A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold.

BACKGROUND: The common cold is a frequent, acute, and mild upper respiratory human disease. Nasal congestion has been considered the most bothersome symptom in the common cold, impacting quality of life (QoL). Topical decongestants containing steroids benefit QoL in allergic rhinitis, but no published research has assessed the impact of topical decongestants on QoL in the common cold. OBJECTIVE: To evaluate the effects of xylometazoline hydrochloride 0.1% (Otrivin, GSK Consumer Healthcare SARL, Switzerland) for up to 7 days on QoL in participants with nasal congestion associated with the common cold. DESIGN: This was a decentralized, longitudinal, open-label study. METHODS: The study enrolled 136 participants (⩾18 years) with early symptoms of the common cold, of which 102 were included in the modified intention-to-treat (mITT) population. Within 24 h of study product receipt, participants confirmed a 'plugged nose' and ⩾1 other common cold symptom. Primary endpoints were Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score, total and individual symptom scores, and total QoL score. Secondary endpoints were additional QoL scores. Exploratory and post hoc analyses included median days to resolution for each QoL factor and analyses of five QoL categories. RESULTS: Consistent improvements in symptoms and QoL were seen in the mITT population. From day 1, improvements were seen in the 'plugged nose' symptom (p = 0.0023), WURSS-21 total QoL score, and all individual QoL scores (p < 0.0001 for all). After the last dose needed, significant improvements were seen in sleep quality (73%), vitality (76%), physical activity (71%), social activity (80%), and sensation (81%). No serious or unexpected adverse events were reported. CONCLUSION: This study is the first to demonstrate in a real-life setting that treating nasal congestion in adults with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living [Otrivin: Quality of Life (QoL) Impact in a Real-World Setting; https://clinicaltrials.gov/study/NCT05556148].

Impact of xylometazoline hydrochloride 0.1% on quality of life in people with blocked nose associated with the common coldThe common cold is a widespread, mild respiratory illness for which a hallmark symptom is a blocked or stuffy nose, which makes breathing and sleeping difficult. This study focused on how a nasal spray called Otrivin (containing xylometazoline hydrochloride 0.1%) impacts the quality of life (QoL) of people suffering from nasal congestion due to the common cold.Participants answered a questionnaire called the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21), which helped understand how people experience respiratory symptoms and how different aspects of QoL were impacted. Participants also responded to eight additional QoL questions not covered in the WURSS-21.The results showed that from the first day of using the nasal spray, participants experienced significant relief from the blocked nose symptom and reported an overall improvement in their QoL and well-being, such as in sleep quality, energy levels, senses, and physical and social activities.In conclusion, this real-world study demonstrated that using xylometazoline hydrochloride 0.1% nasal spray during the common cold can significantly improve nasal congestion and various aspects of a person's daily life. These findings provide valuable evidence for using this nasal spray to relieve symptoms and enhance the overall well-being of individuals with the common cold.

Hemorrhagic stroke caused by xylometazoline poisoning.

An increase in the use of over-the-counter medications has been observed in recent years. This also concerns xylometazoline, approved for the treatment of allergic rhinitis or upper respiratory tract infections. We present the fatal case of a 40 year-old-woman with a massive hemorrhagic stroke. Initial toxicology tests of biological material collected during autopsy revealed the presence of xylometazoline. No other significant toxicology findings were noted. LC-MS/MS method has been developed to determine xylometazoline concentration, which was 18.6 ng/mL in blood and 498.9 ng/mL in urine. The macroscopically detected hemorrhagic focus was confirmed by histopathological which confirmed hemorrhagic infarcts in the brain tissue, especially in the subarachnoid area. No other pathological changes were found. Based on findings from autopsy and toxicological analyses, the direct cause of death was concluded to be hemorrhagic stroke resulting from xylometazoline intoxication. Although xylometazoline products are regarded as relatively safe and are available over the counter, the risk of adverse effects, in particular stroke leading to death, should be considered. If adverse effects are observed, it is reasonable to measure the concentration of the drug in blood and urine. With such data, it will be possible to assess the actual exposure to this xenobiotic and draw firmer conclusions.

The role of the topical nasal decongestant oxymetazoline as a novel therapeutic option for post-acne erythema: A split-face, double-blind, randomized, placebo-controlled trial.

Post-acne erythema (PAE) is one of the most common sequelae of acne inflammation. Unfortunately, the treatment of PAE remains challenging due to limited effective topical treatments. The objectives of this study were to evaluate the efficacy and safety of topical oxymetazoline hydrochloride (OxH) 0.05% solution for PAE. This study was a split-face, participants-and investigators-blinded, randomized, placebo-controlled trial conducted between December 2021 and March 2022 in Bangkok, Thailand. Healthy adults aged from 18 to 45 years with mild to severe PAE, according to the Clinician's Erythema Assessment (CEA), on both sides of the face were eligible. After randomization, each participant applied the OxH to one side of their face and a placebo to the contralateral face twice daily for 12 weeks. The primary outcome was PAE lesion counts. The secondary outcomes were erythema index, clinical response rate at week 12 ("clear," "almost clear," or "at least two-grade improvement" by CEA), and patient satisfaction scores. A total of 30 participants were enrolled. The OxH-treated skin showed a significantly greater mean difference (MD) reduction in PAE lesion counts than the placebo after 8 weeks of treatment (4.30, 95% confidence interval [CI] 1.42-7.18). Similarly, the MD reduction of the erythema index was higher in the OxH-treated skin from the second week (11.82, 95% CI 8.48-15.15). Additionally, the OxH-treated side also achieved a higher clinical response rate after 8 weeks of treatment (40.00% vs. 6.67%; p = 0.002) and rated higher satisfaction than those using the placebo at the end of the study (mean [standard deviation] satisfaction score 8.30 [0.18] vs 7.40 [0.18], P < 0.001). There were no serious adverse events or flares of erythema during the study. In conclusion, our study demonstrated that the topical OxH 0.05% solution was effective, well-tolerated, and safe for reducing PAE without a rebound effect. It could be a choice of PAE management. Trial Registration: Thai Clinical Trials Registry No. TCTR20211207004.

The Indispensable Nasal Decongestant: Patients' Views and Perspectives on Nasal Decongestant Overuse.

BACKGROUND: Rhinitis medicamentosa (RM) is a type of nonallergic rhinitis caused by prolonged use of nasal decongestants (NDs). Although it is a preventable phenotype of rhinitis, little is known about patients dealing with this condition. OBJECTIVE: To gain a better understanding of patients' views and experiences of ND overuse, and potential facilitators and barriers to discontinue the overuse. METHODS: We performed a qualitative study using in-depth semistructured interviews with 22 patients who have been using an ND on an almost daily basis for at least 6 months. The interviews were conducted face-to-face, audio-recorded, and transcribed verbatim. Data analysis followed the grounded theory approach. RESULTS: Interviewees described the large impact of nasal congestion on their daily lives. Despite efforts to try other treatment options, the ND was considered the only effective aid to resolve the troublesome symptom. Most participants were aware that the prolonged use was problematic, sometimes leading to hiding behavior in order to avoid criticism by others including their health professionals. Many participants expressed a strong will to discontinue. However, multiple barriers to withdrawal were identified including fear of surgery or the impact of withdrawal on sleep, lack of good alternatives, and negative experiences with past withdrawal attempts. Patients thus face a dilemma in which the barriers to withdrawal currently outweigh the possible benefits. CONCLUSION: The use of NDs is considered indispensable by many chronic users. The facilitators and barriers identified in this study provide opportunities to reduce the use of NDs and the prevalence of RM in the future.

Use of xylometazoline in hospitalised infants: is it safe? A retrospective cohort study.

OBJECTIVE: When infants suffer from nasal congestion, xylometazoline spray or drops can be effective to facilitate breathing and drinking. However, case reports on side effects have resulted in international warnings regarding use of xylometazoline in infants. Nevertheless, the incidence of these side effects in hospitalised infants is unknown. DESIGN: Retrospective cohort study. SETTING: Teaching hospital between 2017 and 2021. PATIENTS: Infants under 2 years of age. EXPOSURE: Receiving either saline-only (unlimited frequency, concentration 0.9%) or in combination with xylometazoline (maximum three times daily, concentration 0.025%). MAIN OUTCOME MEASURES: Predefined potential side effects (events), including among others apnoea, nausea, bradycardia, cyanosis and nosebleeds, were extracted from patient records, and the probability to be caused by saline only or xylometazoline-saline was determined using the ADR Probability Scale. RESULTS: We included 898 admitted children during 1285 treatment episodes who received saline with or without xylometazoline. 26 events occurred in the saline-only group (incidence 20.0/100 treatment episodes), and 117 events occurred in the xylometazoline saline group (incidence of 10.5/100 treatment episodes), which was significantly lower (OR 0.47 95% CI 0.29 to 0.75, p=0.002). No definite linked or life-threatening events were found. Three nosebleeds had a probable link to the use of xylometazoline-saline, and all other events could only possibly be linked to saline-only or xylometazoline saline use. The incidence of all events was higher in the saline-only group as compared with the xylometazoline saline group, except nausea, which had a similar occurrence (p=0.65). Results were very similar across (gestational) age groups, gender and reasons for admission. CONCLUSION: The use of low-dose xylometazoline seems to be safe in hospitalised infants.

[Nasal toilet in infants with rhinitis: nasal passage crucial, so treat with xylometazoline]. / Neustoilet bij zuigelingen met rinitis.

A good nasal passage is crucial for neonates and infants, as they rely on obligate nasal breathing. Feeding problems and dyspnoea are commonly seen in infants with nasal obstruction.In this article, we emphasize the importance of relieving nasal congestion caused by an infection. An effective therapy to reduce nasal obstruction, caused by mucus, is rinsing with saline. Xylometazoline can be added if the effect of saline is insufficient. However, guidelines are often cautious with prescribing nasal decongestants in infants. These recommendations are mainly based on case reports, and often concern overdoses or other medication than xylometazoline. The risk of severe side effects with xylometazoline in young children is low if the dosage is adequate.

Safety of topical administration of nasal decongestants and vasoconstrictors in paediatric nasal surgery - A systematic review.

OBJECTIVES: Topical intranasal decongestants are essential in nasal surgery to improve operative field. There are concerns regarding safety in paediatric population. Data on safety and safe dosage are limited. This systematic review evaluated the literature on safety and dosage of intranasal decongestant in paediatric population. METHODS: We performed a systematic search of PubMed, EMBASE, Cochrane library for relevant articles. Quality assessment was done on included articles. RESULTS: A total of 10 articles were included: five case reports; three observational studies; and two randomised control trials. Decongestants evaluated were phenylephrine, oxymetazoline, epinephrine, xylometazoline, and cocaine. In total, 209 patients were included. Side effects reported included bradycardia, tachycardia and hypertension. These were mostly self-limiting and of no clinical compromise to the patients. A total of 4/209 (1.9%) of patients required treatment for these reported effects. No mortality was reported in the included studies. CONCLUSION: In the paediatric population, the literature suggests that when delivered in a pre-specified, controlled dosage, the haemodynamic effects of phenylephrine, oxymetazoline, xylometazoline are minimal and of no clinical significance. There is scope for further studies to establish safe dosage in the paediatric population given the paucity of current literature.

Topical Nasal Decongestant Oxymetazoline: Safety Considerations for Perioperative Pediatric Use.

The over-the-counter nasal decongestant oxymetazoline (eg, Afrin) is used in the pediatric population for a variety of conditions in the operating room setting. Given its vasoconstrictive properties, it can have cardiovascular adverse effects when systemically absorbed. There have been several reports of cardiac and respiratory complications related to use of oxymetazoline in the pediatric population. Current US Food and Drug Administration approval for oxymetazoline is for patients ≥6 years of age, but medical professionals may elect to use it short-term and off label for younger children in particular clinical scenarios in which the potential benefit may outweigh risks (eg, active bleeding, acute respiratory distress from nasal obstruction, acute complicated sinusitis, improved surgical visualization, nasal decongestion for scope examination, other conditions, etc). To date, there have not been adequate pediatric pharmacokinetic studies of oxymetazoline, so caution should be exercised with both the quantity of dosing and the technique of administration. In the urgent care setting, emergency department, or inpatient setting, to avoid excessive administration of the medication, medical professionals should use the spray bottle in an upright position with the child upright. In addition, in the operating room setting, both monitoring the quantity used and effective communication between the surgeon and anesthesia team are important. Further studies are needed to understand the systemic absorption and effects in children in both nonsurgical and surgical nasal use of oxymetazoline.

Abuse or Misuse of OTC Decongestant Produces Serious Adverse Effects.

A rising number of cases of misuse and abuse of propylhexedrine (Benzedrex), an over-the-counter nasal decongestant, have been documented. Misuse of this drug can lead to serious and potentially fatal cardiac and psychiatric adverse effects.

Comparative nasal airflow with loratadine-pseudoephedrine and fluticasone nasal spray for allergic rhinitis.

BACKGROUND: Although it is known that oral antihistamine-pseudoephedrine combination tablets have a faster onset than intranasal corticosteroid sprays in the treatment of allergic rhinitis after the first dose, the magnitude of change has not been measured in a comparative manner. Furthermore, the sensation of sprayed liquid in the nose may lead patients to mistakenly believe that intranasal steroid sprays work instantly. OBJECTIVE: To evaluate, numerically, nasal airflow changes provided by a single dose of loratadine-pseudoephedrine tablet (LP) and fluticasone propionate nasal spray (FP) in participants experiencing allergic rhinitis symptoms, including nasal congestion. METHODS: This single-center, double-blinded, placebo-controlled, crossover study evaluated objective nasal airflow changes in patients with a documented sensitivity to ragweed pollen. Participants were randomized to receive 1 of 4 treatment sequences, and their peak nasal inspiratory flow (PNIF) was measured in a span of 4 hours after pollen exposure in an environmental exposure unit. RESULTS: Average change in PNIF was 31% with LP in the course of the study, significantly greater than with placebo and FP (12% and 15%, respectively; P < .001). Nevertheless, FP did not produce a significant change compared with its placebo. At hour one post-dose, LP had a clinically significant 31% increase in PNIF, whereas FP only yielded an 8.6% increase (P < .001). Measurable nasal airflow improvements are associated with the opening of nasal passages, allowing congested patients to breathe more freely. CONCLUSION: A single dose of LP quickly and significantly (P < .001) improved nasal airflow after ragweed pollen challenge in an environmental exposure unit. Comparatively, FP did not display this same benefit. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03443843.

Decongestant use and the risk of myocardial infarction and stroke: a case-crossover study.

Pharmacovigilance reports of cerebral and cardiovascular events in those who use decongestants have triggered alerts related to their use. We aimed to assess the risk of stroke and myocardial infarction (MI) associated with the use of decongestants. We conducted a nested case-crossover study of patients with incident stroke and MI identified in France between 2013 and 2016 in two systematic disease registries. Decongestant use in the three weeks preceding the event was assessed using a structured telephone interview. Conditional logistic multivariable models were used to estimate the odds of incident MI and stroke, also accounting for transient risk factors and comparing week 1 (index at-risk time window, immediately preceding the event) to week 3 (reference). Time-invariant risk factors were controlled by design. In total, 1394 patients with MI and 1403 patients with stroke, mainly 70 years old or younger, were interviewed, including 3.2% who used decongestants during the three weeks prior to the event (1.0% definite exposure in the index at-risk time window, 1.1% in the referent time window; adjusted odds ratio (aOR), 0.78; 95%CI, 0.43-1.42). Secondary analysis yielded similar results for individual events (MI/stroke). We observed no increased risk of MI or stroke for patients 70 years of age and younger without previous MI or stroke who used decongestants.

Treating acute rhinitis and exacerbations of chronic rhinitis - A role for topical decongestants?

Acute nasal symptoms are troublesome for patients. In addition, these symptoms are encountered frequently by individuals because of common infectious diseases, especially rhinovirus, giving rise to a 'common cold'. Acute nasal symptoms include rhinorrhoea, sneezing, nasal itch and congestion. Of these, nasal congestion is the most irritating. Because topical nasal decongestants provide rapid and dramatic relief from these symptoms, especially nasal congestion, they are frequently used and abused by patients. Guidance for indications, choice of most efficacious decongestant and recommendations for limiting side effects are thus essential to be imparted to patients by doctors.

Predisposing factors of rhinitis medicamentosa: what can influence drug discontinuation?

BACKGROUND: the primary end point of our study was to define risk factors and identify the underlying conditions that may have led to the abuse of vasoconstrictors in rhinitis medicamentosa. Moreover, we analysed factors that may influence the vasoconstrictors discontinuation. METHODOLOGY: this was a prospective case-control observational study. Cases and controls were evaluated at the baseline in order define factors that may have influenced onset of rhinitis medicamentosa. They were re-evaluated at 3 months to verify symptoms control and drug discontinuation. Finally, they underwent a phone call questionnaire after 12 months regarding drug discontinuation. A potential bias of our study is that evaluating discontinuation we included subjects treated differently according to the main diagnosis. RESULTS: patients with rhinitis medicamentosa were more frequently smokers than controls, they had higher mean HAMA scores and positive psychiatric diseases history. Additionally, we frequently detected a local inflammation at nasal cytology in patients with rhinitis medicamentosa. A significant improvement in all nasal symptoms scores was observed in cases and controls but 29.4% of cases did not discontinue the vasoconstrictors. Two major factors negatively influenced discontinuation: positive nasal cytology and pathological HAMA score. CONCLUSION: we observed that positive local inflammation, anxiety and smoking habit correlate positively with vasoconstrictors abuse. In addition, we demonstrated that anxiety and local inflammation were the most important factors impairing drug discontinuation.

Should Excess Topical Decongestant Use Raise a Red Flag? Rhinitis Medicamentosa and Opioid Use Disorder.

OBJECTIVE: The objective of this study was to determine whether patients with rhinitis medicamentosa (RM) have an increased odds of having an opioid use disorder (OUD) and which characteristics may predict this association. METHODS: The authors conducted a retrospective case control study of patients 18 years and older who presented to the otolaryngology clinic at an academic medical center from January 2013 through December 2017. Cases, defined as patients who presented with excessive decongestant nasal spray usage based on history, were matched to control patients who presented with chronic rhinitis and did not report regular nasal decongestant usage. The charts were reviewed for patients that carried a problem of opioid abuse, identified using ICD-9 codes 304.XX or ICD-10 codes F11.XX. The primary outcome of this study was the odds of having an OUD. Secondary outcomes were assessed by summary statistics. RESULTS: One hundred and thirty-one cases of RM were matched to 1871 controls of chronic rhinitis. Seven cases (5.3%) and 24 (1.3%) controls had a diagnosis of OUD, consistent with an odds ratio of 3.98 for opioid abuse in patients with RM (95% CI: 1.47-9.71). Oxymetazoline was used by 85.5% (n = 112) of patients with RM. Thirty-six patients (27.1%) with RM underwent nasal surgery following a diagnosis of RM, of which twenty patients (55.6%) were prescribed opioids following the procedure. CONCLUSIONS: RM is associated with increased odds of having an OUD.

Rhinitis medicamentosa: a nationwide survey of Canadian otolaryngologists.

BACKGROUND: Rhinitis medicamentosa is a non-allergic form of rhinitis that is typically caused by prolonged use of topical nasal decongestants. This condition commonly affects young adults and treatment is not trivial. We aimed to survey Canadian Otolaryngologists to determine practice patterns and their opinions regarding this under-studied condition. METHODS: An electronic survey was sent to practicing Otolaryngologists within the Canadian Society of Otolaryngology - Head and Neck Surgery. The survey contained 16 questions pertaining to the diagnosis and treatment of rhinitis medicamentosa, as well as opinions on public and primary care awareness of proper use of nasal decongestants. RESULTS: The survey was distributed to 533 Otolaryngologists and 69 surveys were returned (response rate of 13%). Cessation and weaning of decongestant (96%), and intranasal steroids (94%) were the most common methods for treating RM. Intranasal saline rinses (55%) and oral steroids (25%) were also supported by some respondents. For those who recommended cessation/weaning, 61% also concurrently introduced an intranasal steroid during this process. The majority responded that current warnings on nasal decongestants were inadequate (75%), and were not visible enough (79%). CONCLUSIONS: Rhinitis medicamentosa is a common, and very preventable condition. Although the literature lacks a standardized approach to RM, our survey has shown that many Otolaryngologists diagnose and treat RM in a similar manner. Treatment tends to focus on decongestant cessation, often with concurrent introduction of intranasal steroids. It was felt the warning labels on the topical medications are not currently satisfactory.