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Original

Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part 3: Alleviation of hypoxia, muscle-wasting, and modulation of redox functions in amyotrophic lateral sclerosis 

Rui Li, Xiaojing Han, Qiudong Wang, Chenghui Wang, Wei Jing, Haihan Zhang, Jun Wang, and Weidong Pan

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Volume 62 (2024) p. 169 - 177

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 62 – No. 4/2024 (169-177)

Rui Li¹#², Xiaojing Han², Qiudong Wang³, Chenghui Wang¹, Wei Jing¹, Haihan Zhang¹, Jun Wang¹, and Weidong Pan¹#²#⁴

¹Deparment of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, ²First Department of Encephalopathy, Anhui Provincial Hospital of Integrated Chinese and Western Medicine (The Third Affiliated Hospital of Anhui University of Chinese Medicine), Anhui, ³Department of Integrative Neurology, Pudong Traditional Chinese Medicine Hospital, and ⁴Encephalopathy Laboratory, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
Objective: The aim of this clinical study is to obtain evidence for the clinical efficacy of Bu-Shen-Jian-Pi formula (BSJP), a traditional Chinese medicine, used for the treatment of amyotrophic lateral sclerosis, a relatively rare, progressive and usually fatal disease possibly associated with alterations in tissue redox status, hypoxia, and muscular injury.
Background: The active agents in BSJP formula^† causing apoptosis, modulation of redox changes, and alterations in the immune status have been studied previously by us using cell cultures. The findings from these investigations have been incorporated into pharmacology databases employed in our analysis of BSJP using network pharmacology analysis/artifical intelligence. This information has been used here in the design of the investigation and to optimize evaluation of the clinical efficacy and usefulness of this herbal medicine, as far as possible using evidence-based medicine criteria.
Materials and methods: The design of the study was a randomized multi-center, controlled clinical trial in 127 patients with confirmed diagnoses of amyotrophic lateral sclerosis. Patients and investigator were double-blinded. Clinical efficacy was determined using the Amyotrophic Lateral Sclerosis Symptom Score in Integrative Treatment Scale (ALS-SSIT) and the Amyotrophic Lateral Sclerosis Rating Scale-Revised (ALSFRS-R), together with tests of limb muscle strength using the manual muscle test (MMT), forced vital capacity (FVC), and clinical chemistry laboratory tests over a 20-week observation period.
Results: The scores of ALS-SSIT in the BSJP group increased significantly (22%) after treatment. The ALSFRS-R score in the BSJP group decreased significantly after treatment (19%). The rate of decrease in muscle function (MMT score) in most BSJP patients was lower than that in the control group, where the differences in the scores for the trapezius and triceps brachii were statistically significant compared to the control group. The fall in FVC in the BJSP group was significantly slower than in the control group. There were no marked differences observed in the frequency of side effects. Serum vitamin D3 levels in the BSJP group showed greater increases compared to the control group.
Conclusion: BSJP treatment reduced the rate of progression of amyotrophic lateral sclerosis according to the ALS-SSITS and ALSFRS scores and significantly reduced the rate of deterioration in muscle function in the limbs of amyotrophic lateral sclerosis patients. The modes of action of BSJP in treating amyotrophic lateral sclerosis are probably diverse and multi targeted, some of which may involve regulation of serum vitamin D3 and alleviation of the impairments in liver and kidney function.Correspondence to:
Dr. Jun Wang
and
Professor Weidong Pan
Department of Neurology, Shuguang Hospital
Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, China
Email: [email protected]; [email protected]

Review

Amyotrophic lateral sclerosis rehabilitation management and non-pharmacological symptomatic treatment: A review 

Yuetong Shan, Wei Jing, Haihan Zhang, Yizhou Liu, Shangyu Wei, Feifei Wu, and Weidong Pan

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Volume 64 (2026) p. 38 - 46

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