Medication May Help Treat Cocaine Addiction For The First Time.


Photo credit: Drug Enforcement Administration

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There are no current FDA-approved medications for cocaine addiction, but that might be about to change. A new study published in JAMA Psychiatry from researchers at University of Virginia’s Department of Psychiatry and Neurobehavioral Sciences has shown that cocaine dependence can be treated with the repurposed medication topiramate.

Topiramate (trade name Topamax) is an anticonvulsant that has been used to treat a variety of conditions, such as seizures associated with epilepsy and Lennox-Gastaut syndrome, bipolar disorder, alcohol dependance, and migraine prevention.

The double-blind study consisted of 142 individuals addicted to cocaine. Half of the group was randomly assigned to receive topiramate while the other half was given a placebo. Over the course of the 12 weeks for the study, the topiramate group reported significantly more cocaine-free days which indicate the likelihood of cocaine-free weeks. Additionally, the topiramate group reported fewer cravings and increased functioning when compared to the placebo group.

Side effects were mild and minimal, including inattentiveness, skin tingling, taste distortions, and decreased appetite. High doses of topiramate have been associated with glaucoma, though that was not a factor in this study. Ultimately, the results of the study suggest that topiramate is a safe and effective drug for combatting cocaine dependence.

Because topiramate has been shown to be effective in cocaine and alcohol addictions, head researcher Bankole A. Johnson is optimistic that understanding how the chemicals interact with the brain could help scientists understand the neurobiological cause of addiction.

Cocaine, a derivative of the South American coca plant, causes more emergency room visits than any other illegal substance. Cocaine is an intense stimulator of the central nervous system and affects the circulatory system by increasing heart rate while constricting blood vessels. Cocaine use can lead to stroke or cardiac arrest, which may cause death.

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Probiotics Likely Do Little to Soothe Colicky Babies.


Sad news for sleep-deprived parents: probiotics may not quiet their colicky babies, a new meta-analysis suggests.

Evidence is still insufficient “to support probiotic use to manage colic, especially in formula-fed infants, or to prevent infant crying,” lead author Valerie Sung, MPH, and colleagues report in an articlepublished online October 7 in JAMA Pediatrics.

Colic, defined as excessive crying or fussing for no apparent reason, affects up to 20% of infants younger than 3 months, but its etiology remains unclear, write Sung, from the Murdoch Children’s Research Institute and Royal Children’s Hospital, Parkville, Australia, and coauthors. Some evidence points to an association with food allergies, but other data show differences in gut microflora between babies with and without colic. “The logical next step is to determine whether intervening to alter gut microbiota can effectively prevent or reduce infant crying,” the authors write.

Use of probiotics, products that use live microorganisms to confer health benefits, can change the infant gut environment and has been shown to suppress intestinal inflammation, strengthen mucosal barriers, and modulate gut contractility, any of which could produce uncomfortable symptoms and contribute to an infant’s irritability. In a meta-analysis, the authors sought to determine whether probiotics were better than no or standard treatment at reducing the duration of infant crying or distress, number of episodes of crying or distress, and proportion of infants with colic (crying or fussing for at least 3 hours a day, at least 3 days a week, for at least 1 week).

The authors identified 12 randomized, clinical trials including 1825 infants: 271 term babies with colic, 1534 term infants without colic, and 20 preterm newborns without colic. Five studies focused on probiotics specifically to manage colic, and 7 examined the use of probiotics to reduce infant crying. Some of the studies examined use of a single product, whereas others looked at the use of multiple products administered together. The products were administered as drops, capsules, or formula in a range of doses. All of the studies were placebo-controlled. Daily infant crying time was the most common reported outcome. The analysis was conducted according to guidelines from the Cochrane Handbook for Systematic Reviews of Interventions.

Mean daily crying time was significantly less in 2 of 7 trials in which probiotics were used to prevent colic; there were no differences between probiotics and placebo in the other 5 trials. Of the 5 trials examining probiotics in the management of colicky episodes, probiotics were significantly more effective than placebo in 3 trials in which Lactobacillus reuteri was administered in drops to breast-fed, full-term infants. Compared with placebo, probiotics were associated in those trials with a median reduction in daily crying time of 62.10 minutes (95% confidence interval [CI], −85.82 to −44.38 minutes; P < .001), but there was substantial heterogeneity among the trials. The authors conclude that the effect of probiotics in treating colic remains unclear because of the difficulty in comparing studies that examined vastly different products on different populations.

At least one outside expert agrees with this conclusion, despite some reservations about the authors’ methods. “The definition of colic was not rigorously controlled; there is likely to be no single cause of colic and no single treatment that is effective,” said Frank R. Greer, MD, professor of pediatrics, Wisconsin Perinatal Center, Meriter Hospital, Madison, Wisconsin. “The dosages and specific probiotic preparations were too variable[, and] whether they were given prenatally or not to both mother and infant after delivery also was extremely variable.” In addition, Dr. Greer told Medscape Medical News, “the authors did not use a validated methodology for recording the primary outcome, which was length of crying time.”

In Dr. Greer’s opinion, there is currently no place for probiotics in the management of infant colic. In contrast, he said, it has no serious adverse effects, “other than it adds unnecessarily to the cost of infant formula.”

Is Hypothyroidism Overdiagnosed and Overtreated?


Over the past decade, doctors have become increasingly aggressive at initiating treatment for borderline hypothyroidism, possibly raising the risk for thyroid suppression as an unintended consequence, a new study suggests.

The American Thyroid Association recommends considering levothyroxine therapy at thyroid-stimulating hormone (TSH; thyrotropin) levels of 10 mIU/L or lower if symptoms of hypothyroidism, positive thyroid autoantibodies, or evidence of atherosclerotic cardiovascular disease or heart failure are present. But starting levothyroxine at or below 10 mIU/L in those without symptoms may do more harm than good, it cautions.

Yet in this new 9-year survey of more than 52,000 individuals in the United Kingdom, the number of individuals who received levothyroxine for a thyrotropin level of less than 10 mIU/L increased by 30% over the course of the study.

“This practice may be harmful, given the high risk of developing a suppressed thyrotropin level after treatment,” say the researchers, led by Peter N. Taylor, MRCP, from the Thyroid Research Group at the Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine, United Kingdom, and colleagues, whose findings are published online October 7 in JAMA Internal Medicine.

Asked to comment on the findings for Medscape Medical News, Leonard Wartofsky, MD, chair of the department of medicine, Washington Hospital Medical Center, Washington, DC, said the authors are “raising the red flag that there is potentially overdiagnosis and overtreatment that has some risks.”

Most healthy people have thyrotropin levels less than 2.5 mIU/L, he explained. “If you simply go by the numbers, it’s hard to reconcile a TSH level of 7.9 as being normal when the rest of the population has numbers of 2.5 or less.” However, he added, thyrotropin levels do rise with age, so higher levels are normal for people 70 years of age or more and do not necessarily indicate treatment is necessary.

“Part of the problem is that this is a mild abnormality, and in most published studies it’s been difficult to show a clear benefit of intervention, because the number of subjects participating has been small, the abnormalities are minor, and you can’t show a major clinical effect of intervention,” Dr. Wartofsky observed. “This is a controversial issue, and it’s still unsettled.”

Threshold Lowered After 2004

Using the General Practice Research Database (GPRD; now called the Clinical Practice Research Datalink), which contains the records of more than 5 million patients in 508 primary-care practices across the United Kingdom, Dr. Taylor and coauthors conducted a retrospective cohort study of 52,298 adults who initiated levothyroxine therapy between January 1, 2001, and October 30, 2009, at a median age of 59 years.

Excluded from the study were people with a history of hyperthyroidism, pituitary disease, or thyroid surgery; those who were taking medication that affected thyroid function or whose thyroid problems were related to pregnancy; and/or those whose thyrotropin had been measured more than 3 months prior to beginning treatment.

To gauge the effect of therapy on thyroid function, they also studied thyrotropin levels at 30 to 36 months and 54 to 60 months after treatment began. Female patients outnumbered males by almost 4 to 1.

Following multivariate adjustment, the odds ratio of a patient receiving a levothyroxine prescription for a presenting thyrotropin level of less than 10.0 mIU/L in 2009 compared with 2001 was 1.30 (P < .001), and the number of new levothyroxine prescriptions increased by 74% over the study period.

The median thyrotropin level for initiating treatment fell from 8.7 mIU/L in 2001 to 7.9 mIU/L in 2009.

Individuals prescribed levothyroxine with a thyrotropin level between 4.0 and 10.0 mIU/L instead of exceeding 10.0 mIU/L were more likely to be female, have cardiovascular risk factors, and be older than 70 years when prescribed levothyroxine after 2004, with trends also observed for tiredness and depression, the authors write.

They conclude that “large-scale, prospective studies are required to assess the risk/benefit ratio of current practice.”

Overtreatment Can Lead to Problems, but So Can Undertreatment

Dr. Wartofsky said the study was designed to address whether starting levothyroxine therapy too early may result in overtreatment

Follow-up data showed that the percentage of patients with thyrotropin levels less than 0.1 mIU/L increased from 2.7% to 5.8% and the percentage of those with levels between 0.1 and 0.5 mIU/L increased from 6.3% to 10.2%, suggesting the presence of thyroid suppression. This “could lead to cardiac problems, arrhythmias, and atrial fibrillation and over the long term could lead to loss of bone mineral, osteopenia, and osteoporosis,” he explained.

But, he added, “I’m not particularly overwhelmed by the fact that only 5.8% of the patients were so oversuppressed. I think that is not unusual, even in the hands of expert endocrinologists — sometimes you oversuppress inadvertently.”

And the study does not show what the benefits of earlier treatment might be, probably because it takes longer for them to become apparent, he said. “In my view, there are compelling data that treating these populations does have a salutary effect”: lower serum cholesterol, a lower risk of coronary artery disease, and general symptom relief, among other things.

Is Hypothyroidism Overdiagnosed and Overtreated?


Over the past decade, doctors have become increasingly aggressive at initiating treatment for borderline hypothyroidism, possibly raising the risk for thyroid suppression as an unintended consequence, a new study suggests.

The American Thyroid Association recommends considering levothyroxine therapy at thyroid-stimulating hormone (TSH; thyrotropin) levels of 10 mIU/L or lower if symptoms of hypothyroidism, positive thyroid autoantibodies, or evidence of atherosclerotic cardiovascular disease or heart failure are present. But starting levothyroxine at or below 10 mIU/L in those without symptoms may do more harm than good, it cautions.

Yet in this new 9-year survey of more than 52,000 individuals in the United Kingdom, the number of individuals who received levothyroxine for a thyrotropin level of less than 10 mIU/L increased by 30% over the course of the study.

“This practice may be harmful, given the high risk of developing a suppressed thyrotropin level after treatment,” say the researchers, led by Peter N. Taylor, MRCP, from the Thyroid Research Group at the Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine, United Kingdom, and colleagues, whose findings are published online October 7 in JAMA Internal Medicine.

Asked to comment on the findings for Medscape Medical News, Leonard Wartofsky, MD, chair of the department of medicine, Washington Hospital Medical Center, Washington, DC, said the authors are “raising the red flag that there is potentially overdiagnosis and overtreatment that has some risks.”

Most healthy people have thyrotropin levels less than 2.5 mIU/L, he explained. “If you simply go by the numbers, it’s hard to reconcile a TSH level of 7.9 as being normal when the rest of the population has numbers of 2.5 or less.” However, he added, thyrotropin levels do rise with age, so higher levels are normal for people 70 years of age or more and do not necessarily indicate treatment is necessary.

“Part of the problem is that this is a mild abnormality, and in most published studies it’s been difficult to show a clear benefit of intervention, because the number of subjects participating has been small, the abnormalities are minor, and you can’t show a major clinical effect of intervention,” Dr. Wartofsky observed. “This is a controversial issue, and it’s still unsettled.”

Threshold Lowered After 2004

Using the General Practice Research Database (GPRD; now called the Clinical Practice Research Datalink), which contains the records of more than 5 million patients in 508 primary-care practices across the United Kingdom, Dr. Taylor and coauthors conducted a retrospective cohort study of 52,298 adults who initiated levothyroxine therapy between January 1, 2001, and October 30, 2009, at a median age of 59 years.

Excluded from the study were people with a history of hyperthyroidism, pituitary disease, or thyroid surgery; those who were taking medication that affected thyroid function or whose thyroid problems were related to pregnancy; and/or those whose thyrotropin had been measured more than 3 months prior to beginning treatment.

To gauge the effect of therapy on thyroid function, they also studied thyrotropin levels at 30 to 36 months and 54 to 60 months after treatment began. Female patients outnumbered males by almost 4 to 1.

Following multivariate adjustment, the odds ratio of a patient receiving a levothyroxine prescription for a presenting thyrotropin level of less than 10.0 mIU/L in 2009 compared with 2001 was 1.30 (P < .001), and the number of new levothyroxine prescriptions increased by 74% over the study period.

The median thyrotropin level for initiating treatment fell from 8.7 mIU/L in 2001 to 7.9 mIU/L in 2009.

Individuals prescribed levothyroxine with a thyrotropin level between 4.0 and 10.0 mIU/L instead of exceeding 10.0 mIU/L were more likely to be female, have cardiovascular risk factors, and be older than 70 years when prescribed levothyroxine after 2004, with trends also observed for tiredness and depression, the authors write.

They conclude that “large-scale, prospective studies are required to assess the risk/benefit ratio of current practice.”

Overtreatment Can Lead to Problems, but So Can Undertreatment

Dr. Wartofsky said the study was designed to address whether starting levothyroxine therapy too early may result in overtreatment

Follow-up data showed that the percentage of patients with thyrotropin levels less than 0.1 mIU/L increased from 2.7% to 5.8% and the percentage of those with levels between 0.1 and 0.5 mIU/L increased from 6.3% to 10.2%, suggesting the presence of thyroid suppression. This “could lead to cardiac problems, arrhythmias, and atrial fibrillation and over the long term could lead to loss of bone mineral, osteopenia, and osteoporosis,” he explained.

But, he added, “I’m not particularly overwhelmed by the fact that only 5.8% of the patients were so oversuppressed. I think that is not unusual, even in the hands of expert endocrinologists — sometimes you oversuppress inadvertently.”

And the study does not show what the benefits of earlier treatment might be, probably because it takes longer for them to become apparent, he said. “In my view, there are compelling data that treating these populations does have a salutary effect”: lower serum cholesterol, a lower risk of coronary artery disease, and general symptom relief, among other things.

Source: JAMA