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| 번호 | 제목 | 등록일 | 조회수 |
|---|---|---|---|
| 40 | Efficacy of Calcium Dobesilate in Treating Acute Attacks of Hemorrhoidal Disease [2001년 10월 DCR] | 2011-11-17 | 3364 |
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B. Builent Mentes, M.D., Ahmet Gorgul, M.D., Ertan Tatlicioglu, M.D., Ferruh Ayoglu, M.D.
From the Departments of Surgery, Gastroenterology, and Public Health, Gazi University Medical School,
Ankara, Turkey PURPOSE: A randomized, double-blind, controlled study was conducted to investigate the efficacy of oral calcium dobesilate therapy in treating acute attacks of internal hemorrhoids.
METHODS: Twenty-nine weU-documented adult patients with first- or second-degree internal hemorrhoids were treated with calcium dobesilate for two weeks, while16 patients received only a high-fiber diet to serve as control. Both symptoms and anoscopic inflammation were scored on a scale from 0 to 2 before (To) and two weeks after treatment (T2). RESULTS: A success rate of 86.21 percent with cessation of bleeding plus lack of severe anitis
anoscopically at two weeks were achieved with calcium dobesilate. The pretreatment symptom score of 2 fell significantly to 0.45 + 0.13, and the pretreatment anitis score of 1.69 -+ 0.09 fell to 0.55 + O. 12 at T 2 (P = 0.0001 for both comparisons). The symptom and anoscopic inflammation scores obtained with calcium dobesilate treamaent were also significantly better than those with diet only (P = 0.0017 and P = 0.0013, respectively). CONCLUSION: Together with recommendations about diet and bowel discipline, oral calcium dobesilate treatment provides an efficient, fast, and safe symptomatic relief from acute symptoms of hemorrhoidal disease. This symptomatic healing is associated with a significant improvement in the
anoscopically observed inflammation. Hemorrhoidal disease is currently believed to be caused by distal displacement and structural
distortion of anal cushions, which are physiologic structures with an important role in defecation and continence. According to some western population statistics, the prevalence is surprisingly" high, with an equal frequency in men and women. Anatomic studies have revealed that the anchoring and supporting subepithelial tissue deteriorates with aging, and the descended loose lining becomes more sensitive to pressure from straining and trauma from stool, occasionally resulting in venous distention, inflammation, erosion, bleeding, and/or thrombosis. Regarding the more common form of internal hemorrhoids, the most common symptom is the passing of bright red blood at stool, Discom£ort, pruritus, soiling, pain, and/or protrusion may also be encountered, especially in advanced or complicated cases. Patients with first-degree (1 °) or 2 ° internal hemorrhoids lack advanced prolapse of the supporting subepithelial tissue of hemorrhoidal cushions. Nevertheless, these patients may experience acute attacks with severe discomfort and bleeding. Especially young men with a tight anal canal can have severe discomfort and severe bleeding during acute attacks, with the minimal visible abnormality of 1 ° internal hemorrhoids. The finding of proctoscopic "anitis," which correlates with enlarged lamina propria capillaries with inflammation, is associated with the occurrence of typical hemorrhoidal bleeding and/or pain. The increasing extent of prolapse defines increasing degrees (2 ° , 3 °, and 4 ° hemolThoids), although it is not always directly correlated to the severity of signs or symptoms. There still exist controversies and lack of agreement on treatment strategies. Radical approaches to eliminate hemorrhoids involve surgicai excision or invasive endoscopic interventions called mucosal fixation methods, such as band ligation or injection sclerotherapy, which depend on inflammation and subsequent scarring, causing attachment to underlying muscle. A more conservative policy is based on the current data that hemorrhoids are normal anatomic structures, and age-related structural changes occur in every person, whereas symptoms develop in only some people. Therefore, hemorrhoidal disease is believed to be a purely clinical condition with chronic symptoms interspersed with recurrent,
self-resolving acute episodes, and symptomatic treatment together with preventive measures might be all that needs to be done. Calcium dobesitate (calcium 2,5-dihydroxybenzenesulfonate) is a drug with previously demonstrated
efficacy in the treatment of diabetic retinopathy and chronic venous insufficiency. These beneficial effects of the drug are related to its ability to decrease capillary permeability, platelet aggregation, and
blood viscosity and to increase lymphatic transport. Because these properties would reasonably be expected to contribute to the acute inflammatory attacks of hemorrhoidal disease, this randomized, doubleblind, controlled study was conducted to investigate the efficacy of calcium dobesilate in treating acute attacks of hemorrhoidal disease, based on objective healing and subjective/symptomatic criteria. DISCUSSION
The results of this study have shown that calcium dobesilate is highly effective in the treatment of acute
attacks of hemorrhoidal disease. Twenty-five (86.21 percent) of 29 patients were noted to be symptom free or significantly improved with complete cessation of bleeding, as reflected by the significant difference between the symptom scores before and two weeks after treatment (P = 0.0001). An important
feature of this study is that the treatment outcome was not based only on symptoms, but also on objective healing criteria. A significant improvement afforded by this agent in the anoscopically observed inflammation deserves emphasis. Both the symptom and objective inflammation scores were significantly better than those of the control-diet group. Although recurrences may occur long term, good symptomatic relief and healing were provided by this method without considerable complications. The duration of calcium dobesilate treatment and the doses used were based on the authors' preliminary clinical impressions with this agent, and we cannot contradict that different regimens would be equally or more effective. In addition, "treatment failure" was decided if symptomatic and objective healing was not accomplished by the second week of the treatment. The possibility, therefore, exists that a more tolerant approach might result in a higher success rate. Nevertheless, the time of relief from symptoms in 86.21 percent of the cases averaged 5.5 days, and we do not believe it is justifiable to insist on any treatment modality that does not result in cessation of bleeding within two weeks. Patients with 1 ° or 2 ° internal hemorrhoids, who dominate in our proctology practice, were included in this study. We therefore cannot contradict that patients with more advanced stages of internal hemorrhoidal disease (3 ° and 4 ° hemorrhoids), and patients with external hemorrhoids, might also benefit from the drug, although the severe structural degeneration and distortion encountered in advanced stages might eventually require correction with. surgery or outpatient mucosal fixation methods. Especially in patients with hemorrhoids, the subepithelial layer with the vascular cushions is loosely
adherent to the underlying circular muscle coat and ,nay easily be prolapsed into the lower anal canal. The descended loose lining becomes more sensitive to pressure from straining and trauma from stool, occasionally resulting in venous distention, inflammation, erosion, bleeding, and/or thrombosis. The mucosa and submucosal vascular cushions can be fixed to the underlying muscular coat by creating submucosal fibrosis or full-thickness ulceration, by way of mucosal fixation methods, such as injection sclerotherapy, infrared photocoagulation, or band tigation. Although the extent of fixation almost never reaches to that of surgical hemorrhoidectomy, most of these akemative fixation methods can be performed in an office setting without anesthesia, and more than 90 percent of hemorrhoidal symptoms can be successfully controlled by such nonexcisional techniques with fewer complications and pain, compared with hemorrhoidectomy. On the other hand, mucosal fixation methods require special equipment and expertise. They are invasive techniques, and considerable side effects and complications may follow. Besides, we know that age-related structural changes occur in every person, while symptoms occasionally develop in only some people. Therefore, especially for 1 ° or 2 ° internal hemorrhoids with mininml structural abnormality, an equally strong argument could be made for alleviating the acute attacks whenever they develop. In contrast to patients with more severe structural distortion of anal cushions (3 ° and 4 ° hemorrhoids), symptomatic treatment together with future preventive measures might be all that needs to be done. In this case, we need an agent that would rapidly eliminate the acute symptoms and would be free of side effects. This study has addressed the efficacy of calcium dobesilate in treating the acute attacks; however, long-term results are lacking because of the short follow-up period. The follow-up is proceeding to document the frequency of recurrent attacks. Nevertheless, together with dietary and the above-cited preventive recommendations, a high recurrence rate is not expected in patients with early grades of hemorrhoidal disease. Besides, recurrent acute attacks are also amenable to medical treatment. As a resuk of the superficial nature of hemorrhoidal disease and the general lack of life-threatening complications, most physicians prefer methods that are readily available. 'q~hus, a major industry, which sells ointments, cushions, heater probes, freezing devices, tablets, suppositories, foams, and food additives, has emerged. "As stated before, hemorrhoidal disease is believed to be a purely clinical condition with chronic symptoms interspersed with recurrent, self-resolving acute episodes, and the possible efficacy of any intervention needs to be documented by prospective, controlled trials. A double-blind, controlled approach was, therefore, undertaken, and it deserves emphasis that more than 40 percent of the control patients improved with only diet and other preventive measures. Nevertheless, the use of calcium dobesitate provided significant advantages regarding subjective/symptomatic and objective/anoscopic healing criteria, compared with the control group. This beneficial effect was free from notable complications. Although we lack histologic data to confirm our results, the anoscopic data suggest that the beneficial effect provided by calcium dobesilate is related to the reduction in edema and anal inflammation typical of acute attacks of hemorrhoidal disease. The well-known angioprotective
action of calcium dobesilate, by reducing the permeability and fragility of microvessels, restricts fluid extravasation; its reduction of plasma viscosity counteracts stasis; and its antiplatelet hyperaggregability effect counteracts thrombosis. Calcium dobesilate possibly acts on the endothelial layer of the capillaries and reduces hyperpermeability. Its vasoprotective effects have shown some promise in the treatment of myocardial infarction. The reduction of high-protein edema by calcium dobesilate is caused by both an increase in lymphatic transport and an enhanced normal proteolysis by macrophages. This reduction in high-protein edema also reduces excess fibrosis and aids in normal remodeling of tissues. In this case, calcium dobesilate was shown to be effective in certain disease states, such as chronic venous insufficiency or diabetic microangiopathy. The combined effect of these properties of calcium dobesilate would reasonably be expected to
contribute to the treatment of acute hemorrhoidal attacks, which are characterized by stasis, edema, and blood clot formation. In this study, the anoscopic inflammation scores two weeks after treatment indicated a significant reduction in macroscopic anal inflammation, regarding edema, hyperemia, and propensity to bleed. This study has confirmed, for the first time, the efficacy of calcium dobesilate in treating acute attacks of hemorrhoidal disease, based on controlled prospective data. To avoid confounding factors caused by- incomparable diets and bowel habits, the daily intake of nonstarch polysaccharides (NSP) was standardized in our patient groups, and the bowel habits were monitored during the follow-up. Furthermore, encouragement was given to correct other general causes of constipation, such as ignoring the need to pass stools, irregular meals, and lack of exercise. This is our standard approach in our proctology unit, and we lack a group of patients treated only by calcium dobesilate and without dietary and lifestyle recommendations. The majority of our patients have unhealthy diet and/or bowel habits, and we find it inappropriate and unethical in a proctology unit not to teach them and only to create control groups. The diet was constituted such that it was cheap, easy to follow, and rich in NSP. NSPs are the m.ajor component of dietary fiber that reaches the colon and demonstrates the physiologic effects of fiber, namely decreased transit time, increased water retention, and the resultant formation of wet, bulky stools. The amount of NSP provided with the diet used in this study is considerably- high and theoretically sufficient to increase colonic movement and stool weight, although these definitive parameters were not investigated. In accordance, 86.7 percent (39/45) of the patients developed soft bulky stools and relatively regular bowel habits soon after the initiation of the diet, whereas this was the case in 22.2 percent before the diet. According to our results, the success rate of the high-fiber diet and relative normalization of bowel habits, by itself, seems to be unsatisfactory (43.75 percent), and we still do not believe that it is practical to insist solely on dietary measures. Nevertheless, high-fiber diet and the related bowel discipline, at the very least, do seem to possess a role in the treatment of hemorrhoidal disease, and they should be used as important adjuncts to successful treatment with any- primary modality.
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