Leczenie farmakologiczne dzieci z refluksem żołądkowo‐przełykowym
Appendices
Appendix 1. CENTRAL search strategy
1. exp Gastroesophageal Reflux/
2. (GER or GOR).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
3. ((gastro‐oesophag* or gastroesophag*) adj reflux).tw.
4. (GERD or GORD).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
5. infant, newborn, diseases/ or infant, premature, diseases/
6. Esophageal Sphincter, Lower/gd, pa, pp [Growth & Development, Pathology, Physiopathology]
7. child nutritional physiological phenomena/ or adolescent nutritional physiological phenomena/ or exp infant nutritional physiological phenomena/
8. or/1‐7
9. Alginates/
10. (gaviscon or alenic alka or almagate or almax or aluminum‐magnesium hydroxide carbonate or aluminum‐magnesium hydroxycarbonate or deprece or genaton or obetine or tisacid).mp.
11. antacid*.mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
12. exp antacids/
13. (magnesium hydroxide or brucite or magnesium hydrate or mil‐par or milk of magnesia).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
14. (aluminum hydroxide or aldrox or algeldrate or alhydrogel or aloh‐gel or alternagel or alu‐cap or alu‐tab or alugel or amphojel or andursil or basalgel or brasivil or brimos or dialume or hydrated alumina or pepsamer or rocgel).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
15. (Maalox$ or alamag or alucol or (alumina and magnesia) or aluminum hydroxide‐magnesium hydroxide or aluminum magnesium hydroxide or co‐magaldrox or gen‐alox or kudrox or magagel or magnalox or magnesium aluminum hydroxide or maldroxal or mintox or mucogel or mylanta ultimate or novalucol or ri‐mox or rulox or supralox).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
16. H2 antagonist*.mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
17. histamine h2 antagonists/ or cimetidine/ or famotidine/ or ranitidine/
18. (Ranitidin$ or azanplus or biotidin or pylorid or raciran or raniberl or ranisen or rantec or sostril or taladine or tritec or wal‐zan or zantac).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
19. (Cimetidine or acitak or altramet or biomet or dyspamet or eureceptor or galenamet or histodil or peptimax or phimetin or tagamet or ultec or zita).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
20. (Famotidine or fluxid or mylanta ar or pepcid or ym 11170).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
21. Proton Pump Inhibitors/ or PPI.tw.
22. (lansoprazol$ or agopton or bamalite or lanzoprazol$ or lanzor or monolitum or ogast or ogastro or opiren or prevacid or prezal or pro ulco or promeco or takepron or ulpax or zoton).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
23. (Pantoprazole or "protium iv" or protonix or "skf‐96022" or Pantotab or Pantopan or Pantozol or Pantor or Pantoloc or Astropan or Controloc or Pantecta or Inipomp or Somac or Ulcepraz or Pantodac).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
24. (omeprazole or losec or nexium or prilosec or rapinex or zegerid or OMEZ or Antra or Gastroloc or Mopral or Omepral).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
25. (Rabeprazole or aciphex or dexrabeprazole or "e 3810" or "ly‐307640" or pariet).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
26. (Esomeprazole or Sompraz or Zoleri or Nexium or Lucen or Esopral or Axagon or Nexiam).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
27. (metoclopramide or cerucal or clopra or degan or gastrobid continus or gastroflux or gastromax or maxolon or maxeran or metaclopramide or metozolv or migravess forte or mygdalon or octamide or primperan or pylomid or reglan or reliveran or rimetin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
28. (domperidon$ or domidon or domperidona gamir or gastrocure or "kw 5338" or motilium or Motillium or Motinorm or nauzelin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
29. (erythromycin or aknemycin or del‐mycin or e‐base or emycin or "e‐solve 2" or emcin clear or emgel or ery‐sol or ery‐tab or eryacne or eryc or erycen or erycette or eryderm or erygel or erymax or erymin or eryped or erythra‐derm or erythro or erythrocot or erythroped or eyemycin or "eyrthromycin ethyl succinate" or gallimycin or ilosone or ilotycin or lauromicina or monomycin or pediamycin or retcin or rommix or romycin or roymicin or rp‐mycin or staticin or stiemycin or "t stat" or theramycin or tiloryth or "vcp‐1" or wyamycin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
30. (bethanechol or bethanecol or duvoid or myo hermes or myocholine or myotonachol or myotonine or pmsbethanechol chloride or urecholine or urocarb).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
31. Sucralfate/
32. (sucralfate or aluminum sucrose sulfate or antepsin or carafate or Sucramal or Pepsigard or Sucral or sucrafil or Sutra or Sulcrate or ulcerban or ulcogant or ulsanic or xactdose).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
33. or/9‐32
34. (exp Adult/ or exp Aged/ or exp Middle Aged/ or exp Young Adult/) not (exp infant/ or exp Infant, Newborn/ or exp Pediatrics/ or exp child/ or exp Adolescent/)
35. 8 and 33
36. 35 not 34
Appendix 2. MEDLINE search strategy
1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
3. randomized.ab.
4. placebo.ab.
5. clinical trials as topic.sh.
6. randomly.ab.
7. trial.ti.
8. or/1‐7
9. exp animals/ not humans.sh.
10. 8 not 9
11. exp Gastroesophageal Reflux/
12. (GER or GOR).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
13. ((gastro‐oesophag* or gastroesophag*) adj reflux).tw.
14. (GERD or GORD).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
15. infant, newborn, diseases/ or infant, premature, diseases/
16. Esophageal Sphincter, Lower/gd, pa, pp [Growth & Development, Pathology, Physiopathology]
17. child nutritional physiological phenomena/ or adolescent nutritional physiological phenomena/ or exp infant nutritional physiological phenomena/
18. or/11‐17
19. Alginates/
20. (gaviscon or alenic alka or almagate or almax or aluminum‐magnesium hydroxide carbonate or aluminum‐magnesium hydroxycarbonate or deprece or genaton or obetine or tisacid).mp.
21. antacid*.mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
22. exp antacids/
23. (magnesium hydroxide or brucite or magnesium hydrate or mil‐par or milk of magnesia).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
24. (aluminum hydroxide or aldrox or algeldrate or alhydrogel or aloh‐gel or alternagel or alu‐cap or alu‐tab or alugel or amphojel or andursil or basalgel or brasivil or brimos or dialume or hydrated alumina or pepsamer or rocgel).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
25. (Maalox$ or alamag or alucol or (alumina and magnesia) or aluminum hydroxide‐magnesium hydroxide or aluminum magnesium hydroxide or co‐magaldrox or gen‐alox or kudrox or magagel or magnalox or magnesium aluminum hydroxide or maldroxal or mintox or mucogel or mylanta ultimate or novalucol or ri‐mox or rulox or supralox).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
26. H2 antagonist*.mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
27. histamine h2 antagonists/ or cimetidine/ or famotidine/ or ranitidine/
28. (Ranitidin$ or azanplus or biotidin or pylorid or raciran or raniberl or ranisen or rantec or sostril or taladine or tritec or wal‐zan or zantac).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
29. (Cimetidine or acitak or altramet or biomet or dyspamet or eureceptor or galenamet or histodil or peptimax or phimetin or tagamet or ultec or zita).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
30. (Famotidine or fluxid or mylanta ar or pepcid or ym 11170).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
31. Proton Pump Inhibitors/ or PPI.tw.
32. (lansoprazol$ or agopton or bamalite or lanzoprazol$ or lanzor or monolitum or ogast or ogastro or opiren or prevacid or prezal or pro ulco or promeco or takepron or ulpax or zoton).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
33. (Pantoprazole or "protium iv" or protonix or "skf‐96022" or Pantotab or Pantopan or Pantozol or Pantor or Pantoloc or Astropan or Controloc or Pantecta or Inipomp or Somac or Ulcepraz or Pantodac).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
34. (omeprazole or losec or nexium or prilosec or rapinex or zegerid or OMEZ or Antra or Gastroloc or Mopral or Omepral).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
35. (Rabeprazole or aciphex or dexrabeprazole or "e 3810" or "ly‐307640" or pariet).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
36. (Esomeprazole or Sompraz or Zoleri or Nexium or Lucen or Esopral or Axagon or Nexiam).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
37. (metoclopramide or cerucal or clopra or degan or gastrobid continus or gastroflux or gastromax or maxolon or maxeran or metaclopramide or metozolv or migravess forte or mygdalon or octamide or primperan or pylomid or reglan or reliveran or rimetin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
38. (domperidon$ or domidon or domperidona gamir or gastrocure or "kw 5338" or motilium or Motillium or Motinorm or nauzelin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
39. (erythromycin or aknemycin or del‐mycin or e‐base or emycin or "e‐solve 2" or emcin clear or emgel or ery‐sol or ery‐tab or eryacne or eryc or erycen or erycette or eryderm or erygel or erymax or erymin or eryped or erythra‐derm or erythro or erythrocot or erythroped or eyemycin or "eyrthromycin ethyl succinate" or gallimycin or ilosone or ilotycin or lauromicina or monomycin or pediamycin or retcin or rommix or romycin or roymicin or rp‐mycin or staticin or stiemycin or "t stat" or theramycin or tiloryth or "vcp‐1" or wyamycin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
40. (bethanechol or bethanecol or duvoid or myo hermes or myocholine or myotonachol or myotonine or pmsbethanechol chloride or urecholine or urocarb).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
41. Sucralfate/
42. (sucralfate or aluminum sucrose sulfate or antepsin or carafate or Sucramal or Pepsigard or Sucral or sucrafil or Sutra or Sulcrate or ulcerban or ulcogant or ulsanic or xactdose).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
43. or/19‐42
44. (exp Adult/ or exp Aged/ or exp Middle Aged/ or exp Young Adult/) not (exp infant/ or exp Infant, Newborn/ or exp Pediatrics/ or exp child/ or exp Adolescent/)
45. 10 and 18 and 43
46. 45 not 44
Appendix 3. EMBASE search strategy
1. Clinical trial/
2. Randomized controlled trial/
3. Randomization/
4. Single‐Blind Method/
5. Double‐Blind Method/
6. Cross‐Over Studies/
7. Random Allocation/
8. Placebo/
9. Randomi?ed controlled trial$.tw.
10. Rct.tw.
11. Random allocation.tw.
12. Randomly allocated.tw.
13. Allocated randomly.tw.
14. (allocated adj2 random).tw.
15. Single blind$.tw.
16. Double blind$.tw.
17. ((treble or triple) adj blind$).tw.
18. Placebo$.tw.
19. Prospective study/
20. or/1‐19
21. Case study/
22. Case report.tw.
23. Abstract report/ or letter/
24. or/21‐23
25. 20 not 24
26. exp Gastroesophageal Reflux/
27. (GER or GOR).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
28. ((gastro‐oesophag* or gastroesophag*) adj reflux).tw.
29. (GERD or GORD).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
30. or/26‐29
31. Alginates/
32. (gaviscon or alenic alka or almagate or almax or aluminum‐magnesium hydroxide carbonate or aluminum‐magnesium hydroxycarbonate or deprece or genaton or obetine or tisacid).mp.
33. antacid*.mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
34. exp antacids/
35. (magnesium hydroxide or brucite or magnesium hydrate or mil‐par).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
36. (aluminum hydroxide or aldrox or algeldrate or alhydrogel or aloh‐gel or alternagel or alu‐cap or alu‐tab or alugel or amphojel or andursil or basalgel or brasivil or brimos or dialume or hydrated alumina or pepsamer or rocgel).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
37. (Maalox$ or alamag or alucol or (alumina and magnesia) or aluminum hydroxide‐magnesium hydroxide or aluminum magnesium hydroxide or co‐magaldrox or gen‐alox or kudrox or magagel or magnalox or magnesium aluminum hydroxide or maldroxal or mintox or mucogel or mylanta ultimate or novalucol or ri‐mox or rulox or supralox).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
38. H2 antagonist*.mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
39. histamine h2 antagonists/ or cimetidine/ or famotidine/ or ranitidine/
40. (Ranitidin$ or azanplus or biotidin or pylorid or raciran or raniberl or ranisen or rantec or sostril or taladine or tritec or wal‐zan or zantac).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
41. (Cimetidine or acitak or altramet or biomet or dyspamet or eureceptor or galenamet or histodil or peptimax or phimetin or tagamet or ultec or zita).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
42. (Famotidine or fluxid or mylanta ar or pepcid or ym 11170).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
43. Proton Pump Inhibitors/ or PPI.tw.
44. (lansoprazol$ or agopton or bamalite or lanzoprazol$ or lanzor or monolitum or ogast or ogastro or opiren or prevacid or prezal or pro ulco or promeco or takepron or ulpax or zoton).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
45. (Pantoprazole or "protium iv" or protonix or "skf‐96022" or Pantotab or Pantopan or Pantozol or Pantor or Pantoloc or Astropan or Controloc or Pantecta or Inipomp or Somac or Ulcepraz or Pantodac).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
46. (omeprazole or losec or nexium or prilosec or rapinex or zegerid or OMEZ or Antra or Gastroloc or Mopral or Omepral).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
47. (Rabeprazole or aciphex or dexrabeprazole or "e 3810" or "ly‐307640" or pariet).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
48. (Esomeprazole or Sompraz or Zoleri or Nexium or Lucen or Esopral or Axagon or Nexiam).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
49. (metoclopramide or cerucal or clopra or degan or gastrobid continus or gastroflux or gastromax or maxolon or maxeran or metaclopramide or metozolv or migravess forte or mygdalon or octamide or primperan or pylomid or reglan or reliveran or rimetin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
50. (domperidon$ or domidon or domperidona gamir or gastrocure or "kw 5338" or motilium or Motillium or Motinorm or nauzelin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
51. (erythromycin or aknemycin or del‐mycin or e‐base or emycin or "e‐solve 2" or emcin clear or emgel or ery‐sol or ery‐tab or eryacne or eryc or erycen or erycette or eryderm or erygel or erymax or erymin or eryped or erythra‐derm or erythro or erythrocot or erythroped or eyemycin or "eyrthromycin ethyl succinate" or gallimycin or ilosone or ilotycin or lauromicina or monomycin or pediamycin or retcin or rommix or romycin or roymicin or rp‐mycin or staticin or stiemycin or "t stat" or theramycin or tiloryth or "vcp‐1" or wyamycin).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
52. (bethanechol or bethanecol or duvoid or myo hermes or myocholine or myotonachol or myotonine or pmsbethanechol chloride or urecholine or urocarb).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
53. Sucralfate/
54. (sucralfate or aluminum sucrose sulfate or antepsin or carafate or Sucramal or Pepsigard or Sucral or sucrafil or Sutra or Sulcrate or ulcerban or ulcogant or ulsanic or xactdose).mp. [mp=title, original title, abstract, name of substance word, subject heading word, unique identifier]
55. or/31‐54
56. (exp Adult/ or exp Aged/ or exp Middle Aged/ or exp Young Adult/) not (exp infant/ or exp Infant, Newborn/ or exp Pediatrics/ or exp child/ or exp Adolescent/)
57. 25 and 30 and 55
58. 57 not 56
Appendix 4. Science Citation Index search strategy
| # 16 | #15 AND #14 Databases=SCI‐EXPANDED Timespan=All Years |
| # 15 | Topic=(single blind*) OR Topic=(double blind*) OR Topic=(clinical trial*) OR Topic=(placebo*) OR Topic=(random*) OR Topic=(controlled clinical trial) OR Topic=(research design) OR Topic=(comparative stud*) OR Topic=(controlled trial) OR Topic=(follow up stud*) OR Topic=(prospective stud*) Databases=SCI‐EXPANDED Timespan=All Years |
| # 14 | #13 NOT #11 Databases=SCI‐EXPANDED Timespan=All Years |
| # 13 | #12 AND #1 Databases=SCI‐EXPANDED Timespan=All Years |
| # 12 | #10 OR #9 OR #8 OR #7 OR #6 OR #5 OR #4 OR #3 OR #2 Databases=SCI‐EXPANDED Timespan=All Years |
| # 11 | Topic=(Adult* or Elderly or Middle Aged or Aged) NOT Topic=(infant* or Newborn* or Pediatric* or child* or baby or babies or babe or Adolescent) Databases=SCI‐EXPANDED Timespan=All Years |
| # 10 | Topic=(Rabeprazole or Esomeprazole or metoclopramide or domperidon* or bethanechol) OR Topic=(Sucralfate) Databases=SCI‐EXPANDED Timespan=All Years |
| # 9 | Topic=(lansoprazol* or Pantoprazole or omeprazole) Databases=SCI‐EXPANDED Timespan=All Years |
| # 8 | Topic=(Proton Pump Inhibitor* OR PPI) Databases=SCI‐EXPANDED Timespan=All Years |
| # 7 | Topic=(Ranitidin*) OR Topic=(Cimetidine) OR Topic=(Famotidine) Databases=SCI‐EXPANDED Timespan=All Years |
| # 6 | Topic=(H2 antagonist*) Databases=SCI‐EXPANDED Timespan=All Years |
| # 5 | Topic=(Maalox*) Databases=SCI‐EXPANDED Timespan=All Years |
| # 4 | Topic=(antacid*) Databases=SCI‐EXPANDED Timespan=All Years |
| # 3 | Topic=(Gaviscon) Databases=SCI‐EXPANDED Timespan=All Years |
| # 2 | Topic=(Alginate*) Databases=SCI‐EXPANDED Timespan=All Years |
| # 1 | Topic=(Gastroesophageal Reflux) OR Topic=(GER or GOR) OR Topic=(GERD or GORD) Databases=SCI‐EXPANDED Timespan=All Years |
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
| Medical treatment compared with no treatment for gastro‐oesophageal reflux disease | ||||||
| Patient or population: children 1 to 16 years of age with erosive oesophagitis Settings: paediatric outpatients Intervention: medical treatment: proton pump inhibitors (omeprazole, lansoprazole, esomeprazole and pantoprazole) or H2‐antagonists (ranitidine, cimetidine or nizatidine) or prokinetics (domperidone, erythromycin) or alginates (Gaviscon Infant® ) Comparison: placebo or no treatment | ||||||
| Outcomes | Age group | Medication | Effect | Number of participants | Quality of the evidence | Comments |
| Improvement in symptom score (primary outcome) | Older children | PPIs | PPIs (omeprazole—50 children (2 studies), lansoprazole—46 children (2 studies) Esomeprazole—153 children (2 studies) and pantoprazole—225 children (3 studies) had moderate evidence of symptom relief | 474 children | ⊕⊕⊕⊝ | Most studies compared same drug, different doses |
| H2‐antagonists | H₂‐antagonists had weak evidence of efficacy, with 1 study (32 children, 1 study) showing equal efficacy of high‐dose ranitidine compared with PPIs, and 1 study (18 children) showing evidence for absence of effect when ranitidine was added to PPI. Cimetidine (33 infants and children) also had very weak evidence for efficacy in delivering symptom relief | 83 children (3 studies) | ⊕⊕⊝⊝ | |||
| Prokinetics | Very weak evidence of efficacy was found for domperidone, with non‐significant improvement in symptoms in only 33% of participants in one study of 17 children | 17 patients | ⊕⊝⊝⊝ | |||
| Infants | PPIs | Weak evidence has been found to support the use of PPIs in infants with GORD (30.infants, 1 study) | 30 infants (1 study) | ⊕⊝⊝⊝ | ||
| H2‐antagonists | No evidence shows the efficacy of ranitidine; however nizatidine (26 infants and children, 1 study) and cimetidine (33 infants and children, 1 study) improved symptoms of GORD | 59 infants (2 studies) | ⊕⊝⊝⊝ | |||
| Alginates | Weak evidence suggests that Gaviscon Infant® improves symptoms in infants with GOR and GORD. The largest study (90 infants) showed significant symptomatic improvement, but another study (20 infants) showed no significant symptom relief | 110 infants | ⊕⊕⊝⊝ | Gaviscon Infant® has changed to become aluminium‐free, and has been assessed in its' current form in only 2 studies since 1999 | ||
| Prokinetics | Very weak evidence of efficacy was found for domperidone, with no improvement compared with placebo, and a significant improvement in symptoms only when combined with Maalox® in 1 study of 80 infants. Symptom improvement was still present at 6 months | 80 patients | ⊕⊝⊝⊝ | All feeds were thickened | ||
| Preterm babies | No robust RCT evidence has been found regarding the efficacy of treatment of patients with GOR/GORD in improving symptoms | |||||
| Children with neurodisabilities | No RCT evidence was identified | |||||
| Adverse events (AEs) | Older children + Infants + Preterm babies | PPIs | Weak evidence shows that increasing the dose may increase the risk of side effects. The risk of side effects was less prominent for omeprazole, lansoprazole and esomeprazole than for pantoprazole | 748 children | ⊕⊕⊝⊝ | 82% of participants taking pantoprazole in one study had an adverse event (mainly headache and diarrhoea) |
| H2‐antagonists | No serious AEs were noted, although 2 participants given cimetidine had diarrhoea, and 1 participant taking nizatidine had an urticarial rash | 109 children | ⊕⊕⊝⊝ | |||
| Prokinetics | No significant adverse events were noted, although 1 study did not comment on AEs | 97 children | ⊕⊝⊝⊝ | The recent MHRA alert is noted | ||
| Alginates | No serious AEs were noted, although in 1 study, 13 participants had constipation and diarrhoea (but no difference between alginate and placebo) | 156 children (5 studies) | ⊕⊕⊝⊝ | |||
| Improvement in reflux index | Older children | PPIs | 1 study assessing omeprazole and 1 study assessing lansoprazole, noted a significant improvement in reflux index | 68 children (2 studies) | ⊕⊕⊝⊝ | |
| H2‐antagonists | 2 studies assessing ranitidine, 1 study assessing cimetidine and 1 study assessing nizatidine noted significant improvements in reflux index. 1 study (32 children) showed equal efficacy of high‐dose ranitidine compared with PPIs, and 1 study (18 children) showed evidence for absence of additional effect when ranitidine was added to PPI | 109 children | ⊕⊕⊝⊝ | |||
| Infants | PPIs | 1 study assessing omeprazole and 1 study assessing esomeprazole noted a significant improvement in reflux index in infants with GORD; in the only study of infants treated with pantoprazole, no improvement in reflux index was noted, but 50% to 70% had a normal reflux index at baseline | 104 infants (3 studies) | ⊕⊕⊝⊝ | ||
| H2‐antagonists | No evidence shows the efficacy of ranitidine; however nizatidine (26 infants and children, 1 study) and cimetidine (33 infants and children, 1 study) improved symptoms of GORD | 59 infants and children | ⊕⊝⊝⊝ | |||
| Preterm babies | Domperidone | A single study of domperidone showed a significant increase in reflux frequency, but duration of reflux significantly improved | 26 babies (1 study) | ⊕⊝⊝⊝ | Short‐duration study (24 hours) | |
| Improvement in endoscopic and histological findings | Older children | PPIs | Moderate evidence showed improvement in endoscopic findings in children given PPIs (omeprazole 50 children—2 studies, lansoprazole 36 participants, 103 children—1 study and esomeprazole 109 children—1 study) | 195 children (4 studies) | ⊕⊕⊕⊝ | |
| H2‐antagonists | Weak evidence showed benefit in H2‐antagonists improving endoscopic findings in 4 studies, with 1 study showing equal benefit compared with PPI, but another study showing no benefit derived from adding H2 antagonist to PPI | 109 children (4 studies) | ⊕⊕⊝⊝ | |||
| Infants | PPIs | No studies of PPIs evaluated endoscopic evidence of improvement | ⊕⊝⊝⊝ | |||
| H2‐antagonists | Weak evidence showed benefit derived from H2‐antagonists improving endoscopic findings in 2 studies, with 2 studies showing significant improvement: 1 with nizatidine (26 infants and children) and another with cimetidine (33 infants and children) | 59 infants and children | ⊕⊕⊝⊝ | |||
| Infants + Children | Prokinetics | No evidence was identified to ascertain efficacy of domperidone in improving endoscopic findings | ⊕⊝⊝⊝ | |||
| Children with neurodisabilities | No evidence was identified for children with neurodisabilities. No evidence was available from which to evaluate erythromycin | |||||
| GRADE Working Group grades of evidence. | ||||||
| Medical treatment compared with no treatment or reassurance for gastro‐oesophageal reflux | |||||
| Patient or population: infants with gastro‐oesophageal reflux Settings: paediatric outpatients Intervention: medical treatment Comparison: no treatment or reassurance | |||||
| Outcomes | Age group | Effect | Number of participants | Quality of the evidence | Comments |
| Improvement in symptom score | Infants | 1 study of the current formulation of Gaviscon Infant® in GOR showed weak evidence of symptomatic improvement (90 participants). 1 study of 20 children showed no symptomatic improvement | 110 participants | ⊕⊕⊝⊝ | Gaviscon Infant® has changed to become aluminium‐free, and has been assessed in its current form in only 2 studies since 1999 |
| 1 study of 162 infants with GOR showed no symptomatic improvement with PPI | 162 infants | ⊕⊕⊝⊝ | |||
| 2 studies showed very poor evidence of symptomatic improvement with domperidone | 97 infants | ⊕⊝⊝⊝ | |||
| GRADE Working Group grades of evidence. | |||||
