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Centre for Evidence-
Based Medicine

Completed Therapy Worksheet for Complementary Medicine

Citation

Schmidt MH, Mocks P, Lay B, Eisert HG, Fojkar R, Fritz Sigmund D, Marcus A, Musaeus B.
Does oligoantigenic diet influence hyperactive/conduct-disordered children - a controlled trial.
Eur Child Adolesc Psychiatry 1997;6:88-95

Are the results of this systematic review of therapy valid?

    • Was the assignment of patients to treatments randomised?
      Yes
    • And was the randomisation list concealed?
      Unclear, but trial was crossover in design
  2. Were all patients who entered the trial accounted for at its conclusion? And were they analysed in the groups to which they were randomised?
    No dropouts reported in this in-patient trial
  3. Were patients and clinicians kept "blind" to which treatment was being received?
    Yes: two diets were prepared, a real diet and a "placebo" diet. Children were unable to tell them apart; other relevant staff were not allowed on ward at mealtimes
  4. Aside from the experimental treatment, were the groups treated equally?
    Yes, see above
  5. Were the groups similar at the start of the trial?
    Yes (crossover trial)

Are the valid results of this randomised trial important?

Calculations:

Less than a 25% better response on two of three behavioural outcomes comparing phases Relative Risk Reduction (RRR) Absolute Risk Reduction (ARR) Number Needed to Treat (NNT)
CER EER (CER - EER)/CER CER - EER 1/ARR
96% 76% (96% - 76%) / 96%
= 21% 		96% - 76%
= 20% 		1/20%
= 5 pts

Can you apply this valid, important evidence about a treatment in caring for your patient?

Do these results apply to your patient?

  1. Is your patient so different from those in the trial that its results can't help you?
    Severity is probably less than those in the trial, but otherwise child is similar
  2. How great would the potential benefit of therapy actually be for your individual patient?
    Assume that we do not expect improvement in this child
  3. Method I: f
    Risk of the outcome in your patient, relative to patients in the trial. expressed as a decimal:_1____

    NNT/f = __5_/__1_ = 5
    (NNT for patients like yours)

Are your patient's values and preferences satisfied by the regimen and its consequences?

  1. Do your patient and you have a clear assessment of their values and preferences?
    Need to find out.
  2. Are they met by this regimen and its consequences?
    Need to discuss whether family is prepared to deal with social consequences of a restricted diet. Possible need for referral to dietician.

Additional Notes

-

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