Saline nasal irrigation for acute upper respiratory tract infections

Probably not a substantial claim: may not pass S3 (load-bearing).

Passali 2005 did not describe methods of randomisation and allocation concealment.

“Methods of randomisation and allocation concealment not described”

• cites Passali 2005 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Passali 2005 did not perform intention-to-treat analysis.

“Intention‐to‐treat analysis not performed”

• cites Passali 2005 sourceCould not verify

  The Methods section says that 200 patients were randomized and that measured data were analyzed using a t test. It does not say whether the analysis included all randomized patients, so the claim that intention-to-treat analysis was not performed cannot be verified from our copy (searched for intention-to-treat, withdrawals, dropouts, and analysis population). (LLM, conf=0.70)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

The review changed the status of two studies from exclusion due to high risk of bias to exclusion due to not meeting inclusion criteria (Inanli 2002; Passali 2005).

“These include changing the status of two studies from exclusion due to high risk of bias to exclusion due to not meeting the inclusion criteria for this review (Inanli 2002; Passali 2005).”

• cites Inanli 2002 sourceNot checked — no full text of the source
• cites Passali 2005 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Passali 2005 failed to meet inclusion criteria because there was no comparison group as a control; both groups received nasal saline via different delivery methods.

“Failed to meet the inclusion criteria, as no comparison group as a control; both groups in the trial received nasal saline via different delivery methods”

• cites Passali 2005 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Passali 2005 had no blinding.

“No blinding”

• cites Passali 2005 sourceCould not verify

  The Methods section describes random assignment to two visibly different treatments, administered under the investigators’ direct control, but does not state whether participants, treatment staff, or outcome assessors were blinded. A search for blinding and masking found no passage that settles the claim that there was no blinding. (LLM, conf=0.72)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

There was doubt as to randomisation used in Passali 2005.

“Doubt as to randomisation used”

• cites Passali 2005 sourcePartly supported

  The Methods section (page not available) says patients were “randomly divided into 2 groups” but does not describe how the randomisation was carried out. That omission supports uncertainty about the method used, not a claim that the paper itself questioned whether randomisation occurred. (LLM, conf=0.78)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Cluster-randomisation did not occur in the included studies.

“Cluster‐randomisation did not occur in the included studies.”

May combine two claims.

There was a reduction in time to resolution of symptoms reported in two trials on adult participants, but the difference was not clinically significant.

“There was a reduction in the outcome of time to resolution of symptoms, which was reported in two trials on adult participants, but the difference was not clinically significant.”

May combine two claims. The quote only partly states this claim.

Five randomised controlled trials met the inclusion criteria, enrolling 749 participants (544 children in three studies and 205 adults in two studies), with 565 participants providing data.

“We identified five RCTs that randomised 544 children (three studies) and 205 adults (exclusively from two studies).”

• Also stated in: § Background · plain

  “We identified five studies, with a total of 749 participants enrolled and 565 participants providing data, which addressed the research question and met the inclusion criteria.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The review included one further study in this updated review (King 2012, unpublished).

“We included one further study in this updated review (King 2012, unpublished).”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The included studies covered a wide range of ages, countries, sample sizes, dosing methods and frequency, and time since onset of URTI symptoms.

“These studies covered a wide range of ages, countries, sample sizes, dosing methods and frequency, and time since onset of URTI symptoms.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The 2014 update selected one study as meeting the inclusion criteria after reading the full text and included it in the updated review (Wang 2009).

“We only selected one study as meeting the inclusion criteria after reading the full text and included it in the updated review (Wang 2009).”

• cites Wang 2009 sourceNot checked — no full text of the source

May combine two claims.

The included studies were highly variable in their design and the symptoms that were measured.

“They were also highly variable in their design and the symptoms that were measured.”

May combine two claims.

Minor nasal discomfort and/or irritation was the only side effect reported by a minority of participants.

“Minor nasal discomfort and/or irritation was the only side effect reported by a minority of participants.”

May combine two claims.

Two studies reported nasal symptom scores at day seven, and neither reported statistical differences between the treatment groups (Adam 1998; King 2012).

“Two studies also reported nasal symptom scores at day seven, again neither reporting statistical differences between the treatment groups (Adam 1998; King 2012).”

• cites Adam 1998 sourceNot checked — no full text of the source
• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Wang 2009 reported no statistical difference in symptom scores between baseline and weeks two and three for four nasal and four non-nasal symptoms, except for daytime rhinorrhoea and nocturnal nasal congestion (P < 0.05).

“Wang 2009 compared the baseline mean score from the first week to the second and third week score for four nasal and four non‐nasal symptoms, and reported no statistical difference in symptoms scores, with the exception of daytime rhinorrhoea and nocturnal nasal congestion (P value < 0.05).”

• cites Wang 2009 sourceNot checked — no full text of the source

The quote only partly states this claim.

In the largest study (401 children aged 6 to 10 years), saline plus standard treatment reduced sore throat score compared with standard treatment alone (MD -0.14, 95% CI -0.24 to -0.04).

“Only the largest study, which studied 401 children aged 6 to 10 years, found significant reductions in a number of symptoms, including nasal secretions, sore throat, nasal breathing score and nasal obstruction, as well as reduced use of additional nasal decongestant medications.”

• Also stated in: § Background · plain

  “The mean sore throat in the intervention groups was 0.14 lower (0.24 to 0.04 lower)”

May combine two claims.

Three studies reported nasal symptoms at day three, and all showed no difference between the saline nasal irrigation group and the observation only group (Adam 1998; Bollag 1984; King 2012).

“Three studies reported nasal symptoms at day three. All showed no difference between the saline nasal irrigation group and the observation only group (Adam 1998; Bollag 1984; King 2012).”

• cites Adam 1998 sourceNot checked — no full text of the source
• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The initial search retrieved 285 trials, of which 280 were excluded and three were assessed as meeting the inclusion criteria.

“Of the total 285 trials retrieved, we excluded 280 based on a review of titles and abstracts. Of the five remaining trials, we assessed three as meeting the inclusion criteria and excluded two as not meeting the minimum quality criteria.”

May combine two claims.

In Bollag 1984, six out of 15 participants (40.0%) did not tolerate treatment with saline nasal drops, while seven out of 16 (43.7%) did not tolerate treatment with phenylephrine drops.

“The study using infant patients reported that six out of 15 participants (40.0%) did not tolerate treatment with saline nasal drops, while seven out of 16 (43.7%) did not tolerate treatment with phenylephrine drops (Bollag 1984).”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Wang 2009 reported a statistically significant mean improvement in nasal peak expiratory flow rate for the normal saline group at an undisclosed medium time point and end of study time point, but no raw data were available to report the size of this difference or comment on clinical significance.

“The authors reported a statistically significant mean improvement in nasal peak expiratory flow rate for the normal saline group at an undisclosed medium time point and end of study time point. However, no raw data were available and therefore we cannot report the size of this difference nor comment on the clinical significance.”

• cites Wang 2009 sourceNot checked — no full text of the source

May combine two claims.

Slapak 2008 found an overall rate of adverse events of 8.7%, most of which were reported by participants in the medium jet group and associated with the higher flow rate.

“The third study, using children, found an overall rate of adverse events of 8.7%, most of which were reported by participants in the medium jet group and associated with the higher flow rate (Slapak 2008).”

• cites Slapak 2008 sourceNot checked — no full text of the source

May combine two claims.

King 2012 found the mean day of well-being was 7.67 days (95% CI 5.33 to 10.00) for the isotonic nasal saline group compared to 10.48 days (95% CI 8.03 to 12.93) for the control group, but this was not statistically significant.

“The mean day of well‐being for the group treated with isotonic nasal saline was 7.67 days (95% CI 5.33 to 10.00) compared to 10.48 days (95% CI 8.03 to 12.93) for the control group. This was not a statistically significant difference.”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

King 2012 and Slapak 2008 found a trend to reduced antibiotic use in the nasal saline group, though this did not reach statistical significance (Analysis 2.1).

“King 2012 and Slapak 2008 compared the use of antibiotics in saline groups versus controls and found a trend to reduced antibiotic use in the nasal saline group, though this did not reach statistical significance (Analysis 2.1).”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Slapak 2008 sourceNot checked — no full text of the source

May combine two claims.

In Adam 1998, among the hypertonic saline irrigation group, 7/33 (21.2%) complained of dry nose and 11/33 (33.3%) reported pain or irritation; among the normal saline irrigation group, 11/36 (30.5%) complained of dry nose and 4/31 (12.9%) reported pain or irritation (P = 0.05 for nasal irritation).

“in the group using hypertonic saline irrigation seven out of 33 participants (21.2%) complained of dry nose and 11 out of 33 (33.3%) reported pain or irritation (Adam 1998). Among the group treated with normal saline irrigation, 11 out of 36 (30.5%) complained of dry nose and four out of 31 (12.9%) reported pain or irritation from the treatment (P value = 0.05 for nasal irritation).”

• cites Adam 1998 sourceNot checked — no full text of the source

May combine two claims.

In Slapak 2008, the mean health status score at follow-up for the control group was 2.6 (SD 1.02) for cold and 2.00 (SD 0.91) for flu, compared with 1.87 (SD 0.84) for cold and 1.59 (SD 0.74) for flu in the saline wash group, with P < 0.05 for both.

“The mean health status score at the follow‐up examination for the subgroups 'entry during cold' and 'entry during flu' respectively was 2.6 (standard deviation (SD) 1.02) and 2.00 (SD 0.91) for the control group, compared with 1.87 (SD 0.84) and 1.59 (SD 0.74) for the saline wash group, with a P value of < 0.05 reported for both groups.”

• cites Slapak 2008 sourceNot checked — no full text of the source

May combine two claims.

Each trial reviewed used different strengths of saline solution, limiting the possibilities for data comparison.

“Each trial reviewed used different strengths of saline solution, again limiting the possibilities for data comparison.”

May combine two claims.

No serious adverse effects occurred in the included trials, although three children in one study experienced nosebleeds (Slapak 2008).

“No serious adverse effects occurred in the included trials, although three children in one study experienced nosebleeds (Slapak 2008).”

• cites Slapak 2008 sourceNot checked — no full text of the source

May combine two claims.

The largest trial (Slapak 2008), which had a high risk of bias, reported statistically significant outcomes for the nasal saline group at follow-up, including reduction of sore throat, nasal secretion and secretion type, nasal breathing score, and improvement in health status score.

“The largest trial, which also had a high risk of bias, reported a number of statistically significant outcomes for the nasal saline group at follow‐up, including reduction of sore throat, nasal secretion and secretion type and nasal breathing score (Slapak 2008). It also reported a significant improvement in the health status score.”

• cites Slapak 2008 sourceNot checked — no full text of the source

May combine two claims.

There were a limited number of RCTs available and all of these studies were small in size.

“There were a limited number of RCTs available and all of these studies were small in size.”

May combine two claims.

There was a trend towards reduced antibiotic use in one study with saline nasal irrigation, and this study also demonstrated a statistically significant reduction in the use of adjunct nasal decongestant treatment with nasal saline irrigation compared to control (Slapak 2008).

“There was a trend towards reduced antibiotic use in one study with saline nasal irrigation and this study also demonstrated a statistically significant reduction in the use of adjunct nasal decongestant treatment with nasal saline irrigation compared to control (Slapak 2008).”

• cites Slapak 2008 sourceNot checked — no full text of the source

May combine two claims.

Minor adverse events were not uncommon, and 40% to 44% of babies were shown to have difficulty with nasal drops.

“Minor adverse events were not uncommon and 40% to 44% of babies were shown to have difficulty with nasal drops.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The new search for studies and content update resulted in no change to conclusions.

“New search for studies and content updated (no change to conclusions)”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

There is evidence for the effectiveness of nasal saline irrigation for chronic sinusitis and allergic rhinitis.

“There is evidence for the effectiveness of nasal saline irrigation for chronic sinusitis (Rabago 2002) and allergic rhinitis (Garavello 2003).”

• cites Rabago 2002Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Garavello 2003 sourceNot checked — no full text of the source

May combine two claims.

The included trials were generally too small and had a high risk of bias, reducing confidence in the evidence supporting the benefits of nasal saline irrigation.

“However, the included trials were generally too small and had a high risk of bias, reducing confidence in the evidence supporting this.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Acute URTIs are mainly caused by viruses.

“While acute URTIs are mainly caused by viruses, antibiotics are often prescribed (Nash 2002).”

• cites Nash 2002 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S4 (based).

A mean difference of -0.33 on a four-point symptom scale may have minimal clinical significance.

“However, a MD of ‐0.33 on a four‐point symptom scale may have minimal clinical significance.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The review used the GRADE approach to interpret the main findings and report outcome-specific information and the overall quality of evidence from the included studies in each comparison.

“In this update, we used the GRADE approach to interpret the main findings and report outcome‐specific information and the overall quality of evidence from the included studies in each comparison (GRADE 2009).”

• cites GRADE 2009Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The review compared outcomes reported in the trial against the protocol for the studies, whenever possible, to assess for reporting bias.

“We compared the outcomes reported in the trial against the protocol for the studies, whenever possible, to assess for reporting bias.”

Classified as probably not a substantial claim.

The review undertook meta-analysis for outcomes with sufficient comparable data using random-effects methods and where heterogeneity did not preclude pooling.

“We undertook meta‐analysis for outcomes where there were sufficient comparable data using random‐effects methods and heterogeneity did not preclude pooling of results.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The review conducted narrative synthesis of results where it was not possible to pool outcome data.

“We conducted narrative synthesis of results where it was not possible to pool outcome data.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The economic impact of the common cold alone on workplace absenteeism is estimated to be billions of dollars.

“The economic impact of the common cold alone on workplace absenteeism is estimated to be billions of dollars (Bramley 2002).”

• cites Bramley 2002 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The unpublished trial was brought to the review team's attention by one author (DK), whose role was supervisor and clinician, and risk-of-bias assessment and data extraction were undertaken by an independent author (BM) with no role in the trial.

“This unpublished trial was brought to the attention of the review team by one of the authors (DK). His role in the trial was as a supervisor and clinician. The 'Risk of bias' assessment and data extraction were undertaken by an independent author (BM) who had no role in this trial.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Prescribing antibiotics for acute URTIs may lead to increased antibiotic resistance and adverse outcomes, as well as being unnecessary for the patient.

“This may lead to increased antibiotic resistance and adverse outcomes, as well as being unnecessary for the patient (NICE 2008).”

• cites NICE 2008Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim.

The review assessed heterogeneity for results measuring similar outcomes.

“We assessed heterogeneity for results measuring similar outcomes.”

May combine two claims.

Most included trials were small and of low quality, with significant shortcomings in design or implementation, contributing to an unclear risk of bias.

“Most trials were small and we judged them to be of low quality, contributing to an unclear risk of bias.”

• Also stated in: § Background · plain

  “Most studies were small and had significant shortcomings in the design or implementation of the research.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The review downgraded evidence from high quality by one level (two if severe) for study limitations including bias for blinding, inconsistency in treatment effects, and imprecision.

“We downgraded the evidence from 'high quality' by one level (two if severe) for study limitations that are likely to have a serious impact on the results, including bias for blinding, inconsistency in treatment effects and imprecision (studies with small numbers had confidence intervals that included minor to very large effect sizes).”

May combine two claims.

Nasal saline is safe but may cause minor adverse effects, such as irritation or a burning sensation, particularly with products using higher flows or concentrations.

“Nasal saline is safe but may cause minor adverse effects, such as irritation or a burning sensation, particularly with products using higher flows or concentrations.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Two review authors independently assessed trial quality with the Cochrane 'Risk of bias' tool and extracted data.

“Two review authors (DK, BM) independently assessed trial quality with the Cochrane 'Risk of bias' tool and extracted data.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Antibiotics are often prescribed for acute URTIs.

“While acute URTIs are mainly caused by viruses, antibiotics are often prescribed (Nash 2002).”

• cites Nash 2002 sourceNot checked — no full text of the source

May combine two claims.

In King 2012, patient blinding was not achievable because the control group did not use a nose spray as placebo; outcome measures were reported and extracted from a symptom diary, removing potential for detection bias (unclear risk of bias).

“In King 2012, patient blinding was not achievable as the control group did not use a nose spray as placebo. The outcome measures were reported and extracted from a symptom diary so removing the role of any potential for detection bias (unclear risk of bias).”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Bollag 1984 reported 28 of 74 participants lost to follow-up, though evenly distributed between trial groups (high risk of bias).

“Bollag 1984 reports that 28 of 74 participants were lost to follow‐up, though evenly distributed between trial groups (high risk of bias).”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In Slapak 2008, patient blinding was largely impossible, and outcome assessors were blinded only to the type of saline spray delivery, not to whether participants were using saline treatment (unclear risk of bias).

“In particular, the design of Slapak 2008 made patient blinding largely impossible as each participant either used the saline spray or did not. The outcome assessors were blinded only to the type of saline spray delivery used and not blinded as to whether or not participants were using the saline treatment (unclear risk of bias).”

• cites Slapak 2008 sourceNot checked — no full text of the source

May combine two claims.

King 2012 adequately discussed patients lost to follow-up, but there was a significant difference in numbers lost to follow-up between treatment and control groups (high risk of bias).

“King 2012 adequately discussed patients lost to follow‐up, however there was a significant difference in numbers lost to follow‐up between the treatment and control groups (high risk of bias).”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Wang 2009 did not blind participants to the nasal spray; for unreported outcomes of sinus X-ray and nasal smear cytology, both outcome assessors were blinded to treatment allocation; blinding was not described for other outcome measures (high risk of bias).

“Wang 2009 did not blind participants to the nasal spray. For the unreported outcomes of sinus X‐ray and nasal smear cytology, both of the outcome assessors were blinded to treatment allocation. Blinding was not described for other outcome measures (high risk of bias).”

• cites Wang 2009 sourceNot checked — no full text of the source

May combine two claims.

Each included trial was only partially blinded (patients, clinicians or outcome assessors; sometimes two, but not all three), suggesting some risk of biased results.

“Each included trial was only partially blinded (patients, clinicians or outcome assessors; sometimes two, but not all three), suggesting some risk of biased results.”

May combine two claims.

In Bollag 1984, outcome assessors were blinded to patient treatment group, but blinding of participants (and parents) was not discussed (unclear risk of bias).

“Conversely, the outcome assessors in Bollag 1984 were blinded to patient treatment group but blinding of participants (and parents) was not discussed (unclear risk of bias).”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Adam 1998 reported 24 of 143 participants lost to follow-up, and a further 35 of the completers failed to submit a complete symptom checklist; intention-to-treat analysis was performed (unclear risk of bias).

“Adam 1998 reported 24 of 143 participants lost to follow‐up, although a further 35 of the completers failed to submit a complete symptom checklist. Intention‐to‐treat analysis was performed (unclear risk of bias).”

• cites Adam 1998 sourceNot checked — no full text of the source

May combine two claims.

In Wang 2009, there was no loss to follow-up, but there are missing data for two participants for the symptom scores used in this review (low risk of bias).

“In Wang 2009 there was no loss to follow‐up. However, there are missing data for two participants for the symptoms scores used in this review. There is one other participant with missing data for an outcome not included in this review (low risk of bias).”

• cites Wang 2009 sourceNot checked — no full text of the source

May combine two claims.

In Adam 1998, participants and clinicians were blinded, but blinding of outcome assessors was not discussed (low risk of bias).

“Participants and clinicians were blinded in Adam 1998, but blinding of outcome assessors was not discussed (low risk of bias).”

• cites Adam 1998 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Two trials used random number tables for allocation (Adam 1998; Bollag 1984).

“Two trials used random number tables (Adam 1998; Bollag 1984).”

• cites Adam 1998 sourceNot checked — no full text of the source
• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Slapak 2008 adequately discussed drop-outs and losses to follow-up, which numbered only 11 out of the initial 401 participants enrolled (low risk of bias).

“Slapak 2008 adequately discussed drop‐outs and losses to follow‐up, which numbered only 11 out of the initial 401 participants enrolled in the trial (low risk of bias).”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Adam 1998, drop-out and losses to follow-up were not discussed, with 24 participants (16%) lost to follow-up, judged unclear risk of attrition bias.

“Drop‐out and losses to follow‐up not discussed. 24 participants (16%) were lost to follow‐up”

• cites Adam 1998 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Adam 1998, patients and clinicians were blinded, judged low risk of performance and detection bias.

“Patients and clinicians blinded; outcome assessors not discussed”

• cites Adam 1998 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The two new studies added to this review have not changed the findings from the last published review.

“The two new studies added to this review have not changed the findings from the last published review.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Bollag 1984, drop-outs and losses to follow-up were adequately discussed, with 28 out of 74 participants dropping out equally in all 3 groups, judged high risk of attrition bias.

“Drop‐outs and losses to follow‐up adequately discussed; 28 out of 74 participants dropped out, equal in all 3 groups”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Slapak 2008 used a commercial isotonic seawater product containing zinc and other elements that may be a factor in the effects of the product.

“In particular, Slapak 2008 used a commercial isotonic seawater product containing zinc and other elements that may be a factor in the effects of the product.”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Adam 1998 used a random numbers table for random sequence generation, judged low risk of selection bias.

“Random numbers table used”

• cites Adam 1998 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

No other potential sources of bias were identified in Adam 1998, judged low risk of other bias.

“No other potential sources of bias identified”

• cites Adam 1998 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Adam 1998 did not mention allocation concealment, judged unclear risk of selection bias.

“Not mentioned in paper”

• cites Adam 1998 sourceNot checked — no full text of the source

May combine two claims.

One study (Wang 2009) reported a significant difference in quality of life and peak nasal expiratory flow, but significant methodological and reporting flaws limit the interpretation of these data.

“One study, reported a significant difference in quality of life and peak nasal expiratory flow (Wang 2009). However, there were significant methodological and reporting flaws that limit the interpretation of these data.”

• cites Wang 2009 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Bollag 1984, outcome assessors were blinded but others including patients/parents were not, and the control group had no comparable intervention, judged unclear risk of performance and detection bias.

“Outcome assessors blinded; others (including patients/parents) not blinded, control group had no comparable intervention to the intervention groups”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The studies are generally at unclear risk of bias, sample sizes are small (most with fewer than 100 participants overall), and the possibility of chance findings and publication bias is high.

“The studies are generally at unclear risk of bias and the sample sizes are small (most with fewer than 100 participants overall) and the possibility of chance findings and publication bias is high.”

May combine two claims.

Wang 2009 had methodological weaknesses: baseline score for individual and total symptom score was calculated as a mean of daily scores during the baseline period of seven days rather than on the day of entry; there was a statistically significant difference between treatment groups at baseline as well as at two and three weeks after treatment; and there were incorrect data in the tables presented

“The Wang 2009 paper also had methodological weaknesses. Patients recorded daily symptoms in a symptom diary, but the baseline score for individual and total symptom score (TSS) was calculated as a mean of daily scores during the baseline period of seven days, rather than on the day of entry to the trial. We also noted that there was a statistically significant difference between the two treatment”

• cites Wang 2009 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Bollag 1984, intention-to-treat analysis was not performed and the original study protocol was not available, judged unclear risk of reporting bias.

“Intention‐to‐treat analysis not performed; original study protocol not available”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

No other potential sources of bias were identified in Bollag 1984, judged low risk of other bias.

“No other potential sources of bias identified”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Adam 1998, intention-to-treat analysis was performed but the original study protocol was not available, judged unclear risk of reporting bias.

“Intention‐to‐treat analysis performed; original study protocol not available”

• cites Adam 1998 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Bollag 1984 did not mention allocation concealment, judged unclear risk of selection bias.

“Not mentioned in paper”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

We included one unpublished study in this updated review (King 2012), which was supervised by one of the authors (DK); the risk of bias assessment and data extraction were undertaken by independent authors (BM, CW) who had no role in this trial.

“We included one unpublished study in this updated review (King 2012). This unpublished trial was supervised by one of the authors (DK), whose role in the trial was as a supervisor and clinician. The 'Risk of bias' assessment and data extraction were undertaken by independent authors (BM, CW), who had no role in this trial.”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Wang 2009 reported statistically significant nasal peak expiratory flow rates but presented no data for this outcome, and the authors were unable to provide this (high risk of bias).

“Wang 2009 reported statistically significant nasal peak expiratory flow rates but presented no data for this outcome. The authors were unable to provide this. Wang 2009 also reported significantly improved quality of life scores in the nasal saline group but again no data were presented or available to the review authors for inclusion in this review (high risk of bias).”

• cites Wang 2009 sourceNot checked — no full text of the source

May combine two claims.

Bollag 1984 provided incomplete data that were not suitable for pooling, reporting only mean scores for each group at baseline and follow-up two days later, with baseline scores varying considerably.

“Bollag 1984 provided incomplete data that were not suitable for pooling, instead reporting only mean scores for each group at baseline and follow‐up two days later, with baseline scores varying considerably.”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Bollag 1984 and Wang 2009 relied on interpretation and reporting of infant patients' symptoms by parents, contributing to potential bias and limiting interpretation of results.

“Furthermore, Bollag 1984 and Wang 2009 relied on interpretation and reporting of infant patients' symptoms by parents, contributing to potential bias and this is a limitation in the interpretation of the results of these studies.”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Wang 2009 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Bollag 1984 used a random numbers table for random sequence generation, judged low risk of selection bias.

“Random numbers table used”

• cites Bollag 1984Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The clinical outcomes measured by each study were largely subjective, focusing on patient-reported symptoms, which increases risk of bias in the results.

“The clinical outcomes measured by each study were largely subjective, focusing on patient‐reported symptoms, which increases risk of bias in the results.”

May combine two claims.

Nasal irrigation with saline is a safe treatment that may be mildly beneficial to some patients, though the existing evidence is too limited to support recommendations for or against its role as a standard intervention.

“Nasal irrigation with saline is a safe treatment that may be mildly beneficial to some patients, though the existing evidence is too limited to support recommendations for or against its role as a standard intervention.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

King 2012 used computer-generated blocks of 10 for randomisation, judged low risk of selection bias.

“Computer‐generated blocks of 10 for randomisation”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

There was a reduction in time to resolution of symptoms reported in two trials, but the difference was not clinically significant.

“There was a reduction in the outcome of time to resolution of symptoms, which was reported in two trials, but the difference was not clinically significant.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In King 2012, recruitment from attending GPs may have biased more serious infections but was unlikely to have affected outcome, judged low risk of other bias.

“Recruited from attending GPs who may have biased more serious infections ‐ unlikely to have affected outcome”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In King 2012, many more participants were lost to follow-up in the treatment group compared with placebo, with only 33 of 62 enrolled completing follow-up, judged high risk of attrition bias.

“Adequately described but many more participants lost to follow‐up in the treatment group compared with placebo. Only 33 of 62 enrolled completed follow‐up”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In Wang 2009, not all pre-specified primary outcomes were reported and some outcomes were reported incompletely, with errors in tabulated data, judged high risk of reporting bias.

“Not all of the study's pre‐specified primary outcomes have been reported; some outcomes of interest in the review are reported incompletely In addition, there are errors in the reported tabulated data.”

• cites Wang 2009 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Inanli 2002 did not describe method of allocation concealment.

“Method of allocation concealment not described”

• cites Inanli 2002 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Slapak 2008, drop-out and losses to follow-up were small and adequately discussed, with 390 of 401 completing the study, judged low risk of attrition bias.

“Drop‐out and losses to follow‐up small and adequately discussed. 390 of 401 completed the study (11 lost to follow‐up)”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Slapak 2008, no patient blinding was possible due to study design, and outcome assessors were blinded to saline delivery method but not to intervention versus control, judged unclear risk of performance and detection bias.

“No patient blinding possible due to study design; outcome assessors blinded to saline delivery method but not to intervention versus control”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Wang 2009, there was a comparatively small loss of participant data (2 out of 69 not included) but no explanation, judged low risk of attrition bias.

“There is a comparatively small loss of participant data (2 out of 69 not included) but no explanation in the paper”

• cites Wang 2009 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The review omitted the outcome 'time off work or school' from Slapak 2008 because it was based on follow-up periods outside the specifications for acute URTIs as specified in the protocol.

“Also, we noted the inclusion of the outcome 'time off work or school' from Slapak 2008 in the original review to be based on follow‐up periods outside of the specifications for acute URTIs as specified in the protocol, so we omitted this from inclusion in this 2014 update.”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In King 2012, all outcomes were reported adequately as pre-described and the original study protocol was available, judged low risk of reporting bias.

“All reported on adequately as pre‐described; original study protocol was available”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based). May combine two claims.

No other potential sources of bias were identified in Slapak 2008, judged low risk of other bias.

“No other potential sources of bias identified”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

In Slapak 2008, intention-to-treat analysis was not performed and the original study protocol was not available, judged unclear risk of reporting bias.

“Intention‐to‐treat analysis not performed; original study protocol not available”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

King 2012 used opaque envelopes that were pre-packaged for allocation, judged low risk of selection bias.

“Allocation done using opaque envelopes that were pre‐packaged”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Wang 2009, most outcome measures were not blinded to participants or researchers, though some outcomes were objective measures less vulnerable to bias, judged high risk of performance and detection bias.

“Poorly described. Most outcome measures were not blinded to participants or researchers. Some outcomes were objective measures, less vulnerable to bias”

• cites Wang 2009 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Inanli 2002 had no blinding.

“No blinding”

• cites Inanli 2002 sourceNot checked — no full text of the source

May combine two claims.

In Wang 2009, there were methodological flaws including averaging symptoms over a week including baseline, and from the data the groups could not be concluded equal at baseline nor improvement due to early treatment effect, judged high risk of other bias.

“In addition to the above, there are some methodological flaws, mainly the averaging of symptoms over a week, especially over the first week that included a baseline measurement. We noted that from the data we cannot conclude that the groups were equal at baseline, nor that the improvement was due to an early treatment effect.”

• cites Wang 2009 sourceNot checked — no full text of the source

May combine two claims.

Slapak 2008 used sequence of clinic arrival for allocation, judged high risk of selection bias.

“Sequence of clinic arrival used for allocation”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Wang 2009, correspondence from authors confirmed randomisation but no detail on method was provided, judged unclear risk of selection bias.

“Correspondence from authors confirmed randomisation but no detail on method”

• cites Wang 2009 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The review changed the primary and secondary outcome measures to avoid duplication; for example, duration of symptoms was a primary outcome in the original review while time to resolution of symptoms was a secondary outcome.

“We changed the primary and secondary outcome measures to avoid duplication; for example, duration of symptoms was a primary outcome in the original review while time to resolution of symptoms was a secondary outcome.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Inanli 2002 failed to meet inclusion criteria because no clinically relevant outcomes were measured.

“Failed to meet the inclusion criteria, as no clinically relevant outcomes measured”

• cites Inanli 2002 sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

The review undertook risk of bias assessment of all new and previously included studies following the new Cochrane recommendations.

“We undertook 'Risk of bias' assessment of all new and previously included studies following the new Cochrane recommendations.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Slapak 2008 did not mention allocation concealment, judged unclear risk of selection bias.

“Not mentioned in paper”

• cites Slapak 2008 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In King 2012, participants knew which allocation they received and outcome was assessed by patient diary only, judged unclear risk of performance and detection bias.

“Participants know which allocation they have received by the nature of their treatment Outcome assessed by patient reporting via symptom diary only”

• cites King 2012Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Inanli 2002 did not control selection bias.

“Selection bias not controlled”

• cites Inanli 2002 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Wang 2009, allocation concealment was not described and there were significant baseline differences between groups, particularly in rhinorrhoea score, judged unclear risk of selection bias.

“Not described in paper, nor obtained from authors. 30 participants assigned to intervention and 39 to placebo group. Significant differences between groups at baseline, particularly in rhinorrhoea score”

• cites Wang 2009 sourceNot checked — no full text of the source