A comparative trial of clomipramine and placebo as adjunctive therapy in arthralgia.

Several studies have reported that both imipramine and clomipramine are valuable adjuncts in the management of chronic pain, in particular that associated with the arthritides. A double-blind between-patients clinical trial of clomipramine and placebo was performed in general practice in patients suffering from arthralgia and who had stable regular predictable pain in the joints without the immediate prospect of natural remission. Clomipramine (25 mg daily) or placebo was administered in addition to standard analgesic or anti-inflammatory therapy. Twenty-eight general practitioners recruited seventy-four patients. Forty-nine patients satisfactorily completed the study and twenty-five 'dropped out'. Twenty-three completers received active medication and twenty-six received placebo. The trial failed to demonstrate any difference between the two adjunctive treatments. These results are in marked contrast to those obtained in other studies. Possible reasons are discussed. The dose may have been inadequate and the consumption of 'rescue analgesics' was inadequately controlled. Previous 'positive studies' had been within-patients designs as opposed to between-patients studies. This methodological difference may be important.