Clinical Guideline: Management of Gastroparesis A single-blinded, randomized pilot study evaluating effects of electroacupuncture in diabetic patients with symptoms suggestive of gastroparesis. Do certain countries produce only positive results? A systematic review of controlled trials. Gastrointestinal tract symptoms among persons with diabetes mellitus in the community. Electroacupuncture Accelerates Solid Gastric Emptying and Improves Dyspeptic Symptoms in Patients with Functional Dyspepsia Gastroparesis Cardinal Symptom Index (GCSI): Development and validation of a patient reported assessment of severity of gastroparesis symptoms Validation of a specific quality of life questionnaire for functional digestive disorders [Observation on therapeutic effect of turtle probing the cave needling method on diabetic gastroparesis]. [A controlled multi-centre clinical trial on cisapride in treatment of functional dyspepsia]. [Observation on the therapeutic effect of needling method for harmonizing spleen-stomach on diabetic gastroparesis]. Effect of Electrical Stimulation on Acupuncture Points in Diabetic Patients with Gastric Dysrhythmia: A Pilot Study
This guideline presents recommendations for the evaluation and management of patients with gastroparesis . Gastroparesis is identified in clinical practice through the recognition of the clinical symptoms and documentation of delayed gastric emptying . Symptoms from gastroparesis include nausea , vomiting , early satiety , postpr and ial fullness , bloating , and upper abdominal pain . Management of gastroparesis should include assessment and correction of nutritional state , relief of symptoms , improvement of gastric emptying and , in diabetics , glycemic control . Patient nutritional state should be managed by oral dietary modifications . If oral intake is not adequate , then enteral nutrition via jejunostomy tube needs to be considered . Parenteral nutrition is rarely required when hydration and nutritional state can not be maintained . Medical treatment entails use of prokinetic and antiemetic therapies . Current approved treatment options , including metoclopramide and gastric electrical stimulation ( GES , approved on a humanitarian device exemption ) , do not adequately address clinical need . Antiemetics have not been specifically tested in gastroparesis , but they may relieve nausea and vomiting . Other medications aim ed at symptom relief include unapproved medications or off-label indications , and include domperidone , erythromycin ( primarily over a short term ) , and central ly acting antidepressants used as symptom modulators . GES may relieve symptoms , including weekly vomiting frequency , and the need for nutritional supplementation , based on open-label studies . Second-line approaches include venting gastrostomy or feeding jejunostomy ; intrapyloric botulinum toxin injection was not effective in r and omized controlled trials . Most of these treatments are based on open-label treatment trials and small numbers . Partial gastrectomy and pyloroplasty should be used rarely , only in carefully selected patients . Attention should be given to the development of new effective therapies for symptomatic control BACKGROUND AND OBJECTIVES The current pharmacological management of diabetic gastroparesis remains difficult . Acupuncture has been widely used for gastrointestinal symptoms . The aim of this study was to investigate the effects of electroacupuncture ( EA ) on solid gastric emptying time , serum gastrin , motilin , pancreatic polypeptide ( PP ) , fasting and postpr and ial blood glucose , and symptoms in patients with diabetic gastroparesis . INTERVENTIONS EA at the Zusanli ( ST 36 ) and Hegu ( LI 4 ) points and sham EA as control were administered by an experienced and licensed acupuncturist . DESIGN This was a pilot study with a r and omized , single-blinded design . SUBJECTS AND SETTING Nineteen ( 19 ) patients with type 2 diabetes who had had symptoms of gastroparesis for more than 3 months were included in the trial and r and omized into two groups . Each group received EA ( n = 9 ) or sham EA ( n = 10 ) consisting of 4 sessions over 2 weeks . OUTCOME MEASURES Symptom severity was evaluated using the Gastroparesis Cardinal Symptom Index ( GCSI ) at baseline , at the end of treatment , and 2 weeks after the end of the trial ; solid-phase gastric half-emptying time was measured by scintigraphy ; in addition , serum gastrin , motilin , PP , fasting , and postpr and ial blood glucose levels were also measured . RESULTS Gastric half-emptying time in 9 patients with diabetic gastroparesis was significantly shortened by EA treatment ( 143.8 + /- 55.9 minutes versus 98.8 + /- 28.6 minutes , p < 0.03 ) . Half-emptying time did not change ( 98.9 + /- 26.4 minutes versus 90.9 + /- 24.8 minutes , p > 0.05 ) in the sham EA group . Symptom severity , as measured by GCSI total score , improved significantly both at the end of treatment ( 2.38 + /- 0.56 versus 1.48 + /- 0.19 , p < 0.001 ) and 2 weeks after the end of the trial ( 2.38 + /- 0.56 versus 1.65 + /- 0.44 , p < 0.01 ) when compared with the baseline in the EA group , but did not change from baseline with sham EA treatment . There were no significant changes in fasting and postpr and ial blood glucose , serum gastrin , motilin , and PP in both groups . No significant adverse events occurred . CONCLUSIONS This study demonstrates that short-term EA at the Zusanli and Hegu points effectively reduces the dyspeptic symptoms  of diabetic gastroparesis and accelerates solid gastric emptying . Sustained improvement in dyspeptic symptoms was observed at 2 weeks after the end of the trial . Its potential for treating gastroparesis may be explored , and a larger trial is required to draw definitive conclusions OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture  was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than  acupuncture  that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture  trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries BACKGROUND Gastrointestinal ( GI ) tract symptoms are common among patients with diabetes mellitus ( DM ) seen in tertiary care centers . The degree to which this reflects referral bias is unclear . OBJECTIVES To determine whether GI tract symptoms are more prevalent in unselected patients with DM from the general community compared with their age- and sex-matched counterparts without DM and to assess the association of GI tract symptoms in persons with DM with psychosomatic symptoms , medication use , and symptoms of autonomic neuropathy . METHODS In this population -based , cross-sectional study , Olmsted County , Minnesota , residents with type 1 DM , a r and om sample of residents with type 2 DM , and 2 age- and sex-stratified r and om sample s of nondiabetic residents ( total of 1262 person for the 4 groups ) were mailed a previously vali date d symptom question naire . RESULTS Heartburn was less common in residents with type 1 DM vs controls ( 12 % vs 23 % ; P<.05 ) . No significant difference in prevalence was detected ( residents with type 1 DM vs controls ; residents with type 2 DM vs controls ) for nausea or vomiting ( 12 % vs 11 % ; 6 % vs 6 % ) , dyspepsia ( 19 % vs 21 % ; 13 % vs 17 % ) , or constipation ( 17 % vs 14 % ; 10 % vs 12 % ) . However , constipation and /or laxative use was slightly more common in residents with type 1 DM ( 27 % vs 19 % ; P<.15 ) , particularly in men , and was associated with the intake of calcium channel blockers . CONCLUSIONS In the community , the prevalence of most GI tract symptoms is similar in persons with or without DM , except for a lower prevalence of heartburn and an increased prevalence of constipation or laxative use in residents with type 1 DM , especially in men . This difference is associated with calcium channel blocker use rather than symptoms of autonomic neuropathy . In community-based practice s , physicians should not immediately assume that GI tract symptoms in patients with DM represent a complication of DM The aims of this study were to investigate the effects of electroacupuncture ( EA ) at ST36 and PC6 points on solid gastric emptying and dyspeptic symptoms in patients with functional dyspepsia . Nineteen patients with functional dyspepsia ( FD ) were involved in the study , consisting of two parts : ( 1 ) acute effects of EA on solid gastric emptying in FD patients with delayed gastric emptying and ( 2 ) short-term ( 2-week ) effects of EA on symptoms in FD patients with normal gastric emptying . Results were as follows . ( 1 ) Ten of the19 patients showed delayed gastric emptying of solids , and acute EA significantly improved delayed gastric emptying ; the halftime for gastric emptying was reduced from 150.3±48.4 to 118.9±29.6 min ( P=0.007 ) . ( 2 ) In the nine patients with normal gastric emptying , 2-week EA significantly decreased the symptom score , from 8.2±3.3 at baseline to 1.6±1.1 ( P < 0.001 ) at the end of treatment . We conclude that EA at the ST36 and PC6 points accelerates solid gastric emptying in FD patients with delayed gastric emptying and relieves dyspeptic symptoms in FD patients with normal gastric emptying Background : Patient-rated symptom assessment s are needed for evaluating the effectiveness of medical treatments and for monitoring outcomes in gastroparesis . Objective : This paper summarizes the development and psychometric evaluation of a new instrument , the Gastroparesis Cardinal Symptom Index ( GCSI ) , for assessing severity of symptoms associated with gastroparesis . Methods : The GCSI was based on review s of the medical literature , patient focus groups , and interviews with clinicians . A sample of 169 patients with a documented diagnosis of gastroparesis participated in the psychometric evaluation study . Patients completed the GCSI , the SF-36 Health Survey , and disability days questions at baseline and after 8 weeks . A r and omly selected sub- sample of 30 subjects returned at 2 weeks to assess test – retest reliability . Clinicians rated severity of symptoms , and both clinicians and patients rated change in gastroparesis-related symptoms over the 8 week study . Results : The GCSI is based on three subscales : post-pr and ial fullness/early satiety ( 4 items ) ; nausea/vomiting ( 3 items ) , and bloating ( 2 items ) . Internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores . Two week test – retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores . Construct validity was supported , given that we observed significant relationships between clinician assessed symptom severity and GCSI total score , significant differences between gastroparesis and dyspepsia patients ( n = 760 ) on GCSI total ( p < 0.0001 ) and subscale scores ( p < 0.03 to p < 0.0001 ) , moderate and significant relationships between GCSI total and SF-36 scores , and significant associations between GCSI total score and reports of restricted activity and bed disability days . Patients with greater symptom severity , as rated by clinicians , reported more symptom severity on GCSI total score . GSCI total scores were responsive to changes in overall gastroparesis symptoms as assessed by clinicians ( p < 0.0001 ) and patients ( p= 0.0004 ) . Conclusion : The findings of this study indicate that the GCSI is a reliable and valid instrument for measuring symptom severity in patients with gastroparesis BACKGROUND Dyspepsia and irritable bowel syndrome are suitable conditions for assessment of quality of life . Their similarities justify the elaboration of a single specific question naire for the two conditions . AIMS To examine the process leading to the validation of the psychometric properties of the functional digestive disorders  quality of life question naire ( FDDQL ) . METHODS Initially , the question naire was given to 154 patients , to assess its acceptability and reproducibility , analyse its content , and reduce the number of items . Its responsiveness was tested during two therapeutic trials which included 428 patients . The question naire has been translated into French , English , and German . The psychometric validation study was conducted in France , United Kingdom , and Germany by 187 practitioners . A total of 401 patients with dyspepsia or irritable bowel syndrome , defined by the Rome criteria , filled in the FDDQL and generic SF-36 question naires . RESULTS The structure of the FDDQL scales was checked by factorial analysis . Its reliability was expressed by a Cronbach ’s α coefficient of 0.94 . Assessment of its discriminant validity showed that the more severe the functional digestive disorders , the more impaired the quality of life ( p<0.05 ) . Concurrent validity was supported by the correlation found between the FDDQL and SF-36 question naire scales . The final version of the question naire contains 43 items belonging to eight domains . CONCLUSIONS The properties of the FDDQL question naire , available in French , English , and German , make it appropriate for use in clinical trials design ed to evaluate its responsiveness to treatment among patients with dyspepsia and irritable bowel syndrome OBJECTIVE To compare therapeutic effects of acupuncture therapy and Motilium on diabetic gastroparesis . METHODS Sixty cases were r and omly divided into a needling method group and a medication group , 30 cases in each group . The needling method group were treated with turtle probing the cave ( a kind of needling manipulation ) as main , with pair-acupoints , Zhongwan ( CV 12 ) and Zusanli ( ST 36 ) , Neiguan ( PC 6 ) and Sanyinjiao ( SP 6 ) selected , once a day , two weeks constituting one course . The medication group were treated with oral administration of 10 mg Motilium , thrice each day , 30 minutes before meals , two weeks constituting one course . The therapeutic effects were observed after 2 courses . RESULTS The total effective rate was 93.3 % in the needling method group and 73.3 % in the medication group , with a significant difference between the two groups ( P<0.05 ) . The needling method group in improvement of epigastric distention and pain , eructation , nausea and vomiting was better than the medication group . CONCLUSION The therapeutic effect of turtle probing the cave needling method on diabetic gastroparesis is significantly better than that of Mutilium A controlled multi-centre clinical trial was conducted for evaluating the efficacy and safety of cisapride in the treatment of 414 cases of functional dyspepsia with 169 cases as control .  Cisapride were given 5 mg three times daily for 4 weeks . The results showed that cisapride could significantly improve the symptoms including early satiety , abdominal distention , epigastric pain and nausea . Total efficacy rate of cisapride and placebo were 92.99 % and 41.42 % respectively . There were statistically significant difference between the two groups . Side-effects are abdominal pain and diarrhoea but most of the patients can endure . The above results indicated that the cisapride was safe and effective in treatment of functional dyspepsia OBJECTIVE To compare the therapeutic effects of acupuncture and Motilium on diabetic gastroparesis ( DGP ) . METHODS Seventy-two cases of DGP were r and omly divided into a treatment group and a control group . The treatment group were treated with needling method for harmonizing spleen-stomach as main , with Quchi ( LI 11 ) , Hegu ( LI 4 ) , Zhongwan ( CV 12 ) , Zusanli ( ST 36 ) , Fenglong ( ST 40 ) , Yinlingquan ( SP 9 ) , Sanyinjiao ( SP 6 ) , Xuehai ( SP 10 ) , Diji ( SP 8) , and others selected , twice each day , 10 days constituting one course , with an in terval of 2 days ; the control group were treated with oral administration of Motilium 10 mg , 3 times each day , 30 min before meals . RESULTS The total effective rate of 91.7 % in the treatment group was better than 77.8 % in the control group ( P < 0.05 ) . CONCLUSION The therapeutic effect of the needling method for harmonizing spleen-stomach on diabetic gastroparesis is better than that of Motilium Background / Aims : Abnormal gastric slow-wave frequencies have been observed in diabetic gastroparesis and are associated with impaired antral motor activity . In this study , we aim ed at evaluating the effect of acupuncture on gastric slow waves in diabetic patients with symptoms suggesting gastric motor dysfunction . Methods : Fifteen patients with type II diabetes who had had dyspeptic symptoms for more than 3 months were enrolled .  Two acupuncture needles were inserted into the subjects ’ legs at the Zusanli points , and electrical stimulation ( 2-Hz pulses ) was delivered for 30 min .  Cutaneous electrogastrography  was performed for 30 min at baseline , for 30 min during acupuncture , and for an additional 30 min after acupuncture .  Serum gastrin , motilin , and human pancreatic polypeptide levels were also measured . Results : There was a significant increase in the percentages of normal frequency during and after acupuncture ( baseline vs. acupuncture and after acupuncture 21.99 ± 19.38 % vs. 45.93 ± 19.72 and 48.92 ± 19.56 % ; p < 0.01 ) . In addition , the percentage of tachygastric frequency was decreased significantly during and after acupuncture . The dominant frequency was also changed significantly . There was an increase of serum human pancreatic polypeptide  during acupuncture ( baseline vs. acupuncture 56.96 ± 27.64 vs. 73.11 ± 22.37 pmol/l ; p < 0.05 ) . Conclusions : The results of this study revealed that electrical stimulation at the Zusanli points could increase the percentage of normal electrogastrography frequency and decrease the percentage of tachygastric frequency in diabetic patients . The data indicate that acupuncture may enhance the regularity of gastric myoelectrical activity in diabetic patients
Background Acupuncture is widely used to treat diabetic patients with dyspeptic symptoms suggestive of gastroparesis in China .
We conducted this systematic review of r and omized controlled trials ( RCTs ) to evaluate the efficacy of acupuncture for diabetic gastroparesis ( DGP ) .