title: Transdermal clonidine in the treatment of severe hyperemesis. A pilot randomised control trial: CLONEMESI.
abstract: OBJECTIVE
  To study the efficacy of transdermal clonidine in the treatment of severe refractory hyperemesis gravidarum (HG), the most severe illness of pregnancy.
  
  
  METHODS
  The study had a randomised, double -blind, placebo-controlled, cross-over design (RCT).
  
  
  METHODS
  Single tertiary referral hospital after admission of patients.
  
  
  METHODS
  Twelve women of gestational age 6-12 weeks and a major grade of HG clinical severity who were unresponsive to standard antiemetic treatment.
  
  
  METHODS
  The patients were randomly treated with and without the active drug (5 mg patch) for two consecutive periods of 5 days. The patients were allocated to a random list to receive first placebo and then active drug or the other way round. Other antiemetic drugs were administered on a scheduled or as-needed basis. All patients received intravenous hydration and thiamine supplementation.
  
  
  METHODS
  Pregnancy Unique Quantification of Emesis (PUQE) and visual analog scale (VAS) clinical scores, positive morning urine ketonuria, number of doses of standard antiemetic drugs required, and number of days off intravenous therapy were compared in the two periods.
  
  
  RESULTS
  Transdermal clonidine led to a significantly greater improvement compared with placebo of the primary (PUQE score P = 0.026 CI 0.43-3.24; VAS score P = 0.010 CI 2.17-12.83) and secondary outcome measures. A reduction of blood pressure was reported for systolic 6 mmHg P = 0.01 and diastolic 3 mmHg P = 0.055.
  
  
  CONCLUSIONS
  This preliminary RCT demonstrates the efficacy of transdermal clonidine in the treatment of severe HG, leading to a significant reduction of symptoms and reducing the need for other supportive measures and medications.
authors.affiliation: Dipartimento di Medicina, Servizio di Medicina Interna, Ospedale Sant'Anna, AOU Città della Salute e della Scienza, Turin, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Maina
authors.forename: M
authors.initials: M
authors.lastname: Arrotta
authors.forename: L
authors.initials: L
authors.lastname: Cicogna
authors.forename: V
authors.initials: V
authors.lastname: Donvito
authors.forename: M
authors.initials: M
authors.lastname: Mischinelli
authors.forename: T
authors.initials: T
authors.lastname: Todros
authors.forename: S
authors.initials: S
authors.lastname: Rivolo
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage* / Q000627:therapeutic use; D003000:Clonidine / Q000008:administration & dosage* / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006939:Hyperemesis Gravidarum / Q000188:drug therapy*; D010865:Pilot Projects; D011247:Pregnancy; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000932:Antiemetics; D003000:Clonidine
keywords: Hyperemesis gravidarum; randomised control trial; transdermal clonidine; treatment