Safe use elements of finished herbal products: insights from consumers and practitioners in Malaysia.

BACKGROUND: The use of finished herbal products (FHPs) among Malaysians today is expanding rapidly leading to a huge market of FHPs in the country. However, the mass production of FHPs in today's market is alarming due to safety-use issues that could lead to serious adverse effects. Nevertheless, demands are still high for FHPs as most consumers perceived it as safe to consume as it is made from natural substances as the active ingredients. This study aims to explore the safe use elements of FHPs identified by two stakeholders: consumers and practitioners in Malaysia and further compare these elements with the current regulations. METHODS: As an exploratory study, its approach is to investigate at an in-depth level of understanding of safe use elements from the involved stakeholders: consumers and practitioners. We had a total of 4 focus group discussion sessions (1 FGD session with consumer and 3 FGD sessions with practitioners) as a method of collecting data from the participants. The FGDs were conducted in local native Malaysian and then being translated by researchers without changing their meanings. Thematic analysis was done which involves methodically reading through the verbatim transcripts and consequently segmenting and coding the text into categories that highlight what the participants have discussed. RESULTS: From the result, we found that both practitioners and consumers agreed a safe FHP must be in compliance with the guidelines from the Ministry of Health Malaysia (MOH). There are other safe use elements highlighted including halal certification, trusted over-the-counter outlets, and published reports on the safety, efficacy, and quality. CONCLUSIONS: In conclusion, both practitioners and consumers agreed that the most important safe-use element is compliance with MOH guidelines, but the depth of discussion regarding the safety elements among these stakeholders holds a very huge gap. Thus, initiatives must be planned to increase the knowledge and understanding about the MOH guidelines towards achieving a sustainable ecosystem in the safe use of FHPs.

Effectiveness of herbal oral care products in reducing dental plaque and gingivitis: an overview of systematic reviews.

Introduction: Numerous clinical trials and systematic reviews have investigated the effectiveness of both herbal and conventional oral care approaches to reducing plaque and gingivitis. However, their findings vary and are inconsistent. Thus, the objective of this umbrella review is to compile data from systematic reviews and provide an overview of the effects of herbal oral care products on tooth plaque and gingivitis. Methods: A comprehensive search of the literature was performed in 6 databases for systematic reviews with or without meta-analyses, published up to 30 May 2023, without any language restrictions. Only clinical trials comparing herbal oral care products (in the form of mouthrinse or toothpaste) against standard oral care products or placebo were considered. Results: Some herbal oral care products, particularly in the form of mouthrinses, have a similar level of positive effect on plaque and gingivitis reduction and, thus, can be used as an adjunct to traditional dentifrices. However, the shorter duration of trials (<4 weeks) and reported publication bias in the clinical trials mean that these findings must be interpreted with caution. Conclusion: To accurately determine the impact of various herbal extracts on periodontal health, well-designed, long-term, and controlled trials that adhere to standardized protocols must be carried out.

Introduction: On a étudié l'efficacité d'approches de soins buccodentaires classiques et à base de plantes pour lutter contre la plaque dentaire et la gingivite dans le cadre de nombreux essais cliniques et revues systématiques. Toutefois, leurs conclusions ont été variables et incohérentes. Cette revue générale vise donc à compiler des données issues de revues systématiques et de présenter un aperçu des effets des produits de soins buccodentaires à base de plantes sur la plaque dentaire et la gingivite. Méthodes: On a procédé à une recherche documentaire exhaustive dans 6 bases de données pour effectuer des revues systématiques, avec ou sans méta-analyses, sans aucune restriction relative à la langue de l'étude, publiées avant le 30 mai 2023. Seuls des essais cliniques comparant des produits de soins buccodentaires à base de plantes (sous forme de rincebouche ou de dentifrice) à des produits de soins buccodentaires classiques ou à des placebos ont été envisagés. Résultats: Quelques produits de soins buccodentaires à base de plantes, en particulier les rince-bouches de ce type, ont des effets positifs comparables en matière de réduction de la plaque et de la gingivite et peuvent donc être utilisés en complément des dentifrices ordinaires. Toutefois, ces résultats doivent être interprétés avec prudence du fait de la durée relativement courte des essais (moins de 4 semaines) et du biais de publication signalé dans les essais cliniques. Conclusion: Pour déterminer avec précision les effets de divers extraits de plantes sur la santé parodontale, il est nécessaire d'avoir recours à des essais bien conçus, à long terme et contrôlés, qui respectent des protocoles normalisés.

Evaluating the Therapeutic Properties of Natural Products in Orthodontic and Surgical Treatment of Dentofacial Deformities: A Systematic Review of Clinical Trials.

The use of natural products as alternatives to traditional pharmacological treatments in orthodontics is gaining interest due to their anti-inflammatory, antibacterial, and antioxidant properties. This systematic review synthesizes evidence from clinical trials to evaluate the efficacy of natural products in reducing inflammation and bacterial presence in orthodontic and orthognathic treatment settings. The database search was conducted across PubMed, Scopus, and Embase up to January 2024. The review focused on randomized controlled trials only. The selected studies centered on the anti-inflammatory, antibacterial, and antioxidant effects of natural products, adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines for data extraction. Nine studies, totaling 358 participants, were included. Significant findings demonstrated a reduction in gingival inflammation by over 40% with the use of Aloe vera compared to chlorhexidine. Another study noted a decrease in bleeding on probing by 13.6 points in the treatment group over placebo. Additionally, honey showed a rapid modulation of plaque pH and significantly reduced bacterial counts of Streptococcus mutans. Furthermore, the use of resveratrol emulgel was linked to substantial improvements in gingival health, with a reduction in the gingival index and probing pocket depth. The results indicate that natural products can significantly enhance orthodontic treatment outcomes by reducing inflammation and bacterial levels. These products offer effective alternatives to traditional treatments and show potential for integration into routine orthodontic care protocols. Further research is encouraged to standardize application methods and dosages to maximize clinical benefits and patient satisfaction.

Use of Aloe Vera Gel as Media to Assess Antimicrobial Activity and Development of Antimicrobial Nanocomposites.

Antimicrobial resistance is a menace to public health on a global scale. In this regard, nanomaterials exhibiting antimicrobial properties represent a promising solution. Both metal and metal oxide nanomaterials are suitable candidates, even though their mechanisms of action vary. Multiple antimicrobial mechanisms can occur simultaneously or independently; this includes either direct contact with the pathogens, nanomaterial uptake, oxidative stress, ion release, or any of their combinations. However, due to their specific properties and more particularly fast settling, existing methods to study the antimicrobial properties of nanoparticles have not been specifically adapted in some cases. The development of methodologies that can assess the antimicrobial properties of metallic nanomaterials accurately is necessary. A cost-effective methodology with a straightforward set-up that enables the easy and quick assessment of the antimicrobial properties of metal nanoparticles with high accuracy has been developed. The methodology is also capable of confirming whether the killing mechanism involves ionic diffusion. Finally, Aloe Vera gel showed good properties for use as a medium for the development of antimicrobial ointment.

A Randomized Single-Blinded Phase II Trial Comparing Efficacy and Quality of Life of Topical Aloe Vera Gel Plus Urea Cream Versus Urea Cream Alone for Prevention of Hand Foot Syndrome in Cancer Patients Receiving Capecitabine.

INTRODUCTION: Capecitabine has been widely prescribed to treat various cancers. The hand foot syndrome (HFS) is the most troublesome adverse effect. Urea cream has been pre-emptively co-prescribed, even though its efficacy is doubtful. Aloe vera gel with urea cream might potentiate each other. This trial was intended to prove the efficacy of this combination. MATERIALS AND METHODS: The investigators conducted a randomized single-blinded phase II study. The participants were randomized 1:1 to receive the combination of aloe vera gel and 10% urea cream (n = 30), the experimental A+U arm and 10% urea cream alone (n = 31), the U arm. The sample size was calculated to have 90% power to show the significant 20% reduction in the incidence of HFS grade 2-3 of the combination therapy with alpha level = 0.05. Both the CTCAE criteria version 5 and the dermatology life quality index (DLQI) were assessed to determine the severity of HFS and quality of life, respectively. RESULTS: Most of the participants had rectal cancer (A+U: 43.3%; U: 41.9%). In the A+U group, 86.7% had grade 0-1 HFS and 13.3% had grade 2-3 HFS. In the U group, 64.5% had grade 0-1 HFS and 35.5% had grade 2-3 HFS (Mann-Whitney U test, p = 0.045). Grade 2-3 HFS was significantly lower in the combination group. CONCLUSION: Combination of aloe vera gel and 10% urea cream ameliorated the severity of HFS in participants taking capecitabine; however, no significant difference in DLQI between the groups was demonstrated.

Understanding maternal Ethnomedical Folklore in Central Uganda: a cross-sectional study of herbal remedies for managing Postpartum hemorrhage, inducing uterine contractions and abortion in Najjembe sub-county, Buikwe district.

Pregnant women in rural Uganda largely rely on medicinal plants for inducing labor, treating postpartum hemorrhage (PPH), and inducing abortion. 90% of the women in both rural and urban Uganda use plants to manage pregnancy symptoms like constipation, heartburn, morning sickness, body aches, nausea, and vomiting. After delivery women continue using plants to manage postpartum complications and for infant care especially herbal baths. This study documented how ethnomedical folklore has been used to aid childbirth, manage postpartum hemorrhage, and induce abortion. METHODS: A cross-sectional ethnobotanical survey was conducted from May - December 2023 in Najjemebe sub-county, Buikwe district. 206 respondents from 12 villages were selected using snowball sampling. Key informants included Traditional Birth Attendants (TBAs) and herbalists. Data was collected using semi-structured questionnaires and focus group discussions. Voucher specimens of the plants were identified and authenticated at Makerere University Herbarium. Data were analyzed using descriptive statistics, Informant Consensus factor (ICF), Use Reports (URs), paired comparisons, and GraphPad Prism® version 9.0.0 software. RESULTS: All respondents (N = 206, 100%), used plants to induce labour, treat PPH, and induce abortion. One hundred four plant species were documented: most cited or preferred were: Hoslundia opposita (N = 109, 53%), Phytolacca dodecandra (N = 72, 35%), and Commelina erecta (N = 47, 23%). The plants belonged to 49 families, Lamiaceae (16.3%) and Fabaceae (14.3%) having the majority of the species. Herbs were 42 (40%) and trees 23 (22%). Oral administration 95(72%) was the commonest, then topical 19 (14.4%) and vaginal 14(10.6%). CONCLUSION: Health surveys revealed that about 27% of deliveries in Uganda take place outside a health facility. Due to the oxytocic effects of plant species reported in this study, they play a triple role of being uterotonics, abortifacients, and treating postpartum haemmorhage. The dilemma lies in the unknown dosages and toxicity levels that could endanger both the mother's and the unborn child's lives. Due to Uganda's high rates of population growth, overall fertility, maternal mortality, and morbidity, policies, and programmes on gendered health provision need to be reevaluated. Integrating herbal medicine into health care systems appears to be a feasible solution.

Adverse events of herbal decoction: A systematic review and meta-analysis over past 10 years.

BACKGROUND: Herbal decoctions (HDs) are the oldest and most common herbal medicine formulations. Different HDs exist, and some consumers are concerned that they may become contaminated during manufacturing. Therefore, the need for a safety assessment of HDs has been raised. This study aimed to investigate the adverse events (AEs) associated with HDs by comprehensively analyzing randomized controlled trials (RCTs) using systematic reviews and meta-analyses. METHODS: A systematic search was conducted on PubMed, Embase, and the Cochrane Library for articles published up to November 2022. The included RCTs compared HDs with other treatments published between 2013 and 2022, and the risk of bias was assessed using RevMan 5.4. Meta-analyses of the number of AEs associated with HDs reported in the included RCTs were also performed. RESULTS: The systematic review included 26 RCTs, and the meta-analysis included 17 RCTs that reported AEs. The meta-analysis comparing HDs with active controls showed that both the number of AEs (14 studies; risk ratio (RR)= 0.50 cases, 95 % confidence interval (CI) [0.29, 0.88]; I2 = 42 %) and the number of patients who complained of AEs (seven studies; RR=0.51 patients, 95 % CI [0.28, 0.94]; I2 =9 %) were fewer in the HDs group than in the active control groups. CONCLUSION: This study showed that HDs are safer than other conventional medications based on the results of qualitative and quantitative syntheses of RCTs.

Herbal remedies as a potential cause of hypoadrenalism.

A 37-year-old woman presented with nausea, vomiting and headache. She was found to be profoundly hyponatraemic with a sodium of 121 mmol/L, which deteriorated following a fluid challenge. An initial hyponatraemia screen identified adrenal insufficiency, with cortisol of 48 nmol/L. History confirmed she had been taking the herbal plant, ashwagandha. After 3 days of fluid restriction and steroid replacement, her sodium returned to normal (139 mmol/L). This article reviews the possible harmful effects of over-the-counter herbal remedies and highlights the importance of considering a wide differential diagnosis in patients presenting with non-specific symptoms.

Evaluation of 90-day repeated dose oral toxicity of an aloe vera inner leaf gel beverage.

Despite its popularity along with many proposed therapeutic applications, the safety profile of Aloe vera gel beverages remains unsettled. The putative toxicology concern has focused on the hydroxyanthraquinone derivatives (HADs) found in the latex portion of the Aloe leaf. Despite harvesting and processing designed to eliminate or significantly reduce these compounds, certain HADs, such as aloin, may be present and have been associated with carcinogenicity in non-decolorized whole leaf extract containing approximately 6400 ppm aloin A and 71 ppm aloin-emodin. Sprague Dawley rats had free access to drinking water or a commercially and widely available Aloe vera gel beverage (Forever Living Products) prepared from the inner leaves of Aloe barbadensis Miller containing 3.43 ppm total aloin for 90 days. Under the conditions of the study and based on the toxicological endpoints evaluated, there were no adverse test substance-related findings, including altered thyroid hormones. No histologic differences or histopathological changes were detected in the multiple tissues and organs examined. The Ki-67 proliferation assay demonstrated no increased cell proliferation in the liver, lungs, kidneys, or urinary bladder, which might have been attributed to the dietary administration of the Aloe vera gel beverage via drinking water for 90 days. These data lend increasing confidence regarding the safety of appropriately processed Aloe vera gel beverages, such as the beverage tested in this study.

Antivirulence and antipathogenic activity of Mayan herbal remedies against Pseudomonas aeruginosa.

ETHNOPHARMACOLOGICAL RELEVANCE: The Yucatan Peninsula has a privileged wealth of vascular plants with which various Mayan herbal formulations have been developed. However, studies on their antipathogenic and antivirulence properties are scarce. AIM OF THE STUDY: Identify antivirulence properties in Mayan herbal remedies and determine their antipathogenic capacity in burn wounds infected with Pseudomonas aeruginosa. MATERIALS AND METHODS: An ethnobotanical study was conducted in Mayan communities in central and southern Quintana Roo, Mexico. Furthermore, the antipathogenic capacity of three Mayan herbal remedies was analyzed using an animal model of thermal damage and P. aeruginosa infection. Antivirulence properties were determined by inhibiting phenotypes regulated by quorum sensing (pyocyanin, biofilm, and swarming) and by the secretion of the ExoU toxin. The chemical composition of the most active herbal remedy was analyzed using molecular network analysis. RESULTS: It was found that topical administration of the remedy called "herbal soap" (HS) for eleven days maintained 100% survival of the animals, reduced establishment of the bacteria in the burn and prevented its systemic dispersion. Although no curative effect was recorded on tissue damaged by HS treatment, its herbal composition strongly reduced swarming and ExoU secretion. Through analysis of Molecular Networks, it was possible to carry out a global study of its chemical components, and identify the family of oxindole monoterpenoid alkaloids and carboline and tetrahydropyrididole alkaloids. In addition, flavonols, flavan-3-ols, and quinic acid derivatives were detected. CONCLUSIONS: The antipathogenic and antivirulence capacity of ancient Mayan remedies makes them a potential resource for developing new antibacterial therapies to treat burns infected by P. aeruginosa.

[Homemade herbal remedies - tradition with practical relevance]. / Pflanzliche bäuerliche Hausmittel ­ Tradition mit Praxisrelevanz.

OBJECTIVE: The preparation of homemade herbal remedies has always been practiced by animal keepers and is still employed in farm animals today. In order to document this practice, an ethnoveterinary study was conducted in Bavaria in 2018-2021. MATERIAL AND METHOD: The farmers were interviewed on site and the reported recipes were documented in detail and, where possible, also carried out during the interviews. The plant parts used were weighed using a laboratory balance in order to be able to calculate a daily dose per animal or the concentration in the end product for as many of these traditional use reports (UR) as possible. RESULTS: A total of 716 recipes for 884 UR were named in the 77 interviews by the participating farmers. Two thirds (69%) of the formulations mentioned consisted of one or more medicinal plants and 31% dealt with other natural home remedies (honey, vinegar, etc.). Overall, the farmers surveyed preferred the use of single plants in their formulations. Most UR were for cattle (77% of all reports). These traditional remedies are most often used in Bavarian stables for the treatment and prophylaxis of gastrointestinal diseases and metabolic disorders. Furthermore, there was a high correspondence of the medicinal plants used with described UR from two historical reference books. The study participants used their homemade herbal remedies with a high degree of satisfaction and thereby act within the scope of their own responsibility as farmers. CONCLUSION AND CLINICAL RELEVANCE: This traditional knowledge of herbal preparations containing active ingredients, which has been passed on for generations, may also be a good starting point for a phytotherapeutic supplement in the treatment of farm animals in veterinary practice. Pharmaceutical and feed law framework conditions must be adhered to.

Effects of herbal compounds on various aspects of endometriosis treatment: a systematic review.

OBJECTIVE: Endometriosis means the presence of tissue similar to normal endometrium outside the uterus. Although surgical, hormonal, and analgesic treatment relieves symptoms and improves fertility, it is associated with side effects and a high recurrence rate. Alternative medicines like medicinal plants have been used for the treatment of chronic diseases. Given the global importance of endometriosis as a chronic disease affecting over 15% of all women in their fertile period, this systematic review aimed to give a comprehensive view of research on medicinal plants. MATERIALS AND METHODS: Comprehensive searches were performed on three databases, including PubMed/MEDLINE, Web of Science Core Collection (Indexes = SCI-EXPANDED, SSCI, A, and HCI Timespan), and Scopus, to identify papers published until June 2023. Keywords, such as "Endometriosis" and "Herbal Medicine", were used to search. A manual search of valid journals followed by a manual search of the references of the retrieved full-text articles was performed. All retrieved articles were imported into a database into Endnote X9. Articles that did not meet the inclusion criteria were excluded from the study, and the full texts of all the articles that met the inclusion criteria were assessed. Studies that evaluated the effects of herbal compounds on various aspects of endometriosis treatment were included in the review. RESULTS: In total, 11 studies were included in the present study. The evidence showed that in addition to safety, drugs available alongside treatments could play an effective role in improving the symptoms associated with endometriosis. In this study, the positive results of using Chinese treatments were reported in aspects such as fertility rate, pain, endometriosis recurrence rate, quality of life, sexual function, CA-125 level, and menopause symptoms. CONCLUSIONS: A wide range of preclinical and clinical studies evaluated the effectiveness and safety of medicinal plants in the treatment of endometriosis symptoms. Thus, alternative treatments for endometriosis with no or low side effects should be included in the holistic treatment of endometriosis upfront. However, there is still a need for well-designed trials to investigate standard interventions and specific and safe doses of herbal medicines.

Research and publication gaps on kratom and kratom products: a scoping review of current literature.

PURPOSE OF REVIEW: Kratom plant, products derived from the plant, and plant phytochemicals are of great interest among researchers, clinicians, and consumers. However, there is a paucity of rigorously collected scientific data on their risk/safety profile and public health impact. This scoping review discusses original research articles published between 2022 and 2023. It focuses on identifying publication gaps on topics related to epidemiology, public health, and risk/safety profiles comparing evidence collected by researchers from Southeast Asia and the West. RECENT FINDINGS: Our review of the Scopus database identified a total of 55 publications, including clinical case reports and case series reports, surveys, studies enrolling human participants, and publications based on large-scale national surveys or large-scale national or international health system database records. SUMMARY: Overall, there is dearth of reliable data on key epidemiological factors, including the prevalence rates, and on objective and reliable indices of the risk/safety profiles. Rigorous and systematic studies including improved epidemiological surveillance, human laboratory, and controlled clinical studies are urgently needed to advance our understanding of public health consequences of consuming kratom and kratom-derived products and to improve our understanding of their risk/safety profile and additional analytical studies to better inform development of needed regulatory oversight.

Effect of prepared herbal mouthwash in maintaining the oral health of school children: A single-blind randomised control trial.

BACKGROUND AND AIM: Oral health is a vital indicator of overall well-being, quality of life, and general health, with historical roots in Unani medicine (i.e. preventive measures, oral hygiene, and treatment). This study aims to assess the efficacy and safety of prepared herbal mouthwash in maintaining oral health among school children. EXPERIMENTAL PROCEDURE: 110 schoolchildren were randomly assigned to the test group (treated with herbal mouthwash -Anacyclus pyrenthrum DC, Punica granutum (pericarp), Capparis spinosa (root bark), and Quercus infectoria Oliv (galls)) and the control group (treated with 0.2 % Chlorhexidine Mouthwash) for 30-days. The response was assessed by DMFT, Salivary pH, Oral hygiene index-simplified (OHI-S), Plaque index (Loe & Silness) (PI), Plaque index simplified (O'Leary et al., 1972) (PI-S), Gingival Index (Löe-Silness) (GI), and Bleeding on probing (BOP) on baseline and 30th day GI and PI were further assessed on 60th, 90th and 120th days to determine the sustainable effect of the intervention. RESULTS: After treatment, Mean OHI-S, PI, PI-S, GI and BOP significantly reduced on the 30th day from baseline (p ≤ 0.001) in both groups. After discontinuing intervention, both groups showed significantly lower PI and GI scores on the 120th day from baseline. (p < 0.001). CONCLUSION: This study revealed that prepared mouthwash is safe and significantly effective in maintaining oral health, and it could be used as an adjunct to mechanical oral hygiene measures.

Evidence for the efficacy of anti-inflammatory plants used in Brazilian traditional medicine with ethnopharmacological relevance.

ETHNOPHARMACOLOGICAL RELEVANCE: When exacerbated, inflammatory processes can culminate in physical and emotional disorders and, if not stopped, can be lethal. The high prevalence of inflammation has become a public health problem, and the need for new drugs to treat this pathology is imminent. The use of medicinal plants has emerged as an alternative, and a survey of data that corroborates its application in inflammatory diseases is the starting point. Furthermore, Brazil harbors a megadiversity, and the traditional use of plants is relevant and needs to be preserved and carefully explored for the discovery of new medicines. AIM OF THE STUDY: This review sought to survey the medicinal plants traditionally used in Brazil for the treatment of inflammatory processes and to perform, in an integrative way, a data survey of these species and analysis of their phytochemical, pharmacological, and molecular approaches. MATERIALS AND METHODS: Brazilian plants that are traditionally used for inflammation (ophthalmia, throat inflammation, orchitis, urinary tract inflammation, ear inflammation, and inflammation in general) are listed in the DATAPLAMT database. This database contains information on approximately 3400 native plants used by Brazilians, which were registered in specific documents produced until 1950. These inflammatory disorders were searched in scientific databases (PubMed/Medline, Scopus, Web of Science, Lilacs, Scielo, Virtual Health Library), with standardization of DECS/MESH descriptors for inflammation in English, Spanish, French, and Portuguese, without chronological limitations. For the inclusion criteria, all articles had to be of the evaluated plant species, without association of synthesized substances, and full articles free available in any of the four languages searched. Duplicated articles and those that were not freely available were excluded. RESULTS: A total of 126 species were identified, culminating in 6181 articles in the search. After evaluation of the inclusion criteria, 172 articles representing 40 different species and 38 families were included in the study. Comparison of reproducibility in intra-species results became difficult because of the large number of extraction solvents tested and the wide diversity of evaluation models used. Although the number of in vitro and in vivo evaluations was high, only one clinical study was found (Abrus precatorius). In the phytochemical analyses, more than 225 compounds, mostly phenolic compounds, were identified. CONCLUSION: This review allowed the grouping of preclinical and clinical studies of several Brazilian species traditionally used for the treatment of many types of inflammation, corroborating new searches for their pharmacological properties as a way to aid public health. Furthermore, the large number of plants that have not yet been studied has encouraged new research to revive traditional knowledge.

Microbiological acceptance criteria, specifications of herbal drugs and herbal drug preparations in various pharmacopoeias: a global scenario.

PURPOSE: A pharmacopoeia is a compendium of guidelines and criteria for drug quality. It was established by a national or regional entity and has legal significance. This applies to administration of drugs in a particular nation or region. METHOD: In this study, the differences and similarities of microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations in 14 national and international pharmacopeias were investigated. RESULTS: It was found that 12 pharmacopeias have given separate microbial limits for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC), and a list of specified microorganisms for which acceptance criteria are defined. However, similarities were noticed in Ph.Eur, Ph. Helv and, BP. Salmonella, and Escherichia coli are the most common pathogens specified for herbal preparations in which boiling water is added prior to use and for internal use in all Pharmacopoeias because they serve as indicators of potential contamination. CONCLUSION: From this study, it can be concluded that the differences in microbial limit tests and their acceptance criteria as specified in the various pharmacopoeias need to be harmonized. It will become a more convenient option for global drug manufacturers to import/export herbal drugs, and this would also eliminate the burden of performing various analytical methods and comply with different microbial acceptance criteria set by various pharmacopoeias. The comparative data obtained from this study will be used to develop strategies for revisions of pharmacopoeias in a harmonized manner with respect to microbiological acceptance criteria, specifications for microbial enumeration of herbal drugs and herbal drug preparations.

Comparative evaluation of the efficacy of probiotic, Aloe vera, povidine-iodine, and chlorhexidine mouthwashes in the treatment of gingival inflammation: A randomized controlled trial.

BACKGROUND: Chemical plaque control with mouthwashes as an adjunct to mechanical plaque control with a toothbrush and dental floss has been considered an effective method for controlling gingivitis. The anti-inflammatory effects of chemical plaque control benefit the oral tissues by reducing inflammation and bleeding. OBJECTIVES: The aim of the present study was to evaluate and compare the clinical efficacy of probiotic, Aloe vera, povidine-iodine, and chlorhexidine (CHX) mouthwashes in treating gingivitis patients by assessing changes in their clinical parameters. MATERIAL AND METHODS: This prospective study was conducted on 40 patients from our outpatient department, divided into 4 groups of 10 patients each: probiotic mouthwash group (group 1); herbal (Aloe vera) mouthwash group (group 2); povidone-iodine mouthwash group (group 3); and CHX mouthwash group (group 4). All participants were provided with the same type of manual toothbrush, the Pepsodent® toothpaste and a respective mouthwash for twice-daily use until the end of a 28-day observation period. Clinical parameters, such as the marginal plaque index (MPI) and bleeding on interdental brushing (BOIB), were recorded at baseline, and on the 14th and 28th day of the study period. RESULTS: All groups showed a significant decrease in the MPI and BOIB scores. The results were similar in patients who used a probiotic mouthwash and those who used a CHX mouthwash. A comparable change in the mean scores was observed among the herbal and povidone-iodine groups from baseline to day 28. CONCLUSIONS: In the treatment of chronic gingivitis patients,a probiotic mouthwash was nearly as effective as CHX in reducing the plaque and bleeding scores. It showed better results in all clinical parameters than herbal and povidone-iodine mouthwashes. Using a mouthwash along with routine tooth brushing can help in treating gingivitis and slow the progression of the periodontal disease.