Indian J Med Res. 1991 Jun;94:177-85.
This paper reports the results of a multicentric, randomized controlled trial to evaluate the efficacy of Kshaarasootra (Ayurvedic medicated thread) in the management of fistula-in-ano, in comparison with conventional surgery. This trial was carried out at Bombay, Chandigarh, New Delhi and Wardha. Complete healing was noted in all 265 patients in the Kshaarasootra series and all 237 patients in the surgery series. The median healing time was, however, significantly longer in the Kshaarasootra series (8 wk) than in the surgery series (4 wk). In both the series, the healing time was least for subcutaneous fistula and highest in the case of high anal fistula. Patients in both the series are being followed up for one year after the completion of treatment, and the recurrence rates, based on 150 patients in each series are 4 per cent in the Kshaarasootra series and 11 per cent in the surgery series, a significant difference (P = 0.03). Transient local burning and increased discharge from the fistulous opening were observed in most patients treated with Kshaarasootra. Mild anal incontinence was observed in 8 patients treated with Kshaarasootra and 13 patients treated with surgery. It is concluded that the long-term outcome with Kshaarasootra is better than with surgery, although the initial healing time is longer. Kshaarasootra thus offers an effective, ambulatory and safe alternative treatment for patients with fistula-in-ano. It also constitutes a new drug delivery technique for conditions like anal fistula.
本文报告了一项多中心随机对照试验的结果，该试验旨在评估克夏拉索特拉（一种阿育吠陀药线）与传统手术相比在肛瘘治疗中的疗效。该试验在孟买、昌迪加尔、新德里和沃尔哈进行。克夏拉索特拉组的265例患者和手术组的237例患者均实现了完全愈合。然而，克夏拉索特拉组的中位愈合时间（8周）显著长于手术组（4周）。在两组中，皮下瘘的愈合时间最短，高位肛瘘的愈合时间最长。两组患者在治疗完成后均接受了一年的随访，基于每组150例患者，克夏拉索特拉组的复发率为4%，手术组为11%，差异有统计学意义（P = 0.03）。在大多数接受克夏拉索特拉治疗的患者中观察到短暂的局部烧灼感和瘘口分泌物增加。在接受克夏拉索特拉治疗的8例患者和接受手术治疗的13例患者中观察到轻度肛门失禁。结论是，尽管克夏拉索特拉的初始愈合时间较长，但其长期疗效优于手术。因此，克夏拉索特拉为肛瘘患者提供了一种有效、非卧床且安全的替代治疗方法。它还构成了一种用于肛瘘等病症的新药物递送技术。
