| Objective: To observe the analgesic benefit and improvement of the quality of life(QOL) in the patients with moderate or -severe cancer pain treated with external Traditional Chinese Medicine(TCM) (zhentong I ) plus analgesic guidelines based on 3-step ladder.Methods: Fifty patients eligible for the study were randomizely assigned into two groups: TCM + opioids group (TG) and opioids group (OG). All the patients in TG were administrated with the external TCM according to the pain regions for several times in order to release pain, and the patients with moderate cancer pain (4 ≦ VAS<7) were added tramadol, individualized, the patients with severe cancer pain (7 = VAS) were added MS CONTIN or Fentanyl Transdermal System, individualized. The patients in OG were treated with the analgesic guidelines according to the VAS alone as same as the patients in TG. The visual analogue scale (VAS) and quality of life were documented and compared. Results: Fifty patients entered the study, in which 25 assigned into TG were added the external TCM. All of them have finished the observe period. A: the analgesic efficacy : (1) The mean pain scores of TG VS OG were decreased to 5. 36 ± 1.00 vs 5.14±1.29, 4.48 ± 1.01 vs 4.40±1.06, 4.18 ± 1.11 vs 4.23±1.04, 3.05+1.21 vs 3.38 + 1.00, respectively, on the day 1, 2, 3, 7. There was no statistically significant difference between the two groups at each observation point of time. (2) The weighted value of VAS was assessed to evaluate the efficacy. On the day 3, 7, NR, MR, PR and CR in the ratio of TG vs OG were 0:16:9:0 vs 1:22:2:0, 0:4:17:4 vs 1:9:19:0 respectively, and the general effective rate were 100% vs96%, 100% vs96% respectively. There were statistically significant differences between the two groups on the day 3 and 7. (3) On the day 3, 7, the response of patients with moderate pain: NR,MR, PR and CR in the ratio of TG vs OG were 0:7:4:0 vs 0:12:0:0, 0:2:6:3 vs 0:6:6:0 respectively, the efficacy of TG were better than OG on day 3 and 7. The response of patients with severe pain: NR, MR, PR and CR in the ratio of TG vs 0G were 0:9:5:0 vs 1:10:2:0, 0:3:10:1 vs 1:2:10:0 respectively, there was no significant difference between the two groups at each observation point of time. B: ?The mean of QOL of TG vs 0G were increased to 39. 80±2. 90 vs 37.80 + 3.68, 41.80 + 2.86 vs 40. 12 + 3. 74, respectively on the day 3, 7. The difference of QOL was significant on the day 3, and there was no difference between the two groups on day 7. ?The differences of QOL between each two of the day 0(before treatment), 3d and 7d were compared(TG vs 0G): 3d-0d: 1.88 + 0.83 re 1.08 + 1.03, 7d~0d: 3.88 + 0.83 re3.40±1.03, 7d-3d: 2.87± 0.83 vs 2.32 + 1.03. The patients in TG could obtain the better QOL earlier. ?The mean of KPS of TG vs 0G were 70. 4 + 9. 78 re 64. 0± 12. 91, 72.8+10.61 vs 64. 4+13. 87, respectively on the day 3, 7. The difference of QOL was significant on the day 7, and there was no difference on day 3.Conclusion: .l.The external TCM plus the analgesic guidelines based on 3-step ladder had a synergetic effect in pain relief. There was a trend the patients added the external TCM could gain the stable pain relief earlier and easier. 2. The patients with moderate pain could obtain better efficacy in TG than 0G. 3. The external TCM plus the analgesic guidelines based on 3-step ladder was more effective on improving the QOL. There was a tendency that the patients treated with the external TCM could obtain the stable improvement of QOL much earlier and easier.
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