Aloe vera Extract in the Therapy of Irritable Bowel Syndrome

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Introduction

Irritable bowel syndrome (IBS) represents one of the most common functional gastrointestinal disorders. Available pharmacotherapy options are characterized by limited efficacy, thus many patients seek complementary and alternative therapy, such as dietary interventions, phytotherapy, or psychotherapy.

One of the modalities of phytotherapy is the use of extract from Aloe barbadensis Milleri or Aloe vera. However, available evidence on the effects of Aloe vera in IBS therapy is limited and contradictory. For instance, in a study evaluating the efficacy of Aloe vera juice, published by Davis et al., no clear effect was observed in IBS patients, although a mild benefit was noted in the subgroup with predominant diarrhea.

Despite the lack of convincing evidence of the positive effects of Aloe vera in IBS therapy, many patients report that regular use of Aloe vera products helps reduce their disease symptoms. The aim of the presented pilot study was therefore to evaluate the effect of a commercial Aloe vera extract (AVH200^®, available on the Czech market, for example as the product Proibs) on disease symptoms compared to placebo.

Methodology, Course, and Goals of the Study

Patients aged 18–65 years with IBS according to the Rome III criteria were included in the randomized double-blind placebo-controlled study. Participants were randomized to therapy with Aloe vera extract (250 mg AVH200^®) or placebo 2× daily for 4 weeks. Randomization and therapy were preceded by an initial 2-week period during which gastrointestinal symptoms were monitored.

Gastrointestinal symptoms were assessed using the IBS Severity Scoring System (IBS-SSS) questionnaire, and psychological symptoms were evaluated using the Hospital Anxiety and Depression scale (HAD). Before and after the treatment period, patients' oroanal transit time was also determined, given that the use of Aloe vera can cause diarrhea due to the induction of intestinal peristalsis.

The primary goal of the study was to change the IBS-SSS score at the end of treatment compared to baseline, defined as a reduction in score by at least 50 points. The study authors also employed an alternative definition of responders to therapy, involving patient-reported adequate relief of at least 50% during the therapy. Secondary objectives included the assessment of changes in IBS-SSS, HAD scores, and oroanal transit time.

Results

A total of 68 patients were randomized to therapy (43 with mixed-type IBS, 20 with diarrhea-predominant IBS, and 5 with constipation-predominant IBS). Thirty-three patients were randomized to Aloe vera extract therapy, and 35 to placebo, with baseline characteristics fundamentally similar between groups, although a trend towards higher IBS-SSS scores was observed in the active therapy group (p = 0.067). A total of 5 participants discontinued the treatment during the study, 4 of whom were in the placebo group.

Primary study goals were not met, yet a trend towards a higher proportion of responders with a reduction in IBS-SSS score by ≥ 50 points was observed in the Aloe vera group (54.5 vs. 31.4 %; p = 0.093). A similar trend was noted for at least 50% symptom relief during therapy (33 vs. 14 %; p = 0.12).

Although primary study goals were not achieved, significant improvement in the pain intensity scale assessed via IBS-SSS was observed in the Aloe vera group compared to placebo at the end of the study (p = 0.030), with a similar trend noted in the overall score (p = 0.10). In the Aloe vera group, a reduction in IBS symptoms was observed at the end of therapy compared to baseline (315 ± 83 vs. 257 ± 107; p = 0.003), but not in the placebo group (276 ± 88 vs. 253 ± 100; ns).

Compared to baseline, significant improvement in IBS-SSS scores for pain intensity (p = 0.011), pain frequency (p = 0.010), and bloating (p = 0.032) was observed in the Aloe vera group at the end of the therapy. These changes were not observed in the placebo group. No significant difference was seen between active treatment and placebo in HAD scores and oroanal transit time.

Conclusion and Discussion

The results of the pilot study indicated that although primary study goals were not met, the administration of Aloe vera extract (AVH200^®) was well-tolerated, safe, and showed promising results on IBS symptoms. The patient sample in this study may have been too small to detect clinically significant differences between groups. Therefore, more extensive clinical research is needed to confirm the results of the pilot study and possibly elucidate the mechanism by which Aloe vera works.

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Sources:
1. Størsrud S., Pontén I., Simrén M. A pilot study of the effect of Aloe barbadensis Mill. extract (AVH200^®) in patients with irritable bowel syndrome: a randomized, double-blind, placebo-controlled Study. J Gastrointestin Liver Dis 2015; 24 (3): 275–280, doi: 10.15403/jgld.2014.1121.243.sst.
2. Davis K., Philpott S., Kumar D., Mendall M. Randomised double-blind placebo-controlled trial of aloe vera for irritable bowel syndrome. Int J Clin Pract 2006; 60 (9): 1080–1086, doi: 10.1111/j.1742-1241.2006.00980.x.