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. 1997 May;40(5):587–590. doi: 10.1136/gut.40.5.587

Double blind cross-over placebo controlled study of omeprazole in the treatment of patients with reflux symptoms and physiological levels of acid reflux--the "sensitive oesophagus".

R G Watson 1, T C Tham 1, B T Johnston 1, N I McDougall 1
PMCID: PMC1027158  PMID: 9203934

Abstract

BACKGROUND: At least 10-15% of patients with reflux symptoms have a normal endoscopy and physiological levels of acid reflux on pH monitoring. Such patients with 50% or more of symptoms associated with acid reflux episodes have "a positive symptom index" (SI), and it has been proposed that this defines the "sensitive oesophagus". AIM: To test the response to omeprazole 20 mg twice daily for four weeks of patients with normal levels of acid reflux using a randomised, placebo controlled, double blind, cross-over design. PATIENTS: Eighteen patients with normal levels of reflux, 12 of whom had a positive SI. METHODS: Response was measured by symptomatic assessment and the SF-36 quality of life (QOL) questionnaire. RESULTS: Patients with a positive SI showed the following improvements on omeprazole compared with placebo: decrease in symptom frequency (p < 0.01), severity (p < 0.01) and consumption of antacids (p < 0.01). In the group with a negative SI only one patient clearly improved. The QOL parameters for bodily pain (65.6 v 53.4, p = 0.03) and vitality (60.6 v 48.8, p = 0.049) were significantly better on omeprazole than placebo for the group overall. CONCLUSION: Omeprazole improves symptoms in 11 of 18 patients with normal endoscopy and pH monitoring, particularly those with a positive SI. This supports the theory that such patients have an oesophagus which is "sensitive" to acid reflux and are part of the GORD spectrum.

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Selected References

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  1. Behar J., Biancani P., Sheahan D. G. Evaluation of esophageal tests in the diagnosis of reflux esophagitis. Gastroenterology. 1976 Jul;71(1):9–15. [PubMed] [Google Scholar]
  2. Brazier J. E., Harper R., Jones N. M., O'Cathain A., Thomas K. J., Usherwood T., Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160–164. doi: 10.1136/bmj.305.6846.160. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Eriksen C. A., Cullen P. T., Sutton D., Kennedy N., Cuschieri A. Abnormal esophageal transit in patients with typical reflux symptoms but normal endoscopic and pH profiles. Am J Surg. 1991 Jun;161(6):657–661. doi: 10.1016/0002-9610(91)91250-m. [DOI] [PubMed] [Google Scholar]
  4. Garratt A. M., Ruta D. A., Abdalla M. I., Buckingham J. K., Russell I. T. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? BMJ. 1993 May 29;306(6890):1440–1444. doi: 10.1136/bmj.306.6890.1440. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Jenkinson C., Coulter A., Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. BMJ. 1993 May 29;306(6890):1437–1440. doi: 10.1136/bmj.306.6890.1437. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Johannessen T. Controlled trials in single subjects. 1. Value in clinical medicine. BMJ. 1991 Jul 20;303(6795):173–174. doi: 10.1136/bmj.303.6795.173. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Johannessen T., Fjøsne U., Kleveland P. M., Halvorsen T., Kristensen P., Løge I., Hafstad P. E., Sandbakken P., Petersen H. Cimetidine responders in non-ulcer dyspepsia. Scand J Gastroenterol. 1988 Apr;23(3):327–336. doi: 10.3109/00365528809093874. [DOI] [PubMed] [Google Scholar]
  8. Johansson K. E., Ask P., Boeryd B., Fransson S. G., Tibbling L. Oesophagitis, signs of reflux, and gastric acid secretion in patients with symptoms of gastro-oesophageal reflux disease. Scand J Gastroenterol. 1986 Sep;21(7):837–847. doi: 10.3109/00365528609011128. [DOI] [PubMed] [Google Scholar]
  9. Johnston B. T., Collins J. S., McFarland R. J., Love A. H. Are esophageal symptoms reflux-related? A study of different scoring systems in a cohort of patients with heartburn. Am J Gastroenterol. 1994 Apr;89(4):497–502. [PubMed] [Google Scholar]
  10. Johnston B. T., McFarland R. J., Collins J. S., Love A. H. Symptom index as a marker of gastro-oesophageal reflux disease. Br J Surg. 1992 Oct;79(10):1054–1055. doi: 10.1002/bjs.1800791022. [DOI] [PubMed] [Google Scholar]
  11. Lewis J. A. Controlled trials in single subjects. 2. Limitations of use. BMJ. 1991 Jul 20;303(6795):175–176. doi: 10.1136/bmj.303.6795.175. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Little A. G., DeMeester T. R., Kirchner P. T., O'Sullivan G. C., Skinner D. B. Pathogenesis of esophagitis in patients with gastroesophageal reflux. Surgery. 1980 Jul;88(1):101–107. [PubMed] [Google Scholar]
  13. Marrero J. M., de Caestecker J. S., Maxwell J. D. Effect of famotidine on oesophageal sensitivity in gastro-oesophageal reflux disease. Gut. 1994 Apr;35(4):447–450. doi: 10.1136/gut.35.4.447. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Mazlam M. Z., Hodgson H. J. Why measure C reactive protein? Gut. 1994 Jan;35(1):5–7. doi: 10.1136/gut.35.1.5. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Norris M. C., Fogel S. T., Dalman H., Borrenpohl S., Hoppe W., Riley A. Labor epidural analgesia without an intravascular "test dose". Anesthesiology. 1998 Jun;88(6):1495–1501. doi: 10.1097/00000542-199806000-00012. [DOI] [PubMed] [Google Scholar]
  16. Shi G., Bruley des Varannes S., Scarpignato C., Le Rhun M., Galmiche J. P. Reflux related symptoms in patients with normal oesophageal exposure to acid. Gut. 1995 Oct;37(4):457–464. doi: 10.1136/gut.37.4.457. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Shi G., Bruley des Varannes S., Scarpignato C., Le Rhun M., Galmiche J. P. Reflux related symptoms in patients with normal oesophageal exposure to acid. Gut. 1995 Oct;37(4):457–464. doi: 10.1136/gut.37.4.457. [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Singh S., Richter J. E., Bradley L. A., Haile J. M. The symptom index. Differential usefulness in suspected acid-related complaints of heartburn and chest pain. Dig Dis Sci. 1993 Aug;38(8):1402–1408. doi: 10.1007/BF01308595. [DOI] [PubMed] [Google Scholar]
  19. Trimble K. C., Douglas S., Pryde A., Heading R. C. Clinical characteristics and natural history of symptomatic but not excess gastroesophageal reflux. Dig Dis Sci. 1995 May;40(5):1098–1104. doi: 10.1007/BF02064206. [DOI] [PubMed] [Google Scholar]
  20. Trimble K. C., Farouk R., Pryde A., Douglas S., Heading R. C. Heightened visceral sensation in functional gastrointestinal disease is not site-specific. Evidence for a generalized disorder of gut sensitivity. Dig Dis Sci. 1995 Aug;40(8):1607–1613. doi: 10.1007/BF02212678. [DOI] [PubMed] [Google Scholar]
  21. Trimble K. C., Pryde A., Heading R. C. Lowered oesophageal sensory thresholds in patients with symptomatic but not excess gastro-oesophageal reflux: evidence for a spectrum of visceral sensitivity in GORD. Gut. 1995 Jul;37(1):7–12. doi: 10.1136/gut.37.1.7. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Wiener G. J., Morgan T. M., Copper J. B., Wu W. C., Castell D. O., Sinclair J. W., Richter J. E. Ambulatory 24-hour esophageal pH monitoring. Reproducibility and variability of pH parameters. Dig Dis Sci. 1988 Sep;33(9):1127–1133. doi: 10.1007/BF01535789. [DOI] [PubMed] [Google Scholar]

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