Prednisolone: a beneficial and safe adjunct to antituberculosis treatment?A randomized controlled trial

SETTING: A referral centre for thoracic diseases in Izmir, Turkey 1992-1995 . OBJECTIVE: To appraise the adjunctive role of prednisolone (PN) in pulmonar y tuberculosis (PTB) with toxic reactions. DESIGN: After excluding other febrile causes, and 2 weeks of four/five-drug antituberculosis therapy insufficient to resolve toxic reactions, 178 huma n immunodeficiency virus (HIV) negative patients with advanced PTB causing persistent high-grade fever (greater than or equal to 38 degrees C), weight loss (greater than or equal to 2 kg/week) and/or low serum albumin levels (<3 g/dL) were randomly allocated to receive either a 12-month course of an tituberculosis treatment using four first-line drugs and PN (20 mg b.i.d. I V/IM initially, decreasing over 40 days) (91 patients-PN group), or 12 mont hs of antituberculosis treatment only (87 patients-CO group). Twice-weekly sputum bacillary count, temperature recorded every 6 hours, weekly weight, serial albumin level and liver function measurements and chest roentgenogra ms were used to assess the effects of PN on PTB. RESULTS: Temperature decreased from 39.1 +/- 0.9 degrees C to 37.9 +/- 0.7 degrees C (P = 0.0030) within the first 72 (+/-9) hours in those patients o n PN treatment, whereas a gradual decline occurred over 22 (+/-3) days in t he CO group. In the PN group, patients' weight increased from 49.7 +/- 4.8 kg to 56.9 +/- 8.3 kg, compared to 47.1 +/- 6.4 kg to 51.3 +/- 5.9 kg in th e CO group (P = 0.0022). Increases in serum albumin levels in the PN and CO groups were from 2.26 +/- 0.8 g/dL to 3.32 +/- 0.6 g/dL and from 2.31 +/- 0.5 g/dL to 2.90 +/- 0.7 g/dL, respectively (P = 0.0035). The radiographic regression and drop in bacillary count were more rapid, and the hospital st ay shorter (53.4 +/- 3.1 days vs 71.3 +/- 5.6 days) in the PN group, althou gh there were no differences in the acid-fast bacilli conversion rates. The re were no detrimental side effects and relapses attributable to PN during the 1-3 year follow-up, even in 18 cases with drug resistance. CONCLUSION: Prednosolone is a beneficial and safe adjunct to 12-month antit uberculosis treatment in advanced PTB causing toxic reactions, provided tha t close clinical, radiographic and bacillary monitoring is exercised.