Real World Evidence of User Experience with Microenemas for Relief of Constipation.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY
Stefanie Rasche, Christer Spegel, Katarina Lundh
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引用次数: 0

Abstract

Background: Constipation is a commonly reported gastrointestinal complaint. Research on this widespread condition focuses mainly on clinical trials for chronic constipation with less emphasis on patient experience and nonchronic situations. Sufferers report that constipation interferes with daily activities and quality of life. It is likely that this is common among all sufferers of constipation, regardless of how often the condition is experienced.

Objective: This work explored attitudes and perceptions of people who experience occasional constipation and self-treat with over the counter products, particularly Microlax® microenemas.

Methods: In this retrospective study, real-world data were collected from 1635 respondents from France and Russia who experienced occasional constipation. Participants completed a questionnaire about their experiences with occasional (not chronic) constipation and perceptions of over the counter treatments of oral laxatives, suppositories, and Microlax microenemas. Questions focused on comfort, quality of life, ease of use, and reliability of these treatments. Participants had used the microenema for treatment of occasional constipation within 3 months of study participation. Occasional constipation was based on the Rome IV diagnostic criteria for adults and babies. Data were analyzed across the total population of all groups, then by subgroup. Success criteria were defined as of at least 70% agreement with the statements scoring ≥ 7 on the scale of 0-10. The proportion of respondents agreeing with the individual statements was calculated using the denominator for the total sample within each group.

Results: This study shows that experiencing even occasional bouts of constipation negatively affect quality of life and well-being. Participants (women aged 25-54 years, older men, and women aged 60-80 years) reported that it severely limited daily life and activities and caused negative emotions and embarrassment. Pregnant women and mothers with babies showed great concern that constipation indicated a serious and painful condition and was bad for their babies. Participants agreed that using Microlax microenema provided greater ease of use, comfort, reliability, and safety than oral laxatives and rectal suppositories.

Conclusions: Sufferers of occasional constipation report that these bouts interfere with their daily lives and reduce quality of life, similar to what is reported for those with chronic constipation based on existing literature. The microenema, Microlax, showed benefits in the relief of occasional constipation compared with oral laxatives and rectal suppositories. Trepidation about using the microenema, experienced before using it, was greatly reduced after the first and subsequent uses. Microlax microenema enabled users to regain the feeling of control and provided positive impacts on quality of life and well-being.

用微enemas缓解便秘的用户体验的真实世界证据。
背景介绍便秘是一种常见的胃肠道症状。对这一普遍病症的研究主要集中在针对慢性便秘的临床试验上,而较少关注患者的体验和非慢性情况。患者表示,便秘会影响日常活动和生活质量。这可能是所有便秘患者的共同感受,无论这种情况发生的频率如何:这项研究探讨了偶尔出现便秘并使用非处方产品(尤其是 Microlax® 微门冬酰胺)进行自我治疗的人的态度和看法:在这项回顾性研究中,我们收集了来自法国和俄罗斯的 1635 名偶尔便秘的受访者的真实世界数据。受访者填写了一份调查问卷,内容涉及他们偶尔(非慢性)便秘的经历,以及对口服泻药、栓剂和 Microlax 微enemas 等非处方治疗方法的看法。问题主要涉及这些疗法的舒适度、生活质量、易用性和可靠性。参与者在参加研究的 3 个月内曾使用过微enema 治疗偶尔便秘。偶发性便秘是根据成人和婴儿的罗马 IV 诊断标准确定的。对所有组别的总人数进行数据分析,然后按分组进行分析。成功标准的定义是,至少 70% 的受访者同意在 0-10 分的评分中得分≥ 7 分的陈述。同意各项陈述的受访者比例以各组总样本的分母进行计算:本研究表明,即使偶尔出现便秘也会对生活质量和幸福感产生负面影响。参与者(25-54 岁女性、老年男性和 60-80 岁女性)表示,便秘严重限制了日常生活和活动,并造成负面情绪和尴尬。孕妇和有婴儿的母亲对便秘表示出极大的担忧,认为便秘是一种严重而痛苦的疾病,对婴儿不利。参与者一致认为,与口服泻药和直肠栓剂相比,使用 Microlax 微灌肠器更加方便、舒适、可靠和安全:结论:偶尔便秘的患者表示,便秘影响了他们的日常生活,降低了生活质量,这与现有文献报道的慢性便秘患者的情况类似。与口服泻药和直肠栓剂相比,微灌肠器 Microlax 在缓解偶发性便秘方面表现出了优势。在第一次使用和多次使用后,使用前的恐惧感大大减少。Microlax 微灌肠器让使用者重新获得了控制感,并对生活质量和幸福感产生了积极影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Drugs - Real World Outcomes
Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
5.00%
发文量
49
审稿时长
8 weeks
期刊介绍: Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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