Perera Nirmal, Liolitsa Danae, Iype Satheesh, Croxford Anna, Yassin Muhammed, Lang Peter, Ukaegbu Obioha, van Issum Christopher
General Medicine, Addenbrookes Hospital, Cambridge, UK.
Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD004322. doi: 10.1002/14651858.CD004322.pub3.
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.
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.
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).
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.
Two authors independently extracted the data and analysed the eligibility of the data for inclusion. Disagreements were resolved by meaningful discussion.
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.
痔疮是肛管和肛周静脉丛的静脉曲张，通常继发于痔静脉丛内持续升高的静脉压（Kumar 2005）。静脉活性药物是一类异质性药物，由植物提取物（如黄酮类化合物）和合成化合物（如羟苯磺酸钙）组成。尽管其确切作用机制尚未完全明确，但已知它们可改善静脉张力、稳定毛细血管通透性并增加淋巴引流。它们已被用于治疗多种病症，包括慢性静脉功能不全、淋巴水肿和痔疮。众多评估静脉活性药物治疗痔疮疾病症状和体征效果的试验表明，其具有潜在益处。
本综述的目的是研究静脉活性药物在减轻痔疮疾病的体征、症状和严重程度方面的疗效，并验证其在痔切除术后的效果。
我们检索了Cochrane图书馆2011年第9期的Cochrane对照试验中心注册库（CENTRAL）、MEDLINE（1950年至2011年9月）和EMBASE（1974年至2011年9月）。
仅使用评估静脉活性药物治疗痔疮疾病的随机对照试验。不纳入交叉试验或整群随机试验进行分析，排除任何采用准随机分配方法的试验。
两位作者独立提取数据并分析数据纳入的合格性。通过有意义的讨论解决分歧。
我们考虑将24项研究纳入最终分析。其中20项研究（共纳入2344名参与者）评估了静脉活性药物与对照干预措施的使用情况。这20项研究中的一项评估了静脉活性药物与药物干预联合使用的情况，另一项研究评估了其与橡皮圈套扎联合使用的情况。其余四项研究包括两项相互比较不同形式静脉活性药物的研究、一项评估静脉活性药物与药物干预联合使用的研究以及一项比较静脉活性药物与红外光凝治疗效果的研究。八项研究因各种原因被排除，包括方法学质量较差。与对照干预相比，静脉活性药物在瘙痒（OR 0.23；95% CI 0.07至0.79）（P = 0.02）、出血（OR 0.12；95% CI 0.04至0.37）（P = 0.0002）、痔切除术后出血（OR 0.18；95% 0.06至0.58）（P = 0.004）、分泌物和渗漏（OR 0.12；95% CI 0.04至0.42）（P = 0.0008）以及总体症状改善（OR 15.99 95% CI 5.97至42.84）（P < 0.00001）等结局方面显示出统计学上显著的有益效果。尽管有益，但与对照干预相比，它们在疼痛（OR 0.11；95% CI 0.01至1.11）（P = 0.06）、痔切除术后疼痛评分（SMD -1.04；95% CI -3.21至1.12）（P = 0.35）或术后镇痛药物消耗量（OR 0.54；95% CI 0.30至0.99）（P = 0.05）方面未显示出统计学上显著的效果。
证据表明，使用静脉活性药物治疗痔疮疾病具有潜在益处，且在减轻痔切除术后症状方面也有益处。出血和总体症状改善等结局显示出统计学上显著的有益效果，从临床试验提供的证据来看，对其总体安全性几乎没有担忧。然而，遇到了方法学上的局限性。为了进一步加强我们的结论，未来需要进行更严格的临床试验，同时考虑到这些局限性。
