| Background and ObjectiveGuangxi Zhuang Autonomous Region is one of the provinces with the highest prevalence of AIDS in China.It is also the earliest pilot province of Chinese herbal medicines(CHMs)therapy in our country.The objective of this study is to explore the knowledge,experience,attitude,belief and satisfaction of HIV infected and AIDS patients in Guangxi Zhuang Autonomous Region towards CHMs treatment,and to explore the factors influencing the treatment compliance of patients.To evaluate the effectiveness and safety of traditional Chinese medicine(TCM)in the treatment of AIDS related diarrhea by synthesizing relevant RCTs.MethodsStudy one:We conducted a semi-structure qualitative interview in a total of 40 HIV/AIDS patients in 3 TCM institutions in Guangxi Zhuang Autonomous Region.interviewees were sampling by purposive methods.the purposive sampling process was according to the principle of dynamic sampling and information saturation,the individual characteristics of the interviewees were as multiple as possible and the information saturation should be verified.All interviews were conducted in clinician's office.Interviews were conducted face-to-face in the provincial capitals.While in the prefecture-level city and the county seat,interviews required a clinician or a nurse to serve as a translator.Interviewers were refered to interviewees by the clinicians and were familiar to interviewees to get informed consent before the interviews.Specific questions in accordance with the interview outline were flexibly changed to make interviewees understand the meaning of the issues.A single interview would take about 20 to 40 minutes.All interviews were recorded using a voice recorder(Sony professional recording pen ICD-P520)after informed consent.The recorded data would be transcribed verbatim.The verbatim data would be analyzed using thematic analysis methods.The analysis tool was RQDA software(Version:0.2-8.Ronggui Huang).Study two:We searched for randomized clinical trials(RCTs)of TCM(herbal medicine,acupuncture,moxibustion and acupoint paster)for HIV/AIDS related diarrhea in China National Knowledge Infrastructure(CNKI),Chinese Academic Conference Papers Database and Chinese Dissertation Database(Wanfang),Chinese VIP Information(VIP),The Chinese Biomedical Literature Database(SinoMed),PubMed,Cochrane Library from their inception to December,2016.A data extraxtion form was used to extract data.Two authors independently screened for inclusion and extraxted data,which inconsistent content debated with the third author.The risk of bias table which recommended by Cochrane handbook was used to evaluate methodological quality.RevMan 5.3 software were used to perform data analysis.Data with low clinical heterogeneity was quantitatively synthesized by Meta-analysis.Data with high clinical heterogeneity was qualitively described.Statistical heterogeneity test were conducted using I2 test.Fixed effect model was applied when I2<50%,else random effect model was applied.Primary outcomes included diarrhea frequency,stool amount,stool quality and scores of diarrhea scale.Secondary outcomes included symptoms improvement,duration from treatment start to symptoms improved,hospitalization,weight,relapse rate,CD4 cell counts,quality of life and safety outcomes.According to GRADE system,GRADEpro GDT online software was applied to produce summary of finding table to evaluate evidence.Using SAS 7.8 software(SAS INSTITUTE INC),Egger linear regression method to evaluate publication bias quantitatively.ResultsThis qualitative study was conducted in three TCM institutions in cities of different levels in Guangxi(a provincial capital,a prefecture-level city and a county seat),40 HIV/AIDS patients were selected by purpose sampling through clinician's recomend to semi-structured individual interviews.All interviewees are from "Basic Construction Project of TCM Prevention and Treatment for AIDS in Guangxi" in national"TCM for AIDS Pilot Programme".Informed consents were got in written or oral form.Interviewees were highly adherent to interviews,with no interviews refused or disrupted.But limited by the degree of education and the personality of the interviewees and time constraints,different interviewees gave detailed or simple answer to a certain question.The voice recording were transcribed into 105613 Chinese characters.The analysis steps included familiarity with the data,the formation of the initial theme frame,the establishment of the index(coding),drawing the guide map,the formation of the overall analysis and interpretation of the spectrum.The thematic framework was preliminarily based on the discussion before the study and was used to form new themes in the follow-up analysis and generated a guide map.Two authors read and encoded the transcripts according to the theme frame that has been formed,and then summary.Finally,the overall analysis of all the formed themes was conducted to draw the map of the relationship between the various themes,and the spectrum of overall analysis was formed.10 themes including infection performance,knowledge,expectation,experience,attitudes,satisfaction,compliance,eaperience of visiting a doctor and doctor selection were extracted.We found that most interviewees were concerned about their physical changes.In terms of knowledge,interviewees linked disease progression to CD4 cell counts,but they didn't know what kind of CHMs they were taking,and even couldn't tell difference of CHMs from western medicine.However,the Interviewees could tell the possible effect of CHMs,which may comes from the doctor's mission.In addition,the interviewees also had some expectations to CHMs treatment.These expectations were satisfied or not satisfied after the interviewees had experience the efficacy and safety of CHMs,and then combined with knowledge given by culture environment,to influence satisfaction and attitudes towards CHMs.Experience,attitudes and satisfaction interacted each other,to influence CHMs compliance,the compliance change would also influence experience.Experience of visiting a doctor and doctor selection were factors influencing compliance.Systematic review included 24 RCTs 1881 participants of CHM,moxibustion,and CHM combined with acupoint injection for HIV/AIDS related diarrhea.The methodology quality of included trials was generally low.Only six trials(25%,6/24)reported random sequence generation.Two trials(8.3%,2/24)reported allocation concealment.Three trials(12.5%,3/24)reported blinding.In the trials reporting blinding,only one trial reported object of blinding.Only four trials(16.7%,4/24)reported lost to follow-up.None of the trials reported proposal publication,while 19 trials(79.2%,19/24)reported the same outcomes in results and methods.In terms of primary outcomes,there were not enough trials for meta-analysis.Diarrhea frequency in 24 hours in Xielikang capsule plus Loperamide hydrochloride placebo plus foundation treatment versus Loperamide hydrochloride plus Xielikang capsule placebo plus foundation treatment showed significant difference(MD:-0.44,95%CI:[-0.74,-0.14]).General diarrhea scale scores in CHMs plus foundation treatment versus western medicine plus foundation treatment(MD:-1.45,95%CI:[-2.64,-0.26]),CHMs plus western medicine versus western medicine(MD:-1.29,95%CI:[-2.20,-0.38]),CHMs plus western medicine placebo plus foundation treatment versus western medicine plus CHMs placebo plus foundation treatment(MD:-2.22,95%CI:[-3.15,-1.29])showed significant difference.As to secondary outcomes,6 meta-analysis were performed and 5 meta-analysis showed significant difference,they included that effective rate in CHMs versus western medicine(RR:1.34,Random,95%CI:[1.09,1.65],I2=77%),CHMs plus foundation treatment versus western medicine plus foundation treatment(R/R:1.47,Fixed,95%CI:[1.14,1.88],I2=0%),moxibustion versus western medicine(RR:1.11,Fixed,95%CI:[1.01,1.22],12=37%),effective was defined as diarrhea less than or equal to 3 times in 24 hours.mate state score(MD:-19.99,Fixed,95%CI:[-31.44,-8.54],I2=0%)and emotional reaction score(MD:-19.99,Fixed,95%CI:[-31.44,-8.54],I2=0%)of Nottingham QoL scale in CHMs versus western medicine.These meta-analysis were evaluated low or very low by GRADE.Using Egger linear regression to test shows that there was no publication bias(using the outcome with the most included trials,t=-1.04,p=0.3378).Only one trial reported the number of adverse events,there was no significant difference between two groups.Other trials didn't report serious adverse events.ConclusionsHIV/AIDS patients would feel some physical changes after infection,such as be susceptible to diarrhea,cold,fever,skin itching,tired,weight loss and the recession of overall situation.In the process of seeking CHMs treatment,they gradually formed knowledge of the disease and effectiveness/safety of CHMs and produced some expctations accoding to their knowledge and past culture environment,such as hoping CHMs to increase CD4 cell counts,to improve mental state,to improve sleeping,to decrease the frequency of getting cold,to protect their liver function,to benefit their body or to cured the disease.After they recieved CHMs treatment for some time,interviewees had some experiences about the effectiveness and safety of CHMs,they found CHMs can help decreasing viral load,increasing CD4 cell counts stably,increasing weight,improving mental state and sleeping,enhancing physical strength,improving appetite,decreasing the frequency of cold and fever,decreasing diarrhea frequency,improving skin itching and protecting their liver from western medicine.These experiences,attitudes and satisfaction towards CHMs interacted each other,and influenced patients' compliance to CHMs.While patients experienced the same effectiveness and safty benefit to their knowledges and expectations towards CHMs,their experience will increase their satisfaction towards CHMs,then their attitudes will change.Patients with positive attitudes tend to talk about more experience or experience superior to their expectations.Experience of visiting a doctor and doctor selection were factors influencing compliance.Xielikang capsule maybe effective for AIDS related diarrhea in reducing diarrhea frequency.CHMs maybe effective in improving diarrhea related sympotoms.In addition,CHMs and moxibustion maybe effective in increasing number of patients whose diarrhea frequency was below three times in 24hours,CHMs may improving mental and emotional reaction scores of Nottingham QoL scale.This review is conservative with this conclusion because of small sample size and low methodology quality.This conclusion can be verified in the future by more high-quality large sample RCTs. |
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