Abstract：
BACKGROUND: The opioid crisis demands novel solutions for postoperative pain control. Traditional Chinese medicine (TCM) has used herbs for the treatment of pain for thousands of years. We studied whether a synergistic multimodal TCM supplement could reduce the need for conventional pain pills for low risk surgical procedures.
METHODS: In a Phase I/II, prospective, double-blind, placebo-controlled, randomized clinical trial (PRCT), 93 patients were randomized to either TCM supplement or placebo oral medication for low-risk outpatient surgical procedures. Study medications began 3 days preoperatively and continued for 5 days postoperatively. Conventional pain pill use was not restricted. Patients were monitored postoperatively for all forms of pain pill use (Pain Pill Scoring Sheet) and subjective pain ratings (Brief Pain Inventory Short Form). Primary outcomes included type and number of pain pills used and subjective pain ratings. Secondary outcomes included an assessment of mood, general activity, sleep, and enjoyment of life.
RESULTS: TCM use well tolerated. Conventional pain pill use was similar between groups. Linear regression analysis revealed that TCM reduced postoperative pain 3 times faster than placebo (P < .0001) with a 4-fold greater magnitude of relief by postoperative day 5 (P = .008). TCM also significantly improved sleep habits (P = .049) during the postoperative period. TCM effect was independent of type of surgery or amount of preoperative pain.
CONCLUSIONS: This PRCT is the first to show that a multimodal, synergistic TCM supplement is safe and can effectively reduce acute postoperative pain more rapidly, and to a lower level, than conventional pain pills alone.
METHODS: In a Phase I/II, prospective, double-blind, placebo-controlled, randomized clinical trial (PRCT), 93 patients were randomized to either TCM supplement or placebo oral medication for low-risk outpatient surgical procedures. Study medications began 3 days preoperatively and continued for 5 days postoperatively. Conventional pain pill use was not restricted. Patients were monitored postoperatively for all forms of pain pill use (Pain Pill Scoring Sheet) and subjective pain ratings (Brief Pain Inventory Short Form). Primary outcomes included type and number of pain pills used and subjective pain ratings. Secondary outcomes included an assessment of mood, general activity, sleep, and enjoyment of life.
RESULTS: TCM use well tolerated. Conventional pain pill use was similar between groups. Linear regression analysis revealed that TCM reduced postoperative pain 3 times faster than placebo (P < .0001) with a 4-fold greater magnitude of relief by postoperative day 5 (P = .008). TCM also significantly improved sleep habits (P = .049) during the postoperative period. TCM effect was independent of type of surgery or amount of preoperative pain.
CONCLUSIONS: This PRCT is the first to show that a multimodal, synergistic TCM supplement is safe and can effectively reduce acute postoperative pain more rapidly, and to a lower level, than conventional pain pills alone.
摘要：
背景：阿片类药物危机需要新的术后疼痛控制解决方案。传统中药（TCM）使用草药治疗疼痛已有数千年的历史。我们研究了协同多模式中药补充剂是否可以减少低风险外科手术对常规止痛药的需求。
方法：在I/II阶段，prospective,双盲,安慰剂对照,随机临床试验（PRCT），93例患者被随机分为中药补充剂或安慰剂口服药物，用于低风险门诊外科手术。研究药物在术前3天开始，术后持续5天。常规止痛药的使用不受限制。术后监测患者的所有形式的止痛药使用（止痛药评分表）和主观疼痛评分（简短疼痛清单简表）。主要结果包括使用的止痛药的类型和数量以及主观疼痛评分。次要结果包括情绪评估，一般活动,睡眠,和生活的享受。
结果：中药使用耐受性良好。两组之间的常规止痛药使用情况相似。线性回归分析显示，中医减轻术后疼痛的速度比安慰剂快3倍（P<0.0001），术后第5天缓解幅度大4倍（P=0.008）。中医在术后期间也显著改善了睡眠习惯(P=.049)。中医疗效与手术类型和术前疼痛程度无关。
结论：本PRCT首次表明，中药协同补充是安全的，可以更迅速地有效减轻术后急性疼痛，到较低的水平，而不仅仅是传统的止痛药。
方法：在I/II阶段，prospective,双盲,安慰剂对照,随机临床试验（PRCT），93例患者被随机分为中药补充剂或安慰剂口服药物，用于低风险门诊外科手术。研究药物在术前3天开始，术后持续5天。常规止痛药的使用不受限制。术后监测患者的所有形式的止痛药使用（止痛药评分表）和主观疼痛评分（简短疼痛清单简表）。主要结果包括使用的止痛药的类型和数量以及主观疼痛评分。次要结果包括情绪评估，一般活动,睡眠,和生活的享受。
结果：中药使用耐受性良好。两组之间的常规止痛药使用情况相似。线性回归分析显示，中医减轻术后疼痛的速度比安慰剂快3倍（P<0.0001），术后第5天缓解幅度大4倍（P=0.008）。中医在术后期间也显著改善了睡眠习惯(P=.049)。中医疗效与手术类型和术前疼痛程度无关。
结论：本PRCT首次表明，中药协同补充是安全的，可以更迅速地有效减轻术后急性疼痛，到较低的水平，而不仅仅是传统的止痛药。
