According to a new Dutch study, even long antibiotic therapy is ineffective in the treatment of the chronic Lyme disease. The results of the study called PLEASE (Persistent Lyme Empiric Antibiotic Study Europe) were published in NEJM (the New England Journal of Medicine) on 31 March. It was concluded that antibiotics therapy was effective in cases of early diagnosis; however, long-term use of antibiotics was unproductive with possible side effects.
Chronic Lyme Disease Treatment
People suffering from Lyme disease sometimes develop persistent symptoms which are also called as post–Lyme disease syndrome or chronic Lyme disease. Such cases only develop in 20 percent of the patients who developed the Erythema Migrans rash after contracting the Borrelia burgdorferi bacterial infection from a tick bite. Even after initial antibiotic therapy they usually suffer from pain, fatigue, and neurologic or cognitive problems.
The CDC says there are approximately 30,000 cases of Lyme disease reported in the U.S. every year. In 2014 the CDC found that about 96 percent of confirmed Lyme disease cases were mainly reported from 14 northeast and upper Midwest states e.g. New York, Massachusetts, etc.
PLEASE was the largest-ever study carried out on 280 patients with chronic Lyme disease symptoms. The initial aim was to find out which of the two antibiotic regimes were more effective for treatment. Surprisingly, neither provided relief after administration of different drugs for 14 weeks. The clinical trial was carried out at the Radboud University Medical Center and Sint Maartenskliniek in Netherlands.
“The patients reported no benefits fromprolonged antibiotics on any of the scales compared to those who received placebo,” said Dr. Bart Jan Kullberg, M.D., and Ph.D., and the lead author of the study. “These patients need customized care, not just a prescription for antibiotics.”
The clinical trial comprised three different study groups for the comparison of long- and short-term treatment. All of the patients were given 2,000 mg of open-label intravenous ceftriaxone on a daily basis for two weeks and then divided into three groups and administered different drugs for the next 12 weeks.
The first group chosen for the short-term treatment was administered with the antibiotic drug ceftriaxone commonly known as Rocephin, followed by a placebo and was called the placebo group. Twice on a daily basis the placebo group was given two different placebo capsules.
The second group was chosen for longer-term treatment and given the drug ceftriaxone followed by Doxycycline, also called Doryx, and was called the Doxycycline group. The second group received 100 mg of doxycycline orally, twice daily.
The third group was also chosen for comparison of long-term treatment, but with a different antibiotic drug. It was called the clarithromycin–hydroxychloroquine group since the second drug used was Plaquenil. The third group received 500mg of clarithromycin combined with 200mg of hydroxychloroquine twice daily.
Throughout the study, 205 patients or 73.2 percent reported suffering from at least one negative reaction to the drugs. In the same way nine patients or 3.2 percent of the subjects informed of having developed a serious side effect e.g. nausea and diarrhea. Meanwhile 19 patients, equal to 6.8 percent of the study group, developed serious side effects, which led to discontinuation.
In conclusion, prolonged antibiotic treatment did not lead to a better quality of life in people with chronic Lyme disease. Overall participants from all three groups informed of physical and mental progress but no significant difference was found in any of the three groups. After treatment ended the patients were also subjected to a 26-week follow-up and even it did not provide any conflicting observations.
Earlier studies were found to be consistent with current results. Dr. Charles Ericsson, head of clinical infectious diseases at McGovern Medical School at UTHealth and member of the Memorial Hermann-Texas Medical Center, said, “This is sort of a further nail in the coffin in the controversy over chronic Lyme disease, or whatever you want to call it when people who have had Lyme disease have residual symptomatology.”
The trial listed several limitations. For one, they did not carry out a complete placebo effect trial as the patients were given antibiotics for the first two weeks. The study compared long-term therapy with short-term therapy rather than placebo. Secondly, it is possible the B. burgdorferi infection had still been active in some of the patients, leading to improvement following the drug treatment. Thirdly, it is not ethical to withhold the available treatment from diseased individuals unless the actual cause and mode of action of the disease is scientifically known.
Patients were chosen on the basis persistent symptoms manifestation such as bone pain, arthritis, arthralgia, neuralgia, sensory disturbances, dysesthesia, neuropsychological or cognitive disorders, and persistent fatigue. The patients were also tested to confirm they were infected with the B. burgdorferi infection and were recruited from 2010 till 2013. The patients completed questionnaires asking about their symptoms, fitness level, quality of life and well-being, before and after the treatment period. The questionnaires were filled at 26, 40 and 52 weeks of the treatment period.
Generally, the research concluded antibiotics are not the answer for chronic Lyme disease.
“We don’t really know what is the cause of this syndrome,” Dr. Kullberg said. “It could be an immune response to the prior infection, sensitization to the infection or genetic variation that makes them sensitive to prolonged symptoms after an infection. But the answer may not be found in prescribing a prolonged course of antibiotics.”
Lyme disease is a major disease in the U.S. and the CDC reports from 2001 till 2010, the most affected groups were 5-10 year old girls and 40-50 year old men, followed by 20-30 years old men. 70 percent of affected individuals develop Erythema Migrans, while Arithritis forms in 30 percent of diseased people. In the same way, nine percent of those infected progress to Bell’s palsy, and one percent get cardiac problems or Meningitis. For reasons unknown, in 2009 the incidence of Lyme disease increased the most in the U.S. and especially more cases are reported annually between the months of June and July, while the least are reported in December and January.