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

Jawahar, M S and Rajaram, K and Sivasubramanian, S and Paramasivan, C N and Chandrasekar, K and Kamaludeen, M N and Thirithuvathas, A J and Ananthalakshmi, V and Prabhakar, R (2005) Treatment of lymph node tuberculosis – a randomized clinical trial of two 6-month regimens. Tropical Medicine and International Health, 10 (11). pp. 1090-1098. ISSN Print: 1360-2276; Online: 1365-3156

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Abstract

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 twodrug 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 twiceweekly, 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.

Item Type:	Article
Uncontrolled Keywords:	tuberculous lymphadenitis, lymphadenitis, clinical trial, treatment
Subjects:	Tuberculosis > Clinical Research
Divisions:	Clinical Research
Depositing User:	Dr. Rathinasabapati R
Date Deposited:	27 Nov 2013 09:28
Last Modified:	09 Mar 2016 07:07
URI:	http://eprints.nirt.res.in/id/eprint/698

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