| Objective: To evaluate and compare the clinical efficacy and safety of otilonium bromide(OB) and pinaverium bromide(PB) in patients with diarrhea-predominant irritable bowel syndrome(IBS-D).Methods: This was a prospective, open-label, single-center, random, parallel-control and two stage cross-over design study. Eighty-four out-patients with IBS-D were assigned randomly to group OB or group PB. At baseline, the patients in group OB were treated with OB 40 mg t.i.d, while in group PB with PB 50 mg t.i.d,and both two groups were treated with Entrocoor dinatibiogen 0.5 t.i.d,glutamine entero-soluble capsule 2 piece t.i.d. At the 14 th day,if the therapy was effective defined with 50%decreasing of the total symptom score the drug was continued used 14 days;if invalid,the medicant was switched to OB or PB for another 14-day’s couse. The total treatment course was 4 weeks. Before and after the treatment, the GI-symptom score and adverse events were recorded. The first end-point was the intensity and frequency of abdominal pain,while the secondary end-points were the intensity of abdominal distention and diarrhea and patients’ degree of satisfaction.Results:1. Of 84 IBS-D patients(M/F=38/46, with 41.15+10.54 years of the average age), 43 cases were in group OB, and another 41 caeses in group PB. At the 14 th day, the reducing rate of abdominal pain score in group OB was 43.45±28.28, and 45.53±28.48 in group PB, which had no statistically significant difference(P=0.757). There was no statistically significant difference in the reduction of abdominal pain frequency(1.68 ± 1.25 vs2.13 ± 1.21, P = 0.144). At the 28 th day, there was no statistically significant difference respectively in the reducing rate of abdominal pain score(68.82±27.59 vs 63.33±22.22, P = 0.520) and in the reduction of abdominal pain frequency(2.41±1.48 vs 2.75±1.44, P = 0.350) between the two groups.2. At the 14 th day, there was no statistically significant difference in the reducing rate of abdominal distention score(40.30±34.31 vs 33.53±25.12, P = 0.478) and in the reducing rate of diarrhea score(39.04±31.31 vs 43.93±30.54, P = 0.471) between the two groups respectively.At the 28 th day,,the reducing rate of abdominal distention score(57.50±29.16 vs 50.00±27.84, P = 0.596) and the reducing rate of diarrhea score(58.18±28.72 vs70.95±22.34, P = 0.112) in the both groups were higher than those at the 14 th day. At the 28 th day, there was no statistically significant difference in the global efficacy(secondary end-point) in the both groups(70.00% vs 71.05%,P>0.05). In some patients who were invalid after 14-days therapy and then switched to OB or PB, the reducing rate of abdominal distension score, abdominal pain,diarrhea,and the reduction of abdominal pain frequency were significantly improved(P < 0.05).3.There were no statistically significant differences in the incidence of adverse reactions(16.28% vs 14.63%,P>0.05)and patient degree of satisfaction(82.5% vs84.21%,P>0.05) between the two groups.Conclusions: The results showed that both OB and PB had similarly efficiency and safety in short-time therapy for IBS-D patients,whose abdominal pain,abdominal distention, diarrhea were improved respectively. So, the two medicants can be an emergency choice or an alternate choice for the symptom-onset in IBS-D patients. |
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