A randomized controlled trial to compare steroid with cyclosporine for the topical treatment of oral lichen planus.

OBJECTIVE: To compare the effectiveness of cyclosporine solution versus triamcinolone acetonide in orabase in the treatment of oral lichen planus (OLP) in reducing signs and symptoms. STUDY DESIGN: One hundred thirty-nine biopsy-proven OLP patients were randomly assigned to cyclosporine (68) or steroid (71) applied onto the target lesion and affected areas. Assessments were at weeks 0, 2, 4, 8 by clinical scoring and grid measurement of the target lesion (reticulation, erythema, ulceration). Patients ranked severity of pain and burning sensation using visual analog scales. RESULTS: Although clinical response, pain, burning sensation, area of reticulation, erythema, and ulceration at week 4 were all worse in patients receiving cyclosporine than in those receiving steroid, the differences were not statistically significant. Large patient-to-patient variability was evident over the observation period, with little evidence of marked changes in levels over time in both treatment groups. CONCLUSION: Topical cyclosporine appears no more effective than steroid in the treatment of oral lichen planus.

A randomized, placebo-controlled trial of thymosin-alpha1 and lymphoblastoid interferon for HBeAg-positive chronic hepatitis B.

Combination therapy between two immunomodulators used for treatment of chronic hepatitis B was explored based on reported therapeutic efficacy of interferon-alpha, and thymosin-alpha1 as monotherapeutic agents to determine if combination therapy was superior to interferon alone. This double-blinded, randomized, placebo-controlled trial compares the addition of thymosin-alpha1, 1.6 microg taken three times per week (combination therapy) or thymosin placebo (monotherapy) to lymphoblastoid interferon (Wellferon), 5 million international units (MIU) taken three times per week, for 24 weeks. Entry criteria included positive hepatitis B e antigen (HBeAg); alanine aminotransferease (ALT) > or = 1.5 x upper normal limit, but < or = 10 x upper normal limit; positive HBV DNA; absence of cirrhosis; treatment naivety and no co-morbid factors. A total of 98 HBeAg-positive patients were recruited, of which 48 were randomized to combination therapy and 50 to monotherapy. The primary endpoint was the loss of HBeAg at 72 weeks. The secondary endpoints were HBeAg seroconversion, normalization of ALT, loss of HBV DNA and improvement in histology. The HBeAg loss was 45.8% and 28.0% for combination therapy and monotherapy, respectively (difference, 17.8%; 95% CI -1.2%-35.3%, P = 0.067). There was a trend towards HBeAg loss when using combination therapy. There were also no statistically significant differences between the different therapies with respect to the secondary endpoints of HBeAg seroconversion, changes in histology, normalization of ALT or loss of HBV DNA. In conclusion, this trial showed a 17.8% improvement in HBeAg loss rates using combination therapy over interferon monotherapy. This could clinically indicate a potential important difference that would need confirmation in subsequent trials.

Randomized trial of Alemtuzumab for prevention of graft rejection and preservation of renal function after kidney transplantation.

BACKGROUND: A randomized, multicenter, controlled trial was undertaken to evaluate the safety and efficacy of Alemtuzumab, a powerful lytic agent for both T and B lymphocytes, in the prophylaxis of rejection in renal transplantation (RTx). METHODS: Thirty patients were randomized to receive Alemtuzumab together with low-dose cyclosporine (CsA) monotherapy (CAMPATH, n = 20) or to full doses of CsA with azathioprine and corticosteroids (Standard, n = 10). CsA was administered at doses to achieve whole-blood trough CsA levels of 90 to 110 ng/mL and 180 to 225 ng/mL in CAMPATH and Standard groups, respectively. RESULTS: Per protocol, CsA trough levels were lower in patients assigned to CAMPATH post-RTx (median trough level of 119 vs. 166 ng/mL at 6 months, CAMPATH vs. Standard; 95% confidence interval, -92 to -34). At 6 months post-RTx, serum creatinine, graft and patient survivals, incidence of biopsy proven acute rejection (25% vs. 20%, CAMPATH vs. Standard), overall treatment failure, and severe and moderate infections were comparable. Whereas all patients receiving Standard therapy required maintenance corticosteroids at 6 months, of the 17 of 20 patients with functioning grafts in CAMPATH, 15 (88%, 95% confidence interval, 53%-97%) were steroid free. CONCLUSION: These results suggest that Alemtuzumab is an effective induction agent that permits low-dose steroid-free immunosuppression in RTx.

A randomized controlled trial to compare calcipotriol with betamethasone valerate for the treatment of cutaneous lichen planus.

BACKGROUND: Topical calcipotriol is a vitamin D3 analogue which influences keratinocyte proliferation and differentiation. Its efficacy in cutaneous lichen planus has not been well evaluated. METHODS: This is a randomized open-label trial comparing the effectiveness of calcipotriol 50 microg/g versus betamethasone 0.1% ointments twice daily for 12 weeks in patients with cutaneous lichen planus, with respect to thickness, pigmentation, clearance and pruritus. Patient self-assessment was made at 0, 4, 8 and 12 weeks post randomization using visual analogue scales (VAS). Clinical assessment was made at week 12 and adverse events noted. Clinical response was defined as 75% or more for lesion flattening and absent or minimal pigmentation, and 50% or more for clearance. RESULTS: A total of 31 patients were randomized: 15 to calcipotriol and 16 to betamethasone. Clinically assessed lesion flattening occurred in approximately half the patients. With calcipotriol, there were two responses for pigmentation and one for clearance but none with betamethasone. Patient VAS indicated a gradual improvement in all measures but with little difference between the treatments. The largest difference indicated a 12-point disadvantage to calcipotriol for thickness but this was not statistically significant (p=0.09). Side effects reported were erythema (one patient) and increased pruritus (two patients), all with calcipotriol. CONCLUSION: Calcipotriol appears no more effective than betamethasone. The course of the disease appears to be affected in the same way by both treatments.