Systematic evaluation on curative effects of traditional Chinese medicine retention enemas for patients with radiation proctitis lable at ScienceDirect Chinese Nursing Research 3 (2016) 176e180 Conten[.]
Chinese Nursing Research (2016) 176e180 Contents lists available at ScienceDirect Chinese Nursing Research j o u r n a l h o m e p a g e : http://www.journals.elsevier.com/chinese-nursing-research Original article Systematic evaluation on curative effects of traditional Chinese medicine retention enemas for patients with radiation proctitis Xin-Man Wang a, Song-Ge An b, Lin Yang c, Fan-Jie Meng d, * a North Anhui Health Vocational College, Suzhou, Anhui 234000, China Department of Traditional Chinese Medicine, The First People's Hospital of Suzhou, Suzhou, Anhui 234000, China c School of Graduates, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China d Teacher Development and Evaluation Center, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China b a r t i c l e i n f o a b s t r a c t Article history: Received 18 June 2016 Received in revised form 24 July 2016 Accepted 24 August 2016 Available online 16 November 2016 Objectives: To systematically evaluate the curative effects of traditional Chinese medicine retention enemas for patients with radiation proctitis Methods: Reports on randomized controlled trials (RCTs) on traditional Chinese medicine retention enemas in the treatment of radiation proctitis were searched in the Cochrane Library, PubMed, EMBASE, EBSCO, ISI, CNKI, VIP, WanFang Data and CBM databases The publication dates were from inception to May 2014, and a literature screening, data extraction, quality evaluation and cross checks were independently conducted by two reviewers in accordance with the inclusion and exclusion criteria A metaanalysis was then carried out using RevMan 5.3 software Results: In total, 14 RCTs were included, and of these, only 10 RCTs involving 702 patients were included in the meta-analysis The meta-analysis showed that the total efficacy of traditional Chinese medicine retention enemas was higher for patients with radiation proctitis compared with that in control group, RR ¼ 4.83, 95% CI (2.98, 7.84), P < 0.000 01; the results from four studies indicated that the improvement of clinical symptoms due to traditional Chinese medicine retention enemas was higher than that of the control group Conclusions: The implementation of traditional Chinese medicine retention enemas could improve the total efficacy of treatment and provide relief in patients with radiation proctitis © 2016 Shanxi Medical Periodical Press Publishing services by Elsevier B.V This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) Keywords: Traditional Chinese medicine retention enema Radiation proctitis Systematic evaluation Meta-analysis Clinical efficiency Clinical symptoms Introduction Radiation proctitis is an intestinal tract complication induced by large doses of radiotherapy at the site of the rectum Its clinical symptoms include diarrhea, abdominal pain, mucous and bloody stool, anal pain, tenesmus and functional and mechanical intestinal obstruction.1,2 It is the most serious complication of the abdominal and pelvic cavity and appears within one to two weeks after radiotherapy It has no standard effective therapy According to medical home institutions, the prevalence of radiation proctitis is estimated to be between 10% and 20%.1 International literature reports the prevalence of radiation proctitis to be between 5% and 20% after radiotherapy treatment for prostate cancer, rectal cancer, bladder cancer, cervical cancer, testicular cancer and uterine cancer.3 Traditional Chinese medicine uses the role of the intestinal wall to absorb drugs and efficiently achieve the purpose of treatment Recently, various reports have been developed on the use of traditional Chinese medicine retention enemas, which show some curative effects However, these results are not consistent Therefore, the purpose of this systematic review was to evaluate the curative effects of traditional Chinese medicine retention enemas for radiation proctitis and to provide more clinical and drug treatment options for this condition Materials and methods 2.1 Inclusion and exclusion criteria * Corresponding author E-mail address: mfj127@tjutcm.edu.cn (F.-J Meng) Peer review under responsibility of Shanxi Medical Periodical Press Studies were included if they met all of the following criteria: (1) Type of study: randomized controlled trials; (2) Participants: patients with radiation proctitis induced by radiotherapy; age, type of http://dx.doi.org/10.1016/j.cnre.2016.11.007 2095-7718/© 2016 Shanxi Medical Periodical Press Publishing services by Elsevier B.V This is an open access article under the CC BY-NC-ND license (http://creativecommons org/licenses/by-nc-nd/4.0/) X.-M Wang et al / Chinese Nursing Research (2016) 176e180 disease, length and stage of disease were not limited; languages were English and Chinese; (3) Type of intervention: studies comparing traditional Chinese medicine retention enemas with Western medicine retention enemas; the decoction of traditional Chinese medicine were not limited, and Western medicine included gentamicin, lidocaine or procaine and hormones, with or without normal saline; (4) Outcomes: ①The total efficacy; the total efficacy (%) ¼ (total cases-ineffective cases)/total cases 100%; inefficacy was defined as clinical symptoms and endoscopic checks having no improvement or worsening; total effectiveness included cure, significant curative effects, effectiveness and improvement; ② Clinical symptoms score Studies were excluded if they met the following criteria: (1) Duplicated publications; (2) Animal experiments 2.2 Research strategy The Cochrane Library, PubMed, EMBASE, EBSCO, ISI, CNKI, VIP, WanFang Data and CBM databases were searched from inception to May 2014 The studies' included references were also traced The following keywords were used in the database search: coloclysis*, enema*, clys*, enteroclysis, radioactive proctitis, radioactive rectitis, radiation rectitis, radiation-induced rectitis, radiation proctopathy, radiation proctitis, radiation-induced proctitis These terms were adjusted for each database Google Scholar was searched as a complement to the above search 2.3 Study selection Two authors independently examined titles and abstracts to exclude clearly irrelevant reports They then examined the full text of each report to determine its eligibility Disagreements about a study's inclusion were resolved by discussions among the three authors 2.4 Data extraction and quality evaluation Two authors independently extracted the characteristics and assessed the methodological quality of the included studies using a piloted electronic data extraction form The content from the data extraction included first author, year of publication, study design, participants' characteristics, drug, enema method, dosage, length of treatment and outcomes, among others The methodological quality was assessed using the risk of bias tools in accordance with the Cochrane Handbook 5.1.0.4 The risk of bias tools included six terms: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting and other bias The authors of the included studies were contacted if important data were unclear or not reported Disagreements were resolved by checks of the studies and discussion among the three authors 2.5 Statistical analysis Cochrane Collaboration Review Manage software (RevMan 5.3) was used for the data analysis Dichotomous data were reported as relative risk (RR) with a 95% confidence interval (95%CI) Statistical heterogeneity was quantified using a chi-square test, and inconsistency was interpreted based on I2 If the pooled studies lacked heterogeneity (P > 0.1, I2 < 50%), the fixed effects model was used; otherwise, the random effects model was used A sensitivity analysis, subgroup analysis or Meta-regression was used when needed If the heterogeneity was substantial, then only a descriptive analysis was applied The level of statistical significance was 0.05 177 Results 3.1 Included studies and study characteristics In total, 1211 studies were retrieved After duplicates were removed, 476 studies remained The initial screening of reading titles and abstracts collected 109 studies Then, full text articles were reviewed, and 14 RCTs satisfied the selection criteria Ultimately, 10 RCTs5e14 were included in this meta-analysis (Fig 1) In total, 702 patients were enrolled in these studies, with 366 patients in the experimental group and 336 patients in the control group The study characteristics are shown in Table All of studies referred to randomization; Two studies5,9 applied a random number table, and the remaining studies provided no detailed descriptions of their method of randomization None of the included studies mentioned allocation concealment, blinding and other bias 3.2 Meta-analysis 3.2.1 The total efficiency In total, the meta-analysis included 10 studies5e14 involving 702 patients (366 patients in the experimental group, 336 patients in the control group) The meta-analysis showed that traditional Chinese medicine retention enemas significantly improved the total efficiency [OR ¼ 4.83; 95%CI, (2.98, 7.84); P < 0.000 01] with no significant heterogeneity (P < 0.67, I2 ¼ 0%) (Fig 2) The sensitivity analysis showed that the random effect model and fixed effect model were consistent in indicating a stable result 3.2.2 Clinical symptoms score In total, article5,9,10,12 reported the clinical symptoms scores for abdominal pain, diarrhea, and tenesmus and defecation difficulty The meta-analysis was unable to use this information because of different standards for scoring symptoms, but these studies indicated that the experimental group experienced more improvement than the control group of their tenesmus and defecation difficulty Two studies9,10 found that traditional Chinese medicine retention enemas were better at improving abdominal pain, while Zhang et al.12 found no significant difference between the two groups in improvement of abdominal pain Two studies10,12 found no significant difference between the two groups in improvement of diarrhea Two articles5,9 reported the clinical symptoms scores of hematochezia and stool characteristics and frequency The meta-analysis was unable to use this information because of skewed data and small sample sizes, but both studies reported that the experimental group experienced more improved clinical symptoms than the control group 3.3 Safety analysis Only study5 reported adverse events and relapse No adverse events were indicated in the two groups, and no recurrence was shown in the experimental group Two cases of recurrence were reported in the control group 3.4 Reporting bias A funnel plot showed basic asymmetry, which indicated an unlikelihood of reporting bias among the included studies (Fig 3) Discussion This review included 14 RCTs to compare the curative effects of traditional Chinese medicine retention enemas with Western 178 X.-M Wang et al / Chinese Nursing Research (2016) 176e180 Fig Flow chart of selected studies for systematic review medicine retention enemas Ten RCTs involving 702 patients were included in the meta-analysis The meta-analysis showed that the total efficacy of traditional Chinese medicine at relieving clinical symptoms of radiation proctitis was higher compared with the control group Of the 14 included studies, prescriptions of traditional Chinese medicine mainly included decoctions of Rhizoma bletillae, compound QinBai gramules, PingKui powders and prescriptions for clearing heat and toxins.5,7,13 The ingredients in the frequently used prescriptions included the following: Herba thymi (8 times), Rhizoma bletillae and Cotex phellodendri (5 times each), Radix glycyrrhizae, Sophora flower, and Radix et rhizoma rhei (4 times each), Herba patriniae, Radix pulsatillae, Rhizoma coptidis, Radix ledebouriellae and Semen coicis (3 times each), Radix paeoniae rubra, Radix notoginseng, Rhizoma atractylodis macrocephalae, Flos lonicerae, Radix scutellariae, Herba taraxaci and Herba portulaca (2 times each) Radiation proctitis belongs to the category of traditional Chinese medicine that includes “diarrhea”, “hematochezia” and “bleeding sprouting from the anus”,15 and it is considered to constitute damp heat that diffuses downward.16 In traditional Chinese etiology, radioactive rays are intended to beat toxins, but the accumulation of heat in the body's interior damages ZhengQi After a long time, deficiencies in the spleen cause YangQi to not take up middle jiao Eventually, qi stagnation and blood stasis occur, leading to symptoms of diarrhea, abdominal pain, hematochezia, tenesmus and anal pain Herbal thymi is used to clear Table Characteristics of the included studies Study Number of participants E C Zhang 20105 Yang 20126 Xu 20107 Yu 20118 Xiao 20149 Wang 201310 Tian 201311 Zhang 201312 Zhang 200413 Xiang 199614 23 29 40 38 30 30 60 34 44 38 23 29 40 38 29 30 30 34 41 42 Age (years) Intervention E C 44e61 34e75 30e78 30e77 22e69 43e70 39e78 18e70 Average 59.3 42e60 T T T T T T T T T T W W W W W W W W W W (Gentamicin, Procaine, Prednisone, Epinephrine) (NS, Gentamicin, Lidocaine, Dexamethasone) (NS, Gentamicin, Lidocaine, Dexamethasone) (NS, Gentamicin, Lidocaine, Dexamethasone) (Gentamicin, Procaine, Prednisone, Epinephrine) (NS, Gentamicin, Lidocaine, Dexamethasone) (NS, Gentamicin, Procaine, Epinephrine, Dexamethasone) (Gentamicin, Procaine, Prednisone, Epinephrine) (NS, Gentamicin, Procaine, Dexamethasone) (NS, Gentamicin, Procaine, Dexamethasone) Length of treatment (day) Dosage (mL/d) Outcomes 14 20 28 28 60 14 30 14 Not mentioned 20 400 100 100 100 400 400 400e600 200 100 150 ①②③ ① ① ① ①② ①② ① ①② ① ① Note: E ¼ experimental group; C ¼ control group; T ¼ traditional Chinese medicine enemas; W ¼ Western medicine enemas; NS ¼ normal saline; ① ¼ clinical effect; ② ¼ clinical symptoms score; ③ ¼ adverse events and relapse rate X.-M Wang et al / Chinese Nursing Research (2016) 176e180 179 Fig Forest plot comparison: the total efficacy Conclusions Traditional Chinese medicine retention enemas can improve the effects of clinical interventions, but more high quality RCTs are needed in future research Additionally, more research is needed on the outcomes of clinical symptoms to fully explore the efficiency of traditional Chinese medicine retention enemas and observe their long-term efficacy and safety Patients with radiation proctitis are often found to have deficiency syndromes later on, including spleen and kidney deficiencies, which should be further explored.16 Conflicts of interest All of the contributing authors declare no conflicts of interest Fig Funnel plot away heat and toxins, stifling bleeding and stopping pain.17 Rhizoma bletillae has astringent and styptic properties It can be used to stop bleeding, promote wound repair and has anti-tumor effects.18 Coted phellodendri have anti-inflammatory and anti-ulcer effects and pertain to eliminating heat-dampness, thereby removing heat and toxins.19 It is used to stop diarrhea Herbal patriniae and radix pulsatillae have anti-tumor effects and pertain to eliminating heat-toxins and stasis, promoting pus discharge and blood circulation, expelling dampness, cooling blood and relieving dysentery.20,21 It is used to treat abdominal pain, tenesmus and bloody purulent stool Radix paeoniae rubra can clear heat, cool blood, remove blood stasis and relieve pain.22 In short, traditional Chinese medicines are primarily used to clear heat and toxins, dry dampness, arrest bleeding and stop pain to reduce patients' symptoms, including abdominal pain, diarrhea, hematochezia and tenesmus, among others Although the pooled studies showed no significant heterogeneity, several limitations still existed First, the methodological quality of the included studies was low Most of the included studies did not describe the method of random sequence generation, allocation concealment and blinding, which could have affected the validity of the studies' results Second, herbal formulation, dosage, frequency, temperature and enema retention time were different in each included study; thus, they were unable to be systematically summarized Third, all the studies included in this review were published in the Chinese language Fourth, the definitions of clinical symptoms were inconsistent, which could have limited the meta-analysis Lastly, most of the included studies did not report the safety of the intervention Acknowledgments Xin-Man Wang and Song-Ge An contributed equally to this study References Ren JP, Sun GJ The new progress of radiation proctitis in traditional Chinese medicine Res Integr Trad Chin West Med 2013;5:99e100 (in Chinese) Liu YX Combination of Traditional Chinese and Western Medicine on Oncology Beijing: China Press of Traditional Chinese Medicine; 2005:139e140 (in Chinese) Rustagi T, Mashimo H Endoscopic management of chronic radiation proctitis World J Gastroenterol 2011;17:4554e4562 Higgin JPT, Green S Cochrane Handbook for Systematic Review of Interventions Version 5.1.0 The Cochrane Collaboration; 2011 (updated March 2011) www cochrane-handbook.org.2014.5.12 Zhang HX Clinical observation of traditional Chinese medicine enema for chronic radiation proctitis in cervical cancer Global Trad Chin Med 2010;3: 280e282 (in Chinese) Yang YT Curative effect of traditional Chinese medicine retention enema for patients with radiation proctitis J Guangdong Med College 2012;30:630e631 (in Chinese) Xu X, Jiang TS, Wang XQ, Zhu HM Prescription for heat and toxin clearing retention enematreatment for radiation proctopathy with 40 cases Shaanxi J Trad Chin Med 2010;31:1634e1635 (in Chinese) Yu HL, Xu X, Zhu HM Clinical observation and nursing care on 38 cases of radiation proctopathy with prescription for heat and toxin clearing retention enema Jinlin Med J 2011;32:7586e7587 (in Chinese) Xiao C, Lu ZW, Fu XB, Wang ZQ, Li KY Clinical observation on 30 cases of chronic radiation proctopathy with damp-heat brewing internally with compound QinBai granules retention enema Guid J Trad Chin Med Pharm 2014;20: 44e45 (in Chinese) 10 Wang Y, Lu WP Shi WG.Clinical observation on 30 cases of acute radiation proctitis treated with Pingkuisan powder Hebei J TCM 2013;35:23e25 (in Chinese) 11 Tian AZ Clinical nursing on 60 cases of radiation proctitis after cervical cancer radiotherapy with traditional Chinese medicine retention enema J Qilu Nurs 2013;19:108e109 (in Chinese) 180 X.-M Wang et al / Chinese Nursing Research (2016) 176e180 12 Zhang J, Zhou JH, Li CH, Fan QY The clinical effect of decoction of Pulsatillae plus with Xilei powder retention enema for acute radiation proctitis Clin J Trad Chin Med 2013;25:852e853 (in Chinese) 13 Zhang QG, Yu Y Curative effect analysis of traditional Chinese medicine enema for patients with radiation proctitis Jiangxi J Trad Chin Med 2004;35:24 (in Chinese) 14 Xiang DZ, Zhang SC, Wu ZQ, Zhou WQ Curative effect observation of traditional Chinese medicine decoction plus XiLei powder retention enema in the treatment of radiation proctopathy Acta Acad Med Zunyi 1996;19:124e125 (in Chinese) 15 Li PW, Cui HJ Practical Combination of Traditional Chinese and Western Medicine on Medical Oncology Beijing: China Press of Traditional Chinese Medicine.; 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Combination of Traditional Chinese and Western Medicine on Medical Oncology Beijing: China Press of Traditional Chinese Medicine. ; 2007:41e43 (in Chinese) 16 Zhang DZ Traditional Chinese and Western Medicine. .. observation of traditional Chinese medicine enema for chronic radiation proctitis in cervical cancer Global Trad Chin Med 2010;3: 280e282 (in Chinese) Yang YT Curative effect of traditional Chinese medicine