Manuka Honey Nasal Rinse Study

Not Applicable

Withdrawn

Interventions: Other: Saline mixed with Manuka Honey
Other: NeilMed Saline Sinus Rinse

Brief Summary: The purpose of this study is to evaluate whether high-volume nasal rinses with a manuka honey/saline mixture will improve symptom scores, nasal endoscopic findings and CT scan findings compared to nasal saline rinse without manuka honey in patients with chronic rhinosinusitis.

Manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in New Zealand. It has been shown to have antibacterial activity against common bacteria that cause chronic sinusitis.

Detailed Description: If the subject chooses to participate in the study, the subject will be asked to fill out a symptom questionnaire at the beginning of the study and at each follow-up visit. The subject will be randomly assigned (much like the flip of a coin) to one of two treatment arms in addition to the prescribed medical treatments: 1) nasal rinses twice daily with a saline solution (standard therapy) or 2) nasal rinses with a saline solution mixed with manuka honey (the experimental therapy.) Subjects in the manuka honey/saline rinse arm will perform the experimental rinses twice daily for one month, and then will continue with saline rinses twice daily, with manuka honey added to the rinses only as needed. Nasal rinsing of some kind will be continued through the entire study period.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Saline mixed with Manuka Honey	Saline mixed with Manuka Honey	Saline mixed with MH nasal rinses participants will be instructed how to mix a rounded teaspoon of MH (Wedderspoon® 100% Raw Manuka Honey Active 16+) with 4-6 oz of lukewarm distilled or previously boiled water, to add along with distilled or previously boiled water and the NeilMed® Sinus Rinse packet to the rinse bottle to a final volume of 240 ml. Participants will be instructed to rinse slowly with the MH/saline rinse mixture to maximize contact time with the MH/saline mixture.
NeilMed Saline Sinus Rinse	NeilMed Saline Sinus Rinse	Saline nasal rinses will be performed using a NeilMed® Sinus Rinse 240 ml bottle and one NeilMed® packet containing sodium chloride/sodium bicarbonate at a concentration to make an isotonic solution when mixed with distilled or previously boiled water.

Primary Outcome Measures

Name	Time	Method
Change in SNOT-22 Symptomatic Scores at 3 months	Change from baseline at 3 months	There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
Change in SNOT-22 Symptomatic Scores at 6 months	Change from baseline at 6 months	There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
Change in SNOT-22 Symptomatic Scores at 1 month	Change from baseline at 1 month	There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.

Secondary Outcome Measures

Name	Time	Method
Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months	Change in baseline at 3 months
Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month	Change in baseline at 1 month
Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months	Change in baseline at 6 months
Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months	Change in baseline at 3 months

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