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Double-Blind, Randomized Clinical Trial of Troxerutin-Carbazochrome in Patients with Hemorrhoids

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Double-Blind, Randomized Clinical Trial of Troxerutin-Carbazochrome in Patients with Hemorrhoids European Review for Medical and Pharmacological Sciences 2000; 4: 21-24 Double-blind, randomized clinical trial of troxerutin-carbazochrome in patients with hemorrhoids F. SQUADRITO, D. ALTAVILLA, S. OLIARO BOSSO* Istituto di Farmacologia, Servizio di Farmacologia Clinica, University of Messina (Italy) *Pharmafar Srl – Torino (Italy) Abstract. – This multicenter, double-blind, function by reducing abnormal leakage. This randomised study was undertaken to determine compound is able to inhibit the enzyme cathe- the efficacy and safety of a combination of trox- chol-ortho-methyl-transferase (COMT); this, in erutin 150 mg and carbazochrome 1.5 mg com- pared to carbazochrome alone in patients with turn, leads to more sustained local epinephrine acute uncomplicated hemorrhoids. levels. Other mechanisms of action have been Patients were administered by the intramuscu- claimed, involving an inhibition of jaluronidase lar route (one ampoule) twice daily for one week. and histamine synthesis at the vascular wall, Both subjective and objective efficacy vari- and a decreased blood viscosity and erythro- ables significantly improved in the combination cytes aggregation1. The profibrinolytic and rhe- drug group only, thus demonstrating the ratio- ological activities of troxerutin appeared well nale for a combination therapy. 2 Treatments were safe and well tolerated either correlated with its plasma levels . at a local or systemic level. Carbazochrome – (3-hydroxy-1-methyl-1,5,6- indolinedione semicarbazone) – a stable oxy Key Words: epinephrine derivative, devoid of any adrener- Troxerutin, Carbazochrome, Hemorrhoids, Controlled gic action, is able to enhance microcirculatory clinical trial. tone, thus decreasing the hemorrhage time3. In patients with chronic venous insufficien- cy, this combination demonstrated to effec- tively control signs and symptoms of venous stasis with a twice-daily im administration Introduction and to be safe and well tolerated4,5. The primary objective of the present dou- The combination of troxerutin and car- ble-blind, randomised, controlled study was bazochrome (Fleboside® ampoules) finds its to evaluate efficacy and tolerability of this rationale on the pharmacological interaction combination treatment regimen compared to of the two active components on the micro- carbazochrome alone, in patients with acute, circulation. uncomplicated hemorrhoids, in order to vali- Troxerutin – (2-[3,4-Bis(2-hydroxyethoxy) date the rationale of the fixed combination phenyl]-[[6-O-deoxy-a-L-mannopyranosyl)-β- product with relevance to the treatment of D-glucopyranosyl]-oxy]-5-hydroxy-7-(2-hy- hemorrhoids. droxyethoxy)-4H-1-benzopyran-4-one) – is a bioflavonoid and the main component of a mixture, the O-(β-hydroxyethyl) rutosides, which also contains mono-, di-, tetra-, and oth- Patients and Methods er trihydroxyethyl derivatives of rutin. The term oxerutins is applied to a mixture of 5 dif- Study design ferent o-(β-hydroxyethyl) rutosides, not less This double-blind, parallel-group, controlled than 45% of which is troxerutin. This substance study was conducted on an out-patient popula- shows an ability to increase vascular resistance tion addressing to the Clinical Pharmacology at the arteriolar level and to improve capillary Unit of the University of Messina. 21 F. Squadrito, D. Altavilla, S. Oliaro Bosso Patient eligibility was determined at a A total of 100 subjects were enrolled at the screening visit at which a medical history was end of the screening period. Patients were the taken and a complete physical examination, divided into two parallel groups of 50 sub- including endoscopy, was performed. jects each, after the randomisation proce- Eligible patients (those meeting a diagnosis dure. of acute uncomplicated hemorrhoids accord- ing to the Merck Manual6) were randomised Measurements to either receive the combination product Clinical visits were scheduled weekly dur- (troxerutin 150 mg and carbazochrome 1.5 ing the enrolment period, at the start of treat- mg) twice daily by the intramuscular route, or ment, and after the 1-week period of treat- one of the ingredients (saline containing car- ment; a follow-up visit was scheduled 1 week bazochrome 1.5 mg to give the solution the after study completion. same appearance as the combination prod- Vital signs were measured and an interim uct) twice daily by the same route, during a 7- medical history was taken at each clinic visit. day period. Vital signs were measured 3 times at 2- This study was performed in accordance minute intervals after the patient sat quietly with the requirements of ICH Good Clinical for at least 5 minutes, with mean sitting sys- Practice, the Declaration of Helsinki as tolic blood pressure (sSBP), sitting diastolic amended in Hong Kong in 1989, and institu- blood pressure (sDBP), and sitting heart rate tional review board approval. The protocol (SHR) calculated from the average of the 3 and statement of informed consent were ap- measurements. proved by the Institutional Review Board Haematology, blood chemistry (including prior to the beginning of the trial. Written in- prothrombine time) and urinalysis were mea- formed consent was obtained from each pa- sured at screening and after the 1-week treat- tient before entry the study, and patients ment period. were informed of their right to withdraw at any time. Efficacy variables Subjective efficacy variables (anal discom- Patients fort, spontaneous local pain and pain at defe- Patients with acute uncomplicated hemor- cation), and objective signs (proctorrhagia, rhoids who were at least 30 years of age were proctitis, anal prolapse), were evaluated by a eligible if their diagnosis was endoscopically four-point scale from 0 = absent to 4 = severe. confirmed. All patients who entered the dou- ble-blind treatment period were required to Safety assessment have developed hemorrhoidal symptoms dur- All adverse events were coded from the ing the preceding ten days in the absence of verbatim term according to the World Health any other medication. Organisation Adverse Reaction Terminology Patients with any of the following criteria dictionary by body system and preferred were ineligible: advanced hemorrhoids re- term6. quiring surgery; type I diabetes mellitus; Vital sign measurements of concern were congestive heart failure being treated with defined as follows: anti-platelet drugs; or presence of clinically SBP (< 120 mm Hg), DBP (< 60 mm Hg), significant renal, hepatic, or other concur- and HR (< 50 o > 120 beats/min). rent severe disease. Use of fibrinolytic drugs, other venous-acting medications or Statistical analysis an investigational drug within 30 days of An intent-to-treat analysis of all patients screening, analgesic (other than a 5% lido- randomly allocated to receive study medica- caine ointment) or non-steroidal anti-in- tion or control drug was performed. flammatory drugs within 7 days of screen- Randomisation was performed using a pseu- ing, or concomitant use of medications do-random number table generated by a vali- known to affect pain or hemostasis were not dated software (GraphPadTM, Sorrento allowed. Women who were pregnant or lac- Valley, California, USA). tating were excluded, as were patients with The power of the study was assessed ac- active alcohol or drugs abuse. cording to the following calculation: 22 Double-blind, randomized clinical trial of troxerutin-carbazochrome in patients with hemorrhoids Sample sizes were calculated using GraphPad 0.001), whereas in the control group only anal StatMate version 1.01i, GraphPad Software, San Diego discomfort and spontaneous pain showed a California USA, www.graphpad.com ® 1995-98, GraphPad Software Inc. All rights reserved. significant improvement (p = 0.05) (Figure 1). Objective signs (proctorrhage, proctitis and N per Power Power Power anal prolapse) were not altered by the 7-day group 99% 95% 90% course of the control drug, but showed some amelioration after the study drug, with a sig- 40 0.49 0.41 0.37 50 0.43 0.36 0.33 nificant reduction of local hemorrhage (p < 0.001) and inflammation (p < 0.0001). Anticipated SD of each group (assume equal): 0.5, The frequency of application of the local Alpha = 0.05, two-tailed. anaesthetic ointment significantly decreased (p < 0.01) in the active drug-treatment group only. Clinical scores were analysed using a The results of the subgroup analysis of effi- Wilcoxon pairwise statistics for each treatment cacy according to patients’ age and sex were group. Statistical significance between groups consistent with the analysis of the total pa- was determined using the two-tailed Mann- tient population. However, the limited num- Whitney U test. For the safety assessments, ber of patients in each subgroup precluded summary statistics of laboratory test values and statistical evaluation of differences between incidence of adverse events were determined. subgroups. Safety results All subjects completed the study without Results experiencing any adverse reactions, both at the local and systemic level. Patients The mean changes from baseline in labora- The groups of patients randomly allocated tory variables were generally small and less to receive study medication, or control drug than 5% for each treatment group. had similar demographic and clinical charac- The exception was VES which decreased teristics at baseline (Table I). 8% in the combination drug group, this being All patients who were randomised were < possibly related to an anti-inflammatory ac- 60 years of age and were Caucasian. The two
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