Approximately 19 million children under the age of 5 worldwide suffer from severe acute malnutrition. This condition contributes greatly to mortality and disease burden among children. In order to reduce the risk of death from severe acute malnutrition, nutritional and medical intervention is required. Furthermore, bacterial infection can complicate cases of severe acute malnutrition, since the risk of infection is high. For this reason, in 1999 the World Health Organization (WHO) recommended the routine use of broad spectrum antibiotics for the management of severe acute malnutrition. More recent statistics show that malnutrition is 4 to 5 times as high as the number before the introduction of standards of treatment. Despite the recent developments, there has been no strong evidence about whether the use of the same medical protocol for community based regimens should be used. Thus, researchers conducted a randomized, double-blind, placebo-controlled trial in Niger to examine the effect of routine amoxicillin use on nutritional recovery in children with severe acute malnutrition.
Overall, 64% of the children enrolled in the study recovered from severe acute malnutrition. However, these results did not significantly indicate that routine provision of amoxicillin was superior to placebo for nutritional recovery in children with uncomplicated severe acute malnutrition. First, Amoxicillin reduced the risk of hospitalization when compared to placebo, but about 53% of children transferred to inpatient care were admitted to the hospital for malnutrition. Next, among hospitalized children, there was no significant differences in mean of stay between the placebo group and intervention group, but both groups recovered at the same times. Despite these findings, researchers were able to conclude that amoxicillin reduced the risk of transfers to inpatient care due to complicated gastroenteritis and showed benefits over short-term weight gain.
From this study, it seems that overall Amoxicillin did not show superiority to placebo treatment. These findings challenge the view that routine antibiotic therapy is always necessary or beneficial for the treatment of severe acute malnutrition. Eliminating the use of Amoxicillin could help simplify the treatment regimen, which would result in increased cost savings associated with drugs, staff, and systems for delivery. In addition, there are multiple factors that can be costly to treat, such infections that result from resistance to antibiotic regimens. I believe that it’s good that these researchers decided to check the treatment guidelines for using amoxicillin, because determining the true value of the regimen and be greatly beneficial for the future treatment of severe acute malnutrition. Do you believe it is important to routinely research established treatment guidelines? Why or why not? Are you aware of any treatment guidelines that have been updated in the past few years?
Isanaka S, Langendorf C, Berthe F et al. Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children. N Engl J Med. 2016; 374:444-453
One of the biggest issues facing global health is the severe malnutrition affecting millions of children around the world. The malnutrition in these children is so severe that medical intervention is necessary. Severe malnutrition cases can be further complicated by bacterial infections and broad-spectrum antibiotics were prescribed for treatment of those infections. The treatment of infections is coupled with nutritional recovery, generally in complicated cases. This study conducted by Isanaka and colleagues studied the use of amoxicillin in the treatment of bacterial infections in children with uncomplicated severe malnutrition. In 2007, the World Health Organization supported the use of community-based treatment of severe malnutrition with the goal that they were identify and treatment more malnourished children. This previous publication, however, did not examine the effectiveness of the drug therapy protocol.
During this study, the children were randomly assigned to two groups: the amoxicillin group and the placebo group. Both groups of participants were also provided with the Ready to Use Therapeutic Food (RUTF), which is meant to provide them with all of their basic nutritional needs to aid in nutritional recovery. Follow-up appointments were scheduled at 4, 8, and 12 weeks form the start of the study. During these visits, stool, urine, and blood samples were obtained and tested for signs of bacterial infection. The primary outcome of the study was nutritional recovery at 8 weeks, based on increased measurement of the upper arm, a lack of edema, and a weight-for-height z score of -2 or higher. Secondary outcomes were nonresponse or no changes at 8 weeks, death from any cause, or transfer to inpatient.
Overall, the study found no significant difference in the likelihood of nutritional recovery between the amoxicillin and placebo groups. Despite this, the time to nutritional recovery as significantly reduced in the amoxicillin group. The amoxicillin group also had a significantly decreased overall risk of transfer to inpatient facilities but did not affect the mean time to transfer to inpatient. Amoxicillin increased early increases in weight and mid-upper-arm circumference and decreased the frequency of diarrhea. Despite all of these findings the researchers concluded that routine amoxicillin use in this population does not significantly effects nutritional recovery.
This study provided an interesting insight into the routine use of antibiotics and questioned their efficacy and necessity. This study produced some interesting results but the improvement in weight gain and the slight decreases in adverse events were observed in the short-term. This study did not look at the long-term effects of this type of therapy and because of this cannot say that this improvement in weight gain lasts for any extended period of time. The ultimate goal of this treatment is long-term nutritional stability and the nature of this study cannot speak to this outcome. Additionally, as suggested in the paper, it may be unclear whether the amoxicillin is actually affecting nutritional recovery or serving as a protective agent while the RUTF actively impacts nutritional status. All of these confounding factors make it unclear whether amoxicillin is beneficial under these circumstances and further research will be required to assess the necessity of antibiotic use in this population.
Isanaka S, Langendorf C, Berthé F, et al. Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children. N Engl J Med. 2016 Feb 4;374(5):444-53.