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Background: Oral mucositis is a common and severe complication of head and neck radiation therapy. Silymarin is a
polyphenolic flavonoid extracted from the milk thistle exhibits a strong antioxidant activity, and anti-inflammatory
effects. The efficacy for the treatment was assessed in comparison with indomethacin.
Patients and Methods: A prospective, randomized, double blind; placebo controlled study was conducted in 65 of
chemotherapy-induced oral mucositis patients; plasma IL-1β, leptin, and Trolox equivalent antioxidant capacity
(TEAC) were assessed for 3 orally treated groups; Silymarin 140mg, or Indomethacin 25mg, or placebo, 3 times daily
for 14 days, radiation technique and dose were similar. The oral mucositis was assessed weekly according to OMAS
and WHO scale, pain related to oral mucositis was scored subjectively by visual analog scale.
Results: Patients' characteristics showed no significant differences between tested groups. Statistical significance
showed in; lower OMAS value at the time of using Silymarin, and lower mean time to healing of oral mucositis in
Silymarin treated group compared to Indomethacin treated and placebo groups. Ulcer healing and pain relief were
seen in 100% of Silymarin treated group but only 40% of Indomethacin treated group compared to placebo after 5
days of treatment. Serum IL-1β, leptin were reduced significantly, and TEAC showed significant elevation in Silymarin
treated group compared to baseline and other tested drugs.
Conclusion: Silymarin could interrupt or block the mucositis process at multiple targets that protect the mucosa and
promote healing of chemotherapy-induced mucositis by reducing the incidence, blocking the oxidative stress and
anti-inflammatory actions.
Key words: Silymarin, chemotherapy-induced mucositis, IL-1β, leptin. (J Bagh Coll Dentistry 2011;23(4):81-89).

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Background: Recurrent aphthous ulcer is a chronic inflammatory disease of the oral mucosa. Substance P has activity in the inflammatory response. Transforming growth factor beta (TGF-β) as immune-modulators regulates the immune response and has anti-inflammatory, pro-inflammatory effects. Pistacia lentiscus (mastic) of Anacardiaceae family have pharmacological activities like anti-inflammatory, antioxidant, and used in treatment of wound and repair. The aim of this study is to find the safety and efficacy of a new product mastic orabase; experimentally and clinically.Methods: This research studied two parts: first; experimentally for assessment of mastic orabase effects on rabbit dermal irritation, efficacy of mastic orabase on the induced ulceration, with histopathology of rabbits’ tissues, and safety: therapeutic index and safety factor. Second; clinical efficacy of mastic orabase on the healing of RAU by assessment of ulcer size reduction, inflammation, healing time, pain, saliva substance P and TGF-β levels in RAU patients, and monitoring for any adverse effects or adverse drug reactions.Results: Experimental study of topical mastic orabase treatment showed significant reduction of inflammation and ulcer size, healing time. Safety of mastic orabase was confirmed by no dermal irritation, no toxicity, and wide therapeutic index range. Clinical study showed reduction of inflammation, ulceration, healing in short time, pain was relieved from the first topical dose, and the anti-inflammatory activity of mastic orabase was confirmed by reduction of salivary substance P and TGF-β elevation.Conclusion: Mastic orabase showed dose-dependent efficacy in the treatment of recurrent aphthous ulceration, short healing time. This may be related to effect of mastic orabase on proinflammatory and anti-inflammatory mediators; substance P and TGF-β.

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Background: Herpes simplex virus type 1 causes recurrent herpes labialis, a common disease afflicting up to 40% of adults worldwide. A randomized, double–blind trial was conducted to compare the effectiveness & the patient tolerance of topically applied 0.5% zinc sulphate suspension with those of a placebo in the treatment of herpes simplex lesion.Patients & Methods: Sixty patients were enrolled in this study. The effectiveness & symptomatic relief of pain were recorded and Fisher exact test were used.Results: The zinc sulphate group showed significantly complete healing (p=0.001) than the placebo group & pain free during the follow-up period. The zinc sulphate group showed significantly better than the placebo group during the follow-up period. The safety that has been recorded of the drug were satisfactory, there is no pain with zinc sulphate group, no side effects.Conclusion: Topically applied 0.5% zinc sulphate suspension is an effective drug for the treatment of herpes simplex lesion in a short period with pain less.

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Background: Coronary artery bypass grafting (CABG) is associated with a systemic inflammatory response. Systemic inflammatory response with secretion of cytokines & activation of leukocytes & endothelial cells is induced by CABG surgery; proinflammatory cytokines such as TNF_α, IL_1β are released in to the circulation in response to CABG surgery & have been suggested to play an important role in the pathogenesis of myocardial dysfunction in ischaemia reperfusion injury. Silymarin is a polyphenolic flavonoid derived from milk thistle (Silybum marianum) that has antioxidant, anti-inflammatory, cytoprotective effects, silymarin inhibit TNF_α & IL_1β.This study was designed to elucidate the anti-inflammatory effect of silymarin in CABG patients.Patients & methods: Thirty patients scheduled for CABG surgery in a prospective, randomized study. Twenty patients received silymarin 140 mg cap. Three times daily, given 3 days before surgery, then compared to the control group. Blood sample was drawn before & after surgery for full investigation; WBCs, differential counts; Neutrophils, Monocytes, Lymphocytes, Hb, PCV, ESR, total cholesterol, LDL, HDL, Triglycerides, SGOT, SGPT. B.urea, S.creatinin.Results: There was a decrease in post operative values of WBCs, Neutrophil, monocyte, lymphocyte, ESR, total cholesterol, SGOT, SGPT, B.urea, S.creatinine in patients treated with silymarin, compared to control. There was an increase in postoperative values of HDL in treated patients compared to control.Conclusion: Silymarin treatment is associated with an effect on the measured parameters. The data suggest that this drug may have a direct anti-inflammatory effect which explains its clinical benefit.

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Background: Atopic dermatitis is a chronic inflammatory disease that causes eczema, rashes, and itching. It is most common in younger people & adolescence. Recurrent relapses are a characteristic feature of atopic eczema. Anti-inflammatory therapy of exacerbations is aimed to control effectively disease activity and permit a return to basic dermatological therapy as soon as possible. Oxidative stress & inflammatory responses are thought to be responsible for the pathogenesis of atopic dermatitis. Silymarin is a polyphenolic flavonoid derived from the seed of milk thistle (Silybum marianum (L.) Gaertner) that has anti-inflammatory, antioxidant and cytoprotective effect. The aim of this study was to evaluate the anti-inflammatory effect of topical preparation of silymarin in atopic dermatitis.Patients & method: Forty-three patients with atopic dermatitis (26 female, 14 male, 3 - 34 years old) were participated in the single blind, placebo controlled, 8-week trial. Of these, 10 patients were treated with 0.05 %, 10 patients were treated with 0.1 %, 10 patients were treated with 0.2 % topical preparation of silymarin, twice daily. The other 10 patients were received placebo twice daily.Results: There was a statistically significant improvement. A statically significant was seen in mean total body surface area involvement over time. Mean total body surface area was 25.675% at baseline & decreased to 1% at 2-4 week.Silymarin ointment was proven to act rapidly, to be highly effective, excellent improvements in pruritis, erythema, & skin irritation were noted in the patients who received 0.1 % & 0.2 % silymarin ointment topical treatment in comparison with the control group.Conclusion: Topical treatment of silymarin is more effective, safe & may represent a breakthrough drug in the manegment of atopic dermatitis.

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Background: Herpes simplex virus is a common human pathogen that establishes life-long latent infections. Thedevelopment of new antiviral drugs, especially herbal preparations remain desirable. Lavender has been shown topossess antibacterial, antifungal, antiviral actions.This study was designed to compare the safety and efficacy of topical Lavender cream, acyclovir cream, withplacebo for the treatment of herpes simplex labialis patients.Patients and Methods: Randomized, double blind, placebo-controlled study for herpes simplex labialis treatment, atotal of 75 enrolled patients divided to three groups and given study medications; group I: Lavender cream, group II:Acyclovir cream, group III: placebo, applied topically to the lesion three times daily for 5 days. Patient’s responses totreatment were followed by clinical evaluation of healing time, size of the lesion and pain sensation, and safety ofusing the topical treatment. Patients assessed themselves the day of the scab fell off. They also graded, on a dailybasis, their perception of relief from pain and the overall benefit from treatment. Also evaluating levels of theImmunoglobulin (IgG, IgE, IgM, IgA, and IgD) in the serum of herpes simplex labialis patients.Results: Herpes simplex patients showed a significant reduction in the healing time, size of lesions, and significant painrelief from the first topical dose as a result of treatment with lavender cream associated with immunity stateimprovement.Conclusions: Lavender cream is a new candidate as a safe and effective topical treatment for herpes simplex labialislesions.

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Many reports confirm ulcers as an adverse effect of drugs such as nicorandil and aspirin. The exact responsible mechanisms of ulceration have until now not proved. Mucosal ulcers associated with the onset of ulcer are manifested by an increase in proinflammatory cytokine, excessive prostaglandin, and up-regulation of Endothilin-1 level, which directly impacts the release of leptin. These, released locally within mucosal tissues, have played a role in controlling the extent of local inflammatory responses and processes of mucosal repair. This study was designed to find out the correlation of plasma leptin and prostaglandin levels as a possible mechanism of oral ulcer formation as an adverse effect of nicorandil. The effect of nicorandil for inducing ulceration was assessed. The plasma leptin and prostaglandin E2 for the tested groups in relation to the studied parameters (gender, and daily body weight change) were estimated in albino rats. Nicorandil causes mucous membrane damage, inflammation, and ulceration. A significant reduction of plasma leptin level, which was dose-dependent, and a non-significant reduction of serum prostaglandin E2 level. The mechanisms of ulcer induction as an adverse effect of nicorandil can be related to dose-dependant leptin and prostaglandin E2 levels, which affects on repair and healing process.

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Background: Recurrent aphthous stomatitis is commonly observed and is mediated by the immune system. Lesionsappear as painful, tiny, discrete vesicles. Flax (Linum usitatissimum) has antiseptic, anti-inflammatory properties. Thepresent study was a randomized, double-blinded, placebo controlled conducted to assess the efficacy of Flax paintin this disease.Methods: Dermal irritation study; was performed by primary irritation to the skin and measured by a patch-testtechnique on the intact skin of the albino rabbit. Clinical study; 64 RAS patients, randomized to receive Flax paint orplacebo topically (three times a day, for five days). The efficacy of the treatment was estimated (healing time, ulcersize reduction, pain score, change in condition), β-2 microglobulin (β-2M), α-1Antitrypsin (α-1AT), CRP & ESR, Safety,tolerance, side effects were assessed.Results: Dermal irritation test in vivo showed no sign of irritation in Flax paint. Clinical study; four days after treatment,95% of Flax group were completely healed from aphthous ulcers, compared with placebo group ( p < 0.0001). Flaxpaint group showed significant pain reduction after the 1st or 2nd dose application compared to baseline andplacebo. Serum β-2M, α-1AT, CRP, & ESR values showed significant reduction in Flax paint treated group comparedto baseline and placebo. No sign of adverse effects or tolerance.Conclusion: This is the first time reporting that Flax paint reduced the time to repair mucosal tissue (ulcer healing), andpain persistence, it has anti-inflammatory, and analgesic effect. There was no evidence of any adverse effects

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