Little evidence for drug treatments for oral submucous fibrosis

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Oral Submucous fibrosis (OSMF) is a chronic disease caused by the use of areca nut. It  is associated with significant morbidity (including pain and reduced oral opening) and an increased risk for malignancy. The aim of this review identify the published literature on the role of various drugs in the treatment of oral submucous fibrosis.

The authors searched Medline, Embase and the Cochrane CENTRAL databases. Studies of  level III and IV classified using the Oxford Centre for Evidence-Based Medicine system  were excluded. The main outcome measures used were improvement in oral ulceration, burning sensation, blanching and trismus.

13 publications  were included  (3 randomized controlled trials and 10 clinical trials/controlled clinical trials), involving  1157 patients.

They found a wide range of agents had been used, steroids, hyaluronidase, human placenta extracts, chymotrypsin and collagenase, pentoxifylline, nylidrin hydrochloride, iron and multivitamin supplements including lycopene.  The systemic agents were associated with few adverse effects like gastritis, gastric irritation and peripheral flushing with pentoxifylline, and flushingly warm skin with nylidrin hydrochloride; all other side-effects were mild and mainly local.

The authors concluded

The drug treatment that is currently available for oral submucous fibrosis is clearly inadequate. There is a need for high-quality randomized controlled trials with carefully selected and standardized outcome measures.

Chole RH, Gondivkar SM, Gadbail AR, Balsaraf S, Chaudhary S, Dhore SV, Ghonmode S, Balwani S, Mankar M, Tiwari M, Parikh RV. Review of drug treatment of oral submucous fibrosis. Oral Oncol. 2011 Dec 27. [Epub ahead of print] PubMed PMID: 22206808.

Related reviews

This review has, not unsurprisingly, similar findings to two broader reviews covering the treatment of OSMF.  The more recent of the two by Kerr et al was published in Oral Diseases earlier  in 2011 and a commentary on this review is available in the Evidence-based Dentistry Journal.   The other,  a Cochrane Review by Fedorowicz et al was last updated in 2008.   There have been two additional randomised controlled trials that are included in the newer publications, however, there is still concern over the quality of the trials that have been conducted. Consequently patient education aimed at stopping the chewing habit must remain an important part of management.

Kerr AR, Warnakulasuriya S, Mighell AJ, Dietrich T, Nasser M, Rimal J, Jalil A, Bornstein MM, Nagao T, Fortune F, Hazarey VH, Reichart PA, Silverman S, Johnson NW. A systematic review of medical interventions for oral submucous fibrosis and future research opportunities. Oral Dis. 2011 Apr;17 Suppl 1:42-57. doi: 10.1111/j.1601-0825.2011.01791.x. Review. PubMed PMID: 21382138.

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.


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