title: Combination therapy with gold and hydroxychloroquine in rheumatoid arthritis: a prospective, randomized, placebo-controlled study.
abstract: We studied combination therapy with two slow-acting antirheumatic drugs given concurrently in active rheumatoid arthritis (RA). A 12-month prospective randomized controlled trial compared gold and hydroxychloroquine in 52 patients to gold and placebo in 49. The patients continued to receive non-steroidal anti-inflammatory drugs and analgesics. They were selected from three rheumatology centres in the West Midlands. Combination therapy led to a greater number of withdrawals due to adverse reactions (18 cases compared to 10 receiving gold/placebo). Patients completing 12 months' therapy (27 taking gold/hydroxychloroquine and 32 on gold/placebo) were compared using five clinical, seven laboratory, and one radiological measure. All 13 variables favoured gold/hydroxychloroquine with an overall advantage of 20-25% for the combination. This only reached statistical significance (at the 1% level) for C-reactive protein. An overall disease activity index was better at 12 months (at the 5% level) and showed a more rapid response with gold/hydroxychloroquine. This is the first randomized prospective placebo-controlled trial to show a significant advantage from a combination of two slow-acting drugs. There are many different ways of giving such combinations and we consider these should be explored to maximize the effectiveness of treatment for RA.
authors.affiliation: St. Bartholomew's Hospital, London.
authors.forename: D L
authors.initials: DL
authors.lastname: Scott
authors.forename: P T
authors.initials: PT
authors.lastname: Dawes
authors.forename: E
authors.initials: E
authors.lastname: Tunn
authors.forename: P D
authors.initials: PD
authors.lastname: Fowler
authors.forename: M F
authors.initials: MF
authors.lastname: Shadforth
authors.forename: J
authors.initials: J
authors.lastname: Fisher
authors.forename: S
authors.initials: S
authors.lastname: Clarke
authors.forename: M
authors.initials: M
authors.lastname: Collins
authors.forename: P
authors.initials: P
authors.lastname: Jones
authors.forename: A J
authors.initials: AJ
authors.lastname: Popert
mesh_terms: D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D006046:Gold / Q000627:therapeutic use*; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D008875:Middle Aged; D010146:Pain; D010919:Placebos; D011446:Prospective Studies; D011859:Radiography; D011897:Random Allocation; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D010919:Placebos; D006886:Hydroxychloroquine; D006046:Gold