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Efficacy and tolerability of a spray with Salvia officinalis in the treatment of acute pharyngitis - A randomised, double-blind, placebo-controlled study with adaptive design and interim analysis
Abstract
This randomised, double-blind, parallel group phase II/III study with adaptive two-stage design and interim analysis compared the efficacy and tolerability of spray (containing a Salvia officinalis fluid extract) against placebo in the treatment of patients with acute viral pharyngitis. -
in two study parts, a total of 286 patients with subjective and objective evidence of pharyngitis were randomized. In the first study part 122 patients were enrolled. In the second study part 164 patients were included. The treatment duration per patient was 3 days, including one baseline visit and one final visit. -
Area under Curve for change of throat pain intensity (spontaneous pain), documented every 15 minutes within the first 2 hours after the first application as compared to baseline using a visual analog scale (VAS 100 mm). -
Following the interim analyses of the first study part the 15 % spray containing 140 microl sage extract per dose was the most promising preparation for the second study part (main study) whereas for the 30% and the 5% preparation results made superiority over placebo unlikely in the final analysis. Overall, the 15 % spray was significantly superior to placebo for the primary efficacy variable with regard to a reduction of the throat pain intensity score. Only minor side effects such as dry pharynx or burning of mild intensity were seen. -
The efficacy and tolerability profile of a 15 % sage spray indicated that this preparation provides a convenient and safe treatment for patients with acute pharyngitis. A symptomatic relief occurred within the first two hours after first administration and was statistically significantly superior to placebo.
... The plant extracts were found to be very effective antifungal and antimicrobial agents. [31] Viral Pharyngitis (Hubbert et al., 2006) investigated the double-blind randomized study on plant extracts from Salvia officinali L. effectiveness in viral pharyngitis. In the study, a total of 286 patients with subjective and objective evidence of pharyngitis were randomized. ...
... The efficacy and tolerability profile of a 15 % sage spray indicated that this preparation provides a convenient and safe treatment for patients with acute pharyngitis. [32] Antiangiogenic Activity (Keshavartz et al., 2010) carried forward with antiangiogenic properties in the plant Salvia officinalis L. Angiogenesis is a process in the promotion of cancer and its metastasis. The aerial parts of the plant Salvia officinalis L. were extracted with ethanol and its successive hexane, ethyl acetate, n-butanol, and aqueous fractions using human umbilical vein endothelial cells capillary tube formation and rat aorta models in a three-dimensional collagen matrix. ...
... In a recent phase II/III experiment, a sage spray (15% Salvia officinalis fluid extract) was found to be more effective than a placebo spray for relieving acute viral pharyngitis; the sage spray showed statistically significant improvement over the placebo within the first two hours after treatment. [49] Alzheimer's Dementia: ...
Diabetes is a diverse group of disorder characterized by hyperglycemia due to an deficiency in insulin production. Diabetes mellitus's chronic hyperglycemia is linked to end organ damage, dysfunction, and failure, including blood vessel, kidney, retina, and nervous system. With over 62 million cases of diabetes being identified in India, the disease is rapidly turning into a true epidemic. The majority of synthetic oral hypoglycemic medications available for the disease's treatment are costly, have significant adverse effects, and/or cannot be used while pregnant. As a result, a growing number of people worldwide are turning to traditional herbal remedies to prevent and treat diabetes. Spices having antioxidant, hypoglycemic, and hypolipidemic characteristics may be effective in the therapy of diabetes. As a result, these spices are growing in popularity due to their potential efficacy, little to nonexistent adverse effects, and synergistic effects. Spices are compounds used in food as coloring, flavoring, or preservation. They might be fresh or dried seeds, bark, roots, fruits, or even vegetables. This paper includes phytochemical screening of spices which have crucial role in the treatment of diabetis mellitus.
... Christensen et al. (2010) Pain a.15% spray containing 140 μl of the plant extract per dose may lead to reduction of the throat pain intensity. Hubbert et al. (2006) b. Its antinociceptive effect was not more powerful than benzydamine hydrochloride. ...
Sage (Salvia officinalis L.) of the Lamiaceae family contains a healthy dose of vitamins, minerals and rich in several nutrients. Schisandra berry (Schisandra chinensis (Turcz.) Baill. (Magnoliaceae) or Wu-Wei-Zi, which means the fruit of five tastes, is a generally used herb in traditional Chinese medicine (TCM). The five tastes of Schisandra berry refer to its impact on the five visceral organs in the body. S. chinensis has been utilized to treat sleep disorders and a tonic for kidney and brain in traditional Chinese medicine. The five important components of S. chinensis are Schisandrol B, Schisandrin A, γ-Schisandrin, Gomisin N, and Schisandrin C. The aim of this review was to outline the most notable traditional and modern health benefits of common sage and Schisanda berries. Common sage has several promising health benefits which can be consumed fresh, dried, or as a tea. It has shown antioxidant, anti-diabetes, anti-cancer, anti-obesity, anti-cholesterol, anti-bacterial, and anti-diarrheal activities. Health benefits of S. chinensis are antimicrobial, anti-cancer, anti-obesity, anti-diabetic, and anti-aging related effects. The treatment with natural herbal medicines which are also super-fruit and non-synthetic drugs is recommended.
... Christensen et al. (2010) Pain a.15% spray containing 140 μl of the plant extract per dose may lead to reduction of the throat pain intensity. Hubbert et al. (2006) b. Its antinociceptive effect was not more powerful than benzydamine hydrochloride. ...
Sage (Salvia officinalis L.) of the Lamiaceae family contains a healthy dose of vitamins, minerals and rich in several nutrients. Schisandra berry (Schisandra chinensis (Turcz.) Baill. (Magnoliaceae) or Wu-Wei-Zi, which means the fruit of five tastes, is a generally used herb in traditional Chinese medicine (TCM). The five tastes of Schisandra berry refer to its impact on the five visceral organs in the body. S. chinensis has been utilized to treat sleep disorders and a tonic for kidney and brain in traditional Chinese medicine. The five important components of S. chinensis are Schisandrol B, Schisandrin A, γ-Schisandrin, Gomisin N, and Schisandrin C. The aim of this review was to outline the most notable traditional and modern health benefits of common sage and Schisanda berries. Common sage has several promising health benefits which can be consumed fresh, dried, or as a tea. It has shown antioxidant, anti-diabetes, anti-cancer, anti-obesity, anti-cholesterol, anti-bacterial, and anti-diarrheal activities. Health benefits of S. chinensis are antimicrobial, anti-cancer, anti-obesity, anti-diabetic, and anti-aging related effects. The treatment with natural herbal medicines which are also super-fruit and non-synthetic drugs is recommended.
... Sage is also one of the medicinal plants widely used in folk medicine thanks to its therapeutic effects mainly on type 2 diabetes (5), as well as on pain especially pharyngitis (6). In addition, S. officinalis has been reported to improve cognitive function for patients having Alzheimer's disease (7). Nowadays, its essential oils (EOs) are used in many industrial fields due to their wide spectrum of biological activities, such as antimicrobial, antiviral, and antioxidant activities (4). ...
Introduction: Medicinal plants, including spontaneous or cultured herbaceous and forest products, represent an inexhaustible source of traditional and effective remedies thanks to their active major compounds. The present work consists of an ethnobotanical study of three species namely, Daucus carota, Dittrichia viscosa, and Salvia officinalis, commonly used in Taounate region (Northern Morocco) to treat various diseases.
Methods: An ethnopharmacological survey was conducted in Taounate region during a period of three months from January to March 2022, using semi-structured individual interviews. Then, the collected data were analyzed statistically using Microsoft Office software “Excel 2013” and System Package for Social Sciences (SPSS).
Results: Leaves, flowers, and stems were the most common parts used to prepare traditional remedies. Decoction, infusion, and cataplasm were the most used preparation methods, and the oral route was the most common method of administration for the studied plants. Moreover, the plants intervened in the treatment of digestive, genito-urinary, dermatological, neurological, and metabolic diseases.
Conclusion: Information collected during this study shed light on the interesting know-how in traditional herbal medicine in the study area, and on the frequent use of medicinal plants as an alternative to synthetic drugs by the population of Taounate, to treat different diseases. Thereafter, the study’s results can constitute an important database for pharmacologists, phytochemists, toxicologists, and clinical researchers for the development of new drugs based on natural substances.
... f. (aloe-vera), Calendula officinalis L. (Pot marigold), and Matricaria recutita L. [67], both applied as a mouthwash in the prevention of oral diseases in cancer patients. Salvia officinalis L. (sage) was studied as a spray against acute pharyngitis [86] and oral mucositis [68]; Echinacea/sage spray was also assayed against sour trough [87], as well as Alchemilla vulgaris [88]; and a mixture of Matricaria recutita L., Calendula officinalis L. and Aloe vera L., in addition to honey, was also studied [89]. ...
Despite high incidence rates and severe complications, the management of xerostomia lacks clinical guidelines. The aim of this overview was to summarize the clinical experience derived from the last 10 years of treatments and prevention using systemic compounds. Results showed that the cytoprotective drug amifostine, and its antioxidant agents, are the most discussed as preventive agents of xerostomia in head and neck cancer (HNC) patients. In the presence of the disease, the pharmacological treatments have been mainly directed to stimulate secretion of the damaged salivary glands, or to counteract a decreased capacity of the antioxidant system, in view of an increasing of reactive oxygen species (ROS). However, the data demonstrated low ability of the drugs, together with a great number of side effects, which strongly limit their use. Concerning traditional medicine (TM), valid clinical trials are so limited that neither the efficacy nor the absence of interferences to concomitant chemical therapies can be validated. Consequently, the management of xerostomia and its devastating complications remain a very significant void in daily clinical practice.
... Similar conditions are traditionally treated using Fragaria vesca L. (wild strawberry) from the Rosaceae family (EMA, 2018a; Kirsch et al., 2020). Salvia officinalis L. (sage) from the family Lamiaceae has a long history of medicinal use, in folk medicine it has been used as a remedy for many problems including inflammations and gastric disturbances (EMA, 2016;Ginko et al., 2023;Hubbert et al., 2006). Sambucus nigra L. (elder, family Viburnaceae) is for centuries used to treat fever, coughing, and upper respiratory tract problems, or urinary tract infections (Mehmood et al., 2019). ...
Ethnopharmacological relevance:
Salvia officinalis L., Sambucus nigra L., Matricaria chamomilla L., Agrimonia eupatoria L., Fragaria vesca L. and Malva sylvestris L. are plants that have a long tradition in European folk medicine. To this day, they are part of medicinal teas or creams that help with the healing of skin wounds and the treatment of respiratory or intestinal infections. However, so far these plants have not been investigated more deeply than in their direct antibacterial effect.
Aim of the study:
Our research is focused on adjuvants that inhibit the mechanism of antibiotic resistance or modulate bacterial virulence. Based on a preliminary screening of 52 European herbs, which commonly appear as part of tea blends or poultice. Six of them were selected for their ability to revert the resistant phenotype of nosocomial bacterial strains.
Methods:
Herbs selected for this study were obtained from commercially available sources. For the extraction of active compounds ethanol was used. Modulation of virulence was observed as an ability to inhibit bacterial cell-to-cell communication using two mutant sensor strains of Vibrio campbellii. Biofilm formation, and planktonic cell adhesion was measured using a static antibiofilm test. Ethidium bromide assay was used to checked the potential of inhibition bacterial efflux pumps. The antibacterial activities of the herbs were evaluated against resistant bacterial strains using macro dilution methods.
Results:
Alcohol extracts had antibacterial properties mainly against Gram-positive bacteria. Of all of them, the highest antimicrobial activity demonstrated Malva sylvestris, killing both antibiotic resistant bacteria; Staphylococcus aureus with MIC of 0.8 g/L and Pseudomonas aeruginosa 0.7 g/L, respectively. Fragaria vesca extract (0.08 g/L) demonstrated strong synergism with colistin (4 mg/L) in modulating the resistant phenotype to colistin of Pseudomonas aeruginosa. Similarly, the extract of S. officinalis (0.21 g/L) reverted resistance to gentamicin (1 mg/L) in S. aureus. However, Sambucus nigra and Matricaria chamomilla seem to be a very promising source of bacterial efflux pump inhibitors.
Conclusion:
The extract of F. vesca was the most active. It was able to reduce biofilm formation probably due to the ability to decrease bacterial quorum sensing. On the other hand, the activity of S. nigra or M. chamomilla in reducing bacterial virulence may be explained by the ability to inhibit bacterial efflux systems. All these plants have potential as an adjuvant for the antibiotic treatment.
Harpagophytum procumbens, also known as the devil’s claw, is a species from southern and southwestern Africa. In the wild, it grows mainly in arid desert areas, specifically in the Kalahari Basin. This perennial, groundling plant belongs to the sesame (Pedaliaceae) botanical family.
Dried and powdered root tubers (Harpagophyti radix) are the main medical raw material. The powder, as well as the liquid and the dry extracts are used for the production of tablets, capsules, tinctures and
ointments. Healing properties are provided by biologically active substances in the roots, mainly iridoid glycosides, including: harpagoside, harpagide and procumbide, as well as phenylethanoid glycosides
(verbascoside and isoverbascoside), flavonoids, triterpenes, phenolic acids, phytosterols and quinones.
The minimum content of the harpagoside determines the recognition of the raw material as medicinal, and should be at least 1.2%. The devil's claw is used in herbal medicine by African and other continents inhabitants. Preparations from devil’s claw available on the market are currently very popular in the treatment of inflammatory diseases of bones and joints. Extracts of devil’s claw roots have antiinflammatory, analgesic and antioxidant properties. In addition, they have an antimicrobial effect. They are also effective in the treatment of various skin diseases and wounds.
Keywords: Harpagophyti radix, iridoid glycosides, medicinal plant
The potential and practical use of this raw material in the pharmaceutical industry are very promising due to the fact that Jerusalem artichoke has the following effects: lowering cholesterol (normalizing lipid metabolism disorders), reducing elevated glucose content (helpful in the treatment of type II diabetes), facilitating processes slimming (helps to reduce body weight), reducing the content of uric acid, immunostimulating, protecting the gastric mucosa, auxiliary in diseases of the cardiovascular system, in chronic infectious diseases, states of chronic fatigue. There are also indications of antitumor activity of Jerusalem artichoke, due to its antioxidant, anti-inflammatory, and immunostimulatory properties. When talking about the commercialization of science and the search for products based on cheap, easily available, renewable raw materials using environmentally friendly technology (the so-called green chemistry or white biotechnology), chemical raw materials based on topinambour are very promising and innovative, especially for the pharmaceutical industry .
In an open study the efficacy and safety of a defined, etheric-oil free extract of sage (Salvia officinalis L.) flowers was tested in 300 patients with nervous and physical exhaustion. Following 5 weeks of treatment there were reported a diminuation of typical complaints as welt as an improvement of the patients general condition. The overall tolerability was assessed as good for most of the patients. A clinically relevant 20% increase of mean serum iron was measured in some of the patients, which might be the pharmacological basis for the clinical efficacy. The mechanisms of the extract's action are unknown. Active ingredients are supposed to be Labiatae-tannins, especially rosmarinic acid. Rosmarinic acid has been shown to inhibit unspecific complement-activation, lipoxygenase and synthesis of leucotrienes.
This review presents results of the chemistry and pharmacology of the bisbenzylisoquinoline alkaloids which are reported from 1986 through 1988.
To compare betamethasone with placebo as an adjuvant to antibiotic therapy in the treatment of acute exudative pharyngitis.
The study was a randomized, doubled-blind, placebo-controlled, single-center, parallel, outpatient clinical trial. After consent was obtained, each patient was asked to rate his or her pain on a 10-cm numbered visual analog scale (VAS; 0-10). All of the patients received injectable benzathine penicillin. If allergic to penicillin, they were started on a 10-day course of polyenteric-coated erythromycin (PCE). Each patient was randomized to receive either i.m. betamethasone or i.m. placebo. All patients were contacted by telephone at 24 and 48 hours by one of the study investigators and asked to rate their pain based on another VAS. If their pain was not resolved by 48 hours, they were called again daily between the third and seventh days after the initial visit to determine the time of pain resolution.
A total of 92 patients were enrolled in the study, with 46 randomized to receive placebo and 46 to receive betamethasone. Eight patients were excluded from the statistical analysis because of inability to obtain follow-up. Demographic comparison showed that gender distributions, ages, mean initial pain scores, mean times to the first and second follow-up calls, and treatment regimens were similar in the 2 groups. There were significantly better pain scores for the betamethasone group at first follow-up (p = 0.0005), at second follow-up (p = 0.004), and in number of hours until relief of pain (p = 0.004). When only those patients with a positive culture for a streptococcus species were analyzed, there also were significant reductions in pain score at the first (p = 0.006) and second (p = 0.02) follow-up visits.
Pain relief was greater and more rapid in patients treated with betamethasone as an adjuvant therapy in acute exudative pharyngitis.