Dieter J. Ziegenhagen

Addition of senna improves colonoscopy preparation with lavage: a prospective randomized trial

Attempts have been made to further improve the widely performed colonoscopy preparation with lavage. In a prospective study, 120 outpatients and inpatients scheduled for total colonoscopy were randomized to two preparatory regimens. The day before endoscopy either extractum sennae (N = 60) or a placebo solution (N = 60) was given. Just before examination all patients underwent whole gut irrigation with a polyethylene glycol electrolyte lavage solution (PEG-ELS). Adequacy of preparation, patient tolerance, and the necessary amount of PEG-ELS were assessed. Physician assessment of colon cleansing showed superiority in the group with additional laxative. The colon was free of solid debris in 66.7% of patients after PEG-ELS and in 90% after senna/PEG-ELS administration (p less than 0.01). Patient tolerance was similar in both groups with 86.7% vs. 83.3% of subjects rating the preparation as tolerable. Severe adverse events were not observed. In the senna/PEG-ELS group, significantly less (p less than 0.05) lavage fluid was needed. We conclude that the combination of senna and PEG-ELS is more effective than PEG-ELS in cleansing the colon for colonoscopy.

Cisapride treatment of constipation-predominant irritable bowel syndrome is not superior to placebo.

Background and Aim:  Previous studies with cisapride reported conflicting results in patients with constipation–predominant irritable bowel syndrome (IBS). To gain further evidence, this randomized double‐blind study was carried out.

Oral cisapride increases gallbladder volume in volunteers

It has been previously reported that intravenous application of cisapride leads to a contraction of the gallbladder. To evaluate this potential prokinetic effect cisapride was given to healthy subjects in the clinically relevant oral form. In a randomized double‐blinded placebo controlled design gallbladder volumes were monitored by ultrasound.

Cisapride increases gallbladder volume in gallstone patients before and after extracorporeal shock wave lithotripsy.

We have previously shown that oral cisapride causes a dose‐related increase of fasting gallbladder volume in healthy subjects. The present study investigates the effect of cisapride on gallbladder motility in 16 patients with gallbladder stones: 8 patients had no biliary symptoms, but the other 8 patients with symptomatic gallstone disease were studied before and 6 weeks after extracorporeal shock wave lithotripsy (ESWL). For each study the patients received a single oral dose of 20 mg cisapride; fasting gallbladder volume was measured by ultrasound before, and for 120 minutes after, drug administration. In the 8 asymptomatic patients a mean maximal increase of the fasting volume to 152.7 ± 7.6% of the initial value was observed at a mean 97.5 ± 8.3 minutes after cisapride ingestion. Similarly, in the 8 patients with biliary pain mean fasting volume after cisapride ingestion increased to 141.3 ± 5.7% before ESWL treatment and to 145.0 ± 5.8% after ESWL and 6 weeks of oral litholytic therapy. There were no significant differences between the results in the symptomatic and asymptomatic patients. Our results indicate that cisapride increases the gallbladder volume in gallstone patients regardless of biliary symptoms. Similar volume changes were observed before therapy and after ESWL with bile acid therapy. The therapeutic efficacy of litholytic agents could be diminished by simultaneous cisapride administration.

Induced gall-bladder contraction accelerates fragment clearance after extracorporeal shockwave lithotripsy

At the end of extracorporeal shockwave lithotripsy (ESWL) gallstone fragments are dispersed throughout the gall‐bladder. In this state they should be expelled more easily than when later sedimented to the gall‐bladder fundus. Thus, a randomized study was performed to evaluate the clinical benefit of induced gall‐bladder contraction after ESWL. One hundred and five patients with radiolucent gallstones (1–3 stones, diameter ≤ 30 mm) were randomized to received either saline or an infusion of 0.2 μg/kg ceruletide. Stone clearance rates and incidence of biliary symptoms were recorded. Clearance rates at 6 weeks and 3 months after ESWL were significantly (P≤ 0.025) improved by the ceruletide infusion. This effect, resulting in shortened bile acid therapy, was limited to patients with small solitary stones and dependent on a good initial fragmentation. Major side effects attributable to ceruletide were not observed. These results suggest that induced gall‐bladder contraction can be successfully applied as an adjuvant treatment in a subgroup of patients with small solitary gallstones.

Hinweise für Patientinnen und Patienten

Die Erforderlichkeit einer Behandlung mit einem Betäubungsmittel aus der Anlage I zu § 1 BtMG richtet sich nach dem konkreten Krankheitsbild im Einzelfall sowie danach, ob vergleichbar geeignete und verfügbare Therapiealternativen vorliegen. Ein ärztlicher Bericht soll Auskunft über die für die Entscheidung maßgeblichen Tatsachen geben. Das BfArM muss durch die vorgelegten Unterlagen im Rahmen einer qualifizierten Plausibilitätskontrolle zu dem Ergebnis gelangen können, dass eine Behandlung mit dem beanspruchten Betäubungsmittel mangels geeigneter und verfügbarer Therapiealternativen erforderlich ist.