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A multicenter randomized controlled trial of tonsillectomy combined with steroid pulse therapy in patients with immunoglobulin A nephropathy.

ABSTRACT:

Background

The study aim was, for the first time, to conduct a multicenter randomized controlled trial to evaluate the effect of tonsillectomy in patients with IgA nephropathy (IgAN).

Methods

Patients with biopsy-proven IgAN, proteinuria and low serum creatinine were randomly allocated to receive tonsillectomy combined with steroid pulses (Group A; n = 33) or steroid pulses alone (Group B; n = 39). The primary end points were urinary protein excretion and the disappearance of proteinuria and/or hematuria.

Results

During 12 months from baseline, the percentage decrease in urinary protein excretion was significantly larger in Group A than that in Group B (P < 0.05). However, the frequency of the disappearance of proteinuria, hematuria, or both (clinical remission) at 12 months was not statistically different between the groups. Logistic regression analyses revealed the assigned treatment was a significant, independent factor contributing to the disappearance of proteinuria (odds ratio 2.98, 95% CI 1.01-8.83, P = 0.049), but did not identify an independent factor in achieving the disappearance of hematuria or clinical remission.

Conclusions

The results indicate tonsillectomy combined with steroid pulse therapy has no beneficial effect over steroid pulses alone to attenuate hematuria and to increase the incidence of clinical remission. Although the antiproteinuric effect was significantly greater in combined therapy, the difference was marginal, and its impact on the renal functional outcome remains to be clarified.

SUBMITTER: Kawamura T

PROVIDER: S-EPMC4106640 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceImmunoglobulin A nephropathy is a major cause of end-stage renal disease worldwide; previous methods of medical management, including use of renin-angiotensin system inhibitors and corticosteroids, remain unproven in clinical trials.ObjectiveTo investigate the possible association between tonsillectomy and outcomes in patients with IgA nephropathy.Design, setting, and participantsThis cohort study included 1065 patients with IgA nephropathy enrolled between 2002 and 2004 and divided into 2 groups, those who underwent tonsillectomy and those who did not. Initial treatments (renin-angiotensin system inhibitors or corticosteroids) within 1 year after renal biopsy were also evaluated. A 1:1 propensity score matching was performed to account for between-group differences and 153 matched pairs were obtained. Follow-up concluded January 31, 2014. Analysis was conducted between September 11, 2017, and July 31, 2018.ExposureTonsillectomy.Main outcomes and measuresThe primary outcome was the first occurrence of a 1.5-fold increase in serum creatinine level from baseline or dialysis initiation. Secondary outcomes included additional therapy with renin-angiotensin system inhibitors or corticosteroids initiated 1 year after renal biopsy and adverse events.ResultsIn 1065 patients (49.8% women; median [interquartile range] age, 35 [25-52] years), the mean (SD) estimated glomerular filtration rate was 76.6 (28.9) mL/min/1.73 m2 and the median (interquartile range) proteinuria was 0.68 (0.29-1.30) g per day. In all, 252 patients (23.7%) underwent tonsillectomy within 1 year after renal biopsy and 813 patients (76.3%) did not undergo tonsillectomy. The primary outcome was reached by 129 patients (12.1%) during a median (interquartile range) follow-up of 5.8 (1.9-8.5) years. In matching analysis, tonsillectomy was associated with primary outcome reduction (hazard ratio, 0.34; 95% CI, 0.13-0.77; P = .009). In subgroup analyses, benefit associated with tonsillectomy was not modified by baseline characteristic differences. Those undergoing tonsillectomy required fewer additional therapies 1 year following renal biopsy (adjusted hazard ratio, 0.37; 95% CI, 0.20-0.63; P < .001) without increased risks for adverse events, except transient tonsillectomy-related complications.Conclusions and relevanceThis study found that tonsillectomy was associated with a lower risk of renal outcomes in patients with IgA nephropathy. The potential role of tonsillectomy should be considered for preventing end-stage renal disease in patients with IgA nephropathy.

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Project description:Rationale & objectiveStudies of immunoglobulin A nephropathy (IgAN) have suggested the therapeutic benefit of simultaneously adding tonsillectomy to corticosteroid therapy. However, the efficacy of tonsillectomy monotherapy in the absence of simultaneous use of corticosteroids is unclear.Study designPatients with IgAN treated with tonsillectomy monotherapy were analyzed retrospectively. Clinical parameters, including kidney function slope, were compared before and after tonsillectomy.Setting & participantsPatients with biopsy-proven IgAN who received tonsillectomy monotherapy at our hospital between 2007 and 2018.Results20 Japanese patients with IgAN were included in this study (mean follow-up period, 135 months from initial biopsy diagnosis to tonsillectomy). All patients had been treated with renin-angiotensin-aldosterone system inhibitors. 17 patients had a history of induction therapy with corticosteroids. Mean time to tonsillectomy from termination of corticosteroid therapy was 84 months. Hematuria, proteinuria, and clinical remission were achieved in 13 of 17 (76%), 10 of 17 (59%), and 8 of 20 (40%) patients at medians of 3.0, 6.0, and 13.5 months, respectively, after tonsillectomy. The slope of the estimated glomerular filtration rate (eGFR) increased significantly during the 81-month observation period, including the periods before and after tonsillectomy (-2.59 vs 1.05 mL/min/1.73 m2 per year; P < 0.001). The effect on eGFR slope was consistent in 11 patients with reduced GFR (eGFR < 60 mL/min/1.73 m2) at the time of tonsillectomy (-3.07 vs -0.39 mL/min/1.73 m2 per year; P < 0.001).LimitationsSmall sample size. Lack of a control (no-tonsillectomy) group due to the difficulty of setting the baseline time point (which corresponded to tonsillectomy in our sample). Potential exclusion of patients with the most severe disease who are likely to receive corticosteroids. Lack of generalizability to patients in other countries.ConclusionsTonsillectomy monotherapy may prevent kidney function decline in some patients with IgAN with kidney disease that has been progressive despite long-term application of conventional therapies.

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