Abstract
Objective
This study aims to evaluate and compare the outcomes of two antitubercular chemotherapy regimen prescribed for 9 months (group A) and 12 months (group B) on patients with Potts spine without neurological deficit.
Study Design
A prospective study in which 59 patients were included, who were prescribed either of the regimes. The outcome measures were noted immediately after the completion of the treatment, at 6 and 12 months. The variables were evaluated on the basis of clinical, hematological, and radiological criteria, which included pain, Hb, ESR, CRP, and kyphotic angle. A mixed model ANOVA was used to compare group A and group B across different times of assessment (0, 6, and 12 months posttreatment) for each variable separately. The level of significance was p < 0.05. Also, the differences from baseline at 6 and 12 months were compared across groups. As the data were not normally distributed, Mann Whitney U test was used. The p value was adjusted for multiple comparisons to be less than 0.05/2 or 0.025.
Result
Both the groups were demographically comparable. Pain (ODI) was found to be improved in both the groups, but on comparison 12-month regime was found to have reduced pain scores than 9-month regime during 6-month follow-up (ODI: group A 19.2 and group B 17.3) but in the 12-month follow-up showed no statistical difference in pain score (ODI: group A 13.9 and group B 12.6). There was no neurological deterioration in both groups. CRP improved in both the groups (group A 7.31 and group B 7.03) and no statistical significant difference was found between the two regimes. There was an increment in Hb levels and kyphotic angle in both the groups, but the comparison could not be drawn between the two groups for both the variables as baseline values were not comparable whereas ESR reduced in both the groups but because of the significant difference at baseline, none of the groups could be compared. To make the groups comparable, a nonparametric analysis was used which showed a statistically significant deterioration of kyphotic angle in group A (0.6 degree) than in group B (0.2 degree) at the end of 1-year follow-up, but it was not found to be significant clinically. Also, statistically significant results were obtained for Pain scores with better improvement of pain with –group A than group B (group A 14 and group B 10) but again the improvement was clinically nonsignificant.
Conclusion
After 1-year follow-up of patients who had completed their antitubercular treatment, we can conclude that there was no additional benefit of prescribing antitubercular therapy for 12 months over 9 months in patients of Potts spine (1 or 2 level) without any neurological deficit. Long-term follow-up is needed to further establish the advantage of 9-month regime over 12-month regime.