Interventions for managing oral submucous fibrosis.

BACKGROUND: Oral submucous fibrosis (OSF) is a chronic disease of the oral cavity that causes progressive constriction of the cheeks and mouth accompanied by severe pain and reduced mouth opening. OSF has a significant impact on eating and swallowing, affecting quality of life. There is an increased risk of oral malignancy in people with OSF. The main risk factor for OSF is areca nut chewing, and the mainstay of treatment has been behavioural interventions to support habit cessation. This review is an update of a version last published in 2008. OBJECTIVES: To evaluate the benefits and harms of interventions for the management of oral submucous fibrosis. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 5 September 2022. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) of adults with a biopsy-confirmed diagnosis of OSF treated with systemic, locally delivered or topical drugs at any dosage, duration or delivery method compared against placebo or each other. We considered surgical procedures compared against other treatments or no active intervention. We also considered other interventions such as physiotherapy, ultrasound or alternative therapies. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. participant-reported resumption of normal eating, chewing and speech; 2. change or improvement in maximal mouth opening (interincisal distance); 3. improvement in range of jaw movement; 4. change in severity of oral/mucosal burning pain/sensation; 5. ADVERSE EFFECTS: Our secondary outcomes were 6. quality of life; 7. postoperative discomfort or pain as a result of the intervention; 8. participant satisfaction; 9. hospital admission; 10. direct costs of medication, hospital bed days and any associated inpatient costs for the surgical interventions. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included 30 RCTs (2176 participants) in this updated review. We assessed one study at low risk of bias, five studies at unclear risk of bias and 24 studies at high risk of bias. We found diverse interventions, which we categorised according to putative mechanism of action. We present below our main findings for the comparison 'any intervention compared with placebo or no active treatment' (though most trials included habit cessation for all participants). Results for head-to-head comparisons of active interventions are presented in full in the main review. Any intervention versus placebo or no active treatment Participant-reported resumption of normal eating, chewing and speech No studies reported this outcome. Interincisal distance Antioxidants may increase mouth opening (indicated by interincisal distance (mm)) when measured at less than three months (mean difference (MD) 3.11 mm, 95% confidence interval (CI) 0.46 to 5.77; 2 studies, 520 participants; low-certainty evidence), and probably increase mouth opening slightly at three to six months (MD 8.83 mm, 95% CI 8.22 to 9.45; 3 studies, 620 participants; moderate-certainty evidence). Antioxidants may make no difference to interincisal distance at six-month follow-up or greater (MD -1.41 mm, 95% CI -5.74 to 2.92; 1 study, 90 participants; low-certainty evidence). Pentoxifylline may increase mouth opening slightly (MD 1.80 mm, 95% CI 1.02 to 2.58; 1 study, 106 participants; low-certainty evidence). However, it should be noted that these results are all less than 10 mm, which could be considered the minimal change that is meaningful to someone with oral submucous fibrosis. The evidence was very uncertain for all other interventions compared to placebo or no active treatment (intralesional dexamethasone injections, pentoxifylline, hydrocortisone plus hyaluronidase, physiotherapy). Burning sensation Antioxidants probably reduce burning sensation visual analogue scale (VAS) scores at less than three months (MD -30.92 mm, 95% CI -31.57 to -30.27; 1 study, 400 participants; moderate-certainty evidence), at three to six months (MD -70.82 mm, 95% CI -94.39 to -47.25; 2 studies, 500 participants; moderate-certainty evidence) and at more than six months (MD -27.60 mm, 95% CI -36.21 to -18.99; 1 study, 90 participants; moderate-certainty evidence). The evidence was very uncertain for the other interventions that were compared to placebo and measured burning sensation (intralesional dexamethasone, vasodilators). Adverse effects Fifteen studies reported adverse effects as an outcome. Six of these studies found no adverse effects. One study evaluating abdominal dermal fat graft reported serious adverse effects resulting in prolonged hospital stay for 3/30 participants. There were mild and transient general adverse effects to systemic drugs, such as dyspepsia, abdominal pain and bloating, gastritis and nausea, in studies evaluating vasodilators and antioxidants in particular. AUTHORS' CONCLUSIONS: We found moderate-certainty evidence that antioxidants administered systemically probably improve mouth opening slightly at three to six months and improve burning sensation VAS scores up to and beyond six months. We found only low/very low-certainty evidence for all other comparisons and outcomes. There was insufficient evidence to make an informed judgement about potential adverse effects associated with any of these treatments. There was insufficient evidence to support or refute the effectiveness of the other interventions tested. High-quality, adequately powered intervention trials with a low risk of bias that compare biologically plausible treatments for OSF are needed. It is important that relevant participant-reported outcomes are evaluated.

The effectiveness of self-management interventions in adults with chronic orofacial pain: A systematic review, meta-analysis and meta-regression.

BACKGROUND: Psychosocial risk factors associated with chronic orofacial pain are amenable to self-management. However, current management involves invasive therapies which lack an evidence base and has the potential to cause iatrogenic harm. OBJECTIVES: To determine: (a) whether self-management is more effective than usual care in improving pain intensity and psychosocial well-being and (b) optimal components of self-management interventions. DATABASES AND DATA TREATMENT: Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO, WHO International Clinical Trials Registry Platform and Clinical Trials.gov were searched. Meta-analysis was used to determine effectiveness, and GRADE was used to rate quality, certainty and applicability of evidence. RESULTS: Fourteen trials were included. Meta-analyses showed self-management was effective for long-term pain intensity (standardized mean difference [SMD] -0.32, 95% confidence interval [CI] -0.47 to -0.17) and depression (SMD -0.32, 95% CI -0.50 to -0.15). GRADE analysis showed a high score for certainty of evidence for these outcomes and significant effects for additional outcomes of activity interference (-0.29 95% CI -0.47 to -0.11) and muscle palpation pain (SMD -0.58 95% CI -0.92 to -0.24). Meta-regression showed nonsignificant effects for biofeedback on long-term pain (-0.16, 95% CI -0.48 to 0.17, p-value = 0.360) and depression (-0.13, 95% CI -0.50 to 0.23, p-value = 0.475). CONCLUSIONS: Self-management interventions are effective for patients with chronic orofacial pain. Packages of physical and psychosocial self-regulation and education appear beneficial. Early self-management of chronic orofacial pain should be a priority for future testing. SIGNIFICANCE: This systematic review provides clear evidence for effectiveness of combined biomedical and psychological interventions (incorporating self-management approaches) on long-term outcomes in the management of chronic orofacial (principally TMD) pain. Self-management should be a priority for early intervention in primary care in preference to invasive, irreversible and costly therapies. Further research is needed firstly to clarify the relative effectiveness of specific components of self-management, both individually and in conjunction, and secondly on outcomes in other types of chronic orofacial pains.

Psychosocial interventions for the management of chronic orofacial pain.

BACKGROUND: Psychosocial factors have a role in the onset of chronic orofacial pain. However, current management involves invasive therapies like occlusal adjustments and splints which lack an evidence base. OBJECTIVES: To determine the efficacy of non-pharmacologic psychosocial interventions for chronic orofacial pain. SEARCH METHODS: The following electronic databases were searched: the Cochrane Oral Health Group Trials Register (to 25 October 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4), MEDLINE via OVID (1950 to 25 October 2010), EMBASE via OVID (1980 to 25 October 2010) and PsycINFO via OVID (1950 to 25 October 2010). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: Randomised controlled trials which included non-pharmacological psychosocial interventions for adults with chronic orofacial pain compared with any other form of treatment (e.g. usual care like intraoral splints, pharmacological treatment and/or physiotherapy). DATA COLLECTION AND ANALYSIS: Data were independently extracted in duplicate. Trial authors were contacted for details of randomisation and loss to follow-up, and also to provide means and standard deviations for outcome measures where these were not available. Risk of bias was assessed and disagreements between review authors were discussed and another review author involved where necessary. MAIN RESULTS: Seventeen trials were eligible for inclusion into the review. Psychosocial interventions improved long-term pain intensity (standardised mean difference (SMD) -0.34, 95% confidence interval (CI) -0.50 to -0.18) and depression (SMD -0.35, 95% CI -0.54 to -0.16). However, the risk of bias was high for almost all studies. A subgroup analysis revealed that cognitive behavioural therapy (CBT) either alone or in combination with biofeedback improved long-term pain intensity, activity interference and depression. However the studies pooled had high risk of bias and were few in number. The pooled trials were all related to temporomandibular disorder (TMD). AUTHORS' CONCLUSIONS: There is weak evidence to support the use of psychosocial interventions for chronic orofacial pain. Although significant effects were observed for outcome measures where pooling was possible, the studies were few in number and had high risk of bias. However, given the non-invasive nature of such interventions they should be used in preference to other invasive and irreversible treatments which also have limited or no efficacy. Further high quality trials are needed to explore the effects of psychosocial interventions on chronic orofacial pain.