Slower progression of amyotrophic lateral sclerosis with external application of a Chinese herbal plaster-The randomized, placebo-controlled triple-blinded ALS-CHEPLA trial.

Background: Amyotrophic lateral sclerosis (ALS) is a chronic neurodegenerative disease characterized by gradually increasing damage to the upper and lower motor neurons. However, definitive and efficacious treatment for ALS is not available, and oral intake in ALS patients with bulbar involvement is complicated due to swallowing difficulties. Hypothesis/purpose: This study investigated whether the external plaster application of the herbal composition Ji-Wu-Li efficiently slows ALS progression because prior studies obtained promising evidence with oral herbal applications. Study design: The randomized, triple-blinded study compared the efficacy, safety, and tolerability of the application of Ji-Wu-Li plaster (JWLP) with placebo plaster (PLAP). Methods: In total, 120 patients with definite ALS, clinically probable ALS, or clinically probable laboratory-supported ALS were randomized in a 1:1 ratio to receive JWLP or PLAP. Patients were treated and observed for 20 weeks. The primary outcome was the ALSFRS-R score, while the secondary outcomes were the ALS-SSIT score and weight loss. Results: The mean±SD decrease in the ALSFRS-R over 20 weeks differed by 0.84 points in a group comparison (JWLP, -4.44 ± 1.15; PLAP, -5.28 ± 1.98; p = 0.005). The mean increase in the ALS-SSIT over 20 weeks differed by 2.7 points in a group comparison (JWLP, 5.361.15; PLAP, 8.06 ± 1.72; p < 0.001). The mean weight loss over 20 weeks differed by 1.65 kg in a group comparison (JWLP, -3.98 ± 2.61; PLAP, -5.63 ± 3.17; p = 0.002). Local allergic dermatitis suspected as causal to the intervention occurred in 10 of 60 participants in the JWLP group and 9 of 60 participants in the PLAP group. Systemic adverse events were mild, temporary, and considered unrelated to the intervention. Conclusion: The JWLP showed clinical efficacy in the progression of ALS, as measured by the ALSFRS-R, ALS-SSIT, and weight loss in a randomized, placebo-controlled trial. Because skin reactions occurred in both groups, the covering material needs improvement. All of the Ji Wu Li herbal ingredients regulate multiple mechanisms of neurodegeneration in ALS. Hence, JWLP may offer a promising and safe add-on therapy for ALS, particularly in patients with bulbar involvement, but a confirmative long-term multicentre study is required.

Amyotrophic Lateral Sclerosis Symptom Score in Integrative Treatments (ALS-SSIT) for Evaluating Therapeutic Effect of Traditional Chinese Medicine: A Prospective Study.

Objective: To evaluate the reliability, validity, sensitivity, and clinical applicability of a new scale-the amyotrophic lateral sclerosis symptom score in integrative treatments (ALS-SSIT)-for measuring the effect of traditional Chinese medicine (TCM) in patients with amyotrophic lateral sclerosis (ALS). Methods: A total of 160 patients with ALS were enrolled and followed up for 6 months. All patients received TCM. Patients were evaluated at enrollment and at the end of 6 months with a new scale, the ALS-SSIT, developed after extensive consultations with TCM experts with several years of experience in the treatment of ALS. The 36-item Medical Outcomes Study Short Form (SF-36) scale and the amyotrophic lateral sclerosis functional rating scale (ALSFRS) were used as the reference standards. Results: The acceptance rate and completion rate of the ALS-SSIT scale were high, and the content validity was confirmed by experts. Test-retest performed at enrollment and at 6 months showed good reliability of the ALS-SSIT scale (Cronbach α, 0.9172 and 0.9181, respectively). The ALS-SSIT scale score showed significant change at 6 months, indicating the ability to reflect the change in disease severity. Conclusion: The ALS-SSIT appears to be a feasible, reliable, and sensitive tool for the evaluation of the effect of TCM in patients with ALS.

Use of l-3-n-Butylphthalide within 24 h after intravenous thrombolysis for acute cerebral infarction.

OBJECTIVE: Observe the clinical efficacy of l-3-n-Butylphthalide (NBP) in acute ischemic stroke (AIS) patients within 24 h after intravenous thrombolysis using recombinant tissue plasminogen activator (hereafter termed "IT"). METHODS: One-hundred and seventy-eight patients with AIS were divided randomly into two groups: NBP and control. The former was given a NBP injection within 24 h after IT. After intravenous injection of NBP for 8-10 days, patients switched to soft capsules of NBP before or during meals. NBP treatment was continued for ≥30 days after hospital discharge. In the control group, NBP was not injected within 24 h after IT, and NBP capsules were not given after 8-10 days. Both groups were reviewed for CT or MRI 24 h after IT. The National Institutes of Health Stroke Scale (NIHSS) score was calculated. The number of patients with a modified Rankin scale (mRS) 0-2 before, 24 h, and 90 days after IT was documented. Prevalence of cerebral hemorrhage and reocclusion of blood vessels after IT was calculated. RESULTS: There were no differences in sex, age, blood pressure, blood glucose, or cerebral-infarction types between the two groups before treatment. The NIHSS score 24 h after IT and the percentage of mRS scores 0-2 were not significantly different between the two groups. Compared with the control group, the NIHSS score in the NBP group was significantly improved at 90 days, and the number of patients with a mRS score 0-2 increased significantly. There was no significant difference in hemorrhage prevalence after IT between the two groups. Prevalence of blood-vessel occlusion after IT was significantly lower in the NBP group than that in the control group. CONCLUSION: Use of NBP within 24 h after IT can reduce the prevalence of reocclusion of blood vessels without increasing the risk of cerebral hemorrhage.