Treatment of lymph node tuberculosis – a randomized clinical trial of two 6‐month regimens

Abstract

OBJECTIVE: The currently recommended treatment for lymph node tuberculosis is 6 months of\ud rifampicin and isoniazid plus pyrazinamide for the first 2 months, given either daily or thrice weekly.\ud The objective of this study was to assess the efficacy of a 6-month twice-weekly regimen and a daily twodrug\ud regimen.\ud METHODS: Patients with biopsy confirmed superficial lymph node tuberculosis were randomly allocated\ud to receive either a daily self-administered 6-month regimen of rifampicin and isoniazid, or a twiceweekly,\ud directly observed, 6-month regimen of rifampicin and isoniazid plus pyrazinamide for the first\ud 2 months, in Madurai, South India, Patients were followed up for 36 months after completing treatment.\ud RESULTS: Of 277 enrolled patients, data was available for analysis in 268. At the end of treatment, 116\ud of 134 [87%; 95% confidence interval (CI) 81–93%] patients in each treatment group had a favourable\ud clinical response; 14 (11%; 95% CI 6–16%) and 17 (13%; 95% CI 7–19%) patients had a doubtful\ud response, and 4 (3%; 95% CI 0–6%) and 1 (1%; 95% CI 0–2%) patients had an unfavourable response\ud among those treated with the daily and twice-weekly regimen, respectively. During 36 months after\ud completion of treatment, five patients [2 (2%; 95% CI 1–3%) and 3 (2%; 95% CI 1–3%) patients\ud treated with the daily and twice-weekly regimen, respectively] had relapse of lymph node tuberculosis, of\ud 260 assessed. Adverse reactions probably attributable to the treatment regimens occurred in 1% of the\ud patients treated daily and in 11% of those treated twice-weekly (P < 0.001). At the end of 36 months\ud after treatment, 126 of 134 (94%; 95% CI 90–98%) and 129 of 134 (96%; 95% CI 94–98%) of the\ud patients treated with the daily and twice-weekly regimen, respectively, had a successful outcome.\ud CONCLUSION: Both the self-administered daily regimen and the fully observed twice-weekly regimen\ud were highly efficacious for treating patients with lymph node tuberculosis and may be considered as\ud alternative options to the recommended regimens