A double-blind placebo controlled trial of Efamol Marine on skin and joint symptoms of psoriatic arthritis.

Fish oil may be beneficial in the treatment of psoriasis and in RA. We examined the potential benefit of Efamol Marine, a combination of evening primrose oil and fish oil in the treatment of 38 patients with PsA. Patients with PsA were entered in a double-blind placebo controlled study and received either 12 Efamol Marine capsules or 12 placebo capsules daily for 9 months. All patients received placebo capsules for a further 3 months. At month 3 of the study patients were asked to reduce their intake of NSAIDs and maintain that decrease provided there was no worsening of their joint symptoms. Clinical assessments of skin and joint disease severity and activity were performed at 0, 1, 3, 6, 9 and 12 months. All measures of skin disease activity including severity, percentage body affected and itch were unchanged by Efamol Marine. The NSAID requirement remained the same between both treatment groups. In addition, there was no change demonstrated in the activity of arthritis as measured by duration of morning stiffness. Ritchie articular index, number of active joints, ESR and CRP. However, a rise in serum TXB2 was observed in the active group during the placebo phase; in addition a fall in leukotriene B4 production occurred during the active phase period followed by a marked rise during the placebo phase suggesting some laboratory documented anti-inflammatory effect. In conclusion, this study suggests that Efamol Marine may alter prostaglandin metabolism in patients with PsA, although it did not produce a clinical improvement and did not allow reduction in NSAID requirement. A larger dose of essential fatty acid may be needed to produce a clinical benefit.

A double blind, randomised, multicentre comparison of two doses of intravenous iloprost in the treatment of Raynaud's phenomenon secondary to connective tissue diseases.

OBJECTIVE: To compare low (0.5 ng/kg/min) and standard dose (2 ng/kg/min) iloprost (a stable carbacyclin analogue of prostacyclin) in patients with Raynaud's phenomenon secondary to connective tissue disorders. DESIGN: Double blind, random allocation, three six hour infusions on consecutive days. Follow up period eight weeks. SETTING: Rheumatology units, five teaching hospitals. PATIENTS: 55 Patients with Raynaud's phenomenon (greater than seven attacks per week), 32 secondary to well documented classical progressive systemic sclerosis (American Rheumatism Association criteria), 11 CREST syndrome, 5 mixed connective tissue disease, 1 rheumatoid arthritis, 1 Sjögren's syndrome, 1 childhood dermatomyositis, and 4 abnormal nailfold capillaroscopy and antibody profiles but no definite diagnosis. INTERVENTIONS: All other treatment for Raynaud's phenomenon was discontinued two weeks before entry. 28 Patients were randomly allocated to receive the low dose, 27 the standard dose. Differing dilutions allowed infusion rates to be started at 10 ml/h with increments of 10 ml/h every 15 minutes until infusion rates reached 0.5 ng/kg/min and 2 ng/kg/min respectively. MAIN OUTCOME MEASURE(s)--Reduction in frequency, duration, and severity of attacks of Raynaud's phenomenon. Assessment of ulcer and ischaemic lesion healing. RESULTS: Both dosage regimens were equally effective in reducing severity, frequency, and duration of Raynaud's attacks. Ulcer healing occurred to similar degree in both treatment groups (standard dose 44%, low dose 39%). Low dose was associated with significantly fewer side effects. CONCLUSIONS: Both dosage regimens reduce severity of Raynaud's phenomenon and encourage ulcer healing. Low dose was associated with fewer side effects and was better tolerated by the patients.

A study of the longterm efficacy and toxicity of cyclosporine A in rheumatoid arthritis.

We determined the longterm efficacy and toxicity of cyclosporine A in rheumatoid arthritis (RA) in an open clinical trial, at a single centre, outpatient rheumatology clinic. The initial dose was 5 mg/kg/day increased to 10 mg/kg/day with adjustments for toxicity and plasma cyclosporine A levels. We measured efficacy by the Ritchie articular index, pain and function on a 10 cm visual analog scale, C-reactive protein (CRP) and erythrocyte sedimentation rate. Toxicity was evaluated by patient reports, serum creatinine, cyclosporine A levels and liver function tests. Median treatment duration was 29 months (16.5-38). At 24 months median reduction in Ritchie articular index was 50% (9-79); pain: 49% (21-77), with a 50% (4-76) improvement in function; and CRP fell by 72.5% (22-87). The main side effect was a 40% (27-47) decline in estimated creatinine clearance. We conclude that cyclosporine A at doses below 5 mg/kg/day is associated with clinically significant improvements in indices of disease activity in RA. Renal dysfunction was the most frequent side effect.

Iron deficiency anaemia in patients with rheumatic disease receiving non-steroidal anti-inflammatory drugs: the role of upper gastrointestinal lesions.

Upper gastrointestinal lesions associated with non-steroidal anti-inflammatory drug (NSAID) treatment are commonly implicated as the cause for iron deficiency anaemia in patients with rheumatic diseases. Such patients, however, may also have other causes for iron deficiency, including blood loss from the intestine. One hundred and four patients (mean age 58 years; male 21, female 83; smokers 14) with rheumatic disease (rheumatoid 91, others 13) and absent bone marrow iron stores (mean haemoglobin 83 g/l) were examined. At endoscopy 47 of 104 (45%) had upper gastrointestinal lesions (oesophageal ulcer 4, gastric ulcer 25, gastric erosion 13, duodenal ulcer 4, gastric ulcer and duodenal ulcer 1). Endoscopic healing was assessed in 23 patients with upper gastrointestinal lesions. Eighteen of 23 (78%) lesions healed with treatment. An improvement of anaemia occurred in 10 of 18 (56%) patients with healed lesions. Twenty three of 104 (22%) patients had dyspeptic symptoms. Ten of 23 (43%) patients with dyspepsia had an upper gastrointestinal lesion as compared with 30 of 81 (37%) patients without dyspepsia. A faecal occult blood test result was available in 53 patients. Of these, 13 were positive while 40 were negative. An upper gastrointestinal lesion was present in seven of 13 (54%) patients positive for the faecal occult blood test as compared with 14 of 40 (35%) negative for the test. Thus upper gastrointestinal lesions have previously been overestimated as the cause of iron deficiency anaemia in patients receiving NSAIDs. A positive faecal occult blood test or the presence of dyspepsia is not associated with upper gastrointestinal lesions in such patients.

The relationship of sulfoxidation status to efficacy and toxicity of penicillamine in the treatment of rheumatoid arthritis.

Penicillamine shows some structural similarities to carbocysteine. The ability to oxidize carbocysteine, i.e., the sulfoxidation status, shows a bimodal distribution in the general population. In this study, sulfoxidation status was determined in 50 of 60 rheumatoid arthritis patients receiving penicillamine. We found that poor sulfoxidation status, compared with good sulfoxidation status, was associated with a 3.9 times higher incidence of toxicity.