Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease
Condition: Behcet's Syndrome
MeSH terms: Behcet Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports
      of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients
      could be explained by genetic difference between the Silk Road BD and sporadic BD from other
      parts of the world.

      To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a
      randomized double-blind controlled crossover study in Iran, which is in the middle of the
      Silk Road, and has the second highest prevalence of BD in the world.
    

Detailed description: 
      Patients: They were selected as consecutive patients.

      The entry criteria was: age between 14 and 60 years, confirmed diagnosis of Behcet's Disease,
      absence of major organ involvement (eye, brain, lung, and cardio-vascular involvement),
      having at least one active symptom, and no treatment for at least one month. Patients were
      explained the study design and they gave a signed written consent. During the two phases of
      study, if a major organ involvement appeared, the patient was moved out of the study. All
      patients fulfilled the new International Criteria for Behcet's Disease.

      Method: patients were randomized at the study entry to take either colchicine or placebo. At
      4 months, they were crossed over. Those who were taking colchicine went on placebo and those
      on placebo went on colchicine. Each patient tried therefore, both colchicine and placebo. The
      primary outcome was the effect of colchicine on the disease activity index, the IBDDAM
      (16-17). To calculate the overall IBDDAM of the baseline, the IBDDAM of the last 12 months
      (prior to the study) of each manifestation was calculated and added together. The overall
      disease activity index was then divided to the number of months (12 months) to have the mean
      activity index per month. IBDDAM was then measured every 2 months (in the middle and at the
      end, in each arm of the study). The total IBBDAM of the 4 months was then divided by 4 to
      have the mean activity index per month. The secondary outcome was to see how the individual
      symptoms responded to colchicine (IBDDAM of each manifestation).

      Statistical analysis: The analysis was done by the intention to treat method. As the
      difference between IBDDAM before and after treatment had normal distribution Student T test
      for paired samples were used to evaluate the outcome in the colchicine and the placebo group.
      As the Levene's test showed the homogeneity of variance, ANOVA (one way) was used to test the
      effect of treatment (colchicine and placebo) and gender on patients' outcome. The dependent
      variable was the difference between IBDDAM (before and after the treatment). The independent
      variables were the treatment, and the gender. SPSS 15 was used for all statistical
      calculations.
    

Intervention name(s): Colchicine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg Colchicine per day for 4 months; One tablet placebo per day for 4 months
Other intervention name(s): Modacine
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral aphthosis; Genital aphthosis; Psuedofolliculitis; Erythem nodusom; Joint manifestations; Colchicine