[Therapy of active Crohn disease with Boswellia serrata extract H 15]. Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee--a randomized double blind placebo controlled trial. Randomized, placebo‐controlled, double‐blind trial of Boswellia serrata in maintaining remission of Crohn's disease: Good safety profile but lack of efficacy Effects of Boswellia serrata gum resin in patients with ulcerative colitis. Effects of Boswellia serrata gum resin in patients with bronchial asthma: results of a double-blind, placebo-controlled, 6-week clinical study. Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial Effects of gum resin of Boswellia serrata in patients with chronic colitis. The use of an anti-inflammatory supplement in patients with chronic kidney disease Comparative Efficacy and Tolerability of 5-Loxin® and Aflapin® Against Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study Topical Boswellic acids for treatment of photoaged skin. Effects of topical boswellic acid on photo and age-damaged skin: clinical, biophysical, and echographic evaluations in a double-blind, randomized, split-face study. Curcumin and Boswellia serrata Modulate the Glyco-Oxidative Status and Lipo-Oxidation in Master Athletes A Placebo-Controlled Double-Blind Study Demonstrates the Clinical Efficacy of a Novel Herbal Formulation for Relieving Joint Discomfort in Human Subjects with Osteoarthritis of Knee. Clinical comparison of oral administration and viscosupplementation of hyaluronic acid (HA) in early knee osteoarthritis Treatment of osteoarthritis with a herbomineral formulation: a double-blind, placebo-controlled, cross-over study. A cosmeceutical formulation based on boswellic acids for the treatment of erythematous eczema and psoriasis Use of an alpha lipoic, methylsulfonylmethane and bromelain dietary supplement (Opera®) for chemotherapy-induced peripheral neuropathy management, a prospective study A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin® for treatment of osteoarthritis of the knee Co-analgesic therapy for arthroscopic supraspinatus tendon repair pain using a dietary supplement containing Boswelliaserrata and Curcumalonga: a prospective randomized placebo-controlled study A 32-Week Randomized, Placebo-Controlled Clinical Evaluation of RA-11, an Ayurvedic Drug, on Osteoarthritis of the Knees Ginkgo biloba for Dementia A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial Can psychological models bridge the gap between clinical guidelines and clinicians' behaviour? A randomised controlled trial of an intervention to influence dentists' intention to implement evidence-based practice
BACKGROUND The purpose of this clinical trial was to compare efficacy and safety of the Boswellia serrata extract H15 with mesalazine for the treatment of active Crohn 's disease . PATIENTS AND METHODS R and omised , double-blind , verum-controlled , parallel group comparison for which 102 Patients were r and omised . The per protocol population included 44 patients treated with H15 and 39 patients treated with mesalazine .  As primary outcome measure the change of the Crohn Disease Activity Index ( CDAI ) between the status of enrolment and end of therapy was chosen . H 15 was tested on non-inferiority compared to st and ard treatment with mesalazine . RESULTS The CDAI between the status of enrolment and end of therapy after treatment with H15 was reduced by 90 and after therapy with mesalazine by 53 scores in the mean . In this non-inferiority-trial the test hypothesis was confirmed by the statistical analysis . The difference between both treatments could not be proven to be statistically significant in favor to H15 for the primary outcome measure . The secondary efficacy endpoints confirm the assessment of the comparison of H15 and mesalazine . The proven tolerability of H15 completes the results of the shown clinical efficacy . CONCLUSIONS The study confirms that therapy with H15 is not inferior to mesalazine . This can be interpreted as evidence for the efficacy of H15 according to the state of art in the treatment of active Crohn 's disease with Boswellia serrata extract , since the efficacy of mesalazine for this indication has been approved by the health authorities . Considering both safety and efficacy of Boswellia serrata extract H15 it appears to be superior over mesalazine in terms of a benefit-risk-evaluation Osteoarthritis is a common , chronic , progressive , skeletal , degenerative disorder , which commonly affects the knee joint . Boswellia serrata tree is commonly found in India . The therapeutic value of its gum ( guggulu ) has been known . It posses good anti-inflammatory , anti-arthritic and analgesic activity . A r and omized double blind placebo controlled crossover study was conducted to assess the efficacy , safety and tolerability of Boswellia serrata Extract ( BSE ) in 30 patients of osteoarthritis of knee , 15 each receiving active drug or placebo for eight weeks . After the first intervention , washout was given and then the groups were crossed over to receive the opposite intervention for eight weeks . All patients receiving drug treatment reported decrease in knee pain , increased knee flexion and increased walking distance . The frequency of swelling in the knee joint was decreased . Radiologically there was no change . The observed differences between drug treated and placebo being statistically significant , are clinical ly relevant . BSE was well tolerated by the subjects except for minor gastrointestinal ADRs . BSE is recommended in the patients of osteoarthritis of the knee with possible therapeutic use in other arthritis Background : Complementary therapies are frequently used by patients with inflammatory bowel disease ( IBD ) . The aim of this study was to evaluate the efficacy and safety of long‐term therapy with a new Boswellia serrata extract ( Boswelan , PS0201Bo ) in maintaining remission in patients with Crohn 's disease ( CD ) . Methods : In 22 German centers a double‐blind , placebo‐controlled , r and omized , parallel study was performed . In all , 108 out patients with CD in clinical remission were included . Patients were r and omized to Boswelan ( 3 × 2 capsules/day ; 400 mg each ) or placebo for 52 weeks . The primary endpoint was the proportion of patients in whom remission was maintained throughout the 52 weeks . Secondary endpoints were time to relapse , changes of Crohn 's Disease Activity Index ( CDAI ) , and IBD Question naire ( IBDQ ) scores . Results : The trial was prematurely terminated due to insufficient discrimination of drug and placebo with regard to the primary efficacy endpoint . A total of 82 patients were r and omized to Boswelan ( n = 42 ) or placebo ( n = 40 ) . Sixty‐six patients could be analyzed for efficacy . 59.9 % of the actively treated patients and 55.3 % of the placebo group stayed in remission ( P = 0.85 ) . The mean time to diagnosis of relapse was 171 days for the active group and 185 days for the placebo group ( P = 0.69 ) . With respect to CDAI , IBDQ , and laboratory measurements of inflammation , no advantages in favor of active treatment were detected . Regarding safety concerns , no disadvantages of taking the drug compared to placebo were observed . Conclusions : The trial confirmed good tolerability of a new Boswellia serrata extract , Boswelan , in long‐term treatment of CD . However , superiority versus placebo in maintenance therapy of remission could not be demonstrated . ( Inflamm Bowel Dis 2011 Ulcerative colitis is a chronic inflammatory disease of the colon where leukotrienes are suggested to play an important role for keeping inflammation active . Boswellic acids , the biologically active ingredients of the gum resin of Boswellia serrata ( Sallai guggal ) , have been shown to be specific , nonredox and noncompetitive inhibitors of 5-lipoxygenase , the key enzyme of leukotriene bio synthesis . In patients suffering from ulcerative colitis grade II and III the effect of Boswellia serrata gum resin preparation ( 350 mg thrice daily for 6 weeks ) on stool properties , histolopathology and scan microscopy of rectal biopsies , blood parameters including Hb , serum iron , calcium , phosphorus , proteins , total leukocytes and eosinophils was studied . Patients receiving sulfasalazine ( 1 g thrice daily ) served as controls . All parameters tested improved after treatment with Boswellia serrata gum resin , the results being similar compared to controls : 82 % out of treated patients went into remission ; in case of sulfasalazine remission rate was 75 % The gum resin of Boswellia serrata , known in Indian Ayurvedic system of medicine as Salai guggal , contains boswellic acids , which have been shown to inhibit leukotriene bio synthesis . In a double-blind , placebo-controlled study forty patients , 23 males and 17 females in the age range of 18 - 75 years having mean duration of illness , bronchial asthma , of 9.58 + /- 6.07 years were treated with a preparation of gum resin of 300 mg thrice daily for a period of 6 weeks . 70 % of patients showed improvement of disease as evident by disappearance of physical symptoms and signs such as dyspnoea , rhonchi , number of attacks , increase in FEV subset1 , FVC and PEFR as well as decrease in eosinophilic count and ESR . In the control group of 40 patients 16 males and 24 females in the age range of 14 - 58 years with mean of 32.95 + /- 12.68 were treated with lactose 300 mg thrice daily for 6 weeks . Only 27 % of patients in the control group showed improvement . The data show a definite role of gum resin of Boswellia serrata in the treatment of bronchial asthma Background and aims The objective of this study was to investigate the effect of Boswellia serrata extract ( BSE ) on symptoms , quality of life , and histology in patients with collagenous colitis . Material s and methods Patients with chronic diarrhea and histologically proven collagenous colitis were r and omized to receive either oral BSE 400 mg three times daily for 6 weeks or placebo . Complete colonoscopy and histology were performed before and after treatment . Clinical symptoms and quality of life were assessed by st and ardized question naires and SF-36 . The primary endpoint was the percentage of patients with clinical remission after 6 weeks ( stool frequency ≤3 soft /solid stools per day on average during the last week ) . Patients of the placebo group with persistent diarrhea received open-label BSE therapy for a further 6 weeks . Results Thirty-one patients were r and omized ; 26 patients were available for per- protocol - analysis . After 6 weeks , the proportion of patients in clinical remission was higher in the BSE group than in the placebo group ( per protocol 63.6 % ; 95%CI , 30.8–89.1 vs 26.7 % , 95%CI , 7.7–55.1 ; p = 0.04 ; intention-to-treat 43.8 % vs 26.7 % , p = 0.25 ) . Compared to placebo , BSE treatment had no effect on histology and quality of life . Five patients discontinued BSE treatment prematurely . Discontinuation was due to adverse events ( n = 1 ) , unwillingness to continue ( n = 3 ) , or loss to follow-up for unknown reasons ( n = 1 ) . Seven patients received open-label BSE therapy , five of whom achieved complete remission . Conclusions Our study suggests that BSE might be clinical ly effective in patients with collagenous colitis . Larger trials are clearly necessary to establish the clinical efficacy of BSE Patients studied here suffered from chronic colitis characterized by vague lower abdominal pain , bleeding per rectum with diarrhoea and palpable tender descending and sigmoid colon . The inflammatory process in colitis is associated with increased formation of leukotrienes causing chemotaxis , chemokinesis , synthesis of superoxide radicals and release of lysosomal enzymes by phagocytes . The key enzyme for leukotriene bio synthesis is 5-lipoxygenase . Boswellic acids were found to be non-redox , non-competitive specific inhibitors of the enzyme 5-lipoxygenase . We studied the gum resin of Boswellia serrata for the treatment of this disease . Thirty patients , 17 males and 13 females in the age range of 18 to 48 years with chronic colitis were included in this study . Twenty patients were given a preparation of the gum resin of Boswellia serrata ( 900 mg daily divided in three doses for 6 weeks ) and ten patients were given sulfasalazine ( 3 gm daily divided in three doses for 6 weeks ) and served as controls . Out of 20 patients treated with Boswellia gum resin 18 patients showed an improvement in one or more of the parameters : including stool properties , histopathology as well as scanning electron microscopy , besides haemoglobin , serum iron , calcium , phosphorus , proteins , total leukocytes and eosinophils . In the control group 6 out of 10 patients showed similar results with the same parameters . Out of 20 patients treated with Boswellia gum resin 14 went into remission while in case of sulfasalazine  remission rate was 4 out of 10 . In conclusion , this study shows that a gum resin preparation from Boswellia serrata could be effective in the treatment of chronic colitis with minimal side effects Abstract Chronic kidney disease ( CKD ) is characterized by a continuous reduction in kidney function , increased inflammation , and reduced antioxidant capacity . The objective of this study was to assess the effects of a herbal supplement on systemic inflammation and antioxidant status in non-dialysis CKD patients . Sixteen patients with CKD ( 56.0±16.0 yrs , 171.4±11.9 cm , 99.3±20.2 kg ) were r and omly chosen to receive a herbal supplement composed of Curcuma longa and Boswellia serrata , or placebo . Plasma levels of interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNF-α ) , glutathione peroxidase ( GPx ) , and serum C-reactive protein ( CRP ) were measured at baseline and 8 weeks . Baseline data demonstrated elevated inflammation and low antioxidant levels . A significant time effect ( p=0.03 ) and time x compliance interaction effect ( p=0.04 ) were observed for IL-6 . No significant differences were observed for any other variables . This study demonstrates that mild and moderate CKD is associated with chronic inflammation and low antioxidant activity . Systemic inflammation and impaired antioxidant status may be greater in CKD population s with multiple comorbidities . Curcumin and Boswellia serrata are safe and tolerable and helped to improve the levels of an inflammatory cytokine 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 , r and omized , 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 : IS RCT N80793440 ) . 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 st and ard 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 clinical ly 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 evidence s 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 Boswellic acids ( BAs ) are pentacyclic triterpenes extracted from the gum resins of the tropical tree Boswellia serrata . They are orally administered in traditional Indian medicine for the treatment of several inflammatory disease and cancer because of their anti-inflammatory and immunomodulatory activities as well as stimulatory effects on fibroblasts . The present authors have investigated efficacy , tolerability , and safety of a base cream containing 0.5 % BAs in the treatment of clinical manifestations of photoaging of facial skin with a r and omized , double-blind , placebo-controlled , split-face study . Fifteen female volunteers applied the creams with or without BAs on the half sides of the face once daily for 30 days . Significant improvements of the Dover 's global score for photoaging , tactile roughness , and fine lines , as well as , with noninvasive diagnostic techniques , an increase of elasticity , a decrease of sebum excretion , and a change of echographic parameters were observed with topical BAs in comparison with placebo . The treatment was always well tolerated without adverse effects . The present findings seem to indicate that topical application of BAs may represent a suitable treatment option for selected features of skin photoaging Boswellic acids ( BAs ) are pentacyclic triterpenes with strong anti-inflammatory activity ; their most important source is the extract of the gum resin of Boswellia serrata , a tropical tree that grows in India and Africa . In the present r and omized , double-blind , split-face , comparative study we have assessed efficacy , tolerability , and safety of a base cream containing 0.5 % BAs as compared to the same cream without these active ingredients in the treatment of clinical manifestations of photoaging of facial skin . Fifteen female volunteers were enrolled ; they applied creams once daily for 30 days . At baseline , at the end of the treatment , and after a 2-month follow-up , clinical findings were assessed according to the Dover classification scale for photoaging and by biophysical and ecographic measurements . We registered a significant improvement of tactile roughness and fine lines in the half side of the face treated with BAs ; noninvasive instrumental diagnostic investigations showed an improvement of elasticity , a decrease of sebum excretion , and a change of echographic parameters suggesting a reshaping of dermal tissue . The treatment was always well tolerated without adverse effects . The present findings seem to indicate that the topical application of BAs may represent a suitable treatment option for selected features of skin photoaging Background : Chronic intensive exercise is associated with a greater induction of oxidative stress and with an excess of endogenous advanced glycation end-products ( AGEs ) . Curcumin can reduce the accumulation of AGEs in vitro and in animal models . We examined whether supplementation with curcumin and Boswellia serrata ( BSE ) gum resin for 3 months could affect plasma levels of markers of oxidative stress , inflammation , and glycation in healthy master cyclists . Methods . Forty-seven healthy male athletes were r and omly assigned to Group 1 , consisting of 22 subjects given a Mediterranean diet ( MD ) alone ( MD group ) , and Group 2 consisted of 25 subjects given a MD plus curcumin and BSE ( curcumin/BSE group ) . Interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNFα ) , high-sensitivity c-reactive protein ( hs-CRP ) , total AGE , soluble receptor for AGE ( sRAGE ) , malondialdehyde ( MDA ) , plasma phospholipid fatty acid ( PPFA ) composition , and non-esterified fatty acids ( NEFA ) were tested at baseline and after 12 weeks . Results : sRAGE , NEFA , and MDA decreased significantly in both groups , while only the curcumin/BSE group showed a significant decline in total AGE . Only the changes in total AGE and MDA differed significantly between the curcumin/BSE and MD groups . Conclusions . Our data suggest a positive effect of supplementation with curcumin and BSE on glycoxidation and lipid peroxidation in chronically exercising master athletes LI73014F2 is a novel composition prepared from extracts of Terminalia chebula fruit , Curcuma longa rhizome , and Boswellia serrata gum resin with synergistic benefit in 5-Lipoxygenase ( 5-LOX ) inhibition . This herbal composition with strong anti-5-LOX activity exhibited significant pain relief as indicated through improvements in weight-bearing capacity in a monosodium iodoacetate-induced osteoarthritis ( OA ) model of Sprague-Dawley rats . A 90-day r and omized , placebo-controlled double-blind study evaluates the clinical efficacy and tolerability of LI73014F2 in the management of symptoms of OA of the knee ( Clinical Trial Registration No. CTRI/2014/01/004338 ) . Subjects , ( n = 105 ) , were r and omized into three groups : placebo ( n = 35 ) , 200 mg/day of LI73014F2 ( n = 35 ) , and 400 mg/day of LI73014F2 ( n = 35 ) . All study participants were evaluated for pain and physical function by using st and ard tools , that is , Visual Analog Scale , Lequesne 's Functional Index , and Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) at the baseline ( day 0 ) and on day 14 ± 3 , 30 ± 3 , 60 ± 3 , and at the end of the study ( day 90 ± 3 ) . In addition , routine examinations on biochemical parameters in serum , urine , and hematological parameters were conducted on each visit to assess the safety of the study material . At the end of the trial period , LI73014F2 conferred significant pain relief , improved physical function , and quality of life in OA patients . In conclusion , pre clinical and clinical data together strongly suggest that the herbal formulation LI73014F2 is a safe and effective intervention for management of joint discomfort , demonstrating efficacy as early as 14 days Purpose Osteoarthritis ( OA ) is a progressive , chronic and degenerative joint disease characterized by a loss of articular cartilage . Treatment of OA is largely palliative based on nonsteroidal anti-inflammatory drugs , opioids and injections of steroids . Regarding conservative treatment , intra-articular injections of hyaluronic acid ( HA ) can play a role in early symptomatic knee OA . Material s and methods Between August 2015 and September 2015 , sixty patients ( 32 males and 28 females ) between 40 and 70 years old were r and omly allocated into two groups : Half were treated with three weekly intra-articular injections of hyaluronic acid 1.6 % ( group A ) , while the others were treated with Syalox 300 Plus ® ( hyaluronic acid 300 mg + Boswellia serrata extract 100 mg ) 1 tab/die for 20 days and afterward Syalox 150 ® ( hyaluronic acid 150 mg ) 1 tab/die for other 20 days ( group B ) . All patients were evaluated clinical ly with American Knee Society Score ( AKSS ) and visual analogue scale ( VAS ) for the pain before the treatment and after 3 months . Results AKSS of the patients in both groups was significantly increased by the treatment , and VAS score was significantly reduced . In both groups , two subgroups were created with patients older than 60 years and patients younger than 60 years . Better results are reported in younger patients of group A and older subjects in group B. Conclusions Despite several limitations , the results of the study have shown that HA injection and oral administration may have beneficial therapeutic effects on patients with early osteoarthritis . Different outcomes in younger and older subject suggested a combined therapy first with local infiltrations and then with oral composition The clinical efficacy of a herbomineral formulation containing roots of Withania somnifera , the stem of Boswellia serrata , rhizomes of Curcuma longa and a zinc complex ( Articulin-F ) , was evaluated in a r and omized , double-blind , placebo controlled , cross-over study in patients with osteoarthritis . After a one-month single blind run-in period , 42 patients with osteoarthritis were r and omly allocated to receive either a drug treatment or a matching placebo for a period of three months . After a 15-day wash-out period the patients were transferred to the other treatment for a further period of three months . Clinical efficacy was evaluated every fortnight on the basis of severity of pain , morning stiffness , Ritchie articular index , joint score , disability score and grip strength . Other parameters like erythrocyte sedimentation rate and radiological examination were carried out on a monthly basis . Treatment with the herbomineral formulation produced a significant drop in severity of pain ( P less than 0.001 ) and disability score ( P less than 0.05 ) . Radiological assessment , however , did not show any significant changes in both the groups . Side effects observed with this formulation did not necessitate withdrawal of treatment Background Boswellic acids ( BAs ) show anti-inflammatory properties in a variety of inflammatory diseases , including rheumatoid arthritis , osteoarthritis , and asthma . A topical administration route is currently used to deliver active compounds in psoriatic and eczematous patients . In this double-blind study we compare a novel BA formulation ( containing Bosexil ® , INCI [ International Nomenclature of Cosmetic Ingredients ] : lecithin , Boswellia serrata resin extract ) with a placebo formulation . A third arm of the trial received a formulation of Vaccinium myrtillus seed oil , previously demonstrated as an effective local treatment for psoriatic lesions . Methods Patients with psoriasis or erythematous eczema were r and omly assigned , in a 1:1:1 ratio , to Bosexil ® , V. myrtillus seed oil , or placebo . In order to evaluate the effects of treatment , the changes of scales and erythema from diagnosis to the end of treatment were scored in psoriatic patients , while changes in itch and erythema were analyzed for erythematous eczema patients .  Psoriasis Area Severity Index and Eczema Area and Severity Index scores were also calculated . Results In patients with psoriasis  , scales and erythema improved both with Bosexil ® and the V. myrtillus seed oil treatment in comparison with placebo . In particular , the treatment with Bosexil ® formulation improved scales ( 70 % of cases ) and erythema ( 50 % of cases ) without any case of worsening . In patients with eczema , the administration of placebo did not result in any improvement in 90 % of cases , and in the remaining 10 % worsened both itch and erythema .  Bosexil ® formulation improved both itch ( 60 % of cases ) and erythema ( 60 % of cases ) without any case of worsening . V. myrtillus seed oil improved itch and erythema in 66.7 % and 77.8 % of patients , respectively . Conclusion A topical formulation of Bosexil ® may be promising for the treatment of psoriasis and erythematous eczema . Long-term studies are recommended to evaluate the adherence to this topical treatment and its clinical benefits in real life Chemotherapy-induced peripheral neuropathy ( CIPN ) is a major clinical problem associated with a number of cytotoxic agents . OPERA ® ( GAMFARMA srl , Milan , Italy ) is a new dietary supplement where α-lipoic acid , Boswellia Serrata , methylsulfonylmethane and bromelain are combined in a single capsule . The aim of this prospect i ve study was to determine the efficacy and safety of OPERA ® supplementation in a series of patients affected by CIPN . We selected 25 subjects with CIPN evolving during or after chemotherapy with potentially neurotoxic agents . Patients were enrolled at the first clinical manifestation of neuropathy . CIPN was assessed at the enrollment visit and subsequently repeated every 3 weeks until 12 weeks . Primary endpoint was the evaluation of changes of measured scores after 12 weeks of therapy compared to baseline evaluation . Secondary endpoints were the evaluation of neuropathy reduction at 12 weeks after beginning of therapy with OPERA ® . Analysis of VAS data showed reduction in pain perceived by patients . According to NCI-CTC sensor and motor score , mISS scale and TNSc scale , both pain and both sensor and motor neuropathic impairment decreased after 12 weeks of treatments . Treatment with OPERA supplement was well tolerated ; no increase in the toxicity profile of any of the therapeutic regimen that the patients were undergoing was reported . OPERA ® was able to improve CIPN symptoms in a prospect i ve series of patients treated with neurotoxic chemotherapy , with no significant toxicity or interaction . Prospect i ve RCT in a selected patients ’ population is warranted to confirm its promising activity Introduction 5-Loxin ® is a novel Boswellia serrata extract enriched with 30 % 3-O-acetyl-11-keto-beta-boswellic acid ( AKBA ) , which exhibits potential anti-inflammatory properties by inhibiting the 5-lipoxygenase enzyme . A 90-day , double-blind , r and omized , placebo-controlled study was conducted to evaluate the efficacy and safety of 5-Loxin ® in the treatment of osteoarthritis ( OA ) of the knee . Methods Seventy-five OA patients were included in the study . The patients received either 100 mg ( n = 25 ) or 250 mg ( n = 25 ) of 5-Loxin ® daily or a placebo ( n = 25 ) for 90 days . Each patient was evaluated for pain and physical functions by using the st and ard 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 . Additionally , the cartilage degrading enzyme matrix metalloproteinase-3 was also evaluated in synovial fluid from OA patients . Measurement of a battery of biochemical parameters in serum and haematological parameters , and urine analysis were performed to evaluate the safety of 5-Loxin ® in OA patients . Results Seventy patients completed the study . At the end of the study , both doses of 5-Loxin ® conferred clinical ly and statistically significant improvements in pain scores and physical function scores in OA patients . Interestingly , significant improvements in pain score and functional ability were recorded in the treatment group supplemented with 250 mg 5-Loxin ® as early as 7 days after the start of treatment . Corroborating the improvements in pain scores in treatment groups , we also noted significant reduction in synovial fluid matrix metalloproteinase-3 . In comparison with placebo , the safety parameters were almost unchanged in the treatment groups . Conclusion 5-Loxin ® reduces pain and improves physical functioning significantly in OA patients ; and it is safe for human consumption . 5-Loxin ® may exert its beneficial effects by controlling inflammatory responses through reducing proinflammatory modulators , and it may improve joint health by reducing the enzymatic degradation of cartilage in OA patients .Trail Registration ( Clinical trial registration number : IS RCT N05212803 . Background The cuff tendon that is most prone to full-thickness rotator cuff tears is the supraspinatus ( SSP ) . Arthroscopic SSP repair ensures good to satisfactory mid- to long-term clinical outcomes . However , the intense postoperative pain reduces rehabilitation compliance and is cause of patient dissatisfaction . Many natural compounds act by inhibiting inflammatory pathways in a similar way to anti-inflammatory drugs Material s and methods This was a prospect i ve r and omized trial design ed to assess the analgesic effect of a dietary supplement ( DS ) containing Boswellia serrata and Curcuma longa in a population of subjects with full-thickness SSP tendon tear treated by arthroscopy . Three weeks before surgery , patients were r and omized to receive Tendisulfur ® ( group T ) or a placebo ( group P ) for 2 months . The primary outcome measure was subjective VAS pain . Secondary outcomes measures were Constant – Murley score simple shoulder test , and patient global assessment ( PGA ) scores . Patients were assessed immediately at baseline and subsequently at 1 , 2 , 4 , 6 , 8 , 12 , and 24 weeks . Results Stratification of pain scores and subscores demonstrated significantly lower overall pain scores in group T versus group P at 1 week ( p = 0.0477 ) , and lower but not significantly different scores on week 2 ( p = 0.0988 ) ; at subsequent time points , differences were not significant ( p > 0.05 ) . PGA scores were good in all subjects . Conclusions In conclusion , this study provides objective data on the effect of a DS containing natural substances , added to st and ard analgesics , on postoperative RC pain . DS alleviated short and partially mid-term pain , while long-term pain was unchanged . This limitation can probably be addressed by a dosage increase over the first 4 weeks and by extending treatment by 1 or 2 months Background : The ancient Indian ( Asian ) Ayurvedic medicinal system uses herbomineral drugs to treat arthritis . Despite centuries of use , very few have been tested by drug trials . RA-11 ( ARTREX , MENDAR ) , a st and ardized multiplant Ayurvedic drug ( Withania somnifera , Boswellia serrata , Zingiber officinale , and Curcuma longa ) is currently used to treat arthritis . Objective : The objective of this study was to evaluate the efficacy and safety of RA-11 in patients with symptomatic osteoarthritis ( OA ) of the knees . Methods : A total of 358 patients with chronic knee pain were screened free-of-cost in “ arthritis camps ” in an Indian metropolis . Ninety patients with primary OA of the knees ( ACR classification ; Arthritis Rheum 1986;29:1039–1049 ) were found eligible ( postanalgesic washout pain visual analog score [ VAS ] ≥40 mm in either or both knees on body weight-bearing activities ) to enroll into a r and omized , double-blind , placebo-controlled , parallel efficacy , single-center , 32-week drug trial ( 80 % power to detect 25 % difference , P = 0.05 , 2-sided ) . Concurrent analgesics/nonsteroidal antiinflammatory drugs and steroids in any form were not allowed . Lifestyle and /or dietary restrictions , as per routine Ayurveda practice s , were not imposed . Pain VAS ( maximum pain in each knee recorded by the patient during the preceding 48 hours ) and modified WOMAC ( Western Ontario McMaster University OA Index , Likert scale , version 3.0 ) were the primary efficacy variables . The WOMAC section on “ physical function difficulty ” was modified for Indian use and vali date d before the trial . Routine laboratory testing was primarily done to monitor drug safety . At baseline , the groups ( active = 45 , placebo = 45 ) were well matched for several measures ( mean pain VAS : active = 6.17 ; placebo = 6.5 ) . Results :1 ) Efficacy : Compared with placebo , the mean reduction in pain VAS at week 16 ( active = 2.7 , placebo = 1.3 ) and week 32 ( active = 2.8 , placebo = 1.8 ) in the active group was significantly ( P < 0.05 , analysis of variance [ ANOVA ] ) better . Similarly , the improvement in the WOMAC scores at week 16 and week 32 were also significantly superior ( P < 0.01 , ANOVA ) in the active group . 2 ) Safety : Both the groups reported mild adverse events ( AE ) without any significant difference . 3 ) Withdrawals : Twenty-eight patients were discontinued . None reported drug-related toxicity . The majority failed follow up/compliance . No differences were observed between the groups . Conclusion : This controlled drug trial demonstrates the potential efficacy and safety of RA- 11 in the symptomatic treatment of OA knees over 32 weeks of therapy Abstract Objective : To systematic ally review the clinical evidence of Ginkgo biloba preparations as a symptomatic treatment for  dementia .  Methods : Computerised literature search es were performed to identify all double-blind , r and omised , placebo-controlled trials assessing clinical end-points of Ginkgo biloba extract as a treatment for dementia . Data bases included Medline , Embase , Biosis and the Cochrane Library . There were no restrictions regarding the language of publication . Data were extracted in a st and ardised , predefined fashion , independently by both authors . Results : Nine double-blind , r and omised , placebo-controlled trials met the inclusion criteria and were review ed . These studies are of varying method ological quality . They collectively suggest that Ginkgo biloba extract is more effective for dementia than placebo . However , a number of caveats pertain . Few , generally mild , adverse effects were reported . Conclusion : These findings are encouraging and warrant independent , large scale confirmatory and comparative trials Background The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietary supplement ( InstaflexTM Joint Support , Direct Digital , Charlotte , NC ) compared to placebo on joint pain , stiffness , and function in adults with self-reported joint pain .  InstaflexTM is a joint pain supplement containing glucosamine sulfate , methylsufonlylmethane ( MSM ) , white willow bark extract ( 15 % salicin ) , ginger root concentrate , boswella serrata extract ( 65 % boswellic acid ) , turmeric root extract , cayenne , and hyaluronic acid . Methods Subjects included 100 men and women , ages 50 - 75 years , with a history ( > 3 months ) of joint pain , and were r and omized to Instaflex ™ or placebo ( 3 colored gel capsules per day for 8 weeks , double-blind administration ) . Subjects agreed to avoid the use of non-steroidal anti-inflammatory drugs ( NSAID ) and all other medications and supplements targeted for joint pain . Primary outcome measures were obtained pre- and post- study and included joint pain severity , stiffness , and function ( Western Ontario and McMaster Universities [ WOMAC ] ) , and secondary outcome measures included health-related quality of life ( Short Form 36 or SF-36 ) , systemic inflammation ( serum C-reactive protein and 9 plasma cytokines ) , and physical function ( 6-minute walk test ) . Joint pain symptom severity was assessed bi-weekly using a 12-point Likert visual scale ( 12-VS ) . Results Joint pain severity was significantly reduced in Instaflex ™ compared to placebo ( 8-week WOMAC , ↓37 % versus ↓16 % , respectively , interaction effect P = 0.025 ) , with group differences using the 12-VS emerging by week 4 of the study ( interaction effect , P = 0.0125 ) . Improvements in ability to perform daily activities and stiffness scores  in Instaflex ™ compared to placebo were most evident for the 74 % of subjects reporting knee pain ( 8-week WOMAC function score , ↓39 % versus ↓14 % , respectively , interaction effect P = 0.027 ; stiffness score , ↓30 % versus ↓12 % , respectively , interaction effect P = 0.081 ) . Patterns of change in SF-36 , systemic inflammation biomarkers , and the 6-minute walk test did not differ significantly between groups during the 8-week study Conclusions Results from this r and omized , double blind , placebo-controlled community trial support the use of the Instaflex ™ dietary supplement in alleviating  joint pain severity in middle-aged and older adults , with mitigation of difficulty performing daily activities most apparent in subjects with knee pain . Trial registration Clinical Trials.gov Identifier : Objective The lag between publication of evidence for clinical practice and implementation by clinicians may be decades . Research using psychological models demonstrates that changing intention is very important in changing behaviour . This study examined an intervention ( rehearsing alternative actions ) to change dentists ' intention to implement evidence -based practice ( EBP ) for third molar ( TM ) management . Design R and omised controlled trial / postal . Setting Primary care . Subjects and methods Dentists were r and omly selected from the Scottish Dental Practice Board Register , then r and omly allocated to intervention or control groups , and sent a question naire . The intervention group listed management alternatives to TM extraction prior to their TM extraction intention , and the control group did not . Based on psychological models for reducing a behaviour 's frequency ( EBP is weighted against TM extraction ) , prior listing of alternatives should decrease extraction intention . Main outcome measure Intention to extract TMs . Results A total of 99 dentists — 70 Males , 29 Females ; mean age = 41.42 years ( SD = 8.62 ) participated in the study . The intervention significantly influenced intention to extract TMs , as desired . Despite similar background and knowledge of management alternatives , participants in the intervention group had significantly lower intention to extract :  control group mean ( SD ) = 0.39 ( 1.99 ) ; intervention group mean ( SD ) = −0.78 ( 1.89 ) ; mean difference ( SE ) = 1.17 ( 0.42 ) ; 95 % confidence interval for the difference = 0.34 to 1.99 . Conclusion Results suggest this intervention , which successfully influenced a proximal predictor of behaviour pertinent to dental EBP , may result in improved EBP in a service-level trial . Basing implementation interventions and trial methodology on psychological models may effectively bridge the gap between clinical guidelines and practice
The evidence for the effectiveness of B serrata extracts is encouraging but not compelling
OBJECTIVE To assess evidence from r and omised clinical trials about the effectiveness of  extracts of Boswellia serrata ( frankincense ) .