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Randomized, double‐blind, placebo‐controlled trial of oral aloe vera gel for active ulcerative colitis
Author(s) -
Langmead L.,
Feakins R. M.,
Goldthorpe S.,
Holt H.,
Tsironi E.,
De Silva A.,
Jewell D. P.,
Rampton D. S.
Publication year - 2004
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2004.01902.x
Subject(s) - aloe vera , medicine , placebo , ulcerative colitis , gastroenterology , erythrocyte sedimentation rate , odds ratio , clinical trial , randomized controlled trial , colitis , surgery , disease , pathology , traditional medicine , alternative medicine
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.