Percentage of evaluable patients remaining free from gastric and duodenal ulcer disease during therapy as calculated by life table methods. The difference between any 2 of the active treatments for time to occurrence of gastroduodenal ulcer was not statistically significant.

Graham DY , Agrawal NM , Campbell DR, et al. Ulcer Prevention in Long-term Users of Nonsteroidal Anti-inflammatory Drugs : Results of a Double-blind, Randomized, Multicenter, Active- and Placebo-Controlled Study of Misoprostol vs Lansoprazole.

Arch Intern Med. From the Department of Medicine, Veterans Affairs Medical Center, Houston, Tex Dr Graham ; Department of Medicine, Duke University Medical Center, Durham, NC Dr Agrawal ; Department of Medicine, University of Kansas School of Medicine, University of Missouri, Kansas City, School of Medicine, Department of Veterans Affairs Medical Center, and Saint Luke's Hospital, Kansas City Dr Campbell ; MCP Hahnemann University, Philadelphia, Pa Dr Haber ; TAP Pharmaceutical Products Inc, Lake Forest, Ill Mss Collis and Lukasik ; and Abbott Laboratories, Abbott Park, Ill Dr Huang.

Background Studies that report prevention of ulcer recurrence among long-term users of nonsteroidal anti-inflammatory drugs NSAIDs that do not stratify for Helicobacter pylori status may not be generalizable to the large population of individuals without H pylori.

Methods This was a prospective, double-blind, multicenter, active- and placebo-controlled study among patients without H pylori who were long-term users of NSAIDs and who had a history of endoscopically documented gastric ulcer.

Patients were randomized to receive placebo, µg of misoprostol 4 times a day, or 15 or 30 mg of lansoprazole once daily for 12 weeks. Ulcer status was determined by endoscopy at 4, 8, and 12 weeks. A significantly higher proportion of patients in the misoprostol group reported treatment-related adverse events and early withdrawal from the study.

When the poor compliance and potential adverse effects associated with misoprostol are considered, proton pump inhibitors and full-dose misoprostol are clinically equivalent.

The benefit in terms of relief from pain and stiffness is accompanied by the risk of developing a peptic ulcer and a serious, life-threatening ulcer complication. The use of the synthetic prostaglandin, misoprostol Cytotec; Pharmacia, Bridgewater, NJ , as a form of replacement therapy repeatedly has been shown to prevent NSAID-induced gastroduodenal ulcers and reduce the incidence of life-threatening ulcer complications.

Recently, more profound acid suppression with proton pump inhibitors has been reported as being associated with acceleration of ulcer healing and prevention of ulcer relapse among long-term users of NSAIDs.

Subsequent analyses showed that H pylori status had a marked effect on outcome and the development of endoscopic ulcers, with H pylori infection being associated with an overrepresentation of duodenal ulcers.

There is also increasing evidence that the use of antisecretory therapy with H 2 -receptor antagonists or proton pump inhibitors is associated with acceleration of corpus gastritis in those with H pylori infection, 26 - 31 which may make it prudent to eradicate H pylori in those for whom long-term NSAID and antisecretory cotherapy is contemplated.

This study attempted to overcome some of the shortcomings of the OMNIUM and ASTRONAUT studies. We report the results of a large, double-blind, multicenter, randomized, active- and placebo-controlled study designed to identify the optimal therapy for preventing unequivocal NSAID-induced gastric or duodenal ulcers.

Two thirds of patients enrolled in this study had previously completed participation in a healing trial for NSAID-associated gastric ulcer. Pretreatment H pylori status was determined by a rapid urease test CLOtest; Tri-Med Specialties Inc, Draper, Utah or histologic analysis, which was graded according to the updated Sydney System.

Use of a proton pump inhibitor, H 2 -receptor antagonist, or misoprostol within 24 hours before study entry was not permitted. Approval for the study was obtained from the institutional review board of each of the 63 participating centers in North America, and written informed consent was obtained before patient enrollment.

Patients were randomly assigned in blocks of 4 to receive 12 weeks of placebo, µg of misoprostol 4 times daily with or after meals and a bedtime snack, or 15 or 30 mg of lansoprazole once daily before breakfast.

Both patients and investigators remained masked to treatment group with the exception of those receiving misoprostol. Patients received antacid tablets Gelusil; Parke-Davis, Morris Plains, NJ for use as needed for symptom relief.

Patients were instructed to avoid antiulcer medication other than study medication, ulcerogenic medication except NSAIDs or aspirin as noted herein , and agents that alter hemostasis. Compliance and adverse events were assessed by returned pill count and direct questioning at each treatment visit.

Symptoms were assessed on a daily basis by patient diary, where patients recorded episodes of daytime and nighttime abdominal pain defined as none, mild, moderate, or severe , study drug and NSAID dosing information, and frequency of antacid consumption.

Endoscopy with biopsy was performed each month for 3 consecutive months to determine the presence of a gastric ulcer s. Esophageal and duodenal mucosa were also evaluated. Statistical analyses were conducted using statistical software SAS version 6. Per-protocol and intent-to-treat analyses were conducted for ulcer occurrence, abdominal pain, and antacid use, the latter 2 based on patient daily diary data.

For all efficacy and safety end points, pairwise comparisons were made between treatment groups. The comparability of the treatment groups at baseline was assessed with respect to demographic variables using the χ 2 test F test for age and medical and social histories by the Fisher exact test.

Baseline severity of symptoms, based on an investigator interview, was compared among the treatment groups using the Cochran-Mantel-Haenszel method for ordered response variables. Life table methods were used to estimate the ulcer incidence rates.

The life table analysis of time to ulcer occurrence was performed using the Cochran-Mantel-Haenszel method to test treatment differences between groups. Factors including age; sex; race; treatment for an acute NSAID-associated gastric ulcer immediately before study enrollment; hiatal hernia; investigator; alcohol, tobacco, or caffeine use; and acute baseline gastric ulcer size measured during a screening endoscopy conducted when the subject participated in a previous healing study were controlled for in the analysis.

The treatment groups were compared with respect to percentage of days with and average severity of daytime and nighttime abdominal pain and amount of antacid use based on diary data using the Wilcoxon 2-sample test. The Fisher exact test was used to compare the incidence of treatment-related adverse events defined as possibly or probably related between the treatment groups.

Two patients 1 each in the placebo and mg lansoprazole groups who did not take study medication were not included in the intent-to-treat analysis of ulcer occurrence or adverse events Table 1.

Three patients were excluded in 2 categories but were counted once in the total of 82 excluded patients. The treatment groups were well matched at baseline, including demographic characteristics, social history, previous history of gastrointestinal disorders, recent treatment for an NSAID-associated gastric ulcer, and severity of symptoms Table 2.

Most patients reported no daytime or nighttime abdominal pain at baseline. The distribution across treatment groups was similar.

Patients could have taken more than 1 NSAID. These observations were unaffected after adjustment for potentially influential factors, including age, sex, race, treatment for an acute NSAID-associated gastric ulcer before study enrollment, hiatal hernia, investigator, and alcohol, tobacco, or caffeine use.

There were no statistically significant differences between any of the active treatment groups after adjusting for acute baseline gastric ulcer size. Similar trends were observed in the results of the intent-to-treat analysis of gastric ulcer prevention data throughout the week treatment period.

Absence of a gastric ulcer after 8 or 12 weeks of treatment was different among those receiving placebo, misoprostol, or lansoprazole.

There was no statistical difference between any 2 of the active treatments for time to occurrence of gastroduodenal ulcers Figure 2. To evaluate the impact of the early patient withdrawals from the misoprostol group, the worst-case scenario, where patients who withdrew from the study prematurely eg, because of an adverse event were classified as a treatment failure eg, equivalent to having a gastric ulcer , was evaluated.

Lansoprazole-treated patients experienced significantly less severe and significantly fewer days with daytime abdominal pain than evaluable misoprostol-treated patients based on analyses of patient diaries Table 3.

Similar trends were observed in the results of the intent-to-treat analysis of diary data throughout the week treatment period. One patient in the mg lansoprazole group experienced an upper gastrointestinal tract hemorrhage during the study.

Studies designed to evaluate ulcer prevention among long-term users of NSAIDs have varied regarding study design, data analysis, and results presented. Several trials with antisecretory drugs showed the outcome differed with gastric ulcers compared with duodenal ulcers and H pylori —infected ulcers compared with ulcers not infected with H pylori.

That is unfortunate since randomization would have ensured that if there were a difference in outcome in relation to H pylori status, the overall results of the study would not hinge on the proportion of patients with or without the infection.

A study conducted in Hong Kong of patients with bleeding ulcers who were long-term users of NSAIDs shows the importance of this stratification. Among those with H pylori infection, misoprostol was similar to omeprazole 5.

The present study was designed to avoid those shortcomings by comparing 2 doses of a proton pump inhibitor lansoprazole with the full therapeutic dose of misoprostol and placebo in patients with unequivocal NSAID-associated ulcers. As with omeprazole, lansoprazole was superior to placebo, with no evidence of a major dose response effect.

We confirmed that gastric ulcers recurred during the week follow-up in a greater percentage of patients receiving placebo compared with those receiving lansoprazole or misoprostol. The results with gastroduodenal ulcer retained the same rank order. These conclusions appear to be in sharp contrast to the reported poor overall results of misoprostol vs omeprazole in the OMNIUM study.

To claim superiority, the OMNIUM study also included end points other than ulcer prevention eg, the presence of heartburn to obtain "superiority. Endoscopic ulcer prevention does not necessarily equate with prevention of ulcer complications.

In that study, a history of peptic ulcer or ulcer-related bleeding was an important prognostic factor for identifying those who would develop ulcer complications and currently would prompt a test-and-treat strategy with regard to H pylori infection.

Whether this would have influenced outcome is not known. Thus, failure to identify and treat H pylori infection in the MUCOSA study may have biased the outcome. Studies are needed to test whether a proton pump inhibitor can prevent life-threatening ulcer complications among long-term users of NSAIDs.

Because misoprostol and antisecretory drugs act by different mechanisms and low-dose misoprostol is better tolerated than full-dose therapy but has a lower rate of protection , 12 the combination of low-dose misoprostol and a proton pump inhibitor might provide optimum results.

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You may opt-out of email communications at any time by clicking on the unsubscribe link in the e-mail. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Bedsores are caused by pressure against the skin that limits blood flow to the skin.

Limited movement can make skin vulnerable to damage and lead to development of bedsores. Constant pressure on any part of your body can lessen the blood flow to tissues. Blood flow is essential for delivering oxygen and other nutrients to tissues.

Without these essential nutrients, skin and nearby tissues are damaged and might eventually die. For people with limited mobility, this kind of pressure tends to happen in areas that aren't well padded with muscle or fat and that lie over a bone, such as the spine, tailbone, shoulder blades, hips, heels and elbows.

Your risk of developing bedsores is higher if you have difficulty moving and can't change position easily while seated or in bed. Risk factors include:. You can help prevent bedsores by frequently repositioning yourself to avoid stress on the skin.

Other strategies include taking good care of your skin, maintaining good nutrition and fluid intake, quitting smoking, managing stress, and exercising daily. Mayo Clinic does not endorse companies or products.

Advertising revenue supports our not-for-profit mission. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. This content does not have an English version. This content does not have an Arabic version. Overview Warning signs of a bedsore Enlarge image Close.

Warning signs of a bedsore Relieve pressure on an area that is showing signs of being stressed. Bedsore Enlarge image Close.

Bedsore Bedsores are areas of damaged skin and tissue caused by sustained pressure — often from a bed or wheelchair — that reduces blood circulation to vulnerable areas of the body.

Request an appointment. Thank you for subscribing! Sorry something went wrong with your subscription Please, try again in a couple of minutes Retry. By Mayo Clinic Staff. Show references Pressure ulcers. Merck Manual Professional Version. Accessed Dec. Berlowitz D. Clinical staging and management of pressure-induced injury.

Office of Patient Education. How to prevent pressure injuries. Mayo Clinic; Pressure injury. Ferri FF. If the patient needs to take NSAIDs, the doctor may prescribe a counter-medicine to take alongside it. Antacids Treatment : Peptic ulcer medications such as antacids for ulcer disease may be prescribed to treat mild cases.

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HEALTH LIBRARY Health Videos Peptic Ulcers: Symptoms, Causes, Treatment, And Prevention. Digestive System. Peptic Ulcers: Symptoms, Causes, Treatment, And Prevention. Emad Fayyad A gastroenterology specialist, Dr.

Updated On:December 22, Symptoms Causes Risk-Factors Complications Treatment Prevention. What Are Peptic Ulcers? There are three types of peptic ulcers that are commonly seen: Stomach ulcers, also known as gastric ulcers, are open sores that develop on the tissue lining of the stomach.

Ulcers formed in the upper part of the small intestine, known as the duodenum, are referred to as duodenal ulcers. Esophageal ulcers are ulcers that develop in the lower part of the esophagus. Peptic Ulcer Symptoms People with peptic ulcer disease commonly exhibit the following symptoms: Nausea Abdominal pain Bloated or belched stomach Heartburn Bloody stool Chest pain Vomiting, sometimes with blood Sudden weight loss Appetite changes Difficulty breathing Feeling faint When to See a Doctor for Peptic Ulcers You should contact your general physician as soon as you start experiencing the symptoms listed above with severity or when over-the-counter medications, such as antacids for ulcers, fail to alleviate the pain or do so, but the pain returns.

There are two main factors that directly lead to the breakdown of the protective mucus lining: Helicobacter pylori H.

Risk Factors for Peptic Ulcer Disease The risk of getting peptic ulcers is heightened if a person: Is a heavy smoker.

Smoking increases the chances of H. pylori infection in those that already have the bacteria present in their digestive system. Is a heavy drinker. Is constantly stressed out. While mental stress has not been proven to cause the development of peptic ulcers directly, symptoms of peptic ulcers are more aggravated in those who suffer from mental stress.

Makes chronic use of corticosteroids. This increases the risk of getting peptic ulcers since corticosteroids weaken the immune system. Eats spicy foods regularly. Spicy foods increase the buildup of acids in the digestive tract.

Book an appointment with a Medcare specialist in a minute. Complications Arising from Peptic Peptic Ulcer needs to be treated at the first instance.