No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
The external use of comfrey: A practitioner survey
Abstract
Aim:
The survey aimed to assess how often and in what ways herbal practitioners use comfrey (Symphytum officinale L.) externally in everyday practice.
Methods:
A 2-sided A4 survey was sent to all UK members of the National Institute of Medical Herbalists, the College of Practitioners of Phytotherapy and the Association of Master Herbalists with viable practice addresses (n = 598).
Results:
239 herbalists responded, of whom 179 (75%) reported regularly using comfrey, in 15% of their consultations. It was most commonly prescribed as a cream for tendon, ligament and muscle problems, for fractures, and for wounds, the indications for which it was also perceived to be most effective. Comfrey was rated least effective for haemorrhoids, varicose veins and boils and was considered to carry the greatest risk when prescribed for ulcers, wounds and boils.
Conclusion:
Practitioner experience suggests that comfrey can be used safely and effectively externally for certain indications.
... Allantoins stimulate cellular metabolism and growth in subcutaneous tissue as well as bone, tendon, and ligament. On the other hand, rosmarinic acid has antioxidant and anti-inflammatory effects and inhibits the syn-thesis of prostaglandins [25]. ...
... Consistent with the current study, Frost et al. [25], Sowa et al. [21], Miškulin et al. [19], Gilca et al. [32], Alamgir [33], and Jarić et al. [34] highlighted the anti-bruising effects of Comfrey. However, these studies only addressed the properties of Comfrey or its effects on variables other than bruising and neglected its anti-bruising effects. ...
... Anders et al. [35] showed that cutaneous medications containing Comfrey root (5% and 10%) were as effective as or even more effective than diclofenac, in healing ultraviolet-induced erythema. Moreover, these anti-bruising effects can be due to the plant compounds including allantoin, ellagic acid, and rosmarinic acid [21,25]. Smith et al. [26] and Staiger [36] highlighted the anti-inflammatory and stimulatory effects of Comfrey on granulation, tissue regeneration, and rapid healing. ...
Objectives:
Bruising is an important side effect of enoxaparin injection. Comfrey (Symphytum officinale) is used to treat different types of wounds, bone fractures, and bruising in traditional medicine in many countries for centuries. This study aimed to determine the effects of the Comfrey ointment on the bruise size and color following enoxaparin injection.
Methods:
This double-blind randomized clinical trial was conducted on 80 patients with acute coronary syndrome (ACS). The participants were randomly divided into two groups of 40, namely Comfrey and Placebo. Changes in bruise size and color in both groups were assessed daily before and after the intervention.
Results:
The Comfrey and Placebo groups were homogeneous in demographic and clinical variables. A downward trend was observed in the bruise size in both groups throughout the study. However, the bruise size was smaller in the Comfrey group than the Placebo group on day 2-5 of the intervention. Moreover, there was a significant difference in bruise color between the groups, with a shorter healing course in the Comfrey group.
Conclusion:
The Comfrey ointment accelerated the healing process of enoxaparin injection-induced bruising in patients with ACS. It is recommended as a safe and simple approach for these patients.
... Nowadays, various comfrey root formulations are recommended in bone fractures, painful muscles and joints, distortions and hematomas (Frost et al., 2014). The analgesic and anti-inflammatory effects of rosmarinic acid and allantoin are considered to play the major role in the beneficial effects of Symphytum roots (Awang, 1987; Barnes et al., 2007;Seigner et al., 2019). ...
... Even though numerous clinical trials have demonstrated the potency of S. officinale as an anti-inflammatory remedy in muscle and jointrelated inflammatory disorders (Frost et al., 2014), the key bioactive constituents as well as their molecular action mechanisms remain elusive. This work was aimed at isolating by liquid-liquid chromatography (LLC) and identifying by in-depth spectroscopic analyses the main phenolic constituents of comfrey root as well as assessing their in vitro antioxidant and ex vivo inhibitory activity on pro-inflammatory cytokine release in lipolysaccharide (LPS)-stimulated human neutrophils. ...
... Comfrey roots have been traditionally used worldwide due to their anti-inflammatory potential (Barnes et al., 2007;Bruneton, 2016;Frost et al., 2014). However, the key activity-determining constituents as well as the cellular and molecular mechanisms involved in their therapeutic effects remain elusive. ...
Ethnopharmacological relevance
Symphytum officinale L. (comfrey, Boraginaceae) has been traditionally used for millennia in joint distortions, myalgia, bone fractures and hematomas. However, key activity-determining constituents and molecular mechanisms underlying its use have not been completely elucidated.
Aim of the study
The objective of this study was to isolate and identify the major compounds from a hydroethanolic root extract of S. officinale and evaluate their antioxidant potential, alongside their effect on the cytokine production of ex vivo stimulated neutrophils, thus providing scientific support for the traditional use of comfrey root.
Material and methods
Four caffeic acid oligomers were isolated from comfrey roots by liquid-liquid chromatography, their structures being established by MS and NMR analyses. In vitro antioxidant evaluation was performed by DPPH and ABTS assays. The cytotoxicity of isolated compounds was established by flow cytometry. The effect on cytokine release, such as interleukin (IL)-1β, IL-8 and tumor necrosis factor alpha (TNF-α), in lipopolysaccharide (LPS)-stimulated neutrophils was determined by enzyme-linked immunosorbent assay (ELISA).
Results
The main constituents found in comfrey root were represented by four caffeic acid oligomers, namely globoidnan B (1), rabdosiin (2), rosmarinic acid (3) and globoidnan A (4). Rabdosiin, globoidnans A and B were isolated for the first time from S. officinale. In the in vitro antioxidant tests, compound 2 was the most active, with EC50 values in DPPH and ABTS assays of 29.14 ± 0.43 and 11.13 ± 0.39, respectively. Neutrophils’ viability over the tested concentration domain of 12.5–50 μM was not altered. At 50 μM, all compounds significantly inhibited IL-1β release, with compound 3 (45.60% release vs. LPS stimulated neutrophils) being the most active, followed by compounds 1 (53.85%), 2 (69.89%) and 4 (60.68%).
Conclusions
The four caffeic acid oligomers reported in S. officinale root may contribute to the overall anti-inflammatory activity for which comfrey preparations are used in traditional medicine.
Chemical compounds studied in this article
Globoidnan A (PubChem CID: 56841780). Globoidnan B (SpectraBase CID: 6x5Eig4VgdC). Rabdosiin (PubChem CID: 471121). Rosmarinic acid (PubChem CID: 5281792)
... Bioactivation occurs in the liver by the action of oxidases, with transformation to pyrrole intermediates that bind to DNA, proteins, and glutathion, thus causing cell disfunction and cell death (Wiedenfeld and Edgar, 2011). Even in case of preparations for cutaneous use only, the main concern for the clinical safety of comfrey preparations is related to the content of pyrrolizidine alkaloids, with the potential of absorption through intact skin followed by metabolic activation (Frost et al., 2014). In the assessment report on Symphytum officinale L., radix, the Committee on Herbal Medicinal Products of the European Medicines Agency refers to the acceptable daily intake of pyrrolizidine alkaloids as maximum 0.007 μg/kg/day for cutaneous preparations, the use being restricted to intact skin (HMPC, 2015). ...
... Received 3 November 2017; Received in revised form 21 December 2017; Accepted 22 December 2017 pyrrolizidine-depleted plant material or obtained from special cultivars that do not synthesize pyrrolizidine alkaloids (Staiger, 2012). Root preparations are utilized for the external treatment of joint complaints, painful muscle, bone fractures, distortions and haematomas (Bruneton, 1999;Frost et al., 2014). Therapeutic properties of comfrey root are based on its anti-inflammatory and analgesic effects, mainly due to allantoin and rosmarinic acid (Awang, 1987;Barnes et al., 2007). ...
Comfrey root preparations are used for the external treatment of joint distortions and myalgia, due to its analgesic and anti-inflammatory properties. Up to date, key activity-determining constituents of comfrey root extracts have not been completely elucidated. Therefore, we applied different approaches to further characterize a comfrey root extract (65% ethanol). The phenolic profile of comfrey root sample was characterized by HPLC-DAD-QTOF-MS/MS. Rosmarinic acid was identified as main phenolic constituent (7.55 mg/g extract). Moreover, trimers and tetramers of caffeic acid (isomers of salvianolic acid A, B and C) were identified and quantified for the first time in comfrey root. In addition, pyrrolizidine alkaloids were evaluated by HPLC-QQQ-MS/MS and acetylintermedine, acetyllycopsamine and their N-oxides were determined as major pyrrolizidine alkaloids in the comfrey root sample. Lastly, the antioxidant activity was determined using four assays: DPPH and ABTS radicals scavenging assays, reducing power assay and 15-lipoxygenase inhibition assay. Comfrey root extract exhibited significant antioxidant activities when compared to known antioxidants. Thus, comfrey root is an important source of phenolic compounds endowed with antioxidant activity which may contribute to the overall bioactivity of Symphytum preparations.
... Many studies have reported hepatoxicity, carcinogenicity and mutagenicity in the acute/chronic ingestion of pyrrolizidine-containing plants. Regarding the safety of comfrey preparations, even when they are intended primarily for topical application, the primary focus lies in the presence of pyrrolizidine alkaloids, which have the ability to be absorbed through the skin and subsequently activated metabolically (Frost et al., 2014). Therefore, many studies focus on the evaluation of the content of pyrrolizidine alkaloids while data on the content of other compounds are very limited. ...
Comfrey (Symphytum officinale L.) has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey external preparations. In recent years, significant research has focused on evaluating the chemo-biological profile of comfrey. The aim is to broaden the medicinal applications of this genus to encompass new pharmacological uses and to discuss the toxicological effect of comfrey oral and dermal preparations considering pyrrolizidine content. Nevertheless, to date there are no previous report on volatile organic compound profile using gas chromatography coupled with mass spectrometry. According to the European Union herbal monograph, Symphytum officinale L., radix herbal preparation should be prepared using ethanol 65% (V/V) as extraction solvent. Prepared in this way, the liquid extract was tested for Volatile organic compounds profile, dynamic viscosity, pH value and antiradical activity. Using gas chromatography coupled with mass spectrometry, a total of 22 compounds were identified. The kinematic viscosity of the obtained extract was 2.25 ±0.06 mm2/s while pH value was 6.55. Antiradical activity, measured with the DPPH test was 59.96 ±0.45%. In conclusion, the 65% ethanolic extract prepared according to European Union herbal monograph standards showed low levels of allantoin, indicating a deviation from traditional expectations while at the same time, the extract demonstrated a wide range of volatile organic compounds and high antiradical activity, suggesting potential therapeutic benefits beyond its traditional uses.
... Comfrey root as a medicinal product has been widely accepted and marketed in at least 10 countries. However, the hepatotoxic pyrrolizidine 2 alkaloids in comfrey limit its long-term and oral consumption [13,14]. Therefore, improvement of comfrey extraction is required to maximize levels of polyphenols while minimizing levels of pyrrolizidine alkaloids in order to produce the best therapeutic effect [11]. ...
The root extracts of Symphytum officinale (comfrey) are commonly used in traditional medicine to treat muscle, joint, skin and bone disorders. However, little information is available on the biomedical functions of comfrey leaves. In this study, sequencing results of Internal Transcribed Spacer and trnL-trnF genes showed that plants purchased from the local market were comfrey and named as S. officinale WL (WL). The optimal extraction conditions of WL leave with the highest extract yield and contents of total phenols and flavonoids by microwave-assisted extraction were identified. The antioxidative and anti-inflammatory activities and possible molecular mechanism(s) of the WL leaf extract (WLE) were evaluated. Furthermore, the major component of WLE was identified as rosmarinic acid by HPLC. Results showed that the optimal extract condition was obtained with 750W microwave power, 50℃, 75% methanol, the solid-to-solvent ratio of 1:10, and 15 minutes. Results of all DPPH, ABTS and superoxide radical scavenging activities, reducing power, ferrous ion chelating activity, and ferric reducing antioxidant power showed high antioxidative capacities of WLE. Furthermore, WLE showed obvious DNA protecting activity. WLE attenuated lipopolysaccharides-stimulated inflammation by suppressing iNOS, COX-2, IL-1β, IL-6, and TNF-α expressions in RAW264.7 macrophages. These attenuations involved in inactivations of lipopolysaccharides-induced NF-κB and MAPK signaling pathways.
... However, in others, including Poland, the quality and safety of comfrey products is not controlled because they are mainly cosmetics, dietary supplements, or dried herbs-herbal substances. Moreover, despite the regulations allowing comfrey root for medicinal purposes only, products containing comfrey leaf (Symphyti folium) are not only widely advertised and recommended on the Internet, but, according to research by Frost et al. [7], also widely prescribed by herbalists-almost half (49.53%) of 179 UK herbalists regularly use comfrey roots and leaves in their practice. ...
Comfrey (Symphytum officinale L.) has a long tradition of use in the treatment of muscu-loskeletal disorders. However, due to hepatotoxic pyrrolizidine alkaloids (PAs), the EMA restricts the use of comfrey root (CR) to external use only and for short periods of time. Recent studies indicate a low permeability of PAs across the skin, calling into question the safety of topical application of products containing comfrey preparations. The aim of our work was to develop and validate an HPLC method enabling the separation of isomeric PAs from comfrey and, on this basis, to assess the potential toxicity of CR and comfrey leaf (CL) obtained from various Polish sources. The qualitative and quantitative analysis of PAs via HPLC-MS/MS was performed in MRM mode. The results obtained confirmed a lower content of PAs in CL than in CR and showed a wide variation in the composition of PAs in CR, with a much more stable profile of PAs in CL. Factor analysis confirmed that CRs and CLs differ in PA content, which is influenced by the growth conditions and geographical origin. The determined concentrations of PAs prove that in some CRs available on the Polish herbal market, the content of PAs may exceed the daily dose considered safe.
... Comfrey with the latin name Symphytum officinale L. It is a widespread plant for therapy in South America, Europe, and parts of Asia. In ancient medicine, comfrey extract was sed topically, mainly or the therapy of joint disorders, wounds and muscle injuries [1], supported clinical [2]. The comfrey plant can also be used as a mouthwash, strep throat, dietary supplement [3], diarrhea treatment [4], metrorhagia [5] and as comfrey leaf tea [6]. ...
Allantoin is a compound contained in comfrey leaves. This research aims to obtain optimal condition parameters of ionic liquid-ultrasound-assisted extraction (IL-UAE) comfrey leaves to attract allantoin compounds. Comfrey leaves are extracted with eight ionic liquids by ultrasound-assisted extraction (UAE) and screened for allantoin levels. The best ionic liquid from the screening results is optimized response surface methodology (RSM) with Box-Behnken design with three factors and three levels to determine the optimum extraction conditions for allantoin levels. Determination of levels is carried out with TLC densitometry. The results of the IL screening obtained [HMIM]Cl as the best IL in the evaluation of optimization of extraction parameters. The results of optimization of extraction condition parameters [HMIM]Cl obtained the highest allantoin levels on the sixth run of 306.396 μg / g of powder at the ratio of solvents to powders of 10 mL / g, concentrations [HMIM] Cl 1 mol / L and extraction time of 30 minutes.
... Nevertheless, there are some restrictions for comfrey applications. Comfrey has been linked to liver damage (Frost et al., 2014), which is associated with the presence of pyrrolizidine alkaloids in the plant. Pyrrolizidine alkaloids such as lycopsamine are significantly found in of the comfrey plant (0.2%-0.4%) (Liu et al., 2009). ...
Comfrey (Symphytum officinale L.) contains rosmarinic acid which has different pharmacological activities, such as antioxidant and anti-inflammatory activities. However, the medicinal use of comfrey is limited by the hepatotoxic effect of lycopsamine in comfrey, which overshadows the health benefits of rosmarinic acid. Natural deep eutectic solvents (NADES) have a wide range of extraction properties, that provides a new approach to the detoxification of comfrey. In the present study, betaine-based and choline chloride-based NADES were screened for selective extraction of rosmarinic acid over lycopsamine. Ultrasonication was used in conjunction with NADES extraction. The chemical profile of the NADES extracts on antioxidant, anti-inflammatory and hepatotoxic activities were investigated using some chemical reagents. Betaine-urea (1:2 molar ratio, 50% water) obtained the highest content of rosmarinic acid and a low level of lycopsamine (1.934 and 0.018 mg/g, respectively). Betaine-urea was also shown to be more effective to extract rosmarinic acid compared to methanol-UAE under the same conditions, which gave lower rosmarinic acid and higher lycopsamine levels (0.007 and 0.031 mg/g, respectively). Betaine-urea extracts showed higher antioxidant and anti-inflammatory properties as compared with other NADES extracts, however, had lower hepatotoxic profile. This study recommends the use of betaine-urea to detroxify comfrey to open wider opportunities for the development of comfrey for medicinal use.
... Symphytum officinale (comfrey) (family Boraginaceae) is a herb used in folk medicine. S. officinale leaves and the roots were used in the treatment of gastrointestinal tract ulcerations, bones, and respiratory diseases [17][18][19]. S. officinale contains allantoin, carotene, hydroxycinnamic acid, and essential oils. Comfrey also contains hepatotoxic pyrrolizidine alkaloids, so its long-term consumption is not recommended [20,21]. ...
Lately, there has been increased interest in the development of phytochemical alternatives for the prevention and treatment of type 2 diabetes, the alternatives that are able to reduce or prevent glucose absorption by inhibiting digestive enzymes. In this context, this study aims to analyze the inhibitory α-amylase and α-glucosidase activities of Artemisia abrotanum and Symphytum officinale polyphenolic compound-rich extracts obtained by membrane technologies (micro- and ultrafiltration). Polyphenols and flavones content, HPLC-MS polyphenolic compounds profiling, antioxidant activity, and cytotoxic potential of these herbs were determined. Major phenolic acid compounds were chlorogenic acid, ellagic acid, caffeic acid, and rosmarinic acid. The flavone content was higher in the case of A. abrotanum extracts, and the major compounds were rutin and umbelliferone. The polyphenolic-rich extract of A. abrotanum had the highest quantities of polyphenols, 977.75 µg/mL, and flavones, 552.85 µg/mL, as well as a pronounced α-amylase inhibitory activity (IC50 1881.21 ± 1.8 mg/mL), a value close to acarbose inhibitory activity (IC50 1110.25 ± 8.82 mg/mL) that was used as the control for both enzymes. The α-glucosidase inhibitory activity was higher for both herb extracts, more pronounced for S. officinale polyphenolic-rich extract (IC50 291.56 ± 2.1 mg/mL), a value higher than that of acarbose (IC50 372.35 ± 3.2 mg/mL). These plants show potential as a complementary therapy for type 2 diabetes management.
... Frost i wsp. (3) donoszą, że liść i korzeń żywokostu, zarówno wysuszone, jak i świeże, są stosowane przez 75% brytyjskich zielarzy w dolegliwościach bólowych i stanach zapalnych zlokalizowanych w układzie kostno--mięśniowym, w tym będących wynikiem urazów, tj. złamaniach i pęknięciach kości, stłuczeniach objawiających się zasinieniem i obrzękiem oraz stanach pooperacyjnych. ...
Comfrey root – Symphyti radix has been present in medicine since ancient times. Nowadays, European Medicine Agency (EMA) restricts its only for external use, in short therapies not exceeding 10 days. The last decade has been characterized by the progress in research on the chemical composition and metabolism of biologically active compounds present in the root and leaves. The result is the presence of herbal medicinal products containing comfrey root extracts with reduced content or free of toxic pyrrolizidine alkaloids on the European market of herbal products. Moreover, the medicinal properties of leaves from another Symphytum species, namely Russian comfrey, are also in the use. The results of clinical trials indicate the beneficial effects of plant raw materials obtained from comfreys in musculoskeletal system disorders – comfrey root and skin inflammations – leaves of Russian comfrey. The paper presents the history of use, chemical composition, therapeutic effect and toxicity of comfrey, as well as characterizes clinical trials on products containing comfrey extracts from root and leaves.
... Several randomized, controlled trials have demonstrated the efficacy of topical comfrey preparations in the treatment of muscle and joint pain (Staiger, 2012). A herbal practitioner survey of the external use of comfrey in the United Kingdom indicated that comfrey is rated most effective for fractures, wounds, post-surgery healing, and problems with tendon, ligament, and muscle; while it is less effective for treating boils, hemorrhoids, and varicose veins (Frost et al., 2014). Humans have widely consumed comfrey as a vegetable and taken comfrey formulations of tea or tablets. ...
The complex chemical nature of herbal dietary supplements makes it difficult to evaluate their efficacy and safety. The integration of traditional toxicological approaches with high-throughput molecular profiling technologies provides new approaches to investigate alterations in gene/protein activities and the biological pathways/functions that respond to xenobiotic compounds in animals and humans. This chapter provides examples of the application of transcriptomic profiling in evaluating the safety and toxicity of dietary supplements. These examples from our laboratories include a study where functional genomics analysis led to conventional toxicological research, a study illustrating functional genomics ability to distinguish the carcinogenic effects in target and nontarget tissues, a study highlighting common mechanisms of action discovered in cross-species analysis of gene expression, and a study integrating gene expression changes with a mechanistic pathway analysis.
... On the pharmaceutical market there are a multitude of monocomponent or mixed preparations of comfrey extracts, most being in the form of creams, gels or ointments recommended against back pain, osteoarthritis of gonarthrosis, joint and muscle conditions, sprains and muscle fever . According to a survey conducted in the UK, 75% of the interviewed herbalists (179 respondents out of 239) prescribed comfrey products for tendon, ligament or muscle problems, fractures, wounds, and perceived it to be most effective for fractures, tendon, ligament or muscle problems, post-surgery and wounds (Frost et al., 2014). Externally, it is also used in vascular disorders (thrombophlebitis, phlebitis, hematomas, varicose ulcers), stomatitis, dental abscesses, hemorrhoids, varicose veins, psoriasis, as poultices, gargles, mouth washes or creams (Aprotosoaie & Stanescu, 2010;Duke et al., 2002;Hancianu et al., 2008;Istudor, 2005;Parvu, 2006;Stanescu et al., 2014). ...
... The use of comfrey and the other herbs matches the human use in Canada and in other countries. For example, 179 of 239 UK members of the Association of Master Herbalists, the College of Practitioners of Phytotherapy and the National Institute of Medical Herbalists reported using comfrey creams for ligament, muscle and tendon problems (Frost et al. 2014). Some supplements given to horses were reviewed by Williams and Lamprecht (2008). ...
Introduction
This paper describes an update to research conducted between 2000 and 2004 to describe the use of ethnoveterinary products among horse owners in Trinidad and British Columbia, Canada. The racehorse industry in Trinidad has seen a major decline as many breeding farms have shut down.
Methods
Previous respondents were contacted and horse owners met professionally in the last 4 years, some of whom were associated with Horse Council British Columbia (24,000 members). One racehorse owner was still working at one of the five horse racing tracks in British Columbia and conducted training and riding lessons. Three BC respondents offered boarding. The study in Trinidad involved none of the previous respondents as most of them either had passed away or were no longer working in the industry. The respondents who volunteered to participate were between 25 and 80 years of age and had been working in the racing industry all their life.
Results
Twenty-one plants were found to be used in Trinidad, 20 of which were reported in the previous study, and the use of cannabis (a genus of flowering plants in the family Cannabaceae) was not previously reported. In addition, commercial herbal preparations were reported to be used in 2018 which were not reported in the previous study. A similar finding in the use of commercial preparations was observed in respondents from British Colombia. Turmeric pills were suggested for inflammations. Ancient remedies were also used such as honey and cobwebs for wounds. The use of diatomaceous earth for parasites was not considered safe for the gastric lining of the horse. Products from two websites were being used by British Columbia respondents. One website was called Riva’s Remedies, while the other one was called Greenhawk. Commercial products from HorsePower Herbs website were used by respondents from Trinidad.
Discussion
The ethnoveterinary remedies were consistent in 2018 as was recorded in the previous study. The range of use was not as widespread, and the practice appeared to be limited to key respondents who obtained the knowledge from a relative or mentor. The use of prepared herbal remedies was also considered to be a last resort. The additional use of commercially available herbal products was a novel finding which was a similar finding for respondents from British Colombia and Trinidad.
Conclusion
More commercial products, both herbal and not, are used in Trinidad and Canada, than was apparent in the previous research conducted by two of the authors.
... Symphytum officinale L. (Boraginaceae), commonly known as Comfrey, is a medicinal plant and has been reported to have properties to heal blunt injuries, bruises, fractures, dislocated joints, damaged muscles and tendons, heal ulcers, etc. (Frost et al., 2014;Staiger, 2012). Symphytum officinale is recommended for consolidation of bone fractures and to accelerate bone mineralization (Grube et al., 2007). ...
Ethnopharmacological relevance:
Mesenchymal stem cells (MSCs) are multipotent stem cells possessing regenerative potential. Symphytum officinale (SO) is a medicinal plant and in homoeopathic literature, believed to accelerate bone healing.
Aim of the study:
This study aimed to determine if homoeopathic doses of SO could augment osteogenesis in MSCs as they differentiate into osteoblasts in vitro.
Materials and methods:
Bone marrow samples were obtained from patients who underwent bone grafting procedures (n = 15). MSCs were isolated, expanded and characterized by flow cytometry (CD90, CD105). Cytotoxicity of SO was evaluated by MTT assay. Osteogenic differentiation was induced in MSCs with β-glycerophosphate, ascorbic acid and dexamethasone over 2 weeks. Different homoeopathic doses of SO (MT, 3C, 6C, 12C and 30C) were added to the basic differentiation medium (BDM) and efficiency of MSCs differentiating into osteoblasts were measured by evaluating expression of Osteocalcin using flow cytometry, and alkaline phosphatase activity using ELISA. Gene expression analyses for osteoblast markers (Runx-2, Osteopontin and Osteocalcin) were evaluated in differentiated osteoblasts using Q-PCR.
Results:
Flow cytometry (CD90, CD105) detected MSCs isolated from bone marrow (93-98%). MTT assay showed that the selected doses of SO did not induce any cytotoxicity in MSCs (24 h). The efficiency of osteogenic differentiation (2 weeks) for different doses of Symphytum officinale was determined by flow cytometry (n = 10) for osteoblast marker, Osteocalcin, and most doses of Symphytum officinale enhanced osteogenesis. Interestingly, gene expression analysis for Runx-2 (n = 10), Osteopontin (n = 10), Osteocalcin (n = 10) and alkaline phosphatase activity (n = 8) also showed increased osteogenesis with the addition of Symphytum officinale to BDM, specially mother tincture.
Conclusions:
Our findings suggest that homoeopathic dose (specially mother tincture) of Symphytum officinale has the potential to enhance osteogenesis.
... Ethnoveterinary use -abscesses, dog bites, bleeding wounds, sprains, postoperative bleeding, deep wounds, abrasions, articular cartilage injury, partial tear of cruciate ligament Grube et al., 2007;Sowa et al., 2018;Jedlinszki et al., 2017;Frost et al., 2014 The positive effect (increased mobility and reduced pain) of a daily application of 6g comfrey root extract ointment (3 x 2 g) on osteoarthritis of the knee was proven in a double-blind, randomised, placebo-controlled, bicenter clinical trial for 3 weeks on 67 men and 53 women with an average age of 57.9 years. Extract equivalent to diclofenac. ...
Ethnopharmacological relevance
There are insufficient safe and effective treatments for chronic pain in pets. In cases such as osteoarthritis there is no commercially available cure and veterinarians use NSAIDs to manage pain. Pet owners may have to plan for a lifetime of plant-based treatment for the conditions that lead to chronic pain in pets. Phytopharmacotherapies have the advantage of being less toxic, cheap or free, readily available, are more likely to be safe for long-term use and have the potential to reset the immune system to normal functioning.
Aim of the study
To examine the recently published medicinal plant research that matches unpublished data on ethnoveterinary medicines (EVM) used for pets in Canada (British Columbia) to see if the EVM data can provide a lead to the development of necessary drugs.
Materials and methods
In 2003 semi-structured interviews were conducted with 60 participants who were organic farmers or holisitic medicinal/veterinary practitioners obtained using a purposive sample. A draft manual prepared from the data was then evaluated by participants at a participatory workshop that discussed the plant-based treatments. A copy of the final version of the manual was given to all research participants. In 2018, the recently published research matching the EVM data was reviewed to see if the EVM practices could serve as a lead for further research.
Results and conclusion
Medicinal plants are used to treat a range of conditions. The injuries treated in pets in British Columbia included abscesses (resulting from an initial injury), sprains and abrasions. Dogs were also treated with medicinal plants for rheumatoid arthritis, joint pain and articular cartilage injuries. More than 40 plants were used. Anal gland problems were treated with Allium sativum L., Aloe vera L., Calendula officinalis L., Plantago major L., Ulmus fulva Michx., Urtica dioica L. and Usnea longissima Ach. Arctium lappa, Hydrangea arborescens and Lactuca muralis were used for rheumatoid arthritis and joint pain in pets.
Asthma was treated with: Linum usitatissimum L., Borago officinalis L., Verbascum thapsus L., Cucurbita pepo L., Lobelia inflata L., and Zingiber officinale Roscoe. Pets with heart problems were treated with Crataegus oxyacantha L., Cedronella canariensis (L.) Willd. ex Webb & Berth, Equisetum palustre L., Cypripedium calceolus L., Pinus ponderosa Douglas ex Lawson, Humulus lupulus L., Valeriana officinalis L., Lobelia inflata L., Stachys officinalis (L.) Trev., and Viscum album L. The following plants were used for epilepsy, motion sickness and anxiety- Avena sativa L., Valeriana officinalis, Lactuca muralis (L.) Fresen., Scutellaria lateriflora L., Satureja hortensis L., and Passiflora incarnata L.
Plants used for cancer treatment included Phytolacca decandra, Ganoderma lucidum, Lentinula edodes, Rumex acetosella, Arctium lappa, Ulmus fulva, Rheum palmatum, Frangula purshiana, Zingiber officinale, Glycyrrhiza glabra, Ulmus fulva, Althea officinalis, Rheum palmatum, Rumex crispus and Plantago psyllium. Trifolium pratense was used for tumours in the prostate gland. Also used were Artemisia annua, Taraxacum officinale and Rumex crispus.
This review of plants used in EVM was possible because phytotherapy research of the plants described in this paper has continued because few new pharmaceutical drugs have been developed for chronic pain and because treatments like glucocorticoid therapy do not heal. Phytotherapuetic products are also being investigated to address the overuse of antibiotics. There have also been recent studies conducted on plant-based functional foods and health supplements for pets, however there are still gaps in the knowledge base for the plants Stillingia sylvatica, Verbascum thapsus, Yucca schidigera and Iris versicolor and these need further investigation.
... It is clinical proved that comfrey relieves pain, inflammation and swellig of muscles and joints in the case of degenerative arthritis, acute back pain, sprains, bruises and strains after injuries and sports injuries, also in children over 3 years old [32]. In a survey conducted among the members of the Association of Master Herbalists, the College of Practitioners of Phytotherapy and the National Institute of Medical Herbalists from England, it has been shown that comfrey is commonly recommended as a cream for tendons, ligaments, muscle problems and fractures [36]. Another study tested comparatively two topical creams that contained, in addition to 10 and 20 % comfrey, tannic acid and eucalypt with a reference cream that contains only eucalypt. ...
Plants constitute an inexhaustible source of bioactive compounds that can be valuable for research in the chemistry field of anti-inflammatory compounds. This review describes several plants from international and national flora that have been shown to have anti-inflammatory activity in various clinical trials. The paper includes: general aspects regarding the vegetal source, compounds responsible for anti-inflammatory activity, mechanism of action and clinical trials carried out with extracts or products containing standardized extracts.
... Desde el siglo XVI se ha usado en aplicaciones externas para contusiones, dolores articulares y reumáticos, en enfermedades del tracto digestivo, entre otros. [1][2][3][4][5][6][7] Al respecto, se sabe que el Comfrey contiene polisacáridos y glicopéptidos responsables de la actividad antiinflamatoria. 8,9 Varias propiedades le han sido atribuidas a compuestos presentes en esta especie, como el ácido rosmarínico y en especial a la alantoína, entre estas se pueden citar:ser el responsable del inicio de la división celular y el crecimiento del tejido conjuntivo, huesos, cartílagos y de la aceleración de la cicatrización. ...
Introduction: The Comfrey (Symphytum officinalis (L.) (fam. Boraginacea), is a plant that has been used for therapeutic purposes in popular medicine. It has been used externally for bruises, joint pains and rheumatic and also its use for treatment of diseases of the digestive tract. Due to the presence of some hepatotoxic alkaloids, its use has been restricted only to the external. Objetive: To determine the content of entire polifenoles and to study the antirust potential of the polar extracts of the leaves of Comfrey. Methods: The extracts of the leaves of Comfrey were prepared in different solvents: methanol - water to 50%, water and acetate of ethyl. Polyphenol content was then determined by the Folin-Ciocalteu method, and the antioxidant activity by the methods of DPPH •+ (1.1-diphenyl-2-picrylhydrazyl) and ABTS•+ (2.2'-azinobis (3- ethylbenzothiazoline-6-sulfonic acid). Results: The three studied polar extracts showed antioxidant potential. The methanol extract showed the highest concentration of polyphenols with a value of 6.93 mg Gallic acid/g dry extract. This same extract had the highest antioxidant potential by the two methods, since most power showed radical scavenging. Conclusions: The antioxidant potential of polar extracts of Comfrey and total polyphenol content was evident.
... Several randomized, controlled trials have demonstrated the efficacy of topical comfrey preparations in the treatment of muscle and joint pain (Staiger, 2012). Recently, an herbal practitioner survey of the external use of comfrey in the United Kingdom indicated that comfrey is rated most effective for fractures, wounds, healing after surgery, and problems with tendons, ligaments, and muscles, although it is less effective for treating boils, hemorrhoids, and varicose veins (Frost et al., 2014). Humans have consumed comfrey widely as a vegetable and have taken comfrey formulations of tea or tablets. ...
The complex chemical nature of dietary supplements makes it difficult to evaluate their efficacy and safety. The integration of traditional toxicological approaches with high-throughput molecular profiling technologies provides new approaches to investigate alterations in gene/protein activities and the biological pathways/functions that respond to xenobiotic compounds in animals and humans. This chapter provides examples of the application of gene expression profiling in evaluating the safety and toxicity of dietary supplements. These examples from our laboratories include a study in which functional genomics analysis led to conventional toxicological research, a study illustrating the ability of functional genomics to distinguish the carcinogenic effects in target and nontarget tissues, a study highlighting common mechanisms of action discovered in cross-species analysis of gene expression, and a study integrating gene expression changes with a mechanistic pathway analysis.
... On the other hand, ethanolic extracts of Pluchea sagittalis, Sedum dendroideum, Symphytum officinale and Tanacetum vulgare were cytotoxic to keratinocytes at higher concentrations (results not shown). Taking comfrey (S. officinale) as an example, herbal practitioners consider the species effective for the treatment of wounds and with little risk (Frost et al., 2014). So, although comfrey presented cytotoxicity, its popular use cannot be disregarded once the plant can be acting in wound healing through different pathways. ...
In der Volksmedizin werden Zubereitungen aus Symphytum officinale zur Wundbehandlung, bei Prellungen und Verstauchungen eingesetzt. Die European Medicines Agency hat 2015 die Datenlage zum Wirkstoff und zu den pharmakologischen und klinischen Studien zusammengefasst und die Beinwellwurzel unter „traditional use“ eingestuft. Das Prädikat umfasst Pflanzenmedizin, die seit mehr als 30 Jahren in Europa angewendet wird. Trotz plausibler Wirksamkeit reichte der Wissensstand nicht für das Prädikat „well-establisheduse“. Dies hätte eine detaillierte Kenntnis des Wirkstoffs erfordert, außerdem einen umfassenden Nachweis für die antioxidative, antientzündliche und wundheilungsfördernde Wirkung sowie für die Wirksamkeit in klinischen Studien. Die vorliegenden Studien weisen auf eine mäßige Evidenz der Wirksamkeit von Zubereitungen aus dem Beinwell bei Sprunggelenksdistorsion, Knie- und Rückenschmerzen. Bei Hämatomen, Dekubitus, stumpfen Traumata ohne und mit Hautabschürfungen gibt es Hinweise auf Wirksamkeit. Beweisend angelegte Studien müssten jetzt die Wirkgrößen bei den einzelnen Indikationen definieren. Beinwell-Zubereitungen, bei denen mithilfe eines Spezialverfahrens die Pyrrolizidinalkaloide entfernt wurden, können ohne Bedenken auch langfristig eingesetzt werden.
Symphytum officinale (comfrey) is a perennial herb native to West Asia and Europe. Its root extracts are commonly used as a natural remedy to treat muscle, joint, skin, and bone disorders, especially in Europe. However, more information is needed on the biomedical functions of comfrey leaves. This study’s sequencing results of internal transcribed spacer and trnL–trnF genes showed that plants purchased from the local market were comfrey and named S. officinale WL (WL). The suitable extraction conditions of the WL leaves with the highest extract yield and total phenols and flavonoid contents by microwave-assisted extraction were identified. The antioxidative and anti-inflammatory activities and possible molecular mechanism(s) of the WL leaf extract (WLE) were evaluated. Furthermore, the major component of WLE was identified as rosmarinic acid by HPLC. Results showed that the optimal extract condition was obtained with 750 W microwave power, 50 °C, 75% methanol, the solid-to-solvent ratio of 1:10, and 15 min. Results of all DPPH, ABTS, and superoxide radical scavenging activities, reducing power, ferrous ion chelating activity, and ferric reducing antioxidant power showed high antioxidative capacities of WLE. Furthermore, WLE showed prominent DNA-protecting activity. WLE attenuated lipopolysaccharide-stimulated inflammation by suppressing iNOS, COX-2, IL-1β, IL-6, and TNF-α expressions in the RAW264.7 macrophages. These attenuations are involved in the inactivation of lipopolysaccharide-stimulated NF-κB and MAPK signaling pathways. Therefore, the comfrey leaf extract obtained via a time- and energy-saving microwave-assisted extraction may be a potential antioxidative and anti-inflammatory biomedicinal agent.
Plants contain a diverse variety of chemical compounds that play a crucial role in maintaining good health. Different plant parts are used in Ayurvedic or traditional Indian medicine practices to treat different ailments and diseased conditions. A group of food supplements, known as nutraceuticals, are also based on the components present in these plant parts to help provide immunity and help to regulate the metabolism for a healthy living. However, it has come to light that these plant parts used in medicine and as nutrition supplements can lead to severe toxicity in our body, thus triggering severe health problems. Therefore it is essential to understand which plant species should not be used in day-to-day life and what are its toxic constituents. This chapter highlights different groups of plants and their respective parts that should be avoided to use in any form or in meager amounts to restricting the concentration of its toxic constituents to a minimal.
Introduction:
Symphytum officinale L. (comfrey, Boraginaceae) is a cultivated or spontaneously growing medicinal plant that is traditionally used for the treatment of bone fractures, hematomas, muscle pains and joint pains. A wide range of topical preparations and dried roots for ex tempore applications are marketed in European drug stores or pharmacies.
Objective:
The aim of this study was to perform the qualitative and quantitative analysis of pyrrolizidine alkaloids (PAs) and phenolic compounds in the hydroethanolic extracts of 16 commercial comfrey root batches purchased from 12 different European countries.
Methods:
Liquid chromatography hyphenated with high-resolution tandem mass spectrometry (LC-HRMS/MS) was used for the profiling of PAs and phenolic compounds, whereas LC-MS/MS and liquid chromatography with diode array detection (LC-DAD) were used for their quantification.
Results:
20 PAs (i.e. intermedine, lycopsamine, acetylintermedine, acetyllycopsamine, symphytine, symphytine-N-oxide), 17 phenolic compounds (i.e. caffeic and rosmarinic acids, rabdosiin, globoidnan A, globoidnan B) and 9 nonphenolic compounds (sugars, organic and fatty acids) were fully or partly annotated in the analysed samples. In addition, the quantitative analyses revealed that globoidnan B, rabdosiin and globoidnan A are new phenolic markers that can be used together with rosmarinic acid and PAs for the quality control of commercial comfrey root batches.
Conclusions:
This study brings new insights into the phytochemical complexity of S. officinale, revealing not only numerous toxic PAs, but also a significant number of valuable phenolic compounds that could contribute to the bioactivities of comfrey-based preparations.
The effects of extraction techniques on the physicochemical properties, antioxidant activity and antihyperglycemic activity of comfrey polysaccharides (CPs) were evaluated. Four techniques were used to extract CPs: hot water extraction (HW), ultrasonic-assisted extraction (UA), enzyme-assisted extraction (EA) and enzyme-ultrasonic-assisted extraction (EUA). Experimental results indicated that CPs extracted by the UA (UA-CPs) and EUA methods (EUA-CPs) had higher extraction yields. The four CPs showed the same monosaccharide composition but a significant difference in monosaccharide content. CPs showed antioxidant activities and antihyperglycemic activities in a concentration-dependent manner. UA-CPs exhibited better antioxidant capacity, which might have been related to its smaller molecular weight and higher uronic acid content. In addition, UA-CPs showed notable α-glucosidase inhibition activity. These results suggested that ultrasonic-assisted extraction technology was more beneficial to enhance the extraction yields of the polysaccharides, and obtain higher bioactive polysaccharides from comfrey.
The urban ethnobotany study provides a generalized survey on ethnobotanical knowledge preserved in Samogitia (Lithuania) and on the practical application of this knowledge in modern therapy. We registered 113 medicinal plants from 57 plant families used for therapeutic purposes. The most commonly used families of medicinal plants were Asteraceae, Lamiaceae and Rosaceae and the most commonly used plants - Calendula officinalis L., Vaccinium vitis-idaea L., Valeriana officinalis L., Hypericum perforatum L., Artemisia absinthium L., Symphytum officinale L., Quercus robur L., Populus x canescens Aiton, Anthemis tinctoria E.C. Buxton, Achillea millefolium L., Acorus calamus L. and Aesculus hippocastanum L. Most commonly, medicinal plants were used for alimentary tract disorders (22%), disorders of the respiratory tract (20%), wounds, other traumas and bites (10%), renal and urinary tract disorders (10%), nervous and emotional disorders (9%). Despite easily accessible modern medical assistance, the inhabitants of the studied region were actively using their experience in traditional herbal medicine for primary healthcare.
In dermatologic practice conservative treatment of venous leg ulcers is limited to medicamentous and physical therapy. In severe, chronic, infected venous leg ulcers there is a need for additional therapy, most commonly physical therapy. With intent to find a new therapeutic method, great attention has been given to herbal remedies, which have been applied in conventional dermatologic practice during a certain period of time, in, order to treat different dermatologic diseases, such as disorders of venous circulation and different ulcerations in general. This study included 30 patients with various number of venous leg ulcers, who were treated with combined therapy of polarized light combined with herbal remedy and patients who were in control group. To investigate the rate of its influence on wound healing, we have studied 3 components of the healing process: a reduction of surface area, depth and volume of the leg ulcer. Patients were seen at the initial visit and at +1, +3, +5 and +7 weeks of treatment. When compared different scores within the 2 groups that were obtained for 3 scored features at each visit (paired t-test, p<0.05), it was established that combined appliance of polarised light with herbal remedies accelerated ulcer healing.
The present work evaluates wound healing activity of leaves extracts of Symphytum officinale L. (comfrey) incorporated in three pharmaceutical formulations. Wound healing activity of comfrey was determined by qualitative and quantitative histological analysis of open wound in rat model, using allantoin as positive control. Three topical formulations, carbomer gel, glycero-alcoholic solution and O/W emulsion (soft lotion) were compared. The histological analysis of the healing process shows significant differences in treatment, particularly on its intensity and rate. The results indicate that emulsion containing both extracts, commercial and prepared, induced the largest and furthest repair of damaged tissue. This could be evidenced from day 3 to 28 by increase in collagen deposition from 40% to 240% and reduction on cellular inflammatory infiltrate from 3% to 46%. However, 8% prepared extract in emulsion presented the best efficacy. This work clearly demonstrates that comfrey leaves have a wound healing activity. The O/W emulsion showed to be the vehicle most effective to induce healing activity, particularly with extracts obtained from comfrey leaves collected in Minas Gerais state in Brazil. It shows the best efficacy to control the inflammatory process and to induce collagen deposition at 8% concentration.
Postal and electronic questionnaires are a relatively inexpensive way to collect information from people for research purposes. If people do not reply (so called 'non-responders'), the research results will tend to be less accurate. This systematic review found several ways to increase response. People can be contacted before they are sent a postal questionnaire. Postal questionnaires can be sent by first class post or recorded delivery, and a stamped-return envelope can be provided. Questionnaires, letters and e-mails can be made more personal, and preferably kept short. Incentives can be offered, for example, a small amount of money with a postal questionnaire. One or more reminders can be sent with a copy of the questionnaire to people who do not reply.
It's about integrating individual clinical expertise and the best external evidenceEvidence based medicine, whose philosophical origins extend back to mid-19th century Paris and earlier, remains a hot topic for clinicians, public health practitioners, purchasers, planners, and the public. There are now frequent workshops in how to practice and teach it (one sponsored by the BMJ will be held in London on 24 April); undergraduate1 and postgraduate2 training programmes are incorporating it3 (or pondering how to do so); British centres for evidence based practice have been established or planned in adult medicine, child health, surgery, pathology, pharmacotherapy, nursing, general practice, and dentistry; the Cochrane Collaboration and Britain's Centre for Review and Dissemination in York are providing systematic reviews of the effects of health care; new evidence based practice journals are being launched; and it has become a common topic in the lay media. But enthusiasm has been mixed with some negative reaction.4 5 6 Criticism has ranged from evidence based medicine being old hat to it being a dangerous innovation, perpetrated by the arrogant to serve cost cutters and suppress clinical freedom. As evidence based medicine continues to evolve and adapt, now is a useful time to refine the discussion of what it is and what it is not.Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The …
To describe the patterns of prescription and dispensing of herbal medicines employed by Western herbal practitioners in Australia.
A national postal survey sent to all full members of the National Herbalist Association of Australia (NHAA).
Nationwide clinics of professional herbal practitioners in Australia.
Measures of medicinal use were collected including aspects of prescription, formulation, dispensing and preparation forms of medicines used. The practitioners were asked if they dispensed their own medicines, about the form of herbal preparations used, aspects of formulation and dosages.
The predominant prescription by most Western herbal practitioners in Australia is individualised herbal formulae rather than the use of single herbs. Traditional preparations of herbals such as teas and powders are used but liquid herbal extracts are most commonly dispensed. These liquid medicines are in the form of highly concentrated fluid extracts in ratios of 1:1 or 1:2, herb material to liquid. Pre-formulated tablets or capsules made by herbal manufacturers are being incorporated into modern practice but most prescriptions are individualised liquid formulae prepared and dispensed, from the clinic dispensary, after patient consultation. In addition to internal prescriptions, topical creams, pessaries, douches, gargles, eyebaths and poultices or washes are still incorporated into treatments. Although there is variation in used dosage ranges, the predominant system is that of pharmacologically active doses of highly concentrated fluid extracts.
The professional prescription of Western herbal medicines is different to commercial usage. As opposed to pre-formulated tablets, or use of single herbals, the vast majority of Western herbalists in Australia construct individualised herbal formulations for their patients after consultation. The preferred form of administration of these prescriptions is as highly concentrated liquid herbal extracts in pharmacologically active doses.
Comfrey (Symphytum officinale L) is a medicinal plant with anti- inflammatory, analgesic and tissue regenerating properties. In a double- blind, multi-centre, randomised, placebo-controlled group comparison study on patients suffering from unilateral acute ankle sprains (n ≃ 142, mean age 31.8 years, 78.9% male), the percutaneous efficacy of an ointment of comfrey extract (Kytta-Salbe® f, 4 treatments per day for 8 days) could be confirmed decisively. Compared to placebo, the active treatment was clearly superior regarding the reduction of pain (tonometric measurement, p < 0.0001, as the primary efficacy variable) and ankle oedema (figure of eight method, p ≃ 0.0001). Statistically significant differences between active treatment and placebo could also be shown for ankle mobility (neutral zero method), and global efficacy. Under active treatment, no adverse drug reactions were reported. The good local and global tolerance of the trial medication could also be confirmed. The study results are consistent with the known pre- clinical and clinical data about comfrey.
In spite of a variety of established therapeutic approaches to the treatment of acne vulgaris, up to 12.7% of patients cannot be cured using these methods. To overcome the limitations of established therapies, botanicals and natural mineral preparations are also used to treat acne. The aim of our study was to investigate the efficacy of topical preparations of peloid and medicinal plants from Montenegro in an acne therapy regimen. The study design was a retrospective cohort study, with two cohorts defined by the type of topical preparation used: one cohort (n = 70) was comprised of the patients treated with Peloderm (a topical preparation containing both peloid and medicinal plants' extracts), and another cohort (n = 70) of the patients was treated with Antiacne (a topical preparation with only medicinal plants' extracts). Patients in both cohorts were treated for 18 months. In both treatment groups, the FDA acne severity score improved gradually throughout the study visits. However, final FDA acne severity score (after 18 months of topical treatment) was significantly (T = 7.556, df = 1, p = 0.000) lower in the Peloderm group (1.0 ± 0.0) than in the Anitiacne group (1.8 ± 0.9). Both topical preparations of peloid and selected medicinal plants from Montenegro, in ratios observed in this study, are efficacious and safe options for topical treatment of acne, with the peloid preparation demonstrating somewhat greater potency.
External preparations of the herb comfrey (most commonly Symphytum officinale L.) are widely available for over-the-counter, practitioner and healthcare professional usage. Traditional practice suggests comfrey can be used to treat musculoskeletal disorders, wounds and various other conditions; however a full and critical coverage of the evidence base has not yet been undertaken.
A critical scoping review was undertaken. Six bibliographic databases, 10 grey literature databases and nine trials registers were searched plus reference lists of included studies and a descriptive overview of comfrey. Randomised or non-randomised clinical trials assessing the external use of comfrey for any indication were included and methodological and reporting quality were assessed. Observational studies were included only in the assessment of adverse events. Studies were grouped and summarised according to the type of indication treated.
Of 1348 identified records, 64 full texts were screened for inclusion and 26 were included in the review - 13 RCTs, 5 non-randomised controlled trials and 8 observational studies evaluating treatments for ankle distortion, back pain, abrasion wounds, venous leg ulcers and osteoarthritis. The majority of included trials had an overall unclear risk of bias due to poor quality of reporting. Few adverse events were reported.
Individual clinical trials showed evidence of benefit for ankle distortion, back pain, abrasion wounds and osteoarthritis. Topical application appears to be safe but further rigorous assessment is needed. Systematic reviews focussing on particular indications may clarify the treatment effect and safety of external comfrey preparations.
ContextThe NIMH Yellow Card Scheme was initiated in 1994 as a means for reporting adverse events directly relating to herbal medicines individually prescribed by herbal practitioners in the clinical setting. Current research in herbal medicine relies mostly on studies investigating the efficacy and adverse effects of over the counter manufactured products or isolated constituents. It does not take in to account the complex intervention of clinical herbal practice.Objectives
To provide an overview of adverse reactions as reported by qualified herbalists by the NIMH Yellow Card Scheme to inform clinical practice and disseminate information to the wider healthcare community.SettingClinical experience as reported by NIMH professional herbal practitioners.ResultsNo serious adverse events have been reported by the NIMH Yellow Card system meaning there have been no fatalities or lasting serious harmful effects of herbal medicines prescribed by herbal practitioners. The outcomes in all 60 reports are reported as a full recovery. Symptoms usually resolve within hours to a few days after stopping the medicine. Common reactions reported include headache; gastric disturbance; skin irritation; sleep disturbance; agitation; hypersensitivity or allergic reaction. In the event of an adverse reaction it is difficult to identify one herb involved as it is common to herbal practice to prescribe medicines on an individual basis in combination and other factors such as individual sensitivities, diet and lifestyle changes are often involved.Conclusions
The reports provide an important information source of clinical experience and relevance to practitioners and safety issue concerns. Clinical data combined with traditional empirical documentation enhances knowledge of evidence based practice.
Background:
Before extraction and synthetic chemistry were invented, musculoskeletal complaints were treated with preparations from medicinal plants. They were either administered orally or topically. In contrast to the oral medicinal plant products, topicals act in part as counterirritants or are toxic when given orally.
Objectives:
To update the previous Cochrane review of herbal therapy for osteoarthritis from 2000 by evaluating the evidence on effectiveness for topical medicinal plant products.
Search methods:
Databases for mainstream and complementary medicine were searched using terms to include all forms of arthritis combined with medicinal plant products. We searched electronic databases (Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to February 2013, unrestricted by language. We also searched the reference lists from retrieved trials.
Selection criteria:
Randomised controlled trials of herbal interventions used topically, compared with inert (placebo) or active controls, in people with osteoarthritis were included.
Data collection and analysis:
Two review authors independently selected trials for inclusion, assessed the risk of bias of included studies and extracted data.
Main results:
Seven studies (six different medicinal plant interventions; 785 participants) were included. Single studies (five studies) and non-comparable studies (two studies) precluded pooling of results.Moderate evidence from a single study of 174 people with hand osteoarthritis indicated that treatment with Arnica extract gel probably results in similar benefits as treatment with ibuprofen (non-steroidal anti-inflammatory drug) with a similar number of adverse events. Mean pain in the ibuprofen group was 44.2 points on a 100 point scale; treatment with Arnica gel reduced the pain by 4 points after three weeks: mean difference (MD) -3.8 points (95% confidence intervals (CI) -10.1 to 2.5), absolute reduction 4% (10% reduction to 3% increase). Hand function was 7.5 points on a 30 point scale in the ibuprofen-treated group; treatment with Arnica gel reduced function by 0.4 points (MD -0.4, 95% CI -1.75 to 0.95), absolute improvement 1% (6% improvement to 3% decline)). Total adverse events were higher in the Arnica gel group (13% compared to 8% in the ibuprofen group): relative risk (RR) 1.65 (95% CI 0.72 to 3.76).Moderate quality evidence from a single trial of 99 people with knee osteoarthritis indicated that compared with placebo, Capsicum extract gel probably does not improve pain or knee function, and is commonly associated with treatment-related adverse events including skin irritation and a burning sensation. At four weeks follow-up, mean pain in the placebo group was 46 points on a 100 point scale; treatment with Capsicum extract reduced pain by 1 point (MD -1, 95% CI -6.8 to 4.8), absolute reduction of 1% (7% reduction to 5% increase). Mean knee function in the placebo group was 34.8 points on a 96 point scale at four weeks; treatment with Capsicum extract improved function by a mean of 2.6 points (MD -2.6, 95% CI -9.5 to 4.2), an absolute improvement of 3% (10% improvement to 4% decline). Adverse event rates were greater in the Capsicum extract group (80% compared with 20% in the placebo group, rate ratio 4.12, 95% CI 3.30 to 5.17). The number needed to treat to result in adverse events was 2 (95% CI 1 to 2).Moderate evidence from a single trial of 220 people with knee osteoarthritis suggested that comfrey extract gel probably improves pain without increasing adverse events. At three weeks, the mean pain in the placebo group was 83.5 points on a 100 point scale. Treatment with comfrey reduced pain by a mean of 41.5 points (MD -41.5, 95% CI -48 to -34), an absolute reduction of 42% (34% to 48% reduction). Function was not reported. Adverse events were similar: 6% (7/110) reported adverse events in the comfrey group compared with 14% (15/110) in the placebo group (RR 0.47, 95% CI 0.20 to 1.10).Although evidence from a single trial indicated that adhesive patches containing Chinese herbal mixtures FNZG and SJG may improve pain and function, the clinical applicability of these findings are uncertain because participants were only treated and followed up for seven days. We are also uncertain if other topical herbal products (Marhame-Mafasel compress, stinging nettle leaf) improve osteoarthritis symptoms due to the very low quality evidence from single trials.No serious side effects were reported.
Authors' conclusions:
Although the mechanism of action of the topical medicinal plant products provides a rationale basis for their use in the treatment of osteoarthritis, the quality and quantity of current research studies of effectiveness are insufficient. Arnica gel probably improves symptoms as effectively as a gel containing non-steroidal anti-inflammatory drug, but with no better (and possibly worse) adverse event profile. Comfrey extract gel probably improves pain, and Capsicum extract gel probably will not improve pain or function at the doses examined in this review. Further high quality, fully powered studies are required to confirm the trends of effectiveness identifed in studies so far.
To assess the efficacy of thrice daily topical 4Jointz utilizing Acteev technology (a combination of a standardized comfrey extract and a pharmaceutical grade tannic acid, 3.5 g/day) on osteoarthritic knee pain, markers of inflammation and cartilage breakdown over 12 weeks.
Adults aged 50-80 years (n = 133) with clinical knee OA were randomised to receive 4Jointz or placebo in addition to existing medications. Pain and function were measured using a visual analogue scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) scale at baseline, 4, 8 and 12 weeks. Inflammation was measured analysing IL-6 expression and CTX-2 presence as representative for cartilage breakdown using ELISA, at baseline and 12 weeks.
Pain scores significantly reduced in the group who received 4Jointz compared to the group who received placebo after 12 weeks using both the VAS (-9.9 mm, P = 0.034) and the KOOS pain scale (+5.7, P = 0.047). Changes in IL-6 and CTX-2 were not significant (-0.04, P = 0.5; -0.01, P = 0.68). Post-hoc analyses suggested that treatment may be most effective in women (VAS -16.8 mm, P = 0.008) and those with milder radiographic osteoarthritis (OA) (VAS -16.1 mm, P = 0.009). Rates of adverse events were similar in both groups, excepting local rash that was more common amongst participants receiving 4Jointz (21% vs 1.6%, IRR 13.2, P = 0.013), but only 26% (n = 4) of participants with rashes discontinued treatment. There were no changes in systemic blood results.
Topical treatment using 4Jointz reduced pain but had no effect on inflammation or cartilage breakdown over 12 weeks of treatment. Trial registration: Australia and New Zealand Clinical Trials registry ACTRN12610000877088.
A postal survey of all members of the UK National Institute of Medical Herbalists (NIMH) was conducted to determine what conditions herbalists treat most frequently, what herbs or combination of herbs herbalists use to treat those conditions, and how herbalists rate the effectiveness and safety of those herbs. Of the 317 questionnaires sent out, 62 were completed and returned (response rate 19.6%). The conditions most commonly listed by respondents as being those that they frequently treat were: premenstrual syndrome/premenstrual tension; irritable bowel syndrome; menopausal symptoms; eczema; ‘arthritis’. Several herbs that are often used by herbalists in the treatment of these conditions can be identified. Many of these herbs have been used traditionally and are rated by herbalists as being safe and effective, but lack evidence to support this from controlled clinical trials. These data could be used to generate hypotheses which, in turn, should be tested, e.g. in randomized controlled trials. © 1998 John Wiley & Sons, Ltd.
American skullcap (Scutellaria lateriflora) is a popular herb in traditional medicine systems and western materia medica for the treatment of anxiety and related disorders. It is reported to be one of the most widely used medicinal herbs, with anecdotal evidence for minimal side-effects and with no known toxicity. This article summarises the results of a pilot survey conducted amongst herbal medicine practitioners on their use of S. lateriflora. An email survey was conducted amongst herbal medicine practitioners in the UK and Ireland. It aimed to gather information on the extent of, and indications for, current use of S. lateriflora, its perceived effectiveness and its safety. Herbal medicine practitioners were selected from the membership list of the National Institute of Medical Herbalists (NIMH). All members with identifiable email addresses were contacted (n = 377) and responses were received from 62 (a 16% response rate). The results of the survey suggested that S. lateriflora is highly regarded amongst herbal medicine practitioners as an effective intervention for reducing anxiety and stress and is commonly prescribed for these conditions and related co-morbidities. The results were not conclusive as the response rate was low and respondents were only those with email access.
The wound healing effects of the topically applied preparation Traumaplant® containing a concentrate (10% active ingredient) from the aerial parts of medicinal comfrey (Symphytum × uplandicum Nyman) were examined in a randomized, controlled, clinical double-blind study. An otherwise identical low-dose preparation (1% active ingredient) was used as a control. The study population consisted of 108 children aged 3-12 years (n=54/group) with fresh abrasions. A 50% healing rate was reached 0.9 days earlier with the higher than with the lower concentration cream. The difference in the healing rate (0.38±0.18/day [95% CI 0.33-0.4] vs. 0.26±0.14/day [95% CI 0.222-0.297]) was statistically significant (p=0.0002). Physicians and children/parents both rated the efficacy of the 10% cream as significantly better than that of the control preparation (physicians' assessment after 2-3 and 7-9 days for verum vs. control: 90.7 and 92.6% vs. 55.6 and 74.0% of the healing rates were rated as "good" or "very good", respectively; p=0.0004 and 0.01). In subgroup analyses, there was no significant influence on the healing rate of the time elapsed between the accident and the first consultation, the wound surface, the affected body part, the origin of the injury and gender. There were no reported adverse effects or problems with tolerability such as local skin irritations. The results justify application of the Symphytum herb extract cream in children with blunt traumata with or without abrasions.
To profile the profession of Western herbal medicine (WHM) in the UK.
A self-completion postal questionnaire sent to a sample of practitioners of WHM in England.
A typical practitioner of WHM in the UK is female, aged 41-50, white, and practises part-time from a shared clinic or from home. Motivations to embark on a career in WHM are grounded in an interest in natural healing and the desire to help others. The practice of WHM in the UK responds extensively to women's health needs. Tensions in the practice of WHM are identified between a framework of healthcare that is described as 'traditional' and the influences of evidence-based developments in healthcare.
Women, both as practitioners and as patients, and women's health needs play a central role in the contemporary practice of WHM in the UK.
This paper provides significant ethnobotanical information on pharmaceutical plant uses in Northern Navarra from an area known both for its high biological diversity and its cultural significance, suggesting the survival of uses lost elsewhere. Collect, analyze and evaluate the ethnobotanical knowledge about medicinal plants in Northern Navarra (Iberian Peninsula) with 4243 km(2) and 71,069 inhabitants.
We performed semi-structured interviews with 253 informants (mean age 69; 61% women, 39% men) in 120 locations, identified the plant reported and analyzed the results, comparing them with those from other territories.
The informants reported data on 174 medicinal plants belonging to 63 botanical families. This work is focused on human medicinal plant uses, which represent 98% of the pharmaceutical uses (1725 use reports). The species with the highest number of cites are Chamaemelum nobile, Sambucus nigra and Verbena officinalis, with a long tradition of use in The Mountain (Navarra). All different plant parts are used; aerial part is exploited more frequently than other plant parts. Most of the listed remedies use a single ingredient, typically soaked in water. Usually, the administration is primarily oral followed by topical applications.
The main ailments treated are digestive troubles, wounds and dermatological problems, and respiratory affections. Informants reported 24 new or scarcely cited uses for 23 medicinal plants. For 35% of the species (8) we have not found bibliographical references in the scientific literature and 48% (11) have only one to three references.
Previous research into complementary and alternative medicine has failed to accord each form of alternative medical intervention individual significance. This research
considers medical herbalism in Britain and investigates the re-presentation of its knowledge within a scientific framework as a strategy in a process of professionalisation. Data were gathered from herbalists' own statements that provided the answers to how? and why? this occurred. Whilst it is suggested that much science is
heavily influenced by its social and cultural enviromnent, the tenacious portrayal of biomedicine as science is taken as accepted orthodoxy. Dolby's model, whereby unorthodox science assumes the features of orthodox science to become accepted as science, is forwarded as an explanation of how herbal medicine has been re-presented as phytotherapy and therefore 'scientific'. The influences of the sociocultural
enviromnent and the sociopolitical enviromnent on herbalism's recognition and acceptance by both the state and conventional medicine are suggested as explanations
of why phytotherapy has been promoted by some herbalists.
It is noted that such transformative measures have not radically affected the professional practice of medical herbalists, nor are they universally welcomed. The anomaly between institutional education of herbalism in terms of phytotherapy and the continuing practice of herbalism as a 'tradition' is noted. The relative identities of practitioners - with a cultural identity - and herbal institutions - with a social identity - is suggested as the explanation for the discontinuity between institutional
knowledge and actual practice. It is also argued that medical herbalists have an element of altruism in their practice that is noteworthy beyond an assumed professional service orientation. Herbalists' differences of view regarding the acceptability of promoting phytotherapy as a route to recognition and acceptance appear to be subordinated by fears and anxieties about possible future govermnent legislation and EU harmonisation regulations.
Venous leg ulcers represent a significant public health problem that will increase as the population ages. Numerous herbs and their extracts are potentially conducive to wound healing, including the ability to serve as an antimicrobial, antifungal, astringent, etc. A total of 32 patients with venous leg ulcers were randomized into two groups: a group with herbal therapy treatment (PT) (17 patients) and a control group (C) (15 patients). The investigation focused on five controls of parameter changes important for ulcer healing and the control of microbiological flora. Within-treatment analysis of the PT group showed that, following herbal therapy treatment, there was a significant decrease in the scores of surface leg ulcer and venous leg ulcer after week 7 of treatment (p < 0.05). In group C following topical antibiotic treatment there was no significant decrease in the surface leg ulcer. Comparing the results of decreased venous leg ulcer surface of the) PT group with the C group showed a significant difference at p < 0.05 after week 7 of treatment. The number of different types of isolated bacterial species decreased significantly (p < 0.05) after the use of herbal preparations. The results of this pilot study demonstrate the healing and antimicrobiological effects of herbal therapy on non-infected venous leg ulcer.
The objective was to show the superiority of comfrey root extract ointment to placebo ointment in patients with acute upper or lower back pain.
The study was conducted as a double-blind, multicentre, randomised clinical trial with parallel group design over a period of 5 days (SD 1). The patients (n = 120, mean age 36.9 years) were treated with verum or placebo ointment three times a day, 4 g ointment per application. The trial included four visits.
The primary efficacy variable was the area under the curve (AUC) of the visual analogue scale (VAS) on active standardised movement values at visits 1 to 4. The secondary efficacy variables were back pain at rest using assessment by the patient on VAS, pressure algometry (pain-time curve; AUC over 5 days), global assessment of efficacy by the patient and the investigator, consumption of analgesic medication and functional impairment measured using the Oswestry disability index.
There was a significant treatment difference between comfrey extract and placebo regarding the primary variable. In the course of the trial the pain intensity on active standardised movement decreased on average (median) approximately 95.2% in the verum group and 37.8% in the placebo group.
The results of this clinical trial were clear-cut and consistent across all primary and secondary efficacy variables. Comfrey root extract showed a remarkably potent and clinically relevant effect in reducing acute back pain. For the first time a fast-acting effect of the ointment (1 h) was also witnessed.
The project of modernising Western herbal medicine in order to allow it to be accepted by the public and to contribute to contemporary healthcare is now over two decades old. One aspect of this project involves changes to the ways knowledge about medicinal plants is presented. This paper contrasts the models of Evidence-Based Medicine (EBM) and Traditional Knowledge (TK) to illuminate some of the complexities which have arisen consequent to these changes, particularly with regard to the concept of vitalism, the retention or rejection of which may have broad implications for the clinical practice of herbal medicine. Illustrations from two herbals (central texts on the medicinal use of plants) demonstrate the differences between these frameworks in regard to how herbs are understood. Further, a review of articles on herbal therapeutics published in the Australian Journal of Herbal Medicine indicates that practitioners are moving away from TK and towards the use of EBM in their clinical discussions.
A 23 year old man presented with hepatic veno-occlusive disease and severe portal hypertension and subsequently died from liver failure. Light microscopy and hepatic angiography showed occlusion of sublobular veins and small venous radicles of the liver, associated with widespread haemorrhagic necrosis of hepatocytes. The patient had been on a predominantly vegetarian diet and, prior to his illness, took comfrey leaves which are known to contain hepatotoxic pyrrolizidine alkaloids. Comfrey is widely used as a herbal remedy, but so far has only been implicated in two other documented cases of human hepatic veno-occlusive disease. A possible causal association of comfrey and this patient's veno-occlusive disease is suggested by the temporal relationship of the ingestion of comfrey to his presentation, the histological changes in the liver and the exclusion of other known causes of the disease.
Cette observation decrit une maladie veino-occlusive provoquee par des thes aux herbes achetes dans un magasin de produits dietetiques et illustre la large utilisation des produits renfermant des alcaloides pyrrolizinodiniques meme dans les nations industrialisees
Venocclusive disease, a form of Budd-Chiari syndrome, was diagnosed in a 49-yr-old woman. The patient had portal hypertension associated with obliteration of the smaller hepatic venules. A liver biopsy specimen showed centrilobular necrosis and congestion. Analysis of food supplements the woman regularly consumed showed the presence of pyrrolizidine alkaloids. The major source was a powder purporting to contain ground comfrey root (Symphytum sp). We calculated that during the 6 mo before the woman was hospitalized, she had consumed a minimum of 85 mg of pyrrolizidine alkaloids (15 micrograms/kg body wt X day). The clinical and analytic findings were consistent with chronic pyrrolizidine intoxication, indicating that low-level, chronic exposure to such alkaloids can cause venocclusive disease.
The term ‘benefit-risk ratio’ is often used as a general term linked to the use of a medicine. To balance risk and benefit is, however, a very complex exercise. For most medicines the benefits are limited to a few indications and for an individual patient there is usually only a single benefit sought but the potential risks are multiple.
Perceptions of risks versus benefits are influenced to a great extent by the context in which they occur. Thus, perception of risk may be different to actual risk. In the end in any given situation, the acceptable risk-to-benefit balance is an individual judgement on the part of the patient or the prescriber.
For newer medicines, where there is likely to be limited experience, conser-vative estimates of the overall merit seem preferable so that the prescriber will use the drug critically. Subsequently, re-evaluation of the risk-to-benefit balance is necessary as greater knowledge of efficacy and adverse effects is acquired.
It is possible to provide a general ‘principle of threes’ structure for a merit assessment based upon the concepts of seriousness, duration and incidence as related to disease indication, disease amelioration by a medicine, and the adverse effects ascribed to the medicine. This allows a rapid first comparison of medicines for a given indication.
In using this general conceptual model in a transparent fashion for a given hypothesis and context, it is possible to identify the essential data used and assumptions involved that make up a merit statement. The quality and value, particularly of risk data, is problematic. Risk perception is an issue that needs to be clearly identified alongside a merit analysis. A simple merit assessment should pave the way for more focused studies.
Comfrey (Symphytum officinale L.) is a medicinal plant with anti-inflammatory, analgesic and tissue regenerating properties. In a double-blind, multicenter, randomized, placebo-controlled, group comparison study on patients suffering from unilateral acute ankle sprains (n = 142, mean age 31.8 years, 78.9% male), the percutaneous efficacy of an ointment of comfrey extract (Kytta-Salbe f, four treatments per day for 8 days) was confirmed decisively. Compared to placebo, the active treatment was clearly superior regarding the reduction of pain (tonometric measurement, p<0.0001, as the primary efficacy variable) and ankle edema (figure-of-eight method, p = 0.0001). Statistically significant differences between active treatment and placebo could also be shown for ankle mobility (neutral zero method), and global efficacy. Under active treatment, no adverse drug reactions were reported. The good local and global tolerance of the trial medication could also be confirmed. The study results are consistent with the known pre-clinical and clinical data concerning comfrey.
In a controlled, double blind, randomized multicentre study, the efficacy and safety of the topical comfrey product Traumaplant (10% active ingredient of a 2.5:1 aqueous ethanolic pressed juice of freshly harvested, cultivated comfrey herb (Symphytum x uplandicum NYMAN), corresponding to 25 g of fresh herb per 100 g of cream; n = 104) was tested against a 1% product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n = 99) in 203 patients with acute ankle distortion. With the high concentration, decrease of the scores for pain on active motion, pain at rest and functional impairment was highly significant and clinically relevant on days T3-4 as well as T7 (p < 0.001). Amelioration of swellings as compared to reference was also significant on day 3-4 (p < 0.01). Efficacy was judged good to excellent in 85.6% of cases with verum and in 65.7% of cases with reference on day 3-4. Overall tolerability was excellent.
In the treatment of minor blunt injuries several topical drugs are known to have anti-inflammatory and analgesic properties. They represent, however, two fundamentally different major pharmacological therapy approaches: the "chemical-synthetical" and the "phytotherapeutical" approach. The main objective of this trial (CODEC_2004) was to compare the efficacy and tolerability of an ointment of Comfrey extract (Extr. Rad. Symphyti) with that of a Diclofenac gel in the treatment of acute unilateral ankle sprain (distortion). In a single-blind, controlled, randomized, parallel-group, multicenter and confirmatory clinical trial outpatients with acute unilateral ankle sprains (n=164, mean age 29.0 years, 47.6% female) received either a 6 cm long ointment layer of Kytta-Salbe f (Comfrey extract) (n=82) or of Diclofenac gel containing 1.16 g of diclofenac diethylamine salt (n=82) for 7 +/- 1 days, four times a day. Primary variable was the area-under-the-curve (AUC) of the pain reaction to pressure on the injured area measured by a calibrated caliper (tonometer). Secondary variables were the circumference of the joint (swelling; figure-of-eight method), the individual spontaneous pain sensation at rest and at movement according to a Visual Analogue Scale (VAS), the judgment of impaired movements of the injured joint by the method of "neutral-zero", consumption of rescue medication (paracetamol), as well as the global efficacy evaluation and the global assessment of tolerability (both by physician and patient, 4 ranks). In this study the primary variable was also to be validated prospectively. It was confirmatorily shown that Comfrey extract is non-inferior to diclofenac. The 95% confidence interval for the AUC (Comfrey extract minus Diclofenac gel) was 19.01-103.09h*N/cm2 and was completely above the margin of non-inferiority. Moreover, the results of the primary and secondary variables indicate that Comfrey extract may be superior to Diclofenac gel.
The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.
This randomised, double-blind, bicenter, placebo-controlled clinical trial investigated the effect of a daily application of 6g Kytta-Salbe f (3 x 2 g) over a 3 week period with patients suffering from painful osteoarthritis of the knee. The two hundred and twenty patients examined consisted of 153 women and 67 men of an average age of 57.9 years. On average, the complaints relating to osteoarthritis of the knee had persisted for 6.5 years. Two hundred and twenty patients were included in the Full Analysis Set (FAS) and safety collective, 186 (84.5%) in the Valid Case Analysis Set (VCAS) collective. In the course of the trial, the visual analog scale (VAS) total score (primary target value) in the verum group dropped by 51.6 mm (54.7%) and in the placebo group by 10.1 mm (10.7%). The average difference between the groups of 41.5 mm (95% confidence interval=34.8 to 48.2 mm) or 44.0% is significant (p<0.001). The significance is confirmed through the evaluation of the diary, the VCAS evaluation and the separate assessment of the two centres. This also applies to the separate assessment of the VAS total score following pain at rest and on movement. The WOMAC (Western Ontario and McMaster Universities) total score (secondary target value) also improved similar to the VAS total score. At the end of the trial, a reduction by 60.4 mm (58.0%) was recorded for the verum group and a reduction of 14.7 mm (14.1%) for the placebo group. The average group difference of 45.7 mm (95% confidence interval=37.1 to 54.3 mm) or 43.9% is significant (p<0.001). The difference between the treatment groups increased systematically and significantly, in parallel with the duration of the treatment. Thus, the superiority of the treatment with Kytta-Salbe f over that with the placebo is proven, even by means of the multi-factorial multivariate analysis for repetitive measurements. In respect of the explorative secondary target values SF-36 (quality of life), angle measurement (mobility of the knee), CGI (clinical global impression) and global assessment of efficacy by the physician and the patient, a significant superiority (p<0.001 each) of the verum group over the placebo group was also proven. The results suggest that the comfrey root extract ointment is well suited for the treatment of osteoarthritis of the knee. Pain is reduced, mobility of the knee improved and quality of life increased.
Wound healing effects of a topically applied preparation (Traumaplant) containing a concentrate (10 % active ingredient) from the aerial parts of medicinal comfrey (Symphytum x uplandicum NYMAN: ) were examined in a randomized clinical double-blind study including 278 patients with fresh abrasions (verum: n = 137), among them 64 patients of up to 20 years of age (verum n = 29, reference product n = 35). An otherwise identical low-dose preparation (1 % active ingredient; n = 141) was used as a reference.
After 2-3 days of application of the study medication a highly significantly and clinically relevantly faster initial reduction of wound size of 49 + or - 19 % versus 29 + or - 13 % per day in favour of verum (p < 5x10(-21)) was found. From linear regression time to complete healing was determined to be 2.97 days faster with verum than with reference (4.08 vs. 7.05 days, p = 7.4 x 10(-45) in the t-Test comparison of regression lines). The physicians rated efficacy as good to very good in 93.4 % of cases, as compared to 61.7 % in the group treated with the reference product (p = 2 x 10(-11)). On a scale of 0-100 verum was rated with 84.4 + or - 10.1 points by the patients themselves. The reference product was rated with 65.5 + or - 24.8 points (p = 6.1 x 10(-18)). In subgroup analyses no significant influence of abrasion area, gender and age on healing effects was found, albeit a tendency towards better effects with increasing age was observed. No adverse effects or problems with drug tolerability occurred. Specifically, cutaneous reactions were observed in none of the patients throughout the 10 day observation phase.
Symphytum herb extract can be attributed distinct wound healing effects, effects that can explicitly be used in paediatry.
The lost language of plants
- S Buhner
Buhner S. The lost language of plants. White River Junction: Chelsea Green
Publishing Company; 2002.
The efficacy of a phytotherapeutic agent in the treatment of non-activated osteoarthritis of the knee [Behandlung der nich-taktivierten Gonarthrose: Besserung durch ein Phytotherapeutikum]. Ther-apiewoche 1992
- Schmidtke
- Schrezenmeier
Schmidtke-Schrezenmeier G. The efficacy of a phytotherapeutic agent in the treatment of non-activated osteoarthritis of the knee [Behandlung der nich-taktivierten Gonarthrose: Besserung durch ein Phytotherapeutikum]. Ther-apiewoche 1992;42:1322e5.
Theatrum Botanicum or the Theatre of plants. London: Tho Cotes
- J Parkinson
Parkinson J. Theatrum Botanicum or the Theatre of plants. London: Tho Cotes;
1640.
Assessment report on Symphytum officinale L., radix; 2011 Available at
- European Agency
European Medicines Agency. Assessment report on Symphytum officinale L., radix; 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_ library/Herbal_-_HMPC_assessment_report/2011/08/WC500110648.pdf.
Concepts in risk-benefit assessment
- Edwards I B Wiholm
- Martinez
Edwards I, Wiholm B, Martinez C. Concepts in risk-benefit assessment. Drug Saf 1996;15:1e7.
Wycia ˛ g wodny _ zywokostu w lec-zeniu niekt orych chor ob sk ory niemowla ˛ t [[Aqueous extract of Symphytum officinale in the treatment of some skin diseases in infants
- Z Ziolkowski
- J Orszulak
- Wojtanowska
Ziolkowski Z, Orszulak J, Wojtanowska H. Wycia ˛ g wodny _ zywokostu w lec-zeniu niekt orych chor ob sk ory niemowla ˛ t [[Aqueous extract of Symphytum officinale in the treatment of some skin diseases in infants]]. Pediatr Pol 1957;32(12):1353e60.