A prospective, randomized controlled trial of sanguisorba oil in the treatment of tamoxifen-related vaginitis in breast cancer patients

Objective: To evaluate the clinical efficacy of sanguisorba oil in the treatment of tamoxifen-related (TAM) vaginitis in breast cancer patients. Methods: This prospective, randomized controlled trial (from April 2012 to April 2015) included 112 breast cancer patients with TAM-related vaginitis. Patients were randomized 1:1 to the sanguisorba oil group or control group. Patients in the sanguisorba oil group were treated with conventional basic therapy followed by 2g sanguisorba oil for external application after cleaning the vulva in the morning and at night, while patients in the control group were treated with conventional basic therapy alone. Clinical symptom score and curative effect evaluation were collected at two time points (e.g. before treatment and after 7 days at end of treatment). All the data were calculated by using SPSS17.0 software. Results: The clinical symptom score between two groups was not statistically significant before treatment (P 0.05). After treatment, however, the sanguisorba oil group had a better clinical symptom score compared to control group (P 0.05). In addition, the main symptoms in the sanguisorba oil group including colpoxerosis, vaginal itching or burning, frequency, urgency or urodynia were largely alleviated after 10 days of treatment (P 0.05). No significant difference of clinical symptom score was found in control group after treatment (P 0.05). The clinical cure rate of the sanguisorba oil group and the control group were 7.1% and 0%, respectively, with significant difference (P 0.05). No adverse reaction was found during the treatment process in the two groups. Conclusions ： Taken together, external use of sanguisorba oil was effective in the treatment of TAM-related vaginitis and/or urinary irritation in breast cancer patients. With the advantage of convenience, safety and low price, sanguisorba oil treatment improves the compliance of breast cancer patients with TAM-related vaginitis, and should be promoted in clinical practice for oncologists.