title: Single-dose versus two-dose administration of methotrexate for the treatment of ectopic pregnancy: a randomized controlled trial.
abstract: OBJECTIVE
  Can a two-dose methotrexate treatment protocol improve the treatment success rate compared with a single-dose protocol in women with an ectopic pregnancy?
  
  
  CONCLUSIONS
  The two-dose protocol was not superior to the single-dose protocol for the treatment of ectopic pregnancy.
  
  
  BACKGROUND
  Although the two-dose methotrexate protocol for ectopic pregnancy was recently introduced to combine the efficacy and convenience of the fixed multi-dose and single-dose protocols, studies comparing the success rates, treatment satisfaction and acceptability of the single-dose and two-dose treatment protocols for ectopic pregnancy are currently lacking.
  
  
  METHODS
  A randomized trial was conducted on 92 participants with tubal ectopic pregnancy, between May 2013 and April 2015.
  
  
  METHODS
  Patients who were diagnosed with tubal ectopic pregnancy and who elected to undergo systemic methotrexate treatment were randomly assigned to follow either the single-dose (n = 46) or two-dose protocol (n = 46). The primary outcome measure was treatment success without surgical intervention. The secondary outcome measures were the incidence of methotrexate-associated side effects, β-human chorionic gonadotrophin (β-hCG) resolution time, cost of care received and treatment satisfaction.
  
  
  RESULTS
  There were no differences in baseline characteristics between the groups. The success rates between the single-dose and two-dose groups did not show a significant difference [82.6 versus 87.0%; relative risk (RR) 0.95; 95% confidence interval (CI) 0.80-1.13]. However, the success rate in a subgroup of participants with a pretreatment β-hCG level of >5000 mIU/ml appeared to be higher in the two-dose group than in the single-dose group (80.0 versus 58.8%), although the difference was not statistically significant. No significant differences in methotrexate-associated side effects, cost or treatment satisfaction were observed between the groups. The two-dose group required a lower number of days for the β-hCG level to decrease to <5 mIU/ml than the single-dose group (25.7 ± 13.6 versus 31.9 ± 14.1 days; P = 0.025).
  
  
  CONCLUSIONS
  Some caution is warranted in interpreting the results due to an overoptimistic sample size calculation on the basis of the biggest difference as reported in literature between the success rates of two protocols.
  
  
  CONCLUSIONS
  The single-dose protocol with the option to elaborate to a second dose in the case of treatment failure could stand as the treatment for most cases of ectopic pregnancy.
  
  
  BACKGROUND
  None.
  
  
  BACKGROUND
  www.clinicaltrials.gov, no. NCT01855568.
  10 May 2013.
  26 May 2013.
authors.affiliation: Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Taejong
authors.initials: T
authors.lastname: Song
authors.affiliation: Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, 650-9 Yeoksam-1 Dong, Gangnam-gu, Seoul 135-081, Republic of Korea.
authors.forename: Mi Kyoung
authors.initials: MK
authors.lastname: Kim
authors.affiliation: Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, 650-9 Yeoksam-1 Dong, Gangnam-gu, Seoul 135-081, Republic of Korea.
authors.forename: Mi-La
authors.initials: ML
authors.lastname: Kim
authors.affiliation: Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, 650-9 Yeoksam-1 Dong, Gangnam-gu, Seoul 135-081, Republic of Korea.
authors.forename: Yong Wook
authors.initials: YW
authors.lastname: Jung
authors.affiliation: Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, 650-9 Yeoksam-1 Dong, Gangnam-gu, Seoul 135-081, Republic of Korea.
authors.forename: Bo Seong
authors.initials: BS
authors.lastname: Yun
authors.affiliation: Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, 650-9 Yeoksam-1 Dong, Gangnam-gu, Seoul 135-081, Republic of Korea sjseongcheil@naver.com.
authors.forename: Seok Ju
authors.initials: SJ
authors.lastname: Seong
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D006063:Chorionic Gonadotropin / Q000097:blood; D005260:Female; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011247:Pregnancy; D011271:Pregnancy, Ectopic / Q000188:drug therapy*
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D006063:Chorionic Gonadotropin; D008727:Methotrexate
keywords: ectopic pregnancy; medical treatment; methotrexate; success rate; tubal pregnancy