| Cucchiara et al (1993) | 32 children (6 months to 13 years) with severe reflux oesophagitis and failed ranitidine and cisapride. Patients randomised to high dose ranitidine (20 mg/kg/day) or omeprazole (40 mg/day/1.73m2) for 8 weeks | RCT | Clinical | Both regimens effective. Decreased clinical score (p<0.01) Omep: 24 (15–33) to 9 (0–18) Ran: 19.5 (12–33) to 9 (6–12) | Double blind RCT; 7 (22%) drop out; 6 month follow up. High relapse rate after treatment; 5/13 (38%) ranitidine and 7/12 (58%) omeprazole patients were still symptomatic, 2 required antireflux surgery |
| | | Oesophageal pH monitoring (OpHM) | Decreased OpHM reflux time Omep: 129 (84–217) to 44.6 (0.16–128) Ran: 207 (66–306) to 58.4 (32–128) | |
| | | Gastroscopy (histology) | Decreased histologic score (p<0.01) Omep: 8 (6–10) to 2(0–6) Ranit: 8 (8–10) to 2(2–6) | |
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| Kato et al (1996) | 13 cases (3–18 years) with oesophagitis and/or ulcer; failed cimetidine or famotidine. Omeprazole 0.6 mg/kg/day | Case-control | Gastroscopy | Benefit in biopsy (healing rate): 2 weeks 46%; 4 weeks 85%; 6 weeks 92%; 8 weeks 92% | Criteria for healing not clear (biopsy results not reported); No controls No pretreatment pH studies; No treatment for patients with H pylori; 7/12(58%) relapsed. |
| 9 controls; 5 without GI disease, 4 with ulcers treated with cimetidine or famotidine | | Gastric-pHM | Mean gastric pH Controls: 2.1 (1.8–2.5) Omep: 5.2 (3.0–6.6) (p=0.005) Cim/Fam: 3.1 (1.9–3.8) (p=0.05) | |
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| Gunasekaran et al (1993) | 15 children (0.8–17 years) with oesophagitis and failed H2 blocker and prokinetic therapy; 4 with fundoplication | Case series | Clinical | Follow up:3 months: decreased symptoms 75% 6 months: decreased symptoms all | No controls; 8 neurologically impaired children and 1 with CF. Gastroscopy at 6 months only done on patients with endoscopic evidence of oesophagitis at first follow up |
| Omeprazole (0.7–3.3 mg/kg/day) for 5.5–26 months. Dose titrated upward against 24° EpHM | | Gastroscopy | 6 months: 9/15 had gastroscopy and all 9 improved | |
| | | OpHM | Before treatment pH<4 for 11–88% of time. After treatment normal pH (<4 for < 6% of time) | |
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| De Giacomo et al (1997) | 10 children (25–109 months) with abnormal GOR and severe oesophagitis, failed prokinetic, H2 blocker or antacid therapy | Case series | Clinical | Decreased symptoms all (p<0.05) Decreased score all | No controls; 4 (40%) with significant comorbidities; 6 (60%) relapse after therapy; 3 required antireflux surgery |
| | | Gastroscopy Histology OpHM | No difference in histologic scores Decreased GOR (%, no., no. >5 min., and longest GOR) | |
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| Alliet et al (1998) | 12 children (2.9 ± 0.9 months); oesophagitis and failed cimetidine, positioning, cisapride, or Gaviscon therapy. Omeprazole 0.5 mg/kg/day for 6 weeks | Case series | Clinical | Decreased symptoms 10/12 (83%) | No controls. One year follow up 83% asymptomatic |
| | | Gastroscopy Biopsy | 9 (75%) had completely normal mucosa; 3 (25%) improved 8 (67%) completely healed; 4 (33.%) improved | |
| | | OpHM during Rx | Decreased intragastric acidity (no p values) | |
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| Hassall et al (2000) | 57 children (1–16years) with erosive oesophagitis and pathologic acid reflux (pH <4 for >6% of the time). Treatment began at 0.7 mg/kg/day and increased by 0.7 mg/kg/day q 5–14 days to a max of 3.5 mg/kg/day if pathologic reflux was still present. Treatment continued for 3 months after healing dose was determined | Case series (prospective) | Clinical | Decreased symptoms: 53 (93%) | 21 (37%) neurologically impaired; 7 (12%) repaired oesophageal atresia. No treatment for patients with H pylori No long term follow up |
| | | Gastroscopy | Healed: 54 (98%). Median healing time 102 days | |
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| Karjoo et al (1995) | 153 children (6–18 years) with >3 weeks of epigastric pain had OGD; 129 (84%) with oesophagitis were given high dose ranitidine (4 mg/kg/dose BID-TID for 4 weeks); 38 (30%) non-responsive to ranitidine were given omeprazole (20 mg/day) for 8 weeks | Case series (prospective) | Gastroscopy | 91/129 (70%) responded to ranitidin;e 38/129 (30%) non-responsive to ranitidine; 33/38 (87%) responded to omeprazole (p<0.05); 5 (4%) failed both treatments (3 had Nissen fundoplications) | Degree of oesophagitis on gastroscopy predictive of response to ranitidine (90% of patients with grade 1 respond). No long term follow up |