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

Jawahar, M.S.; Rajaram, K.; Sivasubramanian, S.; Paramasivan, C.N.; Chandrasekar, K.; Kamaludeen, M.N.; Thirithuvathas, A.J.; Ananthalakshmi, V.; Prabhakar, R.

Tropical Medicine and International Health; 2005; 10; 1090-1098.

Summary: Objective: The currently recommended treatment for lymph node tuberculosis is 6 months of rifampicin and isoniazid plus pyrazinamide for the first 2 months, given either daily or thrice weekly. The objective of this study was to assess the efficacy of a 6-month twice-weekly regimen and a daily two drug regimen.

Methods: Patients with biopsy confirmed superficial lymph node tuberculosis were randomly allocated to receive either a daily self-administered 6-month regimen of rifampicin and isoniazid, or a twice-weekly, directly observed, 6-month regimen of rifampicin and isoniazid plus pyrazinamide for the first 2 months, in Madurai, South India, Patients were followed up for 36 months after completing treatment.

Results : Of 277 enrolled patients, data was available for analysis in 268. At the end of treatment, 116 of 134 [87%; 95% confidence interval (CI) 81–93%] patients in each treatment group had a favourable clinical response; 14 (11%; 95% CI 6–16%) and 17 (13%; 95% CI 7–19%) patients had a doubtful response, and 4 (3%; 95% CI 0–6%) and 1 (1%; 95% CI 0–2%) patients had an unfavourable response among those treated with the daily and twice-weekly regimen, respectively. During 36 months after completion of treatment, five patients [2 (2%; 95% CI 1–3%) and 3 (2%; 95% CI 1–3%) patients treated with the daily and twice-weekly regimen, respectively] had relapse of lymph node tuberculosis, of 260 assessed. Adverse reactions probably attributable to the treatment regimens occurred in 1% of the patients treated daily and in 11% of those treated twice-weekly ( P < 0.001). At the end of 36 months after treatment, 126 of 134 (94%; 95% CI 90–98%) and 129 of 134 (96%; 95% CI 94–98%) of the patients treated with the daily and twice-weekly regimen, respectively, had a successful outcome.

Conclusion: Both the self-administered daily regimen and the fully observed twice-weekly regimen were highly efficacious for treating patients with lymph node tuberculosis and may be considered as alternative options to the recommended regimens.

Keywords: tuberculous lymphadenitis, lymphadenitis, clinical trial, treatment

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