CRSO

MEDLINE (Ovid)

Embase (Ovid)

Web of Science (Web of Knowledge)

#1 MESH DESCRIPTOR Rhinitis

#2 MESH DESCRIPTOR Conjunctivitis

#3 (rhinit* or Rhinoconjunctivitis or conjunctivitis):TI,AB,KY

#4 #1 OR #2 OR #3

#5 MESH DESCRIPTOR Allergens EXPLODE ALL TREES

#6 MESH DESCRIPTOR Pollen EXPLODE ALL TREES

#7 MESH DESCRIPTOR Hypersensitivity EXPLODE ALL TREES

#8 (allerg* or hypersensitivit* or perennial or nonseason* or season* or pollen* or dust or hair* or dander or mite*):TI,AB,KY

#9 #5 OR #6 OR #7 OR #8

#10 #4 AND #9

#11 MESH DESCRIPTOR Rhinitis, Allergic EXPLODE ALL TREES

#12 MESH DESCRIPTOR Conjunctivitis, Allergic EXPLODE ALL TREES

#13 (hayfever or "hay fever" or pollenosis or pollinosis or SAR or PAR):TI,AB,KY

#14 #10 OR #11 OR #12 OR #13

#15 MESH DESCRIPTOR Solutions

#16 MESH DESCRIPTOR Hypertonic Solutions

#17 MESH DESCRIPTOR Saline Solution, Hypertonic EXPLODE ALL TREES

#18 MESH DESCRIPTOR isotonic solutions EXPLODE ALL TREES

#19 MESH DESCRIPTOR Sodium Chloride EXPLODE ALL TREES

#20 MESH DESCRIPTOR Mineral Waters EXPLODE ALL TREES

#21 MESH DESCRIPTOR seawater EXPLODE ALL TREES

#22 MESH DESCRIPTOR Hypotonic Solutions EXPLODE ALL TREES

#23 (saline or "sodium chloride" or saltwater or hypertonic* or hypotonic* or isotonic* or hypersaline or "sea water" or seawater or ((salt* or thermal or mineral or sulfur* or bromic or iodic* or bromide or iodine or bromine) and (water* or solution*))):TI,AB,KY

#24 #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23

#25 MESH DESCRIPTOR Therapeutic Irrigation

#26 MESH DESCRIPTOR Nasal Lavage EXPLODE ALL TREES

#27 MESH DESCRIPTOR Administration, Inhalation EXPLODE ALL TREES

#28 MESH DESCRIPTOR Administration, Intranasal EXPLODE ALL TREES

#29 MESH DESCRIPTOR Nasal Sprays EXPLODE ALL TREES

#30 MESH DESCRIPTOR Buffers EXPLODE ALL TREES

#31 (douch* or spray* or lavag* or wash* or rinse* or rinsing or irrigat* or pulsed or nebulise* or aerosol* or buffer* or atomis* or atomiz* or (squeeze and bottle)):TI,AB,KY

#32 (intranasal or inhalation* or irrigator):TI,AB,KY

#33 #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32

#34 #24 and #33

#35 (sterimar or NeilMed or nasaline or navage or marimer or physiomer or Emcur or "simply saline" or "nasal mist" or ayr or salex or "otrovin saline" or ISCS or Prorhinel or SSBI):TI,AB,KY

#36 (nasal or intranasal or sinus or nose or sinonasal) ADJ3 (irrigation* or rinsing or rinse* or wash* or lavage or douch* or hygiene):TI,AB,KY

#37 MESH DESCRIPTOR Mineral Waters EXPLODE ALL TREES WITH QUALIFIERS TU

#38 #34 or #35 or #36 or #37

#39 #14 and #38

1 Rhinitis/

2 Conjunctivitis/

3 (rhinit* or Rhinoconjunctivitis or conjunctivitis).ab,kf,ti.

4 1 or 2 or 3

5 exp Allergens/

6 exp Pollen/

7 exp Hypersensitivity/

8 (allerg* or hypersensitivit* or perennial or nonseason* or season* or pollen* or dust or hair* or dander or mite*).ab,kf,ti.

9 5 or 6 or 7

10 4 and 9

11 exp Rhinitis, Allergic/

12 exp Conjunctivitis, Allergic/

13 (hayfever or "hay fever" or pollenosis or pollinosis or SAR or PAR).ab,kf,ti.

14 10 or 11 or 12 or 13

15 Solutions/

16 Hypertonic Solutions/

17 exp Saline Solution, Hypertonic/

18 exp isotonic solutions/

19 exp Sodium Chloride/

20 exp Mineral Waters/

21 exp seawater/

22 exp Hypotonic Solutions/

23 (saline or "sodium chloride" or saltwater or hypertonic* or hypotonic* or isotonic* or hypersaline or "sea water" or seawater or ((salt* or thermal or mineral or sulfur* or bromic or iodic* or bromide or iodine or bromine) and (water* or solution*))).ab,kf,ti.

24 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23

25 Therapeutic Irrigation/

26 exp Nasal Lavage/

27 exp Administration, Inhalation/

28 exp Administration, Intranasal/

29 exp Nasal Sprays/

30 exp Buffers/

31 (douch* or spray* or lavag* or wash* or rinse* or rinsing or irrigat* or pulsed or nebulise* or aerosol* or buffer* or atomis* or atomiz* or (squeeze and bottle)).ab,kf,ti.

32 (intranasal or inhalation* or irrigator).ab,kf,ti.

33 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32

34 24 and 33

35 (sterimar or NeilMed or nasaline or navage or marimer or physiomer or Emcur or "simply saline" or "nasal mist" or ayr or salex or "otrovin saline" or ISCS or Prorhinel or SSBI).ab,kf,ti.

36 ((nasal or intranasal or sinus or nose or sinonasal) adj3 (irrigation* or rinsing or rinse* or wash* or lavage or douch* or hygiene)).ab,kf,ti.

37 exp Mineral Waters/tu [Therapeutic Use]

38 34 or 35 or 36 or 37

39 14 and 38

1 rhinitis/

2 conjunctivitis/

3 (rhinit* or Rhinoconjunctivitis or conjunctivitis).ab,kw,ti.

4 1 or 2 or 3

5 exp allergen/

6 exp pollen/

7 exp hypersensitivity/

8 (allerg* or hypersensitivit* or perennial or nonseason* or season* or pollen* or dust or hair* or dander or mite*).ab,kw,ti.

9 5 or 6 or 7 or 8

10 4 and 9

11 exp allergic rhinitis/

12 exp allergic conjunctivitis/

13 (hayfever or "hay fever" or pollenosis or pollinosis or SAR or PAR).ab,kw,ti.

14 10 or 11 or 12 or 13

15 "solution and solubility"/

16 exp hypertonic solution/

17 exp sodium chloride/

18 exp isotonic solution/

19 exp mineral water/

20 exp sea water/

21 exp hypotonic solution/

22 (saline or "sodium chloride" or saltwater or hypertonic* or hypotonic* or isotonic* or hypersaline or "sea water" or seawater or ((salt* or thermal or mineral or sulfur* or bromic or iodic* or bromide or iodine or bromine) and (water* or solution*))).ab,kw,ti.

23 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22

24 lavage/

25 exp nasal lavage/

26 exp inhalational drug administration/

27 exp intranasal drug administration/

28 exp nose spray/

29 exp buffer/

30 (douch* or spray* or lavag* or wash* or rinse* or rinsing or irrigat* or pulsed or nebulise* or aerosol* or buffer* or atomis* or atomiz* or (squeeze and bottle)).ab,kw,ti.

31 (intranasal or inhalation* or irrigator).ab,kw,ti.

32 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31

33 23 and 32

34 (sterimar or NeilMed or nasaline or navage or marimer or physiomer or Emcur or "simply saline" or "nasal mist" or ayr or salex or "otrovin saline" or ISCS or Prorhinel or SSBI).ab,kw,ti.

35 ((nasal or intranasal or sinus or nose or sinonasal) adj3 (irrigation* or rinsing or rinse* or wash* or lavage or douch* or hygiene)).ab,kw,ti.

36 33 or 34 or 35

37 14 and 36

#1 TOPIC: (rhinit* or Rhinoconjunctivitis or conjunctivitis)

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#2 TOPIC: (allerg* or hypersensitivit* or perennial or nonseason* or season* or pollen* or dust or hair* or dander or mite*)

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#3 #2 AND #1

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#4 TOPIC: (hayfever or "hay fever" or pollenosis or pollinosis)

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#5 #4 OR #3

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#6 TOPIC: ((saline or "sodium chloride" or saltwater or hypertonic* or hypotonic* or isotonic* or hypersaline or "sea water" or seawater or ((salt* or thermal or mineral or sulfur* or bromic or iodic* or bromide or iodine or bromine) and (water* or solution*))))

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#7 TOPIC: ((douch* or spray* or lavag* or wash* or rinse* or rinsing or irrigat* or pulsed or nebulise* or aerosol* or buffer* or atomis* or atomiz* or (squeeze and bottle)))

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#8 TOPIC: ((intranasal or inhalation* or irrigator))

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#9 #8 OR #7

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#10 #9 AND #6

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#11 TOPIC: ((sterimar or NeilMed or nasaline or navage or marimer or physiomer or Emcur or "simply saline" or "nasal mist" or ayr or salex or "otrovin saline" or ISCS or Prorhinel or SSBI))

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#12 TOPIC: ((nasal or intranasal or sinus or nose or sinonasal) NEAR/3 (irrigation* or rinsing or rinse* or wash* or lavage or douch* or hygiene))

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#13 #12 OR #11 OR #10

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

#14 #13 AND #5

Indexes=SCI‐EXPANDED, CPCI‐S Timespan=All years

CINAHL (EBSCO)

ICTRP

ClinicalTrials.gov

LILACS

S37 S14 AND S36

S36 S32 OR S33 OR S34 OR S35

S35 (MH "Mineral Water/TU")

S34 TX (nasal or intranasal or sinus or nose or sinonasal) N3 (irrigation* or rinsing or rinse* or wash* or lavage or douch* or hygiene)

S33 TX (sterimar or NeilMed or nasaline or navage or marimer or physiomer or Emcur or "simply saline" or "nasal mist" or ayr or salex or "otrovin saline" or ISCS or Prorhinel or SSBI)

S32 S23 AND S31

S31 S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30

S30 TX (intranasal or inhalation* or irrigator)

S29 TX (douch* or spray* or lavag* or wash* or rinse* or rinsing or irrigat* or pulsed or nebulise* or aerosol* or buffer* or atomis* or atomiz* or (squeeze and bottle))

S28 (MH “Buffers+”)

S27 (MH “Administration, Intranasal+”)

S26 (MH “Administration, Inhalation+”)

S25 (MH “Nasal Lavage+”)

S24 (MH “Therapeutic Irrigation”)

S23 S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22

S22 TX saline or "sodium chloride" or saltwater or hypertonic* or hypotonic* or isotonic* or hypersaline or "sea water" or seawater or ((salt* or thermal or mineral or sulfur* or bromic or iodic* or bromide or iodine or bromine) and (water* or solution*))

S21 (MH “Hypotonic Solutions+”)

S20 (MH "Mineral Water")

S19 (MH “Sodium Chloride+”)

S18 (MH “isotonic solutions+”)

S17 (MH “Saline Solution, Hypertonic+”)

S16 (MH “Hypertonic Solutions”)

S15 (MH “Solutions”)

S14 S10 OR S11 OR S12 OR S13

S13 TX hayfever or "hay fever" or pollenosis or pollinosis or SAR or PAR

S12 (MH “Conjunctivitis, Allergic+”)

S11 (MH "Rhinitis, Allergic, Perennial") OR (MH "Rhinitis, Allergic, Seasonal")

S10 S8 AND S9

S9 S4 OR S5 OR S6 OR S7

S8 S1 OR S2 OR S3

S7 TX allerg* or hypersensitivit* or perennial or nonseason* or season* or pollen* or dust or hair* or dander or mite*)

S6 (MH “Hypersensitivity+”)

S5 (MH “Pollen+”)

S4 (MH "Allergens+")

S3 TX rhinit* or Rhinoconjunctivitis or conjunctivitis

S2 (MH “Conjunctivitis”)

S1 (MH "Rhinitis")

rhinit* AND saline OR rhinit* AND salt AND water OR hayfever AND saline OR hayfever AND salt AND water

(rhinitis OR hayfever) AND (saline OR (salt AND water)) | Interventional Studies

(TW:rhinit* OR TW:rinit OR TW:hayfever OR TW:”hay fever” OR TW:pollinosis OR TW:pollenosis) AND (TW:salin* OR TW: water* OR TW: Agua*)

REF ID:

Study title:

Date of extraction:

Extracted by:

General comments/notes (internal for discussion):

Flow chart of trial

Group A (Intervention)

Group B (Comparison)

No. of people screened

No. of participants randomised ‐ all

No. randomised to each group

No. receiving treatment as allocated

No. not receiving treatment as allocated

‐ Reason 1

‐ Reason 2

No. dropped out

(no follow‐up data for any outcome available)

No. excluded from analysis¹ (for all outcomes)

‐ Reason 1

‐ Reason 2

¹This should be the people who received the treatment and were therefore not considered 'dropouts' but were excluded from all analyses (e.g. because the data could not be interpreted or the outcome was not recorded for some reason).

Information to go into 'Characteristics of included studies' table

Methods

X arm, double/single/non‐blinded, [multicentre] parallel‐group/cross‐over/cluster‐RCT, with x duration of treatment and x duration of follow‐up

Participants

Location: country, no. of sites etc.

Setting of recruitment and treatment:

Sample size:

• Number randomised: x in intervention, y in comparison

• Number completed: x in intervention, y in comparison

Participant (baseline) characteristics:

• Age:

• Gender:

• Main diagnosis: [as stated in paper]

• Type of allergic rhinitis: [persistent or intermittent as per ARIA 2008 guidelines]

• Severity of allergic rhinitis: [mild or moderate/severe as per ARIA 2008 guidelines]

• Type of allergic trigger: [e.g. mites, pollens, animals, etc.]

• Other important effect modifiers, if applicable: (e.g. comorbidity of asthma):

Inclusion criteria:[state diagnostic criteria used for allergic rhinitis, polyps score if available]
Exclusion criteria:

Interventions

Intervention (n = x): intervention name including tonicity, method of administration [including volume], frequency of administration, duration of treatment

Comparator group (n = y):

Use of additional interventions (common to both treatment arms):

Outcomes

Outcomes of interest in the review:

Primary outcomes:

• Disease severity, as measured by patient‐reported symptom score (such as the Total Nasal Symptom Score (TNSS) questionnaire and visual analogue scales)

• Significant adverse effects: epistaxis

Secondary outcomes:

• Patient‐reported individual symptom scores for the following symptoms:

  • nasal obstruction/blockage/congestion

  • nasal discharge (anterior or posterior rhinorrhoea ‐ identify which one, or if both have been reported)

  • nasal itching

  • sneezing

• Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) and Rhinitis Symptom Utility Index (RSUI)

• Health‐related quality of life, using generic quality of life scores, such as the SF‐36, EQ‐5D and other well‐validated instruments

• Other local adverse effects: local irritation/discomfort, aural symptoms

• Endoscopic score (e.g. Lund‐Mackay/Lund‐Kennedy)

Other outcomes reported by the study:

• [List outcomes reported but not of interest to the review]

Funding sources

'No information provided'/'None declared'/State source of funding

Declarations of interest

'No information provided'/'None declared'/State conflict

Notes

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Quote: "…"

Comment:

Allocation concealment (selection bias)

Quote: "…"

Comment:

Blinding of participants and personnel (performance bias)

Quote: "…"

Comment:

Blinding of outcome assessment (detection bias)

Quote: "…"

Comment:

Incomplete outcome data (attrition bias)

Quote: "…"

Comment:

Selective reporting (reporting bias)

Quote: "…"

Comment:

Other bias (see section 8.15)

Insensitive/non‐validated instrument?

Quote: "…"

Comment:

Other bias (see section 8.15)

Quote: "…"

Comment:

Findings of study: continuous outcomes

Results (continuous data table)

Outcome

Group A

Group B

Other summary stats/Notes

Mean

SD

N

Mean

SD

N

Mean difference (95% CI), P values etc.

Disease‐specific HRQL

(instrument name/range)

Time point:

Generic HRQL

(instrument name/range)

Time point:

Symptom score (overall)

(instrument name/range)

Time point:

Added total ‐ if scores reported separately for each symptom (range)

Time point:

Nasal blockage/obstruction/congestion

(instrument name/range)

Nasal discharge (anterior or posterior rhinorrhoea ‐ specify which one if it is known)

(instrument name/range)

Sneezing

(instrument name/range)

Nasal itching

(instrument name/range)

Endoscopic score

(instrument name/range)

Comments:

Results (dichotomous data table)

Outcome

Intervention

Group A

Group B

Other summary stats/notes

No. of people with events

No. of people analysed

No. of people with events

No. of people analysed

P values, RR (95% CI), OR (95% CI)

Epistaxis/nosebleed

Nasal saline

Local irritation (sore throat, oral thrush, discomfort)

Nasal saline

Local adverse effects: Eustachian tube dysfunction

Nasal saline

The following adverse effects will only be extracted if the comparison arm is one of the interventions indicated

Osteoporosis (minimum 6 months)

INCS

Stunted growth (children, minimum 6 months)

INCS

Can also be measured as average height

Mood disturbances

Oral steroids

Gastrointestinal disturbances (diarrhoea, nausea, vomiting, stomach irritation)

Oral steroids

Antibiotics

Insomnia

Oral steroids

Osteoporosis (minimum 6 months)

INCS

Oral steroids

Skin irritation

Antibiotics

Anaphylaxis or other serious allergic reactions such as Stevens‐Johnson syndrome

Antibiotics

Antihistamine and decongestant adverse events: somnolence, irritability, insomnia, rhinitis medicamentosa, prolonged middle ear effusion

Antihistamines/decongestants

Comments: