Six versus 12 Months of Anti Tubercular Therapy in Patients With Biopsy Proven Spinal Tuberculosis: A Single Center, Open Labeled, Prospective Randomized Clinical Trial-A Pilot study.

STUDY DESIGN

A single center pilot study, open labeled, prospective randomized clinical trial.

OBJECTIVE

To compare six versus 12 months of anti TB therapy in patients with biopsy proven spinal TB.

SUMMARY OF BACKGROUND DATA

There is no clear consensus or evidence based guidelines for the duration of treatment of spinal tuberculosis. We studied if 6 and 12 months of anti tubercular therapy (ATT) had equivalent outcomes at 24 months from completion of therapy.

METHODS

A prospective randomized open labeled clinical trial of 6 versus 12 months ATT in patients with biopsy proven spinal-vertebral tuberculosis. The primary end point was absence of recurrence 24 months after completing therapy. Secondary end points were clinical cure at the end of therapy, significant adverse effect of ATT, need for delayed surgery, and residual neurological dysfunction.

RESULTS

Hundred patients, randomized to 6 or 12 months ATT, were followed up for a minimum of 24 months from completion of therapy. All patients completed scheduled duration of ATT, with one crossover from 6 months ATT group to 12 months. There were no recurrences of disease on the 24 months follow up following completion of ATT. All 100 patients met criteria for cure at time of stopping medicines. One patient (12 months group) had residual neurological dysfunction at the time of stopping treatment, which completely resolved over the next 12 months.There were no patients with major drug induced hepatitis. One patient (12 months group) needed percutaneous drainage of an abscess. None needed surgical re-exploration for persistent infection of implant removal.

CONCLUSION

This pilot study concludes that, in patients with biopsy proven spinal-vertebral, TB, 6 and 12 months of ATT give similar clinical outcomes at 24 months of completion of therapy.

LEVEL OF EVIDENCE