Effects of Chicory and Fumitory on Hot Flashes Among Breast Cancer Survivors: A Randomized, Double-Blind Placebo-Controlled Trial.

Objectives: Hot flashes are unpleasant long-term complications of breast cancer. This study aimed to evaluate the effects of a traditional Persian medicine containing extracts of Cichorium intybus L. (chicory) and Fumaria parviflora L. (Fumitory) extract syrup (CFS) compared with placebo when used as intended. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting/Location: The Oncology Ward of Shahid Modarres Hospital (Tehran, Iran). Subjects: Breast cancer survivors undergoing hormone deprivation therapy. Interventions: Patients were randomly allocated to receive 5 mL CFS or placebo syrup three times a day, for 4 weeks. Outcome measures: The co-primary outcomes were self-reported daily hot flashes frequency and severity scores assessed using self-reported daily dairies, including 1 week of baseline data. Results: Of the 148 patients screened, 137 were eligible, and 96 were randomly allocated to receive either CFS (n = 48) or placebo (n = 48). All participants who returned their dairies were compliant and analyzed as randomized in the a priori per-protocol analysis. After 4 weeks of treatment, both the mean daily hot flashes frequency and severity score had reduced by 57% in the CFS group and 10% in the placebo group. The overall weekly mean daily hot flashes frequency (effect size ηp2 0.221, p < 0.001, n = 66) and severity scores (effect size ηp2 0.160, p = 0.001, n = 66) were significantly lower in the CFS group compared with the placebo group (one-within one-between repeated-measures analysis of variance adjusted for baseline). CFS was well tolerated, with similar proportions of serious and nonserious adverse events occurring in both groups. Conclusions: This is the first study to report the effects of chicory or fumitory for the treatment of hot flashes. The findings provide preliminary evidence that CFS can improve hot flashes in breast cancer survivors undergoing hormone deprivation therapy. More research is warranted to confirm its effectiveness, safety, and mechanisms of action. Clinical Trial Registration: IRCT20210226050506N1.

Efficacy of topical Citrullus colocynthis (bitter apple) extract oil in chemotherapy-induced peripheral neuropathy: A pilot double-blind randomized placebo-controlled clinical trial.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common complications in patients with cancer. Citrullus colocynthis (bitter apple) has been used in traditional Persian medicine as an effective pain relief, especially for neuralgia. We designed a pilot clinical trial to evaluate the safety and efficacy of topical C. colocynthis oil in management of CIPN in breast cancer patients. Thirty-four cancer patients with CIPN were randomly enrolled in two arms of a randomized, double-blind, placebo-controlled clinical trial. The patients were treated by topical C. colocynthis oil or placebo, two times per day for 2 months. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) score was set as the primary outcome measure. No significant improvement was observed in the total score of FACT/GOG-Ntx scale (2.40 ± 1.90 vs. 1.05 ± 1.36, p = .879) in drug and placebo groups, respectively. There was also no significant improvement in the mean scores of FACT/GOG-Ntx in the sensory, motor, hearing, and functional domains in the two study groups. According to the results of this preliminary study, topical C. colocynthis oil failed to improve the symptoms of CIPN compared with placebo.