OBJECTIVETo verify the clinical efficacy and safety of the proven Chinese Compound Changjitai (CJT), in treating the diarrheic irritable bowel syndrome (DIBS).

METHODSRandomized controlled open clinical trial design was adopted, 45 patients were randomly divided into two groups, CJT and pinaverium bromide (PVB) were given as treated and control agent respectively. IBS scoring system (BSS), defecation state questionnaire (DSQ) were used to record the changes of the patients' main symptoms before and after treatment.

RESULTSThe total effective rate of CJT group was 83.3%, while that of PVB was 73.3%. CJT was superior in efficacy to that of PVB in improving stool quality, reducing defecation episodes of diarrheic patients, alleviating tenesmus symptoms, decreasing bellyache days and ameliorating abdominal distention. Any drug-related adverse reaction was not seen.

CONCLUSIONThe efficacy of CJT in treating DIBS is definite and without any toxic and adverse effects.

Adult ; Diarrhea ; drug therapy ; etiology ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Irritable Bowel Syndrome ; complications ; drug therapy ; Male ; Middle Aged ; Morpholines ; therapeutic use ; Phytotherapy

OBJECTIVETo study the clinical effect of Tongxie Yaofang (TXYF) Granule in treating diarrhea-predominate irritable bowel syndrome (D-IBS) and its possible mechanism.

METHODSA total of 120 patients were assigned to two groups using stratified block randomization, 80 in the intervention group and 40 in the control group. To the intervention group the TXYF granule was given at one package each time, twice a day; the control group was treated with Miyarisan three times a day, two tablets each time. The course of treatment was 4 weeks for both groups. The total efficacy in them was compared, and data of scoring on stool (Bristol method), abdominal pain, abdominal distension, and mental condition were collected before treatment and 2 and 4 weeks after treatment. The activation of mast cells (MCs) of six patients chosen from each group was detected as well before and after treatment.

RESULTSNo significant difference between the two groups in terms of the total efficacy or the scores of symptoms before and after treatment was found (P>0.05). The number of activated MCs was decreased in the intervention group after treatment, showing significant difference as compared with that before treatment as well as with that in the control group after treatment (P<0.01).

CONCLUSIONSTXYF is an effective preparation for the treatment of D-IBS. It can quickly lessen abdominal pain and distention, improve the property of stool, and improve mental tension and depression in patients. Its mechanism of action might be through the adjustment of MCs activation to decrease visceral hypersensitivity.

Abdominal Pain ; drug therapy ; etiology ; immunology ; Administration, Oral ; Adult ; Diarrhea ; drug therapy ; etiology ; immunology ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Humans ; Irritable Bowel Syndrome ; complications ; drug therapy ; immunology ; Male ; Mast Cells ; drug effects ; Middle Aged

OBJECTIVETo observe the effect of Changji' an (CJA) oral liquid on the activated signal alterative intensity (ASAI) in intracranial algesthesia domain in patients with diarrhea type irritable bowel syndrome (IBS) due to Gan-Pi disharmony.

METHODSTwenty-four patients were randomly divided into 2 groups, 14 in the treated group and 10 in the control group, they were administrated with CJA and placebo respectively. The sensory threshold and score in the two groups recorded by rectal inflation test were compared and analyzed. The change of ASAI in intracranial algesthesia domain was analyzed by functional magnetic resonance imagine (fM-RI) during rectum being inflated with 30 ml, 60 ml, 90 ml and 120 ml of gas respectively.

RESULTSThe initial sensory thresholds in the two groups were insignificantly different, but significant difference did show between the two groups in urgent defecation threshold and pain threshold after treatment (P < 0.05). Comparison in visual simulative scores between the two groups after treatment at rectal inflated for 30 ml showed no significant difference, but it showed significant difference when the inflation was over 30 ml (P < 0.05). In the treated group, the ASAI in insula cortex when rectal inflation being 90 ml or 120 ml and that in thalamus when rectal inflation being 120 ml were significantly decreased (P < 0.05). But in the control group, it changed insignificantly after treatment.

CONCLUSIONThe treatment of CJA on Gan-Pi disharmony caused diarrhea type IBS might be effected by regulating the ASAI in intracranial insula cortex and thalamus.

Adult ; Aged ; Brain ; physiopathology ; Diagnosis, Differential ; Diarrhea ; etiology ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Irritable Bowel Syndrome ; complications ; drug therapy ; physiopathology ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Pain Threshold ; drug effects ; Phytotherapy ; Sensory Thresholds ; drug effects ; Signal Transduction

BACKGROUND/AIMS: Antispasmodic agents have been used in the management of irritable bowel syndrome. However, systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome. Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium. We compared fenoverine with trimebutine for the treatment of patients with IBS. METHODS: A multicenter, randomized, double-blind, non-inferiority clinical study was conducted to compared fenoverine with trimebutine. Subjects were randomized to receive either fenoverine (100 mg three times a day) or trimebutine (150 mg three times a day) for 8 weeks. A total of 197 patients were analyzed by the intention-to-treat approach. The primary endpoint was the proportion of patients who had 30% reduction in abdominal pain or discomfort measured by bowel symptom scale (BSS) score at week 8 compared to the baseline. The secondary endpoints were changes of abdominal bloating, diarrhea, constipation, overall and total scores of BSS, and overall satisfaction. RESULTS: At week 8, fenoverine was shown to be non-inferior to trimebutine (treatment difference, 1.76%; 90% CI, -10.30-13.82; p=0.81); 69.23% (54 of 78 patients) of patients taking fenoverine and 67.47% (56 of 83 patients) of patients taking trimebutine showed 30% reduction in abdominal pain or discomfort compared to the baseline. There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group. CONCLUSIONS: Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability.
Abdominal Pain/etiology ; Adult ; Constipation/etiology ; Diarrhea/etiology ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Irritable Bowel Syndrome/complications/*drug therapy ; Male ; Middle Aged ; Parasympatholytics/*therapeutic use ; Phenothiazines/*therapeutic use ; Severity of Illness Index ; Treatment Outcome ; Trimebutine/*therapeutic use