bloating, and total constipation plus bloating scores for the herbal extract and placebo groups. The repeated measures analysis of variance tests showed a significant time/group interaction for the herbal extract effect on improving all three scores. There were significant improvements in the average constipation (p=0.0034), bloating (p<0.001) and constipation plus bloating scores (p<0.001) for the herbal extracts group compared to no improvement for the placebo arm. There were no reports of AEs over the 2-week period. CONCLUSION:The results from this pilot study suggest a blended extract of Quebracho, Conker Tree and M. balsamea Willd can safely manage symptoms in IBS-C subjects. MATERIALS AND METHODS:This was a 2-week doubleblind, randomized, placebo-controlled study of patients previously diagnosed with IBS-C (N=16). Subjects were randomized at baseline and assessed using a scoring system for symptoms of constipation, bloating, and a total constipation plus bloating score before receiving the blended herbal extract or placebo. At baseline and 2 weeks, vital signs, concomitant medications, diary entries of symptoms, and adverse events were recorded as well as assessment of constipation, bloating, and a total constipation plus bloating score. Treatment group, time of symptom scores, and the interaction between group and time were analyzed. Paired t-tests were used to assess temporal effects within each treatment group. RESULTS: There were no baseline differences in the constipation,

The aim of this case series was to retrospectively examine the symptom response of irritable bowel syndrome with constipation (IBS-C) patients administered an herbal extract in a real-world setting. Twenty-four IBS-C patients in a community office practice were provided a combination over-the-counter dietary supplement composed of quebracho (150 mg), conker tree (470 mg) and M. balsamea Willd (0.2 mL) extracts (Atrantil™) and chose to take the formulation for a minimum of 2 wk in an attempt to manage their symptoms. Patient responses to the supplement were assessed by visual analogue scale (VAS) for abdominal pain, constipation and bloating at baseline and at 2 wk as part of standard-of-care. Patient scores from VAS assessments recorded in medical chart data were retrospectively compiled and assessed for the effects of the combined extract on symptoms. Sign tests were used to compare changes from baseline to 2 wk of taking the extract. Significance was defined as P < 0.05. Twenty-one of 24 patients (88%) responded to the dietary supplement as measured by individual improvements in VAS scores for abdominal pain, bloating and constipation symptoms comparing scores prior to administration of the extract against those reported after 2 wk. There were also significant improvements in individual as well as mean VAS scores after 2 wk of administration of the combined extract compared to baseline for abdominal pain [8.0 (6.5, 9.0) vs 2.0 (1.0, 3.0), P < 0.001], bloating [8.0 (7.0, 9.0) vs 1.0 (1.0, 2.0), P < 0.001] and constipation [6.0 (3.0, 8.0) vs 2.0 (1.0, 3.0), P < 0.001], respectively. In addition, 21 of 24 patients expressed improved quality of life while taking the formulation. There were no reported side effects to administration of the dietary supplement in this practice population suggesting excellent tolerance of the formulation. This pilot retrospective analysis of symptom scores from patients before and after consuming a quebracho/conker tree/M. balsamea Willd extract may support the formulation's use in IBS-C.

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