Evidence map›Paper›PMID 32404169›Full record

Trial reportBMC complementary medicine and therapies2020

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

Adeleh Sahebnasagh, Arash Ghasemi, Jafar Akbari, Abbas Alipour, Hossein Lashkardoost, Shahram Ala, Seyed Jalal Hosseinimehr, Ebrahim Salehifar

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary medicine and therapies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06837597 (Jianzhong Qushi Formula for Treating Chronic Radiation Induced Proctitis), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06837597 phase3not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Jianzhong Qushi Formula for Treating Chronic Radiation Induced Proctitis : a Multicenter, Prospective, Randomized Controlled Clinical Trial

TypeinterventionalSponsorCancer Institute and Hospital, Chinese Academy of Medical SciencesRan2025 to 2029Enrolled168ConditionsChronic Radiation ProctitisArmsJianzhong Qushi Formula, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Radiation proctitis as a differential of lower GIT bleeding in Nigeria: A case series.Nigerian medical journal : journal of the Nigeria Medical Association
    Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Adeleh SahebnasaghClinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran.
Arash GhasemiEmam Khomeini Hospital, Mazandaran University of Medical Sciences, Sari, Iran.
Jafar AkbariPharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Abbas AlipourEpidemiology, Faculty of Medicine, Community medicine Department, Mazandaran University of Medical Sciences, Sari, Iran.
Hossein LashkardoostSchool of Public Health, North Khorasan University of Medical Sciences, Bojnurd, I.R, Iran.
Shahram AlaPharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Seyed Jalal HosseinimehrDepartment of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Ebrahim SalehifarGastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. salehifare@yahoo.com.ORCID http://orcid.org/0000-0001-8162-6950
Mazandaran University of Medical Sciences · IRNorth Khorasan University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute 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.

methodsForty-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.

resultsThe 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).

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

trial registrationIRCT201606042027N6. Registration date: 2016-09-04.

Indexed as

AloeAgedC-Reactive ProteinDouble-Blind MethodFemaleHumansIranMaleMiddle AgedOintmentsPelvic NeoplasmsPlant PreparationsProctitisProspective StudiesQuality of LifeRadiation InjuriesC-Reactive ProteinOintmentsPlant PreparationsAcute radiation ProctitisAloe veraComplicationsPelvic neoplasmsPrevention

Identifiers

PMID32404169
PMCPMC7222341
OpenAlexW3024582975

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.