 |
 |
Due to unusual interest this item and comment from CSR APR 01 are posted here ahead of time: Freed C et al;New England Journal of Medicine 2001;344:710-719: Trials in human subjects for acceptance or approval of new therapy need to account for the placebo effect. This is espec- ially true in the case of fetal tissue transplants for PD, which are complicated, difficult, risky, and subject to delay of a year or more before clinical results are apparent. The tantalizing possibility of even partial cure or remission makes this first controlled trial most important. They divided their cohort of 40 patients in 2 halves, matched as well as they could in age and other characteristics. All in one half got the transplant, with care to make the procedure as uniform as possible. The rest got the same in every detail, up to completion of the drilled hole, but instead of the next step, perforation of the dura, they returned to recovery and the uniform protocol from there on. All subjects had accepted the 50% odds of a sham procedure on the promise of getting the real one after the one-year control period if they so wished. Until then, neither subjects nor attendants knew which arm they were in. The operating surgeons weren't told until the drilled hole was done, and from that point on took no further part in care or follow-up examinations of the subjects. In general, the transplants survived and grew, with modest clinical benefit to recipients 60 or younger, but little or none to those older than 60. Tabular data suggest that the transplants led to more frequent hallucinations, delusions, and other psychoses (8 vs 1) and more falling (9 vs 3). Dyskinesia worsened in the sham group (as might be expected after 1 year), but after initial improvement, in some transplant recipients as well, despite reduction of levodopa intake. For those reasons, some of the younger placebo subjects declined the transplant and older ones were advised against it. Fischbach G, McKhann G;NEJM 2001;344:463-465 (editorial): Faint praise of the above item, noting that there is much to learn before such transplants can become accepted therapy. Cheers, Joe -- J. R. Bruman (818) 789-3694 3527 Cody Road Sherman Oaks, CA 91403-5013