A Crossover, Placebo-controlled Clinical Study Of Warming Collaterals In The Treatment Of Chemotherapeutic Peripheral Neuropathy

There are two review articles in the thesis.The first one introduced the research progress of TCM external treatment in chemotherapy-induced peripheral neuropathy(CIPN),including traditional Chinese medicine fumigation bath,acupuncture,electro-acupuncture,acupoint application,hot Pack with Chinese Herbal Medicine and comprehensive treatment combining traditional Chinese and Western Medicine.CIPN is characterized by tingling,numbness,paresthesia or dyskinesia,which belongs to Chinese medicine "Numb" "Arthromyodynia" or"Collateral Disease".Most of TCM doctors have reached an agreement on the cause of"deficiency syndrome"and"blood stasis".The main rules of treatment are supplementing qi,activating blood circulation,dredging collaterals and removing blood stasis.While many TCM external treatment trials have been completed to show a good pain relief and improvement of the quality of life of CIPN,most of these studies are small sample single center study and the specific mechanism is not clear.The second one reviewed the research progress of the Chinese drug Geranium,including its chemical composition,pharmacological action and clinical application.Geranium is the important medicine of the prescription for this clinical trial and it has anti-inflammatory,analgesic,anti-tumor and immune function proved by modern pharmacology.The trial showed that Wenjingtongluo treatment had prominently relieved pain,numbness and paresthesia effect of CIPN,so it is much important to clarify the effective components and mechanism of Geranium.The clinical study was conducted in a randomized,placebo-controlled trial of Wenjingtongluo treatment on the TCM external treatment of CIPN.Objective:To observe the efficacy and safety of Wenjingtongluo on TCM external treatment for CIPN and to provide a method of TCM external treatment with clinical advantages.Methods:A total of 48 patients were randomly divided into group A and group B according to the ratio of 1:1,by using a randomized,placebo-controlled study.Group A was treated with TCM granules for external use in the first 7 days,after a washout period of 14 days,cross to group B to continue to use placebo for 7 days.Group B used placebo in the first 7 days,after a washout period of 14 days,cross to group A to continue to use TCM granules for 7 days.Patients soaked their hands and feet in Chinese herbal extract or placebo for 20 minutes,twice daily for 7 days.Record the patient's hand and foot pain index(pain NRS score),peripheral neurotoxicity grading index(NCI-CTCAE v4.03 standard),quality of life index(FACT/GOG-Ntx)regularly to evaluate the treatment effect.All statistical tests were two-sided test using SPSS 21.0.Results:(1)Patients were observed in 43 cases,there were no obvious adverse reactions,including 14 male and 29 female,with an average age of 61.42 years(median age of 62 years).(2)Paclitaxel and oxaliplatin were the most common chemotherapeutic agents in this trial and were accounted for about 81.4%.(3)Pain relief:The mean value of NRS in group A was 2.87 lower than that before treatment in the first stage.The NRS of group B decreased by 3.09 points in the second stage After treatment,the total effective rate of group A was 95.45%and 95.24%of group B,with no significant difference between the two groups(P>0.05).Compared with placebo,Wenjingtongluo treatment could effectively and persistently alleviate the CIPN pain symptom,and had no obvious relationship with the medication order.(4)Peripheral neurotoxicity grade:The effective rate of reducing neurotoxicity was 86.36%of group A and 85.71%of group B.It was showed that Wenjingtongluo treatment could reduce the neurotoxicity grade of CIPN.(5)Quality of life:In the first stage,the FACT/GOG-Ntx of group A decreased by an average of 6.22 points,while group B decreased by an average of 4.62 points in the second stage of the treatment.The trial proved that Wenjingtongluo treatment could significantly improve the quality of life,and had no obvious relationship with the medication order.Conclution:It is strongly effective to treat CIPN with Wenjingtongluo TCM external use.It is worthy to promote external treatment of TCM on the treatment of malignant tumor complications.