Nasal Rinse and its Benefits
Saline irrigation is a safe, inexpensive and effective method for treating chronic nasal and sinus symptoms, according to a new study.
Researchers at the University of Michigan Health System also concluded that saline irrigation — the flushing of nasal passages with a salt water mixture — is more effective than commonly used saline sprays at providing short-term relief of chronic nasal symptoms.
The study included 121 adults with chronic nasal and sinus symptoms. Sixty were treated for eight weeks with saline irrigation, and 61 were treated with saline spray. The patients in the saline irrigation group showed greater improvement at two, four and eight weeks. After completion of the study, 61 percent of patients in the spray group reported having symptoms “often or always,” compared with 40 percent of patients in the irrigation group. “The irrigation group achieved a clinically significant improvement in quality of life in terms of severity of their symptoms, whereas the spray group did not. Strikingly, (the irrigation group) also experienced 50 percent lower odds of frequent nasal symptoms compared with the spray group,” lead author Dr. Melissa A. Pynnonen, clinical assistant professor in the department of otolaryngology, said in a prepared statement.
The study, published in the current issue of the journal Archives of Otolaryngology — Head & Neck Surgery, received funding from NeilMed Pharmaceuticals, which makes a saline sinus rinse. Tens of millions of Americans suffer from chronic nasal and sinus conditions. Treatments include antibiotics, antihistamines and anti-inflammatory drugs. The findings of this study suggest that doctors should recommend saline
irrigation more often for patients with chronic sinus and nasal conditions, Pynnonen and her colleagues said.
Additional Research
Qualitative Aspects of Nasal Irrigation Use by Patients With Chronic Sinus Disease in a Multimethod Study
David Rabago, MD, Bruce Barrett, MD, PhD, Lucille Marchand, MD, Rob Maberry, BA, and Marlon Mundt, MS
University of Wisconsin Madison, Madison, Wisc
CORRESPONDING AUTHOR: David Rabago, MD, Department of Family Medicine, UW-Madison, 777 South Mills St, Madison, WI 53715, rabago@fammed.wisc.edu
Received August 1, 2005; Revised November 23, 2005; Accepted November 29, 2005.
This article has been cited by other articles in PMC.PURPOSE We qualitatively assessed attitudes regarding use of hypertonic saline nasal irrigation (HSNI) for frequent rhinosinusitis and chronic sinonasal symptoms in a 3-part, multimethod study.
METHODS We conducted semistructured, in-depth interviews with 28 participants who recently used nasal irrigation in studies assessing HSNI.
RESULTS Four themes emerged: (1) HSNI improved self-management of sinus symptoms, creating a sense of empowerment; (2) HSNI produced rapid and long-term improvement in quality of life; (3) participants identified discomfort, time, and mild side effects as barriers to HSNI use; and (4) participants identified aspects of training and at-home use that overcame these barriers.
CONCLUSION HSNI is a safe, well-tolerated, inexpensive, effective, long-term therapy that patients with chronic sinonasal symptoms can and will use at home with minimal training and follow-up. Success with HSNI will likely be improved by patient education.
Keywords: Nasal irrigation, sinusitis/therapy, rhinosinusitis, chronic sinus symptoms, quality of life, qualitative study
INTRODUCTION
Rhinosinusitis1 is a common clinical problem with considerable morbidity and often-refractory symptoms, accounting for approximately 26.7 million office and emergency department visits and resulting in $5.8 billion in direct costs for 1996.2 Rhinosinusitis was the fifth most common diagnosis for which antibiotics were prescribed from 1985 to 1992.3 The Centers for Disease Control and Prevention has estimated the 1994 number of cases of chronic rhinosinusitis in the United States to be 35 million, a prevalence of 134/1,000.4 The impact on patients’ quality of life is significant.5
Originally part of the Yogic and Ayurvedic traditions, hypertonic saline nasal irrigation (HSNI) is an adjunctive therapy for rhinosinusitis and sinus symptoms6–8 that flushes the nasal cavity, facilitating the evacuation of potentially allergen- and irritant-containing mucus9 (Figure 1 ![[triangle]](https://i0.wp.com/www.ncbi.nlm.nih.gov/corehtml/pmc/pmcents/rtrif.gif?w=525)
). Several randomized controlled trials examining HSNI suggest that it is a safe, effective, and tolerable therapy for rhinosinusitis and sinus symptoms.10–17 Previous randomized controlled trials have reported improvement of quality-of-life scores,10–12,17 and improvement of several surrogate measures.12–14,17 In a closely monitored 6-month randomized controlled trial (phase 1, Figure 2 
),17 our group found that daily HSNI using 2% saline is associated with high patient satisfaction, improved quality of life, decreased antibiotic and nasal spray use, and improved sinus symptoms in adult participants with a history of frequent rhinosinusitis and chronic sinus complaints. In a 12-month follow-up study (phase 2),18 we found that patient education without close monitoring enabled phase 1 control participants to initiate and maintain identical HSNI use patterns, and that control participants had the same significant and clinically meaningful improvements in quality of life. HSNI has received attention in the lay press19 and was recently identified as “an important component in the management of most sinonasal conditions” that is “effective and underutilized.”20
). Several randomized controlled trials examining HSNI suggest that it is a safe, effective, and tolerable therapy for rhinosinusitis and sinus symptoms.10–17 Previous randomized controlled trials have reported improvement of quality-of-life scores,10–12,17 and improvement of several surrogate measures.12–14,17 In a closely monitored 6-month randomized controlled trial (phase 1, Figure 2 ),17 our group found that daily HSNI using 2% saline is associated with high patient satisfaction, improved quality of life, decreased antibiotic and nasal spray use, and improved sinus symptoms in adult participants with a history of frequent rhinosinusitis and chronic sinus complaints. In a 12-month follow-up study (phase 2),18 we found that patient education without close monitoring enabled phase 1 control participants to initiate and maintain identical HSNI use patterns, and that control participants had the same significant and clinically meaningful improvements in quality of life. HSNI has received attention in the lay press19 and was recently identified as “an important component in the management of most sinonasal conditions” that is “effective and underutilized.”20Successful use of even proven therapy is often difficult for patients, however.21 Clinicians may be hesitant to prescribe unfamiliar therapy, and misunderstandings between clinician and patient often occur.22 HSNI is associated with difficult adherence issues because rinsing the nasal cavity is not intuitive. Clinicians and patients would be well served by descriptive information of successful HSNI use, but no study has assessed the natural history of long-term use of HSNI and its incorporation into daily life. We therefore undertook a qualitative study (phase 3) to assess perceptions, experiences, and strategies regarding successful HSNI use at the conclusion of phases 1 and 2.
The study protocol was approved by the University of Wisconsin Health Sciences Human Subjects Committee. The inclusion criterion was being an HSNI-user in either the phase 1 randomized controlled trial or the phase 2 follow-up study (Figure 2 ). The primary inclusion criteria of phase 1 was having either 2 episodes of acute sinusitis or 1 episode of chronic sinusitis per year for 2 consecutive years, and a moderate-to-severe overall daily quality-of-life burden of sinus disease. Participants randomized to HSNI in phase 1 received an educational intervention that included a brief discussion of rhinosinusitis, a demonstration of HSNI, and coaching to facilitate each participant’s proficiency. All participants in phase 1 were monitored frequently with validated questionnaires.23 In phase 2, phase 1 control participants were given the same patient-education and pooled into 1 HSNI use group. All phase 2 participants were thereafter assessed less frequently. The mean HSNI use frequency at the time of the interviews was 2.4 irrigations per week after at least 12 months of assessment.18 For the current study, we contacted phase 1 and phase 2 HSNI users sequentially from a randomized list of all 66 possible participants (Figure 2 ). Study personnel tape-recorded interviews of 21 participants in person and 7 participants by telephone at our institution from April to July 2002. We followed a standard qualitative research method of transcribed, in-depth, long interviews.24 The semistructured 30-minute interview consisted of open-ended questions with several prompts that the interviewer could use to encourage salient discussion (Table 1 ). Transcripts were stripped of all identifiers except a code number. All interviews were completed and transcribed before being analyzed. Each transcript was reviewed individually by each of the first 4 authors and was then discussed by all of the first 4 authors in 6 meetings over 2 months using a consensus approach to identify major themes.
). The primary inclusion criteria of phase 1 was having either 2 episodes of acute sinusitis or 1 episode of chronic sinusitis per year for 2 consecutive years, and a moderate-to-severe overall daily quality-of-life burden of sinus disease. Participants randomized to HSNI in phase 1 received an educational intervention that included a brief discussion of rhinosinusitis, a demonstration of HSNI, and coaching to facilitate each participant’s proficiency. All participants in phase 1 were monitored frequently with validated questionnaires.23 In phase 2, phase 1 control participants were given the same patient-education and pooled into 1 HSNI use group. All phase 2 participants were thereafter assessed less frequently. The mean HSNI use frequency at the time of the interviews was 2.4 irrigations per week after at least 12 months of assessment.18 For the current study, we contacted phase 1 and phase 2 HSNI users sequentially from a randomized list of all 66 possible participants (Figure 2 ). Study personnel tape-recorded interviews of 21 participants in person and 7 participants by telephone at our institution from April to July 2002. We followed a standard qualitative research method of transcribed, in-depth, long interviews.24 The semistructured 30-minute interview consisted of open-ended questions with several prompts that the interviewer could use to encourage salient discussion (Table 1 ). Transcripts were stripped of all identifiers except a code number. All interviews were completed and transcribed before being analyzed. Each transcript was reviewed individually by each of the first 4 authors and was then discussed by all of the first 4 authors in 6 meetings over 2 months using a consensus approach to identify major themes.
Consent from 28 participants was obtained from the first 35 HSNI users queried; 7 participants declined to participate, stating they did not have time, resulting in a 28-member sample similar to the 66 HSNI users in phases 1 and 2 in sex, age, and quality-of-life scores at the beginning and end of the studies. One participant had completed phase 1 only, 27 had completed both phases 1 and 2 (Table 2 ). The 28 transcribed interviews were analyzed in 6 meetings. Four major themes emerged (Table 3 ).
). The 28 transcribed interviews were analyzed in 6 meetings. Four major themes emerged (Table 3 ).Major Themes
Empowerment
Among the major themes, participants reported several ways in which use of HSNI improved their ability to control sinus symptoms and their treatment, a major aspect of their health and health care. We have termed this empowerment. Participants expressed a strong sense of satisfaction with the ability to use, monitor, and adjust several aspects of HSNI themselves (eg, water temperature, salinity, timing, frequency) as opposed to making multiple office visits with a clinician. This attitude was commonly reflected in such comments as, “I’ve learned that I can take care of a lot of this [sinus symptoms] by myself, so I do,” and “… [HSNI] makes me feel more in control of my own health and my own sinus condition.” Participants also expressed satisfaction in their perception that at-home use of HSNI greatly reduced the number of trips to their physician and the number of antibiotic prescriptions.
Improvement in Quality of Life
Participants confirmed the results of phases 1 and 2; use of HSNI improved short- and long-term sinus symptoms and sinus-related quality of life. Many participants were enthusiastic, reporting improvements with the first or second use: “… my results were immediate,” and “… almost instant relief of the congestion.” Most participants also confirmed positive long-term effects of HSNI on sinus-related quality of life, and noted a deep sense of satisfaction associated with the diminution of their sinus symptoms, often reflected in moving comments, such as, “It just made a world of difference in my life,” and “… when you suffer from a chronic illness for so long and then you don’t, … it’s such a big relief … (to) enjoy things that people take for granted.” Participants also expressed satisfaction with a perceived association with decreased allergy symptoms and with the naturalness and economy of HSNI.
Barriers to HSNI Use
While HSNI was effective for many participants, many also reported substantial barriers to initial and consistent use of HSNI. These barriers included fear of having water in the nasal cavity, initial unpleasant sensation of water in the nasal cavity, having to learn how to perform HSNI effectively, taking time at home to do HSNI, and experiencing occasional mild side effects. Consistent with phases 1 and 2, such side effects as saline drainage, nasal burning, or irritation were noted but not identified as important enough to stop HSNI.
Strategies to Overcome Barriers to HSNI Use
Participants identified how they overcame barriers to using HSNI. Participants identified each element of the teaching strategy used in the introductory meeting as important in their use of HSNI. These 30-minute meetings were made up of 2 to 6 participants per meeting; they involved a sequence of activities starting with a group discussion of participants’ sinus disease histories, a 5-minute film and discussion of nasal irrigation, and a demonstration and coached practice of HSNI. Participants identified coached practice as the single most important element of the enrollment meeting. Each participant was able to perform the procedure before leaving the enrollment meeting.
Participants also noted several at-home strategies that facilitated regular use, which included incorporating HSNI into an already-existing daily hygiene routine, placing HSNI materials in convenient and accessible locations, adjusting the HSNI use schedule and salinity to decrease or eliminate discomfort, and using warm water. Social concerns were also addressed by our interviewers. Because HSNI therapy is novel for most patients and could engender stigma or embarrassment, we wondered whether social issues played a part in the tendency to regular use. Participants reported reactions from family and friends that included encouragement, surprise, or amusement; none reported that negative reactions from family or friends limited their use of HSNI.
The themes and quotations illustrate participants’ range of experience. The overall story of using HSNI, however, may be better told using an extended quotation. An abbreviated transcript of a representative participant whose narrative provides a more personal view of the major themes can be found in Table 3 . Her reporting was neither especially negative about the initial aspects of nasal irrigation nor overly effusive about her success. It is consistent with the data from this group of participants who had a debilitating condition (chronic sinus symptoms), who were introduced to a nonintuitive therapy, the mastery of which required work and insight (performing HSNI), and who achieved therapeutic success (improved quality of life). Her transcript identified the core themes in a matter-of-fact manner. Bracketed words are the authors’ interpretation of the participant’s original intent; they are used to link ideas or abbreviate wordiness.
. Her reporting was neither especially negative about the initial aspects of nasal irrigation nor overly effusive about her success. It is consistent with the data from this group of participants who had a debilitating condition (chronic sinus symptoms), who were introduced to a nonintuitive therapy, the mastery of which required work and insight (performing HSNI), and who achieved therapeutic success (improved quality of life). Her transcript identified the core themes in a matter-of-fact manner. Bracketed words are the authors’ interpretation of the participant’s original intent; they are used to link ideas or abbreviate wordiness.This study is the third of a 3-phase study assessing HSNI for frequent rhinosinusitis and chronic sinus complaints. Phases 1 and 2 found that participants in both a fastidious25 randomized controlled trial17 and pragmatic follow-up setting18 experienced improved quality of life, reduced sinus symptoms, and decreased use of sinus medications, including antibiotics. The current study is the first to assess the perceptions, experiences, and strategies surrounding use of HSNI and thereby bridge the gap between clinical effectiveness of HSNI in formal studies and success with at-home use. We found that participants receiving clear and focused instruction can overcome initial barriers to HSNI use and can create at-home strategies to facilitate long-term HSNI use.
Effective teaching combined with a positive clinical outcome led to improved quality of life and sense of empowerment for these participants. The introductory meeting set the stage for participants’ use of a therapy by establishing a relationship with research staff and trust in the overall research plan. Group discussion of clinical histories promoted an esprit de corps regarding use of HSNI and participation in the study. Group interaction and discussion have been used to facilitate understanding and acceptance of one’s condition, and the notion that active involvement in therapy can facilitate improved clinical outcomes. Group discussion also served to decrease the alienation and stress that participants may have felt in isolation. Hearing others’ clinical stories likely increased bonds with fellow participants and may have helped participants feel that their own story was heard and valued. Positive effects of group behavior programs have resulted in improved outcomes in other treatment settings.26–28
Early demonstration and coached practice of HSNI ensured proficiency before the participants’ first at-home use. Patient education and coached practice have been identified as important aspects of successful care of chronic illness29 and have been linked to successful treatment of chronic conditions such as asthma and COPD.30
Given that the immediate effect of HSNI under supervision was generally positive, and side effects were limited, participants were able to adapt the scheduling, location, and materials handling to best suit their personal and social context in the long term. This ability to manage their own treatment likely contributed to the reported sense of empowerment and personal control of their chronic symptoms, further enabling continued use. A sense of empowerment among users of complementary medical therapy is consistent with recent findings that characterize patients’ views about complementary medical therapy compared with conventional therapy.31
Because 3 of us (DR, BB, RM) were co-researchers on phases 1 and 2, we anticipated that the comments would be positive, but several aspects of the results surprised us. First was the passion and drama of many reports. Sinus disease, HSNI, and clinical improvement are clearly important to these participants and deeply affect the quality of their lives. Also surprising was the uniform reporting about 2 issues. First, most participants expressed the need to overcome the oddness of pouring water through the nasal cavity, Second, it was worth the effort of doing so, because HSNI truly improved quality of life for this group of participants, most of whom had had less success with multiple previous therapies.
Our study has several limitations. These results may not generalize well to patients who have uncomplicated acute bacterial rhinosinusitis, less-frequent rhinosinusitis, sinus symptoms that are less chronic, or have undergone less HSNI coaching. Recollection of initial experiences and feelings toward HSNI may have been inaccurate, because participants were interviewed 12 to 18 months after starting phase 1. We did not use an iterative process to guide the formulation of interview questions and may have missed issues important to participants. The researchers may have been biased in favor of HSNI because 3 coauthors were familiar with the positive quantitative HSNI results of phases 1 and 2.
Implications for Clinicians
This study has important implications for clinicians. HSNI can be confidently and safely prescribed to patients with chronic sinonasal symptoms. Adherence to HSNI will likely be improved by a patient-education encounter that includes coached practice of HSNI. Consideration should be given to grouping several patients into a single class for patient education. In our clinical practice, we describe the rationale for HSNI as part of the treatment plan for patients with chronic sinonasal complaints; if the patient is interested, we explain the technique with an illustrated patient handout, as shown in Supplemental Appendix, which can be found online at http://www.annfammed.org/cgi/content/full/4/4/295/DC1, and at http://www.fammed.wisc.edu/research/projects/nasalirrigation-instructions.pdf), before we proceed with guided practice. We recommend using nasal irrigation once daily at the onset of sinus symptoms until resolution, and thereafter for maintenance as needed. The materials are inexpensive, and nasal irrigation cups are increasingly available at local pharmacies nationwide.
Implications for Researchers
This study has implications for future HSNI research. Questions remain about the basic science of HSNI, clinical protocol (eg, irrigation schedule, irrigant concentration, buffering, and irrigant delivery system), specific indications, and optimal training techniques and context. These issues require study in a larger patient population with more identified subgroups, including acute bacterial rhinosinusitis, vasomotor rhinitis, and asthma.
In addition, the current study also has implications for primary care research. Integrated, multi-method research techniques in primary care have been described and advocated.32,33 Taken together with phases 1 and 2, the current study is an example of such an approach. By using both qualitative and quantitative methods, a broader and deeper picture of HSNI use emerges than if either were used alone. Phases 1 and 2 used a conventional, quantitative hypothesis-testing approach that produced internally consistent conclusions; HSNI is an effective therapy for patients with recurrent rhinosinusitis and chronic sinonasal complaints. In phase 3, we asked participants to describe and interpret the experience of HSNI. Such qualitative data brings the use of HSNI closer to real clinical life by making the quantitative findings easier to act upon for physicians and patients.
Participants confirmed positive results from 2 previous studies. HSNI is an effective, safe, well-tolerated, inexpensive therapy that patients with frequent rhino-sinusitis and chronic sinus symptoms can learn in the office and use at home over the long term with minimal training and follow-up. Clinical success with HSNI will likely be improved by brief patient education, HSNI demonstration, in-person coaching, and the ability to tailor HSNI use to individual needs.
Notes
Conflicts of interest: none reported
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