Effects of a sucralfate-containing ointment on quality of life and symptoms associated with hemorrhoidal disease: patient-reported results of a Slovakian, pharmacist-led observational survey

Miroslava Snopková, Ondrej Sukel‘, Jan Micanko
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Abstract

This pharmacist-led study evaluated the effect of a rectal ointment containing sucralfate on quality of life, symptom frequency and time to relief of symptoms in Slovakian individuals with hemorrhoidal disease (HD).The multicenter prospective survey was conducted at 45 community pharmacies in Slovakia. Pharmacists invited adults (≥18 years) using sucralfate-containing ointment for their HD-related symptoms to participate.241 patients completed the HEMO-FISS-QoL questionnaire and a survey of symptom frequency at the beginning and end of the 14-day survey period. The primary endpoint was the change in HEMO-FISS-QoL scores in patients with hemorrhoidal symptoms during the 7 days before the initial pharmacy visit. Of the 241 patients enrolled in the survey, 144 had experienced hemorrhoidal symptoms within the preceding 7 days (mean age 51 years; 59.0% female). For these 144 patients, the total HEMO-FISS-QoL score decreased (i.e., quality of life was improved) from baseline by a mean of –8.7 (95% confidence interval –12.6, –6.2; P<0.001) at day 14. The frequency of hemorrhoidal symptoms was significantly reduced (P<0.001 vs baseline). Symptom relief was rapid; at 1-hour post-treatment 54.6% of patients had relief from pain and 56.3% from itching, and by 24 hours post-treatment most patients had relief from these symptoms (77.2% and 73.0%, respectively). No incidents nor adverse events related to sucralfate-containing ointment were reported to pharmacists.The results of this pharmacist-led observational survey suggest that the sucralfate-containing ointment could improve quality of life in patients with HD, providing rapid relief with a good safety profile. To confirm these results in a larger, well-defined patient population, randomized controlled trials in patients with clinically diagnosed HD are warranted.
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含三硫酸软膏对生活质量和痔疮相关症状的影响:一项斯洛伐克药剂师主导的观察性调查的患者报告结果
这项以药剂师为主导的研究评估了一种含有硫硫酸盐的直肠软膏对斯洛伐克痔疮病(HD)患者的生活质量、症状频率和症状缓解时间的影响。在斯洛伐克的45个社区药房进行了多中心前瞻性调查。药剂师邀请使用含蔗糖酸软膏治疗hd相关症状的成年人(≥18岁)参与。在为期14天的调查开始和结束时,241例患者完成了HEMO-FISS-QoL问卷和症状频率调查。主要终点是首次药房就诊前7天有痔疮症状患者的HEMO-FISS-QoL评分的变化。在参与调查的241名患者中,144名患者在前7天内出现过痔疮症状(平均年龄51岁;59.0%的女性)。对于这144名患者,总的HEMO-FISS-QoL评分比基线平均下降了-8.7(95%可信区间-12.6,-6.2;P<0.001)。痔疮症状的发生频率显著降低(与基线相比P<0.001)。症状缓解迅速;治疗后1小时,54.6%的患者疼痛缓解,56.3%的患者瘙痒缓解,治疗后24小时,大多数患者症状缓解(分别为77.2%和73.0%)。药师未见与含三硫酸软膏相关的事故或不良事件报告。这项由药剂师主导的观察性调查结果表明,含三硫酸盐软膏可以改善HD患者的生活质量,提供快速缓解和良好的安全性。为了在更大、定义明确的患者群体中证实这些结果,有必要对临床诊断为HD的患者进行随机对照试验。
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