These incorrect diagnoses have existed for years. But public health officials and clinicians say they are alarmed because of the increasing severity and scope of some treatments in recent years, said Christina Nelson, a medical epidemiologist and author of a report released Thursday by the Centers for Disease Control and Prevention.
Many of the various treatments, including courses of intravenous antibiotics lasting months and years, have no evidence of effectiveness. Studies have shown that prolonged courses of intravenous antibiotics can often result in serious harm, including death.
Unorthodox alternative therapies include intravenous infusions of hydrogen peroxide, electromagnetic frequency treatments, garlic supplements, even stem cell transplants.
Chronic Lyme disease is a diagnosis that some health-care providers use to describe patients with a variety of symptoms such as fatigue, generalized pain, and neurological symptoms.
It’s a confusing term because it’s been used to mean many different things. Some practitioners have used the diagnosis to describe lingering symptoms after infection with the bacteria Borrelia burgdorferi that causes Lyme disease. Others use the catchall term to describe patients with subjective symptoms but no evidence of ever having been infected with the tick-borne illness.
Many of these patients have experienced significant debilitation from their symptoms and failed to find relief after seeing conventional medical practitioners. As a result, some turn to alternative medicine clinics or practitioners who sometimes identify themselves as Lyme disease specialists, or “Lyme literate” doctors, who may subject patients to a host of unproven treatments, the report said.
Typical symptoms of true Lyme disease include fever, headache, fatigue and a skin rash that may have a characteristic bull’s eye shape. If left untreated, infection can spread to joints, the heart and nervous system. The recommended treatment is generally a two-to-four-week course of antibiotics. The CDC estimates about 300,000 people are diagnosed with Lyme each year, and the numbers have been on the rise.
Federal health officials don’t know the number of people who undergo treatments for chronic Lyme disease or the complications that result from such treatments. But based on information received in the past three years from state and local health departments, and from clinicians who have treated patients who have become very sick as a result of these treatments, “we really have a sense that both the treatment and scope are broadening,” Nelson said.
“Health-care providers are seeing the fallout,” she said. “These treatments are really dangerous. This is just the tip of a very large iceberg that no one is talking about.”
One woman in her 50s with progressive weakness, swelling and tingling in her extremities was eventually diagnosed with amyotrophic lateral sclerosis, or ALS. She sought a second evaluation and was told she had chronic Lyme disease. She received seven months of intensive antimicrobial treatment — including drugs that were antifungal agents not recommended for treating Lyme disease — but her weakness worsened. She developed an intractable C. difficile infection, with severe abdominal cramps and diarrhea that persisted for more than two years.
The woman eventually died from complications related to ALS, said Nelson, who had spoken with the patient.
“She ended up spending a lot of money on these treatments, as well as time and effort, and that took away from her other life experiences,” Nelson said.
The CDC is trying to raise awareness about the dangers of misdiagnosis and unproven treatments. The report focuses on the serious bacterial infections associated with prolonged antibiotic treatment. While antibiotics are effective for many conditions, unnecessary antibiotics provide no benefit and actually put patients at risk for serious harm, especially if used for extended periods. The drugs kill beneficial bacteria and allow drug-resistant ones to dominate, and intravenous treatments can introduce new infections.
Neither the CDC or the National Institutes of Health recommends using the diagnosis “chronic Lyme disease,” for several reasons, Nelson said. The diagnosis is often based on clinical judgment, with no objective evidence of Lyme disease, such as standard laboratory testing for Lyme bacteria or even a history of possible tick exposure in an area with endemic Lyme disease.
Clinicians who call themselves “Lyme literate” are often self-annointed; there is no special training program and no requirement to be board certified in infectious disease, Nelson said.
In addition to the woman with ALS, the CDC report describes four other cases that highlight the severity and scope of the harm caused by unproven treatments for chronic Lyme disease. All five patients developed serious complications; two patients died.
- A woman in her late 30s with fatigue and joint pain was prescribed multiple courses of oral antibiotics. Despite that treatment, her symptoms worsened, and she was put on three months of intravenous antibiotics. She got sicker, developed fever and rash and was hospitalized in intensive care. As her condition worsened, she received more powerful intravenous antibiotics and was put on a ventilator. She died of septic shock related to a bloodstream infection.
- An adolescent girl who had years of muscle and joint pain, backaches, headaches and lethargy, received a diagnosis of chronic fatigue syndrome. She sought a second opinion from an alternative medicine clinic and was given a diagnosis of chronic Lyme disease. After eight months of oral and intravenous antibiotics, she had no improvement. One week after antibiotics were stopped, the alternative clinic recommended she receive a dose of a different antibiotic intravenously. That same day, she was rushed to a hospital emergency department with a high fever and signs of septic shock. She was hospitalized in intensive care and later found to have a catheter-associated bacterial infection. She received broad-spectrum antibiotics to treat the infection and was discharged after several weeks.
- A woman in her late 40s received multiple insect bites and developed a flulike illness with pain in her arms, legs and back. One year after her symptoms began, she received a diagnosis of Lyme disease based on the standard laboratory test. She was treated with two four-week courses of oral doxycycline, which is recommended for patients with arthritis associated with untreated Lyme infection. She later developed fatigue and cognitive difficulties. Two years after her initial diagnosis, she was told she had chronic Lyme disease based on results of unvalidated tests. She received multiple courses of oral and intravenous antibiotics for more than a year. She developed back pain and shortness of breath, and was hospitalized twice after a catheter-related infection spread to her back and spine. After treatment for that infection, her back pain eventually improved.
- A woman in her 60s with a low white blood cell count and degenerative arthritis received intravenous immunoglobulin, or antibodies, every three weeks for more than 10 years. She developed an antibiotic-resistant staph infection in her back that turned into an abscess next to her spine that required surgery to drain.