Table.
Summary of Published Studies About Management of Nocturnal Acid-breakthrough in Gastroesophageal Reflux Disease
| Authors | Year | Study design | Results |
|---|---|---|---|
| Hatlebakk et al2 | 1998 | Volunteers (n = 18) 1) OME 40 mg qAM 2) OME 40 mg qPM 3) OME 20 mg bid |
Split dosing was superior. |
| Khoury et al4 | 1999 | Volunteers (n = 21) 1) OME 20 mg AM + OME 20 mg PM + placebo HS 2) OME 20 mg AM + placebo PM + H2RA HS |
Bedtime H2RA did not replace an evening dose of PPI in patients requiring more than a single daily dose of PPI. |
| Xue et al5 | 2001 | GERD patients 1) PPI bid (n = 60) 2) PPI bid + H2RAs HS (n = 45) 3) Both regimen (n = 11) |
A bedtime H2RA enhanced nocturnal gastric pH control and decreased esophageal acid exposure during NAB. |
| Fackler et al6 | 2002 | Volunteers (n = 18), GERD patients (n = 16) OME bid for 2 wk → OME bid + H2RA 300 mg HS for 28 day |
Combination of H2RA and PPI reduced NAB only with introduction of therapy (due to H2RA tolerance). |
| Orr et al7 | 2003 | Symptomatic GERD patients (n = 19) OME 20 mg bid for 1 wk + H2RA or placebo HS + nighttime provocative reflux meal |
In spite of reduction of intragastric acidity, H2RA had no effect on the occurrence of gastroesophageal reflux during sleep. |
| Adachi et al8 | 2003 | Volunteers without H. pylori (n = 10) 1) RAB 20 mg qAM 2) RAB 20 mg qAM + H2RA HS (last day only) 3) RAB 20 mg qAM + continuous H2RA HS 4) RAB 10 mg bid |
Split dosing was better in gastric acid suppression. Continuous H2RA was less effective. |
| Shimatani et al9 | 2004 | Volunteers without H. pylori (n = 18) 1) RAB 10 mg qAM 2) RAB 20 mg qAM 3) RAB 10 mg bid |
Split dosing was more potent and long-lasting acid suppression. |
| Hammer et al10 | 2004 | Volunteer (n = 13) 1) ESM 20 mg bid 2) ESM 40 mg qAM |
Split dosing improved nighttime acid suppression. |
| Katz et al11 | 2007 | Nocturnal GERD patients (n = 54) 1) IR-OME 40 mg HS 2) LPZ 30 mg HS 3) ESM 40 mg HS |
Bedtime dosing with IR-OME was effective with night-time heartburn. |
| Mainie et al12 | 2008 | GERD patients (n = 100) 1) PPI bid (n = 58) 2) PPI bid + H2RA HS (n = 42) |
A bedtime H2RA reduced the percentage time of the intragastric pH < 4 and also NAB. |
OME, omeprazole; qAM, once daily before breakfast; qPM, once daily before dinner; bid, twice a day; HS, at bed time; H2RA, histamine H2 receptor antagonist; PPI, proton pump inhibitor; GERD, gastroesophageal reflux disease; NAB, nocturnal acid-breakthrough; H. pylori, Helicobacter pylori; RAB, rabeprazole; ESM, esomeprazole; IR-OME, immediate release omeprazole; LPZ, lansoprazole.