We aimed to evaluate the efficacy and safety of PB+S (pinaverium bromide 100 mg plus simethicone 300 mg) in patients with irritable bowel syndrome (IBS).
IBS is a multifactorial disorder; thus, combination therapy with different mechanisms of action is expected to be useful. PB+S has shown effectiveness in an open-label clinical study in IBS. However, there are no placebo-controlled trials.
Materials and Methods:
IBS-Rome III patients with abdominal pain/discomfort for at least 2 days within the week prior to baseline assessment were included in this 12-week, randomized, double-blind, placebo-controlled study of PB+S versus placebo, bid. The primary endpoint was overall symptom improvement, evaluated weekly by the patient (Likert Scale). Secondary endpoints included the weekly improvement in the severity of abdominal pain and bloating assessed both by patients (10-cm Visual Analogue Scale) and investigators (Likert Scale); frequency of Bristol Scale stool types (consistency) evaluated by patients and the IBS Quality of Life scores.
A total of 285 patients (female: 83%; 36.5±8.9 y old) received at least 1 dose of PB+S (n=140) or placebo (n=145). No difference was observed in overall symptom improvement between the groups (P=0.13). However, PB+S was superior in abdominal pain (effect size: 31%, P=0.038) and bloating (33%, P=0.019). Patients with IBS-C and IBS-M showed the best improvement in the frequency of stool types with PB+S. No differences were observed in IBS Quality of Life scores and adverse events.
PB+S was superior to placebo in improving abdominal pain and bloating in patients with active IBS. The effect on the frequency of stool consistency was particularly significant in IBS-C and IBS-M.
We sought to assess the feasibility and efficacy of a treatment protocol for nausea and vomiting using the combination of chlorpromazine, a dopamine antagonist antiemetic, and ketamine, a nonopioid analgesic.
Increasing numbers of patients with cannabis use disorder are presenting to emergency departments with a poorly understood syndrome characterized by intractable nausea and vomiting.
This is a prospective, observational study involving a convenience sample of patients with unexplained nausea and vomiting. Subjects were given ketamine 15 mg slow intravenous push and chlorpromazine 12.5 mg intravenous over 15 minutes. Outcomes were number of episodes of emesis after study drug administration; change in nausea severity; change in pain severity; adverse events; and patient satisfaction.
We enrolled 28 subjects on 30 emergency department visits. Twenty-three subjects (82%) reported at least weekly cannabis use with 19 reporting daily use. Initial symptoms were severe, with median pain and nausea scores both 10. After receiving study medication, the mean decrease in pain score over 120 minutes was 4.1 (95% confidence interval: 3.2, 5.0) and the mean decrease in nausea score was 4.9 (95% confidence interval: 4.0, 5.8). There were no adverse events. All 28 subjects who were asked reported they would want to receive these medications again.
In this single-center study, the majority of patients presenting with intractable nausea and vomiting reported heavy cannabis use, and symptoms were severe. The combination of chlorpromazine plus ketamine resulted in rapid, definitive cessation of symptoms in most of these patients without the need for opioids or benzodiazepines.