| Disease | A PROSPECTIVE COHORT STUDY AIMED TO EVALUATE THE CLINICAL EFFICACY OF A SPECIFIC VASOACTIVE HERBAL FORMULA, HUO XUE TONG LUO CAPSULE (HXTL CAPSULE 18 GM PER DAY) [CONTAINING CAJAN LEAF, ANGELICA SINENSIS, RED PEONY, LIGUSTICUM WALLICHII, PEACH KERNEL, CARTHAMUS TINCTORIUS AND RADIX REHMANNIAE] FOR THE TREATMENT OF PATIENTS WITH ASYMPTOMATIC OSTEONECROSIS OF FEMORAL HEAD (ONFH). 55 PATIENTS (59 HIPS) WITH ASYMPTOMATIC ONFH (NO JOINT COLLAPSE) WERE EVALUATED BY STEINBERG STAGING SYSTEM AND NECROSIS RANGE CLASSIFICATION CRITERIA. THEN, THEY WERE GIVEN HXTL CAPSULE UNDER SPECIFIC PROTOCOL. AMONG THEM, 39 MALES AND 16 FEMALES WITH AN AVERAGE AGE OF 36.4 YEARS WERE FOLLOWED UP FOR AN AVERAGE OF 4.38 YEARS DURING TREATMENT. THE AGGRAVATION OF CLINICAL AND IMAGING RESULTS WAS ASSESSED BY INITIAL PAIN AND JOINT COLLAPSE. THE CLINICAL AND IMAGING OUTCOMES OF THESE PATIENTS WERE COMPARED WITH THOSE OF A HISTORICAL CONTROL GROUP FROM THE LITERATURE UNDER CRITICAL INCLUSION CRITERIA. RESULTS: AT THE LATEST FOLLOW-UP, INITIAL PAIN OCCURRED IN FIVE OF 59 (8.5%) HIPS OF PATIENTS TAKING HXTL CAPSULE COMPARED WITH 31 OF 81 (38.3%) CONTROLS (P < 0.001), AND JOINT COLLAPSE OCCURRED IN 13 OF 59 (22.0%) HIPS OF PATIENTS TAKING HXTL CAPSULE COMPARED WITH 26 OF 81 (32.1%) CONTROLS (P < 0.001). THERE WAS NO ASSOCIATION BETWEEN JOINT COLLAPSE AND MULTIPLE KEY FACTORS OF ONFH. ONLY THE LOCATION OF TYPE C2 NECROTIC LESIONS AND THE EXTENT OF LARGE NECROTIC LESIONS PREDICTED JOINT COLLAPSE. |