Discussion
fracture, allergy, allergic rhinitis, ragweed hay fever, Itching
ALLERGY, SEASONAL ALLERGIC RHINITIS, ALLERGY, ALLERGIC RHINITIS, SECONDARY
The present study demonstrates that a single injection of methylprednisolone in conjunction with the start of a birch pollen season, characterized by a severe increase in the amount of airborne pollen, reduced nasal and eye symptoms and resulted in a less frequent use of rescue medication than placebo. The symptom reducing effect was statistically significant, but surprisingly small. There was a 24% improvement in AUC of dCSMS between the two groups. The World Allergy Organization (WAO) recommend an 20% reduction in CSMS when conducting AIT trials to conclude a significant improvement compared to regular antihistamine treatment A problem with all studies of seasonal allergic rhinitis is the variation of pollen exposure among the participants. During 2019 the Seasonal Pollen Integral, comprising all registered birch pollen during the season, was 13,940, which as 260% of the average value during the period 1975–2019 in the Malmö area, Sweden. This is considerably higher than during the previous four years (Fig. The overall response rate among all the study participants was generally good (> 90%). During the baseline run in period, both groups reported dSS and dMS above 0, even though the birch pollen concentration during this period was low. The reasons for this could not be indubitably assessed but are most probably related to a lingering symptom response induced by pollen from birch related trees, like alder and hazel, with a flowering period in Sweden slightly prior to birch.dCSMS has been proposed to be the goldstandard evaluation of treatment efficacy in allergic rhinitis In this study a modification of this scoring algorithm was necessary since systemic steroids were the focus of the evaluation. Despite this, it is our belief that our data is comparable to other clinical allergy trials using the original algorithm. The peak of the birch pollen season at day 9 coincided with the highest dCSMS levels both in the steroid and in the placebo group.During 1960 to 1988, 18 clinical trials were performed investigating the effect of different injectable steroids treating seasonal allergic rhinitis in adults. Nine were double-blind (5 placebo-controlled and 4 comparative), two single-blinded, and seven open trials In a more recent study, Brooks and colleagues compared the effect of three doses of oral methylprednisolone dosed three times a day (6, 12, or 24 mg a day), with placebo in 31 patients with ragweed hay fever during the first four days of the season. 24 mg daily showed statistically significant suppression of obstruction, running and sneezing. Itching showed a tendency to improvement, but it did not reach significance. The eye symptoms were improved at all doses. The treatment started the day before the start of symptom registration and lasted during the 4 days of registration, resulting in a total of 30, 60 and 120 mg, respectively given during the four-day long study period. This should be compared with the total of 80 mg methylprednisolone given as a single depot injection at the start of a three-week registration period in the present study. Thus, it is interesting to notice that middle dose of 60 mg total, which is most comparable to the 80 mg used in the present study, lacked effects on all nasal symptoms.In the second of the only two studies that have investigated the effects of systemic steroids on allergic rhinitis during the last 30 years, the efficacy of intranasal steroid spray (mometasone furoate) was compared with oral corticosteroids (betamethasone) and placebo Our primary endpoint was to investigate if a short course of corticosteroids conjures an effective treatment of AR. Short term safety aspects were determined using the secondary endpoints. During the pollen peak of the season the steroid treated group were less inclined to use nasal steroids but used antihistamine tablets and/or antihistamine eyedrops compared to patients in the control group who used all the available rescue medication. Even though symptom reduction was statistically significant and probably of some clinical value, it was much smaller than anticipated. This bleak effect was mirrored by the absence of steroid induced improvements in the quality of life.No abnormal concentrations of ACTH or bone turn over markers were registered, and no SAEs were reported. These data are in line with the reports found in Swedish Medical Products Agency´s record for intramuscular injection methylprednisolone. Further, it corroborates the conclusion about mostly limited side effects made by Østergaard and colleagues, after reviewing 18 older studies of systemically injected steroids treating seasonal allergic rhinitis. It is important to notice that most publications only report on relatively short-termed side effects and that there is evidence for that the cumulative “life dose” of oral steroids can affect at least the long-termed risk for loss of bone mineral density and the coherent risk of fracture