8602
document
Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status : a randomized , double-blind , placebo-controlled , phase IV study . Flavonoids , such as troxerutin , have been shown to be safe and effective agents for the treatment of chronic venous insufficiency . The fixed combination between troxerutin 150 mg and carbazochrome 1.5 mg ( Fleboside ampoules ) was previously shown to have a good efficacy and safety profile in non-surgical patients with acute uncomplicated hemorrhoids . The purpose of this randomized , double-blind , placebo-controlled study was to investigate the efficacy and tolerability of the active combination in the treatment of post-hemorrhoidectomy patients . 30 patients were randomized to receive one of two treatments : troxerutin 150 mg and carbazochrome 1.5 mg , or placebo , i.m . 3 ml ampoules twice a day for five consecutive days after the surgical procedure , starting from the day of surgery . Efficacy parameters were assessed as follows : at baseline ( T1 ) , after the first administration ( T2 ; day of surgery ) , the second day after the surgical procedure ( T3 ) , and the fifth day after the surgical procedure ( T4 ) ; hemorrhoidal symptoms based on a visual analogue scale ( VAS ) : pain , discharge , bleeding , inflammation , and pruritus ; analgesic intake , if any ; time to restore a physiological defecation ; edema evaluation ( based on a four-point scale : 0 = absent ; 1 = mild ; 2 = moderate ; 3 = severe ) ; camera pictures taken at T1 and T4 ( in selected patients ) ; and blood coagulation tests . Analysis between treatment groups revealed a highly significant difference at T3 and T4 for the total VAS score ( p = 0.007 and p = 0.001 , respectively ) in favor of the active combination treatment . A statistically significant difference was also observed for bleeding and pruritus at T3 and for these two parameters and both inflammation and edema at T4 ( p < 0.001 ) in favor of the active combination group . No adverse events were reported . Neither the active combination nor placebo affected blood coagulation tests . We conclude that intramuscular administration of the fixed combination of troxerutin 150 mg and carbazochrome 1.5 mg is effective , well tolerated and superior to placebo in improving hemorrhoidal and post-surgical symptoms during the five days following surgery .
8603
Intervention_Pharmacological
troxerutin and carbazochrome combination
8604
Intervention_Pharmacological
troxerutin
8605
Intervention_Pharmacological
troxerutin
8606
Intervention_Pharmacological
carbazochrome
8607
Intervention_Pharmacological
troxerutin 150 mg and carbazochrome 1.5 mg
8608
Intervention_Control
placebo
8609
Intervention_Pharmacological
combination of troxerutin
8610
Intervention_Pharmacological
carbazochrome
8611
Intervention_Control
placebo
8612
Outcome_Other
Efficacy
8613
Outcome_Physical
hemorrhoidal symptoms based on a visual analogue scale ( VAS )
8614
Outcome_Pain
pain
8615
Outcome_Physical
discharge
8616
Outcome_Physical
bleeding
8617
Outcome_Physical
inflammation
8618
Outcome_Physical
pruritus
8619
Outcome_Other
analgesic intake , if any ; time to restore a physiological defecation
8620
Outcome_Physical
camera pictures taken at T1 and T4
8621
Outcome_Physical
blood coagulation tests
8622
Outcome_Physical
significant difference
8623
Outcome_Other
total VAS score
8624
Outcome_Physical
bleeding
8625
Outcome_Physical
pruritus
8626
Outcome_Physical
inflammation
8627
Outcome_Physical
edema
8628
Outcome_Adverse-effects
No adverse events
8629
Outcome_Physical
blood coagulation
8630
Participant_Condition
acute uncomplicated hemorrhoids
8631
Participant_Condition
post-hemorrhoidectomy
8632
Participant_Sample-size
30