Open-Label Real-World Pharmacy Purchaser Study of Two Fixed-Dose Combination OTC Cold Treatments; Wick MediNait, Wick DayMed Capsules or a Combination of Both

Gillian Phillipson, D. Ramsey, S. Aspley, I. Fietze
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Abstract

Acute upper respiratory tract infections, i.e. common colds cause multiple symptoms and affect adults on average 2 - 4 times a year and children 6 - 8 times per year. Thousands of non-prescription, over-the-counter products are used by sufferers, aimed at relieving the various both er some symptoms such as cough, nasal congestion, sore throat, etc. This study evaluated real-world effectiveness of Wick MediNait or Wick DayMed medicines alone and together in a combination as a day and night treatment regimen. Adult cold sufferers were recruited in pharmacy by pharmacy staff following self-purchase of either Wick MediNait, Wick DayMed capsules, or the combination of DayMed and MediNait. Participants completed online questionnaires before and after product use (evening of the first day for DayMed and the morning after using MediNait at bedtime). For the primary endpoint “Wick MediNait was effective at relieving my symptoms”, there was a statistically significant difference (p < 0.0001) in the users who Strongly Agreed or Agreed vs. Neither Agreed or Disagreed, Disagreed or Strongly Disagreed. Further, all symptoms evaluated (cough, runny nose, nasal congestion, fever, headache, sore throat, muscle aches and pains, sneezing) were statistically improved after MediNait and DayMed alone and when both were used, and users were satisfied with both treatments. All treatments were well tolerated with minimal adverse event reporting. The diurnal use of DayMed capsules combined with the nocturnal use of MediNait allows cold sufferers to efficiently self-manage their symptom relief throughout the day and night.
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两种固定剂量组合OTC感冒治疗的开放标签真实世界药房购买者研究;Wick MediNait、Wick DayMed胶囊或两者的组合
急性上呼吸道感染,即普通感冒,会引起多种症状,成人平均每年感染2-4次,儿童平均每年感染6-8次。患者使用了数千种非处方非处方药,旨在缓解咳嗽、鼻塞、喉咙痛等各种症状。这项研究评估了Wick MediNait或Wick DayMed药物单独或联合作为昼夜治疗方案的真实有效性。药房工作人员在自行购买Wick MediNait、Wick DayMed胶囊或DayMed和MediNait的组合后,在药房招募成年感冒患者。参与者在使用产品前后(DayMed的第一天晚上和睡前使用MediNait后的第二天早上)完成了在线问卷调查。对于主要终点“Wick MediNait有效缓解了我的症状”,强烈同意或同意的用户与不同意或不同意、不同意或强烈不同意的用户之间存在统计学上的显著差异(p<0.0001)。此外,在单独使用MediNait和DayMed后以及同时使用这两种药物时,所有评估的症状(咳嗽、流鼻涕、鼻塞、发烧、头痛、喉咙痛、肌肉酸痛、打喷嚏)都得到了统计学上的改善,使用者对这两种治疗都感到满意。所有治疗均耐受性良好,不良事件报告最少。DayMed胶囊的日间使用与MediNait的夜间使用相结合,使感冒患者能够在白天和晚上有效地自我管理症状缓解。
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