The therapeutic equivalence of a fixed combination preparation consisting of peppermint oil and caraway oil (PCC, Enteroplant) and the prokinetic agent cisapride (CIS, CAS 81098-60-4) was investigated in a four-week randomized controlled double-blind study with planned adaptive interim analysis. The study comprised 120 outpatients with functional dyspepsia. The efficacy was evaluated in 118 patients. Of these, 60 patients received the enteric-coated combination preparation (2 x 1 capsule containing 90 mg peppermint oil +50 mg caraway oil per day) and 58 patients received the reference preparation cisapride (3 x 10 mg/day). The mean reduction of the pain score (primary variable) recorded on a visual analog scale (VAS) during the four-week treatment was 4.62 points with the peppermint oil/caraway oil preparation. This score was comparable with the mean reduction under cisapride (4.60 points) (p = 0.021; test for equivalence). Equivalence was also found in the secondary variable "frequency of pain" with a reduction by 4.65 points under PCC and by 4.16 points under cisapride carried out on an exploratory basis (p = 0.0034). Comparable results were attained with both treatments in the Dyspeptic Discomfort Score which included the other dyspeptic symptoms as well as intestinal and extraintestinal autonomic symptoms, in the prognosis as appraised by the physician and in the CGI scales (Clinical Global Impressions). Corresponding results were also found in Helicobacter pylori-positive patients and patients with initially intense epigastric pain in the two treatment groups. The combination preparation consisting of peppermint oil and caraway, oil appears to be comparable with cisapride and provides an effective means for treatment of functional dyspepsia. Both medications were tolerated well (adverse events were reported in 12 patients of the PCC group and in 14 patients of the CIS group).

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The influences of acute changes of the serum calcium and of ealeitouin (CT) on the exoerine pancreatic function have been studied in man. During stimu. lation with secretin and choleeystokinin-panereozymin (CCK-PZ) Ca++-glucolactobionate, Na,-EDTA, porcine and human synthetic CT were infused i.v. Hypercalcemia provoked an increase of enzyme secretion under unstimulated and secretin stimulated conditions; however, in the case of CCK-PZ administration enzyme output was not altered. EDTA-hypocalcemia inhibited pancreatic secretion during secretin as well as during CCK-PZ infusions. CT doses above 2 MRCU caused a decrease of enzyme secretion during simultanous secretin/CCK-PZ administration by about 70---80% of the initial value without decreasing serum Ca++; doses of 0.5 MRCU and less were without effect. In none of the experiments bicarbonate secretion was affected. The results show important changes of the pancreatic enzyme secretion during acute hyper-and hypocalcemia, while calcitonin exerts an inhibitory effect daring normocalcemia.

Abstract. The influence of the serum calcium level and of the hormones regulating it, parathyroid hormone (PTH) and calcitonin (CT), on gastric secretion has been studied in the intact, parathyroidectomized (PTX) and thyro‐parathyroidectomized (TX‐PTX) chronic gastric fistula rat. The following test substances have been administered: CaCl2, bovine parathyroid hormone, Na2‐EDTA and porcine calcitonin. An increase of the serum calcium level caused a marked inhibition of gastric secretion, the parathyroid hormone did not show any effect without changes of the calcium level. Calcium decreases after EDTA as well as after calcitonin were also followed by a reduction of gastric secretion. There was no significant difference demonstrable between the intact, PTX‐and TX‐PTX‐animals. The calcitonin effect could be compensated by calcium substitution. A direct influence of PTH and CT on gastric secretion was not detectable; the hormones only exerted indirect effects via the changes of the serum calcium level they induced.