Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients.

Abstract

BACKGROUND:

Acute radiation-induced proctitis (ARP) is the most common side effect following radiotherapy for malignant pelvic disease. This study evaluated the efficacy of Aloe vera ointment in prevention of ARP.

METHODS:

Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. These patients were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured.

RESULTS:

The results of present study demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhea (p < 0.001), rectal bleeding (p < 0.001), and fecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).

CONCLUSION:

This study showed that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.

TRIAL REGISTRATION:

IRCT201606042027N6. Registration date: 2016-09-04.

• Authors: Adeleh Sahebnasagh, Arash Ghasemi, Jafar Akbari, Abbas Alipour, Hossein Lashkardoost, Shahram Ala, Seyed Jalal Hosseinimehr, Ebrahim Salehifar
• Journal: BMC complementary medicine and therapies (BMC Complement Med Ther) Vol. 20 Issue 1 Pg. 146 (May 13 2020) ISSN: 2662-7671 [Electronic] England
• PMID: 32404169 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Ointments
• Plant Preparations
• C-Reactive Protein

Topics

• Aged
• Aloe
• C-Reactive Protein (analysis)
• Double-Blind Method
• Female
• Humans
• Iran
• Male
• Middle Aged
• Ointments (therapeutic use)
• Pelvic Neoplasms (radiotherapy)
• Plant Preparations (therapeutic use)
• Proctitis (prevention & control)
• Prospective Studies
• Quality of Life
• Radiation Injuries (prevention & control)
• Radiotherapy (adverse effects)
• Surveys and Questionnaires