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In Vitro and Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of Nine Antiacne Medicinal Plants.

ABSTRACT: The present in vitro and randomized, double-blind, placebo-controlled trial aims to determine the efficacy and safety of nine Mediterranean antiacne medicinal plants. The antimicrobial, antisebum, and anti-inflammatory activities of the plant extracts were evaluated in cells from the immortalized human keratinocytes (HaCaT) and human monocytic cell line (THP-1) as well as in a double-blind, randomized, and placebo-controlled trial. Most of the extracts showed no significant cytotoxic effects on HaCaT cells up to 250??g/ml. Inula helenium (IH) and Saponaria officinalis (SO) inhibited sebum production at 90??g/ml and 30??g/ml, respectively. The inhibition effect of SO on the growth of Cutibacterium acnes was 1.2 times higher than that of chloramphenicol. IH and SO extracts significantly inhibited the lipopolysaccharide- (LPS-) induced IL-6 and TNF-? production in THP-1 cells reaching the control levels of untreated cells at a concentration of 250??g/ml. SO, IH, and Solanum nigrum (SN) extracts inhibited the nitric oxide (NO) production in a dose-dependent manner. Based on these results, an antiacne herbal cream (AHC) was prepared from different portions of extracts from SO, IH, and SN, and its efficacy was evaluated in a double-blind, randomized, and controlled efficacy study with 41 acne patients, ages 18-24, who were asked to apply AHC (n?=?27) or a placebo (n?=?14) two to three times daily for six weeks. Results obtained indicate that the AHC has unique synergistic effects that halt sebum production, combined with highly antiseptic and anti-inflammatory activity, in which 54.95% (t?=?19.37 P < 0.001) of acne inflammatory and noninflammatory lesions disappeared after two weeks, 85.3%, after five weeks (t?=?14.19 P < 0.001), and 91.4%, at the end of the sixth week of application (t?=?5.7 P < 0.001). In conclusion, SO, IH, and SN as single extracts and in combination as AHC showed significant antimicrobial, antisebum, and anti-inflammatory activities in vitro and in a double-blind, randomized, and controlled antiacne efficacy. Therefore, AHC represents an interesting alternative treatment for acne.

SUBMITTER: Said O

PROVIDER: S-EPMC7368212 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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<i>In Vitro</i> and Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of Nine Antiacne Medicinal Plants.

Said Omar O Khamaysi Iyad I Kmail Abdalsalam A Fulder Stephen S AboFarekh Basheer B Amin Riyad R Daraghmeh Jamila J Saad Bashar B

Evidence-based complementary and alternative medicine : eCAM 20200709

The present <i>in vitro</i> and randomized, double-blind, placebo-controlled trial aims to determine the efficacy and safety of nine Mediterranean antiacne medicinal plants. The antimicrobial, antisebum, and anti-inflammatory activities of the plant extracts were evaluated in cells from the immortalized human keratinocytes (HaCaT) and human monocytic cell line (THP-1) as well as in a double-blind, randomized, and placebo-controlled trial. Most of the extracts showed no significant cytotoxic effe ...[more]

PMID: 32695206

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Project description:No available treatments slow or halt progression of multiple system atrophy, which is a rare, progressive, fatal neurological disorder. In a mouse model of multiple system atrophy, rifampicin inhibited formation of ?-synuclein fibrils, the neuropathological hallmark of the disease. We aimed to assess the safety and efficacy of rifampicin in patients with multiple system atrophy.In this randomised, double-blind, placebo-controlled trial we recruited participants aged 30-80 years with possible or probable multiple system atrophy from ten US medical centres. Eligible participants were randomly assigned (1:1) via computer-generated permuted block randomisation to rifampicin 300 mg twice daily or matching placebo (50 mg riboflavin capsules), stratified by subtype (parkinsonian vs cerebellar), with a block size of four. The primary outcome was rate of change (slope analysis) from baseline to 12 months in Unified Multiple System Atrophy Rating Scale (UMSARS) I score, analysed in all participants with at least one post-baseline measurement. This study is registered with ClinicalTrials.gov, number NCT01287221.Between April 22, 2011, and April 19, 2012, we randomly assigned 100 participants (50 to rifampicin and 50 to placebo). Four participants in the rifampicin group and five in the placebo group withdrew from study prematurely. Results of the preplanned interim analysis (n=15 in each group) of the primary endpoint showed that futility criteria had been met, and the trial was stopped (the mean rate of change [slope analysis] of UMSARS I score was 0.62 points [SD 0.85] per month in the rifampicin group vs 0.47 points [0.48] per month in the placebo group; futility p=0.032; efficacy p=0.76). At the time of study termination, 49 participants in the rifampicin group and 50 in the placebo group had follow-up data and were included in the final analysis. The primary endpoint was 0.5 points (SD 0.7) per month for rifampicin and 0.5 points (0.5) per month for placebo (difference 0.0, 95% CI -0.24 to 0.24; p=0.82). Three (6%) of 50 participants in the rifampicin group and 12 (24%) of 50 in the placebo group had one or more serious adverse events; none was thought to be related to treatment.Our results show that rifampicin does not slow or halt progression of multiple system atrophy. Despite the negative result, the trial does provide information that could be useful in the design of future studies assessing potential disease modifying therapies in patients with multiple system atrophy.National Institutes of Health, Mayo Clinic Center for Translational Science Activities, and Mayo Funds.

Dataset Information

In Vitro and Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of Nine Antiacne Medicinal Plants.

Publications

<i>In Vitro</i> and Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of Nine Antiacne Medicinal Plants.

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