| Part I .Evaluation of the effectiveness of mifepristoneconcomitant with misoprostol for medical abortionObjectives To evaluate the effectiveness of mifepristone concomitant with misoprostol for medical abortion, which investigated effectiveness of medical abortion compared with surgical abortion, the effect of gestational ages, dosages and regimen of mifepristone, misoprostol administered orally or vaginal and the interval mifepristone of subsequent administration of misoprostol on medical abortion. This study was designed to provide the best available choice for women with early unwanted pregnancy, offer evidence for clinical decision-making, and formulate best references for decision-makers to improve the medical abortion clinical guidelines. Methods We searched the potentially related original studies all over the world, and only randomized control trials (RCTs) and clinical control trials (CCTs) were included. Nine databases were electronically searched, correlative websites, such as 'google', and ten journals were searched by hand. The studies included in the references of eligible studies were additionally searched. At least two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation of cross-check. Different opinions would be decided by the third party. Meta-analysis was done by Revman 4.2. Afterheterogeneity test was done (a =0.05), data without heterogeneity could be pooled using fixed effect model, and those with heterogeneity could be solved by sensitivity analysis, subgroup analysis or randomized effect model. Results Eight original trials (n=3348) of medical abortion compared with surgical abortion, nine trials (n=6122) investigated the effect of gestational ages on medical abortion, six trials (n=3575) on mifepristone dosages, five trials (n=1934) on usage of mifepristone, eleven trials(n=3822) on routes of administration, and two trials (n=1609) on intervals of administration of mifepristone and misoprostol . In total, the quality of foreign studies was better than that of China. The rate of complete abortion was higher in surgical abortion group than that of medical abortion group with odds ratio (OR) of 0.18, 95% Confident interval(CI) 0.11 to 0.27. The rate of incomplete abortion and abortion failure was higher in medical abortion group (OR 3.32, 7.36, 95% CI 1.79 to 6.17, 4.17 to 12.98, respectively). The rate of complete abortion in the group with gestational age over 49 days was lower than that with gestational age not more than 49 days (OR0.51, 95%CI 0.43 to 0.61). The rate of incomplete abortion and abortion failure was higher in the group with gestational age over 49 days. (OR 3.37; 1.29, 95% CI 2.30 to 4.94; 0.97 to 1.740).There is comparable effectiveness between the dosages of mifepristone <150 mg and Mifepristone 150-200 mg in achieving complete abortion, incomplete abortion and bleeding time (OR1.59, 95% CI 0.98 to 2.58; OR 0.91, 95% CI 0.54 to 1.54; and weight mean diffrence (WMD) 0.50, 95% CI -0.77 to 1.77), whereas the rate of abortion failure was lower in the mifepristone <150mg group (OR 0.21, 95% CI 0.06 to 0.74), and the time of expelling the pregnant sac was shorter in the mifepristone <150mg group(WMD -0.40, 95% CI -0.73 to -0.07). The dosages of mifepristone >200 mg compared with 150-200 mg showed similar effectiveness in achieving complete abortion, incomplete abortion and abortion failure (OR 0.87; 1.32; 0.87, , and 95% CI 0.66 to 1.14; 0.96 to 1.84; 0.56 to 1.37). The bleeding time was shorter in mifepristone 150-200mg group (WMD 0.65, 95% CI 0.39 to 0.91). There was no significant differences observed in the rate of complete, incomplete, abortion failed, time of expelling pregnant sac and time of menses recovery time between the single and multi-dosage of mifepristone. Misoprostol administered orally is less effective (more incomplete and failures) than that of the vaginal route (OR 2.49, 95% CI 1.91 to 3.25), while there was no significant difference in the bleeding time and pregnant sac expelling time. There was comparable effectiveness in different interval of misoprostone and misoprostol groups. Conclusions This review showed that it was important to improve the quality of Chinese original studies. Although the effectiveness was higher in the surgical abortion group, the rate of complete abortion of medical abortion could achieve 91.6% (1648/1800). This is acceptable to clinicians and women with unwanted pregnancy . The rate of complete abortion was lower in the gestation over 49 days, which had significant difference, but little clinical significance (OR 0.51). It was necessary to consider increasing the gestational age of medical abortion, especially those women who have contradictions of surgical abortion or fearoperation. It was of no use to improve the effectiveness by increasing dosages of mifepristone. Instead, it wasted the limited health resources. It might be possible to decrease the dosage of mifepristone. However, the lowest dosage with adequate effectiveness needs to beinvestigated. Effectiveness of single dosage of misoprostone was similar to that of muti-dosage, but single dosage might be more convenient. Misoprostol administered orally is less effective (more failures) than that of the vaginal route. However, convenience and economy of oral route would be the important factors for clinical decision-making. This review suggests that shortening the interval of mifepristone and misoprostone administration should be considered and the best and shortest interval time need to be identified by better evidence.Part II: Safety Assessment of Mifepristone Concomittant with Misoprostol for Medical Abortion[Abstract] Objectives To evaluate the safety of medical abortion by mifepristone concomittant with misoprotol, and to assess the effect of medical abortion on subsequent pregnancy. Methods We searched MEDLINE, EMBASE, Cochrane Library, Chinese Biomed-database, correlative websites and nine Chinese medical journals. The references of eligible studies were additionally searched. We collected randomized control trials (RCTs), clinical control trials (CCTs), cohort studies, and case reports about serious adverse events all over the world. Two reviewers evaluated the quality of the literatures and extracted the data independently. After testing heterogeneity, data of the trials included were meta-analyzed if appropriate, or otherwise, would be described. Results A total of 101 case series and case reports(n==1376) were included, which comprised allergic events, hemorrhagic shock, rare adverse events such as arrhythmia and deformity of newborns. General adverse reactionscovered abormal bleeding middle allergy and so on. The results of five CCTs (n=2263)indicated that the pregnant women who underwent medicine abortion had more profuse bleeding, abdominalgia, fever and dizziness than those experienced surgical abortion. (OR 3.27, 95% CI 1.14 to 9.38; 1.63,1.14 to 2.34; 1.58, 1.03 to 2.44; and 1.36,1.06 to 1.75). Medical abortion had longer bleeding time than that of surgical abortion (WMD 6.49, 95%CI 6.08 to7.80). There were no significant difference between the two groups in terms of remaining outcomes. There were 177 cases on complication of medical abortion, including moderate allergic reactions, trophoblastic disease, intrauterine adhesious and secondary infertility. In addition, 57 cases of ectopic pregnancy misused medicine. Eight prospective cohort studies with 2,934 cases about the effect of medical abortion on subsequent pregnancy were included. The incidence of miscarriage, postpartum hemorrhage and placental abnormality occurred in the medical abortion group were significantly lower than those in the surgical abortion group (OR 0.42, 95% CI 0.22 to 0.83, 0.58, 0.39 to 0.85, 0.68, 0.54 to 0.87). No other significant difference was observed between the two artificial abortions groups. There was no significant difference in subsequent pregnancy between medical abortion and first pregnancy. Conclusions The incidence of adverse events was very low. However, serious adverse events should be paid close attention in the clinical practice. It was necessary to establish the national reporting system of adverse events. The heavy bleeding is the major problem of medical abortion.More studies need to be conducted. Medical abortion was safer than surgical abortion on subsequent pregnancy, so medical abortion is the preferred option for women without child to terminate their unwanted pregnancy. However, itwas still very important that unnecessary abortion should be avoided.Part HI: Economical Assessment of Artificial AbortionObjective To re-assess original studies about economic analysis of medical abortion in the world, and analyze cost and efficacy of medical abortion so as to help women with early unwanted pregnancy or clinicians with choosing useful and cheap artificial abortion method and provid references for the government in decision making. Method Seven medical literature databases were searched, including MEDLINE, EMBASE, Cochrane Library, and Chinese Biomed-database. Related websites were also searched, and twenty journals were searched by hand. The studies included in the reference list were additionally searched. Different medical methods used for first trimester abortion, comparing with each other were included. Eligibility and trial quality were assessed and the useful data were extracted independently by at least two reviewers with a confirmation of crosscheck. Different opinions were consulted by the third person. The data on outcomes of effectiveness were pooledif possible, otherwise, were described (qualitative systematic review). Results Six original studies with 737 cases were included in this systematic review. Qualitative systematic review was conducted since the methods and interventions of the trials included were totally different. There was no significant difference in effectiveness among different artificial abortion, and the cost—minimization analysis method was used across trials. Drugs, vacuum aspiration, and consultation cost were calculated in all eligible studies. The discount was not considered due to short time of artificial abortion. Sensitive analysis was not used in any of the included trials, which reduced the qualiy of trials. The cost of mifepristone combinedwith misoprostol for medical abortion was cheaper than that of surgical abortion, and it was also cheaper than that of mifepristone concomittant with gemeprostol. Conclusion The cost of mifepristone concomittant with misoprostol for medical abortion perhaps was the lowest in different artificial abortion methods based on the current evidence.This was very useful in clinical practice. The conclusion should be carefully considered due to the quality limitation of the eligible trials. The original economic studies of artificial abortion need to be done in China.Part IV: Assessment of Acceptability of Medical Abortioncompared with Surgical AbortionObjectives To analyze and evaluate acceptability of mifepristone concomittant with misoprostone versus conventional surgical abortion in women with early unwanted pregnancy, to help women with unexpected pregnancy women with choosing a satisfactory method of abortion, and provide the evidence for clinicians to make approapriate clinical decision. Methods Seven databases were searched, including MEDLINE, EMBASE, Cochrane Library, CBMdisc, CNKI, CMCC and VIP. Twelve journals were hand-searched, and references of included studies were additionally searched. Two qualified reviewers screened original articles, evaluated quality of articles, and extracted data independently. After testing heterogeneity, data were pooled using Revman 4.2 if appropriate, otherwise descriptive analysis was applied. Result In total, nine original CCTs were included , (n=3565). Before abortion, more unwanted pregnant women chose the medical abortion because they believed medical abortion was less painful than surgicalabortion (OR 466.51, 95% CI 91.37 to 2381.88). But medical abortion was more slowly than surgical abortion (OR 0.02, 95% CI 0.01 to 0.06). After abortion, Satisfaction of medical abortion was similar to that of surgical abortion, which was not significantly different (P=0.89). However, the re-choice rate and recommendation rate of medical abortion were much higher than that of surgical abortion. (OR2.72, 95% CI 2.13 to 3.47; 4.19, 2.16 to 11.16). Conclusions Medical abortion was less painful, although it was not as quick as surgical abortion, the rate of re-choice and recommending to others were much higher than those of surgical abortion. On one hand, medical abortion would have widely-used prospect in clinic. On the other hand, medical abortion had some disadvantages compared with surgical abortion. Therefore, the two artificial abortion methods couldn't replace each other at present.
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