| [Background]Infertility is one of the common diseases in gynecology.Its incidence rate is high and the trend is increasing among the globe.In China,the incidence rate has reached among 10-15%of the reproductive aged population.Infertility not only affects the physical and psychological health of women,but also brings heavy burdens to the family,society and economy.With the development of various medical technologies,there have also been major advancements in the treatment of infertility.Western medicine has derived different treatment methods and technologies for different etiologies and pathogenesis of infertility,including non-drug treatment,medication,surgical method,and IVF.However,these new treatments and techniques have not yet brought about a new turning point for patients with infertility,the effects are not satisfactory and still causing heavy financial burden on infertile patients.The use of traditional Chinese medicine in the treatment of infertility has long been fruitful.Its cost is relatively low and the effect is significant.In recent years,increasing research has been done on this area in order to explore the possibility of improving the effectiveness and safety in treatments of infertility.External therapies is also one of the most important resource and intervention in traditional Chinese medicine.Studies have shown that different methods of external therapies having a positive therapeutic effect on different types of infertility.However,there is no comprehensive analysis and discussion on the effectiveness of the study on external therapies has been conducted.The external therapies methods are diverse but the study is fragmented.Discussion and analysis of the data in this area is expected.Evidence-based medicine is emerging in the field of research in traditional Chinese medicine in recent years.It is believed that the use of evidence-based medicine in the study of traditional Chinese medicine will certainly demonstrate the excellence of traditional Chinese medicine and will be conducive to the long-term development of traditional Chinese medicine.In this study,Meta-analysis will be used to discuss the treatment of infertility by external therapies of traditional Chinese medicine.[Objective]To examine the effectiveness and safety of external Chinese medicine in treating infertility.[Methods]According to the Cochrane Handbook 5.1.0 in reviewing randomized controlled trials(RCT),data extraction,evaluation of the quality and discussion of finding are carried out.Databases including EMBASE,MEDLINE,Cochrane Library,CINAHL,Wanfang Dara,CBM,CMCC,CNJ,CNKI and HKInChiP were searched.The time limit was set between December 1997 to December 2018.Randomized controlled clinical trials with the sample of infertile women of childbearing age(age 18 years of age)were included.The experimental group should employ the intervention of external therapies of Chinese medicine,included but not limited to acupoint therapies(acupuncture,moxibustion,acupuncture catgut embedding,electricity acupuncture,acupoint injection),enema,external application.It can be combined with conventional western medicine treatment.The control group can employ western medicine conventional treatment include Western medicine and surgical treatment.The outcome measures must include a comparison of clinical pregnancy rates.Secondary outcome measures may include,but are not limited to,ovulation rate,serum hormone levels,body mass index,tubal patency,adverse reactions,miscarriage rates,etc.Follow the specifications,data extraction should be carried out independently by two researchers.In case of disagreement,it should be discussed with a third researcher in order to reached a final consensus.The quality of the included studies was evaluated according to the Cochrane Handbook version 5.1.0 Assessment of Randomized Controlled Trials.Statistical Methods Statistical analysis was performed using RevMan 5.2 software provided by the Cochrane Collaboration.Data analysis was performed using Risk Ratio(RR),and mean difference(MD)was used in analyzing continuous variable.95%confidence interval(CI)was set,P?0.05 implies that the difference was statistically significant,P?0.01 implies the difference was statistically significant.If there are two or more interventions using the same type of intervention and the same outcome indicators,the study can be combined for meta-analysis.If the heterogeneity is high,the interventions between studies are not similar,they will not be combined for analysis.If the number of studies included is greater than 10,an inverted funnel analysis of potential publication bias can be made.At the same time,heterogeneity tests should be performed on the included literature,P=0.10 and I2 is defined as the criteria of judgment.If P>0.10 and I2<50%,the Fixed Effects Model is used;if P?0.10 and I2?50,the Random Effects Model is used.[Results]A total of 51 literatures were obtained after searching and screening,and 2 literatures with high risk of bias were excluded.As a result,49 literatures were included.Based on carrying out meta analysis on the 21 groups,of which included outcome measures pregnancy rate,ovulation rate,cervical mucosal score,periodic ovulation rate,tubal patency rate and abortion rate,the following six points could be suggested:(1)In the aspect of improving the pregnancy rate,all results implied that using traditional Chinese medicine or combined with western medication and surgical treatment in improving the outcome of pregnancy was significantly better than the use of Western medicine treatment,the difference was statistically significant.(2)In the aspect of improving ovulation rate of ovulation disorder infertility and Polycystic ovary syndrome infertility patients,the results suggested that the use of acupoint therapies(or combined with western medicine)is better than the western medicine in improving the ovulation rate,the difference was statistically significant.(3)In the aspect of improving cervical mucosa in ovulation disorder infertility patients,the results suggest that the use of Western medicine treatment is superior to the use of acupoint therapies,the difference was statistically significant.(4)In the aspect of improving the cycle ovulation rate in ovulation disorder infertility patients,the results suggested that Western medicine in improving the cycle rate of ovulation is more advantages than acupuncture treatment,the difference was statistically significant.(5)In improving the tubal patency rate in tubal obstruction infertility patients,the results shown that using Chinese medicine external therapies with hydrotubation group and laparoscopic hydrotubation surgery group were better than the only use of Western surgical treatment in improving tubal patency,the difference was statistically significant.But there was no significant difference observed in the groups of Chinese medicine enema group or combined laparoscopic surgery group.(6)In the aspect of improving abortion rate,for the patients with infertility due to ovulation disorder,the results suggest that acupoint therapies is superior to western medicine treatment group in reducing abortion rate,the difference has statistical significance.Summarize other outcomes that do not meet the criteria of Meta-analysis,most of the findings also agree that traditional Chinese medicine treatment has a positive effect on improving the effectiveness of infertility treatments,and it is safe.[Conclusion]In this study,a meta-analysis is conducted from data of clinical randomized controlled trials on the treatment of infertility using external therapies of traditional Chinese medicine.The available evidence suggests that the use of Chinese medicine external therapies or in combination with Western medicine can increase the pregnancy rate and have positive effects on most other outcome measures and safe.On the other hand,due to the existence of various risks of bias and generally low quality of the included literatures,as well as the limitations of this study,it is yet to be fully affirmed that the efficacy of TCM treatment of infertility.Further research is needed.Preliminary attempts are made in this regard and we look forward to have research with higher quality in the future. |
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