Aims: The aim of this study was to explore the efficacy of Jian-Pi Lian-Se Tang (JPLST), a formula of traditional Chinese medicine for the treatment of salivation and frequent nighttime urination (FNU) in patients with amyotrophic lateral sclerosis (ALS). Method: Forty-eight patients with ALS suffering from salivation and/or FNU who were outpatients or inpatients of Shuguang Hospital were included into the study and divided into 2 groups as follows: the JPLST group (n = 24) included patients who were additionally treated with JPLST, and the control group (n = 24) included patients who were treated by routine Western medicine (for 6 weeks). The changes in the quantity of salivation/sialorrhea (QS) (in mL) and in FNU as the primary result and the total scores of the Amyloid Lateral Sclerosis Function Rating Scale (ALSFRS) and of the Epworth Sleepiness Scale (ESS) as the secondary result were used to evaluate the clinical efficacy for both groups. Results: No significant differences were found for the baseline of QS, FNU, and the scores of the ESS and of the ALSFRS before and after treatment for both groups. At the end of the 6th week, 2 patients in the JPLST group and 4 patients in the control group withdrew from the study. QS and FNU were much less severe in the JPLST group than before treatment, and the ESS scores were improved, too. The ALSFRS did not show any significant differences in both groups compared with before treatment at the end of week 6. No side effects were found for both groups by laboratory tests. Conclusion: The much improved parameters of QS, FNU, and ESS for the JPLST group indicate that JPLST may be a potential additional treatment for salivation and FNU in ALS patients. Large-scale multicenter double-blind randomized-control studies are needed to verify the effectiveness of JPLST in improving salivation and FNU in patients with ALS.
Aims. To evaluate the efficacy of Lian-Se formula (LSF), one Chinese herb formulation for treating sialorrhea and frequent overnight urination in patients with Parkinson's disease (PD). Methods. 96 PD patients suffering from sialorrhea and/or frequent nighttime urination were divided into two groups: an LSF group (n = 48) treated with LSF for 6 weeks and a placebo group (n = 48) treated with a placebo formula whose appearance and taste were the same as LSF for 6 weeks. All patients were treated by standard antiparkinsonism medicine according to the PD guideline of China. The changes of the quantity of saliva (QS) (mL), frequency of nighttime urination (FNU) and early sleep activity (ESA), and nocturnal activity (NA) by analyzing actigraphic records as the primary results and the total score of unified Parkinson's disease rating scale (UPDRS) and the Epworth Sleepiness Scale (ESS) as the secondary results were used to evaluate the clinical efficacy in both groups. Results. There were no significant differences in the baseline values of QS, FNU, NA, ESA, UPDRS total score, and ESS between the two groups. At the end of week 6, the QS, FNU, NA, and ESA in the LSF group showed superior results to those of the placebo group with no differences in the total UPDRS score between the two groups during the investigation. The ESS was significantly improved at the end of week 6 compared with the baseline and the placebo group. Laboratory test results indicated there were no side effects in either group. Conclusion. The findings of LSF treatment have clear clinical effects in patients with sialorrhea and frequent overnight urination. LSF thus appears to be a potential choice as an additional drug that can improve the sialorrhea and frequent overnight urination symptoms of PD patients.
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