Osteoarthrosis of the Hip: Synergism or Additive Effect in Combined Medication (with Corticosteroid and Phenylbutazone)

A double-blind study has been carried out in 30 patients to assess the value of Delta-Butazolidin (phenylbutazone 50 mg + prednisone 1.25 mg) in osteoarthrosis of the hip; and to establish the relative importance of the two active constituents. An incomplete crossover design was used, patients being divided into three groups. Each group received, in a randomly allocated sequence, two of the following three medications, for a period of three weeks: Delta-Butazolidin, prednisone 1.25 mg, placebo. The dosage administered was one tablet three times a day, and paracetamol was allowed as rescue analgesic.

The following examinations and assessments were carried out: pain, inter-malleolar spread, walking time, tolerability, paracetamol consumption, haemoglobin, WBC and platelet count, ESR, phenylbutazone plasma levels.

Delta-Butazolidin was found to be more effective than prednisone and placebo for all the variables assessed (except that prednisone had more effect on haemoglobin levels). Prednisone alone was more effective than placebo alone for all parameters (except walking time).

The therapeutic blood levels of phenylbutazone achieved using the small dose of Butazolidin raise the question whether smaller doses of this drug could be recommended in the treatment of patients with osteoarthrosis, with a likely decrease in the incidence of side-effects.

Even though Delta-Butazolidin was the most effective preparation, the clear effect of prednisone alone on a number of parameters strongly suggests that there is an inflammatory component in osteoarthrosis of the hip.