Improvement in health-related quality of life after therapy with omeprazole in patients with coronary artery disease and recurrent angina-like chest pain. A double-blind, placebo-controlled trial of the SF-36 survey

Abstract

BackgroundMany patients with coronary artery disease (CAD) have overlapping gastroenterological causes of recurrent chest pain, mainly due to gastroesophageal reflux (GER) and aspirin-induced gastrointestinal tract damage. These symptoms can be alleviated by proton pump inhibitors (PPIs). The study addressed whether omeprazole treatment also affects general health-related quality of life (HRQL) in patients with CAD.Study48 patients with more than 50% narrowing of the coronary arteries on angiography without clinically overt gastrointestinal symptoms were studied. In a double-blind, placebo-controlled, cross-over study design, patients were randomized to take omeprazole 20 mg bid or a placebo for two weeks, and then crossed over to the other study arm. The SF-36 questionnaire was completed before treatment and again after two weeks of therapy.ResultsPatients treated with omeprazole in comparison to the subjects taking the placebo had significantly greater values for the SF-36 survey (which relates to both physical and mental health), as well as for bodily pain, general health perception, and physical health. In comparison to the baseline values, therapy with omeprazole led to a significant increase in the three summarized health components: total SF-36; physical and mental health; and in the following detailed health concept scores: physical functioning, limitations due to physical health problems, bodily pain and emotional well-being.ConclusionsA double dose of omeprazole improved the general HRQL in patients with CAD without severe gastrointestinal symptoms more effectively than the placebo.

Development, validation, and initial results of the Angioedema Activity Score

“…It consists of 17 items that can be summed up to a total score. The SF-36 is a generic instrument that has been used extensively to detect and compare health-related quality-of-life impairment in dermatologic and nondermatologic diseases (10)(11)(12)(13)(14). It is composed of 36 items that are related to 8 domains and two composite scores, the 'physical component summary' and the 'mental component summary'.…”

Health-related quality of life and blood pressure 12 months after renal denervation

“…Whereas we cannot rule out that the improvement in SF-36 MCS score at 12 months that we describe represents a placebo effect, of the nine cardiovascular-related studies reported by Frendl and Ware [32], baseline or change in SF-36 MCS scores were reported in six studies. There occurred no significant change in SF-36 MCS score in the placebotreated group in five studies [33][34][35][36][37], whereas in one investigation, the examination of the effectiveness of fludrocortisone on postural hypotension in patients with chronic fatigue syndrome [38], the SF-36 MCS score was increased by approximately 3.5 in the placebo group. Interestingly, in this latter study, the level of depression was quite high, with a mean BDI score of 15.…”

Acid Reflux in Patients with Coronary Artery Disease and Refractory Chest Pain

“…Budzy!ski et al completed a trial of the SF-36 survey in patients with CAD and recurrent angina-like chest pain. Improved HRQL scores in patients accepting PPI therapy were found in the survey (10). To investigate the patients' overall state of health (physical, emotional and social), the SF-36 survey was also used as an HRQL instrument in our study.…”

“…Furthermore, the most common cardiac drugs used to treat CAD, particularly nitrates, calcium-channel blockers (CCBs) and antiplatelet drugs, may either predispose CAD patients to GERD or aggravate preexisting GERD (7)(8)(9); hence, escalating treatment can increase chest pain, leading the physician to the erroneous conclusion that the CAD is worsening. Previous studies have provided support for the use of acid suppression with proton pump inhibitors in patients with CAD to decrease pain symptoms and improve the general health-related quality of life (HRQL) (10,11). However, most of these studies were conducted in CAD patients with common chest pain, not refractory chest pain.…”