Aloeride Clinical Trials

Alimentary Pharmacology & Therapeutics, Volume 19 Issue 7, Page 739 - April 2004

Randomized, double-blind, placebo-controlled trial of oral aloe vera gel for active ulcerative colitis
L. Langmead, R. M. Feakins, S. Goldthorpe†, H. Holt†, E. Tsironi, A. De Silva, D. P. Jewell† & D. S. Rampton

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.

References

Bland, J.; Effect of orally consumed Aloe Vera juice on gastrointestinal function in normal humans.
Linus Pauling Institute of Science & Medicine Palo Alto, C.A. Prevention Magazine. 1985.

Blitz, J.J.; Smith, J.W.; Gerard, J.R. Aloe Vera Gel in peptic ulcer therapy; Preliminary report. Journal of the American Osteopathic Association. 1963.62.731-735.

Che, Q.M.; Akoe, T.; Hattori, M.; Kobashi, K.; Namba, T. isolation of a human intestinal bacterium capable of transforming barbaloin to aloe-emodin anthrone.
Planta Med, 1991 Feb. 57(1).15-19.

Galalee, Kandila, Hegazy E, EI Ghoroury M, Gobran W: Aloe Vera and gastrointestinal ulceration, J Drug Res Egypt 7:73- 77, 1975.

Gupta MB, Nath R, Gupta GP, Bhargava KP: Antiulcer activity of some plant triterpenoids, Indian J Med Res 73:649-652,1981.

Kandil A, Gobran W: Protection of gastric mucosa by Aloe Vera. J Druq Res Egypt 11:191-196,1979.

Koo, M.W.L. Aloe Vera; anti-ulcer and anti-diabetic effects.
Phytother Res. 1994. 8(8). 461-464.

Savitskii VI: The effect of tissue preparations on the biochemical processes of the body, In: The use of tissue preparations in animal husbandry and veterinary medicine, Urozhai, Kiev 0:31-41,1966. From: RefZh Otd Vyp Farmakol Khimioter Sredstva Toksikol, No.6, 54638, 1967.

Solov'Eva VP: Effect of Aloe extract on some biochemical indicators of normal and sick persons. Vrachebnoe Oelo ():93-98, 1958.

Suga T, Hirate T: The efficacy of the Aloe plants chemical constituents and biological activities. Cosmet & Toil 98:105-108, 1983.

Vinson JA, Al Kharrat, H., and Andreoli, L. Effect of Aloe vera preparations on the human bioavailability of vitamins C and E. Phytomedicine 12 (2005) 760-765