O. O. Bogomolets National Medical University, Kiev, Ukraine
Consilium Medicum Ukraina. 2011;5(4):12–13 Abstract
The results of an open-label, parallel-group, comparative study of the effectiveness of triple therapy (omeprazole, clarithromycin, and amoxicillin) in combination with intestinal adsorbent (enterosorbent) Enterosgel in patients with peptic ulcer disease (PUD) are presented in this article. It was established that the clinical effect and ulcer healing rate were significantly higher in patients with gastric ulcer that received Enterosgel than in patients of the control group. Using triple therapy combined with Enterosgel led to a significantly higher H.pylori eradication rate in patients with duodenal ulcer. It was found out that Enterosgel not only enhances the effectiveness of the eradication therapy but also improves its tolerance by reducing the side effects of antibiotics. Enterosgel can be widely used as an adjuvant in the treatment of H.pylori-positive PUD.
Peptic ulcer disease (PUD) is characterized by the formation of Helicobacter pylori (H.pylori)-positive peptic ulcers on the mucous membrane of the stomach and/or duodenum. PUD is a widespread disease that affects 10–15% of the world’s adult population [1, 6, 8]. Treatment of PUD with no medications to eradicate H. pylori often leads to recurrence (in 60–80% of cases during year) and complications (in 15–20% of patients). Thanks to application of new algorithms of PUD diagnostics and treatment, the nature of the disease course has significantly changed. The basic strategy of PUD treatment is to eradicate H. pylori, which in most cases allows the disease to be completely cured [6, 7, 9]. According to the international consensus, the recommended first-line treatment for H. pylori infection is a proton-pump inhibitor (PPI)-based triple therapy [2–9]. The effectiveness (successful eradication rate) of triple therapy is 80–93% in different countries and depends on several factors including duration of the treatment, resistance of H. pylori to antibiotics, individual sensitivity of patients to PPIs, compliance of patients, and side effects of the therapy (hepatotoxicity and diarrhea). A promising way to increase the effectiveness of the treatment and reduce the incidence of side effects is to use additional detoxifying agents including intestinal adsorbents (enterosorbents).
The objective of this study was to assess the effectiveness, safety, and tolerance of triple eradication therapy combined with enterosorbent Enterosgel in the treatment of PUD associated with H. pylori.
MATERIALS AND METHODS
60 patients (37 males and 23 females) aged from 18 to 60 years with H. pylori-positive peptic ulcers of the stomach (12 patients) and duodenum (48 patients) were included in this open-label, parallel-group, comparative study. To assess the effectiveness of the eradication therapy combined with enterosorbent Enterosgel, the patients were randomly assigned into two groups.
The experimental group was composed of 30 patients (25 with duodenal ulcer, and 5 patients with gastric ulcer) who received the 7-day triple eradication therapy combined with 10-day administration of Enterosgel. The triple therapy consisted of omeprazole (20 mg 2 times a day), clarithromycin (500 mg 2 times a day), and amoxicillin (1000 mg 2 times a day). Enterosgel was prescribed as 1 tablespoon 3 times a day (45 g/day), 1–2 hours before or after a meal. After finishing the basic course of the treatment, the patients continued to receive omeprazole 20 mg once a day for 2 weeks (with duodenal ulcer) and 3–6 weeks (with gastric ulcer).
The control group consisted of 30 patients (23 patients with duodenal ulcer and 7 patients with gastric ulcer) who received only the 7-day triple therapy and a subsequent omeprazole treatment (20 mg once a day) for 2 weeks (with duodenal ulcer) and 3–6 weeks (with gastric ulcer).
At initial examination, all patients underwent a physical and laboratory examination (total protein and protein fractions, total bilirubin and its fractions, liver function test, blood glucose level, and stool for occult blood), endoscopy with biopsy, pH-measurement of gastric juice, and abdominal ultrasound. Two methods were used for verifying the diagnosis (histopathology and rapid urease test). Pain and dyspeptic syndrome were observed in all patients with duodenal ulcer (100%) and in 9 out of 12 (75%) patients with gastric ulcer. High acidity of gastric juice was revealed in 79.2% of patients with duodenal ulcer and in 66.6% with gastric ulcer.
On day7 of treatment, all patients underwent a physical and laboratory examination.
On day28 after the start of treatment, all patients underwent a physical and laboratory examination, endoscopic assessment. Endoscopy was not performed in patients with duodenal ulcer if no clinical manifestations of disease were observed.
On day49 after the start of treatment, an endoscopic examination was performed in those patients with gastric ulcer who had no complete healing of ulcers within 28 days.
Comparative effectiveness of treatments in the two groups of patients was assessed in terms of following indicators:
clinical improvement rate (reduction or disappearance of all clinical manifestations of the disease) on the 7th, 28th and 49th day after the start of treatment (number and percent of patients);
gastric ulcer healing rate on the 28th and 49th day of the study (number and percent of patients);
H. pylori eradication rate according to the data of 13C-urea breath test performed in 4 weeks after completion of treatment (number and percent of patients).
Data identified as criteria for the effectiveness and tolerance was assessed according to the offered scale, processed statistically, and compared in both the groups.
The effectiveness of treatment was monitored using 13C-urea breath test performed in 4 weeks after completion the treatment. Conclusion regarding the effectiveness and tolerance of the triple therapy with/without Enterosgel was made based on the obtained results.
RESULTS AND DISCUSSION
All patients completed their treatment without interruption. The dynamics of clinical manifestations of the disease in both groups of patients is presented in Table 1.
Table 1. Clinical improvement rate on different days after the start of treatment, n (%)
(n = 30)
(n = 30)
(n = 5)
(n = 25)
(n = 7)
(n = 23)
(for patients with gastric ulcer)
aр < 0.05 vsthe control group. As it can be seen from Table 1, there were revealed no differences in the speed of achieving positive dynamics in patients with duodenal ulcer. In patients of the experimental group with gastric ulcer, the clinical effect occurred quicker as the percentage of the patients with reduction or disappearance of clinical manifestations of the disease on day 28 of the treatment was significantly higher than in the control group (80% vs 71.4%, p < 0.05).
Significant difference was observed in the rate of healing of gastric ulcers within 28days of treatment (Table 2). Complete healing of ulcers took place in 3 out of 5 patients of the experimental group (60%) while healing was noted only in 3 out of 7 patients of the control group (42.8%) during the same period (p < 0.05).
Table 2. The rate of complete healing of gastric ulcers on the 28th and 49th day after the start of treatment, n (%)
(n = 5)
(n = 7)
aр < 0.05 vsthe control group. Application of basic therapy combined with Enterosgel allowed increasing the effectiveness of the treatment (clinical improvement and endoscopic healing) in 28 days in patients with gastric ulcer.
Administration of enterosorbent Enterosgel was accompanied by a significantly higher H. pylori eradication rate in patients with duodenal ulcer (Table 3).
Table 3.H. pylori eradication rate according to the results of 13C-urea breath test performed in 4 weeks after completion of treatment, n (%)
(n = 12)
(n = 48)
(n = 60)
(n = 30)
(n = 5)
(n = 25)
(n = 30)
(n = 7)
(n = 23)
aр < 0.05 vsthe control group. Comparative analysis of tolerance of the eradication therapy with/without Enterosgel was assessed based on the frequency and intensity of the side effects (Table 4).
Table 4. The rate and type of side effects of therapy on the 7th day of treatment, n (%)
aр < 0.05 vsthe control group. No serious side effect was recorded during the treatment. In patients of both the groups, there were observed non-serious side effects associated with the administration of clarithromycin and amoxicillin. The total number of patients with side effects was significantly lower in the group receiving Enterosgel than in the control group (33.3 vs 46.6%, p < 0.05). Besides, symptoms such as abdominal bloating (16.6% vs 26.6%, p < 0.05), diarrhea (16.5% vs 30%, p < 0.05), unpleasant metallic and bitter taste in the mouth (33.3% vs 46.6%, p < 0.05), and transient elevation of transaminases (3.3% vs 13.3%, p < 0.05) were significantly rare in the experimental group than in the control group. More than one side effect was observed in 9 patients (30%) of the experimental group and in 14 patients (46.6%) of the control group (p < 0.05). Excellent and good treatment tolerance was observed in 21 patients (70%) of the experimental group and in 16 patients (53.3%) of the control group (p < 0.05). In other patients, the tolerance was assessed as satisfactory.
The safety of treatment was assessed based on the dynamics in complete blood count and biochemical analysis of blood. No significant changes were noted pertaining to the laboratory parameters of blood except transient elevation of transaminases on day 7 of treatment. Transient hypertransaminasemia was observed in 1 patient (3.3%) of the experimental group and in 4 patients (13.3%) of the control group. Its appearance was probably connected with the hepatotoxic effect of the antibiotics.
Intestinal adsorbent (enterosorbent) Enterosgel is an adjuvant in the treatment of patients with H. pylori-positive PUD.
Enterosgel enhances the effectiveness of the triple eradication therapy, reliably reduces the rate of side effects of antibiotics, and improves their tolerance.
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