암성통증에 대한 SBVP 효과-무작위대조시험, 이중맹검
The Effect of Sweet Bee Venom Pharmacopuncture (SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study
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Objective : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale (NRS) (0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B (SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP (1ml/day) for group A and Normal Saline Placebo (1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan (CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale (NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests (independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group (2.48±1.52 vs 0.97±1.88, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant (5.13±1.77 vs 2.65±0.67, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusions : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.
Abstract
Objective : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale (NRS) (0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B (SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP (1ml/day) for group A and Normal Saline Placebo (1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan (CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale (NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests (independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group (2.48±1.52 vs 0.97±1.88, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant (5.13±1.77 vs 2.65±0.67, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusions : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.
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