{"title":"NOVEMA® NIGHT(苯海拉明+萘普生)治疗疼痛和失眠患者:一项多中心非干预性观察研究的结果","authors":"A. B. Danilov, A. A. Pilipovich, M. V. Pyastolova","doi":"10.14412/2074-2711-2023-6-56-63","DOIUrl":null,"url":null,"abstract":"Pain and sleep disorders are interrelated problems that significantly affect patients’ quality of life (QoL) and daily functioning.Objective: to evaluate the efficacy and safety of the use of the combination of diphenhydramine + naproxen (NOVEMA® NIGHT) in patients with acute pain syndrome or exacerbation of chronic pain syndrome and sleep disorders.Material and methods. The study included 4365 outpatients with acute pain (musculoskeletal pain, post-traumatic pain, headache) and sleep disorders who took naproxen 275 mg, 1 tablet in the morning and diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) for 5 days before bedtime. Pain intensity, using a visual analogue scale (VAS), and sleep disorders were assessed before and after treatment; QoL was assessed after treatment using a five-point scale.Results. During treatment, a reduction or complete regression of pain was observed in 92% of cases (60 [50; 61] points on the VAS before treatment versus 10 [0; 20] after treatment; p<0.0001) and normalisation of sleep in most patients: faster falling asleep – in 81% (χ2=9650.2; p<0.0001), an increase in total sleep duration – in 75.5% (χ2=7351.2; p<0.0001), a decrease in the number of nocturnal awakenings – in 84% of patients (χ2=10,568; p<0.0001). At the end of treatment course, the majority of patients rated their quality of life as 4 out of 5 possible points (4 [4; 5]): 41% of patients – “high quality of life”; 48% – “above average”; 11% – “average”; 0.09% – “below average”). None of the patients had a low QoL. The therapy was well tolerated and no patient discontinued treatment due to adverse events (AEs).Conclusion. Short-term treatment (5 days) with naproxen 275 mg and a combination of diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) at bedtime effectively reduces the pain syndrome associated with insomnia. This therapy significantly improves patients’ QoL and has a low risk of AEs, so that we can recommend NOVEMA® NIGHT as an additional analgesic for patients with concomitant sleep disorders.","PeriodicalId":19252,"journal":{"name":"Neurology, neuropsychiatry, Psychosomatics","volume":"12 4","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"NOVEMA® NIGHT (diphenhydramine + naproxen) in patients with pain and insomnia: results of a multicenter non-interventional observational study\",\"authors\":\"A. B. Danilov, A. A. Pilipovich, M. V. Pyastolova\",\"doi\":\"10.14412/2074-2711-2023-6-56-63\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Pain and sleep disorders are interrelated problems that significantly affect patients’ quality of life (QoL) and daily functioning.Objective: to evaluate the efficacy and safety of the use of the combination of diphenhydramine + naproxen (NOVEMA® NIGHT) in patients with acute pain syndrome or exacerbation of chronic pain syndrome and sleep disorders.Material and methods. The study included 4365 outpatients with acute pain (musculoskeletal pain, post-traumatic pain, headache) and sleep disorders who took naproxen 275 mg, 1 tablet in the morning and diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) for 5 days before bedtime. Pain intensity, using a visual analogue scale (VAS), and sleep disorders were assessed before and after treatment; QoL was assessed after treatment using a five-point scale.Results. During treatment, a reduction or complete regression of pain was observed in 92% of cases (60 [50; 61] points on the VAS before treatment versus 10 [0; 20] after treatment; p<0.0001) and normalisation of sleep in most patients: faster falling asleep – in 81% (χ2=9650.2; p<0.0001), an increase in total sleep duration – in 75.5% (χ2=7351.2; p<0.0001), a decrease in the number of nocturnal awakenings – in 84% of patients (χ2=10,568; p<0.0001). At the end of treatment course, the majority of patients rated their quality of life as 4 out of 5 possible points (4 [4; 5]): 41% of patients – “high quality of life”; 48% – “above average”; 11% – “average”; 0.09% – “below average”). None of the patients had a low QoL. The therapy was well tolerated and no patient discontinued treatment due to adverse events (AEs).Conclusion. Short-term treatment (5 days) with naproxen 275 mg and a combination of diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) at bedtime effectively reduces the pain syndrome associated with insomnia. This therapy significantly improves patients’ QoL and has a low risk of AEs, so that we can recommend NOVEMA® NIGHT as an additional analgesic for patients with concomitant sleep disorders.\",\"PeriodicalId\":19252,\"journal\":{\"name\":\"Neurology, neuropsychiatry, Psychosomatics\",\"volume\":\"12 4\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-12-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurology, neuropsychiatry, Psychosomatics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14412/2074-2711-2023-6-56-63\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurology, neuropsychiatry, Psychosomatics","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14412/2074-2711-2023-6-56-63","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
NOVEMA® NIGHT (diphenhydramine + naproxen) in patients with pain and insomnia: results of a multicenter non-interventional observational study
Pain and sleep disorders are interrelated problems that significantly affect patients’ quality of life (QoL) and daily functioning.Objective: to evaluate the efficacy and safety of the use of the combination of diphenhydramine + naproxen (NOVEMA® NIGHT) in patients with acute pain syndrome or exacerbation of chronic pain syndrome and sleep disorders.Material and methods. The study included 4365 outpatients with acute pain (musculoskeletal pain, post-traumatic pain, headache) and sleep disorders who took naproxen 275 mg, 1 tablet in the morning and diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) for 5 days before bedtime. Pain intensity, using a visual analogue scale (VAS), and sleep disorders were assessed before and after treatment; QoL was assessed after treatment using a five-point scale.Results. During treatment, a reduction or complete regression of pain was observed in 92% of cases (60 [50; 61] points on the VAS before treatment versus 10 [0; 20] after treatment; p<0.0001) and normalisation of sleep in most patients: faster falling asleep – in 81% (χ2=9650.2; p<0.0001), an increase in total sleep duration – in 75.5% (χ2=7351.2; p<0.0001), a decrease in the number of nocturnal awakenings – in 84% of patients (χ2=10,568; p<0.0001). At the end of treatment course, the majority of patients rated their quality of life as 4 out of 5 possible points (4 [4; 5]): 41% of patients – “high quality of life”; 48% – “above average”; 11% – “average”; 0.09% – “below average”). None of the patients had a low QoL. The therapy was well tolerated and no patient discontinued treatment due to adverse events (AEs).Conclusion. Short-term treatment (5 days) with naproxen 275 mg and a combination of diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) at bedtime effectively reduces the pain syndrome associated with insomnia. This therapy significantly improves patients’ QoL and has a low risk of AEs, so that we can recommend NOVEMA® NIGHT as an additional analgesic for patients with concomitant sleep disorders.