This study is the first paper on the budesonide foam rapidly improves the most prominent UC symptoms, such as urgency and nocturnal defecation. According to previous reports about factors influencing the QOL of UC patients in Japan, the daily life of 43.5% of these patients was "significantly affected" by UC symptoms . Similarly, nocturnal defecation is also closely related to the QOL of UC patients. It has been suggested that the frequency of stools and rectal bleeding should not be considered alone in determining the QOL of these patients . Furthermore, the QOL was not investigated in detail in the study; we confirmed that urgent defecation and nocturnal defecation improved significantly at week 2 after budesonide foam administration, indicating that the QOL was also improved.
Our findings confirm the use of budesonide foam as an excellent alternative treatment that can significantly improve the quality of life in UC patients. In UC, inflammation occurs from the rectum just above the anus; therefore, eliminating rectal inflammation is crucial for the complete disappearance of symptoms. In the initial treatment of UC, 5-ASA preparations are usually administered regardless of disease type to induce remission, but there may be minor residual inflammation and symptoms. Our results show that budesonide foam can also eliminate residual inflammation in such cases. Half of the patients utilizing a 5-ASA topical preparation was ineffective, but when substituted with budesonide foam, the symptoms disappeared in 6 weeks, and no worsening cases were observed. Thus, if 5-ASA topical preparations do not induce remission, budesonide foam could be a viable treatment option before systemic steroid administration.
Improvement of the rectal bleeding and urgent defecation two weeks after budesonide foam administration is associated with complete mucosal remission six weeks after treatment [23, 24]. However, only the rectal bleeding and urgent defecation were evaluated, and the response rates for all other clinical symptom scores were unclear; similar results were obtained in the present study. Moreover, the remission rate increased by 16% at week 6 compared to week 2. Thus, even if remission is not achieved at week 2 after budesonide foam administration, it is better to continue the treatment until week 6.
UC patients in clinical remission with a residual SCCAI symptom score of 1 or 2 are commonly observed in routine clinical practice. This study revealed that budesonide foam was effective even for mild residual symptoms such as urgent defecation, mild rectal bleeding, and nocturnal defecations. There are no research reports that present a correlation between SCCAI scores ≤ 2 and QOL. However, these symptoms do have the potential to affect the QOL of patients with UC. The high rate of symptom alleviation observed in our study (more than 50% of the patients at 2 weeks and 70% at 6 weeks) suggests that this formulation is highly beneficial for improving the QOL of these patients. Even though budesonide foam is easier to use than conventional topical preparations, the difficulty of inserting budesonide foam twice a day is a disadvantage for the patient's QOL. Nevertheless, considering that the symptoms can be improved by using budesonide foam for a certain period, it is considered that the overall merit of its use is higher than non-use.
No noticeable side effects were reported in any of the cases in this study. Also, serum cortisol values were not measured in this study, and there was no change in the cortisol value in a previous report . Thus, budesonide foam can be selected as an optional treatment without any safety concerns.
The main limitation of this study is that it was a single-center, retrospective study. In particular, the use of budesonide foam was not based on specific criteria and rather reflects the intentions of the attending physician or patient; thus, selection bias was not excluded. Second, the SCCAI is not a definite objective evaluation index because it is easy for patients to have their own subjective feelings about their symptoms. However, improvement was seen with the SCCAI before and after treatment in the same patient; hence, a certain degree of objectivity was achieved. Additionally, a few patients who received new treatment during the six weeks were excluded from the study, and it is possible that budesonide foam was not effective in those patients. Finally, the adherence rate of budesonide foam administration is uncertain because it was not confirmed the administration rate of the prescribed medication.