A randomised controlled trial of Absorbatox TM C35 in irritable bowel syndrome: a pilot study
Abstract
Background: Irritable Bowel Syndrome (IBS) is one of the most common gastrointestinal
disorders managed by primary care physicians and gastroenterologists. It is a recurrent and
chronic disorder characterised by abdominal discomfort, bloating and altered defecation
patterns. IBS casts significant burdens on patients' quality of life and has an enormous
economic impact through direct costs in health care utilization and indirect costs through
absenteeism from work. Many IBS sufferers have resorted to complimentary and alternative
medicine (CAM) mainly because of the ineffective cure rate with conventional western
treatment. It is estimated that 40% of IBS sufferers seek symptomatic relief from CAM. A lack
of understanding of the pathophysiology mechanism has been labelled as the main cause for
poor IBS management. Nevertheless, several hypotheses have been proposed, including
abnormal motility, visceral hypersensitivity, inflammation and infection, neurotransmitter
imbalance, and psychological factors. In addition, IBS patients are considered to be visceral
hypersensitive to luminal factors and intestinal gas.
Aim: To assess the efficacy of Absorbatox™ C35, a natural, non-toxic zeolite, with enhanced
ion exchange capacity, as well as water and gas adsorbing properties, in the treatment of IBS in
a 6-week randomised , double-blind, placebo-controlled trial with parallel group assignment.
Methods: Ethical approval for the study was received (Ethical approval number NWU-0001-
008-S5) and the necessary consent from trial candidates were received as per international
guidelines. Sixty-seven (67) IBS candidates were recruited for participation. Only thirty-three
(33) patients met the trial entry criteria. IBS candidates were diagnosed using the Rome Ill
diagnostic criteria. Organic diseases were first excluded by a full blood count and a physical
examination. Any alarming symptoms, that could be indicative of diseases other than IBS, were
also excluded during the preliminary examination. A 2-week run-in phase evaluated baseline
symptoms. Patients were randomly assigned using a simple computer generated random
codes system . Patients received 750 mg Absorbatox™ C35 three times daily or Placebo for 4
consecutive weeks. Symptoms were evaluated using validated questionnaires. The primary
outcome was assessed using a global symptom endpoint, "adequate relief' questionnaire.
Patients were characterised as overall responders if they reported "adequate relief' in 50% of
treatment weeks. Secondary outcomes included a 50-point reduction in total severity score
according to the IBS Severity Scoring System (IBS-SSS). The IBS-SSS was used to assess
separate symptom ratings, such as abdominal pain, bloating, "bowel habit satisfaction" and
disease "interference with life in general". Stool parameters, including consistency, frequency
and urgency were also assessed. Statistical analysis was primarily based on intention-to-treat
analysis. Secondary outcomes were analysed through descriptive statistics. Statistical
significance level was pre-set at 0.05, which means that whenever p < 0.05, the null-hypothesis
was rejected .
Results: Seventeen (17) patients received Absorbatox™ C35 and sixteen (16) received
Placebo. Two patients from the Absorbatox™ C35 group did not return after randomisation,
hence only 31 patients were included in the intention to treat analysis. A total of twenty-nine
(29) patients completed the entire study. A dropout rate of 12.12% (4/33) was encountered . At
the end of treatment (12/15) 80% and 50% (8/16) of patients were classified as overall
responders in the Absorbatox™ C35 and Placebo groups respectively (p = 0.085). After three
and four weeks of treatment the number of weekly responders was significantly higher in the
Absorbatox™ C35 group compared to the Placebo group (p = 0.02 and p = 0.016 for week 3
and 4, respectively). Moreover, both Absorbatox™ C35 and the Placebo groups were
associated with significant decreases in the total severity score (p < 0.001 and p = 0.005,
respectively). Likewise, both groups were associated with significant decreases in clinical
parameters like pain, distension, bowel habit satisfaction and disease interference with life in
general. No significant differences were observed between the Absorbatox™ C35 and Placebo
groups in terms of total severity score and separate symptoms ratings. However, after 20 days
of treatment the severity of distension was significantly lower in the Absorbatox™ C35 group
compared to Placebo (p = 0.024). This effect was not sustainable, as the subsequent
assessment (after 30 days of treatment) revealed no statistical significance between the two
groups (p = 0.553). Absorbatox™ C35 was associated with a higher incidence of smooth stool
(p = 0.049), but no significant difference were observed between the treatment groups in terms
of stool frequency and urgency. Adverse events were of similar nature in both groups (p =
0.259).
Conclusions: Although the placebo effect was largely present during the trial, Absorbatox™
C35 showed a trend towards better improvement in several endpoint measurements. The
possible implications for future trials on Absorbatox™ C35 were summarised . A larger trial is
recommended with adequate statistical power, which is to be conducted over an extended
period of time, to obtain inter-subjectivity on the efficiency of Absorbatox™ C35 in IBS
treatment. It was statistically estimated, that for the repetition of these findings under similar
conditions, with an 80% and 50% response rate in Absorbatox™ C35 and Placebo respectively,
45 IBS patients would be needed in each treatment group in order to achieve statistical
significance.
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