A Randomized Controlled Clinical Study On The Efficacy And Safety Of Tibetan Medicine In The Treatment Of Pss

Objective:This study aimed to evaluate the effectiveness and safety of Tibetan Medicine(Wu-wei-gan-lu-keli Tibetan medicated bathing and anointing Bai-mai-ruangao)for patients with post-stroke spasticity.Design:A prospective,multicenter,blinded,randomized controlled intervention trial.Subject:Between December 2013 and February 2017,patients were randomly assigned to the experimental(Tibetan medicine)group or control(conventional rehabilitation)group.Methods:We enrolled adults(aged 18-75 years)at least 1 month after stroke from 15 neurology or clinics in China.Eligible participants were randomly allocated in a 1:1 ratio with a computer-generated list to two groups.Participants in the experimental group received Wu-wei-gan-lu-keli Tibetan medicated bathing and anointing Bai-mai-ruangao.All participants in both groups received conventional rehabilitation.Patients and investigators were masked to treatment allocation.The Modified Ashworth Scale(MAS),the Fugl-Meyer Assessment(FMA)and the Modified Barthel index(MBI)were used to assess the severity of spasticity,motor function of limbs and activities of daily living,respectively.All patients met the diagnosis of stroke(CT or MIR diagnosis),and increased muscle tone of the affected limb(MAS?1+).The primary endpoint was the change in muscle tone(MAS)in the spastic muscles(Elbow flexors,Wrist flexors,Finger flexors,Knee extensors,Ankle plantar flexors)from baseline to 4 weeks.Secondary endpoints included the change from baseline to 4 weeks in motor function of limbs(FMA),activities of daily living(MBI)and the change from baseline to 3 months and 6 months in limbs spasticity(MAS),motor function of limbs(FMA),activities of daily living(MBI).Results:444 patients received the treatment.Baseline characteristics were similar between the two groups.Both groups of patients showed significantly reduced MAS compared to baseline at all time points.The Tibetan medicine group had a significantly greater reduction in MAS in five muscle groups than the conventional group did after 4 week intervention.Improvements were sustained at 3 months and 6 months follow-up.Mean changes from baseline in MAS score in the spastic muscles(Elbow flexors,Wrist flexors,Finger flexors,Knee extensors,Ankle plantar flexors)for Tibetan medicine group were significantly greater than the conventional group at all time points,except the changes of the finger flexors and the knee extensors in the Modified Ashworth Scale between baseline and week 4.There were significantly differences between the two groups in FMA and BI at 4 weeks,3 months and 6 months.Mean changes from baseline in FMA-T,FMA-U,and BI for Tibetan medicine group were significantly greater than the conventional group at all time points.FMA-L generally improved more with Tibetan medicine group than conventional group(not significant)from baseline to week 4.The best intervention time for Tibetan rehabilitation is within 3 months of the course of the disease.In the group I(course of the disease<3 months),mean changes from baseline in MAS score in the spastic muscles(Elbow flexors,Wrist flexors,Finger flexors,Knee extensors,Ankle plantar flexors)for Tibetan medicine group were significantly greater than the conventional group at week 4.The group III(between 6 and 12 months duration)and the group ?(course between 3 to 6 months),are not as good as group I(course of the disease within three months)in Tibetan medicine rehabilitation.In the subgroups of 2*(MAS1+-2)for Tibetan medicine group,there were significant differences between week 4,month 3 and month 6 in greater reduction in MAS.The rehabilitation intervention program of Tibetan medicine is best for relieving the the patients with MAS1+-2.No serious adverse reaction was recorded.All adverse events were mild.Conclusion:Tibetan medicine combined with routine therapy is effective and safe for alleviating post-stroke spasticity,is beneficial for motor function and improvement in ADL.