Oral doxycycline compared to intravenous ceftriaxone in the treatment of Lyme neuroborreliosis: a multicentre, equivalence, randomized, open-label trial.

BACKGROUND: Lyme neuroborreliosis (LNB) is often treated with intravenous ceftriaxone even if doxycycline is suggested to be non-inferior to ceftriaxone. We evaluated the efficacy of oral doxycycline in comparison to ceftriaxone in the treatment of LNB. METHODS: Patients with neurological symptoms suggestive of LNB without other obvious reasons were recruited. The inclusion criteria were: 1) production of B. burgdorferi specific antibodies in cerebrospinal fluid (CSF) or serum; or 2) B. burgdorferi DNA in the CSF; or 3) an erythema migrans during the past three months. Participants were randomized in 1:1 ratio to receive either oral doxycycline 100 mg twice a day for four weeks, or intravenous ceftriaxone 2 g daily for three weeks. The participants described their subjective condition with a visual analogue scale (VAS) from 0 to 10 (0 = normal; 10 = worst) before the treatment, and 4 and 12 months after the treatment. The primary outcome was the change in the VAS score at 12 months. RESULTS: Between Sep 14, 2012 and Dec 28, 2017, 210 adults with suspected LNB were assigned to receive doxycycline (n=104) or ceftriaxone (n=106). The per-protocol analysis comprised 82 patients with doxycycline and 84 patients with ceftriaxone. The mean change in the VAS score was -3.9 in the doxycycline group and -3.8 in the ceftriaxone group (mean difference 0.17 with 95% CI -0.59 - 0.92, which is within the pre-specified equivalence margins of -1 to 1 units). Participants in both groups improved equally. CONCLUSIONS: Oral doxycycline is equally effective as intravenous ceftriaxone in the treatment of LNB.