Effectiveness of Phlai Mixed Cannabis Leaf Oil for The Treatment of Chronic Pain in Elderly Patients: A Double-Blind Randomized Controlled Trial
Mathawee Luplipon, Nitikorn Phoosuwan, Manop Chalachtunyakiti,
Sasipong Tipratchadaporn, Worranan Rangsimawong, Sribud Srichaijaroonpong
This study investigated the effectiveness of a traditional Thai herbal remedy, Phlai (Zingiber montanum), combined with Cannabis Leaf Oil (PMCL), in relieving pain in elderly individuals. The goal was to compare its efficacy with that of conventional treatment, specifically topical diclofenac, for chronic pain relief, and to determine whether PMCL is non-inferior to topical diclofenac. In a randomized trial, participants aged 60–75 years with chronic neck, shoulder, or back pain were assigned to receive either PMCL or topical diclofenac using a randomized method. The primary endpoint of the study was to compare pain intensity reduction between the two groups using a Numerical Rating Scale (NRS) for up to 14 days after treatment. The study ensured that the person measured the NRS and the participants were blinded. Of these 80 participants, 73 completed the study. The primary endpoint measurements were taken at 30 min and on days 1, 3, 7, and 14 in both groups receiving medication. The Mann-Whitney U test revealed no significant differences in the NRS scores between the two medication groups. Non-inferiority was assessed by analyzing the median difference in pain-NRS of the two study groups using the Hodges-Lehmann estimator, with a non-inferiority margin of 0.84, which indicated that the median difference (with a 95% confidence interval) was -1.5 (-3.0 to - 0.5), falling within the non-inferiority range. This shows that PMCL is given to PMCL, meaning that it is non-inferior to topical diclofenac in reducing pain. No differences were observed between the two medication groups regarding adverse drug reactions; therefore, PMCL exhibited efficacy in alleviating chronic pain in the elderly, similar to topical diclofenac, without any significant adverse reactions. These findings indicate that PMCL may be a feasible and equally effective option for pain control in the elderly.
Keywords: Cannabis sativa, Zingiber montanum, Phlai, Elderly, Randomized controlled trial, Non-inferiority trial
