Donta · Medical science monitor : international medical journal of experimental and clinical research 2003 · Case series · n=235

Macrolide therapy of chronic Lyme Disease.

Cited 53 times in the scientific literature.

Level 4 - case-series / case-control

Uncontrolled open-label case series.

PubMed 14586290 · record verified 2026-08-27

What was done

A total of 235 patients presenting with serologic reactivity against Borrelia burgdorferi and symptoms typical of chronic Lyme disease (fatigue, musculoskeletal pain, and neurocognitive dysfunction) were treated with a combination of a macrolide antibiotic (such as clarithromycin) and hydroxychloroquine.

What was found

Eighty percent of patients self-reported an improvement of 50% or more after 3 months of treatment. At 2 months, 20% reported marked improvement (75-100% of normal), rising to 45% at 3 months. Improvement typically did not begin until after several weeks of treatment. No differences were observed among the three macrolide antibiotics used. Patients previously treated with hydroxychloroquine or macrolides alone experienced little or no improvement. Patients ill for 3 or more years had a slower onset of improvement and higher failure rates compared to those ill for less than 3 years.

Why it matters

The paper proposes that alkalinization of acidic endosomes using hydroxychloroquine may augment the clinical activity of macrolides against Borrelia burgdorferi in patients with persistent symptoms.

Limits

The study is an uncontrolled, open-label case series without a randomized comparator or placebo group, precluding attribution of improvement specifically to the drug combination versus placebo effect or natural disease fluctuation. Outcomes were entirely subjective and self-reported without objective clinical metrics, and specific details regarding drug dosages and precise failure rates are omitted in the abstract.

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