A Randomized Controlled Clinical Trial Of Sugar Colloid In The Treatment Of Bacterial Vagina Diseases

Objective: Bacterial Vaginosis(BV)is the most common vaginal infectious disease and is closely related to other vaginal infectious diseases.BV can be diagnosed by the standardized clinical diagnosis or bacterial morphological assessment of laboratory vaginal secretions.However,the method of detecting and diagnosing BV has made little progress,but molecular biology diagnosis is on the rise.At present,BV is still a refractory disease,clinicians are also lack of long-term effective treatments of BV.In addition to the standard antibiotic treatments,other alternative therapies,such as preservatives,disinfectants,vaginal acidifiers,buffers and probiotics,have also made some satisfactory progress in BV long-term prevention.The aim of this study was to explore a novel drug for the treatment of bacterial vaginosis and to compare the efficacy and safety with metronidazole and placeboMethod: By screening 14,822 women of childbearing age in Changchun,Beijing,Shijiazhuang,Zhengzhou,Nanjing and Xi'an,908 patients suspected with bacterial vagina diseases were selected out and 560 of them were chosen to be treated by medicine in 8 hospitals.These patients were divided into three groups in the ratio of 3:1:1,provided respectively with sugar colloid,metronidazole colloid and placebo.5.0g medicine is put into vagina both in morning and at night everyday for consecutive 5 days of these three groups.Clinical curative effect observation and safety evaluation were made during 7 to 10 days and 21 to 35 days after the treatment.Result: There were no significant differences in age,height,weight,blood pressure and pulse between the three groups(P>0.05).After 7 to 10 days of treatment,primary efficacy in the three groups all showed statistical significance(P<0.001)in CMH test for FAS people and PP people.The cure rates of placebo,metronidazole colloid and sugar colloid were respectively 0.90%,70.64% and 82.67% in FAS people.Comparing with sugar colloid,P<0.001 in placebo group,P =0.0068 in metronidazole colloid group.After 21 to 35 days of treatment,primary efficacy in the three groups all showed statistical significance(P<0.001)in CMH test for FAS people and PP people.The cure rates of placebo,metronidazole colloid and sugar colloid were respectively 7.21%,66.06% and 61.09% in FAS people.Comparing with sugar colloid,P<0.0001 in placebo group,P=0.3543 in metronidazole colloid group.No serious adverse event happened among the studied people.Adverse events with the frequency of occurrence over 1% included abnormalities of the gastrointestinal system,the respiratory system,white blood cells,the reticuloendothelial system,the urinary system and female reproductive system.The frequency of adverse reaction: 5.36% in placebo group,12.84% in metronidazole colloid group and 4.83% in sugar colloid group.Conclusion: The short-term curative effect of sugar colloid regimen to treat bacterial vagina diseases was better than placebo and metronidazole colloid,and the long-term curative effect was better than placebo and equalled to metronidazole colloid.occurrence of relevant adverse events in sugar colloid group was lower than that of placebo group and metronidazole colloid group.