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We have noted an unusually high rate of divorce among participants in a recent small treatment trial of multiple sclerosis.1 Of the 29 patients in the study, 19 were married at entry. During the 18 months of follow up, six patients (31%) became involved in divorce proceedings. In four of these, the unaffected spouse left the marriage for another partner. There was a transient breakdown in one other marriage, which did not lead to divorce, after an extramarital affair by the unaffected partner. Since the study ended, there has been one further divorce after an affair by the unaffected spouse. Those patients who became divorced were not distinguishable by their disability, the efficacy of their treatment, or the duration of their disease or marriage.
The divorce rate in this study, equivalent to an annual rate of 21% of married couples, is considerably greater than the annual divorce rate in the United Kingdom for age and sex matched married couples of 2.4%-3.1%.2 Physical disability due to any cause is a risk factor for divorce3 and multiple sclerosis is no exception.4 However, this effect is not sufficient explanation to account for the exceptionally high divorce rate seen during this study. In one Australian study, the most severely disabled patients with multiple sclerosis were four times more likely to have been divorced than the less disabled; but even among the most disabled the prevalence of divorce was only 13%-18% of all prevalent patients.5 We suggest that participation in a treatment trial indirectly precipitates divorce, by exposing marital dissatisfaction in the unaffected spouse. One possible explanation may be that trial participation focuses attention on the affected spouse's disability. Alternatively, perhaps the frequent attentions of an interested medical team during a trial relieve the unaffected partner of a sense of responsibility towards his or her spouse. Another interpretation might be that recruitment to therapeutic trials is biased towards those patients who perceive a greater degree of dissatisfaction with their personal situation. To the best of our knowledge, in no previous treatment trial in multiple sclerosis, nor indeed of any other disease, has such a high rate of divorce been noted.
In the light of these findings it may be prudent to make patients and their spouses (or partners) aware, during the recruitment interviews for clinical trials, of the strains which participation may expose in their relationship.