Addition of Clidinium-C to the 14-Day Proton Pump Inhibitor Based Triple Therapy for Helicobacter pylori Eradication\

Abstract

Helicobacter Pylori (HP) is a Gram-negative, spiral-shaped, motile micro-organism that infects approximately half of the world population and the prevalence of asymptomatic infected patients appears to be age-related (1). The human is its reservoir and the transmission of this microorganism involves oral‑oral and fecal‑oral routes. The infection takes place usually in childhood, within one’s own family (between parents and children or between siblings) (2). Gastric infection by HP is actually considered to be the most relevant cause of chronic gastritis and peptic ulcer disease (PUD). It is also associated with an increased risk of mucosa associated lymphoid tissue (MALT) lymphoma and gastric cancer (3). Selection of the best drug regimens for effective eradication of HP infection is challenging. Some recent studies have suggested that the effectiveness, compliance and side-effects of quadruple regimen containing a gastric acid inhibitor, a bismuth compound and two antibiotics might be comparable with proton pump inhibitors (PPI) -based triple therapy when administered as first-line treatment for HP infection (4-6). However, in other studies showed superiority of quadruple therapy (7). Antibiotic resistance due to frequent and uncontrolled administration and high prevalence of antibiotic side effects are the most common causes of treatment failure. To increase eradication rate, as defined in the Maastricht IV report (8), several clinical trials have been initiated involving extended treatment duration, use of new antibiotics or the addition of probiotics or other drugs regimens (9). In the Maastricht Consensus Report, the 14-day treatment course was superior to the 7-day treatment. Because of the higher antibiotic resistance rates, in developing countries such as Iran, the 14-day treatment regimens is preferred. It has been shown that the large doses of antibiotics used in the triple therapy change the normal bowel flora. This may result in further gastrointestinal adverse events (8, 9). Clidinium bromide in combination with chlordiazepoxide (clidinium –C) is an anticholinergic drug which may help symptoms of cramping and abdominal stomach pain by decreasing gastric acid secretion and slowing the intestinal movement (10). Chlordiazepoxide component of this drug exerts anxiolytic, sedative, hypnotic, anticonvulsant and skeletal muscle relaxant effects. The drug may inhibit monosynaptic and polysynaptic reflexes by acting as an inhibitory neuronal transmitter or by blocking excitatory synaptic transmission. This drug may also directly depress motor nerve and muscle function. The aim of this study was to assess the effect of clidinium-C on HP eradication with a triple therapy including omeprazole, clarithromycin and amoxicillin (OCA) in patients with peptic ulcer disease (PUD). The secondary aim of the study was to investigate the efficacy and safety of clidinium-C in the prevention of side-effects related to HP eradication.