Background/Aims Oral mesalazine is an important treatment for ulcerative colitis (UC), and non-adherence to mesalazine increases the risk of relapse. Controlled-release (CR) mesalazine has 2 formulations: tablets and granules. The relative acceptabilities of these formulations may influence patient adherence; however, they have not been compared to date. This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey.
Methods UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group took either 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6 to 9 weeks. The acceptability and efficacy were evaluated by questionnaires, and adherence was assessed using a visual analog scale. The difference in acceptabilities between the 2 formulations and its impact on adherence were assessed.
Results A total of 49 patients were prospectively enrolled and 33 patients were included in the analysis. Significantly more patients found the tablets to be less acceptable than the granules (76% vs. 33%, P=0.0005). The granules were preferable to the tablets when the 2 formulations were compared directly (73% vs. 21%, P=0.004), for their portability, size, and numbers of pills. The adherence rate was slightly better among patients taking the granules (94% vs. 91%) during the observation period, but the difference was not significant (P=0.139).
Conclusions CR mesalazine granules are more acceptable than tablets, and may therefore be a better option for long-term medication.
Citations
Citations to this article as recorded by
Optimizing 5-aminosalicylate for moderate ulcerative colitis: expert recommendations from the Asia-Pacific, Middle East, and Africa Inflammatory Bowel Disease Coalition Filiz Akyüz, Yoon Kyo An, Jakob Begun, Satimai Aniwan, Huu Hoang Bui, Webber Chan, Chang Hwan Choi, Nazeer Chopdat, Susan J Connor, Devendra Desai, Emma Flanagan, Taku Kobayashi, Allen Yu-Hung Lai, Rupert W Leong, Alex Hwong-Ruey Leow, Wai Keung Leung, Ju Intestinal Research.2025; 23(1): 37. CrossRef
Non-Adherence Rate to Oral Mesalamine in Ulcerative Colitis Patients: A Systematic Review with Meta-Analysis Cristiano Pagnini, Elisabetta Antonelli, Barbara Scrivo, Maria Cappello, Marco Soncini, Roberto Vassallo, Giammarco Mocci, Maria Carla Di Paolo Journal of Personalized Medicine.2025; 15(4): 123. CrossRef
Shared decision-making improves adherence to mesalamine in ulcerative colitis: A prospective, multicenter, non-interventional cohort study in Germany Wolfgang Kruis, Petra Jessen, Julia Morgenstern, Birgitta Reimers, Nike Müller-Grage, Bernd Bokemeyer World Journal of Gastroenterology.2025;[Epub] CrossRef
Prospective Questionnaire Survey on Adherence to Oral 5‐Aminosalicylic Acid in Patients With Ulcerative Colitis Tsuyoshi Beppu, Fumihito Hirai, Kensei Ohtsu, Masahiro Kishi, Teruyuki Takeda, Shigeyoshi Yasukawa, Noritaka Takatsu, Takashi Hisabe, Toshiharu Ueki, Kenshi Yao JGH Open.2025;[Epub] CrossRef
Patent Landscaping of Time-dependent Mesalamine Prolonged-release Granules: A Case Study for Generic Formulation Development Ayush Rohila, Ankit Kumar, Prakash Kumar Sirvi, Sadhana Dhyagala, Sakshi Kunjir, Rajkumar Malayandi Journal of Pharmaceutical Innovation.2025;[Epub] CrossRef
Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey Sakiko Hiraoka, Zhezhou Huang, Fei Qin, Fatima Megala Nathan Arokianathan, Kiran Davé, Shweta Shah, Hyunchung Kim Intestinal Research.2025; 23(4): 524. CrossRef
Continuing or stopping 5‐aminosalicylates in patients with inflammatory bowel disease on anti‐TNF therapy: A nationwide population‐based study Jeongkuk Seo, Seonok Kim, Seung Wook Hong, Sung Wook Hwang, Sang Hyoung Park, Dong‐Hoon Yang, Jeong‐Sik Byeon, Seung‐Jae Myung, Suk‐Kyun Yang, Ye‐Jee Kim, Byong Duk Ye Alimentary Pharmacology & Therapeutics.2024; 60(3): 389. CrossRef
A review on taste masked multiparticulate dosage forms for paediatric Khater AL-Japairai, Samah Hamed Almurisi, Abd Almonem Doolaanea, Syed Mahmood, Fawaz Alheibshy, Ahmed Alobaida, Nadiya Abdul-Halim, Bappaditya Chatterjee International Journal of Pharmaceutics.2023; 632: 122571. CrossRef
Medication Formulation Preference of Mild and Moderate Ulcerative Colitis Patients: a European Survey Xavier Hébuterne, Stephan R Vavricka, Helen C Thorne, Lara MacKenzie-Smith, Raphaël Laoun, Johan Burisch Inflammatory Intestinal Diseases.2023; 8(1): 41. CrossRef
Efficacy and Safety of Vitamin D Adjuvant Therapy for Ulcerative Colitis: A Meta-Analysis Xinyi Guo, Changxing Liu, Yahui Huang, Naeem Jan Computational and Mathematical Methods in Medicine.2022; 2022: 1. CrossRef
Factors Associated with Self-reported Medication Adherence in Japanese Community-dwelling Elderly Individuals: The Nakajima Study Natsuko Ishida, Yurina Tokumoto, Yukio Suga, Moeko Noguchi-Shinohara, Chiemi Abe, Sohshi Yuki-Nozaki, Ayaka Mori, Mai Horimoto, Koji Hayashi, Kazuo Iwasa, Masami Yokogawa, Mai Ishimiya, Hiroyuki Nakamura, Kiyonobu Komai, Ryo Matsushita, Junko Ishizaki, Ma YAKUGAKU ZASSHI.2021; 141(5): 751. CrossRef
Treatment of inflammatory bowel diseases: focusing on 5-aminosalicylates and immunomodulators You Sun Kim Journal of the Korean Medical Association.2021; 64(9): 596. CrossRef
Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review Ji Young Chang, Jae Hee Cheon Precision and Future Medicine.2021; 5(4): 151. CrossRef
Association of Self-Reported Medication Adherence with Potentially Inappropriate Medications in Elderly Patients: A Cross-Sectional Pilot Study Motoyasu Miyazaki, Masanobu Uchiyama, Yoshihiko Nakamura, Koichi Matsuo, Chika Ono, Miwa Goto, Ayako Unoki, Akio Nakashima, Osamu Imakyure International Journal of Environmental Research and Public Health.2020; 17(16): 5940. CrossRef
Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation Satoshi Tamura, Natsuki Ishida, Takahiro Miyazu, Shunya Onoue, Shinya Tani, Mihoko Yamade, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Takahisa Furuta, Ken Sugimoto Scientific Reports.2020;[Epub] CrossRef