Small trial suggests a potential benefit for combination of triamcinolone acetonide and salvianolic acid B for Oral submucous fibrosis patients

shutterstock_32414035 - Betel leaf

Oral submucous fibrosis (OSF) is characterized by chronic inflammation and progressive subepithelial connective tissue fibrosis. This can involve the oral cavity, pharynx and upper third of the oesphagus. It is more commonly found in patients in the Asian subcontinent and the Far East.  The aetiology is considered to be multi-factorial with areca nut chewing, nutritional factors, genetic disposition, and hormonal factors being suggested as causative agents.  OSF cause significant morbidity and is considered a potential malignant condition with a malignant transformation rate as high a 7% in some populations.  The aim of this study was to investigate the effectiveness of triamcinolone acetonide (TA) and salvianolic acid B (SA-B) intralesional combined injection in the treatment of OSF.

Patents with OSF confirmed with biopsy were randomised to receive intralesional injections after topical anaesthesia at weekly intervals, Group A received  triamcinolone acetonide (TA) [n=14 ] , Group B received salvianolic acid B (SA-B) [n=14 ] and group C received TA & SA-B [n=14 ] . All patients were required to perform daily exercises and eliminate harmful oral habits (betel nut chewing, cigarette smoking, and alcohol consumption). Maximum mouth opening and burning sensations were the main outcome measures. Burning sensation was measured using a visual analogue scale (VAS)  Patients were assessed by an examiner blind to group allocations at 10, 20 and 44 weeks.

  •  All of the 42 OSF patients had a betel nut–chewing habit
  • There were improvements in mouth opening and burning sensations  in all three groups.
  • No side effects were reported

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The authors concluded

The findings of the present study demonstrate that a TA and SA-B intralesional combined injection improves the signs and symptoms associated with OSF without obvious side effects.


Treatment options in this are were the subject of a 2008 Cochrane review by Fedorowicz et al and we noted two other reviews in Dental Elf in January 2012. This particular study is small with 42 out of the original 44 completing the study and it is not clear from which groups the drop outs occurred. While this small trial is suggestive of some benefit it is clear that more high quality trials are needed to clarify the most effective treatment for this troublesome condition as previous reviews have found that the available evidence to support the range of drug treatments that have been tried is limited.


Jiang XW, Zhang Y, Yang SK, Zhang H, Lu K, Sun GL. Efficacy of salvianolic acid B combined with triamcinolone acetonide in the treatment of oral submucous fibrosis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Dec 20. Doi:pii: S2212-4403(12)01637-9. 10.1016/j.oooo.2012.10.006. [Epub ahead of print] PubMed PMID: 23260769.

Fedorowicz Z, Chan Shih-Yen E, Dorri M, Nasser M, Newton T, Shi L. Interventions for the management of oral submucous fibrosis. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD007156. DOI: 10.1002/14651858.CD007156.pub2.

Dental Elf  3rd Jan 2012 – Little evidence for drug treatments for oral submucous fibrosis

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