Oral Omeprazole Research Articles

Comparison of oral esomeprazole and oral omeprazole in the treatment of equine squamous gastric disease

Comparison of oral esomeprazole and oral omeprazole in the treatment of equine squamous gastric disease

Clinical effect of acupuncture for gastroesophageal reflux disease based on the "heart-stomach connection" theory and its effects on serum gastrointestinal hormones

To observe the effect of acupuncture on gastroesophageal reflux disease (GERD) based on the "heart-stomach connection" theory, and to explore its possible mechanisms. Seventy patients with GERD were randomly divided into an acupuncture group (35 cases, 2 cases dropped out) and a medication group (35 cases, 1 case dropped out). The patients in the acupuncture group received acupuncture at bilateral Shenmen (HT 7), Neiguan (PC 6), Burong (ST 19), Tianshu (ST 25), Zusanli (ST 36), Gongsun (SP 4), and Zhongwan (CV 12), with needles retained for 30 min, every other day, three times a week. The patients in the medication group were treated with oral omeprazole capsules, once daily, 20 mg each time. Both groups were treated for 8 weeks. Before and after treatment, the GERD questionnaire (GERDQ), GERD-quality of life scale (GERD-QOL), Hamilton depression scale-24 (HAMD-24), Zung self-rating depression scale (SDS), and Zung self-rating anxiety scale (SAS) scores were observed. Serum levels of gastrointestinal hormones (gastrin [GAS], motilin [MTL], and vasoactive intestinal peptide [VIP]) were measured, and the clinical efficacy of both groups was evaluated. Correlation between pre-treatment GERDQ score and GERD-QOL score, HAMD-24 score, SDS score, and SAS score was analyzed. After treatment, the scores of GERDQ, HAMD-24, SDS, and SAS were decreased (P<0.001) and the scores of GERD-QOL were increased (P<0.001), serum levels of GAS and MTL were increased (P<0.001) in both groups, while the serum level of VIP in the acupuncture group was decreased (P<0.001) compared with those before treatment. The acupuncture group had higher GERD-QOL score and lower SAS score than the medication group (P<0.05), with lower serum VIP level (P<0.05). The total effective rate was 75.8% (25/33) in the acupuncture group, and 76.5% (26/34) in the medication group, with no significant difference between the two groups (P>0.05). GERDQ score was negatively correlated with GERD-QOL scores (r =-0.762, P<0.01) and positively correlated with HAMD-24 score, SDS score, and SAS score (r =0.709, 0.649, 0.689, P<0.01) before treatment. Based on the "heart-stomach connection" theory, acupuncture could effectively improve clinical symptoms, quality of life, and negative emotions in patients with GERD. Its mechanism may be related to the regulation of gastrointestinal hormone levels, thereby promoting the contraction of the lower esophageal sphincter.

Comparison of oral esomeprazole and oral omeprazole in the treatment of equine squamous gastric disease.

Oral omeprazole is the accepted treatment for equine squamous gastric disease (ESGD); however, it is not universally effective. Esomeprazole results in more consistent and pronounced acid suppression in men and is more effective than omeprazole in the treatment of oesophageal and gastric disease. Pharmacodynamic and pilot clinical studies have indicated esomeprazole might also be more effective than omeprazole in horses. To compare the efficacy and safety of oral esomeprazole and omeprazole pastes in the treatment of ESGD and, where present, concurrent equine glandular gastric disease (EGGD). Randomised, single-blinded controlled trial. Horses presenting with grade ≥2 ESGD lesions were randomly allocated to receive 4 mg/kg of either a buffered esomeprazole or omeprazole paste orally once daily for 28 days before gastroscopy being repeated within a further 3 days. Videos and images were anonymised and subsequently graded blind by one researcher. The severity of ESGD (and EGGD) lesions before and after treatment, and thereby treatment responses, were compared using univariable logistic regression. A higher proportion of horses had ESGD healing in response to esomeprazole treatment (63/74, 85%) than with omeprazole treatment (43/73, 59%) (odds ratio [OR]: 4.00, 95% confidence interval [CI]: 1.81, 8.82, p = 0.001). In a subset of horses that had concurrent EGGD, a greater proportion of the horses treated with esomeprazole had lesions ≤grade 1 (esomeprazole 28/51, 55%; omeprazole 6/24, 25%; OR: 3.65, 95% CI: 1.25, 10.71, p = 0.02) Using grade 0 as the benchmark for EGGD healing, the difference remained significant (OR: 4.44, 95% CI: 1.33, 14.85, p = 0.02). It may not be possible to extrapolate these results to other populations with different signalment or management. Oral-buffered esomeprazole was a more effective treatment for ESGD (and concurrent EGGD) than oral-buffered omeprazole.

Gastric development of pancreatic acinar cell metaplasia after Vonoprazan therapy in rats.

Vonoprazan is a new acid-suppressing drug that received FDA approval in 2022. It reversibly inhibits gastric acid secretion by competing with the potassium ions on the luminal surface of the parietal cells (potassium-competitive acid blockers or P-CABs). Vonoprazan has been on the market for a short time and there are many clinical trials to support its clinical application. However, medical experience and comprehensive clinical data is still limited, especially on how and if, gastric histology is altered due to therapy. A 12-week experiment trial with 30 Wistar rats was to assess the presence of gastrointestinal morphologic abnormalities upon administration of omeprazole and vonoprazan. At six weeks of age, rats were randomly assigned to one of 5 groups: (1) saline as negative control group, (2) oral omeprazole (40mg/kg), as positive control group, (3) oral omeprazole (40mg/kg) for 4weeks, proceeded by 8weeks off omeprazole, (4) oral vonoprazan (4mg/kg), as positive control group, and (5) oral vonoprazan (4mg/kg) for 4weeks, proceeded by 8weeks off vonoprazan. We identified non-inflammatory alterations characterized by parietal (oxyntic) cell loss and chief (zymogen) cell hyperplasia and replacement by pancreatic acinar cell metaplasia (PACM). No significant abnormalities were identified in any other tissues in the hepatobiliary and gastrointestinal tracts. PACM has been reported in gastric mucosa, at the esophagogastric junction, at the distal esophagus, and in Barrett esophagus. However, the pathogenesis of this entity is still unclear. Whereas some authors have suggested that PACM is an acquired process others have raised the possibility of PACM being congenital in nature. Our results suggest that the duration of vonoprazan administration at a dose of 4mg/kg plays an important role in the development of PACM.

Effectiveness of Omeprazole in Acid Peptic Disease: A Real-World, Patient-Reported Outcome Measures Study.

Objectives This prospective study assessed the effectiveness and patient satisfaction of four-week omeprazole therapy in acid peptic disease (APD). Methods This was an observational, post-marketing, real-world evidence, patient-reported outcome(PRO) measures study. Patients visiting the five study sites across India with symptoms ofAPD, andwho were prescribed oral omeprazole (20/40 mg per day) for at least four weeks were enrolled after obtaining informed consent. Study assessments includedfrequency and severity of symptoms and overall satisfaction reported by the patients using the Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) questionnaire. The satisfaction with therapy was reported by the patients using the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire. Both PAGI-SYM and TSQM were reported by patients on days 14 and 28. Omeprazole safety was assessed based on the adverse events reported by the patients. Results A total of 96 (62 males and34 females) patients were included in the study, of which 38.54% had significant findings related to APD at baseline.The proportion of patients with symptoms reduced to 16.67% on day 14and 8.33% on day 28 with omeprazole therapy. The PAGI-SYM total scores at baseline were 41.32 (15.487), which reduced to 20.86 (11.620) on day 14 (p < 0.0001), and to 8.93 (8.361) on day 28 (p < 0.0001). Significant reductions were also seen in individual symptom scores. The TSQM total scores increased to 36.67 (range: 13 to 63) on day 28 from 34.69 (range: 12 to 58) on day 14. Improvement in scores for all domains of TSQM (effectiveness, convenience, and global satisfaction) was seen on day 28. Improvement in reflux symptoms was reported by 46.74% and 68.48% of patients on day 14 and day 28, respectively. Four (4.17%) patients reported adverse events, which were of mild severity and were unrelated to omeprazole. Conclusions Omeprazole provides significant improvement in PAGI-SYM and TSQM questionnaires on day 14 and day 28.Patients reported the omeprazole-based therapy as effective, convenient, and satisfactory. Omeprazole therapy is safe and effective for the treatment of APD and shows good improvement in APD in patients suffering from duodenal ulcers, gastric ulcers, and reflux oesophagitis.

Evaluation of the effects of medium-term (57-day) omeprazole administration and of omeprazole discontinuation on serum gastrin and serum chromogranin A concentrations in the horse.

Rebound gastric hyperacidity (RGH) secondary to hypergastrinemia has been suggested to contribute to the rapid recurrence of equine squamous gastric disease (ESGD) in horses after discontinuation of omeprazole. To evaluate changes in serum gastrin and chromogranin A (CgA) concentrations in response to medium-term (57-day) omeprazole treatment and after omeprazole discontinuation. Fourteen mature Thoroughbred racehorses in simulated race training. Horses received 2.28 g of oral omeprazole PO q24h for 57 days within a 61-day period, excluding a withholding period applied mid-protocol during which treatment was stopped as part of a concurrent study. Serum samples were collected on day 0 before omeprazole treatment, on day 1 of each week of the treatment period, and for an additional 5 weeks after discontinuation of treatment. Serum gastrin and CgA concentrations were analyzed using radioimmunoassay (RIA) and ELISA, respectively. Median serum gastrin concentrations increased 2.5-fold from baseline to day 7 (P < .001) but did not increase further during the omeprazole treatment period. Median serum gastrin concentrations returned to baseline within 2 to 4 days after administration of the last dose of omeprazole. No effect of treatment or discontinuation was seen in serum CgA concentrations. Serum gastrin concentrations increased in response to omeprazole treatment but returned to baseline within 2 to 4 days after the last dose of omeprazole. No effect of treatment or discontinuation was seen in serum CgA concentrations. Our results do not support the use of tapering protocols in horses.

The Impact of Two Recommended Withholding Periods for Omeprazole and the Use of a Nutraceutical Supplement on Recurrence of Equine Gastric Ulcer Syndrome in Thoroughbred Racehorses.

The impact of recommended withholding periods (RWPs) for omeprazole on the recurrence of Equine Gastric Ulcer Syndrome (EGUS) is unknown. The study was designed to compare the effect of two RWPs on EGUS recurrence post-omeprazole treatment and to determine if a nutraceutical supplement would reduce EGUS recurrence when administrated during an RWP. The study was a blinded, randomized clinical trial. Part 1: Horses were allocated to an RWP0 or RWP2 and crossed over after 4-weeks. Horses received oral omeprazole once daily, except during the RWPs at the end of the treatment periods. Part 2: Horses received omeprazole for 21 days prior to an RWP2 during which they received a nutraceutical supplement. Gastroscopy was performed on Day 0 and pre- and post- RWP. Part 1: More horses were affected by Equine Squamous Gastric Disease (ESGD) after the '2-clear-days' RWP than the 'not on race-day' RWP (p = 0.012). The prevalence of ESGD post-RWP for '2-clear-days' did not differ from day 0 (p = 0.478). Part 2: The prevalence of ESGD post-RWP was lower than on Day 0 (p = 0.046). A difference in recurrence of ESGD was present between the two common RWPs. The implications of this on the welfare of Thoroughbred racehorses warrant further discussion.

A Comparison of the Efficacy of Two Omeprazole Formulations in the Treatment of Equine Gastric Ulcer Syndrome in Racehorses: A Blinded, Randomized Clinical Trial

Equine gastric ulcer syndrome (EGUS) is the most common disease of the stomach in horses and treatment is based on the oral administration of omeprazole for at least 28 days. Aim of this study was to compare the efficacy of two formulations of oral omeprazole—powder paste and gastro-enteric resistant granules—in the treatment of naturally occurring gastric ulcers in racehorses. Thirty-two adult racehorses, aged between 2 and 10 years old, with clinical signs of EGUS were included in this blinded, randomized clinical trial. Two gastroscopies were performed to evaluate gastric lesions in the squamous or glandular mucosa before and after 28 days of treatment. After the first gastroscopy, 2/32 horses were excluded because affected by equine squamous gastric disease (ESGD) 1/4. The remaining horses were divided into 4 groups, and were treated with 2 formulations of omeprazole (gastroenteric resistant granules, group 1, or powder paste, group 3) or with 2 placebo formulations (granules, group 2, or paste, group 4). Treatments were performed in the placebo horses affected by ESGD or equine glandular gastric disease after the T28 gastroscopy control. No differences were found between groups at T0. Differences were found between T0 vs. T28 for granular (P = .002) and powder paste (P = .01) formulations. No differences were detected between the two groups receiving omeprazole formulations at T28 (0.34) and between T0 vs. T28 for either of the groups receiving placebo treatments. For all the variables, the size of the effect was greater than 0.5, proving that the treatments had a considerable effect. Gastro-enteric resistant granules and powder paste omeprazole showed similar efficacy in the treatment of ESGD. The glandular mucosa responded poorly to treatment with omeprazole.

P203 Oral omeprazole and diclofenac intake is associated with increased faecal calprotectin levels: a randomised open-label clinical trial

Abstract Background Non-steroidal anti-inflammatory drugs and proton pump inhibitors are known to affect the diagnostics of gastrointestinal disorders. The aim of this study was to investigate to what extent omeprazole, diclofenac or co-administration of these affects faecal calprotectin (FC) levels, and the normalisation interval after cessation. Methods Participants received 20 mg omeprazole daily for two weeks in the first sequence, 50 mg oral diclofenac three times daily for two weeks in the second and co-administration of these for two weeks in the third, with washout periods in between. The first two sequences were randomised to a different order. FC was measured on day 0, 4, 7, 14, 21, 28 and 35 and thereafter at 7-day intervals until normalisation in each sequence. Results Thirty-two healthy volunteers were included. During drug intake, 39% on diclofenac (median 70.8 µg/g; range 50.2-1080 µg/g), 53% on omeprazole (median 85.3 µg/g; range 51.1-249 µg/g) and 69% on omeprazole + diclofenac (median 101.5 µg/g; range 51.5-532 µg/g) had FC levels above normal. In the diclofenac sequence, FC returned to normal in all participants within two weeks of cessation and in the omeprazole and co-administration sequences, within three weeks of cessation. No statistical significant difference was found with respect to drug order. Conclusion Short-term intake of omeprazole, diclofenac or co-administration appears to increase FC levels. In patients with increased FC on omeprazole alone or in combination with diclofenac, a repeated FC test is recommended at least three weeks after cessation. On diclofenac alone, it is sufficient to repeat the FC test two weeks after cessation.

Oral versus intravenous omeprazole in management of bleeding peptic ulcer: a randomized controlled trial

Background Upper gastrointestinal bleeding (UGIB) is a common gastrointestinal emergency with significant morbidity and mortality. Intravenous (IV) route administration of proton pump inhibitors is more commonly used for prevention of bleeding; however, it is more expensive and invasive than the oral route. We, herein, compared between oral and IV omeprazole in patients with high-risk UGIB regarding outcome. Patients and methods Patients with high risk for rebleeding peptic ulcers were included. All patients initially received IV omeprazole, and then esophagogastroduodenoscopy with hemostatic procedure was done. Thereafter, the patients were allocated to group A, who received oral omeprazole, and group B, who received IV omeprazole. The patients were followed up for 2 weeks for signs of rebleeding. Reendoscopy, angioembolization, or surgery was provided when needed (NCT04170270). Results The study included 189 patients (96 in group A and 93 in group B). Frequency of rebleeding was higher among patients in group B (40%) compared with those in group A (30%) (P: 0.1). Reendoscopy was more frequently required for patients in group B (16.1%) than those in group A (3.1%) (P&lt;0.001). Surgery was mandatory for three (3.2%) patients in group B, whereas angioembolization was used nearly equally in both groups (31.3% in group A vs. 29% in group B). Admission to ICU was more frequently needed (P: 0.02) and the length of hospital stays was longer (P: 0.003) for patients of group B. Regarding UGIB-related deaths, three (3.1%) patients from each group died. Conclusion Oral omeprazole is not inferior to IV omeprazole as adjuvant therapy to control peptic ulcer bleeding and to reduce the frequency of rebleeding.

Evaluation of Proton Pump Inhibitors Prescribing Among Hospitalized Patients: A Cross-Sectional Study.

Proton pump inhibitors (PPIs) are the most effective agents for managing acid-related disorders. However, inappropriate prescribing of PPIs is becoming an issue of concern. This study aimed to assess the appropriate utilization of PPIs in terms of indication, dose, frequency, and route of administration during admission and discharge. Furthermore, direct costs associated with inappropriate PPI use were calculated. A descriptive cross-sectional study was conducted at the internal medicine department of a tertiary hospital in Palestine from January 1, 2021, to June 30, 2021. The medical records of patients aged 18 years or older, hospitalized for 48 hours or more, and receiving oral or intravenous (IV) PPIs during their stay were collected and evaluated for the appropriateness of PPIs prescribed according to clinical guidelines. Of 262 patients, 80.2% had an appropriate indication for prophylaxis (67.6%) or treatment (12.6%). A total of 230 patients were prescribed IV pantoprazole.182 (79.1%) had an appropriate indication, whereas 122/182 (67%) received IV PPI instead of oral without an appropriate indication. Of the 32 patients who received 20 mg of oral omeprazole, 28 (87.5%) had an appropriate indication, dose, and route of administration, whereas 16/28 (57.1%) had an inappropriate frequency. At discharge, 32.5% of patients were discharged with unnecessary PPI prescriptions. The total direct cost of inappropriate PPI Indications and route of administration in 188 patients over six months was $1518. This study showed that most patients received a PPI for an appropriate indication with the correct dose. However, a high prevalence of inappropriate IV pantoprazole administration was observed, resulting in the highest costs, demonstrating the importance of correctly ordering IV medications. Adherence to clinical guidelines, such as those of the American College of Gastroenterology (ACG), will improve the appropriateness of PPI prescribing, prevent complications, and reduce healthcare costs.

Does Omeprazole, the Proton-Pump Inhibitor, Affects the Structure of the Kidney of Male Albino Rats? Histological and Laboratory Study.

This study was done to assess the injurious effects of omeprazole by an in vivo experimental study on rat kidneys. Forty-two adult male albino rats were divided into four groups: Control group (I) in which rats were not administrated any treatment. In Groups IIa, IIb, and IIc rats received daily oral omeprazole in dose of 0.75 mg per kg for 2, 4, and 6 weeks, respectively. At the end of the experiment, blood samples were collected for serum creatinine and blood urea nitrogen measurement. Then, animals were sacrificed, and kidney specimens were processed for paraffin blocks, sectioned and stained with H and E, Mallory trichrome and Periodic acid-Schiff, then examined by the light microscope. Stained sections and image analysis were used to count vacuolated cells, pyknotic nuclei, tubular casts, and area percent of collagen fiber deposition, and then, data were subjected to the statistical analysis. Examination of omeprazole-treated groups showed injury of renal corpuscles, renal tubules, and vascular congestion with inflammatory cell infiltrate in renal interstitium. Thickening of basement membrane with deposition of collagen fibers was also detected. Statistically significant increase in the number of vacuolated cells, pyknotic nuclei, hyaline casts, and area percentage of collagen fiber deposition as compared with the control group was noticed, with deterioration of renal function tests. It was concluded that the long-term use of omeprazole resulted in structural damage of rat renal tissue associated with deterioration of renal function in a time-dependent manner.

Does lesion type or severity predict outcome of therapy for horses with equine glandular gastric disease? - A retrospective study.

Equine glandular gastric disease (EGGD) is a common condition of the horse. Misoprostol is reported to be superior to oral omeprazole and sucralfate for treatment. Long-acting intramuscular injectable omeprazole (LAIOMEP) is a novel treatment shown to be effective in a small population. This study aimed to determine LAIOMEP efficacy compared to misoprostol and oral omeprazole and identify characteristics that predict treatment outcome. All horses that underwent gastroscopy between 2012 and 2019 were reviewed. Lesions were characterised by 4 blinded observers, all of whom are diplomates in equine internal medicine, using established descriptors from the ECEIM consensus statement and subjective severity. Treatment outcome was ranked as worsened, improved or healed. Consensus lesion type, lesion severity and treatment choice were compared to outcome and data screened using univariate analysis (chi-squared) to determine whether each predicted outcome. Lesion types where univariate analysis predicted a trend (p<0.2) were included in a multiple-regression analysis to identify predictors of outcome irrespective of treatment. Only severity significantly predicted final outcome (p = 0.025) with severe lesions being more likely to improve. Treatment choice did not significantly predict outcome. Overall healing rate was 29% (24 horses), and 43% (44 horses) improved. Treatment healing rates were 23% (10), 12% (7) and 27% (7) for LAIOMEP, misoprostol and oral omeprazole, respectively, with improvement in 69% (14), 76% (21) and 61% (9). 64% of the latter group received sucralfate. Worsening occurred in 7% (6). Treatment length varied with a median of 4 weeks (range 4-20 weeks). This study showed poorer therapy outcome compared to previous studies. The only initial lesion descriptor to predict outcome was severity and treatment choice did not affect outcome.

ANAPHYLACTIC REACTION TO OMEPRAZOLE AFTER NEGATIVE PANTOPRAZOLE ALLERGY TESTING

<h3>Introduction</h3> Proton pump inhibitors (PPIs) are widely used inhibitors of gastric acid secretion. PPIs are generally well tolerated with very few side effects and hypersensitivity reactions are rarely described. Here we present an adult man who reports anaphylaxis upon treatment with oral omeprazole. <h3>Case Description</h3> A 56-year-old man presented with symptoms of skin rash with pruritus of the skin upon treatment with oral omeprazole in treating Helicobacter pylori on two separate occasions. The reaction occurred after the first dose of the drug. Allergy skin testing (SKT) to pantoprazole was negative, and the patient tolerated the graded oral challenge to Pantoprazole. To treat the H. pylori infection, the patient took Talicia (amoxicillin, rifabutin, and omeprazole) and developed generalized pruritus, itchy tongue, throat, and bilateral hand swelling within 20 minutes of taking this medication. He also experienced chest tightness, shortness of breath, abdominal pain, dizziness, and vomiting. The patient was taken to the emergency department and received IV Benadryl (25 mg), famotidine (20 mg), methylprednisolone (125 mg), and intravenous fluids (1L NS), with an improvement in his symptoms. Upon follow-up for this anaphylactic reaction, allergy SKT and challenge to penicillin were performed which were negative. <h3>Discussion</h3> This case reinforces the importance of performing SKTs and oral drug challenges for each medication within the PPI drug class. The cross-reactivity between different PPIs is not currently well described, and other PPIs should be avoided unless an SKT and oral drug challenge are performed under close observation. Further studies are needed to provide more information on cross-reactivity among PPIs.

Clinical effect of Anwei Qingyou recipe on peptic ulcer and its effect on the levels of EGF and PGE2: A retrospective study.

Background:To investigate the effect of Anwei Qingyou formula on the clinical treatment of patients with peptic ulcer (PU) and its effect on the levels of epidermal growth factor (EGF) and prostaglandin E2 (PGE2).Methodology:Medical records of 83 patients with PU, treated in our hospital from January 2020 to January 2021, were retrospectively analyzed. Among them, 40 patients received conventional triple therapy (scheme I), that is, oral omeprazole, clarithromycin and amoxicillin, twice a day, and 43 patients received conventional triple therapy + Anwei Qingyou formula, taken orally twice a day (scheme II). The improvement of clinical symptoms, the quality of ulcer healing, clinical effectiveness and recurrence rate were analyzed after 4 weeks of treatment. Patients were followed up for six months.Results:After treatment with corresponding regimen, the total clinical effective rate of scheme II was 97.57% (42/43), which was significantly higher than 82.50% (33/40) of scheme I. Six-month follow-up results showed that the recurrence rate in scheme II patients was 4.65% (2/43), which was significantly lower than 20.00% (8/40) in the scheme I group (χ 2 = 5.479, 4.607, all P < .05). After one course of treatment, the levels of serum EGF and PGE2 in scheme II group were higher than those in scheme I group (P < .05).Conclusion:In combination with the conventional western medicine treatment, Anwei Qingyou formula administration in PU patients effectively improves the overall control of the disease and therapeutic effectiveness.

Herbal Medicine Hewei Jiangni Decoction Is Noninferior to Oral Omeprazole for the Treatment of Nonerosive Gastroesophageal Reflux Disease: A Randomized, Double-Blind, and Double-Dummy Controlled Trail.

Objectives Conventional approaches for patients with nonerosive gastroesophageal reflux disease (NERD) were not satisfactory. This study aimed to evaluate the effectiveness and mechanisms of Chinese herbal medicine Hewei Jiangni Decoction (HWJND) as a novel and promising regimen for NERD. Methods A total of 128 patients with NERD were randomly assigned to the Treatment group and Control group. The patients from the Treatment group were administered HWJND (81 g) plus dummy omeprazole (20 mg) daily for 8 weeks, and the others were given dummy HWJND granules (81 g) plus omeprazole (20 mg). The clinical efficacy was assessed using the gastroesophageal reflux disease questionnaire (GERD-Q) scale, patient reported outcomes (PRO) scale, and short form health survey 36 (SF-36) scale at week 4. Moreover, its pharmacological and molecular mechanisms were elucidated based on network pharmacology and molecular docking. Results Due to case shedding and other reasons, 109 patients, including 56 in the Treatment group and 53 in the Control group completed this study. Our results showed that HWJND significantly improved heartburn, regurgitation, epigastric pain, nausea, and sleep disturbance, which led to a significant reduction of GERD-Q scores in NERD patients. In addition, PRO scores of NERD patients with HWJND administration were improved, and sufficient relief of physical role, body pain, general health, social function, and mental health on the SF-36 scale was also observed in patients after HWJND treatment. We further showed that the curative effect of HWJND was close to that of omeprazole, except for the better improvement of general health and social function. What's more, the main active ingredients of HWJND included quercetin, beta-sitosterol, naringenin, baicalein, and kaempferol were retrieved, and the protective effects of HWJND against NERD may be closely related to targets such as TNF, IL6, IL1B, MMP9, CXCL8, and EGFR, which were mainly enriched in IL-17 signaling pathway and TNF signaling pathway. Conclusion Our findings demonstrate that HWJND is noninferior to oral omeprazole for the treatment of patients with NERD, plays a therapeutic role through multiple targets and diverse pathways, and holds promise for complementary and alternative therapy for the treatment of NERD. This trial is registered with http://www.chictr.org.cn, Chinese Clinical Trials Registry [ChiCTR2200055960].

Effect of Laparoscopic Sleeve Gastrectomy on the Pharmacokinetics of Oral Omeprazole Using a Population Approach.

Omeprazole is commonly prescribed to obese patients and patients after laparoscopic sleeve gastrectomy (LSG). The pharmacokinetics of oral omeprazole after LSG are still unknown. Therefore, the aim of this study was to investigate the pharmacokinetics of oral omeprazole in obese patients before and after LSG. A total of 331 blood samples were collected from 62 obese patients preoperatively (visit 1) followed by 41 patients 7 days post-LSG (visit 2) and 20 patients 1 month post-LSG (visit 3). Population pharmacokinetic analysis was performed using NONMEM to characterize the effect of LSG on omeprazole absorption and disposition. A one-compartment model with 12 transit absorption compartments and linear elimination successfully described the data. Compared with pre-surgery, the oral omeprazole time to maximum plasma concentration (Tmax) was reduced and maximum plasma concentration (Cmax) was higher, but the apparent clearance (CL/F) and area under the plasma concentration–time curve (AUC) were unchanged 7 days and 1 month after surgery. In addition, the CYP2C19 genotype and liver function exhibited a significant influence on omeprazole CL/F. LSG increased the rate of omeprazole absorption but did not affect omeprazole exposure. A dose of 20 mg omeprazole once daily may be adequate for relieving gastrointestinal tract discomfort at short-term follow-up post-LSG.

Abomasal ulcers: Do ranitidine or omeprazole prevent phenylbutazone-induced lesions in sheep?

Treatment and prevention of gastric ulcers are well known in monogastric animals; however, there are uncertainties about the preventive effects of acid-reducer drugs, their dosages and the best route of administration to ruminants. The object of this research was to test the preventive actions of ranitidine and omeprazole on abomasal ulcer development in sheep treated with a high dosage of non-steroidal anti-inflammatory drug. Eight healthy adult sheep with abomasal cannula were distributed in two contemporary and balanced 4 × 4 Latin squares (eight animals per group). For seven days, animals in the control group received high doses of phenylbutazone (4.4 mg/kg, every 12 h) while the treated groups received the same high doses of phenylbutazone plus an acid-reducer drug, namely 2 mg/kg of intravenous ranitidine every 12 h; 0.4 mg/kg of intravenous omeprazole; 4 mg/kg of oral paste omeprazole, both once a day. Intravenous omeprazole caused phlebitis, increasing serum fibrinogen content, and 75 % of the treated animals were diagnosed with type 1a ulcers in abomasal mucosa. Oral omeprazole showed no adverse effects, but was not effective in preventing type 1a ulcer in 50 % of animals, which was the same amount as diagnosed in control group. Despite of a minor heart rate increase, ranitidine treated animals showed only 37.5 % of abomasal injuries. Based on clinical findings, intravenous ranitidine is apparently better than omeprazole in prevention of abomasal ulcers, but another kind of experimental design comparing group by group is required and strongly recommended to ensure the beneficial effect of ranitidine.

Omeprazole-induced galactorrhea in kidney transplant patients\u2014a case report

BackgroundOmeprazole belongs to the pharmacological classifications of proton pump inhibitors and is a widely used medicine. All proton pump inhibitors have a common mechanism of action and are prodrugs that require activation in an acidic environment. Omeprazole is extensively metabolized in the liver by cytochrome 2C19 and cytochrome 3A4, which are responsible for drug interactions. Omeprazole-induced galactorrhea is a rare adverse event of drug metabolism and is often underreported.Case presentationThis is a case of a 26-year-old unmarried Asian (Bhutanese) female who underwent kidney transplant and was administered standard antirejection medication (tacrolimus, prednisolone, and leflunomide) along with an antihypertensive agent. She came to the emergency department with complaints of nausea, vomiting, abdominal pain, chronic gastritis, anemia, hypertension, and loss of appetite. The tacrolimus trough level was in the subtherapeutic range at admission. The tacrolimus dose was adjusted, and oral omeprazole was administered. After 3 days, she experienced milk production from her left breast, which according to the patient was her second incidence after omeprazole ingestion.ConclusionCausality assessment using Naranjo’s algorithm and recovering from galactorrhea after stopping omeprazole and omeprazole rechallenge with the reappearance of galactorrhea confirmed omeprazole as the causative agent. Tacrolimus interferes with omeprazole metabolism and increases tacrolimus levels in the blood. Caution needs to be taken when omeprazole is administered with other drugs that interfere with metabolizing enzymes.

Evaluation of CYP2C19 activity using microdosed oral omeprazole in humans

PurposeTo investigate the suitability of microdosed oral omeprazole for predicting CYP2C19 activity in vivo in combination with simultaneous assessment of CYP3A and CYP2D6 activity using both microdosed midazolam and yohimbine.MethodsAn open, fixed-sequence study was carried out in 20 healthy participants. Single microdosed (100 µg) and therapeutic (20 mg) doses of omeprazole were evaluated without comedication and after administration of established CYP2C19 perpetrators fluconazole (inhibition) and rifampicin (induction). To prevent degradation of the uncoated omeprazole microdose, sodium bicarbonate buffer was administered. The pharmacokinetics of omeprazole and its 5-hydroxy-metabolite were assessed as well as the pharmacokinetics of midazolam and yohimbine to estimate CYP3A4 and CYP2D6 activity.ResultsCalculated pharmacokinetic parameters after administration of 100 µg and 20 mg omeprazole in healthy subjects suggest dose proportionality. Omeprazole clearance was significantly decreased by fluconazole from 388 [95% CI: 266–565] to 47.2 [42.8–52.0] mL/min after 20 mg omeprazole and even further after 100 µg omeprazole (29.4 [24.5–35.1] mL/min). Rifampicin increased CYP2C19-mediated omeprazole metabolism. The omeprazole hydroxylation index was significantly related to omeprazole clearance for both doses. Both fluconazole and rifampicin altered CYP3A4 activity whereas no change of CYP2D6 activity was observed at all.ConclusionsMicrodosed oral omeprazole is suitable to determine CYP2C19 activity, also during enzyme inhibition and induction. However, the administration of sodium bicarbonate buffer also had a small influence on all victim drugs used.Trial registrationEudraCT: 2017–004270-34.