Clinical research on the effectiveness and safety of Uchasingihwan for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A multicenter, randomized, controlled equivalence trial

IF 2.8 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research Pub Date : 2024-09-30 DOI:10.1016/j.imr.2024.101090

Bonhyuk Goo , Jung-Hyun Kim , Eun-Jung Kim , Dongwoo Nam , Hyun-Jong Lee , Jae-Soo Kim , Yeon-Cheol Park , Yong-Hyeon Baek , Sang-Soo Nam , Byung-Kwan Seo

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Abstract

Background

This study aimed to establish the clinical evidence regarding the effectiveness and safety of Uchasingihwan (UCSGH) in improving pain, function, and quality of life in patients with lumbar herniated intervertebral disc (LHIVD).

Methods

This was a multicenter, randomized, controlled, equivalence trial with two parallel arms. Seventy-four participants with LHIVD were recruited and randomly allocated to the experimental and control groups. The participants in each group took 2.5 g of UCSGH granule or loxoprofen 60 mg tablet three times a day for six weeks. Additionally, both groups received the same acupuncture treatment once a week for six weeks. Outcomes about effectiveness and safety were assessed at baseline and 3, 6, and 10 weeks after screening.

Results

As the primary outcome, the mean differences with a 95 % confidence interval (CI) of changes in low back pain between the two groups at weeks 6 (95 % CI:9.26, 8.37) and 10 (95 % CI:9.03, 9.62) from baseline were within the equivalence limit. Also, changes in radiating pain at weeks 6 (95 % CI:1.70, 15.69) and 10 (95 % CI:4.72, 13.75) were within the equivalence limit. Outcome measures for function and quality of life also showed no statistical difference. Regarding safety, the frequency of adverse events related to intervention was lower in UCSGH.

Conclusion

UCSGH showed the equivalent level of effectiveness as loxoprofen in reducing low back and radiating pain in LHIVD patients and showed sufficient safety to be used as a complementary treatment option.

Trial registration

ClinicalTrials.gov (NCT03386149), CRIS (KCT0002848).

查看原文本刊更多论文

关于 Uchasingihwan 治疗腰椎间盘突出症引起的腰痛伴根性病变的有效性和安全性的临床研究：多中心、随机对照等效试验

背景本研究旨在建立有关Uchasingihwan（UCSGH）改善腰椎间盘突出症（LHIVD）患者疼痛、功能和生活质量的有效性和安全性的临床证据。招募了 74 名腰椎间盘突出症患者，并将他们随机分配到实验组和对照组。每组患者服用 2.5 克 UCSGH 颗粒剂或 60 毫克洛索洛芬片剂，每天三次，连续服用六周。此外，两组均接受每周一次的相同针灸治疗，为期六周。结果作为主要结果，两组患者在第6周（95 % CI：9.26，8.37）和第10周（95 % CI：9.03，9.62）时腰背痛的变化与基线的平均差异（95 % 置信区间）均在等效范围内。此外，放射痛在第 6 周（95 % CI：1.70, 15.69）和第 10 周（95 % CI：4.72, 13.75）的变化也在等效范围内。功能和生活质量方面的结果也没有统计学差异。结论UCSGH在减轻LHIVD患者腰背痛和放射痛方面的疗效与洛索洛芬相当，并显示出足够的安全性，可作为一种辅助治疗方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Integrative Medicine Research Medicine-Complementary and Alternative Medicine

CiteScore

6.50

自引率

2.90%

发文量

审稿时长

12 weeks

期刊介绍： Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.