Randomised Double-Blind Placebo-Controlled Trial Of Aloe Vera For Irritable Bowel Syndrome

K. Davis; S. Philpott; D. Kumar; M. Mendall

Disclosures

Int J Clin Pract. 2006;60(9):1080-1086. 

In This Article

Summary and Introduction

Summary

Aloe vera (AV) is suggested to be beneficial in treating irritable bowel syndrome (IBS) symptoms, but no scientific trials exist to confirm this. We aim to assess the efficacy of AV on IBS in refractory secondary care patients. Patients with IBS were randomised to receive AV or matching placebo for a month. Symptoms were assessed at baseline, 1 and 3 months. Fifty-eight patients randomised, 49 completed the protocol to 1 month and 41 to 3 months. Eleven of thirty-one (35%) AV patients, and 6 of 27 (22%) placebo patients responded at 1 month (p = 0.763). Diarrhoea predominant patients showed a trend towards a response to treatment at 1 month (10/23 V 2/14, p = 0.07). There was no evidence that AV benefits patients with IBS. However, we could not rule out the possibility that improvement occurred in patients with diarrhoea or alternating IBS whilst taking AV. Further investigations are warranted in patients with diarrhoea predominant IBS, in a less complex group of patients.

Introduction

Irritable bowel syndrome (IBS) is a common disorder affecting up to 50% of patients attending gastroenterology outpatients and 10-20% of the population.[1,2,3,4,5] It is a multi-symptom condition characterised by abdominal pain/discomfort, change in bowel habit (either towards constipation, diarrhoea or combination of both), feeling of incomplete evacuation, distension or bloating and passage of mucus. Patients tend to follow a chronic course of symptoms with intermittent exacerbations.

There are a number of specific treatments available for this disorder. Conventional medical management options include treatment with antispasmodics or constipating agents/laxatives and bulking agents. Patients towards the more severe end of the spectrum of the disorder may require anxiolytics or even antidepressants. These conventional treatments are of modest efficacy only, and only muscle relaxants[6] and low-dose antidepressant therapy have shown to be of any benefit in double-blind placebo-controlled trials.[7] It is not surprising therefore that two-thirds of refractory patients fail to respond to such treatments. Patients in secondary and tertiary care are even less responsive to standard therapies. Complementary therapies include dietary changes, hypnotherapy, cognitive behavioural therapy and Aloe vera (AV), and although there is plenty of anecdotal evidence, these have not been scientifically evaluated.

Aloe vera is a plant that can produce latex and gel. The gel is extracted from the leaf, and it is this substance that is most used as a treatment. AV has been evaluated in a number of different clinical contexts and some promising results have been found for its use in controlling cardiovascular risk factors[8] and diabetes,[9] besides being beneficial in areas of dermatology.[10,11] One explanatory factor for this is the anti-inflammatory properties of the plant.[12] More recently, AV has been evaluated in patients with active ulcerative colitis (UC),[13] and this study found that patients who had taken AV over 4 weeks had a higher frequency of clinical remission and improvement compared to those taking the placebo. It is possible that these anti-inflammatory effects of AV could have beneficial effects on symptoms of IBS by reducing gut hypersensitivity.

The aim of this study was to assess the efficacy of AV using the Natural Living Products (NLP) formulation on symptoms of IBS in refractory secondary care patients. In this preparation alloin, which can cause diarrhoea, is nearly eliminated with a remaining concentration of less than 1 p.p.m. It is the polysaccharides in the preparation which NLP claim exert an anti-inflammatory action. It was decided to evaluate a 1-month course of treatment with two further months of follow-up, as the primary aim was to determine whether there was any beneficial effect with short-term treatment, and if so whether this was maintained after cessation of therapy.

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