• Infection with Helicobacter pylori – therapeutic regimens

    November 12, 2014

    The peptic ulcer is a disease of the stomach and / or of the duodenum, which is characterized by the appearance of an ulcerative defect due to the peptic action of hydrochloric acid. The incidence of the peptic ulcer is 6-10% of the population, while the ratio of the duodenal and gastric ulcer is 4:1. The incidence of gastric ulcer is equal in both men and women, while duodenal ulcer is predominant in men at a ratio of 2:1. The main etiological factor in 90-100% of the patients with duodenal ulcers and in 60% of those with gastric ulcer is an infection with Helicobacter pylori.

    The infection with Helicobacter pylori (HP) is the most common infection in people. Its diagnostics has made significant progress in the recent years. New tests have been introduced and the factors that affect the accuracy of diagnostic tests and their interpretation have been analyzed.
    The most important factor for optimizing the accuracy of the tests for a proper diagnosis is to clarify whether the patient was previously treated with proton pump inhibitors (PPIs), H2-blockers, antibiotics or bismuth preparations. They all have a bactericidal effect and influence on the urease activity, which is used as a marker for determining the HP. To optimize the accuracy of the tests the use of these medications should be stopped prior to testing – the testing after treatment with PPIs or H2 blockers should be carried out not earlier than 7 to 14 days after stopping the medication, to avoid false negative results. When the eradication is examined after treatment, the testing should be performed at the earliest 4 weeks after stopping the treatment.

    The diagnostic tests for the detection of infection with HP are divided into invasive (taking material for examination after performing gastroscopy), and non-invasive.

    Invasive methods (after gastroscopy)
    – Rapid urease test
    – Histology
    – Microbiological testing

    Non-invasive methods
    – Serology
    – Antigen test in the stool
    – 13c-urease breath test

    Indications for HP eradication (Maastricht III, 2005)
    • Patients with gastroduodenal diseases:
    – Peptic ulcer disease
    – MALT lymphoma
    • Patients with atrophic gastritis
    • I-st degree relatives of individuals with gastric carcinoma
    • Patients with chronic idiopathic thrombocytopenic purpura
    • Long-term use of NSAIDs

    There are minor differences in the indications for the treatment of the various diseases caused by HP in the various national consensuses.

    Throughout the world there is a full agreement that the eradication of an HP infection in peptic ulcer disease prevents the recurrence of ulcer without any antisecretory treatment. It has been shown that the eradication of an HP infection in patients with ulcer disease significantly reduces the funds for the treatment of the disease. Therefore, it is now accepted that the eradication of infection in patients with gastric and duodenal ulcers is imperative.

    The eradication of an HP infection induces endoscopic and histological improvement as well as a reduction of the tumor in 50 to 80% of the patients with gastric MALT lymphoma in the I-st stage. Therefore the eradication of the infection in these patients is the method of choice.

    The eradication of an HP infection can influence the development and progression of gastric cancer. It is not clear what will happen in the gastric remnant after the resection of the distal (antral) gastric cancer, but the majority of the consensus schemes assume that the eradication of the infection after gastric resection is mandatory.
    The eradication of an HP infection in atrophic gastritis without full atrophy of the gastric mucosa leads to an improvement in histology.

    Regimens for eradication

    The triple combination of a proton pump inhibitor (PPI) and two antibiotics for 7-10 days, is the method of choice for eradicating HP infection.

    Standard treatment for the HP infection

    First version:
    – Clarithromycin 2 х 500 mg
    – Amoxicillin 2 х 1000 mg

    Second version:
    – Clarithromycin 2 х 500 mg
    – Metronidazole 2 х 500 mg
    Treatment duration: 7 – 10 days

    The combination always includes the standard dose of PPI 2 times a day/ Lansoprazole 2 x 30 mg/.

    The recommended antibiotics should not be replaced by other representatives of the group of macrolides, penicillins or nitromidazolites (except Tinidazole instead of Metronidazole).

    The uncomplicated duodenal ulcer does not require treatment with antisecretory medication after the 7-10-day course of eradication. In gastric ulcer, in duodenal ulcer after a hemorrhage, in large ulcers of more than 20 mm and in duodenal ulcers with severe periduodenitis after the eradication treatment of 7-10 days, an antisecretory treatment for 4 weeks is carried out, followed by an endoscopic control to demonstrate the healing of the ulcer and control the eradication.

    The combination PPI + Clarithromycin + Amoxicillin causes less resistance to clarithromycin than the regime PPI + Clarithromycin + Metronidazole.

    Both treatment combinations can be used for the iradication of the infection, while the preferred combination currently is PPI / Lansoprazole / + Clarithromycin + Amoxicillin.

    The combination PPI / Lansoprazole / + Amoxicillin + Metronidazole gives lower eradication by 10% and is therefore not recommended.

    HP eradication – sequential therapy
    Combination of 1 – 5 days
    – PPI/ Lansoprazole / 2 x 30 mg daily
    – Amoxicillin 2 x 1000 mg

    Combination of 6-10 days
    – PPI/ Lansoprazole / 2 x 30 mg daily
    – Clarithromycin 2 x 500 mg
    – Tinidazole 2 x 500 mg

    The following repeated treatment courses are recommend upon initial failure:

    – PPI / Lansoprazole / + 2 x 30 mg
    – Bismuth subcitrate 4 x 120 mg
    – Tetracycline 4 x 500 mg
    – Metronidazole 3 x 500 mg

    After the failure of the second eradication, patients have to be directed to a specialist gastroenterologist. After the failure of the second eradication, the sensitivity of HP to different antibiotics (secondary resistance) has to be examined microbiologically (after taking biopsy). The therapeutic approach is determined by the results of the microbiological testing. A failed regimen should never be repeated!

    For the treatment of the Helicobacter pylori infection Tchaikapharma High Quality Medicines offers on the Bulgarian market: PPI Lansoprazol and the antibiotic Clarithromycin with the following brand names:

    AF496 LanzAcid (Lansoprolol) 30 mg x 30 tabl. – 9.75 BGN
    JF 400 Klacar (Clarithromycin) 500 mg x 14 tabl. – 14.99 BGN