Divide deepens over treatment of persistent Lyme disease symptoms

Weeks after a study debunks use of long-term antibiotics, state legislators approve a measure requiring insurance providers to pay for it.

Ticks found on a deer. – MV Times

A recent study published in the New England Journal of Medicine concluded that long-term use of antibiotics is not an effective treatment for people with persistent Lyme disease symptoms. The study was done in the Netherlands; clinicians examined 280 people with persistent symptoms of Lyme disease, namely, “pain, fatigue, and neurologic or cognitive disturbances.”

Subjects were divided into three groups. One group was treated with doxycycline, another with clarithromycin-hydroxychloroquine, and another with a placebo, for 14 weeks. The three groups showed about the same rate of improvement.

The study concluded, “In patients with persistent symptoms attributed to Lyme disease, longer-term antibiotic treatment did not have additional beneficial effects on health-related quality of life.”

Additionally, the study said, long-term antibiotics can do more harm than good: “Although the side effects were mostly minor, 68.6 percent of the patients reported at least one adverse reaction that was thought to be drug-related, which should lessen the temptation among physicians to prescribe longer courses of antibiotics just in case they might help.”

Professor Sam Telford, expert on tick-borne diseases and professor of infectious disease and global health at Tufts University, told The Times that the results of the new study should not be discounted because it was done in Europe, where different strains of Borrelia burgdorferi, the bacterium that causes Lyme disease, are found.

“It’s even more valuable, because there’s a strain there that goes to the brain, and it’s very rarely found here,” Mr. Telford said. “Neurologic Lyme disease is much more common there. The bottom line remains, you still see no difference with long-term antibiotics.”

The Dutch study is the latest in a succession of similar studies done in the past 10 years, which have reached the same conclusion about the efficacy of long-term antibiotic treatment.

A 2007 study published in the New England Journal of Medicine stated, “Chronic Lyme Disease (CLD) is a misnomer, and the use of prolonged, dangerous, and expensive antibiotic treatments for it is not warranted. Because of the confusion in how the term CLD is employed, experts in this field do not support its use.”

A 2008 study published by the Infectious Disease Clinics of North America stated, “At this point, the overwhelming evidence shows that prolonged antibiotic therapy does not offer lasting or substantive benefit in treating patients with post–Lyme disease syndrome. Therefore, it is time to move forward to test other approaches that may help these patients.”

The 2015 study “Lyme disease: A rigorous review of diagnostic criteria and treatment,” published in the Journal of Autoimmunity, concluded, “Antibiotics are routinely and typically used to treat patients with Lyme disease, but there is no evidence that prolonged or recurrent treatment with antibiotics change the natural history of Lyme disease.”

Current protocol from the Centers for Disease Control and Prevention (CDC) recommends doxycycline therapy for 10 to 21 days for people testing positive for Lyme disease in Western blot or enzyme-linked immunosorbent assay (ELISA) blood tests. People usually see an improvement in 24 to 72 hours after starting antibiotics. But for roughly 10 percent of the infected, the symptoms can last months, even years.

There is a growing schism in medical professionals and epidemiologists about the source of these symptoms. Some believe the cause is chronic Lyme disease (CLD), where symptoms persist but people do not test positive for the Borrelia burgdorferi bacterium. CLD advocates maintain that the most effective treatment is long-term, intravenous antibiotics, which can be extremely expensive.

The CDC does not recognize CLD. It classifies the malady as post-treatment Lyme disease syndrome (PTLDS), the result of residual damage to tissues and the immune system that occurred during the Lyme disease infection, and for which long-term antibiotics are ineffective, as the aforementioned studies concluded.

The CDC estimates that over 300,000 people will be infected with Lyme disease in the United States this year. Massachusetts currently ranks third in the country in number of infections per 100,000 people, and Chilmark has the highest infection rate in the state.

Clarity on how to best treat the long-suffering 10 percent remains elusive.

“It’s a hard one,” Mr. Telford said. “If I were chronically ill, I’d want to try everything possible to get better. But I think this latest study underscores that some people are barking up the wrong tree.”

Politicians vote yes

In the face of this uncertainty, the Massachusetts House of Representatives voted to include a provision in the fiscal year 2017 budget that will require insurance companies “to cover the cost of Lyme disease treatment as prescribed by licensed physicians.” H. 4198 was filed by Representative David Linsky of Natick, and sponsored by Cape and Islands Representative Tim Madden, among many others. Nine of the legislators who voted for the bill have had Lyme disease.

The budget has been passed to the State Senate, and will ultimately go to Governor Charlie Baker for approval.

A March 28 Boston Globe editorial was sharply critical of H. 4198, concluding, “Patients whose lives up been upended by Lyme disease need more answers, but they should come out of a medical lab, not a legislature … the proposed mandate isn’t backed up by existing science.”

Rep. Madden told The Times that he is cognizant of the studies that question the use of long-term antibiotics, and of the Boston Globe editorial, but the anecdotal evidence he’s received from constituents was ultimately more convincing.

“It’s always difficult to go against something that’s data-driven, but there was so much testimony at the hearings, including a number of people from the Vineyard, who said long-term treatment helped,” he said. “It’s hard to argue when someone tells you to your face that something made a big difference. They were very passionate, and I found them believable. Keep in mind it still requires a prescription; people can’t just go out and get it.” Although health insurers contended the proviso will add significant costs, which will ultimately be borne by consumers, an independent study by the Center for Health Insurance Analysis concluded that it would add no more than 13 cents per policy.

“The biggest problem I see with the bill is that there’s no evidence that these people have Lyme disease, so treating specifically for Lyme disease doesn’t make any sense,” Mr. Telford said. “It’s a Catch-22, because the insurance company usually wants a specific diagnosis before covering the treatment. But to claim that it’s Lyme disease when there’s no evidence for it is making an insurance company pay for something for which there is no objective evidence.”

Mr. Telford said the recent report in the New England Journal of Medicine underscores this point.

“But people debunk studies, no matter who does them,” he said. “No study is going to satisfy anybody.”