Cipla Nasowash Starter Kit

Sinonasal disease, which includes chronic rhinosinusitis, allergic rhinitis, and viral upper respiratory infections, is a significant cause of morbidity. Medical therapy has been the basis for treating these sinonasal diseases. Medications include short and long-term antibiotic therapy, topical and systemic steroids, topical and oral decongestants, oral antihistamines, and mucolytics. Surgery, is another therapeutic option, however, it is generally relegated to disease that is refractory to medical treatment.

Saline Nasal Irrigation (SNI) is known to be an adjunctive therapy for upper respiratory conditions which bathes the nasal cavity with saline solution. It is a simple, inexpensive procedure that has been used to treat upper respiratory conditions especially of the nasal cavity and the sinuses. SNI really is as simple as running a gentle saline solution through the nasal passages and sinuses. The procedure involves flushing the nasal cavity with saline solution which improves mucociliary clearance by moisturizing the nasal cavity and removing encrusted material. For the purpose of nasal irrigation, a high number of irrigation systems and methods are offered. These include the use of saline sprays, drops, syringes and squeeze-bottles. Current medical literature indicates that large volume saline nasal irrigation, delivered with low positive pressure provides superior symptom relief to patients with sinus disease and nasal allergies.

Nasowash:

Nasowash is a non-medicated, sterile, preservative free saline irrigation kit for nasal and sinus washing.

Composition: 

Nasowash Starter Kit contains

• 1 nasowash squeeze bottle; a 200 ml sterile squeeze bottle used for nasal washing
• 10 nasowash sachets; each sachet consisting of 7.8 g of pre-mixed dry powder; containing
  • Sodium Chloride 4.0 g,
  • Small amounts of Sodium Bicarbonate and Xylitol.

When mixed with lukewarm water, each 7.8 g sachet will produce 200 ml of saline wash for use. This solution is an alkaline buffered hypertonic (2%) saline with xylitol.

The solution is an alkaline buffered hypertonic saline solution with xylitol.

This alkaline buffered hypertonic saline has an advantage of effectively drawing out the mucus out of the sinuses by improving the ciliary activity and in turn, overall mucocialiary clearance. This especially helps relieving post nasal drip as well as sinus pressure.

An additive like xylitol makes the nasal membranes slippery, helping to guard against the pathogens inside the nasal cavity.  Xylitol also helps to inhibit the bacteria frequently associated with sinus infections. Xylitol is non-toxic and safe to be used. 

Indications for Use

Nasal Irrigation may be used for a variety of nasal and sinus conditions. Their use is mainly included in the management of:

•           Rhinosinusitis

•           Viral upper respiratory infections

•           Allergic rhinitis

•           Atrophic rhinitis

•           Fungal rhinosinusitis

•           Nasal congestion

•           Post-operative conditions (especially after Functional Endoscopic Sinus Surgery            i.e. FESS).

Saline nasal irrigation is recommended for overall nasal hygiene.

Although there are very few absolute contraindications for SNI, patients with incompletely healed facial trauma, those suffering from conditions associated with an increased risk for aspiration (such as neuromuscular disorders).

Dosage:

Saline nasal irrigation can be done once or twice a day. However, the dosage and duration of use may vary depending on the condition for which it is used.

Saline nasal irrigation can be done anytime of the day. However, it is recommended that nasal washing is done at least one hour before going to bed.

Sinonasal disease, which includes chronic rhinosinusitis, allergic rhinitis, and viral upper respiratory infections is a significant cause of morbidity. Upper respiratory tract infections, sinusitis, and allergic rhinitis are amongst the most frequent reasons for visits to primary care physicians and are the leading cause of absenteeism in the United States. It is estimated that approximately 134 million Indians suffer from chronic sinusitis. 1 in 8 Indians are said to suffer from sinusitis caused by the inflammation of the paranasal sinuses¹.

Medical therapy has been the basis for treating these sinonasal diseases. Medications include short and long-term antibiotic therapy, topical and systemic steroids, topical and oral decongestants, oral antihistamines, and mucolytics. Surgery, is another therapeutic option, however, it is generally relegated to disease that is refractory to medical treatment.

Nasal irrigation is a simple, inexpensive and effective procedure in alleviation of these sinonasal symptoms. The origins of nasal irrigation are believed to be from the ancient Hindu practice of Ayurveda, whose roots are traced to the Vedas. Nasal irrigations are often mentioned as adjunctive measures in treating many sinonasal conditions. However, nasal irrigations are often much more than merely an adjunctive therapy. They are an important component in the management of sinonasal conditions.

This fact file gives a comprehensive view of the use of saline nasal irrigation, summarizing the data on the mechanisms as well as the efficacy and safety of saline irrigation in patients with sinonasal diseases.

History of Saline Nasal Irrigation

The use of SNI in the treatment of nasal and sinus disorders has its roots in an ancient Ayurvedic technique known as Jal neti, which literally means "nasal cleansing" in Sanskrit. With origins based in the yoga tradition, nasal irrigation has been used throughout India and South East Asia. Although not commonly practiced by Western cultures, these Eastern cultures have performed Jal neti as routinely as brushing one's teeth for centuries. It is intended mainly for the cleaning of the air passageways in the head, and it has been used for thousands of years to alleviate sinus and allergy symptoms. The technique is used to flush out the debris and allergens from the nasal cavities by using gravity to draw the flow of saline water through the nasal passages. SNI has been identified as “an important component in the management of most sinonasal conditions that is effective yet underutilized”³. It is a procedure recommended routinely by otolaryngologists ⁴.

Fig 1: In early days, nasal irrigation therapy was performed using a neti pot filled with saline solution

An Introduction to Saline Nasal Irrigation

In general, healthy people’s respiratory tract is protected from airborne contagion and debris by mucociliary layer that lines the sinonasal cavity. Allergens are trapped in the sticky mucus layer, and the ciliary action propels the excess mucus out of the sinuses towards the nasopharynx. Damage to this mucociliary transport system is an important factor in the development of sinonasal diseases, leading to a stasis of mucus. The numerous proteins found in nasal mucus include inflammatory mediators, defensins and many whose function is not understood, leading to rhinologic conditions like rhinosinusitis and upper respiratory infections. Medical management of these symptoms includes antibiotics, decongestants, corticosteroids and mucolytics. However, the key to symptom relief is to physically wash away this excess mucus and allergens from the nasal passages. Thus hypotheses include that nasal irrigation may decrease inflammation through the removal of mucus, that it may improve mucociliary clearance, and that it may remove thickened mucus that cannot be handled by the cilia. This physical washing away of excess mucus, allergens or debris is called irrigation. Use of irrigation solutions before patients take decongestants or corticosteroids improves these medications’ penetration and presumably, also its efficacy.

Saline Nasal Irrigation (SNI) is known to be an adjunctive therapy for upper respiratory conditions which bathes the nasal cavity with saline solution. It is a simple, inexpensive procedure that has been used to treat upper respiratory conditions especially of the nasal cavity and the sinuses. SNI really is as simple as running a gentle saline solution through the nasal passages and sinuses. The procedure involves flushing the nasal cavity with saline solution which improves mucociliary clearance by moisturizing the nasal cavity and removing encrusted material. For the purpose of nasal irrigation, a high number of irrigation systems and methods are offered. These include the use of saline sprays, drops, syringes and squeeze-bottles. Current medical literature indicates that large volume saline nasal irrigation, delivered with low positive pressure provides superior symptom relief to patients with sinus disease and nasal allergies.

The benefits derived from nasal saline use are likely due to one or more local effects, including decreased viscosity of nasal secretions, decreased edema of the nasal mucosa, and removal of debris, bacteria, allergens and inflammatory mediators.

For an effective nasal rinse, a large volume irrigation system containing a quantity of 200-250 ml is currently considered useful in order to displace mucus, allergens and debris from the nasal passages. Thus, an appropriate nasal irrigation must have the following characteristics:

• Capacity to hold large volume of saline solution (200-250 ml)
• Ability to deliver the solution with low but adequate pressure to the nasal passages; which is sufficient to displace mucus, allergens and debris.
• Saline solution must travel up the nasal passage, flow over the septum and out through the other nasal passage. This entire cycle when complete will give a thorough cleansing job.

The greater efficacy of irrigation over saline spray may be due to greater volume, increased delivery pressure, and mechanical debridement achieved with irrigation.²

Mechanism of Action

The exact mechanisms of action of SNI are not clearly understood. The mucus lining of the nasal cavity constitutes one of the body’s first lines of defense against potential pathogenic organisms, and these organisms may subsequently become entrapped in the mucus. SNI may enhance the movement of the mucus in the nasopharynx, directly clean the nasal mucosa, and aid in thinning nasal secretions. It may promote clearance of inflammatory mediators such as histamines and prostaglandins, prevent secondary infection and promote mucosal healing. SNI is also thought to play an important role in the postoperative period; because it reduces the risk of adhesions and promotes ostiomeatal patency. Finally, chronic sinonasal disease leads to a decline in mucociliary clearance and this is presumed to be a result of osmotic changes in the mucus layer or reduction in the ciliary beat frenquency.  

 Fig 2: Mechanism of action of Saline Nasal Irrigation

Thus, the procedure involves flushing the nasal cavity with saline solution, which majorly promotes the following four conditions:

•          Direct physical cleaning of mucus, crusts, debris, allergens and air pollutants.

•          Removal of inflammatory mediators (histamines, leukotrienes, prostaglandins).

•          Improved mucociliary clearance by moisturizing the nasal cavity and improved ciliary     beating. ⁶

•          Evidence shows that pulsating saline irrigation can remove bacteria also⁵

Clinical Efficacy

Few comparative, prospective and reproducible studies consistently demonstrate SNI’s efficacy. The efficacy of SNI in varied indications has been summarized here.

Summary of efficacy trials:

Safety

SNI has been associated with rare and generally mild side effects. These include:

• ear fullness,
• burning or stinging of the nasal mucosa
• epistaxis

The solution used for irrigation should be distilled, sterile or previously boiled due to the risks involved with using potentially contaminated water. The presence of the amoeba Naegleria fowleri in unboiled or otherwise unsterilized water can cause the brain infection primary amoebic meningoencephalitis; which carries a 95% risk of fatality¹⁵. Device contamination with bacteria could play a role in potentiating recalcitrant infections. Thus, cleaning and maintenance of the device is vital.

Saline Nasal Therapy for Sinonasal Conditions: What does the evidence suggest?

Irrigation vs. Spray

Nasal Irrigations Performed with Large Volume More Effective than Nasal Sprays²

Aim: To determine if saline nasal irrigation performed with large volume and delivered with low positive pressure are more effective than saline sprays at improving chronic nasal and sinus symptoms

Study Design:

Prospective, randomized controlled trial.

N= 127 adults with chronic nasal and sinus symptoms

Patients were randomly assigned:

• Saline irrigation (n= 64)
• Saline spray (n=63)  for 8 weeks

Assessments:

Frequency of symptoms

Changes in severity of symptoms by mean 2-Item Sino-Nasal Outcome (SNOT- 20) score

Results:                      

A total of 121 patients were evaluable. The irrigation group achieved lower SNOT-20 Scores than the spray group at all 3 time points: 4.4 points lower at 2 weeks (p=0.02); 8.2 points lower at 4 weeks (p< 0.001); and 6.4 points lower at 8 weeks (p=0.002).

When symptom frequency was analyzed, 40% of the subjects in the irrigation group reported symptoms “often or always” at 8 weeks compared with 61% in the spray group. No significant differences in sinus medication use were seen between groups.

Conclusion:

Nasal irrigations performed with a large volume and delivered with low positive pressure are more effective than saline sprays over an 8-week period of treatment of chronic nasal and sinus symptoms among a community based population with self-reported symptoms.

Hypertonic vs. Isotonic

Hypertonic Saline Solution More Effective than Isotonic Saline Solution¹⁶

Aim:  A comparative study to evaluate the effect of hypertonic saline (3.5%) and isotonic saline (0.9%) on QoL in patients with chronic sinusitis

Study Design:

Double-blind, randomized comparative study

50 patients with chronic sinusitis (18-45 yrs) were randomized into two groups:

Group A: isotonic saline 0.9% (n=25)

Group B: hypertonic saline 3.5% (n=25)

Ten drops three times a day in both nostrils; for 4 weeks

Assessments:

Pre- and post-treatment x-rays of the paranasal sinuses (Water’s view)

Symptom evaluation using Visual Analogue Score

Results:

The following observations were made in 42 patients who completed the treatment schedule.

Analysis of pre-treatment and post-treatment radiological scores revealed highly significant improvement in Group B (5.67 to 3.62) compared to Group A (5.38 to 4.71) (p=0.003).

Patients in Group B had significant improvement in nasal congestion by the end of fourth week when compared to group A.

 A significant improvement in nasal congestion was observed in both the groups but it was found to be more pronounced in group B.

Overall, symptomatic assessment in Group A showed that mean difference between first week and fourth week scores was 5.38±0.73 and that of Group B was 6.40±0.88 (p=0.003).

Conclusion:

Hypertonic saline was found to be more efficacious than isotonic saline solution, and was shown to improve the QoL of patients with chronic sinusitis. Hypertonic saline was well tolerated by the patients.

Improved Mucociliary Clearance with Hypertonic Saline¹⁷

Aim: The aim of this study was to determine if mucociliary clearance (MCC) in vivo was improved significantly by the use of a buffered hypertonic saline (3%, pH 7.6) vs. buffered normal saline irrigations.

Study Design: Twenty-one volunteers aged 25 to 45 years, without any significant sinonasal diseases were selected to participate in the study.

Assessments: MCC was assessed by using the saccharin clearance test method.

Results: Improvement in mucociliary transit times was seen with buffered hypertonic saline solutions vs. buffered normal saline (3.1 minute improvement compared to 0.14 minutes, P = 0.02, and 17% improvement compared to 2%, P = 0.013).

Conclusion: Buffered hypertonic saline nasal irrigation to improve mucociliary transit times of saccharin, while buffered normal saline had no such effect.

Buffered vs. Non- buffered

Buffered Saline with Mild Alkalinity Most Preferred for Nasal Symptom Relief ¹⁸

Aim: To study the effect of alkalinity of isotonic nasal saline irrigation on nasal symptoms, mucociliary clearance, nasal patency, and patient’s preference in patients with allergic rhinitis (AR).

Study Design: A double-blind, randomized, three-arm crossover study.

Patients with AR were enrolled. Three kinds of isotonic nasal saline irrigations: non buffered (pH 6.2–6.4), buffered with mild alkalinity (pH 7.2–7.4), and buffered with alkalinity (pH 8.2–8.4) were given one at a time, in different orders.

Patients rinsed their nose with 240 ml of one solution twice daily for 10 days and then swapped to the others. The washout period was at least 5 days.

Assessments:

Primary outcomes were nasal symptoms, mucociliary clearance time, and nasal patency. Outcomes were compared between baseline and post treatment and also between various kinds of solution. Secondary outcomes were patients’ preference and adverse events.

Results: 36 subjects entered the study, and there were no dropouts.

Overall nasal symptom was significantly improved from baseline (P=0.03) only by buffered solution with mild alkalinity.

Sneezing was significantly improved from baseline (P=0.04) only by buffered solution with alkalinity.

When comparing between the three nasal irrigations, there were no differences in all parameters. The patients significantly preferred the buffered solution with mild alkalinity (P=0.02).

Conclusions: Buffered isotonic saline with some degree of alkalinity may improve nasal symptoms. Buffered isotonic saline with mild alkalinity is the most preferred.

Buffered Hypertonic Saline Effective after Endonasal Surgery¹⁹

Aim: To compare the effect of different nasal irrigation solutions on mucociliary clearance and nasal patency.

Study Design: A prospective randomized study

Forty-five patients who underwent septoplasty were divided into three groups postoperatively.

Each group was administered with 2.3% buffered hypertonic seawater, 0.9% buffered isotonic saline solution and 0.9% non buffered isotonic saline, respectively, as irrigation fluid.

Assessments:

Saccharine test and acoustic rhinometer were used to determine mucociliary activity and nasal patency. Patients were asked about the burning sensation using a 10-cm visual analog scale.

Results:

On the 20th day, there was a significant difference in SCT between the hypertonic buffered saline group and non-buffered isotonic saline (P = 0.003).

Differences between preoperative and postoperative 20^th day saccharine clearance times for each group (b Buffered, nb non buffered, SCT saccharine clearance time).

Buffered hypertonic saline improved nasal airway patency more than the buffered isotonic saline (P = 0.004).

Conclusion:

Buffered hypertonic solutions used after endonasal surgery have been advantageous for both mucociliary clearance and postoperative decongestion.

Effect of Xylitol

Greater Symptom Improvement with Xylitol Irrigation as compared to Saline Irrigation²⁰

Aim: To determine the tolerability of xylitol mixed with water as a nasal irrigant and to evaluate whether xylitol nasal irrigation results in symptomatic improvement of subjects with chronic rhinosinusitis.

Study Design: A prospective, randomized, double-blinded, controlled crossover pilot study.

Methods: 20 subjects were instructed to perform sequential 10-day courses of daily xylitol and saline irrigations in a randomized fashion, with a 3-day washout irrigation rest period at the start of each treatment arm.

Assessments:

Sino-Nasal Outcome Test 20 (SNOT-20)

Visual Analog Scale (VAS) scores reported at the beginning and end of each irrigation course.

Results:

Fifteen of the 20 subjects (75%) returned their SNOT-20 and VAS data for analysis.

There was a significant reduction in SNOT-20 score during the xylitol phase of irrigation (mean drop of 2.43 points) as compared to the saline phase (mean increase of 3.93 points), indicating improved sinonasal symptoms (P = 0.0437).

There was no difference in VAS scores. No patient stopped performing the irrigations owing to intolerance of the xylitol, although its sweet taste was not preferred by three subjects (21%). One patient reported transient stinging with xylitol.

Conclusions: Xylitol in water is a well-tolerated agent for sinonasal irrigation. In the short term, xylitol irrigations result in greater improvement of symptoms of chronic rhinosinusitis as compared to saline irrigation.

GUIDELINE RECOMMENDATIONS

Xylitol in water is a well-tolerated agent for sinonasal irrigation.

The European Position Paper guidelines²¹ on Chronic Rhinosinusitis and nasal polyps, recommends the use of xylitol along with saline for post operative treatment in adults with chronic rhinosinusitis. Xylitol irrigations result in greater improvement of symptoms of chronic rhinosinusitis as compared to saline irrigation.

Saline Nasal Irrigation: What do the Guidelines say?

• European Position Paper (ERS/EAACI)  on Rhinosinusitis and Nasal Polyps

The European Position Paper on the Primary Care Diagnosis and Management of Rhinosinusitis and Nasal Polyps 2012; recommends the use of saline nasal irrigation, alone or as an adjunct therapy in addition to antibiotics and intranasal steroids with hypertonic or isotonic saline, leading to decrease in nasal secretions and nasal edema.

• Clinical Practice Guideline: Adult Sinusitis

Intranasal saline irrigations with either physiologic or hypertonic saline are recommended as an adjunctive treatment in adults with acute bacterial rhinosinusitis (weak, low-moderate).

Nasowash

Nasowash is a non-medicated, sterile, preservative free saline irrigation kit for nasal and sinus washing.

Composition: 

Nasowash Starter Kit contains

• 1 nasowash squeeze bottle; a 200 ml sterile squeeze bottle used for nasal washing
• 10 nasowash sachets; each sachet consisting of 7.8 g of pre-mixed dry powder; containing

• Sodium Chloride 4.0 g,
• Small amounts of Sodium Bicarbonate and Xylitol.

When mixed with lukewarm water, each 7.8 g sachet will produce 200 ml of saline wash for use. This solution is an alkaline buffered hypertonic (2%) saline with xylitol.

The solution is an alkaline buffered hypertonic saline solution with xylitol.

This alkaline buffered hypertonic saline has an advantage of effectively drawing out the mucus out of the sinuses by improving the ciliary activity and in turn, overall mucocialiary clearance. This especially helps relieving post nasal drip as well as sinus pressure.

An additive like xylitol makes the nasal membranes slippery, helping to guard against the pathogens inside the nasal cavity.  Xylitol also helps to inhibit the bacteria frequently associated with sinus infections. Xylitol is non-toxic and safe to be used.  

Indications for Use

Nasal Irrigation may be used for a variety of nasal and sinus conditions. Their use is mainly included in the management of:

• Rhinosinusitis
• Viral upper respiratory infections
• Allergic rhinitis
• Atrophic rhinitis
• Fungal rhinosinusitis
• Nasal congestion
• Post-operative conditions (especially after Functional Endoscopic Sinus Surgery i.e. FESS).

Saline nasal irrigation is recommended for overall nasal hygiene.

Although there are very few absolute contraindications for SNI, patients with incompletely healed facial trauma, those suffering from conditions associated with an increased risk for aspiration (such as neuromuscular disorders).

Dosage and Administration

Dosage:

Saline nasal irrigation can be done once or twice a day. However, the dosage and duration of use may vary depending on the condition for which it is used.

Saline nasal irrigation can be done anytime of the day. However, it is recommended that nasal washing is done at least one hour before going to bed.

Method of Administration:

Nasal Irrigation is essentially performed using a plastic squeeze bottle (nasowash squeeze bottle) that holds around 200 ml of liquid. Along with it comes nasowash sachets, that contain salt (sodium chloride with sodium bicarbonate and xylitol) required for nasal irrigation. To use, boil water and let it cool until lukewarm. Follow the 5 steps to attain nasal rinsing.

Place in Therapy

Saline nasal irrigation is recommended as an adjunctive therapy for a variety of sinonasal conditions which includes;

• Allergic rhinitis
• Atrophic rhinitis
• Viral upper respiratory tract infections
• Chronic rhinosinusitis
• Fungal rhinosinusitis
• Post-operative adjunct after functional endoscopic sinus surgery
• Overall nasal hygiene