Abstract

Background: Fibromyalgia is a chronic pain condition characterized by widespread pain and frequently associated symptoms such as fatigue, sleep disturbance, and cognitive complaints. Cannabinoid-based interventions have been investigated as potential options for symptom management, but the clinical evidence remains heterogeneous. Objective: To describe changes in self-reported pain intensity over 12 months among 20 women with fibromyalgia receiving a full-spectrum Cannabis sativa oral MCT-infused oil together with a topical formulation. Methods: Twenty women aged 37–65 years were observed prospectively for one year. The oral preparation contained 5% THC and 2.5% CBD, with 2.5 mg THC and 1.25 mg CBD per drop; dosing was one drop per 10 kg body weight twice daily. A topical cream containing coconut oil, shea butter, and full-spectrum Cannabis sativa MCT-infused oil was applied morning and night to painful areas, with the study protocol also including application to the nostrils, umbilical area, and vaginal area. Pain was recorded on a 0–10 scale before treatment and after 12 months. Paired analyses included the paired t-test and Wilcoxon signed-rank test. Results: Mean baseline pain was 9.15 ± 0.75 and mean pain after 12 months was 3.10 ± 0.72, corresponding to a mean reduction of 6.05 points (95% CI 5.66–6.44) and a 66.1% reduction in mean pain intensity. All 20 participants had lower pain scores at follow-up. The paired t-test showed a statistically significant within-person change (t(19) = 32.77, p < 0.001); the Wilcoxon signed-rank test also indicated a statistically significant reduction (p < 0.001). Conclusion: A substantial reduction in self-reported pain intensity was observed during the 12-month period. Because this was a small, uncontrolled, unblinded observational case series using a combined oral and topical protocol, the findings demonstrate an association over time and do not establish that Cannabis sativa caused the observed improvement. Controlled studies with standardized products, dosing, and safety monitoring, and validated multidimensional outcomes are warranted.

Keywords

fibromyalgia, Cannabis sativa, cannabinoids, THC, CBD, chronic pain, medical cannabis, observational study, case series