In two centres in Korea 350 patients with a diagnosis of
tuberculosis of the thoracic and/or lumbar spine were allocated at random: in
Masan to in-patient rest in bed (IP) for six months followed by out-patient treatment or to ambulatory out-patient treatment (OP) from the start; in Pusan to out-patient treatment with a
plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J). All patients recieved
chemotherapy with PAS with
isoniazid for eighteen months, either supplemented with
streptomycin for the first three months (SPH) or without this supplement (PH), by random allocation. The main analysis of this report concerns 299 patients (eighty-three IP, eighty-three OP, sixty-three J, seventy No J; 143 SPH, 156 PH). Pre-treatment factors were similar in both centres except that the patients in Pusan had, on average, less extensive lesions although in a greater proportion the disease was radiographically active. One patient (J/SPH) died with active
spinal disease and three (all No J/SPH) with
paraplegia. A fifth patient (IP/PH) who died from cardio
respiratory failure also had
pulmonary tuberculosis. Twenty-three patients required operation and/or additional
chemotherapy for the spinal lesion. A sinus or clinically evident
abscess was either present initially or developed during treatment in 41 per cent of patients. Residual lesions persisted in ten patients (four IP, two OP, one J, three No J; six SPH, four PH) at five years. Thirty-two patients had
paraparesis on admission or developing later. Complete resolution occurred in twenty on the allocated regimen and in eight after operation or additional
chemotherapy or both. Of the remaining four atients, all of whom had operation and additional
chemotherapy, three died and one still had
paraparesis at five years. Of 295 patients assessed at five years 89 per cent had a favourable status. The proportions of the patients responding favourably were similar in the IP (91 per cent) and OP (89 per cent) series, in the J (90 per cent) and No J (84 per cent) series and in the SPH (86 per cent) and PH (92 per cent) series.