Background
Materials and methods
Aloe vera
Preparation and formulation of Aloe vera ointment
Study design
Primary endpoint
Radiation treatment
Secondary endpoints
Sample size, study and statistical analysis
Ethics
Results
Participants
Characteristics | Aloe (n = 19) | Placebo (n = 23) |
---|---|---|
Age, mean ± SD (absolute range), y | 61.5 ± 13.1 | 63.3 ± 11.8 |
Male sex, No. (%) | 11 (57.9%) | 16 (69.6%) |
BMI, mean (SD), kg/m2 | 25.8 ± 3.2 | 25.3 ± 2.8 |
Dose of radiotherapy in each session, cGy | 181.5 ± 4.8 | 186.3 ± 9.3 |
Total dose of radiotherapy received, cGy | 5944.4 ± 1157.9 | 5721.7 ± 1111.2 |
Concomitant medication, No(%) | ||
NSAIDs | 1 (5.3) | 1 (4.3) |
Opioid | 2 (10.5) | 1 (4.3) |
Anticholinergic | 0 (0) | 2 (8.7) |
Alpha Blocker | 2 (10.5) | 2 (8.7) |
Cardiovascular | 10 (52.6) | 8 (34.8) |
Condition, No(%) | ||
HTN | 7 (36.8) | 6 (26.1) |
Diabetes | 4 (21.05) | 8 (34.8) |
Dyslipidemia | 2 (10.5) | 4 (17.4) |
IHD | 2 (10.5) | 2 (8.7) |
Pelvic Surgery | 4 (21.05) | 7 (30.4) |
Effect of Aloe vera rectal ointment on symptoms
Week | Effect | ||||
---|---|---|---|---|---|
1 Median (Q1,Q3)a | 6 Median (Q1,Q3)a | Within group | Between group | ||
Rectal Bleeding | Aloe vera | < 0.001 (< 0.001- < 0.001) | < 0.001 (< 0.001- < 0.001) | 0.55 | < 0.001 |
Placebo | < 0.001 (< 0.001- < 0.001) | < 0.001 (< 0.001–1) | 0.04 | ||
Rectal Pain | Aloe vera | < 0.001 (< 0.001–1) | < 0.001 (< 0.001- < 0.001) | 0.15 | 0.14 |
Placebo | < 0.001 (< 0.001–1) | 1 (< 0.001–2) | < 0.001 | ||
Diarrhea | Aloe vera | < 0.001 (< 0.001- < 0.001) | < 0.001 (< 0.001- < 0.001) | 0.54 | < 0.001 |
Placebo | < 0.001 (< 0.001- < 0.001) | 1 (1–1.25) | < 0.001 | ||
Fecal urgency | Aloe vera | < 0.001 (< 0.001- < 0.001) | < 0.001 (< 0.001- < 0.001) | 0.42 | 0.001 |
Placebo | < 0.001 (< 0.001- < 0.001) | 1 (< 0.001–1) | < 0.001 | ||
Total Clinical Symptoms | Aloe vera | < 0.001 (< 0.001–1) | < 0.001 (< 0.001–0.75) | 0.13 | < 0.001 |
Placebo | < 0.001 (< 0.001–1) | 2.5 (1.75–4.25) | < 0.001 | ||
Proctitis | Aloe vera | < 0.001 (< 0.001- < 0.001) | < 0.001 (< 0.001- < 0.001) | 0.7 | 0.92 |
Placebo | < 0.001 (< 0.001- < 0.001) | < 0.001 (< 0.001- < 0.001) | 0.65 | ||
Cystitis | Aloe vera | 1 (< 0.001–1) | 0.5 (< 0.001–1.75) | 0.7 | 0.91 |
Placebo | < 0.001 (< 0.001–1) | 1 (< 0.001–2) | 0.06 | ||
RTOG Total | Aloe vera | 1 (< 0.001–1) | 0.5 (< 0.001–1.75) | 0.8 | 0.03 |
Placebo | 1 (< 0.001–2) | 2 (1–3) | < 0.001 | ||
QOL | Aloe vera | < 0.001 (< 0.001- < 0.001) | < 0.001 (< 0.001- < 0.001) | 0.74 | < 0.001 |
Placebo | < 0.001 (< 0.001- < 0.001) | 1 (< 0.001–1) | 0.001 | ||
CRP | Aloe vera | 5.1 (2.1–11) | 2.5 (2.0–4.5) | 0.02 | 0.009 |
Placebo | 4.9 (2.0–6.3) | 7.1 (4.27–17.2) | 0.001 |