AIM: The aim of this prospective, multicenter, randomized, placebo-controlled trial was to evaluate the efficacy of a commercial combination of simethicone and activated charcoal (Carbosylane) on dyspeptic symptoms in patients consulting a general practitioner. PATIENTS AND METHODS: A total of 132 patients were studied. Treatment duration was 3 months, followed by a 2 months follow-up period. RESULTS: At the end of the treatment period, the percentage of patients with a reduction of at least two points on the symptom intensity scale was significantly higher with Carbosylane than with a placebo (P=0.043). Compared with placebo, the intensity of three symptoms (abdominal fullness, bloating and the sensation of slow digestion) was significantly decreased after 90 days of Carbosylane (P<0.05). At the end of the post-treatment follow-up, the percentages of patients with moderate or severe global complaints were 6.78% and 21.43% in the Carbosylane and placebo groups, respectively (P<0.03). CONCLUSION: Among patients consulting a general practitioner for dyspeptic syndrome, 3 months of treatment with Carbosylane resulted in significant symptomatic improvement. The improvement was still evident 2 months after the end of treatment.
RCT Entities:
AIM: The aim of this prospective, multicenter, randomized, placebo-controlled trial was to evaluate the efficacy of a commercial combination of simethicone and activated charcoal (Carbosylane) on dyspeptic symptoms in patients consulting a general practitioner. PATIENTS AND METHODS: A total of 132 patients were studied. Treatment duration was 3 months, followed by a 2 months follow-up period. RESULTS: At the end of the treatment period, the percentage of patients with a reduction of at least two points on the symptom intensity scale was significantly higher with Carbosylane than with a placebo (P=0.043). Compared with placebo, the intensity of three symptoms (abdominal fullness, bloating and the sensation of slow digestion) was significantly decreased after 90 days of Carbosylane (P<0.05). At the end of the post-treatment follow-up, the percentages of patients with moderate or severe global complaints were 6.78% and 21.43% in the Carbosylane and placebo groups, respectively (P<0.03). CONCLUSION: Among patients consulting a general practitioner for dyspeptic syndrome, 3 months of treatment with Carbosylane resulted in significant symptomatic improvement. The improvement was still evident 2 months after the end of treatment.