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狗蔷薇、荨麻和普通春黄菊草药组合治疗耳鸣症状的疗效:一项双盲随机临床试验。

Therapeutic effects of Rosa canina, Urtica dioica and Tanacetum vulgare herbal combination in treatment of tinnitus symptoms: A double-blind randomised clinical trial.

机构信息

Department of Research, Arka Education and Clinical Research Consultants, Tehran, Iran.

Student Research Committee, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.

出版信息

Clin Otolaryngol. 2023 Mar;48(2):151-157. doi: 10.1111/coa.13989. Epub 2022 Dec 5.

DOI:10.1111/coa.13989
PMID:36268807
Abstract

OBJECTIVE

To evaluate the effect of Neurotec® herbal capsule (100 mg twice a day for 3 months) on the tinnitus symptoms in comparison with the placebo.

DESIGN

A double-blind randomised clinical trial.

SETTING

Otolaryngology clinic of Baqiyatallah Hospital.

PARTICIPANTS

Patients suffering from subjective tinnitus.

MAIN OUTCOME MEASURES

Pure tone audiometry was measured at .5, 1, 2, 4 and 6 kHz frequencies before and after the third month of intervention. In addition, Tinnitus Handicap Inventory (THI) questionnaire as well as visual analogue scale (VAS) for tinnitus loudness, daily annoyance, daily life or sleep disturbance, daily perception and mood alteration were evaluated.

RESULTS

Finally, 103 (69 males and 34 females) patients with a mean age of 51.33 ± 13.91 years were analysed. In contrast with control group, patients in intervention group showed a remarkable decrease in THI score after 3 months of treatment (p < .05). Although both groups had improvements in VAS scores, mood disturbance, daily tinnitus perception and daily life alteration scores were only improved in the intervention group. The mean pure tone air and bone conduction were not significantly different between the control and the intervention group at baseline and 3 months after the intervention at .5, 1, 2 and 4 kHz (p > .05).

CONCLUSION

A 3-month treatment with Neurotec capsules in addition to patient education is of benefit for managing symptoms in patients with chronic tinnitus.

摘要

目的

评估 Neurotec®草药胶囊(每天两次,每次 100 毫克,持续 3 个月)对耳鸣症状的疗效,与安慰剂进行比较。

设计

双盲随机临床试验。

地点

Baqiyatallah 医院耳鼻喉科诊所。

参与者

患有主观性耳鸣的患者。

主要观察指标

在干预后第 3 个月之前和之后,在.5、1、2、4 和 6 kHz 频率下测量纯音听阈。此外,还评估了耳鸣残疾量表(THI)问卷以及耳鸣响度、日常烦恼、日常生活或睡眠干扰、日常感知和情绪改变的视觉模拟量表(VAS)。

结果

最终,分析了 103 名(69 名男性和 34 名女性)平均年龄为 51.33±13.91 岁的患者。与对照组相比,干预组患者在治疗 3 个月后 THI 评分显著下降(p<.05)。尽管两组 VAS 评分均有所改善,但干预组的情绪干扰、日常耳鸣感知和日常生活改变评分仅得到改善。在基线和干预后 3 个月,在.5、1、2 和 4 kHz 时,对照组和干预组的纯音空气和骨传导平均值在统计学上无显著差异(p>.05)。

结论

Neurotec 胶囊治疗 3 个月,并结合患者教育,对管理慢性耳鸣患者的症状有益。

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