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Efficacy and tolerability of hyaluronic acid, tea tree oil and methyl-sulfonyl-methane in a new gel medical device for treatment of haemorrhoids in a double-blind, placebo-controlled clinical trial

Abstract

Topical formulations are widely used in anti-haemorrhoidal treatment, but often lacking controlled clinical trials. Here, we report the results from a controlled clinical trial performed with a new gel medical device (Proctoial) containing hyaluronic acid with tea tree oil and methyl-sulfonyl-methane as major components. The total number of 36 haemorrhoidal patients (grade 1–3) was enrolled in a double-blind, placebo-controlled clinical trial and divided into 2 equal parallel groups. The anal pain, pain during defecation, visible bleeding, pruritus and irritation/inflammation were recorded before and after 14-day treatment using a visual analogue scale both by the investigators and by the patients. Safety and tolerability of the treatments were also recorded. The new gel medical device statistically significantly reduced all the symptoms after the treatment compared to placebo. The results indicated also a very good tolerability and safety of the treatments.

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References

  1. 1.

    Acheson AG, Scholenfield JH (2008) Management of haemorrhoids. BMJ 336:380–383

    PubMed  Article  Google Scholar 

  2. 2.

    Nisar PJ, Scholenfield JH (2003) Managing haemorrhoids. BMJ 327:847–851

    PubMed  Article  Google Scholar 

  3. 3.

    Hancock BD (1992) Haemorrhoids. BMJ 304:1042–1044

    PubMed  Article  CAS  Google Scholar 

  4. 4.

    Willis S et al (2010) Haemorrhoids a collagen disease? Colorectal Dis 12:1249–1253

    PubMed  Article  CAS  Google Scholar 

  5. 5.

    Lupo MP (2006) Hyaluronic acid fillers in facial rejuvenation. Semin Cutan Med Surg 25:122–126

    PubMed  Article  CAS  Google Scholar 

  6. 6.

    Laurent TC, Fraser JRE (1992) Hyaluronan. FASEB J 6:2397–2404

    PubMed  CAS  Google Scholar 

  7. 7.

    Volpi N et al (2009) Role, metabolism, chemical modifications and applications of hyaluronan. Curr Med Chem 16:1718–1745

    PubMed  Article  CAS  Google Scholar 

  8. 8.

    Kim YO et al (2009) The anti-inflammatory effects of methylsulfonylmethane on lipopolysaccharide-induced inflammation responses in murine macrophages. Biol Pharm Bull 32(4):651–656

    PubMed  Article  CAS  Google Scholar 

  9. 9.

    Carson CF et al (2006) Melaleuca alternifolia (Tea Tree) oil: a review of antimicrobial and other medicinal properties. Clin Microbiol Rev 19((1):50–62

    PubMed  Article  CAS  Google Scholar 

  10. 10.

    Papadopoulos CJ et al (2006) Susceptibility of pseudomonas to Melaleuca Alternifolia (tea tree) oil and components. J Antimicrob Chemother 58:449–451

    PubMed  Article  CAS  Google Scholar 

  11. 11.

    Burdick JA, Prestwich GD (2011) Hyaluronic acid hydrogels for biomedical applications. Adv Mater 23(12):H41–H56

    PubMed  Article  CAS  Google Scholar 

  12. 12.

    Dechert TA et al (2006) Hyaluronan in human acute and chronic dermal wounds. Wound Rep Reg. 14:252–258

    Article  Google Scholar 

  13. 13.

    Parcell S (2002) Sulphur in human nutrition and applications in medicine. Altern Med Rev. 7(1):22–44

    PubMed  Google Scholar 

  14. 14.

    Fernandez Garcia MI et al (2009) Efficacy and safety of topical diltiazem 2% in anal fissure. Farm Hosp 33(2):80–88

    PubMed  Article  CAS  Google Scholar 

  15. 15.

    Perrotti P et al (1999) Topical nifedipine for conservative treatment of acute haemorrhoidal thrombosis. Colorectal Dis 2:18–21

    Article  Google Scholar 

  16. 16.

    Gioiella G et al (2004) Clinical study on the pharmacological treatment of haemorrhoids with 0.25% oxethacaine chlorhydate. Clin Ter 155(10):443–445

    PubMed  CAS  Google Scholar 

  17. 17.

    Tjandra JJ et al (2007) Rectogesic (glyceryl trinitrate 0.2%) ointment relieves symptoms of haemorrhoids associated with high resting anal canal pressures. Colorectal Dis 9(5):457–463

    PubMed  Article  CAS  Google Scholar 

  18. 18.

    Perrotti P et al (2010) Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study. Can J Surg 53(1):17–23

    PubMed  Google Scholar 

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Correspondence to G. Spasovski.

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Joksimovic, N., Spasovski, G., Joksimovic, V. et al. Efficacy and tolerability of hyaluronic acid, tea tree oil and methyl-sulfonyl-methane in a new gel medical device for treatment of haemorrhoids in a double-blind, placebo-controlled clinical trial. Updates Surg 64, 195–201 (2012). https://doi.org/10.1007/s13304-012-0153-4

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Keywords

  • Haemorrhoids
  • Hyaluronic acid
  • Tea tree oil
  • Methyl-sulfonyl-methane
  • Gel medical device
  • Clinical study