Prospective, controlled clinical trial of Ankaferd Blood Stopper in children undergoing tonsillectomy

doi:10.1016/j.ijporl.2009.09.029

International Journal of Pediatric Otorhinolaryngology

Volume 73, Issue 12, December 2009, Pages 1742-1745

https://doi.org/10.1016/j.ijporl.2009.09.029 Get rights and content

Abstract

Objectives

This is a prospective study evaluating the efficacy of Ankaferd Blood Stopper as a hemostatic agent compared to hemostasis by means of knot-tie after cold knife dissection tonsillectomy.

Methods

Study design was the use of ABS and the KT to reach hemostasis for patients undergoing tonsillectomy. ABS is applied on right side tonsil fossa and KT is used on left side tonsil fossa. Measured outcomes such as blood loss, surgical time, and complication will be assessed. In total, 47 consecutive patients undergoing cold knife dissection tonsillectomy were studied, in all of whom Ankaferd Blood Stopper wet tampon was used for right side tonsil hemorrhage and knot-tie technique for left side tonsil hemorrhage. Data were collected intraoperatively. Follow-up visits of all patients were completed at postoperative days 1, 3, 7, and 10.

Results

Ankaferd Blood Stopper side had shorter hemostasis time after tonsil removal than knot-tie side (3.19 ± 0.74 min vs 7.29 ± 2.33 min [mean ± SD], p < 0.01) and less blood loss (1.57 ± 2.26 ml vs 14.04 ± 7.23 ml [mean ± SD], p < 0.01). In addition, KT number was less with ABS side as compared to KT side (p < 0.01).

Conclusions

The side on which Ankaferd Blood Stopper was used had statistically significant differences in hemostasis time, blood loss, and knot-tie number in the operation period. Ankaferd Blood Stopper is safe and efficient, and it decreases intraoperative bleeding, reduces operating time, as compared to the traditional hemostasis methods after cold knife dissection tonsillectomy.

Introduction

Tonsillectomy is one of the most common operations performed in the otorhinolaryngology practice. Various surgical procedures for tonsillectomy are performed with a wide array of options with each having its own advantages and disadvantages. Although numerous techniques have been introduced and used to perform tonsillectomy, cold knife tonsillectomy is still frequently used by most of the surgeons [1]. After the cold knife dissection, tonsillectomy needs some methods to control the hemorrhage. Hemostasis is achieved by either mechanical (ligation) or electrosurgical means. In an optimal situation of tonsillectomy, a surgical procedure would be the one that generates minimal postoperative pain, little or no bleeding, is completed in minimal operation time, and allows the patient to return to their normal daily activities in the shortest period of time [2], [3].

ABS is a hemostatic agent composed of plant extracts which are Urtica dioica (0.06 mg/ml), Vitis vinifera (0.08 mg/ml), Glycyrrhiza glabra (0.07 mg/ml), Alpinia officinarum (0.07 mg/ml), and Thymus vulgaris (0.05 mg/ml). Each of the constituents has some effects on the endothelium, blood cells, angiogenesis, cellular proliferation, vascular dynamics and cell mediators. The basic mechanism of action for ABS is the formation of an encapsulated protein network representing focal points for vital erythrocyte aggregation [4], [5]. ABS could be used effectively to manage external bleeding in clinical settings such as skin bleeding and/or superficial mucosal blood oozing.

This study will evaluate the clinical efficacy of ABS in children undergoing tonsillectomy. This hemostatic technique will be compared to the traditional technique of knot-tie (KT) hemostasis in cold knife dissection pediatric tonsillectomy. Intraoperative bleeding, time to hemostasis, knot-tie number in the operation period, and postoperative complications were compared for each technique.

Section snippets

Patients and methods

This study was performed at ENT Clinic. A prospective, not randomized, nonblinded study was undertaken between November 2008 and February 2009. Setting was tertiary referral center. Study protocol was approved by the Ethics Committee of Hospitals.

This study was conducted on pediatric population. Patients with chronic tonsillitis, tonsillar hypertrophy, and obstructive sleep apnea syndrome were included in the study. Patients with bleeding disorders, aspirin use within 2 weeks prior to surgery,

Statistics

For statistical analysis, NCSS 2007&PASS 2008 Statistical Software (Utah, USA) was used for comparison. Data were entered into Wilcoxon test for the quantitative analysis.

Results

The study consists of 47 consecutive procedures all performed by the otorhinolaryngology staff. The study population comprised 24 (51.1%) males, 23 (48.9%) females; age range was 4–14 years old (mean ± SD: 6.97–2.68 yrs). 6 (12.8%) had OSAS and 41 had chronic tonsillitis (87.2%) in our study. A detailed database was prepared for prospective recordings.

The side in which the ABS was compared to KT had significantly shorter times to hemostasis (3.19 ± 0.74 min vs 7.29 ± 2.33 min [mean ± SD], p < 0.01). The

Discussion

Tonsillectomy continues to be one of the most common surgical procedures performed worldwide in the pediatric population. Despite advances in surgical and hemostatic techniques such as bipolar radiofrequency, laser, coblation, harmonic scalpel and thermal welding, however, post-tonsillectomy morbidity remains a significant problem [6], [7]. Actually bleeding after tonsillectomy is associated with significant morbidity and rare mortality. Our prospective study of ABS showed effective hemostasis

Conclusion

Our results showed that ABS reduces intraoperative hemorrhage and operation time. It is a safe, efficient, and easy to use hemostatic agent with no side effects. Therefore we recommend ABS during routine tonsillectomy for healthy children. Further study could be carried out to determine possible benefits in the post-tonsillectomy hemorrhages.

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Cited by (80)

Antitumor activity of Ankaferd Blood Stopper® on MCF-7 breast cancer: A proteomic approach to ascertain the mechanism of the action
2021, Journal of Herbal Medicine
Ankaferd Blood Stopper® (ABS) is a non-toxic product comprising solely herbal extracts. It is approved by the Turkish Ministry of Health to be used to stop external and internal bleeding immediately. Together with its wound healing and antimicrobial features; the anti-neoplastic effect of the compound on different cancer types was also demonstrated previously. This study aimed to explore the anti-tumor effect of ABS on the MCF-7 breast cancer cell line.
A proteomic approach was chosen to investigate the alteration of the levels of cancer-related proteins of MCF-7 upon subjection to ABS. The proteins were extracted after the 24 h incubation of the cells with the compound (8 μL/mL) and sorted by 2-DE gel electrophoresis. Subsequently, the proteomic profiles of the samples were compared by image analysis. The proteins which were found to be significantly over- or under-expressed were identified by MALDI-TOF/TOF-MS.
Proteomic studies revealed that ABS caused a deviation in the levels of certain proteins including chaperones, p97, ATP5B, SELENBP1, PDIA6, and RPS10P5. The proteins that were significantly up- or down-regulated were further analyzed by using MALDI-TOF/TOF-MS.
ABS was validated to target certain proteins that were aberrantly expressed in breast cancer, especially the ER⁺ subtype. Thus, it can be concluded that this product may be employed for the treatment of breast cancer given its non-toxic and anti-tumor characteristics.
Ankaferd hemostat (ABS) as a potential mucosal topical agent for the management of COVID-19 syndrome based on its PAR-1 inhibitory effect and oestrogen content
2020, Medical Hypotheses
COVID-19 due to the SARS-CoV-2 infection is a multi-systemic immune syndrome affecting mainly the lungs, oropharyngeal region, and other vascular endothelial beds. There are tremendous ongoing efforts for the aim of developing drugs against the COVID-19 syndrome-associated inflammation. However, currently no specific medicine is present for the absolute pharmacological cure of COVID-19 mucositis. The re-purposing/re-positioning of already existing drugs is a very important strategy for the management of ongoing pandemy since the development of a new drug needs decades. Apart from altering angiotensin signaling pathways, novel drug candidates for re-purposing comprise medications shall target COVID-19 pathobiology, including pharmaceutical formulations that antagonize proteinase-activated receptors (PARs), mainly PAR-1. Activation of the PAR-1, mediators and hormones impact on the hemostasis, endothelial activation, alveolar epithelial cells and mucosal inflammatory responses which are the essentials of the COVID-19 pathophysiology. In this context, Ankaferd hemostat (Ankaferd Blood Stopper, ABS) which is an already approved hemostatic agent affecting via vital erythroid aggregation and fibrinogen gamma could be a potential topical remedy for the mucosal management of COVID-19. ABS is a clinically safe and effective topical hemostatic agent of plant origin capable of exerting pleiotropic effects on the endothelial cells, angiogenesis, cell proliferation and vascular dynamics. ABS had been approved as a topically applied hemostatic agent for the management of post-surgical/dental bleedings and healing of infected inflammatory mucosal wounds. The anti-inflammatory and proteinase-activated receptor axis properties of ABS with a considerable amount of oestrogenic hormone presence highlight this unique topical hemostatic drug regarding the clinical re-positioning for COVID-19-associated mucositis. Topical ABS as a biological response modifier may lessen SARS-CoV-2 associated microthrombosis, endothelial dysfunction, oropharyngeal inflammation and mucosal lung damage. Moreover, PAR-1 inhibition ability of ABS might be helpful for reducing the initial virus propagation and mocasal spread of COVID-19.
Hemostatic Powders in Gastrointestinal Bleeding. A Systematic Review.
2015, Gastrointestinal Endoscopy Clinics of North America
Histopathological evaluation of Ankaferd blood stopper use in the rabbit septoplasty model
2015, International Journal of Pediatric Otorhinolaryngology
Citation Excerpt :
Ankaferd blood stopper accelerates the formation of an encapsulated protein web by interacting with all blood proteins and fibrinogen particles [7,8]. Although ABS has been reported to be an effective topical agent used against mucosal bleedings such as in gastrointestinal hemorrhages, urological surgery, adenoidectomy and tonsillectomy, and anterior epistaxis [9–13], there has been no study on its use in septoplasty. The purpose of the present study was to assess the use of ABS, an organic hemostatic agent of herbal origin, in septoplasty operations and to determine its effect on nasal septal tissues in the rabbit model.
The purpose of this study was to assess the use of Ankaferd blood stopper (ABS), an organic hemostatic agent of plant origin, in septoplasty operations, and to determine its effect on nasal septal tissues in the rabbit model.
The study was performed on 30 New Zealand adult male rabbits each weighing 2500–3500 g (average: 3000 g). The rabbits were randomly divided into 4 groups, namely, the control group (without septoplasty), the septoplasty + tampon group, the septoplasty + ABS group, and the septoplasty + tampon + ABS group. All animals were sacrificed after two weeks, and the nasal septums were total removed using the lateral rhinotomy technique. The specimens were obtained from similar sites of cartilaginous nasal septum. The sections were stained with hematoxylin–eosin and Mason trichrome stains and studied under the light microscope by the same pathologist who evaluated the mucosal ulcerations, the severity of inflammatory cell infiltration, the mucosal thickness, and the cartilage thickness. The data obtained were statistically analyzed using the Kruskal–Wallis variance analysis and the Mann–Whitney U test.
No mucosal ulceration or inflammatory cell infiltration was detected in any of the rabbit groups. There was a statistically significant difference between the groups in terms of mucosal thickness and cartilage thickness (p < 0.05). The values of mucosal thickness in the groups mentioned above were 147.7 ± 17.6 μm, 205.7 ± 36.7 μm, 139.6 ± 14.8 μm, and 190.2 ± 17.5 μm, respectively. The values of cartilage thickness were 398.2 ± 28.9 μm, 546.2 ± 35.3 μm, 363.7 ± 24.7 μm, and 447.8 ± 28.2 μm, respectively. There was no significant difference between the control group and the septoplasty + ABS group in terms of mucosal thickness and cartilage thickness (p > 0.05). However, there was a significant increase in nasal mucosal and cartilage thickness in tampon-using groups when compared with the other groups (p < 0.05).
Although nasal tampons provide the contact of mucoperichondrium with the cartilage, they are generally accepted as a discomfort for patients. Ankaferd blood stopper can be used instead of nasal tampons to increase patient comfort.
Invited Discussion on: Comparison of the Ankaferd Blood Stopper Tampon and the Merocel Nasal Tampon after Septoplasty Surgery
2023, Aesthetic Plastic Surgery
Comparison of the Ankaferd Blood Stopper Tampon and the Merocel Nasal Tampon after Septoplasty Surgery
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Prospective, controlled clinical trial of Ankaferd Blood Stopper in children undergoing tonsillectomy

Abstract

Objectives

Methods

Results

Conclusions

Introduction

Section snippets

Patients and methods

Statistics

Results

Discussion

Conclusion

Otolaryngol. Head Neck Surg.

Int. J. Pediatr. Otorhinolaryngol.

Am. J. Otolaryngol.

Operative Tech. Otolaryngol.

Fitoterapia

Comparative audit of tonsillectomy

Clin. Otolaryngol. Allied Sci.

Lethal outcome of post-tonsillectomy hemorrhage

Eur. Arch. Otorhinolaryngol.

Pain versus bleeding risk following tonsillectomy: do patients and doctors agree?

J. Laryngol. Otol.

Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper

J. Int. Med. Res.

Hemostatic efficacy of Ankaferd Blood Stopper in a swine bleeding model

Med. Princ. Pract.

Post-tonsillectomy hemorrhage rates: are they technique-dependent?

Otolaryngol. Head Neck Surg.