Intest Res.  2019 Jan;17(1):87-93. 10.5217/ir.2018.00078.

Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients

• Yagisawa K
• Kobayashi
• Ozaki R
• Okabayashi S
• Toyonaga T
• Miura M
• Hayashida
• Saito E
• Nakano M
• Matsubara
• Hisamatsu
• Hibi T

• KMID: 2438447
• DOI: http://doi.org/10.5217/ir.2018.00078

Abstract

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.

Keyword

Colitis, ulcerative; Mesalamine; Medication adherence; Patient acceptance of health care; Drug compounding

MeSH Terms

Colitis, Ulcerative*
Drug Compounding
Humans
Medication Adherence
Mesalamine*
Patient Acceptance of Health Care
Patient Compliance
Prospective Studies
Recurrence
Tablets*
Ulcer*
Visual Analog Scale
Mesalamine
Tablets

Figure

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  Fig. 1. Study design. Questionnaire 1, acceptability of tablets; questionnaire 2, acceptability of granules; questionnaire 3, comparison of tablets and granules.

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  Fig. 2. (A) Questionnaire 1: acceptability of tablets. (B) Questionnaire 2: acceptability of granules. (C) Questionnaire 3: comparison of tablets and granules. All the original questionnaires were written in Japanese. CR, controlled-release.

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  Fig. 3. Answers to the questions: (A) “Did you find the tablets/granules difficult to take?” (questionnaires 1 and 2, Q. I; n=33, chi-square test, P=0.0005), and (B) the reasons for the answers (multiple answers allowed). CR, controlled-release.

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  Fig. 4. Answers to the question: (A) “Which formulation did you find easier to take?” (questionnaire 3, Q. I; n=33, chi-square test, P=0.004), and (B) the reasons for the answers (multiple answers allowed). CR, controlled-release.

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  Fig. 5. Patient adherence rates to tablets and granules (n=33, paired t-test, P=0.139). High adherence, ≥80%; low adherence, <80%.

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  Fig. 6. Change of partial Mayo score before and after taking each formulation (no significant change was observed through this study. (A) Tablet (n=33, P=0.478) and (B) granules (n=33, P=0.838).

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  Fig. 7. Answers to the question “Which formulation did you feel was more effective?” (questionnaire 3, Q. V; n=33, chi-square test, P=0.753).

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