistical adjustment for relevant potential confounders, a higher risk was observed for both all-cause mortality (hazard ratio [HR], 1.24 [95% CI, 1.05-1.47]; P=.01) and AAA-related mortality (HR, 4.37 [95% CI, 2.51-7.66]; P<.001) after open compared with endovascular repair. Hospital length of stay was 6.5 days longer and incisional repair was higher with open repair. One-year readmission, repeat AAA repair, and leg amputation did not differ between the two approaches.

This study has immediate implications for clinical counseling and referrals of patients who we were following and are now referring for large AAA’s. While the study’s retrospective analysis design may not be at the top of the evidence-based hierarchy, it’s a good example of how CER often yields the "best available evidence" for our clinical questions. Practicing clinicians will be well-served familiarizing ourselves with CER research if, for no other reason, than the following: funding agencies and health care insurers are paying attention. Cost-effective treatment approaches will likely receive preferential or exclusive reimbursement. This will undoubtedly have a stunning and transformative effect on the complexion of our practices.

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. The opinions expressed are solely those of the author. He reports having no relevant conflicts of interest. To contact him, send an e-mail to ebbert.jon@mayo.edu.

Last week, the Centers for Disease Control and Prevention released a report on the percentage of adults with activity limitations. The report stated that adults aged at least 75 years are almost three times as likely as adults aged 65-74 years (11.0% versus 3.7%) to require the help of another person with activities of daily living (ADLs) and with instrumental activities of daily living (IADLs) (18.8% versus 6.5%). ADLs were defined as eating, bathing, dressing, or getting around inside this home. IADLs were defined as everyday household chores, doing necessary business, shopping, or getting around for other purposes. Although not specifically analyzed in this report, my clinical observations tell me that activity limitations among patients with diabetes are higher than those without.

Serendipitously, the New England Journal of Medicine recently published data from the Look AHEAD (Action for Health in Diabetes) study investigating the effects of a lifestyle intervention to improve fitness and decrease loss of mobility among diabetics. In this study, 5,145 overweight or obese adults between the ages of 45 and 74 years with type 2 diabetes were randomized to an intensive lifestyle intervention or an educational session control (N Engl J Med 2012; 366:1209-17).

The intensive lifestyle intervention was designed to achieve a mean weight loss from baseline of more than 7% and to increase the duration of physical activity to more than 175 minutes a week. Intervention components included: 1) a portion-controlled diet; 2) a multi-component approach to intervention (including behavioral techniques, diet modification, physical activity, and social support); 3) ongoing regular contact throughout the follow-up period; and 4) weight loss medication and advanced behavioral strategies for participants having difficulty achieving or maintaining weight loss. Moderate-intensity walking was encouraged as the primary type of physical activity. At four years, the lifestyle-intervention group had a relative reduction of 48% in the risk of loss of mobility, as compared with the support group (odds ratio, 0.52; 95% confidence interval, 0.44 to 0.63). Weight loss was slightly more influential in preventing loss of mobility than improved fitness, but both contributed to the effect.

Findings from this study have important implications for our clinical practice. First, physical activity was a cornerstone in this intervention and relied on unsupervised exercise. For our patients with diabetes, we can give the following exercise prescription: total of 175 minutes of moderate intensity (e.g., walking) exercise over at least 5 days a week with a minimum of 10 minutes per exercise session. Second, we can work toward removing barriers to exercise such as foot pain by assisting our patients in obtaining supportive footwear and writing prescriptions as necessary. Medicare will cover the cost of one pair of therapeutic shoes (diabetic shoes) and inserts for people with diabetes. Third, since weight loss plays a critical role in reducing mobility loss, we can use this information to motivate our patients to achieve an ideal body weight with dietary modifications (e.g., portion control plates, reducing carbohydrate consumption), exercise prescriptions, and possibly medications (e.g., orlistat).

Virtually all of our patients with diabetes want to remain in their current living environments. We now have data to motivate lifestyle changes to increase the probability that they can.

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, MN. The opinions expressed are solely those of the author. Email: ebbert.jon@mayo.edu.

Last week, the Centers for Disease Control and Prevention released a report on the percentage of adults with activity limitations. The report stated that adults aged at least 75 years are almost three times as likely as adults aged 65-74 years (11.0% versus 3.7%) to require the help of another person with activities of daily living (ADLs) and with instrumental activities of daily living (IADLs) (18.8% versus 6.5%). ADLs were defined as eating, bathing, dressing, or getting around inside this home. IADLs were defined as everyday household chores, doing necessary business, shopping, or getting around for other purposes. Although not specifically analyzed in this report, my clinical observations tell me that activity limitations among patients with diabetes are higher than those without.

Serendipitously, the New England Journal of Medicine recently published data from the Look AHEAD (Action for Health in Diabetes) study investigating the effects of a lifestyle intervention to improve fitness and decrease loss of mobility among diabetics. In this study, 5,145 overweight or obese adults between the ages of 45 and 74 years with type 2 diabetes were randomized to an intensive lifestyle intervention or an educational session control (N Engl J Med 2012; 366:1209-17).

The intensive lifestyle intervention was designed to achieve a mean weight loss from baseline of more than 7% and to increase the duration of physical activity to more than 175 minutes a week. Intervention components included: 1) a portion-controlled diet; 2) a multi-component approach to intervention (including behavioral techniques, diet modification, physical activity, and social support); 3) ongoing regular contact throughout the follow-up period; and 4) weight loss medication and advanced behavioral strategies for participants having difficulty achieving or maintaining weight loss. Moderate-intensity walking was encouraged as the primary type of physical activity. At four years, the lifestyle-intervention group had a relative reduction of 48% in the risk of loss of mobility, as compared with the support group (odds ratio, 0.52; 95% confidence interval, 0.44 to 0.63). Weight loss was slightly more influential in preventing loss of mobility than improved fitness, but both contributed to the effect.

Findings from this study have important implications for our clinical practice. First, physical activity was a cornerstone in this intervention and relied on unsupervised exercise. For our patients with diabetes, we can give the following exercise prescription: total of 175 minutes of moderate intensity (e.g., walking) exercise over at least 5 days a week with a minimum of 10 minutes per exercise session. Second, we can work toward removing barriers to exercise such as foot pain by assisting our patients in obtaining supportive footwear and writing prescriptions as necessary. Medicare will cover the cost of one pair of therapeutic shoes (diabetic shoes) and inserts for people with diabetes. Third, since weight loss plays a critical role in reducing mobility loss, we can use this information to motivate our patients to achieve an ideal body weight with dietary modifications (e.g., portion control plates, reducing carbohydrate consumption), exercise prescriptions, and possibly medications (e.g., orlistat).

Virtually all of our patients with diabetes want to remain in their current living environments. We now have data to motivate lifestyle changes to increase the probability that they can.

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, MN. The opinions expressed are solely those of the author. Email: ebbert.jon@mayo.edu.

Last week, the Centers for Disease Control and Prevention released a report on the percentage of adults with activity limitations. The report stated that adults aged at least 75 years are almost three times as likely as adults aged 65-74 years (11.0% versus 3.7%) to require the help of another person with activities of daily living (ADLs) and with instrumental activities of daily living (IADLs) (18.8% versus 6.5%). ADLs were defined as eating, bathing, dressing, or getting around inside this home. IADLs were defined as everyday household chores, doing necessary business, shopping, or getting around for other purposes. Although not specifically analyzed in this report, my clinical observations tell me that activity limitations among patients with diabetes are higher than those without.

Serendipitously, the New England Journal of Medicine recently published data from the Look AHEAD (Action for Health in Diabetes) study investigating the effects of a lifestyle intervention to improve fitness and decrease loss of mobility among diabetics. In this study, 5,145 overweight or obese adults between the ages of 45 and 74 years with type 2 diabetes were randomized to an intensive lifestyle intervention or an educational session control (N Engl J Med 2012; 366:1209-17).

The intensive lifestyle intervention was designed to achieve a mean weight loss from baseline of more than 7% and to increase the duration of physical activity to more than 175 minutes a week. Intervention components included: 1) a portion-controlled diet; 2) a multi-component approach to intervention (including behavioral techniques, diet modification, physical activity, and social support); 3) ongoing regular contact throughout the follow-up period; and 4) weight loss medication and advanced behavioral strategies for participants having difficulty achieving or maintaining weight loss. Moderate-intensity walking was encouraged as the primary type of physical activity. At four years, the lifestyle-intervention group had a relative reduction of 48% in the risk of loss of mobility, as compared with the support group (odds ratio, 0.52; 95% confidence interval, 0.44 to 0.63). Weight loss was slightly more influential in preventing loss of mobility than improved fitness, but both contributed to the effect.

Findings from this study have important implications for our clinical practice. First, physical activity was a cornerstone in this intervention and relied on unsupervised exercise. For our patients with diabetes, we can give the following exercise prescription: total of 175 minutes of moderate intensity (e.g., walking) exercise over at least 5 days a week with a minimum of 10 minutes per exercise session. Second, we can work toward removing barriers to exercise such as foot pain by assisting our patients in obtaining supportive footwear and writing prescriptions as necessary. Medicare will cover the cost of one pair of therapeutic shoes (diabetic shoes) and inserts for people with diabetes. Third, since weight loss plays a critical role in reducing mobility loss, we can use this information to motivate our patients to achieve an ideal body weight with dietary modifications (e.g., portion control plates, reducing carbohydrate consumption), exercise prescriptions, and possibly medications (e.g., orlistat).

Virtually all of our patients with diabetes want to remain in their current living environments. We now have data to motivate lifestyle changes to increase the probability that they can.

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, MN. The opinions expressed are solely those of the author. Email: ebbert.jon@mayo.edu.

A colleague of mine recently made me aware of a resolution in the Kansas House of Representatives "requesting the Kansas Department of Health and Environment to conduct a study regarding tobacco harm reduction." This cacophonous social debate centers on the idea of recommending chewing tobacco (i.e., snuff) to cigarette smokers to reduce societal harm associated with cigarette smoking. Cigarette smoking remains the leading cause of preventable death and disability in the United States, and tobacco harm reduction (THR) has been proposed as a way to mitigate this ongoing public health disaster. One way to more clearly understand this debate is to consider it at two levels: the societal and the individual.

At the societal level, one must envision the population impact of having all smokers switch to smokeless tobacco. Smokeless tobacco is associated with fewer health risks than cigarettes, but it is not "risk free." Statistical modeling has suggested that widespread public health advocacy of this approach could result in net population harm with some smokers becoming "dual users" (i.e., smoking cigarettes and using smokeless tobacco simultaneously). Dual use of tobacco may be associated with more risk than cigarette smoking alone. THR also undermines clear indoor air policies, which are effective in reducing cigarette consumption, because it allows smokers to maintain tobacco dependence by using smokeless tobacco at times when they cannot smoke. Not surprisingly, THR is endorsed by cigarette manufacturers who now also sell smokeless tobacco. THR advocates decree that the reduction in societal adverse health consequences if all smokers switched to smokeless would be significant. The likelihood of this occurring is probably overestimated as smokeless tobacco is already widely available and very few of my smokers are electing to switch.

At the individual level, it is important that primary care providers remain cognizant of the risks associated with our clinical recommendations. Whenever we prescribe or recommend treatment, we assume responsibility for both the clinical benefits and the adverse effects, or risks. Long-term use of smokeless tobacco is associated with an increased risk for adverse cardiovascular events (i.e., stroke and myocardial infarction) and cancer. If we were to recommend that our patients switch from cigarettes to smokeless tobacco, we would necessarily be assuming the responsibility for adverse health effects associated with smokeless tobacco. Regarding the medications currently available for tobacco dependence treatment, we can stand confident with the Food and Drug Administration approval for their use and the thousands of patients who have used these medications safely. If our patients develop cancer or have a heart attack or stroke from the smokeless tobacco that we recommended to treat their smoking addiction, who do we have to blame but ourselves?

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. He has received support from Pfizer, maker of varenicline (Chantix), to conduct clinical trials for smoking cessation and has received consulting fees from GlaxoSmithKline, maker of Nicorette. The opinions expressed are solely those of the author. Send him an e-mail at ebbert.jon@mayo.edu.

A colleague of mine recently made me aware of a resolution in the Kansas House of Representatives "requesting the Kansas Department of Health and Environment to conduct a study regarding tobacco harm reduction." This cacophonous social debate centers on the idea of recommending chewing tobacco (i.e., snuff) to cigarette smokers to reduce societal harm associated with cigarette smoking. Cigarette smoking remains the leading cause of preventable death and disability in the United States, and tobacco harm reduction (THR) has been proposed as a way to mitigate this ongoing public health disaster. One way to more clearly understand this debate is to consider it at two levels: the societal and the individual.

At the societal level, one must envision the population impact of having all smokers switch to smokeless tobacco. Smokeless tobacco is associated with fewer health risks than cigarettes, but it is not "risk free." Statistical modeling has suggested that widespread public health advocacy of this approach could result in net population harm with some smokers becoming "dual users" (i.e., smoking cigarettes and using smokeless tobacco simultaneously). Dual use of tobacco may be associated with more risk than cigarette smoking alone. THR also undermines clear indoor air policies, which are effective in reducing cigarette consumption, because it allows smokers to maintain tobacco dependence by using smokeless tobacco at times when they cannot smoke. Not surprisingly, THR is endorsed by cigarette manufacturers who now also sell smokeless tobacco. THR advocates decree that the reduction in societal adverse health consequences if all smokers switched to smokeless would be significant. The likelihood of this occurring is probably overestimated as smokeless tobacco is already widely available and very few of my smokers are electing to switch.

At the individual level, it is important that primary care providers remain cognizant of the risks associated with our clinical recommendations. Whenever we prescribe or recommend treatment, we assume responsibility for both the clinical benefits and the adverse effects, or risks. Long-term use of smokeless tobacco is associated with an increased risk for adverse cardiovascular events (i.e., stroke and myocardial infarction) and cancer. If we were to recommend that our patients switch from cigarettes to smokeless tobacco, we would necessarily be assuming the responsibility for adverse health effects associated with smokeless tobacco. Regarding the medications currently available for tobacco dependence treatment, we can stand confident with the Food and Drug Administration approval for their use and the thousands of patients who have used these medications safely. If our patients develop cancer or have a heart attack or stroke from the smokeless tobacco that we recommended to treat their smoking addiction, who do we have to blame but ourselves?

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. He has received support from Pfizer, maker of varenicline (Chantix), to conduct clinical trials for smoking cessation and has received consulting fees from GlaxoSmithKline, maker of Nicorette. The opinions expressed are solely those of the author. Send him an e-mail at ebbert.jon@mayo.edu.

A colleague of mine recently made me aware of a resolution in the Kansas House of Representatives "requesting the Kansas Department of Health and Environment to conduct a study regarding tobacco harm reduction." This cacophonous social debate centers on the idea of recommending chewing tobacco (i.e., snuff) to cigarette smokers to reduce societal harm associated with cigarette smoking. Cigarette smoking remains the leading cause of preventable death and disability in the United States, and tobacco harm reduction (THR) has been proposed as a way to mitigate this ongoing public health disaster. One way to more clearly understand this debate is to consider it at two levels: the societal and the individual.

At the societal level, one must envision the population impact of having all smokers switch to smokeless tobacco. Smokeless tobacco is associated with fewer health risks than cigarettes, but it is not "risk free." Statistical modeling has suggested that widespread public health advocacy of this approach could result in net population harm with some smokers becoming "dual users" (i.e., smoking cigarettes and using smokeless tobacco simultaneously). Dual use of tobacco may be associated with more risk than cigarette smoking alone. THR also undermines clear indoor air policies, which are effective in reducing cigarette consumption, because it allows smokers to maintain tobacco dependence by using smokeless tobacco at times when they cannot smoke. Not surprisingly, THR is endorsed by cigarette manufacturers who now also sell smokeless tobacco. THR advocates decree that the reduction in societal adverse health consequences if all smokers switched to smokeless would be significant. The likelihood of this occurring is probably overestimated as smokeless tobacco is already widely available and very few of my smokers are electing to switch.

At the individual level, it is important that primary care providers remain cognizant of the risks associated with our clinical recommendations. Whenever we prescribe or recommend treatment, we assume responsibility for both the clinical benefits and the adverse effects, or risks. Long-term use of smokeless tobacco is associated with an increased risk for adverse cardiovascular events (i.e., stroke and myocardial infarction) and cancer. If we were to recommend that our patients switch from cigarettes to smokeless tobacco, we would necessarily be assuming the responsibility for adverse health effects associated with smokeless tobacco. Regarding the medications currently available for tobacco dependence treatment, we can stand confident with the Food and Drug Administration approval for their use and the thousands of patients who have used these medications safely. If our patients develop cancer or have a heart attack or stroke from the smokeless tobacco that we recommended to treat their smoking addiction, who do we have to blame but ourselves?

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. He has received support from Pfizer, maker of varenicline (Chantix), to conduct clinical trials for smoking cessation and has received consulting fees from GlaxoSmithKline, maker of Nicorette. The opinions expressed are solely those of the author. Send him an e-mail at ebbert.jon@mayo.edu.

One-third of our patients are obese. Perhaps more than any other group, primary care clinicians are painfully aware of the staggering health and financial costs associated with this disease. Obesity is a disease, not a lifestyle choice. Obesity is the second most important cause of preventable mortality in the United States after tobacco. Our patients are literally dying under their own body weight.

I feel frequently overwhelmed and incapable of addressing weight issues amidst the myriad of other clinical issues. Most of my patients have heard my diet and exercise spiel and have already been referred to the dietician numerous times. A recent patient asked if I could just “fix it with a pill.” This may be an indictment of modern medicine interacting with unreasonable patient expectations. For some patients, however, medication may be the only or the best option.

Last month, the American Journal of Clinical Nutrition published an article evaluating two-year outcomes of combination therapy with phentermine and topiramate (Am. J. Clin. Nutr. 2012;2:297-308).

Phentermine was a component of the infamous “fen-phen” (fenfluramine/phentermine) combination that was withdrawn from markets worldwide because of several concerns including cardiac valvulopathy. Valvulopathy was likely mediated through the serotonergic effects of fenfluramine on heart valve serotonin receptors. Phentermine was not associated with this effect and is still available on the market, currently Food and Drug Administration-approved for the short-term treatment of obesity. Phentermine is a psychostimulant (DEA Schedule Class IV) with an appetite suppressing effect. Topiramate (TPM) is an anti-epileptic that has a well-researched effect on weight loss likely mediated through appetite suppression. TPM also appears to have an effect on energy balance and metabolic rate leading directly to body fat reduction. In this study, subjects with a BMI (27-45) and at least 2 weight-related comorbidities who participated in a previous 56-week randomized, placebo-controlled study of phentermine/TPM were continued on their assigned medication or placebo for another 52 weeks. Groups were:  lifestyle intervention + placebo; lifestyle intervention + 7.5 mg phentermine/46 mg (controlled release) TPM; or lifestyle plus 15 mg phentermine/92 mg controlled-release TPM. A total of 676 patients (78%) in the previous study agreed to enroll in this extension study.

At week 108, phentermine/TPM was associated with significant and sustained weight loss. Percentage changes from baseline in body weight were –1.8%, –9.3%, and –10.5% for placebo, 7.5/46, and 15/92, respectively. Significantly more phentermine/TPM treated subjects at each dose achieved at least 5%, at least 10%, at least 15%, and at least 20% weight loss compared with placebo (P less than 0.001). Phentermine/TPM improved cardiovascular and metabolic variables and decreased the incidence of diabetes. The combination was well-tolerated.

The phentermine/TPM combination of medication is currently being considered by the FDA as a new drug application for obesity. On February 22, 2012, an FDA advisory committee voted 20:2 to recommend that FDA approve phentermine/TPM as an obesity treatment. However, the FDA does not have to follow the recommendation of their advisory committee. In fact, a previous obesity medication combination (bupropion/naltrexone) received an FDA advisory committee vote of 13:7 in favor of approval, but the FDA rejected it based upon cardiovascular concerns related to bupropion.

The benefit of phentermine/TPM combination of medication for the treatment of obesity is established. What the FDA needs to do is thoughtfully weigh the risks of this combination against the risk of having limited options in our armamentarium to combat the obesity epidemic. We have a lot of endovascular stents being approved to treat the sequelae of obesity, but few options to treat the disease. If this medication combination alleviates the burden of obesity on patients and the medical system, isn’t it worth the risk? Our patients need options and many of them are running out of time.

Dr. Ebbert reported having no conflicts of interest.  

One-third of our patients are obese. Perhaps more than any other group, primary care clinicians are painfully aware of the staggering health and financial costs associated with this disease. Obesity is a disease, not a lifestyle choice. Obesity is the second most important cause of preventable mortality in the United States after tobacco. Our patients are literally dying under their own body weight.

I feel frequently overwhelmed and incapable of addressing weight issues amidst the myriad of other clinical issues. Most of my patients have heard my diet and exercise spiel and have already been referred to the dietician numerous times. A recent patient asked if I could just “fix it with a pill.” This may be an indictment of modern medicine interacting with unreasonable patient expectations. For some patients, however, medication may be the only or the best option.

Last month, the American Journal of Clinical Nutrition published an article evaluating two-year outcomes of combination therapy with phentermine and topiramate (Am. J. Clin. Nutr. 2012;2:297-308).

Phentermine was a component of the infamous “fen-phen” (fenfluramine/phentermine) combination that was withdrawn from markets worldwide because of several concerns including cardiac valvulopathy. Valvulopathy was likely mediated through the serotonergic effects of fenfluramine on heart valve serotonin receptors. Phentermine was not associated with this effect and is still available on the market, currently Food and Drug Administration-approved for the short-term treatment of obesity. Phentermine is a psychostimulant (DEA Schedule Class IV) with an appetite suppressing effect. Topiramate (TPM) is an anti-epileptic that has a well-researched effect on weight loss likely mediated through appetite suppression. TPM also appears to have an effect on energy balance and metabolic rate leading directly to body fat reduction. In this study, subjects with a BMI (27-45) and at least 2 weight-related comorbidities who participated in a previous 56-week randomized, placebo-controlled study of phentermine/TPM were continued on their assigned medication or placebo for another 52 weeks. Groups were:  lifestyle intervention + placebo; lifestyle intervention + 7.5 mg phentermine/46 mg (controlled release) TPM; or lifestyle plus 15 mg phentermine/92 mg controlled-release TPM. A total of 676 patients (78%) in the previous study agreed to enroll in this extension study.

At week 108, phentermine/TPM was associated with significant and sustained weight loss. Percentage changes from baseline in body weight were –1.8%, –9.3%, and –10.5% for placebo, 7.5/46, and 15/92, respectively. Significantly more phentermine/TPM treated subjects at each dose achieved at least 5%, at least 10%, at least 15%, and at least 20% weight loss compared with placebo (P less than 0.001). Phentermine/TPM improved cardiovascular and metabolic variables and decreased the incidence of diabetes. The combination was well-tolerated.

The phentermine/TPM combination of medication is currently being considered by the FDA as a new drug application for obesity. On February 22, 2012, an FDA advisory committee voted 20:2 to recommend that FDA approve phentermine/TPM as an obesity treatment. However, the FDA does not have to follow the recommendation of their advisory committee. In fact, a previous obesity medication combination (bupropion/naltrexone) received an FDA advisory committee vote of 13:7 in favor of approval, but the FDA rejected it based upon cardiovascular concerns related to bupropion.

The benefit of phentermine/TPM combination of medication for the treatment of obesity is established. What the FDA needs to do is thoughtfully weigh the risks of this combination against the risk of having limited options in our armamentarium to combat the obesity epidemic. We have a lot of endovascular stents being approved to treat the sequelae of obesity, but few options to treat the disease. If this medication combination alleviates the burden of obesity on patients and the medical system, isn’t it worth the risk? Our patients need options and many of them are running out of time.

Dr. Ebbert reported having no conflicts of interest.  

One-third of our patients are obese. Perhaps more than any other group, primary care clinicians are painfully aware of the staggering health and financial costs associated with this disease. Obesity is a disease, not a lifestyle choice. Obesity is the second most important cause of preventable mortality in the United States after tobacco. Our patients are literally dying under their own body weight.

I feel frequently overwhelmed and incapable of addressing weight issues amidst the myriad of other clinical issues. Most of my patients have heard my diet and exercise spiel and have already been referred to the dietician numerous times. A recent patient asked if I could just “fix it with a pill.” This may be an indictment of modern medicine interacting with unreasonable patient expectations. For some patients, however, medication may be the only or the best option.

Last month, the American Journal of Clinical Nutrition published an article evaluating two-year outcomes of combination therapy with phentermine and topiramate (Am. J. Clin. Nutr. 2012;2:297-308).

Phentermine was a component of the infamous “fen-phen” (fenfluramine/phentermine) combination that was withdrawn from markets worldwide because of several concerns including cardiac valvulopathy. Valvulopathy was likely mediated through the serotonergic effects of fenfluramine on heart valve serotonin receptors. Phentermine was not associated with this effect and is still available on the market, currently Food and Drug Administration-approved for the short-term treatment of obesity. Phentermine is a psychostimulant (DEA Schedule Class IV) with an appetite suppressing effect. Topiramate (TPM) is an anti-epileptic that has a well-researched effect on weight loss likely mediated through appetite suppression. TPM also appears to have an effect on energy balance and metabolic rate leading directly to body fat reduction. In this study, subjects with a BMI (27-45) and at least 2 weight-related comorbidities who participated in a previous 56-week randomized, placebo-controlled study of phentermine/TPM were continued on their assigned medication or placebo for another 52 weeks. Groups were:  lifestyle intervention + placebo; lifestyle intervention + 7.5 mg phentermine/46 mg (controlled release) TPM; or lifestyle plus 15 mg phentermine/92 mg controlled-release TPM. A total of 676 patients (78%) in the previous study agreed to enroll in this extension study.

At week 108, phentermine/TPM was associated with significant and sustained weight loss. Percentage changes from baseline in body weight were –1.8%, –9.3%, and –10.5% for placebo, 7.5/46, and 15/92, respectively. Significantly more phentermine/TPM treated subjects at each dose achieved at least 5%, at least 10%, at least 15%, and at least 20% weight loss compared with placebo (P less than 0.001). Phentermine/TPM improved cardiovascular and metabolic variables and decreased the incidence of diabetes. The combination was well-tolerated.

The phentermine/TPM combination of medication is currently being considered by the FDA as a new drug application for obesity. On February 22, 2012, an FDA advisory committee voted 20:2 to recommend that FDA approve phentermine/TPM as an obesity treatment. However, the FDA does not have to follow the recommendation of their advisory committee. In fact, a previous obesity medication combination (bupropion/naltrexone) received an FDA advisory committee vote of 13:7 in favor of approval, but the FDA rejected it based upon cardiovascular concerns related to bupropion.

The benefit of phentermine/TPM combination of medication for the treatment of obesity is established. What the FDA needs to do is thoughtfully weigh the risks of this combination against the risk of having limited options in our armamentarium to combat the obesity epidemic. We have a lot of endovascular stents being approved to treat the sequelae of obesity, but few options to treat the disease. If this medication combination alleviates the burden of obesity on patients and the medical system, isn’t it worth the risk? Our patients need options and many of them are running out of time.

Dr. Ebbert reported having no conflicts of interest.  

As I prepare for my addiction medicine boards later this year, I am sharply reminded of the enormous undiagnosed burden of alcohol abuse in primary care. Nearly one-fourth of Americans over the age of 12 years report binge drinking (consuming 5 or more alcoholic drinks on one occasion) and 7% report regular heavy drinking. Alcohol is the third leading cause of preventable death in the United States after tobacco and obesity. Half of alcohol-related deaths are due to acute effects (e.g., accidents, poisoning) and half are due to chronic effects (e.g., cirrhosis, cardiomyopathy). Despite the tremendous disease toll, time limitations and the absence of readily accessible resources for addressing high-risk alcohol use behaviors are the unhappy clinical reality.

A recent editorial in The American Journal of Addictions reminds us of an effective, evidence-based care model designed to assess and address substance use disorders known as SBIRT (Screening, Brief Intervention, Referral, and Treatment). The authors point out that a single question screener, “In the past year, have you had any times when you had 5 (for women, 4) or more drinks at one sitting?” is 84% sensitive and 78% specific for hazardous drinking, and 88% sensitive and 66% specific for current alcohol use disorders. Substantial evidence exists for the effectiveness of brief interventions for reducing harmful drinking when delivered by a physician or other health professional. In a study including roughly 500,000 participants, SBIRT resulted in a 39% decline in heavy alcohol use at 6 months.

The Substance Abuse and Mental Health Services Administration (SAMHSA) defines the SBIRT model as involving a brief intervention of 5-10 minutes in duration triggered by universal screening delivered in a nonsubstance abuse treatment setting. Both the screening and counseling are reimbursable.  

So where do we go from here? We could all consider a universal screener for problem drinking on intake forms for new and established patients. Interested clinicians can learn more about brief alcohol interventions and can obtain tools kits and forms online for free.

SAMSHA provides a treatment facility locator that includes more than 11,000 addiction treatment programs, including residential treatment centers, outpatient treatment programs, and hospital inpatient programs for drug addiction and alcoholism. This information is maintained and updated by the U.S. Department of Health and Human Services. Early identification of problem drinking provides the greatest opportunity for changing a patient’s future and reducing alcohol-related morbidity and mortality down the road.

Dr. Ebbert reported having no relevant conflicts of interest.   

As I prepare for my addiction medicine boards later this year, I am sharply reminded of the enormous undiagnosed burden of alcohol abuse in primary care. Nearly one-fourth of Americans over the age of 12 years report binge drinking (consuming 5 or more alcoholic drinks on one occasion) and 7% report regular heavy drinking. Alcohol is the third leading cause of preventable death in the United States after tobacco and obesity. Half of alcohol-related deaths are due to acute effects (e.g., accidents, poisoning) and half are due to chronic effects (e.g., cirrhosis, cardiomyopathy). Despite the tremendous disease toll, time limitations and the absence of readily accessible resources for addressing high-risk alcohol use behaviors are the unhappy clinical reality.

A recent editorial in The American Journal of Addictions reminds us of an effective, evidence-based care model designed to assess and address substance use disorders known as SBIRT (Screening, Brief Intervention, Referral, and Treatment). The authors point out that a single question screener, “In the past year, have you had any times when you had 5 (for women, 4) or more drinks at one sitting?” is 84% sensitive and 78% specific for hazardous drinking, and 88% sensitive and 66% specific for current alcohol use disorders. Substantial evidence exists for the effectiveness of brief interventions for reducing harmful drinking when delivered by a physician or other health professional. In a study including roughly 500,000 participants, SBIRT resulted in a 39% decline in heavy alcohol use at 6 months.

The Substance Abuse and Mental Health Services Administration (SAMHSA) defines the SBIRT model as involving a brief intervention of 5-10 minutes in duration triggered by universal screening delivered in a nonsubstance abuse treatment setting. Both the screening and counseling are reimbursable.  

So where do we go from here? We could all consider a universal screener for problem drinking on intake forms for new and established patients. Interested clinicians can learn more about brief alcohol interventions and can obtain tools kits and forms online for free.

SAMSHA provides a treatment facility locator that includes more than 11,000 addiction treatment programs, including residential treatment centers, outpatient treatment programs, and hospital inpatient programs for drug addiction and alcoholism. This information is maintained and updated by the U.S. Department of Health and Human Services. Early identification of problem drinking provides the greatest opportunity for changing a patient’s future and reducing alcohol-related morbidity and mortality down the road.

Dr. Ebbert reported having no relevant conflicts of interest.   

As I prepare for my addiction medicine boards later this year, I am sharply reminded of the enormous undiagnosed burden of alcohol abuse in primary care. Nearly one-fourth of Americans over the age of 12 years report binge drinking (consuming 5 or more alcoholic drinks on one occasion) and 7% report regular heavy drinking. Alcohol is the third leading cause of preventable death in the United States after tobacco and obesity. Half of alcohol-related deaths are due to acute effects (e.g., accidents, poisoning) and half are due to chronic effects (e.g., cirrhosis, cardiomyopathy). Despite the tremendous disease toll, time limitations and the absence of readily accessible resources for addressing high-risk alcohol use behaviors are the unhappy clinical reality.

A recent editorial in The American Journal of Addictions reminds us of an effective, evidence-based care model designed to assess and address substance use disorders known as SBIRT (Screening, Brief Intervention, Referral, and Treatment). The authors point out that a single question screener, “In the past year, have you had any times when you had 5 (for women, 4) or more drinks at one sitting?” is 84% sensitive and 78% specific for hazardous drinking, and 88% sensitive and 66% specific for current alcohol use disorders. Substantial evidence exists for the effectiveness of brief interventions for reducing harmful drinking when delivered by a physician or other health professional. In a study including roughly 500,000 participants, SBIRT resulted in a 39% decline in heavy alcohol use at 6 months.

The Substance Abuse and Mental Health Services Administration (SAMHSA) defines the SBIRT model as involving a brief intervention of 5-10 minutes in duration triggered by universal screening delivered in a nonsubstance abuse treatment setting. Both the screening and counseling are reimbursable.  

So where do we go from here? We could all consider a universal screener for problem drinking on intake forms for new and established patients. Interested clinicians can learn more about brief alcohol interventions and can obtain tools kits and forms online for free.

SAMSHA provides a treatment facility locator that includes more than 11,000 addiction treatment programs, including residential treatment centers, outpatient treatment programs, and hospital inpatient programs for drug addiction and alcoholism. This information is maintained and updated by the U.S. Department of Health and Human Services. Early identification of problem drinking provides the greatest opportunity for changing a patient’s future and reducing alcohol-related morbidity and mortality down the road.

Dr. Ebbert reported having no relevant conflicts of interest.   

A significant percentage of my recent clinical encounters have been patients with musculoskeletal, predominantly spinal, pain. I am always amazed by patients who admit that they will gladly pay a chiropractor hundreds of dollars while, in the same breath, they complain about a $4 co-pay for medications that I prescribe for the same problem. I have nothing against chiropractors. Quite the opposite, I think they might be onto something. They may have already known that our medications are not as good as touching the patient or engaging them in self-mobilization exercises. But some of us still need to be convinced.

A recently published randomized trial evaluating the comparative effectiveness of spinal manipulation therapy (SMT), medication, and home exercises with advice (HEA) may help persuade some of those skeptics (Ann Intern Med. 2012;156:1-10). Participants with mechanical, nonspecific current neck pain of 2-12 weeks duration were recruited through the community. Treatment took place over 12 weeks. SMT involved “a high-velocity type of joint thrust manipulation” and “a low-velocity type of joint oscillation” provided by chiropractors. Medications included NSAIDs, acetaminophen, or both and non-responders received narcotics or muscle relaxants by a licensed physician. HEA was provided in two 1-hour sessions focusing on “gentle controlled movement” of the neck and shoulder joints, neck retraction, extension, flexion, rotation, lateral bending, and scapular retraction. Participants were instructed to do 5 to 10 repetitions per day; laminated instruction cards were provided.

For pain, SMT was associated with a statistically significant advantage over medication after weeks 8, 12, 26, and 52 (P less than or equal to 0.010). HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. HEA was associated with higher satisfaction with care.

In this study, medication performed the worst. Spinal manipulation was not demonstrably better than home exercises with advice. Primary care clinicians seeing patients with neck pain need to fight deeply-ingrained urges to “fix it with a pill” (or at least I do). Instead, we need office hand-outs of self-mobilization exercises for every potentially injured body part that can readily handed to and reviewed with patients. At the very least, this will decrease the number of daily complaints about medication co-pays.

Jon O. Ebbert, M.D., is professor of medicine at the Mayo Clinic in Rochester, Minn. He reported having no conflicts of interest.

A significant percentage of my recent clinical encounters have been patients with musculoskeletal, predominantly spinal, pain. I am always amazed by patients who admit that they will gladly pay a chiropractor hundreds of dollars while, in the same breath, they complain about a $4 co-pay for medications that I prescribe for the same problem. I have nothing against chiropractors. Quite the opposite, I think they might be onto something. They may have already known that our medications are not as good as touching the patient or engaging them in self-mobilization exercises. But some of us still need to be convinced.

A recently published randomized trial evaluating the comparative effectiveness of spinal manipulation therapy (SMT), medication, and home exercises with advice (HEA) may help persuade some of those skeptics (Ann Intern Med. 2012;156:1-10). Participants with mechanical, nonspecific current neck pain of 2-12 weeks duration were recruited through the community. Treatment took place over 12 weeks. SMT involved “a high-velocity type of joint thrust manipulation” and “a low-velocity type of joint oscillation” provided by chiropractors. Medications included NSAIDs, acetaminophen, or both and non-responders received narcotics or muscle relaxants by a licensed physician. HEA was provided in two 1-hour sessions focusing on “gentle controlled movement” of the neck and shoulder joints, neck retraction, extension, flexion, rotation, lateral bending, and scapular retraction. Participants were instructed to do 5 to 10 repetitions per day; laminated instruction cards were provided.

For pain, SMT was associated with a statistically significant advantage over medication after weeks 8, 12, 26, and 52 (P less than or equal to 0.010). HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. HEA was associated with higher satisfaction with care.

In this study, medication performed the worst. Spinal manipulation was not demonstrably better than home exercises with advice. Primary care clinicians seeing patients with neck pain need to fight deeply-ingrained urges to “fix it with a pill” (or at least I do). Instead, we need office hand-outs of self-mobilization exercises for every potentially injured body part that can readily handed to and reviewed with patients. At the very least, this will decrease the number of daily complaints about medication co-pays.

Jon O. Ebbert, M.D., is professor of medicine at the Mayo Clinic in Rochester, Minn. He reported having no conflicts of interest.

A significant percentage of my recent clinical encounters have been patients with musculoskeletal, predominantly spinal, pain. I am always amazed by patients who admit that they will gladly pay a chiropractor hundreds of dollars while, in the same breath, they complain about a $4 co-pay for medications that I prescribe for the same problem. I have nothing against chiropractors. Quite the opposite, I think they might be onto something. They may have already known that our medications are not as good as touching the patient or engaging them in self-mobilization exercises. But some of us still need to be convinced.

A recently published randomized trial evaluating the comparative effectiveness of spinal manipulation therapy (SMT), medication, and home exercises with advice (HEA) may help persuade some of those skeptics (Ann Intern Med. 2012;156:1-10). Participants with mechanical, nonspecific current neck pain of 2-12 weeks duration were recruited through the community. Treatment took place over 12 weeks. SMT involved “a high-velocity type of joint thrust manipulation” and “a low-velocity type of joint oscillation” provided by chiropractors. Medications included NSAIDs, acetaminophen, or both and non-responders received narcotics or muscle relaxants by a licensed physician. HEA was provided in two 1-hour sessions focusing on “gentle controlled movement” of the neck and shoulder joints, neck retraction, extension, flexion, rotation, lateral bending, and scapular retraction. Participants were instructed to do 5 to 10 repetitions per day; laminated instruction cards were provided.

For pain, SMT was associated with a statistically significant advantage over medication after weeks 8, 12, 26, and 52 (P less than or equal to 0.010). HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. HEA was associated with higher satisfaction with care.

In this study, medication performed the worst. Spinal manipulation was not demonstrably better than home exercises with advice. Primary care clinicians seeing patients with neck pain need to fight deeply-ingrained urges to “fix it with a pill” (or at least I do). Instead, we need office hand-outs of self-mobilization exercises for every potentially injured body part that can readily handed to and reviewed with patients. At the very least, this will decrease the number of daily complaints about medication co-pays.

Jon O. Ebbert, M.D., is professor of medicine at the Mayo Clinic in Rochester, Minn. He reported having no conflicts of interest.

One of the greatest challenges of modern medicine is antimicrobial resistance. Most clinicians exercise discretion when writing antibiotic prescriptions for patients in front of us. However, many of our practices have disease-specific intervention protocols that decrease clinician burden and facilitate patient care, but that put antibiotic prescribing on autopilot. One common protocolized intervention addresses urinary tract infections. Ciprofloxacin has been the UTI workhorse for many of us because it is effective and well-tolerated. However, increasing resistance and calls to put ciprofloxacin “on reserve” have prompted changes in our UTI protocols.

Last week, the Journal of the American Medical Association published a comparative evaluation of cefpodoxime and ciprofloxacin to see if we could expand our UTI treatment armamentarium (JAMA. 2012;307:583-9). Cefpodoxime has broad spectrum antimicrobial activity and would provide a useful alternative to fluoroquinolones for cystitis treatment if demonstrated to be similar in efficacy. In this study, three hundred women with acute cystitis were randomized to cefpodoxime or ciprofloxacin given for 3 days. The primary outcome was clinical cure at 30 days. E. coli caused most cystitis (75%). Overall, 4% of isolates (4% of E. coli and 8% of non−E. coli) were nonsusceptible to ciprofloxacin and 8% (4% of E. coli and 36% of non−E. coli) were nonsusceptible to cefpodoxime. The overall cure rate at 30 days using an intent-to-treat approach in which patients lost to follow-up were considered having had a clinical cure, was 93% (139/150) for ciprofloxacin compared with 82% (123/150) for cefpodoxime (difference of 11%; 95% CI, 3%-18%). The investigators had pre-determined that a greater than 10% lower rate of cure for cefpodoxime was clinically inferior, so they concluded that cefpodoxime did not meet criteria for noninferiority for achieving clinical cure. The authors speculated that cephalosporins probably fail because fewer women achieved eradication of vaginal E. coli colonization with cefpodoxime than with cirprofloxacin.

The Infectious Diseases Society of America suggested that fluoroquinolones be reserved for important uses other than acute cystitis, and thus should be considered alternative antimicrobials for acute cystitis. Nitrofurantoin could be used, but insurance companies currently are mailing “information letters” about the dangers of using this drug in older patients due to concerns about drug accumulation in people with less than optimal renal function. Fosfomycin could be used, but we have had some trouble finding it in our local pharmacies.

The take-home message is that current studies do not support the use of cefpodoxime as a first-line fluoroquinolone-sparing antimicrobial for acute uncomplicated cystitis. More research needs to be conducted on the efficacy of narrow-spectrum cephalosporins to increase our options. Most importantly, we need to be continually reviewing our local resistance patterns, guideline panel recommendations, and the emerging evidence to intelligently update our disease-specific treatment protocols.

Dr. Ebbert reported having no relevant conflicts of interest.  

One of the greatest challenges of modern medicine is antimicrobial resistance. Most clinicians exercise discretion when writing antibiotic prescriptions for patients in front of us. However, many of our practices have disease-specific intervention protocols that decrease clinician burden and facilitate patient care, but that put antibiotic prescribing on autopilot. One common protocolized intervention addresses urinary tract infections. Ciprofloxacin has been the UTI workhorse for many of us because it is effective and well-tolerated. However, increasing resistance and calls to put ciprofloxacin “on reserve” have prompted changes in our UTI protocols.

Last week, the Journal of the American Medical Association published a comparative evaluation of cefpodoxime and ciprofloxacin to see if we could expand our UTI treatment armamentarium (JAMA. 2012;307:583-9). Cefpodoxime has broad spectrum antimicrobial activity and would provide a useful alternative to fluoroquinolones for cystitis treatment if demonstrated to be similar in efficacy. In this study, three hundred women with acute cystitis were randomized to cefpodoxime or ciprofloxacin given for 3 days. The primary outcome was clinical cure at 30 days. E. coli caused most cystitis (75%). Overall, 4% of isolates (4% of E. coli and 8% of non−E. coli) were nonsusceptible to ciprofloxacin and 8% (4% of E. coli and 36% of non−E. coli) were nonsusceptible to cefpodoxime. The overall cure rate at 30 days using an intent-to-treat approach in which patients lost to follow-up were considered having had a clinical cure, was 93% (139/150) for ciprofloxacin compared with 82% (123/150) for cefpodoxime (difference of 11%; 95% CI, 3%-18%). The investigators had pre-determined that a greater than 10% lower rate of cure for cefpodoxime was clinically inferior, so they concluded that cefpodoxime did not meet criteria for noninferiority for achieving clinical cure. The authors speculated that cephalosporins probably fail because fewer women achieved eradication of vaginal E. coli colonization with cefpodoxime than with cirprofloxacin.

The Infectious Diseases Society of America suggested that fluoroquinolones be reserved for important uses other than acute cystitis, and thus should be considered alternative antimicrobials for acute cystitis. Nitrofurantoin could be used, but insurance companies currently are mailing “information letters” about the dangers of using this drug in older patients due to concerns about drug accumulation in people with less than optimal renal function. Fosfomycin could be used, but we have had some trouble finding it in our local pharmacies.

The take-home message is that current studies do not support the use of cefpodoxime as a first-line fluoroquinolone-sparing antimicrobial for acute uncomplicated cystitis. More research needs to be conducted on the efficacy of narrow-spectrum cephalosporins to increase our options. Most importantly, we need to be continually reviewing our local resistance patterns, guideline panel recommendations, and the emerging evidence to intelligently update our disease-specific treatment protocols.

Dr. Ebbert reported having no relevant conflicts of interest.  

One of the greatest challenges of modern medicine is antimicrobial resistance. Most clinicians exercise discretion when writing antibiotic prescriptions for patients in front of us. However, many of our practices have disease-specific intervention protocols that decrease clinician burden and facilitate patient care, but that put antibiotic prescribing on autopilot. One common protocolized intervention addresses urinary tract infections. Ciprofloxacin has been the UTI workhorse for many of us because it is effective and well-tolerated. However, increasing resistance and calls to put ciprofloxacin “on reserve” have prompted changes in our UTI protocols.

Last week, the Journal of the American Medical Association published a comparative evaluation of cefpodoxime and ciprofloxacin to see if we could expand our UTI treatment armamentarium (JAMA. 2012;307:583-9). Cefpodoxime has broad spectrum antimicrobial activity and would provide a useful alternative to fluoroquinolones for cystitis treatment if demonstrated to be similar in efficacy. In this study, three hundred women with acute cystitis were randomized to cefpodoxime or ciprofloxacin given for 3 days. The primary outcome was clinical cure at 30 days. E. coli caused most cystitis (75%). Overall, 4% of isolates (4% of E. coli and 8% of non−E. coli) were nonsusceptible to ciprofloxacin and 8% (4% of E. coli and 36% of non−E. coli) were nonsusceptible to cefpodoxime. The overall cure rate at 30 days using an intent-to-treat approach in which patients lost to follow-up were considered having had a clinical cure, was 93% (139/150) for ciprofloxacin compared with 82% (123/150) for cefpodoxime (difference of 11%; 95% CI, 3%-18%). The investigators had pre-determined that a greater than 10% lower rate of cure for cefpodoxime was clinically inferior, so they concluded that cefpodoxime did not meet criteria for noninferiority for achieving clinical cure. The authors speculated that cephalosporins probably fail because fewer women achieved eradication of vaginal E. coli colonization with cefpodoxime than with cirprofloxacin.

The Infectious Diseases Society of America suggested that fluoroquinolones be reserved for important uses other than acute cystitis, and thus should be considered alternative antimicrobials for acute cystitis. Nitrofurantoin could be used, but insurance companies currently are mailing “information letters” about the dangers of using this drug in older patients due to concerns about drug accumulation in people with less than optimal renal function. Fosfomycin could be used, but we have had some trouble finding it in our local pharmacies.

The take-home message is that current studies do not support the use of cefpodoxime as a first-line fluoroquinolone-sparing antimicrobial for acute uncomplicated cystitis. More research needs to be conducted on the efficacy of narrow-spectrum cephalosporins to increase our options. Most importantly, we need to be continually reviewing our local resistance patterns, guideline panel recommendations, and the emerging evidence to intelligently update our disease-specific treatment protocols.

Dr. Ebbert reported having no relevant conflicts of interest.