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Saturday
Oct242009

Todiben

An  Isador Nabi advanced pre-publication, pre-review, pre-approval and post marketing advisory on

 

                       The Multicenter Orthogenetic Replicate Trials (MORT) of Todiben™ in the treatment of Diffuse Amorphous Malaise (DAM)

Fritz Tenureman, Jason Reising, Allan Orda, Helen Wiels, Bill Pendin and Arthur Blatant

 

          Diffuse Amorphous Malaise (DAM) is the fastest-growing complaint among Americans above the age of six.  It is defined in the national catalog of vague disorders as an undescribable malaise in three or more body parts for more than three consecutive days in any one month, with “malaise” being any score above six on the Blaine-Fischman scale, or 15 on the Fischman-Dober scale or anything at all on the Dober-Krane scale.

          MORT studied 8112 pairs of pink identical twin nurses, or 16,225 subjects.(The odd number is due to rounding error). The participants were assigned at random to be treated with 20 mg of Todiben™ three times a day or a placebo of biochemically inert material (in this case, ground glass).  In order to avoid carryover effects from prior experience, data from the first month of the trial was discarded by means of the Polisanto Data Discarder. During this period 120 subjects in the placebo group and 96 in the treatment group dropped out of the study for a variety of reasons, the most frequently cited being death and panic.  In all such cases the remaining twin was humanely excluded from the study.  Subjects received as nominal compensation a free dinner at the Hunan-in-Boston Restaurant and Take-out.

          The study was conducted at 13 clinical centers of the Business University Research Partnership (BURP) spread out over the continental United States and some undisclosed locations in former socialist countries.  Here we report on the aggregate results of centers 3 and 8 during month 2.  In order to preserve confidentiality and proprietary information, names and numbers have been altered. The data from the other centers were destroyed by the means described above.

          Results

Two subjects in the placebo group (2.1%) and one subject in the treatment group(0.9%) reported or were diagnosed with DAM. Thus Todiben™ reduced the risk of DAM by 43%. The absence of statistical significance is most likely due to the small sample size of this subset and the overly cautious dosing.

          Conclusions

          it is recommended that Todiben™ be used for the treatment and prevention of DAM at 60 mg per day with smaller doses for children, babies, cardiac patients more than 70 years old, and pets.

 

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References (1)

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  • Response
    Richard Levins - Human Ecology - Writings - Todiben

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