The effects of procaine/haematoporphyrin on age-related decline: a double-blind trial. A controlled trial of "gerioptil".
A randomized, double-blind study of procaine/haematoporphyrin (KH3) has been carried out over two years in a selected population of healthy elderly subjects. The period of study exceeds 500 patient years. The trial population was weighted to contain a larger proportion of subjects aged over 75 years than a standard population; those receiving active KH3 had similar characteristics on entry to those receiving placebo. Over the course of two years, KH3 was shown to be an active substance in that: (a) decrement in the consolidation of new learning was prevented in the treatment group (less than 1.0%, as against 38% in the placebo group); (b) the prevalence of incontinence increased significantly in the placebo group, but not in the active group (P less than 0.05); (c) there was a significant increase in grip strength in the active treatment group (+22%, P less than 0.01 v. placebo); (d) more adverse reactions were observed on treatment with KH3 (P less than 0.005). nan
This review suggests that the evidence for detrimental effects of procaine and its preparations is stronger than the evidence for benefit in preventing and/or treating dementia or cognitive impairment.
There is some evidence from older studies that procaine preparations might improve memory in persons without cognitive impairment. However, the clear evidence of side effects suggests that the risks might outweigh the benefits. In the light of this, the strong marketing claims for procaine preparations should be withdrawn until trials of adequate size, duration and quality have been conducted.