title: Possible advantages and drawbacks of adding flexible sigmoidoscopy to hemoccult-II in screening for colorectal cancer. A randomized study. Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee--a randomized double blind placebo controlled trial. Single flexible sigmoidoscopy screening to prevent colorectal cancer: baseline findings of a UK multicentre randomised trial. Effects of gum resin of Boswellia serrata in patients with chronic colitis. A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin® for treatment of osteoarthritis of the knee A 32-Week Randomized, Placebo-Controlled Clinical Evaluation of RA-11, an Ayurvedic Drug, on Osteoarthritis of the Knees Effects of Boswellia serrata gum resin in patients with bronchial asthma: results of a double-blind, placebo-controlled, 6-week clinical study. The Norwegian Colorectal Cancer Prevention (NORCCAP) screening study: baseline findings and implementations for clinical work-up in age groups 50-64 years. Effects of Boswellia serrata gum resin in patients with ulcerative colitis. Design, Organization and Management of a Controlled Population Screening Study for Detection of Colorectal Neoplasia: Attendance Rates in the NORCCAP Study (Norwegian Colorectal Cancer Prevention) [Therapy of active Crohn disease with Boswellia serrata extract H 15]. Treatment of osteoarthritis with a herbomineral formulation: a double-blind, placebo-controlled, cross-over study. Compliance and findings in a Swedish population screened for colorectal cancer with sigmoidoscopy. Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial
abstract: BACKGROUND Flexible sigmoidoscopy ( FS ) has been recommended as a screening method to reduce mortality from colorectal cancer ( CRC ) . The present study evaluates the effect of adding FS to the fecal occult blood test Hemoccult-II ( H-II ) on diagnostic yield of colorectal neoplasia . METHODS A total of 10,978 normal persons aged 50 - 75 years were invited to participate , 5495 persons being allocated at r and om to H-II and FS and 5483 to H-II alone .  RESULTS In spite of a lower compliance ( 40 % versus 56 % ) for the combined procedure , the diagnostic yield of colorectal neoplasia was higher than for H-II alone ( 12 CRC versus 4 CRC , and 72 large adenomas versus 14 ) . Within 24 - 62 months after screening there were fewer CRCs detected after  H-II + FS than after H-II alone . The stage distribution was less favorable than in screen-detected cases . CONCLUSION One FS may not be an optimal way of screening , but FS deserves to be evaluated in r and omized population studies including repeated H-II tests in the control arm 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 This r and omised controlled trial is examining the hypothesis that a single flexible sigmoidoscopy screening offered at around age 60 years can lower the incidence and mortality of  colorectal cancer .  We report here on acceptability , safety , feasibility , and yield . METHODS Men and women aged 55 - 64 years , in 14 UK centres , who responded to a mailed question naire that they would attend for flexible sigmoidoscopy screening if invited , were r and omly assigned screening or control ( ratio one to two ) . The control group was not contacted . Small polyps were removed during screening , and colonoscopy was undertaken if high-risk polyps ( three or more adenomas , size 1 cm or greater , villous , severely dysplastic , or malignant ) were found . FINDINGS Of 354,262 people asked about their interest in having flexible sigmoidoscopy screening , 194,726 ( 55 % ) responded positively , and 170,432 eligible individuals were r and omised .  Attendance among those assigned screening was 71 % ( 40,674 of 57,254 ) . 2131 ( 5 % ) were classified as high-risk and referred for colonoscopy ; 38,525 with no polyps or only low-risk polyps detected were discharged . Distal adenomas were detected in 4931 ( 12.1 % ) and distal cancer in 131 ( 0.3 % ) . Proximal adenomas were detected in 386 ( 18.8 % of those undergoing colonoscopy ) and proximal cancer in nine cases ( 0.4 % ) . 62 % of cancers were Dukes ' stage A or locally excised . There was one perforation after flexible sigmoidoscopy and four after colonoscopy . An average of 48 people were screened , and two or three colonoscopy referrals generated , per centre each week . Interpretation Our flexible sigmoidoscopy screening regimen is acceptable , feasible , and safe . The prevalence of neoplasia is high , and colonoscopy referral rates of 5 % are acceptable 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 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 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 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 R and omized controlled trials of sufficient power testing the long-term effect of screening for colorectal neoplasia only exist for faecal occult blood testing ( FOBT ) . There is indirect evidence that flexible sigmoidoscopy ( FS ) may have a greater yield . The aim of this study was to determine the diagnostic yield of screening with FS or a combination of FS and FOBT in an average-risk population in an urban and combined urban and rural population in Norway . METHODS 20,780 men and women ( 1:1 ) , aged 50 - 64 years , were invited for once-only screening ( FS only or a combination of FS and FOBT ( 1:1 ) )  by r and omization from the population registry . A positive FS was defined as a finding of any neoplasia or any polyp > or = 10 mm . A positive FS or FOBT qualified for colonoscopy . RESULTS Overall attendance was 65 % . Forty-one ( 0.3 % ) cases of CRC were detected . Any adenoma was found in 2208 ( 17 % ) participants and 545 ( 4.2 % ) had high-risk adenomas . There was no difference in diagnostic yield between the FS and the FS and FOBT group regarding CRC or high-risk adenoma . Work-up load comprised 2821 colonoscopies in 2524 ( 20 % ) screenees and 10 % of screenees were recommended later colonoscopy surveillance . There were no severe complications at FS , but six perforations after therapeutic colonoscopy ( 1:336 ) . CONCLUSIONS The present study bodes well for future management of a national screening programme , provided that follow-up results reflect adequate proof of a net benefit . It is highly question able whether the addition of once-only FOBT to FS will contribute to this effect 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 % Background : In the past three decades , the incidence of colorectal cancer ( CRC ) in Norway has doubled , surpassing all other Nordic countries for both men and women to become the most frequently diagnosed cancer . A small-scale , r and omized study on flexible sigmoidoscopy ( FS ) screening in Telemark , Norway , has shown a reduction in accumulated CRC incidence after 13 years . The aim of our study was to evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions ( polypectomy ) , and to test out the management and organization mimicking a countrywide screening service . A total of 13,823 men and women ( 1:1 ) , age 55 - 64 years , were drawn r and omly from the population registries in Oslo ( urban ) and the county of Telemark ( mixed urban and rural ) and invited to have a screening examination . The rest of the relevant age cohorts constituted the control groups . In the screening group , 535 individuals were excluded according to exclusion criteria , rendering 13,288 individuals eligible for screening examination . Methods : A once only screening model was used . In the screening group , individuals were r and omized to have a once only FS or a combination of FS and faecal occult blood test ( FOBT ) . Results : The overall attendance rate was 8,849 out of 13,288 ( 67 % ) ; 73 % in Telemark and 60 % in Oslo . Attendance for FS only was 68 % and 65 % for combined FS&FOBT . Conclusions : The present FS/FS&FOBT screening study obtained a high acceptance rate for both screening modalities . The attendance rate was stable throughout the trial , suggesting an acceptable model for management of future countrywide screening 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 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 AIM The aim of this study was to evaluate the patterns of compliance and the frequency of adenomas and neoplasms in a Swedish population . METHODS In 1996 , 2000 men and women born in 1935 or 1936 were selected at r and om from the population registers of Uppsala and Malmö/Lund . All subjects were invited by mail to participate . In a r and omised study design , subjects were either called up by a nurse to schedule the appointment for sigmoidoscopy or instructed to call themselves . At sigmoidoscopy  subjects with a cancer , an adenoma ( neoplastic polyp ) or more than three hyperplastic polyps were scheduled for a complete colonoscopy . RESULTS Thirty-nine percent ( 770/1988 ) of all the invited subjects had a sigmoidoscopy .  The participation differed between the two centres , 47 % at the Uppsala centre and 30 % at the Malmö/Lund centre ( P<0.01 ) . There was no statistically significant difference between the two different invitation groups . In all , 98 subjects ( 13 % ) were planned for  colonoscopy .  Thirty-one ( 35 % ) of the subjects having a colonoscopy were women and 57 ( 65 % ) were men . Fifty-five true adenomas were found in 46 subjects . All together , six subjects had proximal adenomas . Five adenocarcinomas were diagnosed , all within the reach of the sigmoidoscope . CONCLUSIONS The compliance was lower and the adenomas were fewer than expected . To increase compliance it is necessary with rigorously controlled invitation routines 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
target: The evidence for the effectiveness of B serrata extracts is encouraging but not compelling
background: OBJECTIVE To assess evidence from r and omised clinical trials about the effectiveness of  extracts of Boswellia serrata ( frankincense ) .