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Meta-Analysis
. 2012 Aug 15;2012(8):CD004322.
doi: 10.1002/14651858.CD004322.pub3.

Phlebotonics for haemorrhoids

Nirmal Perera  1 , Danae Liolitsa, Satheesh Iype, Anna Croxford, Muhammed Yassin, Peter Lang, Obioha Ukaegbu, Christopher van Issum
Affiliations
Meta-Analysis

Phlebotonics for haemorrhoids

Nirmal Perera et al. Cochrane Database Syst Rev. .

Abstract

Background: Haemorrhoids are variceal dilatations of the anal and perianal venous plexus and often develop secondary to the persistently elevated venous pressure within the haemorrhoidal plexus (Kumar 2005). Phlebotonics are a heterogenous class of drugs consisting of plant extracts (i.e. flavonoids) and synthetic compounds (i.e. calcium dobesilate). Although their precise mechanism of action has not been fully established, they are known to improve venous tone, stabilize capillary permeability and increase lymphatic drainage. They have been used to treat a variety of conditions including chronic venous insufficiency, lymphoedema and haemorrhoids.Numerous trials assessing the effect of phlebotonics in treating the symptoms and signs of haemorrhoidal disease suggest that there is a potential benefit.

Objectives: The aim of this review was to investigate the efficacy of phlebotonics in alleviating the signs, symptoms and severity of haemorrhoidal disease and verify their effect post-haemorrhoidectomy.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library 2011 issue 9 , MEDLINE (1950 to September 2011) and EMBASE (1974 to September 2011).

Selection criteria: Only randomised controlled trials evaluating the use of phlebotonics in treating haemorrhoidal disease were used. No cross-over or cluster-randomized trials were included for analysis and any trial which had a quasi-random method of allocation was excluded.

Data collection and analysis: Two authors independently extracted the data and analysed the eligibility of the data for inclusion. Disagreements were resolved by meaningful discussion.

Main results: We considered twenty-four studies for inclusion in the final analysis. Twenty of these studies (enrolling a total of 2344 participants) evaluated the use of phlebotonics versus a control intervention. One of these twenty studies evaluated the use of phlebotonics with a medical intervention and another study with rubber band ligation.The remaining four studies included two which compared different forms of phlebotonics with each other, one study which evaluated phlebotonics with a medical intervention and one study which compared the use of phlebotonics with infrared photocoagulation. Eight studies were excluded for various reasons including poor methodological quality.Phlebotonics demonstrated a statistically significant beneficial effect for the outcomes of pruritus (OR 0.23; 95% CI 0.07 to 0.79) (P=0.02), bleeding (OR 0.12; 95% CI 0.04 to 0.37) (P=0.0002), bleeding post-haemorrhoidectomy (OR 0.18; 95% 0.06 to 0.58)(P=0.004), discharge and leakage (OR 0.12; 95% CI 0.04 to 0.42) (P=0.0008) and overall symptom improvement (OR 15.99 95% CI 5.97 to 42.84) (P< 0.00001), in comparison with a control intervention. Although beneficial they did not show a statistically significant effect compared with a control intervention for pain (OR 0.11; 95% CI 0.01 to 1.11) (P=0.06), pain scores post-haemorrhoidectomy (SMD -1.04; 95% CI -3.21 to 1.12 ) (P= 0.35) or post-operative analgesic consumption (OR 0.54; 95% CI 0.30 to 0.99)(P=0.05).

Authors' conclusions: The evidence suggests that there is a potential benefit in using phlebotonics in treating haemorrhoidal disease as well as a benefit in alleviating post-haemorrhoidectomy symptoms. Outcomes such as bleeding and overall symptom improvement show a statistically significant beneficial effect and there were few concerns regarding their overall safety from the evidence presented in the clinical trials.However methodological limitations were encountered. In order to enhance our conclusion further, more robust clinical trials which take into account these limitations will need to be performed in the future.

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Conflict of interest statement

No conflicts of interest are present and no declarations of interest are present.

Figures

1
1
Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.1 Pain (dichotomous variable)
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2
Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.2 Pain scores (post‐haemorrhoidectomy).
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Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.3 Bleeding.
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Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.4 Bleeding post‐haemorrhoidectomy taken at 2 weeks (dichotomous variable).
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Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.5 Pruritus.
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Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.6 Discharge or Leakage.
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Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.7 Overall symptom improvement.
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Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.8 Analgesic intake (post‐operative day 2)
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9
Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.9 Adverse events (side‐effects)
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Forest plot of comparison: 1 Phlebotonic versus placebo or control intervention, outcome: 1.10 Non‐Compliance.
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Methodological quality graph: Review authors' judgements about each methodological quality item presented as percentages across all included studies.
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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Funnel plot of comparison: 1 Phlebotonic versus placebo or control intervention, for outcome: 1.7 Overall symptom improvement.
1.1
1.1. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 1 Pain.
1.2
1.2. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 2 Pain scores (post‐haemorrhoidectomy).
1.3
1.3. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 3 Bleeding.
1.4
1.4. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 4 Bleeding post‐haemorrhoidectomy (dichotomous variable).
1.5
1.5. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 5 Pruritus.
1.6
1.6. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 6 Discharge and Leakage.
1.7
1.7. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 7 Overall symptom improvement.
1.8
1.8. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 8 Analgesic consumption.
1.9
1.9. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 9 Adverse events.
1.10
1.10. Analysis
Comparison 1 Phlebotonic versus placebo or control intervention, Outcome 10 Non‐Compliance.
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References

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