A 15-year assessment of controlled trials of the management of tuberculosis of the spine in Korea and Hong Kong. Thirteenth Report of the Medical Research Council Working Party on Tuberculosis of the Spine.

The final results up to 15 years are reported of clinical trials of the management of tuberculosis of the spine in Korea and Hong Kong. In Korea, 350 patients with active spinal tuberculosis were randomised to ambulatory chemotherapy or bed rest in hospital (in Masan) or a plaster-of-Paris jacket for nine months (in Pusan). Patients in both centres were also randomised to either PAS plus isoniazid for 18 months or to the same drugs plus streptomycin for the first three months. In Hong Kong, all 150 patients were treated with the three-drug regime and randomised to either radical excision of the spinal lesion with bone graft or open debridement. On average, the disease was more extensive in Korea, but at 15 years (or 13 or 14 years in a proportion of the patients in Korea) the great majority of patients in both countries achieved a favourable status, no evidence of CNS involvement, no radiological evidence of disease, no sinus or clinically evident abscess, and no restriction of normal physical activity. Most patients had already achieved a favourable status much earlier. The earlier results of these trials are confirmed by the long-term follow-up with no late relapse or late-onset paraplegia. The results of chemotherapy on an outpatient basis were not improved by bed rest or a plaster jacket and the only advantage of the radical operation was less late deformity compared with debridement. A second series of studies has shown that short-course regimes based on isoniazid and rifampicin are as effective as the 18-month regimes: ambulatory chemotherapy with these regimes should now be the main management of uncomplicated spinal tuberculosis.

RCT Entities:   Population Interventions Outcomes