Amyotrophic lateral sclerosis treated with the modified Bu-Shen-Jian-Pi decoction (mBSJP): Multicenter study

To investigate whether the modified Bu-Shen-Jian-Pi decoction (mBSJP) is more efficacious than the hitherto used and promoted BSJP formula in the treatment of amyotrophic lateral sclerosis (ALS).

ALS is a fatal neurodegenerative disease with no satisfactory treatment option. Currently, there are few palliative care methods that can significantly delay the progression of the disease, and the efficacy of the herbal treatments used hitherto has also been unsatisfactory.

A total of 165 patients with ALS who met the diagnostic criteria after screening were randomly allocated into two groups, a modified Bu-Shen-Jian-Pi decoction group referred to as the mBSJP group and the placebo group. Clinical efficacy and side effects were evaluated during a 16-week observation period. Primary outcomes included Amyotrophic Lateral Sclerosis Symptom Score in Integrative Treatment Scale (ALS-SSIT) and Amyotrophic Lateral Sclerosis Rating Scale-Revised (ALSFRS-R) scores, and secondary observation parameters were 36-Item Short-Form Health Survey Questionnaire (SF-36) and forced vital capacity (FVC).

A total of 73 patients in the mBSJP group and 71 patients in the placebo group completed the trial. At the end of the 16^th week of treatment, there were significant statistical differences observed between the two groups in values for both the ALS-SSIT and the ALSFRS-R scores showing that mBSJP significantly delayed progression of the disease and appearance of symptoms compared to the administration of placebo.

Treatment of ALS with mBSJP delays disease progression and is recommended as a treatment option for ALS in regions where the use of traditional Chinese medicine is regulated and approved.