Objective: To evaluate the feasibility, reliability, validity and sensitivity of ALS-SSIT scale—a traditional Chinese medicine (TCM) evaluation scale for therapeutic efficacy in amyotrophic lateral sclerosis (ALS).

Methods: To summarize the experience in traditional Chinese medicine (TCM) in the treatment of ALS and consult experts’ suggestions, and then develop a scale (ALT-SSIT scale) suitable for evaluating the efficacy of TCM in the treatment of ALS. The performance of ALSSSIT scale was evaluated on the day of enrollment and after 6-month of follow-up in 160 patients with ALS who received traditional Chinese medicine treatment. The SF-36 and ALSFRS-R scales were used as references to evaluate the feasibility, reliability, validity and sensitivity of ALS-SSIT scale.

Results: The acceptance and completion rates of ALS-SSIT scale were both higher than 99%. The test-retest reliabilities of ALS-SSIT scale were 0.917 and 0.918 on the day of enrollment and after 6-month of follow-up, respectively. The content validity and sensitivity (total score, score of each field and score of each item) were higher. There was a linear correlation between ALS-SSIT scale and SF-36 and ALSFRS-R scales, which means that ALS-SSIT scale could better reflect the changes in disease condition.

Conclusion: The feasibility, reliability, validity and sensitivity of ALS-SSIT scale in evaluating the efficacy of TCM in the treatment of ALS are satisfactory, which is suitable for clinical application.