Topical nasal spray glucocorticoids are the first-line treatment of choice in the treatment of allergic rhinitis and chronic sinusitis. They have significant anti-inflammatory and edema-reducing effects, and can induce a return of the diseased nasal mucosa to normal. Therefore, patients with rhinosinusitis or parents of children with rhinitis often ask about their side effects, and many of them are afraid of hormones. Because they think the side effects of hormones are too great, they are unwilling to treat them or stop taking them once their symptoms improve. In fact, this is a big misunderstanding. The hormones that we usually come into contact with mostly refer to systemic glucocorticoids (intravenous, intramuscular or oral), and their side effects cannot be underestimated if applied for a long time. In contrast, the hormones used in the nasal cavity are local medications, and the doses used are very, very small compared to systemic medications.
Therefore, nasal hormones are approved by the FDA for use in children over 3 years old, and there are research data showing that the use of the recommended dose of nasal hormones (applied continuously for two years) has no effect on the growth of children. Therefore, the safety of nasal hormones is very high. On the contrary, the improvement of nasal congestion and sleep quality has a positive effect on the growth of children. Of course, it does not mean that nasal hormones do not have any side effects, and a few patients may have adverse reactions of nasal dryness and nasal bleeding with long-term application.
Some parents have doubts about the minimum age of the three commonly used nasal spray hormones – Endosulpride, Reynocort and Cosulpride (3 years old for Endosulpride, 6 years old for Reynocort and 12 years old for Cosulpride). In fact, the active ingredients of all three are similar, and their effects are similar. And they are all products of international famous pharmaceutical companies, so the safety and reliability can be assured. The reason for the age difference is related to the age group of the clinical trials done at that time. After the development of a drug is completed, a large number of clinical studies are needed before it can be officially put into production, which requires a lot of investment in human and financial resources. Generally, studies are done first for adults over 18 years old, then in the age group of 12-18 years old, 6-12 years old, and 3-6 years old in that order; the difference in investment at this time will lead to the difference in the applicable age in the instruction manual. In addition, the instructions are set in the year after the market, these drugs have more than ten years of history. During these ten years of use, international ENT specialists have gained a better understanding of nasal spray hormones, and multicenter studies have shown that the safety of nasal spray hormones is reliable.
Internationally, clinical studies are not usually done on infants and children under the age of 3 years (for ethical reasons), so most of the drugs have a minimum age limit of 3 years or older (and only the competent international pharmaceutical companies can conduct clinical trials on drugs up to the age of 3 years). This does not mean that these drugs cannot be used in infants under 3 years of age, but they should be applied carefully (short-term, small doses) under the guidance of an experienced physician, otherwise there will be no drugs available for infants under 3 years of age.