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Successful management of a difficult case of radiation proctopathy with Ankaferd BloodStopper: a novel indication (with video)
Successful management of a difficult case of radiation proctopathy with Ankaferd BloodStopper: a novel indication (with video) Ali Shorbagi, MD, Bülent Sivri, MD Ankara, Turkey
CASE REPORT A 70-year-old female patient who underwent surgery for rectal cancer at another center in February 2007 presented to our department a year later with rectal bleeding. She had received adjuvant chemoradiotherapy after surgery. A left-sided colonoscopy revealed actively bleeding telangiectasia up to 25 cm from the anal verge. The patient was initially started on a course of mesalazine enema at a dose of 4 g/day; however, this treatment was not tolerated, and citing an increase in symptoms, the patient decided to discontinue therapy. Continued bleeding with marked decrease in hematocrit prompted hospitalization followed by erythrocyte suspension transfusion. She was referred for endoscopic therapy with argon plasma coagulation; however, the profuse nature of the bleeding did not allow for accurate targeting of the bleeding telangiectasia, and despite two separate sessions of “blind” coagulation, the patient’s symptoms persisted. The patient vehemently refused the option of surgery and was subsequently informed about a not-yet-approved option of the “off-label” use of Ankaferd BloodStopper (ABS), a unique medicinal plant extract that gained health ministerial approval in Turkey for the management of external hemorrhage and dental surgery bleeding,1 to achieve hemostasis. There is an increasing number of reports on the off-label use of ABS in several clinical settings.2-8 The experimental nature of the procedure was explained in detail, and after verbal consent was obtained, the patient
was recalled to our endoscopy unit. Approximately 20 mL of ABS solution was applied on the affected areas by using a disposable washing pipe (Model PW-205 L, Olympus Corporation, Tokyo, Japan), which resulted in immediate control of bleeding. Figure 1 depicts endoscopic images of the affected areas before and after application of the agent (Video 1, available online at www.giejournal.org). Hemostasis persisted until the next day, and during a second colonoscopy, argon plasma coagulation was applied to the now more readily visible telangiectasia. Radiation proctopathy is a complication that occurs after pelvic radiation, commonly given for prostate, rectal, and gynecologic malignancies. Symptoms of chronic radiation proctopathy include hematochezia (sometimes quite severe), urgency, constipation, tenesmus, diarrhea, and rectal pain. Pharmacologic treatment options include 5-aminosalicylic acid preparations, corticosteroid enemas, and sucralfate (given orally or as an enema). Argon plasma coagulation offers a safe noncontact method of delivering hemostasis, which has proven to be particularly useful in this setting.9 However, presence of active bleeding may hinder effective application, as in our case. The ABS is a standardized herbal extract obtained from five different plants, Thymus vulgaris, Glycyrrhiza glabra, Vitis vinifera, Alpinia officinarum, and Urtica dioica, in fixed proportions. ABS represents its unique local hemostatic effect by promoting the very rapid (⬍1 s) formation of a protein network that acts as an anchor for vital physiological erythrocyte aggregation, otherwise known as the “ABS-web,”
Figure 1. Endoscopic image of the distal rectum before (A) and after (B) application of Ankaferd BloodStopper (ABS), depicting the formation of a grayish-black ABS “web” with achievement of successful hemostasis.
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Volume 72, No. 3 : 2010
www.giejournal.org
Brief Reports
covering the classic cascade model of the clotting system without independently acting on coagulation factors and platelets. Topical hemostatic efficacy and safety of ABS have been previously demonstrated in animals with normal and defective hemostasis. ABS has been approved for local topical applications in dermal, external postsurgical, and dental bleeding in Turkey. ABS also has been used topically for controlling spontaneous or postbiopsy uncontrolled bleeding from GI cancers, mediastinal bleeding, hemorrhage after retropubic radical prostatectomy, and the management of hemorrhages uncontrolled by standard measures in a wide variety of difficult clinical conditions.2-8 Data on animals and humans have not yet raised any safety concerns. When the mechanism of action is taken into consideration, intravenous leakage of ABS may result in embolic complications, therefore making it essential to avoid accidental intravenous application of the substance. Such an adverse effect has yet to be reported, although it is still in its early days of use. As a novel indication, we believe that ABS would be a useful adjuvant to argon plasma coagulation, since by controlling the active bleed it may help better localize and target telangiectasias. However, there is a dire need for further studies before its actual efficacy and benefit can be evaluated. Abbreviation: ABS, Ankaferd BloodStopper.
REFERENCES 1. Goker H, Haznedaroglu IC, Ercetin S, et al. Haemostatic actions of the folkloric medicinal plant extract Ankaferd BloodStopper. J Int Med Res 2008;36:163-70.
www.giejournal.org
2. Teker AM, Korkut AY, Gedikli O, et al. Prospective, controlled clinical trial of Ankaferd BloodStopper in children undergoing tonsillectomy. Int J Pediatr Otorhinolaryngol 2009;73:1742-5. 3. Huri E, Akgül T, Ayyildiz A, et al. Hemostasis in retropubic radical prostatectomy with Ankaferd BloodStopper: a case report. Kaohsiung J Med Sci 2009;25:445-7. 4. Kurt M, Akdogan M, Onal IK, et al. Endoscopic topical application of Ankaferd Blood Stopper for neoplastic gastrointestinal bleeding: a retrospective analysis. Dig Liver Dis 2009 Jun 18. [Epub ahead of print] 5. Kurt M, Oztas E, Kuran S, et al. Tandem oral, rectal, and nasal administrations of Ankaferd BloodStopper to control profuse bleeding leading to hemodynamic instability. Am J Emerg Med 2009;27:631.e1-2. 6. Bilgili H, Kosar A, Kurt M, et al. Hemostatic efficacy of Ankaferd Blood Stopper in a swine bleeding model. Med Princ Pract 2009;18:165-9. 7. Tuncer I, Doganay L, Ozturk O. Instant control of fundal variceal bleeding with a folkloric medicinal plant extract: Ankaferd BloodStopper. Gastrointest Endosc 2009 Nov 16. [Epub ahead of print] 8. Turhan N, Kurt M, Shorbagi A, et al. Topical Ankaferd BloodStopper administration to bleeding gastrointestinal carcinomas decreases tumor vascularization. Am J Gastroenterol 2009;104:2874-7. 9. Hong JJ, Park W, Ehrenpreis ED. Review article: current therapeutic options for radiation proctopathy. Aliment Pharmacol Ther 2001;15:125362.
Faculty of Medicine, Department of Gastroenterology, Hacettepe University, Ankara, Turkey. Reprint requests: Ali Shorbagi, MD, Faculty of Medicine, Department of Gastroenterology, Hacettepe University, Sıhhiye 06100, Ankara, Turkey. Copyright © 2010 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.12.018
Volume 72, No. 3 : 2010 GASTROINTESTINAL ENDOSCOPY
667
CASE REPORT A 70-year-old female patient who underwent surgery for rectal cancer at another center in February 2007 presented to our department a year later with rectal bleeding. She had received adjuvant chemoradiotherapy after surgery. A left-sided colonoscopy revealed actively bleeding telangiectasia up to 25 cm from the anal verge. The patient was initially started on a course of mesalazine enema at a dose of 4 g/day; however, this treatment was not tolerated, and citing an increase in symptoms, the patient decided to discontinue therapy. Continued bleeding with marked decrease in hematocrit prompted hospitalization followed by erythrocyte suspension transfusion. She was referred for endoscopic therapy with argon plasma coagulation; however, the profuse nature of the bleeding did not allow for accurate targeting of the bleeding telangiectasia, and despite two separate sessions of “blind” coagulation, the patient’s symptoms persisted. The patient vehemently refused the option of surgery and was subsequently informed about a not-yet-approved option of the “off-label” use of Ankaferd BloodStopper (ABS), a unique medicinal plant extract that gained health ministerial approval in Turkey for the management of external hemorrhage and dental surgery bleeding,1 to achieve hemostasis. There is an increasing number of reports on the off-label use of ABS in several clinical settings.2-8 The experimental nature of the procedure was explained in detail, and after verbal consent was obtained, the patient
was recalled to our endoscopy unit. Approximately 20 mL of ABS solution was applied on the affected areas by using a disposable washing pipe (Model PW-205 L, Olympus Corporation, Tokyo, Japan), which resulted in immediate control of bleeding. Figure 1 depicts endoscopic images of the affected areas before and after application of the agent (Video 1, available online at www.giejournal.org). Hemostasis persisted until the next day, and during a second colonoscopy, argon plasma coagulation was applied to the now more readily visible telangiectasia. Radiation proctopathy is a complication that occurs after pelvic radiation, commonly given for prostate, rectal, and gynecologic malignancies. Symptoms of chronic radiation proctopathy include hematochezia (sometimes quite severe), urgency, constipation, tenesmus, diarrhea, and rectal pain. Pharmacologic treatment options include 5-aminosalicylic acid preparations, corticosteroid enemas, and sucralfate (given orally or as an enema). Argon plasma coagulation offers a safe noncontact method of delivering hemostasis, which has proven to be particularly useful in this setting.9 However, presence of active bleeding may hinder effective application, as in our case. The ABS is a standardized herbal extract obtained from five different plants, Thymus vulgaris, Glycyrrhiza glabra, Vitis vinifera, Alpinia officinarum, and Urtica dioica, in fixed proportions. ABS represents its unique local hemostatic effect by promoting the very rapid (⬍1 s) formation of a protein network that acts as an anchor for vital physiological erythrocyte aggregation, otherwise known as the “ABS-web,”
Figure 1. Endoscopic image of the distal rectum before (A) and after (B) application of Ankaferd BloodStopper (ABS), depicting the formation of a grayish-black ABS “web” with achievement of successful hemostasis.
666 GASTROINTESTINAL ENDOSCOPY
Volume 72, No. 3 : 2010
www.giejournal.org
Brief Reports
covering the classic cascade model of the clotting system without independently acting on coagulation factors and platelets. Topical hemostatic efficacy and safety of ABS have been previously demonstrated in animals with normal and defective hemostasis. ABS has been approved for local topical applications in dermal, external postsurgical, and dental bleeding in Turkey. ABS also has been used topically for controlling spontaneous or postbiopsy uncontrolled bleeding from GI cancers, mediastinal bleeding, hemorrhage after retropubic radical prostatectomy, and the management of hemorrhages uncontrolled by standard measures in a wide variety of difficult clinical conditions.2-8 Data on animals and humans have not yet raised any safety concerns. When the mechanism of action is taken into consideration, intravenous leakage of ABS may result in embolic complications, therefore making it essential to avoid accidental intravenous application of the substance. Such an adverse effect has yet to be reported, although it is still in its early days of use. As a novel indication, we believe that ABS would be a useful adjuvant to argon plasma coagulation, since by controlling the active bleed it may help better localize and target telangiectasias. However, there is a dire need for further studies before its actual efficacy and benefit can be evaluated. Abbreviation: ABS, Ankaferd BloodStopper.
REFERENCES 1. Goker H, Haznedaroglu IC, Ercetin S, et al. Haemostatic actions of the folkloric medicinal plant extract Ankaferd BloodStopper. J Int Med Res 2008;36:163-70.
www.giejournal.org
2. Teker AM, Korkut AY, Gedikli O, et al. Prospective, controlled clinical trial of Ankaferd BloodStopper in children undergoing tonsillectomy. Int J Pediatr Otorhinolaryngol 2009;73:1742-5. 3. Huri E, Akgül T, Ayyildiz A, et al. Hemostasis in retropubic radical prostatectomy with Ankaferd BloodStopper: a case report. Kaohsiung J Med Sci 2009;25:445-7. 4. Kurt M, Akdogan M, Onal IK, et al. Endoscopic topical application of Ankaferd Blood Stopper for neoplastic gastrointestinal bleeding: a retrospective analysis. Dig Liver Dis 2009 Jun 18. [Epub ahead of print] 5. Kurt M, Oztas E, Kuran S, et al. Tandem oral, rectal, and nasal administrations of Ankaferd BloodStopper to control profuse bleeding leading to hemodynamic instability. Am J Emerg Med 2009;27:631.e1-2. 6. Bilgili H, Kosar A, Kurt M, et al. Hemostatic efficacy of Ankaferd Blood Stopper in a swine bleeding model. Med Princ Pract 2009;18:165-9. 7. Tuncer I, Doganay L, Ozturk O. Instant control of fundal variceal bleeding with a folkloric medicinal plant extract: Ankaferd BloodStopper. Gastrointest Endosc 2009 Nov 16. [Epub ahead of print] 8. Turhan N, Kurt M, Shorbagi A, et al. Topical Ankaferd BloodStopper administration to bleeding gastrointestinal carcinomas decreases tumor vascularization. Am J Gastroenterol 2009;104:2874-7. 9. Hong JJ, Park W, Ehrenpreis ED. Review article: current therapeutic options for radiation proctopathy. Aliment Pharmacol Ther 2001;15:125362.
Faculty of Medicine, Department of Gastroenterology, Hacettepe University, Ankara, Turkey. Reprint requests: Ali Shorbagi, MD, Faculty of Medicine, Department of Gastroenterology, Hacettepe University, Sıhhiye 06100, Ankara, Turkey. Copyright © 2010 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.12.018
Volume 72, No. 3 : 2010 GASTROINTESTINAL ENDOSCOPY
667