A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance.

BACKGROUND: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses. AIMS AND OBJECTIVES: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo. METHODS: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases. RESULTS: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline. LIMITATIONS: Small sample size and a short follow-up period of our study were major limitations. CONCLUSION: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone.

Combination antioxidant therapy prevents epileptogenesis and modifies chronic epilepsy.

Many epilepsies are acquired conditions following an insult to the brain such as a prolonged seizure, traumatic brain injury or stroke. The generation of reactive oxygen species (ROS) and induction of oxidative stress are common sequelae of such brain insults and have been shown to contribute to neuronal death and the development of epilepsy. Here, we show that combination therapy targeting the generation of ROS through NADPH oxidase inhibition and the endogenous antioxidant system through nuclear factor erythroid 2-related factor 2 (Nrf2) activation prevents excessive ROS accumulation, mitochondrial depolarisation and neuronal death during in vitro seizure-like activity. Moreover, this combination therapy prevented the development of spontaneous seizures in 40% of animals following status epilepticus (70% of animals were seizure free after 8 weeks) and modified the severity of epilepsy when given to chronic epileptic animals.

N-acetylcysteine in dermatology.

N-acetylcysteine is a mucolytic drug which is commonly used as an antidote for acetaminophen toxicity. It is a thiol compound, which acts as a donor of cysteine, leading to replenishment of glutathione and thus acts as an antioxidant. It also has anti-inflammatory effects, alters the levels of neurotransmitters, inhibits proliferation of fibroblasts and keratinocytes and causes vasodilatation. Due to these actions, n-acetylcysteine has found use in several dermatologic conditions in systemic and topical form. The drug has been used as an adjuvant in the management of conditions such as toxic epidermal necrolysis, drug hypersensitivity syndrome, trichotillomania, skin picking disorders and onychotillomania, ichthyoses, contact dermatitis, atopic dermatitis, melasma, pseudoporphyria, connective tissue diseases, wound healing and alopecia. It also has a role in protection from radiation-induced skin damage including photo-ageing, photocarcinogenesis and radiation dermatitis. Most indications in dermatology are supported by case reports, small case series and small trials. Higher quality of evidence is needed for its wider use. The drug is cheap and is generally safe with few adverse effects. Thus a greater role is possible for use of n-acetylcysteine in various skin conditions. This review explores the various uses of n-acetylcysteine in the field of dermatology, the evidence supporting the same, the possible mechanisms of action and the adverse effects of the drug.

Leaves of Cassia tora as a novel cancer therapeutic--an in vitro study.

Cassia tora Linn (Leguminacea) is a medicinal plant traditionally used as laxative, for the treatment of leprosy and various skin disorders. Preliminary phytochemical analysis of leaf showed the presence of polyphenols (3.7 mg gallic acid equivalent per gram dried leaves). The presence of phenolic compound prompted us to evaluate its antioxidant and antiproliferative potential. In the present study C. tora methanolic leaf extract (CTME) was evaluated for its nitric oxide scavenging activity and reducing power assays using Rutin and BHT as standards. The extract was studied for its lipid peroxidation inhibition assay using rat liver and brain. In all assays, a correlation existed between concentration of extract and percentage inhibition of free radical, reducing power and inhibition of lipid peroxidation. The antiproliferative activity of CTME with Cisplatin, anticancer drug was studied using human cervical cancer cells (HeLa). Proliferation of HeLa was measured by MTT assay, cell DNA content by modified diphenylamine method and apoptosis by Caspase 3 activity. The plant extract induced a marked concentration dependent inhibition on proliferation, reduced DNA content and apoptosis in HeLa. These results clearly indicate that C. tora is effective against free radical mediated diseases.

Vitamin E can reduce blood pressure in mild hypertensives.

This triple-blind placebo-controlled clinical trial was performed to determine the effects of the anti-oxidant vitamin E on blood pressure and heart rate in patients with mild hypertension. A total of 70 new mild hypertensive subjects (systolic blood pressure, SBP: 140-160 mmHg; diastolic blood pressure, DBP: 90-100 mmHg) without secondary hypertension were selected from among people referred to the Hypertension Unit of Isfahan Cardiovascular Research Center and divided randomly into two groups of drug (DG) and placebo (PG). All subjects were aged from 20 to 60 years old, without any other cardiovascular risk factors. The drug group received vitamin E tablets (200 IU/day) and the placebo group received placebo only for 27 weeks. At the beginning and the end of the study, the blood vitamin E level was measured fluorimetrically in all subjects according to the Hansen and Warwick method [14, 15]. Blood pressure and heart rate were measured at the beginning, during, and at the end of the study. Blood pressure was measured by a physician using one random zero mercury sphygmomanometer. Personal information and dietary habits of subjects were collected by separate questionnaire. At the end of the study, it was found that the vitamin E supplement had caused a remarkable decrease in SBP (-24% in DG versus -1.6% in PG) and a less remarkable decrease in DBP (-12.5% in DG versus -6.2% in PG) (p < 0.05). The change in heart rate was -4.3% in DG, and -14.0% in PG (p < 0.05). It is concluded that a vitamin E supplement of 200 IU/day can be effective in mild hypertensive patients in the long term, probably due to nitric oxide, and improve their blood pressure status. Therefore, vitamin E supplement could be recommended to such patients.