Study finds long-term treatment of Lyme disease symptoms provides little benefit
Long-term antibiotic therapy does not significantly improve quality of life in patients with persistent symptoms attributed to Lyme disease, according to a study today in the New England Journal of Medicine.
As part of the Persistent Lyme Empiric Antibiotic Study Europe (PLEASE) trial, researchers at two sites in the Netherlands randomized 280 patients with persistent fatigue, musculoskeletal, neurologic, and/or cognitive symptoms to 1 of 3 groups that received a placebo, doxycycline, or clarithromycin plus hydroxychloroquine for 12 weeks.
All patients underwent 2 weeks of intravenous ceftriaxone treatment prior to randomization, including 11% of patients who had never been treated for Lyme disease. During this phase, 131 people (46.8%) reported at least one adverse event, 5 of which were serious and largely due to allergic reactions.
During the 12-week treatment period, 134 adverse events were reported, with patients receiving doxycycline more likely to experience photosensitivity and nausea, and patients receiving the combination of clarithromycin and hydroxychloroquine more commonly reporting nausea, diarrhea, and rash.
The self-reported quality of life for all groups, as measured by mean summary scores on the physical-component of the RAND-36 Health Status Inventory, increased from 31.8 before treatment to 36.4 at 14 weeks, but no significant differences were observed among the three groups. Though quality of life improved, it remained below that of the general population and did not appear to benefit from long-term treatment, the authors said.
In a commentary on the PLEASE study published in the same journal issue, Michael T. Melia, MD, and Paul G. Auwaerter, MD, highlight aspects of the research important to clinical management of Lyme disease patients. The European study population, they pointed out, was subject to Lyme disease from Borrelia afzelii and B garinii, which cause a longer initial period of illness compared with North American Borrelia species. Additionally, only 96 participants had a definitive Lyme disease diagnosis, they noted, casting doubt on whether chronic symptoms could be attributable to the infection.
Given the low benefit provided by long-term antibiotic regimens in the PLEASE study, the commentary authors assert the importance of considering multiple possible causes of chronic pain in clinical practice. They further recommend more research into long-term metabolic and cytokine changes caused by Lyme disease.
Mar 31 NEJM study
Mar 31 NEJM commentary
Study: Flu vaccination associated with lower stillbirth levels
Seasonal flu vaccination is associated with lower stillbirth levels, according to a large cohort study done in Australia during the 2012 and 2013 flu seasons in the Southern Hemisphere. Researchers published their findings yesterday in an early online edition of Clinical Infectious Diseases (CID).
The research group, from Western Australia, looked at midwife records of 58,008 births that occurred between April 2012 and December 2013. Of that total, 52,932 mothers had not been vaccinated and 5,076 had been immunized against seasonal flu during their pregnancies. Analysis revealed that vaccinated women were 51% less likely to experience stillbirths than their unvaccinated peers.
When the investigators focused on stillbirth timing patterns, they observed that rates increased after flu circulation periods and declined in the months before the flu seasons started. Though the seasonal differences weren't statistically significant, they were consistent with earlier findings from Switzerland and from the 2009 H1N1 pandemic.
Annette Regan, MPH, study coauthor and communicable disease project officer at the Western Australia Department of Health, said in a press release from the Infectious Diseases Society of America, the publisher of CID, that the findings showing a vaccination benefit in a range of flu epidemics is encouraging but that many women are missing out. "Unfortunately, we know that about 40% of pregnant women go unvaccinated, missing out on these benefits."
The authors wrote that more research is needed to confirm the potential links between stillbirth, flu seasons, and vaccination, but they hope their data will help convince women and their providers of the vaccine's possible health benefits during pregnancy.
Mar 30 Clin Infect Dis abstract
Mar 30 IDSA press release
Guinea reports 2 more deaths in 9-person Ebola cluster
Two more deaths have been reported in Guinea's recent Ebola flare-up, the third wife of a man who died earlier of a suspected Ebola infection and a mother-in-law, Agence France-Presse (AFP) reported yesterday, citing country health officials.
Fode Tass Sylla, spokesperson for Guinea's response unit, told AFP that the cluster, which is centered in the southern city of Koropara, as of yesterday comprises nine cases and seven deaths. The deaths reflect four confirmed cases and three suspected ones.
In a situation update yesterday the World Health Organization (WHO) said all cases are epidemiologically linked to a chain of transmission in Koropara. It said the first suspected case-patient, a woman in her late 30s, had an illness onset of around Feb 15 and that the source of her illness is still under investigation. It said 1,033 contacts have been identified, 171 of them considered high risk. All but 10 contacts have been traced. The WHO warned that more cases are likely, owing to the large number of contacts.
On Mar 29 the agency said the Ebola Public Health Emergency of International Concern was over, but it warned that further flare-ups linked to lingering virus in survivors are likely, requiring no letup in response capacity.
Mar 30 AFP report
Mar 30 WHO situation report
In other Ebola developments, Inovio Pharmaceuticals reported early positive findings for a phase 1 trial of its DNA vaccine (INO-4212) yesterday at the World Vaccine Congress in Washington, DC, according to a statement from the company.
The trial involved 75 healthy volunteers split into five different groups, with two different plasmids tested separately and together in muscle and skin. One group received doses along with Inovio's proprietary immune activator. Of 69 evaluated subjects, 64 seroconverted and mounted a strong antibody response to a 3-dose regimen; 48 seroconverted after 2 doses. So far the vaccine was well tolerated with no serious systemic adverse events.
Mar 30 Inovio press release
Saudi Arabia reports 1 new MERS case and 1 death
Saudi Arabia's Ministry of Health (MOH) today reported one new MERS-CoV case and the death of a previously reported patient, both in the north-central city of Buraydah.
The MERS-CoV (Middle East respiratory syndrome coronavirus) case involves a 56-year-old Saudi man who is hospitalized in critical condition. He is not a healthcare worker, and the MOH has listed his infection as associated with exposure to camels.
The fatality was in a 70-year-old Saudi man in Buraydah, the site of numerous recent healthcare-associated MERS cases. The man was not a healthcare worker and had an underlying medical condition.
Also included in the MOH report was the recovery from MERS of a 57-year-old foreign man in Buraydah. He is not a healthcare worker and had no preexisting disease.
Today's update brings the MERS-CoV total in Saudi Arabia since 2012 to 1,362 cases, including 582 deaths. Thirteen cases remain active.
Mar 31 MOH update