title: Randomised controlled trials of homeopathy in hyperactive children: treatment procedure leads to an unconventional study design. Experience with open-label homeopathic treatment preceding the Swiss ADHD placebo controlled, randomised, double-blind, cross-over trial.
abstract: BACKGROUND
  Treatment of patients with attention deficit hyperactivity disorder (ADHD) with homeopathy is difficult. The Swiss randomised, placebo controlled, cross-over trial in ADHD patients (Swiss ADHD trial) was designed with an open-label screening phase prior to the randomised controlled phase. During the screening phase, the response of each child to successive homeopathic medications was observed until the optimal medication was identified. Only children who reached a predefined level of improvement participated in the randomised, cross-over phase. Although the randomised phase revealed a significant beneficial effect of homeopathy, the cross-over caused a strong carryover effect diminishing the apparent difference between placebo and verum treatment.
  
  
  METHODS
  This retrospective analysis explores the screening phase data with respect to the risk of failure to demonstrate a specific effect of a randomised controlled trial (RCT) with randomisation at the start of the treatment.
  
  
  RESULTS
  During the screening phase, 84% (70/83) of the children responded to treatment and reached eligibility for the randomised trial after a median time of 5 months (range 1-18), with a median of 3 different medications (range 1-9). Thirteen children (16%) did not reach eligibility. Five months after treatment start, the difference in Conners Global Index (CGI) rating between responders and non-responders became highly significant (p = 0.0006). Improvement in CGI was much greater following the identification of the optimal medication than in the preceding suboptimal treatment period (p < 0.0001).
  
  
  CONCLUSIONS
  Because of the necessity of identifying an optimal medication before response to treatment can be expected, randomisation at the start of treatment in an RCT of homeopathy in ADHD children has a high risk of failure to demonstrate a specific treatment effect, if the observation time is shorter than 12 months.
authors.affiliation: Swiss Association of Homeopathic Physicians, Lucerne, Switzerland. heiner.frei@hin.ch
authors.forename: H
authors.initials: H
authors.lastname: Frei
authors.forename: R
authors.initials: R
authors.lastname: Everts
authors.forename: K
authors.initials: K
authors.lastname: von Ammon
authors.forename: F
authors.initials: F
authors.lastname: Kaufmann
authors.forename: D
authors.initials: D
authors.lastname: Walther
authors.forename: S-F Hsu
authors.initials: SF
authors.lastname: Schmitz
authors.forename: M
authors.initials: M
authors.lastname: Collenberg
authors.forename: M
authors.initials: M
authors.lastname: Steinlin
authors.forename: C
authors.initials: C
authors.lastname: Lim
authors.forename: A
authors.initials: A
authors.lastname: Thurneysen
mesh_terms: D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis* / Q000188:drug therapy; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008297:Male; D008419:Materia Medica / Q000627:therapeutic use*; D015999:Multivariate Analysis; D018579:Patient Selection; D012107:Research Design; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013557:Switzerland; D016896:Treatment Outcome
chemical_list: D008419:Materia Medica