What do systematic reviews say?

NSAIDs (ketorolac oral rinse; systemic celecoxib) vs placebo or no treatment

• Interventions for treating oral leukoplakia to prevent oral cancer 2016 · Cochrane All outcomes

  over 3 months
  SoF 3, Safety of the intervention over 3 months: systemic celecoxib (1 study) - 32 intervention participants reported 56 adverse effects, 20 placebo participants reported 20; 4 grade 3 events; 2 discontinued. Ketorolac…
  2 studies
  GRADE not reported

Topical bleomycin vs placebo or no treatment

• Interventions for treating oral leukoplakia to prevent oral cancer 2016 · Cochrane All outcomes

  up to 3 months
  SoF 5, Safety of the intervention up to 3 months: 'All patients in the bleomycin group developed erythema with erosion by the end of the applications, whereas erythema developed in the placebo group. Discomfort was…
  1 study
  GRADE not reported

Systemic beta carotene or carotenoids (incl. lycopene) vs placebo or no treatment

• Interventions for treating oral leukoplakia to prevent oral cancer 2016 · Cochrane All outcomes

  5 to 12 months
  SoF 2, Safety of the intervention at 5 to 12 months: 'Systemic beta carotene did not cause any adverse effects in 1 study supplementing 10 mg/d (Nagao), and caused adverse effects of varying severity in 9% of…
  3 studies
  GRADE not reported

Herbal extracts (tea components; Chinese herbal mixture; freeze-dried black raspberry gel) vs placebo or no treatment

• Interventions for treating oral leukoplakia to prevent oral cancer 2016 · Cochrane All outcomes

  up to 3 months
  SoF 4, Safety of the intervention up to 3 months: '3 studies measured adverse effects: green tea extract capsules caused high frequency (93%) of adverse effects of varying severity in 1 study; the mixed tea study did…
  3 studies
  GRADE not reported

Vitamin A or retinoids (systemic or topical; incl. 13-cis-retinoic acid, acitretin) vs placebo or no treatment

• Interventions for treating oral leukoplakia to prevent oral cancer 2016 · Cochrane All outcomes

  4 to 12 months
  SoF 1, Safety of the intervention at 4 to 12 months: '3 studies (1 each evaluating topical acitretin, topical 13-cis-retinoic acid, 200,000 IU per week of vitamin A) found no adverse effects. Systemic 13-cis-retinoic…
  4 studies
  GRADE not reported

Bowman-Birk inhibitor vs placebo or no treatment

• Interventions for treating oral leukoplakia to prevent oral cancer 2016 · Cochrane All outcomes

  up to 6 months
  SoF 6, Safety of the intervention up to 6 months: 'Trial authors reported that there were no significant adverse effects. 33 participants in the intervention group reported 75 adverse effects. 25 participants in the…
  1 study
  GRADE not reported

Antioxidants (lycopene, curcumin, Oxitard) vs Placebo or no active treatment

• Interventions for managing oral submucous fibrosis 2024 · Cochrane All outcomes
  Adverse effects (any): 0 in placebo vs 2 minor (flatulence and bloating); 90 (1); no GRADE rating given.
  1 study · 90 participants
  GRADE not reported

Vasodilator vs Placebo or no active treatment

• Interventions for managing oral submucous fibrosis 2024 · Cochrane All outcomes
  Adverse effects (any): 0 placebo vs 14 minor (transient flushing and upper trunk warmness); 85 (2); no GRADE rating.
  2 studies · 85 participants
  GRADE not reported

Abdominal dermal fat graft vs Nasolabial flap

• Interventions for managing oral submucous fibrosis 2024 · Cochrane All outcomes
  Kania 2022 reported 3/30 serious adverse effects (graft failure) requiring prolonged hospital stay in the abdominal dermal fat graft group; no GRADE rating.
  1 study · 30 participants
  GRADE not reported

Intralesional dexamethasone injections vs placebo injection

• Interventions for managing oral submucous fibrosis 2024 · Cochrane All outcomes
  Adverse effects (any): no adverse effects reported; 25 (1); no GRADE rating.
  1 study · 25 participants
  GRADE not reported

Topical triamcinolone acetonide vs pimecrolimus 1%

Topical triamcinolone acetonide showed no clear difference in adverse effects compared with topical pimecrolimus; GRADE not reported.

• Interventions for treating oral lichen planus: corticosteroid therapies 2020 · Cochrane All outcomes

  end of treatment
  RR 0.21 [0.01, 4.10]
  1 study · 35 participants
  GRADE not reported

Topical triamcinolone acetonide vs Topical tacrolimus

Topical triamcinolone acetonide may leads to lower adverse effects compared with topical tacrolimus (low certainty).

• Interventions for treating oral lichen planus: corticosteroid therapies 2020 · Cochrane All outcomes

  3-8 weeks
  RR 0.47 [0.22, 0.99]
  2 studies · 58 participants
  Low

Topical clobetasol propionate vs Topical tacrolimus

It is very uncertain whether topical clobetasol propionate changes adverse effects compared with topical tacrolimus (very low certainty).

• Interventions for treating oral lichen planus: corticosteroid therapies 2020 · Cochrane All outcomes

  3-8 weeks
  RR 0.05 [0.00, 0.83]
  2 studies · 100 participants
  Very low

Topical triamcinolone acetonide vs Topical ciclosporin

Topical triamcinolone acetonide led to lower adverse effects compared with topical ciclosporin; GRADE not reported.

• Interventions for treating oral lichen planus: corticosteroid therapies 2020 · Cochrane All outcomes

  end of treatment
  RR 0.15 [0.05, 0.49]
  1 study · 139 participants
  GRADE not reported

Dexamethasone + nystatin + curcumin (adjunctive) vs Dexamethasone + nystatin + placebo

• Interventions for treating oral lichen planus: corticosteroid therapies 2020 · Cochrane All outcomes
  Amirchaghmaghi 2016: no adverse effects recorded in either group (low-certainty)
  1 study
  Low

Topical clobetasol propionate vs Topical ciclosporin

It is very uncertain whether topical clobetasol propionate changes adverse effects compared with topical ciclosporin (very low certainty).

• Interventions for treating oral lichen planus: corticosteroid therapies 2020 · Cochrane All outcomes

  3-8 weeks
  RR 6.32 [0.84, 47.69]
  1 study · 39 participants
  Very low

Topical corticosteroids vs placebo

It is very uncertain whether topical corticosteroid changes adverse effects compared with placebo (very low certainty).

• Interventions for treating oral lichen planus: corticosteroid therapies 2020 · Cochrane All outcomes

  3-9 weeks
  RR 1.48 [0.48, 4.56]
  3 studies · 88 participants
  Very low

Keratinocyte growth factor (KGF; palifermin or repifermin), intravenous vs placebo

• Pharmacological interventions for preventing dry mouth and salivary gland dysfunction following radiotherapy 2017 · Cochrane All outcomes
  No evidence of a difference in reported adverse events across the three trials (nausea, fever, constipation, diarrhoea, headache, fatigue and others)
  3 studies
  GRADE not reported

Amifostine (intravenous) vs Amifostine (subcutaneous)

• Pharmacological interventions for preventing dry mouth and salivary gland dysfunction following radiotherapy 2017 · Cochrane All outcomes
  Increased hypotension with intravenous delivery (20% vs 8%; P = 0.007); skin rash (10% vs 22%; P = 0.012) and local pain at injection site (0% vs 8%; P = 0.001) worse with subcutaneous; inconclusive for…
  1 study
  GRADE not reported

Topical treatments (benzydamine hydrochloride oral rinse) vs placebo

• Interventions for treating burning mouth syndrome 2016 · Cochrane All outcomes

  short-term (up to 3 months) · benzydamine hydrochloride
  SoF9. Adverse effects: single study narratively reported that no adverse effects occurred from benzydamine hydrochloride oral rinse; 20 participants (1 RCT); very low.
  1 study · 20 participants
  Very low