Randomized clinical trial of endovenous laser ablation versus direct and indirect radiofrequency ablation for the treatment of great saphenous varicose veins.

BACKGROUND: The current treatment strategy for many patients with varicose veins is endovenous thermal ablation. The most common forms of this are endovenous laser ablation (EVLA) and radiofrequency ablation (RFA). However, at present there is no clear consensus on which of these treatments is superior. The objective of this study was to compare EVLA with two forms of RFA: direct RFA (dRFA; radiofrequency-induced thermotherapy) and indirect RFA (iRFA; VNUS ClosureFast™). METHODS: Patients with symptomatic great saphenous vein (GSV) incompetence were randomized to receive EVLA, dRFA or iRFA. Patients were followed up at 2 weeks, 6 and 12 months. The primary outcome was GSV occlusion rate. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score and adverse events. RESULTS: Some 450 patients received the allocated treatment (EVLA, 148; dRFA, 152; iRFA, 150). The intention-to-treat analysis showed occlusion rates of 75·0 (95 per cent c.i. 68·0 to 82·0), 59·9 (52·1 to 67·7) and 81·3 (75·1 to 87·6) per cent respectively after 1 year (P = 0·007 for EVLA versus dRFA, P < 0·001 for dRFA versus iRFA, P = 0·208 for EVLA versus iRFA). VCSS improved significantly for all treatments with no significant differences between them. AVVQ scores also improved significantly for all treatments, but iRFA had significantly better scores than dRFA at 12 months. Significantly more adverse events were reported after treatment with EVLA (103) than after dRFA (61) and iRFA (65), especially more pain. CONCLUSION: Primary GSV occlusion rates were better after iRFA and EVLA than dRFA. All three interventions were effective in improving the clinical severity of varicose veins at 1 year.

Methotrexate and azathioprine for severe atopic dermatitis: a 5-year follow-up study of a randomized controlled trial.

BACKGROUND: Systemic treatment is indicated for moderate-to-severe atopic dermatitis (AD) refractory to topical treatment. Long-term evidence, up to 5 years, of off-label prescribed methotrexate (MTX) and azathioprine (AZA) is lacking. OBJECTIVES: To investigate long-term effectiveness, safety and drug survival of MTX and AZA. METHODS: In an open-label follow-up phase of a clinical trial, patients were seen every 3 months for 5 years. MTX and AZA doses could be increased or decreased concurrent with daily clinical practice. Primary effectiveness outcomes were mean absolute and relative reduction in SCORing Atopic Dermatitis (SCORAD) index and Investigator's Global Assessment (IGA) after 5 years compared with baseline. To assess safety, the type, frequency, severity and relatedness to treatment of adverse events were investigated. Drug survival was analysed by Kaplan-Meier curves. RESULTS: Thirty-five of 43 originally included patients participated, of whom 27 completed the follow-up. At year 5, the mean relative reduction in SCORAD index was similar in the MTX and AZA groups: 53% and 54% using descriptive analysis. Twelve serious adverse events occurred in 5 years; for three there was a possible causal relationship. Drug survival demonstrated a longer survival for MTX, but survival in both groups was low after 5 years (MTXn = 5, AZAn = 1). CONCLUSIONS: Based on this relatively small pragmatic study, MTX and AZA seem to be effective and safe as maintenance treatments in moderate-to-severe AD up to 5 years. Few patients in both groups survive on their originally allocated drug although some discontinued because of controlled AD.