2 Minute Medicine Rewind July 12, 2021

Pregnancy risk by frequency and timing of unprotected intercourse before intrauterine device placement for emergency contraception

1. Probability of pregnancy was low regardless of timing and frequency of unprotected intercourse in the 14 days prior to contraceptive intrauterine device insertion. 

2. Multiple exposures of unprotected intercourse as well as extended time between unprotected intercourse and emergency contraceptive insertion did not have significant effects on one-month post IUD pregnancy rates.

Evidence Rating Level: 1 (Excellent)

Prior studies have assessed the efficacy of emergency contraceptive methods, however the impacts of timing and frequency of episodes of unprotected intercourse have not been fully studied. More specifically, the current clinical guidelines from the World Health Organization (WHO) are for individuals to receive an emergency contraceptive intrauterine device (IUD) up to 5 days after unprotected intercourse. Studies are limited with regards to the efficacy of emergency contraception, such as the IUD, after 5 days post unprotected intercourse as well as the impacts of multiple episodes.  This randomized clinical trial evaluated participants (n=655) between August 2016 and December 2019 in Utah clinics. All participants were required to have negative urine pregnancy tests at the time of IUD insertion as an inclusion criterion. Study enrollment data was collected, including when and how many times unprotected intercourse happened 14 days prior to the insertion of the IUD. Participants were randomly assigned either levonorgestrel 52-mg Intrauterine system (IUS) or a copper T380 IUD; two methods deemed equal in quality and safety. One month after the placement of their IUD, all participants were asked to report any pregnancies. Overall, one participant reported a pregnancy occurring after unprotected intercourse 48 hours prior to IUD insertion. In the remaining cohort, pregnancy risk was not significantly different with higher frequency of unprotected intercourse (risk difference 0.3%, 95% CI 0.3 to 0.8). Furthermore, timing did not have a significant impact either, with similar risks for participants who engaged in unprotected intercourse within the 5 days prior to insertion compared to days 6-14 prior (risk difference 0.2%, 95% CI 0.2 to 0.5). A limitation of this study was that participants were asked to self-report their unprotected intercourse which may be influenced by their own recall biases or stigma leading to underreporting. Overall, this study has clinical relevance, patient-centered importance, as well as highly impactful data for family planning. Barriers to access to quality emergency contraceptives are omnipresent and having a better understanding of pregnancy timelines can lead to improved care.

Association of travel distance to nearest abortion facility with rates of abortion

1. Greater distanced travelled for abortion services were associated with reduced abortion rates.

2. There is an unmet need for abortion care services across the US with higher distance travelled presenting an important barrier to access. 

Evidence Rating Level: 2 (Good)

25% of women in the United States will have an abortion in their lifetime despite varying state policies and restrictions. Health care service closures, lack of facilities or abortion providers are barriers leading to greater distance to abortion services. Not surprisingly, this need for travel leads to additional barriers such as lack of follow up care, less likelihood of seeking aid, or simply the inability to do so. Lack of transportation, inability to take time off, financial or familial restrictions all may contribute to the problem. Therefore, the farther a patient lives from an abortion facility, the less likely they are to receive care. This national cross-sectional geographic analysis collected data from April 2018-October 2019 to further evaluate this relationship. Analyses were conducted with data from 3107 counties across 48 states. Data was collected from the 2015 American Community Survey as well as the US Census in order to calculate the abortion rates per 1000 females of reproductive age (15-44 years). Abortion rates were then compared between counties and distance travelled by car to receive care was calculated. The latter was found using the Advancing New Standards in Reproductive Health national abortion facility database. In the 48 states, there were an estimated 696 760 abortions with a mean abortion rate of 11.1 per 1000 female residents of reproductive age. Greater travel distance was negatively associated with abortion rates specifically, of the female residents of reproductive age reporting a travel distance of less than 5 miles where 21.1 per 1000 females received abortion care. On the other hand, when 120 miles or more of travel distance was reported, only 3.9 per 1000 female residents of reproductive age received abortion care.  One limitation of the study was that the main barrier to access was presented as “travel distance” despite the multitude of other factors that play a role. Laws and state policies, religious beliefs, and underreporting due to stigma can all affect seeking care. Conversely, a strength of the study was the extensive analyses accounting for other factors such as race, age, marital status, education level, and income. Overall, abortion rates declining as travel distance to abortion care increases is clinically important as it indicates the need for more facilities and services. This need will be further exasperated should the US Supreme Court rule in favour for states to increase regulation or ban abortion. In order to focus on patient-centered care, increasing access to abortion services with less distance to travel is required.

Diminished age-related decline of the amygdala in long-term meditation practitioners

1. Increasing age is associated with decrease in brain tissue, reduced volume of the amygdala, and cognitive decline 

2. Regular meditation may slow the age-related deterioration process

Evidence Rating Level: 3 (Average)

Meditation has been studied for its holistic impacts on the physical, emotional, and spiritual health of individuals. One specific subregion of the brain involved in meditation and mindfulness is the amygdala. This region is composed of gray matter which is known to decline in volume with age. This study aimed to better understand the benefits of regular meditation on the slowing of age-related cognitive decline, specifically looking at the amygdala. In order to assess the amygdala, boundaries were established to further quantify its volumetric gray matter, including the centromedial (CM), laterobasal (LB), and superficial (SF) subregions. To do so, the study compared regular meditation practitioners (n=50) to control participants (n=50). Participants were matched for age, sex, total intracranial volume, and underwent similar scanning parameters for brain mapping.  As its preferred means of neuroimaging, the study used T1 weighted magnetization gradient echo sequencing and also compared portions of participant’s gray matter, white matter, and cerebrospinal fluid. These samples were further stratified into CM, LB, and SF; volumes were calculated annually to further analyze changes. This analysis was done using a mass univariate general linear model. The study found that overall, increasing age does lead to smaller volumes in the amygdala and each of its subregions. However, this negative correlation was impacted by meditation with a significantly more gradual slope among meditators compared to controls. In fact, rates of annual tissue loss ranged between 0.379% and 0.505% in the controls compared to 0.027% in meditators. A limitation of the study was the relatively small sample size. Additionally, other health factors potentially influencing the brain, such as participants’ lifestyle, sleep, diet, and exercise habits, were not taken into account. Further research on other regions of the brain could be beneficial as it was noted that areas, such as the hippocampus, were found to be positively correlated with age in meditators. Overall, the study highlighted the benefit of meditation and the potential preventative effects of exercising the amygdala. This “use it or lose it” principle may encourage individuals to engage in mindfulness and meditation practices with the goal not of total avoidance, but rather slowing the ageing process.

Efruxifermin in non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled, phase 2a trial

1. Efruxifermin was an effective and safe treatment found to significantly reduce hepatic fat fraction in order to treat nonalcoholic steatohepatitis. 

2. Participants taking Efruxifermin experienced reduced liver fibrosis, improved lipid profiles, cholesterol, and glycemic controls compared to participants taking the placebo

Evidence Rating Level: 1 (Excellent)

Non-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease (NAFLD) consisting of steatosis, inflammation, and hepatocyte injury. Previous studies have focused on therapeutic mechanisms targeting these characteristics, however there are currently no approved treatments. This study aimed to assess Efruxifermin as a potential treatment for NASH. Efruxifermin, a fusion protein linked to fibroblast growth factor 21 (FGF21), improves lipoprotein profiles, glycemic control, and reduces liver fat. The efficacy and safety of Efruxifermin was assessed using a randomized, placebo-controlled study with participants (n=80) from 27 sites. Participants were evenly distributed into treatment groups after accounting for body mass index, fibrosis stages (F1-F3), hepatic fat fraction (HFF), lipid and glycemic profiles. Participants received either a placebo (n=21), or 28mg (n=19), 50 mg (n=21), or 70mg (n=20) of Efruxifermin for 16 weeks. Treatment was found to significantly reduce HFF by week 12 in all groups receiving Efruxifermin. Specifically, absolute changes from baseline in HFF were 12.3%, 13.4% and 14.1% with the 28mg, 50mg and 70mg of Efruxifermin respectively. Comparatively, the HFF only changed 0.3% in the placebo group. In other words, HFF reductions were significantly greater with Efruxifermin with reductions of 62.9%, 70.6%, and 72.0% in each treatment group respectively compared to the group receiving the placebo (P < 0.0001). Changes in liver injury marker alanine aminotransferase (ALT) was another outcome measured at week 12. Similar to HFF, significant reduction in ALT was seen across all treatment groups compared to the placebo. Furthermore, aspartame amino transferase (AST), Gamma glutamyl transferase (GGT), and alkaline phosphatase (ALP) all followed similar reduction patterns as HFF and ALT. Finally, urate levels also decreased by 14-19% in treatment participants relative to placebo, indicating lower levels of liver stress. Overall, this study presents a potential treatment plan for NASH, however studies at a larger scale are required to continue assessing the efficacy and safety long term.

Association of emotion regulation trajectories in childhood with anorexia nervosa and atypical anorexia nervosa in early adolescence

1. Children who were found to have poor improvement of emotional regulation skills between 3 to 7 years of age were at increased risk for broad anorexia nervosa

Evidence Rating: 2 (Good)

Anorexia nervosa is a highly prevalent psychiatric disorder characterized by restriction of food consumption and debilitating anxiety regarding one’s eating habits, body shape, and weight gain. The majority of cases begin in early adolescence, and as such, childhood interventions have been thought to be a potential effective means of reducing incidence of the disorder. One of the suggested interventions is the facilitation of appropriate development of emotional regulation skills, as clinical samples have found affected individuals to be show suboptimal skills compared to the general population. As prior literature is limited to case control studies in adults however, further investigations are needed to characterize the longitudinal relationship between the two variables. In this population-based birth cohort study, data from 15,896 children born between September 1 2000 to January 11 2002 were analyzed to address this gap in literature. Mothers completed the Children’s Social Behaviour Questionnaire to report their child’s emotion regulation skills at 3, 5, and 7 years. Univariable and multivariable logistic regression models were then used to test their association with symptoms consistent with a DSM-5 diagnosis of anorexia nervosa or atypical anorexia nervosa at 14 years of age, with appropriate adjustments for factors such as cognitive development, family socioeconomic characteristics, and other potential confounding factors. Interestingly, there was no association found between lower emotional regulation ability at 3 years of age and development of symptoms of broad anorexia nervosa (odds ratio [OR],1.21; 95%CI, 0.91-1.63). Rather, a lack of improvement of emotion regulation skills over childhood at 7 years of age was associated with higher odds of developing broad anorexia nervosa (OR, 1.45; 95%CI, 1.16-1.83). This study represents one of the first using longitudinal data to investigate the relationship between emotion regulation and the development of anorexia nervosa. With further research, this may identify an important area that can be used to identify at-risk individuals early in childhood and foster the appropriate development of emotion regulation skills as a means of preventing the disorder. Specifically, the development of fundamental skills such as stress management, overcoming frustration, and building tolerance for discomfort for example, may play a preventative role in the development of anorexia nervosa and other eating disorders.

Image: PD

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