Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy:A Multicenter Double-Blind Randomized Controlled Trial

Objective:To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction(TW)in treating patients with diabetic peripheral neuropathy(DPN).Methods:It is a multicenter double-blinded randomized controlled trial.Participants with DPN were recruited between November 18,2016 and May 30,2018 from 8 hospitals in China.All patients received basic treatments for glycemic management.Patients received foot baths with TW herbal granules either 66.9 g(intervention group)or 6.69 g(control group)for 30 min once a day for 2 weeks and followed by a 2-week rest,as a therapeutic course.If the Toronto Clinical Scoring System total score(TCSS-TS)6 points,the patients received a total of 3 therapeutic courses(for 12 weeks)and were followed up for 12 weeks.The primary outcome was change in TCSS-TS score at 12 and 24 weeks.Secondary outcomes included changes in bilateral motor nerve conduction velocity(MNCV)and sensory nerve conduction velocity(SNCV)of the median and common peroneal nerve.Safety was also assessed.Results:Totally 632 patients were enrolled,and 317 and 315 were randomized to the intervention and control groups,respectively.After the 12-week intervention,patients in both groups showed significant declines in TCSSTS scores,and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment(P<0.05).The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group(P<0.05).The number of adverse events did not differ significantly between groups(P>0.05),and no serious adverse event was related with treatment.Conclusion:Treatment of TW foot baths was safe and significantly benefitted patients with DPN.A low dose of TW appeared to be more effective than a high dose.(Registry No.Chi CTR-IOR-16009331)

Clinical Efficacy and Safety of Bathing with Chinese Medicine Taohong Siwu Decoction(桃红四物汤) for Treatment of Diffuse Cutaneous Systemic Sclerosis:A Randomized Placebo-Controlled Trial

Objective：To examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction（桃红四物汤,TSD） in the treatment of early-stage,mild-moderate diffuse cutaneous systemic sclerosis（dc SSc）.Methods：This randomized,placebo-controlled trial enrolled 148 men and women（18–60 years） with dc SSc（disease duration 12 months） and baseline modified Rodnan skin score（MRSS） 10.Patients were randomized into a TSD group（71 cases bathing with TSD plus oral prednisone） or control group（71 cases bathing with placebo plus oral prednisone）.Bathing（40 ℃,30 min） of the upper and lower limbs was carried out once daily for 12 consecutive weeks.The primary outcome measure was MRSS;secondary outcomes were Raynaud＇s phenomenon（RP） score,quality of life（QOL）,physician visual analogue scale（VAS）,patient VAS,percent predicted diffusing capacity for carbon monoxide（DLCO）,percent predicted forced vital capacity（FVC）,erythrocyte sedimentation rate（ESR）,C-reactive protein（CRP） level and overall treatment effect.Results：The final analysis included 135 patients（control group,68 cases;TSD group,67 cases）.Primary and secondary outcome measures after 2 weeks of treatment showed no improvement（versus baseline） in both groups,with no differences between groups.At 12 weeks,QOL,physician VAS,patient VAS,ESR and CRP were improved in both groups,but MRSS and RP score were improved only in the TSD group（all P〈0.05）.MRSS,RP score,QOL,physician VAS,patient VAS,ESR and CRP differed significantly between groups（all P〈0.05）.Meanwhile,the overall treatment effect was significantly higher in the TSD group than in the control group（P〈0.05）.Adverse events in the two groups were similar（P〉0.05）.Conclusions：Bathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcS Sc and is not associated with serious adverse events.