Randomized, double‐blind, placebo‐controlled trial of oral aloe vera gel for active ulcerative colitis

• Published in: Alimentary pharmacology & therapeutics Vol. 19; no. 7; pp. 739 - 747
• Main Authors: Langmead, L., Feakins, R. M., Goldthorpe, S., Holt, H., Tsironi, E., De Silva, A., Jewell, D. P., Rampton, D. S.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01-04-2004; Blackwell
• Subjects: Administration, Oral; Adult; Aged; Aloe; Biological and medical sciences; Colitis, Ulcerative - drug therapy; Double-Blind Method; Female; Gels; Humans; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Phytotherapy - methods; Plant Preparations - administration & dosage; Treatment Outcome; Randomization; Placebo; Oral administration; Double blind study; Digestive diseases; Intestinal disease; Inflammatory disease; Ulcerative colitis
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2004.01902.x

Summary
Background : The herbal preparation, aloe vera, has been claimed to have anti‐inflammatory effects and, despite a lack of evidence of its therapeutic efficacy, is widely used by patients with inflammatory bowel disease.
Aim : To perform a double‐blind, randomized, placebo‐controlled trial of the efficacy and safety of aloe vera gel for the treatment of mildly to moderately active ulcerative colitis.
Methods : Forty‐four evaluable hospital out‐patients were randomly given oral aloe vera gel or placebo, 100 mL twice daily for 4 weeks, in a 2 : 1 ratio. The primary outcome measures were clinical remission (Simple Clinical Colitis Activity Index ≤ 2), sigmoidoscopic remission (Baron score ≤ 1) and histological remission (Saverymuttu score ≤ 1). Secondary outcome measures included changes in the Simple Clinical Colitis Activity Index (improvement was defined as a decrease of ≥ 3 points; response was defined as remission or improvement), Baron score, histology score, haemoglobin, platelet count, erythrocyte sedimentation rate, C‐reactive protein and albumin.
Results : Clinical remission, improvement and response occurred in nine (30%), 11 (37%) and 14 (47%), respectively, of 30 patients given aloe vera, compared with one (7%) [P = 0.09; odds ratio, 5.6 (0.6–49)], one (7%) [P = 0.06; odds ratio, 7.5 (0.9–66)] and two (14%) [P < 0.05; odds ratio, 5.3 (1.0–27)], respectively, of 14 patients taking placebo. The Simple Clinical Colitis Activity Index and histological scores decreased significantly during treatment with aloe vera (P = 0.01 and P = 0.03, respectively), but not with placebo. Sigmoidoscopic scores and laboratory variables showed no significant differences between aloe vera and placebo. Adverse events were minor and similar in both groups of patients.
Conclusion : Oral aloe vera taken for 4 weeks produced a clinical response more often than placebo; it also reduced the histological disease activity and appeared to be safe. Further evaluation of the therapeutic potential of aloe vera gel in inflammatory bowel disease is needed.