***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: Xerostomia is a common and usually irreversible side effects in patients receiving radiation therapy ( > 50 Gy ) for head and neck cancer . Of 38 patients with radiation-induced xerostomia , 20 in the experimental group were treated with classical acupuncture and 18 patients in the control group received superficial acupuncture as placebo . Within both groups the patients showed significantly increased salivary flow rates after the acupuncture treatment . In the experimental group 68 % and in the control group 50 % of the patients had increased salivary flow rates at the end of the observation period . Among those patients who had had all their salivary gl and s irradiated , 50 % in both groups showed increased salivary flow rates ( > 20 % ) by the end of the observation period of 1 year . The study indicates that among the patients who had increased salivary flow rates already after the first 12 acupuncture sessions , the majority had high probability of continual improvement after the completion of acupuncture treatment . The improved salivary flow rates usually persisted during the observation year . The changes observed in the control group were somewhat smaller and appeared after a longer latency phase . Significant differences for salivary flow rates could be observed only within each group , and there were no statistically significant differences between the groups . There were no differences in the improvement of salivary flow rates between those patients who were irradiated within a year before the acupuncture treatment and those who had received radiation therapy several years earlier . The results indicate that acupuncture might be a useful method for the treatment of radiation-induced xerostomia , and that superficial acupuncture should preferably not be used as placebo acupuncture PURPOSE AND OBJECTIVES This report presents the analysis of the RTOG 0537 multicenter r and omized study that compared acupuncture-like transcutaneous stimulation ( ALTENS ) with pilocarpine ( PC ) for relieving  radiation-induced xerostomia . METHODS AND MATERIAL S Eligible patients were r and omized to twice-weekly 20-minute ALTENS sessions for 24 sessions during 12 weeks or PC ( 5 mg 3 times daily for 12 weeks ) . The primary endpoint was the change in the University of Michigan Xerostomia-Related Quality of Life Scale ( XeQOLS ) scores from baseline to 9 months from r and omization ( MFR ) . Secondary endpoints included basal and citric acid primed whole salivary production ( WSP ) , ratios of positive responders ( defined as patients with ≥20 % reduction in overall radiation-induced xerostomia symptom burden ) , and the presence of adverse events based on the Common Terminology Criteria for Adverse Events version 3 . An intention-to-treat analysis was conducted . RESULTS One hundred forty-eight patients were r and omized . Only 96 patients completed the required XeQOLS  and were evaluable at 9 MFR ( representing merely 68.6 % statistical power ) . Seventy-six patients were evaluable at 15 MFR . The median change in the overall XeQOLS in ALTENS and PC groups at 9 and 15 MFR were -0.53 and -0.27 ( P=.45 ) and -0.6 and -0.47 ( P=.21 ) . The corresponding percentages of positive responders were 81 % and 72 % ( P=.34 ) and 83 % and 63 % ( P=.04 ) . Changes in WSP were not significantly different between the groups . Grade 3 or less adverse events , mostly consisting of grade 1 , developed in 20.8 % of patients in the ALTENS group and in 61.6 % of the PC group . CONCLUSIONS The observed effect size was smaller than hypothesized , and statistical power was limited because only 96 of the recruited 148 patients were evaluable . The primary endpoint-the change in radiation-induced xerostomia symptom burden at 9 MFR-was not significantly different between the ALTENS and PC groups . There was significantly less toxicity in patients receiving ALTENS PURPOSE Radiotherapy-induced xerostomia seriously reduces the quality of life ( QOL ) for patients with head and neck cancer . This study aim ed to investigate the effects of manual acupuncture on objective and subjective assessment of symptom changes in patients with cancer who have with radiation-induced xerostomia . MATERIAL S AND METHODS Twelve ( 12 ) patients with radiation-induced xerostomia were r and omized into 2 groups ( real or sham acupuncture ) . Acupuncture was conducted twice weekly for 6 weeks in a single-blind setting . The effect was evaluated by measuring whole salivary flow rates ( stimulated and unstimulated ) and question naire-based assessment of subjective symptoms pre- and post-treatment ( 3 and 6 weeks after acupuncture treatment ) . RESULTS Both groups showed a slight increase in whole salivary flow rates , with no significant difference between them . However , real acupuncture markedly increased unstimulated salivary flow rates , and improved the score for dry mouth according to the xerostomia question naire , by 2.33 points versus 0.33 in the controls . CONCLUSIONS Our results showed the significantly meaningful amelioration of the subjective sensation of xerostomia closely associated with QOL in patients with head and neck cancer treated with irradiation Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND Radiation treatment of head and neck cancer can cause chronic xerostomia which impairs patients ' quality of life . The study reported here examined the efficacy of acupuncture in alleviating xerostomia symptoms especially dry mouth . PATIENTS AND METHODS A total of 145 patients with chronic radiation-induced xerostomia > 18 months after treatments were recruited from seven UK cancer centres . The study employed a r and omised crossover design with participants receiving two group sessions of oral care education and eight of acupuncture using st and ardised methods . Patient-reported outcome ( PROs ) measures were completed at baseline and weeks 5 , 9 , 13 , 17 , and 21 . The primary outcome was improvement in dry mouth . OBJECTIVE saliva measurements were also carried out . RESULTS Acupuncture compared with oral care , produced significant reductions in patient reports of severe dry mouth ( OR = 2.01 , P = 0.031 ) sticky saliva ( OR = 1.67 , P = 0.048 ) , needing to sip fluids to swallow food ( OR = 2.08 , P = 0.011 ) and in waking up at night to drink ( OR = 1.71 , P = 0.013 ) . There were no significant changes in either stimulated or unstimulated saliva measurements over time . CONCLUSION Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia PURPOSE To study the efficacy and safety of cevimeline in two double-blind trials ( Studies 003 and 004 ) enrolling patients with head and neck cancer in whom xerostomia developed after radiotherapy . METHODS AND MATERIAL S Subjects were r and omly assigned to receive cevimeline , 30 mg three times daily , or placebo for 12 weeks , with the possibility of dose escalation to 45 mg three times daily at 6 weeks . The primary efficacy endpoint was the patient 's final global evaluation of oral dryness ; change in unstimulated salivary flow was a secondary endpoint . RESULTS Five hundred seventy subjects ( 284 in Study 003 and 286 in Study 004 ) were r and omized . Significantly more cevimeline-treated subjects than placebo recipients ( 47.4 % vs. 33.3 % , p = 0.0162 ) in Study 003 reported improvement in dry mouth in the final global evaluation of oral dryness . No significant difference between groups in the final global evaluation was seen in Study 004 , in which a high placebo response rate of 47.6 % was observed . In both studies , cevimeline-treated subjects had significantly greater increases in the objective measure of unstimulated salivary flow than placebo recipients ( p = 0.0093 [ Study 003 ] and p = 0.0215 [ Study 004 ] ) , whereas no significant differences in stimulated salivary flow were observed . The most frequent adverse event was increased sweating . CONCLUSION Cevimeline was well tolerated by patients with xerostomia after radiotherapy for head and neck cancer , and oral administration of 30 - 45 mg of cevimeline three times daily increased unstimulated salivary flow A comparison was made of Oral Balance gel delivered by slow release via a novel intra-oral device versus an oral bolus of gel on the oral health condition and oral health-related quality of life ( OHRQoL ) in patients who had received st and ard head and neck irradiation for nasopharyngeal carcinoma . Twenty-two participants took part in a r and omized single-blind crossover clinical study . Each treatment lasted 4 weeks with an intervening 4 weeks washout period . The GOHAI , Xerostomia Inventory and patient satisfaction measures were self-completed and oral health condition assessed objective ly at baseline ( week 0 ) and weeks 4 , 8 and 12 . Oral Balance gel , in bolus and slow-release forms , was effective in improving aspects of oral health , notably a reduction in oral cariogenic micro-organisms . Slow release of gel via the intra-oral device did not appear to improve OHRQoL whereas gel alone reduced the severity of xerostomia symptoms and was the treatment of choice PURPOSE To determine the efficacy and safety of pilocarpine hydrochloride for symptomatic relief of postradiation xerostomia symptoms and for saliva production in patients with head and neck cancer . PATIENTS AND METHODS One hundred sixty-two head and neck cancer patients who had received at least 40 Gy of radiation ( 117 patients had received > 60 Gy ) with clinical ly significant xerostomia were enrolled onto a r and omized , double-blind , placebo-controlled , multi-center clinical investigation . Patients received 2.5-mg tablets for the first 4 weeks , 5.0-mg tablets for the second 4 weeks , and 10.0-mg tablets for the last 4 weeks of the 12-week study . Patients were allowed to titrate pilocarpine or placebo for improvement in symptoms or to reduce side effects . Patients were evaluated for symptomatic relief by question naires and visual analog scales ( VAS ) , and for saliva production by sialometry . RESULTS Pilocarpine produced a significant improvement ( P = .035 ) in overall global assessment s compared with placebo . There was a statistically significant ( P = .020 ) decreased use of oral comfort agents such as artificial saliva , hard c and y , and water . Values for symptomatic improvement in dryness approached significance ( P = .057 ) . There were statistically significant postdose improvements in whole and parotid salivary flow in pilocarpine treatment groups versus placebo . All pilocarpine dosages tested were judged to be safe . Adverse experiences were primarily sweating , rhinitis , headache , nausea , and urinary frequency , with the most common side effect being mild to moderate sweating . There were no serious drug-related adverse experiences in any of the pilocarpine treatment groups . CONCLUSION It is concluded that pilocarpine produces clinical ly significant benefits for the symptomatic treatment of postradiation xerostomia . Best results were obtained with continuous treatment for 8 to 12 weeks with doses greater than 2.5 mg three times per day BACKGROUND Patients with radiation-induced xerostomia produce little or no saliva . Several studies have demonstrated the efficacy of systemic administration of pilocarpine hydrochloride in individuals with post-radiation xerostomia . However , analysis of pilocarpine lozenges for treatment of post-radiation xerostomia in patients with head and neck cancer has not been reported . METHODS The aim of this study was to quantify improvement in clinical symptoms and salivary function after treatment of post-radiation xerostomia with pilocarpine lozenges . In a double-blinded , placebo-controlled trial , 33 head and neck cancer patients were assigned r and omly to receive Salagen tablet , pilocarpine hydrochloride lozenge ( 3 or 5 mg ) or placebo lozenge every 10 days . At each visit , a subjective evaluation was undertaken through the use of visual analog scales before and at 180 minutes after treatment . Whole resting saliva was collected before and at 0 , 30 , 60 , 90 , 120 , 150 and 180 minutes after treatment . RESULTS The percentage of patients with decreased feeling of oral dryness , sore mouth or speaking difficulties after taking 5-mg pilocarpine lozenge was greater than Salagen or placebo . There were statistically significant increases in salivary production in pilocarpine treatment groups vs. placebo ( P < 0.05 ) . CONCLUSION The 5-mg pilocarpine lozenge produced the best clinical results , but further investigation with a larger group of patients is required Following therapeutic irradiation of the head and neck , patients with profound xerostomia have complaints associated with oral dryness , effects upon use of oral prosthesis , speech , and taste . In addition , xerostomia may lead to risk of oral infections and rampant demineralization of teeth . The use of topical Oral Balance gel and Biotene toothpaste ( Laclede Professional 
    Output:
    
With regard to interventions not included in the meta- analysis , we found no evidence , or very weak evidence , that they can reduce xerostomia symptoms or increase salivary flow in this population .
Pilocarpine and cevimeline should represent the first line of therapy in head and neck cancer survivors with radiotherapy-induced xerostomia and hyposalivation .