***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Forty patients with rheumatoid arthritis and upper gastrointestinal lesions due to non-steroidal anti-inflammatory drugs entered a prospect i ve 6-month double-blind placebo controlled study of dietary supplementation with gamma-linolenic acid 540 mg/day . Nineteen patients received active therapy ( as evening primrose oil 6 g/day ) and 21 received placebo ( olive oil 6 g/day ) . No patient stopped non-steroidal anti-inflammatory therapy but three patients in each group reduced their dose . Other results showed a significant reduction in morning stiffness with gamma-linolenic acid at 3 months and reduction in pain and articular index at 6 months with olive oil . Whilst gamma-linolenic acid may produce mild improvement in rheumatoid arthritis , olive oil may itself have hitherto unrecognized benefits OBJECTIVE To assess the efficacy of topical Tripterygium wilfordii ( TW ) , a Chinese herbal therapy , in rheumatoid arthritis ( RA ) . METHODS A 6 week r and omized double blind placebo controlled study of 61 patients with RA meeting American College of Rheumatology ( ACR ) criteria was conducted in China . The primary outcome was a modified ACR-20 response rate , analyzed by logistic regression analysis . RESULTS The modified ACR-20 response rate differed significantly ( topical TW 58 % vs placebo 20 % ; p = 0.002 ) . There was an 8.1-fold ( 95 % CI 1.9 - 35.4 ) increase in the modified ACR-20 response for the TW compared to the placebo group , adjusted for age and erythrocyte sedimentation rate . CONCLUSION Topical TW appears efficacious for the treatment of RA , but larger studies are needed Controlled trials that use r and omized allocation are the best tool to control for bias and confounding in trials testing clinical interventions . Investigators must be sure to include information that is required by the reader to judge the validity and implication s of the findings in the reports of these trials . In part , complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes . The consoli date d st and ards of reporting trials ( CONSORT ) statement was developed to assist investigators , authors , review ers , and editors on the necessary information to be included in reports of controlled clinical trials . The CONSORT statement is applicable to any intervention , including herbal medicinal products . Controlled trials of herbal interventions do not adequately report the information suggested in CONSORT . Recently , reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for r and omized controlled trials of herbal medicines . We expect that these recommendations will lead to more complete and accurate reporting of herbal trials . We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration , together with examples of good reporting and empirical evidence , where available , for each . These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected BACKGROUND SKI306X , which consists of biologically active ingredients from Clematis m and sburica , Tricbosantbes kirilowii , and Prunella vulgaris , was developed and tested in pre clinical trials in Korea . Those studies found that SKI306X was associated with an anti-inflammatory and analgesic effect , and that it can delay the destruction of cartilage in rheumatoid arthritis ( RA ) . OBJECTIVE The aim of this study was to compare the pain relief and tolerability of SKI306X and celecoxib in patients with RA . METHODS This study was a 6-week , multicenter , r and omized , double-blind , double-dummy , Phase III , noninferiority clinical trial . Eligible patients were aged 18 to 80 years , had a history of RA with a disease duration of > or =3 months , and were functional American College of Rheumatology ( ACR ) class I , II , or III before entry . After a washout period of 2 weeks , patients were r and omized to SKI306X 200 mg TID or celecoxib 200 mg BID for 6 weeks . The primary end point was a change in patient assessment of pain intensity using a visual analog scale ( VAS ) . The secondary end points were a 20 % improvement in response rate as defined by the ACR ( ACR20 ) and the frequency of rescue medication use . Results after 3 and 6 weeks of treatment were compared with baseline and between treatment groups , and all patients were assessed for adverse events ( AEs ) , clinical laboratory data , and vital signs . AEs were identified based on spontaneous reports by patients during interviews conducted by the investigators and the study coordinator . RESULTS Two hundred twenty-two Korean patients from 7 medical centers were assessed and 183 were enrolled and r and omized to 1 of 2 treatment groups . Ninety-one patients ( 10 male , 81 female ; mean [ SD ] age , 52.13 [ 12.64 ] years ; mean [ SD ] duration of RA , 9.08 [ 10.23 ] years ; no. [ % ] of ACR class I , II , and III , 13 [ 14.29 ] , 44 [ 48.35 ] and 34 [ 37.36 ] patients , respectively ) received SKI306X 200 mg TID and 92 patients ( 10 male , 82 female ; mean [ SD ] age , 51.78 [ 10.94 ] years ; mean [ SD ] duration of RA , 8.78 [ 7.78 ] years ; no. [ % ] of ACR class I , II , and III , 14 [ 15.22 ] , 44 [ 47.83 ] , and 34 [ 36.96 ] patients , respectively ) received celecoxib 200 mg BID . An analysis of the change in reported pain intensity as determined by VAS ( mm ) score between baseline and week 3 ( mean [ SD ] , 13.64 [ 16.62 ] vs 14.45 [ 15.89 ] ) , and between baseline and week 6 ( 18.4 [ 20.8 ] vs 17.9 [ 19.1 ] , respectively ) suggested that SKI306X was not inferior to celecoxib . The number of patients who achieved ACR20 response rate was not significantly different between the SKI306X group and the celecoxib group at week 3 ( 16/87 [ 18.4 % ] vs 24/87 [ 27.6 % ] , respectively ) and at week 6 ( 29/87 [ 33.3 % ] vs 29/87 [ 33.3 % ] ) . The frequency of rescue medication use was not significantly different between the SKI306X group and celecoxib group at week 3 ( 54/87 [ 62.1 % ] vs 47/87 [ 54.0 % ] , respectively ) or week 6 ( 57/87 [ 65.5 % ] vs 49/87 [ 56.3 % ] ) . Drug-related AEs were reported by 27 ( 29.7 % ) patients in the SKI306X group and 22 ( 23.9 % ) patients in the celecoxib group . The most frequent drug-related AEs were epigastric pain ( 9/91 [ 9.9 % ] ) in the SKI306X group and glutamyltranferase elevation ( 4/92 [ 4.3 % ] ) in the celecoxib group . No significant between-group differences were observed in the prevalence of drug-related clinical - or laboratory-determined AEs . CONCLUSION The results of this study suggest that SKI306X was generally well tolerated and not inferior to celecoxib in regard to pain relief in these Korean patients with RA The efficacy , tolerance , and safety of CPH 82 ( semisynthetic lignan glycosides ) ( Conpharm AB ) for patients with rheumatoid arthritis ( RA ) were assessed in a 12-week double-blind placebo-controlled study . Thirteen patients out of 15 in the CPH 82 group and 10 out of 15 in the placebo group completed the study .  No improvement was seen in placebo treated patients . Patients treated with CPH 82 showed a statistically significant improvement in most clinical and immunological variables . Some patients treated with CPH 82 reported gastrointestinal discomfort ( diarrhoea and abdominal pain ) OBJECTIVE To examine the efficacy of popular Chinese herbs used in a traditional Chinese medicine ( TCM ) combination of Ganoderma lucidum and San Miao San ( SMS ) , with purported diverse health benefits including antioxidant properties in rheumatoid arthritis ( RA ) . METHODS We r and omly assigned 32 patients with active RA , despite disease-modifying antirheumatic drugs , to TCM and 33 to placebo in addition to their current medications for 24 weeks . The TCM group received G lucidum ( 4 gm ) and SMS ( 2.4 gm ) daily . The primary outcome was the number of patients achieving American College of Rheumatology ( ACR ) 20 % response and secondary outcomes included changes in the ACR components , plasma levels , and ex vivo-induced cytokines and chemokines and oxidative stress markers . RESULTS Eighty-nine percent completed the 24-week study . Fifteen percent in the TCM group compared with 9.1 % in the placebo group achieved ACR20 ( P > 0.05 ) . Pain score and patient 's global score improved significantly only in the TCM group . The percentage , absolute counts , and CD4+/CD8+/natural killer/B lymphocytes ratio were unchanged between groups . CD3 , CD4 , and CD8 lymphocyte counts and markers of inflammation including plasma interleukin-18 ( IL-18 ) , interferon-gamma (IFNgamma)-inducible protein 10 , monocyte chemoattractant protein 1 , monokine induced by IFNgamma , and RANTES were unchanged . However , in an ex vivo experiment , the percentage change of IL-18 was significantly lower in the TCM group . Thirteen patients reported 22 episodes ( 14 in placebo group and 8 in TCM group ) of mild adverse effects . CONCLUSION G lucidum and San Miao San may have analgesic effects for patients with active RA , and were generally safe and well tolerated . However , no significant antioxidant , antiinflammatory , or immunomodulating effects could be demonstrated In rheumatoid arthritis ( RA ) benefit from non-steroidal anti-inflammatory drugs ( NSAIDs ) is mediated through inhibition of the cyclo-oxygenase enzyme , thereby decreasing production of the 2 series prostagl and ins ( PGs ) . The lipoxygenase enzyme is intact , however , allowing leucotriene ( LT ) production , e.g. , LTB4 ( an inflammatory mediator ) . Treatment with evening primrose oil ( EPO ) which contains gamma-linolenic acid ( GLA ) leads to production of the 1 series PGs , e.g. , PGE1 , which has less inflammatory effects . Also LT production is inhibited . Eicosapentaenoic acid ( EPA , fish oil ) treatment provides a substrate for PGs and LTs , which are also less inflammatory . In this study 16 patients with RA were given  540 mg GLA/day ( EPO ) , 15 patients 240 mg EPA and 450 mg GLA/day ( EPO/fish oil ) , and 18 patients an inert oil ( placebo ) . The aim of this study was to determine if EPO or EPO/fish oil could replace NSAID treatment in RA . The initial 12 month treatment period was followed by three months of placebo for all groups . Results at 12 months showed a significant subjective improvement for EPO and EPO/fish oil compared with placebo . In addition , by 12 months the patients receiving EPO and EPO/fish oil had significantly reduced their NSAIDs . After 3 months of placebo those receiving active treatment had relapsed . Despite the decrease in NSAIDs , measures of disease activity did not worsen . It is suggested that EPO and EPO/fish oil produce a subjective improvement and allow some patients to reduce or stop treatment with NSAIDs . There is , however , no evidence that they act as disease modifying agents A report of a r and omized , controlled trial ( RCT ) should convey to the reader , in a transparent manner , why the study was undertaken and how it was conducted and analyzed . For example , a lack of adequately reported r and omization has been associated with bias in estimating the effectiveness of interventions ( 1 , 2 ) . To assess the strengths and limitations of an RCT , readers need and deserve to know the quality of its methods . Despite several decades of educational efforts , RCTs still are not being reported adequately ( 3 - 6 ) . For example , a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin-reuptake inhibitors as first-line management strategy for depression found that only 1 ( 0.8 % ) paper described r and omization adequately ( 5 ) . Inadequate reporting makes the interpretation of RCT results difficult if not impossible . Moreover , inadequate reporting borders on unethical practice when biased results receive false credibility . History of CONSORT In the mid-1990s , two independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement ( 7 ) , which was 
    Output:
    
There is moderate evidence that oils containing GLA ( evening primrose , borage , or blackcurrant seed oil ) afford some benefit in relieving symptoms for RA , while evidence for Phytodolor ® N is less convincing .
Tripterygium wilfordii products may reduce some RA symptoms , however , oral use may be associated with several side effects .