Hypertonic saline nasal irrigation and gargling for the common cold: Results of a pilot randomised controlled trial

S. Ramalingam, C. Graham, L. Morrice, A. Sheikh

Research output: Contribution to journalMeeting abstract

Abstract / Description of output

Background: Viral upper respiratory tract infections (URTI) are very common and have a significant impact on individuals and the economy. Indirect clinical and lab evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may improve clinical and virological outcomes. We designed a pilot randomised controlled trial (RCT) to assess the feasibility of a larger RCT to estimate the effectiveness of HSNIG.
Methods: Adults (>16 years) within 48 h of URTI were randomised into intervention and control arms minimised by sex/smoking status. We proposed to enrol up to 80 to have at least 30 completers per arm. Intervention arm were shown a video, taught to prepare hypertonic saline (HS) with Cornish sea salt, and the highest comfortable concentration of HS ascertained (1.5–3.0%). Control arm participants received usual care. Those with symptoms >48 hours; chronic illness, allergic rhinitis, immunosuppression; pregnant; on antibiotics; or unable to perform HSNIG were excluded. Recruitment rate was the primary outcome; sample return/diary completion, compliance, acceptability, quality-of-life, symptom duration and viral shedding were secondary outcomes. A self-taken nasal swab (Copan) was collected at baseline and first thing on days 1-4 to measure change in viral shedding. Validated symptom diaries were maintained up to 14 days or until they were well for two days or needed medical attention.
Results: Between November 2014–March 2015, we recruited 68 participants (average 3.4 participants/week); two were subsequently not included for analysis (on antibiotics; withdrew immediately after randomisation) (Intervention:Control = 32:34). Baseline characteristics were similar between arms. A virus was identified in 72.7% (48/66) of participants (rhinovirus 58.3%; coronaviruses 31.3%). There was no difference between arms in returning diaries/swabs. 81% opted for 3% HS. 89% thought HSNIG was very-moderately comfortable to perform. The intervention arm cleared URTI 1.9 days earlier than the control arm [mean (SD): 6.8 (2.2) vs. 8.7 (3.3) days, p = 0.012] with a lower average symptom score (13.2 vs. 16.9, p = 0.089). 93% felt HSNIG made a difference. More individuals in the control arm reported over-the-counter medication (86% vs. 50%, p = 0.004), and symptoms in individuals at home after them (70% vs 33%, p = 0.004). Where feedback was available 61%/25%/14% were likely/undecided/unlikely to use HSNIG in the future.
Conclusions: This pilot has demonstrated our ability to recruit and retain participants, and the acceptability of HSNIG. The significant reduction in duration, symptom severity, over-the-counter medication use and illness within households support the need for a larger RCT of this low cost intervention against the common cold.
Original languageEnglish
Pages (from-to)S1-S2
Number of pages2
JournalJournal of Clinical Virology
Issue numberS1
Publication statusPublished - 18 Aug 2015


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