New Traditional Chinese Medicine Supplement Reduces Pain Faster than Conventional Pain Pills Alone: A Phase I/II Prospective, Double-Blinded Placebo-Controlled Randomized Trial

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.Discussion 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.