黑种草籽油局部应用与口服对乙酰氨基酚对老年膝骨关节炎疼痛的影响：一项交叉临床试验。
Effect of Topical Application of Nigella Sativa Oil and Oral Acetaminophen on Pain in Elderly with Knee Osteoarthritis: A Crossover Clinical Trial.
作者信息
Kooshki Akram, Forouzan Reza, Rakhshani Mohammad Hassan, Mohammadi Maryam
机构信息
Ph.D. of Nutrition, Associate Professor, Department of Nutrition & Biochemistry, Faculty member of Medicine school, Sabzevar University of Medical Sciences, Sabzevar, Iran.
MD, Management of Treatment, Sabzevar University of Medical Sciences, Sabzevar, Iran.
出版信息
Electron Physician. 2016 Nov 25;8(11):3193-3197. doi: 10.19082/3193. eCollection 2016 Nov.
BACKGROUND
Limited evidence supports Nigella sativa's role as an effective complementary and alternative medicine and the anti-inflammatory effects of Nigella sativa on patients with allergic rhinitis.
OBJECTIVE
The aim of this study was to investigate the effect of topical application of Nigella sativa oil and oral acetaminophen on pain in the elderly with knee osteoarthritis residing in a parents' home in Sabzevar.
METHODS
This study is done as a crossover clinical trial. After obtaining written consent of elderly patients with osteoarthritis of the knee, they were randomly divided into two groups. In step 1, in group 1, 1 cc of Nigella sativa oil was applied on the knee joint every 8 hours for 3 weeks; for the second group, every 8 hours for 3 weeks, patients were given 1 tablet of 325 mg acetaminophen. After a period of 1 month without medication to wash out each group, in step 2, each treatment group received the drug interaction in the same way as above. Pain was determined using a visual scale (VAS) before and after the first and second stages. Treatment response was defined as a decrease in pain scores over 1.5. Data analysis was performed with an R software mixed model.
RESULTS
This study was done on 40 elderly patients: 18 (45%) men and 22 (55%) women. Their mean year and weight were 75.66±8.9 years and 69.67±14.33 kg, respectively. Study results showed that topical application of Nigella sativa oil and oral acetaminophen reduced pain in elderly with knee osteoarthritis; after using Nigella sativa oil, the reduction of pain was higher (p=0.01).
CONCLUSION
The results of this study showed that topical application of Nigella sativa oil was effective in reducing pain in patients with knee osteoarthritis; therefore, it is recommended as a safe supplement for these elderly.
TRIAL REGISTRATION
The trial was registered at TCTR (http://www.clinicaltrials.in.th/) with the ID: TCTR20160125003.
FUNDING
This study was approved and supported by the Sabzevar University of Medical Sciences.
背景
仅有有限的证据支持黑种草作为一种有效的补充和替代医学的作用，以及黑种草对过敏性鼻炎患者的抗炎作用。
目的
本研究的目的是调查局部应用黑种草油和口服对乙酰氨基酚对居住在萨卜泽瓦尔一家养老院的老年膝骨关节炎患者疼痛的影响。
方法
本研究作为一项交叉临床试验进行。在获得老年膝骨关节炎患者的书面同意后，将他们随机分为两组。在第1步中，第1组每8小时在膝关节上涂抹1毫升黑种草油，持续3周；对于第2组，每8小时给患者服用1片325毫克的对乙酰氨基酚，持续3周。在每组停药1个月以清除药物影响后，在第2步中，每个治疗组以与上述相同的方式接受药物交叉。在第一阶段和第二阶段前后使用视觉模拟量表（VAS）确定疼痛程度。治疗反应定义为疼痛评分降低超过1.5。使用R软件混合模型进行数据分析。
结果
本研究对40名老年患者进行：18名（45%）男性和22名（55%）女性。他们的平均年龄和体重分别为75.66±8.9岁和69.67±14.33千克。研究结果表明，局部应用黑种草油和口服对乙酰氨基酚可减轻老年膝骨关节炎患者的疼痛；使用黑种草油后，疼痛减轻程度更高（p=0.01）。
结论
本研究结果表明，局部应用黑种草油可有效减轻膝骨关节炎患者的疼痛；因此，建议将其作为这些老年人的一种安全补充剂。
试验注册
该试验在泰国临床试验注册中心（http://www.clinicaltrials.in.th/）注册，注册号为：TCTR20160125003。
资金来源
本研究得到萨卜泽瓦尔医科大学的批准和支持。
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