Boswellia Extracts Research Articles

Efficacy of Extracts of Oleogum Resin of Boswellia in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-Analysis.

Knee osteoarthritis (OA) has recently been ranked as the 11th highest contributor to global disability. More than 40% of patients use complementary and alternative medicine including supplements containing phytoextracts with anti-inflammatory properties as those from the Boswellia genus. The aim of this meta-analysis was to evaluate the efficacy of phytoextracts from the oleogum resin of the Boswellia genus as supplementation for patients affected by knee OA. Four electronic databases were used for the research and PRISMA statements were followed throughout the study. The following inclusion criteria were used: (a) the subjects of the study were humans with a diagnosis of knee OA reported by medical staff; (b) randomization and the presence of control (placebo, negative or positive control), and (c) outcomes reported with WOMAC and/or visual analog scale (VAS) score. Publication bias was assessed with a funnel plot and through the Egger test. The Jadad scale was used in order to assess the quality of the studies included. The statistical heterogeneity was assessed using I2 statistics. Results of meta-analysis and subgroup analysis were reported using a forest plot. A total of 13 studies involving 850 (WOMAC) and 1185 (VAS) patients met the inclusion criteria. The meta-analysis did not detect a significant effect of the use of Boswellia extracts between the control and the treatment groups due to the high heterogeneity of the studies (p = 0.0865 for WOMAC) and (p = 0.3966 VAS). However, the subsequent subgroup analysis demonstrated the significant beneficial effect of Boswellia extracts in the treatment of knee OA with respect to a placebo (lower WOMAC score in the treatment groups). This was also confirmed in the meta-regression applied to the WOMAC scores. This is an important finding as people exposed to NSAID-related adverse effects could benefit from the use of Boswellia extracts. However, further high-quality studies are needed to establish the clinical efficacy of extracts from the genus Boswellia.

Anti-neoplastic Properties of Boswellic Acids and their Novel Semi-synthetic Analogs: In vitro, In vivo and Clinical Evidence

Introduction: Recently, Boswellia gum resin extract has been shown to exhibit therapeutic properties against multiple inflammatory illnesses, comprising arthritis, asthma, diabetes, inflammatory bowel disease, and different malignancies. There are growing shreds of evidence that Boswellia extracts and their phytoconstituents could be used in adjuvant and combinatorial chemotherapeutic approaches for the management and prevention of cancer. Aim: The principal objective of this comprehensive investigation is to offer up-to-date and in-depth insights into the anticancer potential of boswellic acids along with their semisynthetic analog that are novel and preventive/therapeutic substitutes for the management of cancer and inflammatory diseases due to their strong potential. Materials and Methods: In the course of this review, a comprehensive compilation of In-vitro, Invivo, and clinical evidence on the antineoplastic potential of boswellic acids was assembled through systematic computerized searches utilizing platforms such as Google Scholar, PubMed, Sci-Hub, and Research Gate. Result: Boswellic acids, the key compounds found in the resin of nearly all the species of the Boswellia plant, have been reported to exhibit therapeutic effects by modulating various targets in different disease conditions. Moreover, semisynthetic derivatives of boswellic acids show strong cytotoxic effects, particularly those with cyanoenone moieties, endoperoxides, and hybrids, which exhibit enhanced potency. Conclusion: In this review, we have sincerely highlighted the effectiveness of novel boswellic acids as alternative preventive and therapeutic agents for the treatment of cancer and inflammatory conditions. Their strong anticancer potential could provide a basis for promising future direction to develop potent anticancer drugs for human malignancies.

Rapid Detection of Adulteration in Boswellia Extracts with Citric Acid by UPLC–HRMS and 1H NMR

Boswellia serrata ole-gum-resin extracts (BSEs) are commonly used as food supplements, especially in osteoarthritis management. The quality standard is established by determining 11-keto-β-boswellic acid (KBA) and acetyl-11-keto-boswellic acid (AKBA) content using high-performance liquid chromatography (HPLC) or assessing the total boswellic acid (TBA) content by titrimetry. The limited geographical distribution of Boswellia species and increasing industrial demand could increase the risk of adulteration in Boswellia-containing products. In this study, 14 BSEs from commercial sources, used in food supplements, were analyzed in comparison with a USP Reference Standard extract. The KBA and AKBA content was determined by HPLC, whereas the TBA content was determined by titration. Targeted UHPLC-high-resolution mass spectrometry (HRMS) was applied to identify the carboxylic acid content in the samples. The 1H NMR spectra of extracts were also analyzed. Only two products met the criteria for KBA and AKBA content. Although, the TBA content complied with the expected amount, 10 extracts contained citric acid levels of 6–11% even though citric acid is not a cha­racteristic component of BSEs. Our results suggest undeclared addition of citric acid to comply with declared contents of TBA when using titration methods. Incorporation of citric acid to industrial samples – in order to alter the outcomes of the titration analysis – was demonstrated for the first time.

Boswellic acid formulations are not suitable for treatment of pediatric high-grade glioma due to tumor promoting potential

Background and aimPediatric high-grade gliomas (pedHGG) comprise a very poor prognosis. Thus, parents of affected children are increasingly resorting to complementary and alternative medicine (CAM), among those Boswellia extracts. However, nothing is known about the therapeutic effectiveness of their active substances, Boswellic acids (BA) in pedHGG. Thus, we aimed to investigate if the three main Boswellic acids (BA) present in Boswellia plants, alpha-boswellic acid (α-BA), beta-boswellic acid (β-BA) and 3-acetyl-11-keto-beta-boswellic acid (AKBA) hold any promising potential for treatment of affected pedHGG patients. Experimental procedureHistone 3 (H3)-wildtype and H3.3K27M-mutant pedHGG cell lines were treated with BA, either alone or in combination with radio-chemotherapy with temozolomide. Cell viability, stemness properties, apoptosis, in ovo tumor growth and the transcriptome was investigated upon BA treatment. Results and conclusionInterestingly, α-BA and β-BA treatment promoted certain tumor properties in both pedHGG cells. AKBA treatment reduced cell viability and colony growth accompanied by induction of slight anti-inflammatory effects especially in H3.3K27M-mutant pedHGG cells. However, no effects on apoptosis and in ovo tumor growth were found. In conclusion, besides positive anti-tumor effects of AKBA, tumor promoting effects were observed upon treatment with α-BA and β-BA. Thus, only pure AKBA formulations may be used to exploit any potential positive effects in pedHGG patients. In conclusion, the use of commercially available supplements with a mixture of different BA cannot be recommended due to detrimental effects of certain BA whereas pure AKBA formulations might hold some potential as therapeutic supplement for treatment of pedHGG patients.

Case report on Reversal of Field Cancerization using Nutraceuticals mapped to the aberrant pathways deciphered via NGS analysis of the neoplastic oral mucosa

Head and neck cancer, particularly oral cancer, presents a significant health concern in Southeast Asia with a high incidence rate, advanced stage of presentation and poor treatment outcomes. The high failure rate is due to recurrence of primary tumor and emergence of second primary tumors (SPTs) due to field cancerization. This case report focuses on a 79-year-old male with a long history of tobacco exposure, resulting in extensive field cancerization within the oral mucosa. This led to sequential development of six primaries both malignant and pre-malignant over the period of 8 years for which the patient underwent multiple surgical resections over these years. The last surgical resection specimen was subjected to Next Generation Sequencing (NGS), genetic and epigenetic alterations were identified causing dysregulation of Janus kinase/signal transducers and activators of transcription signaling pathway (JAK-STAT), Toll-like receptor signalling (TLR) and Extracellular signal regulated kinase (ERK) signalling pathways. The patient post-surgical resection is labelled as disease free; the treatment guidelines do not recommend further prescription of anticancer drugs to prevent another primary and reverse field cancerization. Also, there is lack of approved drugs targeting these pathways, a novel approach was taken using natural supplements (nutraceuticals) to modulate these dysregulated pathways. Curcumin, Epigallocatechin Gallate (EGCG) and Genistein were prescribed to downregulate TLR expression, Boswellia extracts were used to antagonize ERK activation, and Methylsulfonylmethane (MSM), Honokiol, and Berberine were employed to inhibit the JAK-STAT pathway. The patient exhibited good compliance and experienced no adverse effects. Over a span of 24 months, the patient displayed a disease-free status, and the characteristic field cancerization changes within the oral mucosa began to reverse. This unique therapeutic strategy underscores the potential of natural supplements in targeting genetic aberrations and reverting neoplastic processes, ultimately preventing the development of second primary tumors. The study highlights the significance of NGS in unravelling genomic abnormalities underlying neoplasia and supports the exploration of nutraceuticals as a viable option for correcting these aberrations. The successful application of this approach in a real-world case provides a compelling basis for further research and clinical investigation into personalized and integrative approaches for managing oral cancer and potentially other malignancies.

Boswellia for osteoarthritis

Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of boswellia extracts (BEs), or formulations containing BEs for osteoarthritis.

Fast pain relief in exercise-induced acute musculoskeletal pain by turmeric-boswellia formulation: A randomized placebo-controlled double-blinded multicentre study.

Background:Plant extracts with analgesic properties are seldom considered for treatment of acute musculoskeletal pain due to delay in onset of analgesia. Turmeric (Curcuma longa) and boswellia (Boswellia serrata) extracts are well-studied anti-inflammatory compounds gaining in popularity and used as an alternative to conventional treatments for musculoskeletal pain. This study analyzed the analgesic effect of a formulation of turmeric and boswellia extracts in sesame oil (Rhuleave-K, TBF) in reducing exercise-induced acute musculoskeletal pain in healthy participants.Methods:In this randomized double-blinded placebo-controlled, single-dose, single-day, multicentre study, a total of 232 participants (TBF n = 116; placebo n = 116) having moderate-to-severe exercise-induced acute musculoskeletal pain were randomized in an allocation concealed 1:1 ratio to receive a single dose of 1000 mg of TBF or placebo. The outcome measures were numerical rating scale (NRS), categorical pain relief scale (PRS), onset of analgesia, and short form of McGill questionnaire (SF-MPQ). NRS and PRS were measured from predose to every 30 minutes interval of postdose up to 6 hours at rest, with movement and applying pressure on the affected part. The onset of analgesia was measured from the time of dosage and censored at 6 hours of postdose. The sum of pain intensity difference (SPID6) and total pain relief (TOTPAR6) at 6 hours was, respectively, analyzed from NRS and PRS scores.Results:TBF showed a significant reduction in pain intensity (SPID6rest) with 97.85% improvement in cumulative responder analysis compared with 2.46% in placebo. The onset of pain relief was fast and highly significant in the TBF group with 99% of participants having a mean perceptible pain relief at 68.5 minutes (95% confidence interval, 59.5–77.4) and 96% of participants having a mean meaningful pain relief at 191.6 minutes (95% confidence interval, 176.7–206.4) compared to the placebo group. Highly significant and continuous improvement in pain relief was observed in the TBF group with 93% of participants having ≥ 50% of maximum TOTPAR6 with a number needed to treat of 1.1 at rest.Conclusion:Exercise-induced acute musculoskeletal pain can be effectively relieved by TBF (Rhuleave-K) in about 3 hours signifying its strong analgesic activity.

Beneficial Effects on Abdominal Bloating with an Innovative Food-Grade Formulation of Curcuma longa and Boswellia serrata Extracts in Subjects with Irritable Bowel Syndrome and Small Bowel Dysbiosis.

Bloating is a symptom frequently reported by subjects with irritable bowel syndrome (IBS) and small bowel dysbiosis, and Low FODMAP’s diet (LFD) has been used to treat them. Extracts of Curcuma longa and Boswellia serrata share anti-inflammatory and antimicrobial effects that could be useful in the management of these clinical conditions. The aim of this study was to evaluate the efficacy of curcumin and boswellia extracts (as Curcumin Boswellia Phytosome, CBP) and LFD on the relief of abdominal bloating in IBS subjects with small bowel dysbiosis, in comparison to LFD alone, in a 30-day supplementation, randomized trial. IBS participants were randomized to either the intervention (500 mg bid of CBP and LFD) or control arm (LFD). Small bowel dysbiosis has been defined by an increase of urinary indican with normal urinary skatole. A total of 67 subjects were recruited. The intervention group (33 subjects) showed a significant decrease (p < 0.0001) of bloating, abdominal pain, and indican values at the end of the study, when compared to the control group (34 subjects). Moreover, the subjects of the intervention group showed a significantly better (p < 0.0001) global assessment of efficacy (GAE) as compared to controls. In conclusion, in subjects with IBS and small bowel dysbiosis, abdominal bloating can be successfully reduced with a supplementation with CBP and LFD.

Review of the Chemical Composition, Pharmacological Effects, Pharmacokinetics, and Quality Control of Boswellia carterii.

Objective This review aimed to systematically summarize studies that investigated the bioactivities of compounds and extracts from Boswellia. Methods A literature review on the pharmacological properties and phytochemicals of B. carterii was performed. The information was retrieved from secondary databases such as PubMed, Chemical s Services (SciFinder), Google Scholar, and ScienceDirect. Results The various Boswellia extracts and compounds demonstrated pharmacological properties, such as anti-inflammatory, antitumour, and antioxidant activities. B. carterii exhibited a positive effect on the treatment and prevention of many ageing diseases, such as diabetes, cancer, cardiovascular disease, and neurodegenerative diseases. Conclusion Here, we highlight the pharmacological properties and phytochemicals of B. carterii and propose further evidence-based research on plant-derived remedies and compounds.

Ingredients of a Natural Oral Nutritional Supplement and Their Role in the Treatment of Osteoarthritis.

Osteoarthritis is a prevalent degenerative disease affecting a large portion of the world’s aging population. Currently, nonsteroidal anti-inflammatory drugs and acetaminophen are first-line medications for treating osteoarthritis patients’ pain. However, several studies have noted that while these medications control pain they do not halt progressive degeneration and tend to have an unfavorable side-effect profile with prolonged use. Recently, due to their more favorable side-effect profiles, herbal alternatives for controlling osteoarthritis symptoms and for alleviating the progression of the disease are being increasingly studied. Synogesic is a newly developed herbal supplement blend by renowned orthopedic surgeons and physiatrists consisting of turmeric, rutin, ginger root, vitamin C, vitamin D, and boswellia extracts. A study by Sharkey et al. has commented on the efficacy of the blend on the patients with knee osteoarthritis. So far, a review on the ingredients of the blend has not yet carried outbeen. By exploring prominent literature databases including PubMed and ScienceDirect, our aim is to write a narrative review to explore the individual ingredients of this blend and delve into their characteristics, as well as the most recent literature on their mechanism and efficacy in patients with osteoarthritis. Through this, we hope to inform clinicians and patients alike on relevant up-to-date research on the supplement and provide insight on the potential for this supplement for alleviating the disease course of patients with osteoarthritis.

Symptomatic uncomplicated diverticular disease management: an innovative food-grade formulation of Curcuma longa and Boswellia serrata extracts

BackgroundThe treatment of symptomatic uncomplicated colonic diverticular disease (SUDD) is still under debate, and new data show a pathogenic role of dysbiosis and low-grade inflammation in intestinal mucosa. Recent research has highlighted the anti-inflammatory effects of botanical extracts such as Curcuma longa L. and Boswellia serrata Roxb. ex Colebr. The aim of this work is to investigate the potential role of a new delivery formulation of the association of curcumin and boswellia phytosome extracts (CBP) in SUDD.MethodsIn a 30-day one-group longitudinal explanatory study, patients (men and women) were treated with an innovative association of CBP standardized extracts, 500 mg bid.ResultsTreatment of SUDD with the association of CBP was followed by a significant decrease in abdominal pain (p<0.0001). The study group showed that CBP supplementation was efficacious within 10 days and that efficacy was maintained almost constant until the 30th day of intervention.ConclusionA phytosome of curcumin and boswellia extracts may be useful for the relief of SUDD pain. However, controlled studies should be performed for final conclusions to be drawn.

Effects of Sea Buckthorn and Boswellia Extracts in Inflammatory Orofacial Pain by Xerostomia in Rats

Effects of Sea Buckthorn and Boswellia Extracts in Inflammatory Orofacial Pain by Xerostomia in Rats

Plasma Concentrations of Boswellic Acids in Fasting Healthy Humans Supplemented with a Water-Soluble Boswellia Extract (78% AKBA) vs. Reference Boswellia Extract (30% AKBA) (P06-005-19)

ObjectivesA randomized, open label, balanced, two-way crossover study compared the oral bioavailability and pharmacokinetic profiles of two Boswellia products standardized to 3-O-acetyl-11-Keto-β-boswellic acid (AKBA). MethodsTwenty-two fasted male participants completed the study. They received a single oral-dose of water-soluble Boswellia extract 78% (LI51202F1) or the standard Boswellia extract 30% (5-Loxin) at 30 mg AKBA equivalent with 240 mL water on 2 separate occasions 12 days apart. Plasma AKBA and KBA were analyzed using a LC-MS/MS in pre- (0 hr) and post-dose (00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 08.00, 12.00 and 24.00 hrs) blood samples. Pharmacokinetic analysis was performed using WinNonlin® version 7.0 (Pharsight corporation, USA). ResultsComparative analysis of the pharmacokinetic parameters showed LI51202F1 had higher (111.11%) Cmax for AKBA vs. 5-Loxin. The bioavailability indicated by Geometric means of AUC0-t and AUC0-∞ were 25.49% and 16.13% higher in LI51202F1 than 5-Loxin. ConclusionsThe present study demonstrates that oral ingestion of water soluble and standard Boswellia extracts resulted in similar bioavailability. Interestingly, the water-soluble version exhibited higher Cmax and AUC values, which could be attributed to the improved solubility of LI51202F1. Funding SourcesLaila Nutraceuticals.

English

The antimicrobial activity of essential oils of Boswellia and thyme (Boswellia sp., and Thyme sp.) was evaluated against 20 clinical isolates of Streptococcus pneumoniae and 5 isolates of Klebsiella pneumoniae. Essential oils were prepared using methanol and water (1:1) with HPLC technique. Antimicrobial activity and minimum inhibitory concentration (MIC) were measured using disk diffusion method against 20 isolates of S. pneumoniae and 5 isolates of K. pneumoniae isolated from different patients. Flavonoids and phenolic compounds are the main constituents of Boswellia and thyme which may have the antimicrobial activity. Boswellia extract was more efficient than thyme extracts; 60% of S. pneumoniae isolates and one K. pneumoniae isolate were sensitive to Boswellia extract, 30% of S. pneumoniae isolates were sensitive to thyme extract, and no effect on K. pneumoniae clinical isolates was observed. Inhibition zones ranged from 1-12 mm with thyme extract, while Boswellia extracts showed 2 to 30 mm diameters of inhibition zone. This study is significant due to the widespread problem of microbial drug resistance and the need for natural antibiotic to fight diseases. &nbsp; Key words: Thymus sp., Boswellia sp., antibacterial effect, Pneumonia.

Herbal drug related warfarin intoxication

Warfarin is a widely used antithrombotic drug in prevention of both arterial and venous thrombosis. Glucosamine is a popular dietary supplement used in symptomatic treatment of osteoarthritis. The interaction mechanism between these two drugs is not known yet. 63 year old woman, who was taking warfarin therapy 5 mg /day for 5;months for pulmonary embolism (therapeutic INR range:2.0–3.0), visited the emergency room with haematuria and rash. She had synchronous breast and colonic tumours for which right mastectomy and right hemicolectomy were done 5 months ago. Her INR (Internatıonal Normalized Ratio) values were highly increased (12.5) due to consumption of a herbal drug involving glucosamine hydrochloride 250 mg , boswellia extract and grapefruit extract at that day for arthralgia. Boswellia extracts are used in management of osteoarthritis. Naranjo adverse drug reaction probability scale score was 6, which indicated a probable relationship between the patient’s elevated INR and use of two drugs (warfarin and herbal drug) at the same time. After discontinuation of both drugs, two units of fresh frozen plasma were given. Her INR reduced to 2.5; as a result haematuria and rash regressed. This case report suggests a potential interaction between warfarin and both glucosamine and grapefruit extract. The inhibitory effect of grapefruit extract on cytochrome P450 isoenzymes is combined with the effect of glucosamine. Clinicians should be aware of patients taking herbal medicines with such drugs like warfarin which has narrow therapeutic index.

Boswellia Extracts Induce DNA Methylation Changes in Colon Cancer Cells

Boswellia Extracts Induce DNA Methylation Changes in Colon Cancer Cells

Anti-Inflammatory and Anti-Cancer Activity of Boswellic Acids from Frankincense (Boswellia serrata Roxb. et Colebr, B. carterii Birdw.)

The oleo-resinous gum of Boswellia trees has been used for religious rituals, but also for medical purposes in different civilizations for ages. The active principles of the gum resin are boswellic acids. The ethnopharmacology of frankincense indicate activity towards inflammatory diseases and cancer. There is compelling evidence from experimental investigations that boswellic acids reveal anti-inflammatory activity, and the results of clinical trials confirm that Boswellia extracts are also clinically effective. No serious side effects were recorded. Occasional side effects included fatigue, vomiting, diarrhea, unspecific skin rash, azoospermia, and neutropenia. Several investigations using Boswellia extracts or isolated boswellic acids demonstrated growth inhibition of tumors in mice and rats, and increased survival time of animals. The treatment effects were associated with inhibition of AKT, reduced NF-κB activation, and down-regulation of anti-apoptotic proteins. Clinical application in glioblastoma patients showed an improvement of clinical symptoms in terms of edema reduction, but no reduction of tumor size.

Safety and toxicological evaluation of Aflapin®: A novel Boswellia-derived anti-inflammatory product

Boswellia serrata gum resin has been used for treatment of various ailments in different cultures for thousands of years. Aflapin® is a novel synergistic composition derived from B. serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. To assess the safety of Aflapin, a battery of acute and sub-acute toxicity studies were conducted in various animal models according to the OECD test guidelines. The acute oral LD50 of Aflapin was greater than 5000 mg/kg in female Sprague Dawley (SD) rats. Acute dermal LD50 of Aflapin was greater than 2000 mg/kg in SD rats. A primary dermal irritation study conducted using New Zealand White rabbits indicated that Aflapin is non-irritating to skin. Aflapin caused minimal ocular irritation in a primary eye irritation test conducted on New Zealand Albino rabbits. A repeat dose 28-day sub-acute oral toxicity study in SD rats demonstrated no significant signs of toxicity. Various evaluations including hematology, clinical chemistry, gross necropsy, and histopathology did not show any significant adverse changes. The NOAEL of Aflapin was found to be greater than 2500 mg/kg body weight. These studies demonstrate broad spectrum safety of Aflapin in animal models.

Comparative Efficacy and Tolerability of 5-Loxin® and Aflapin® Against Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study

Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the comparative efficacy and tolerability of 5-Loxin(®) and Aflapin(®) in the treatment of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN80793440). Sixty OA subjects were included in the study. The subjects received either 100 mg (n=20) of 5-Loxin(®) or 100 mg (n=20) of Aflapin(®) or a placebo (n=20) daily for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. A battery of biochemical parameters in serum, urine and hematological parameters in citrated whole blood were performed to assess the safety of 5-Loxin(®) and Aflapin(®) in OA subjects. Fifty seven subjects completed the study. At the end of the study, both 5-Loxin(®) and Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Interestingly, significant improvements in pain score and functional ability were recorded as early as 7 days after initiation of the study in the treatment group supplemented with 100 mg Aflapin. Corroborating the improvements in pain scores in treatment groups, our in vitro studies provide evidences that Aflapin(®) is capable of inhibiting cartilage degrading enzyme MMP-3 and has the potential to regulate the inflammatory response by inhibiting ICAM-1. Aflapin(®) and 5-Loxin(®) reduce pain and improve physical functions significantly in OA subjects. Aflapin exhibited better efficacy compared to 5-Loxin(®). In comparison with placebo, the safety parameters were almost unchanged in the treatment groups. Hence both 5-Loxin(®) and Aflapin(®) are safe for human consumption.

Prevention of colonic fibrosis by Boswellia and Scutellaria extracts in rats with colitis induced by 2,4,5‐trinitrobenzene sulphonic acid

Currently, no effective preventive measures or medical therapies are available for intestinal fibrosis and, thus, surgery remains the only available strategy in the management of fibrostenotic enteropathies, especially Crohn's disease. The aim of this study was to evaluate the efficacy of a combined therapy of anti-inflammatory Boswellia and antifibrotic Scutellaria extracts on the development of colonic fibrosis in rats. Chronic colonic inflammation-associated fibrosis was induced in rats by intracolonic administration of 2,4,5-trinitrobenzene sulphonic acid (TNBS). Sixty-four healthy male Sprague-Dawley rats were assigned to five groups: 8 controls, 14 TNBS, 14 TNBS orally treated with Boswellia extracts (50 mg kg(-1) day(-1)), 14 TNBS orally treated with Scutellaria extracts (150 mg kg(-1) day(-1)), and 14 TNBS orally treated with both Boswellia (50 mg kg(-1) day(-1)) and Scutellaria extracts (150 mg kg(-1) day(-1)). The colon was removed after 21 days of treatment and assessed by macroscopic, histological, morphometric and immunohistochemical analyses. For immunohistochemical analysis, alpha-smooth muscle actin (alpha-SMA), collagen types I-III, connective tissue growth factor (CTGF), transforming growth factor-beta1 (TGF-beta1), Smad3, Smad7 and CD3 antibodies were used. Combined oral administration of Boswellia and Scutellaria significantly improved the course and macroscopic findings of TNBS-induced chronic colitis assessed by disease activity index, colon weight, length, adhesions, strictures, dilatation, thickness, oedema, ulcerations and extension of damage. The histological severity of the colonic fibrosis was also notably improved by the treatment and associated with a significant reduction in the colonic expression of alpha-SMA, collagen I-III, CTGF, TGF-beta1, Smad3, and Smad7. These data demonstrate that the prophylactic administration of anti-inflammatory Boswellia and antifibrotic Scutellaria extracts is effective in preventing colonic fibrosis in TNBS-induced colitis. Their antifibrotic mechanism of action seems to be mediated by the inhibition of TGF-beta1/Smad3 pathway.