The effect of the combination of Malva sylvestris L. and Althaea digitata Boiss. on prevention of acute radiation proctitis in patients with prostate cancer

The effect of a combination of Malva sylvestris and Althaea digitata flower powder in prevention of acute radiation proctitis was assessed in patients undergoing radiation therapy (RT) for prostate cancer. This double-blind randomized controlled study was conducted at three centers in Iran. Before starting RT, patients (N = 65) received a 4 g packet of flower powder or placebo to use 3 times a day as an infusion from the first day of RT and for five consecutive weeks including the three weeks of RT. They were visited by a physician 3 times during this period. Acute morbidity was classified according to the Radiation Therapy Oncology Group (RTOG) criteria. Severity of proctitis symptoms was assessed by Visual Analog Scale (VAS) with 10 points. Non-statistical significant differences were observed between the groups in relation to RTOG grade criteria (grade 0: drug 22.8% (N = 8), placebo 10% (N = 3), difference 12.8%; grade 1: drug 65.8%, placebo 64.4%, difference 1.4%; grade 2: drug 11.4% (N = 8), placebo 26.6% (N = 4), difference 15.2%. (P = .059)) According to VAS, the most common complaint was anal burning and diarrhea in the flower powder group showing a significant decrease in these symptoms at the end of the study as compared to the placebo; flower powder (1.56 +/- 1.07) vs placebo (3.82 +/- 1.67) for burning (P < .05) and flower powder (1.06 +/- 0.58) vs placebo (1.95 +/- 0.79) for diarrhea (P = .046). The flower powder prevented anal discomfort and diarrhea induced by prostate radiotherapy, although there were no significant differences between the two groups in RTOG. No serious side effects were reported, so the combination could be suggested for patients who cannot tolerate symptoms of proctitis after further studies.