Int J Gastrointest Interv 2019; 8(4): 160-164
Published online October 31, 2019 https://doi.org/10.18528/ijgii190003a
Copyright © International Journal of Gastrointestinal Intervention.
Abazar Parsi1,* , Maryam Biuseh1, Samira Mohammadi1, Eskandar Hajiani1, Seyed Jalal Hashemi1, Hooman Saeidian2, and Mehdi Biuseh3
1Department of Internal Medicine, Faculty of Medicine, Jundishapur University of Medical Sciences, Ahvaz, Iran
2Department of Pharmaceutics, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
3Substance Abuse Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Correspondence to:Department of Internal Medicine, Faculty of Medicine, Jundishapur University of Medical Sciences, Ahvaz 6135715794, Iran.
E-mail address: Dr_abazar_parsi@yahoo.com (A. Parsi). ORCID: https://orcid.org/0000-0003-3464-7761
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
This randomized clinical trial study was conducted on 160 patients with
The risk ratio of eradication of the infection in the simvastatin group 10 mg and simvastatin 20 mg was 0.375 and 0.625 times in compare with the placebo group, indicating a negative effect of simvastatin 10 and 20 mg on the treatment of
Due to the high efficacy of simvastatin in
Keywords: Adjuvant therapy, Eradication, Helicobacter pylori, Probiotic, Simvastatin
Peptic ulcer disease (PUD) refers to the presence of one or more ulcerative lesions in the lining of the stomach (gastric ulcers) or in the first part of the small intestine (duodenal ulcers). Rarely, nevertheless, peptic ulcers can also occur in the esophagus, jejunum or sometimes in a Meckel’s diverticulum.1 The 2 main etiologies of PUD are infection with the bacterium
Standard triple therapy (TT), which consists of proton pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole, is recommended as first-line therapy for eradication of
In recent years, despite many efforts to eradicate
Several factors involved in the therapy failure such as strain type, high bacterial load, low gastric pH and impairment of mucosal immunity. However, the main reason for the failure therapy is poor compliance and antimicrobial resistance.14 So,
Statins, or 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitors, are a class of lipid-lowering medications that widely prescribed for patients with hypercholesterolemia,15 and have a protective role in several bacterial diseases. In addition to cholesterol lowering effect, statins also have anti-inflammatory properties, including modulation of immune response, regulation of major histocompatibility complex class expression, mucosal proliferation and secretion activity.16 On the other hand, statins have gastroprotective effects and attenuation of peptic ulcer development.17 Studies have recently been reported that combination therapy includes TT regimen (PPI, clarithromycin and amoxicillin) along with statins accelerate the clearance of
Nowadays, probiotics are also considered as an adjuvant therapy to increase the rate of eradication and reduce the side effects of therapy regimens. Administration of probiotics to adults and children have improved
This randomized clinical trial study was performed on 237 patients with
The patients were randomly divided in four groups of 40. The group 1 received a standard quadruple eradication regimen consisting of two antibiotics (clarithromycin 500 mg and amoxicillin 1 g, all twice per day), a PPI (pantoprazole 40 mg twice daily), Bismuth (120 mg twice daily) with placebo (daily), group 2: standard regimen plus probiotic (daily east 250 mg), group 3: standard regimen supplemented with simvastatin (10 mg daily) and group 4: standard regimen plus simvastatin (20 mg daily). Patients were treated for 2 weeks and explanation of the amount and how of taking the drug was given to the participants.
The Eradication was determined by Stool antigen tests at least 1 month after treatment. The presence of
Statistical analysis was conducted with the chi-square for qualitative variables, and analysis of variance (ANOVA) for quantitative analysis of 2 or more groups (IBM SPSS Statistics, ver. 22; IBM Corp., Armonk, NY, USA) with 95% confidence interval. The
In this study, 73 (45.63%) of the subjects were male and 87 (54.38%) were female. There was no significant relationship between patients’ sex in the 4 groups (
Table 1 . The Results of Frequency Distribution of the Sex Patients in the 4 Groups.
Group | Male | Female | |
---|---|---|---|
Placebo | 18 (45.0) | 22 (55.0) | 0.250 |
Probiotic | 14 (35.0) | 26 (65.0) | |
Simostatin 10 mg | 18 (45.0) | 22 (55.0) | |
Simostatin 20 mg | 23 (57.5) | 17 (42.5) |
Values are presented as number (%)..
Table 2 . The Mean Age of Participants in Different Groups.
Group | Age (yr) | |
---|---|---|
Placebo | 38.02 ± 10.33 (19–53) | 0.347 |
Probiotic | 37.85 ± 9.14 (23–56) | |
Simostatin 10 mg | 38.17 ± 9.99 (21–53) | |
Simostatin 20 mg | 34.85 ± 8.86 (21–52) |
Values are presented as mean ± standard deviation (range)..
The results of RR of eradication of
Table 3 . The Results of the Comparison of
Group | Risk ratio (95% confidence interval) | Standard error | z | |
---|---|---|---|---|
Probiotic | 1.13 (0.48–2.62) | 0.486 | 0.27 | 0.785 |
Simostatin 10 mg | 0.38 (0.11–1.31) | 0.24 | −1.53 | 0.126 |
Simostatin 20 mg | 0.63 (0.22–1.75) | 0.328 | −0.89 | 0.372 |
The results of RR of eradication of
Table 4 . Comparison of the Probability Risk Ratio (RR) of Eradication of
Variable | RR (95% confidence interval) | Standard error | z | |
---|---|---|---|---|
Group | ||||
Probiotic | 1.07 (0.46–2.48) | 0.46 | 0.16 | 0.872 |
Simostatin 10 mg | 0.38 (0.11–1.32) | 0.24 | −1.52 | 0.128 |
Simostatin 20 mg | 0.66 (0.24–1.85) | 0.34 | −0.78 | 0.437 |
Sex | ||||
Male | 0.59 (0.26–1.3) | 0.23 | −1.29 | 0.196 |
The results of RR of eradication of
Table 5 . Comparison of the Probability Risk Ratio (RR) of Eradication of
Variable | RR (95% confidence interval) | Standard error | z | |
---|---|---|---|---|
Group | ||||
Probiotic | 1.12 (0.48–2.62) | 0.48 | 0.27 | 0.786 |
Simostatin 10 mg | 0.38 (0.11–1.31) | 0.24 | −1.53 | 0.126 |
Simostatin 20 mg | 0.66 (0.21–1.77) | 0.33 | −0.9 | 0.367 |
Age | 0.99 (0.95–1.03) | 0.019 | −0.27 | 0.785 |
The results of the current study demonstrated that simvastatin accompanied by the 4 drugs standard or routine treatment for 14 days, was able to increase the
Mahdavi23 examined the effect of atorvastatin 40 mg with a three-drug regimen for 14 days aiming at eradication of
Our results demonstrated that the use of probiotic had no significant effect on the rate of
This article is extracted from final thesis of Dr. Maryam Biuseh for his course of internal medicine residency with registration number 96805. This study was supported by Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
No potential conflict of interest relevant to this article was reported.
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