| Disease | MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL, PLACEBO-CONTROLLED CLINICAL TRIAL. 130 CASES WITH MALIGNANT TUMORS AT MIDDLE OR ADVANCED STAGE, AND EXPERIENCING MODERATE OR SERIOUS CANCER SOMATALGIA INDUCED BY BONE METASTASIS OR TUMOR INVASION AND WERE RANDOMLY ALLOCATED TO RECEIVE EITHERTONGKUAIXIAO OINTMENT (TKXO) OR PLACEBO TREATMENT, WITH OPIOID ANALGESICS ORALLY ADMINISTRATED CONCURRENTLY. TKXO IS COMPOSED OF YANHUSUO (RHIZOMA CORYDALIS YANHUSUO), WUYAO (RADIX LINDERAE AGGREGATAE), JIANGHUANG (RHIZOMA CURCUMAE LONGAE), ZIRANTONG (PYRITUM), BAIJIEZI (SEMEN SINAPIS) AND BINGPIAN (BORNEOLUM SYNTHETICUM). TKXO (10 G PER DAY) WAS APPLIIED TO THE SITE OF TENDERNESS (5 CM × 5 CM), WITH 5 DAYS TAKEN AS ONE TREATMENT COURSE. PLACEBO WAS SIMILAR IN SHAPE, COLOR, CONSISTENCY AND ODOR. OBSERVATION PARAMETERS WERE NUMERICAL RATING SCALE (NRS) SCORES,
ANALGESIC EFFICACY, INITIATION EFFECTIVE TIME, PERSISTENT ANALGESIC TIME, EQUIVALENT MORPHINE DOSE, NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) GRADE IN IMPACT OF PAIN MEASUREMENT SCORES, AND SAFETY AND SATISFACTION EXTENT INVESTIGATION. RESULTS: NRS SCORES AND NCCN GRADE IN IMPACT OF PAIN MEASUREMENT SCORES DECREASED SIGNIFICANTLY AFTER 5-DAYS' TREATMENT IN THE TWO GROUPS (P < 0.0001). COMPARED TO THE CONTROL GROUP, INITIATION
EFFECTIVE TIME WAS SIGNIFICANTLY SHORTER (P < 0.05) AND PERSISTENT ANALGESIC TIME WAS SIGNIFICANTLY LONGER (P < 0.01), EQUIVALENT ORAL MORPHINE DOSES OF THE FIRST DAY AND THE WHOLE TREATMENT COURSE WERE SIGNIFICANTLY DECREASED IN THE TKXO TREATMENT GROUP (P < 0.01 OR P < 0.05). NO OBVIOUS ADVERSE EFFECTS WERE FOUND IN THE TKXO GROUP. CONCLUSION: TKXO COMBINED WITH OPIOID ANALGESICS POSSESSES THE ADVANTAGES OF HIGH EFFICACY, FAST ACTION, LONG PERSISTENT ACTION, SAFETY AND CONVENIENCE IN USE, AND IT CAN REDUCE THE DOSE OF OPIOID. |