RESUMO
BACKGROUND: Anal fissure is a common anorectal problem causing severe pain and discomfort to the patients. Chemical sphincterotomy has emerged as a noninvasive alternative to the surgical methods of fissure treatment. The objective of this study was evaluation of the efficacy and the adverse effects of topically applied minoxidil in chemical sphincterotomy of chronic anal fissure in comparison with topical diltiazem. METHODS: A total of 88 patients with chronic anal fissure aged between 15 and 65 years were included in this double-blind, randomized clinical trial and were randomly assigned to either 0.5% minoxidil cream or 2% diltiazem cream twice daily for 2 weeks. The pain intensity, bleeding, wound healing, itching, headache, dizziness, significant drop in blood pressure, allergy and fissure relapse were assessed on a monthly basis for 2 months. RESULTS: Both diltiazem and minoxidil reduced the pain, bleeding and improved fissure healing with no significant difference. There were no between-groups differences in the frequencies of adverse effects, except for itching which was slightly higher with minoxidil during the first month. Allergy occurred in two patients in the minoxidil group, which was not severe and did not lead to discontinuation of the trial. CONCLUSION: Topically administered minoxidil is of equal efficacy as diltiazem in the treatment of chronic anal fissure with low frequency of adverse effects. Thus, it can be considered as an agent for chemical sphincterotomy of anal fissure, but the itching at the beginning of the treatment can affect the adherence of the patient to treatment. Trial registration number IRCT2015041414483N6 (the full trial protocol could be accessed online at www.irct.ir ).
Assuntos
Diltiazem/uso terapêutico , Fissura Anal/tratamento farmacológico , Minoxidil/uso terapêutico , Administração Tópica , Adolescente , Adulto , Pressão Sanguínea/efeitos dos fármacos , Doença Crônica , Diltiazem/administração & dosagem , Diltiazem/efeitos adversos , Método Duplo-Cego , Hipersensibilidade a Drogas/etiologia , Feminino , Fissura Anal/complicações , Cefaleia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Minoxidil/administração & dosagem , Minoxidil/efeitos adversos , Dor/tratamento farmacológico , Dor/etiologia , Estudos Prospectivos , Prurido/induzido quimicamente , Cicatrização/efeitos dos fármacos , Adulto JovemRESUMO
BACKGROUND: Diabetic nephropathy is the most important cause of end stage renal disease (ESRD). Aldosterone is involved in renal damage through induction of fibrosis, inflammation and necrosis in the kidney tissue. Previous studies have demonstrated that the combination of angiotensin receptor blocker (ARB) and spironolactone (an anti-aldosterone drug) are efficient for albuminuria reduction. OBJECTIVES: This study was designed to evaluate the effect of spironolactone alone on diabetic nephropathy. PATIENTS AND METHODS: In this double blind randomized clinical trial, 60 type II diabetic patients with microalbuminuria were enrolled. They were divided into two groups: case group (spironolactone 25 mg and placebo, 30 cases) and control (spironolactone 25 mg plus losartan 25 mg, 30 cases). The treatment success rate (more than 50% reduction in microalbuminuria) was compared between the two groups. RESULTS: After three months, successful treatment was seen in 70% (95% CI: 52 - 83) and 83.3% (CI 95%: 66 - 93) of case and control groups, respectively (P = 0.4). Mean ± SD of serum potassium levels after three months in case and control groups were 4.56 ± 0.38 and 4.39 ± 0.34 mEq/L, respectively (P = 0.08). Mean ± SD of systolic blood pressures in case and control groups were 129.67 ± 9.4 and 130.97 ± 9.4 mmHg, respectively (P = 0.6). Mean ± SD of serum creatinine levels at the end of the study were 0.95 ± 0.15 in case and 0.90 ± 0.22 mg/dL in control group (P = 0.4). CONCLUSIONS: Spironolactone alone is as effective as the combination of spironolactone and losartan on albuminuria reduction in type 2 diabetic patients and can be used alone as an effective drug for diabetic nephropathy.