Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older

PurposeChronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are common functional gastrointestinal disorders. The prevalence of constipation-related issues tends to increase with age. This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.MethodsPatients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled. Efficacy end points common to all trials included changes in stool consistency (Bristol Stool Form Scale), changes in weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), and time to first CSBM and SBM. Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).FindingsThe pooled intention-to-treat population comprised 451 patients aged ≥65 years (mean age, 70 years) and 4364 patients aged <65 years (mean age, 41.9 years), of whom 287 and 2914, respectively, were randomized to receive plecanatide. Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years), and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years). No new safety issues were observed.ImplicationsPlecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C.Clinicaltrials.gov identifiersNCT01982240, NCT02122471, NCT02387359, and NCT02493452.     

Electro-acupuncture vs. sham electro-acupuncture for chronic severe functional constipation: A systematic review and meta-analysis

ObjectivesTo assess the efficacy of electro-acupuncture (EA) relative to sham electro-acupuncture (sham EA) in treating chronic severe functional constipation (CSFC). Methods: A comprehensive search for relevant studies published between January 1, 1951 and May 14, 2020 was conducted in PubMed, the Cochrane Library, Chinese Biomedical Literature Database, Web of Science, and EMbase. Two investigators independently selected studies, extracted data, and assessed the quality of the included studies. The software Endnote X9 was used for screening articles, and the Review Manager 5.3 for analyzing data.ResultsThe meta-analyses involved 6 studies and 1457 individuals. The pooled results favored the EA group for the increase of complete spontaneous bowel movements (CSBMs) per week in the fourth week (MD = 0.80, P = 0.001) during treatment, and further improved in the eight weeks (MD = 1.25, P < 0.001). During the follow-up period, significant changes in CSBMs per week were seen in the experimental group (MD = 1.38, P = 0.008); the effect decreased in the twelfth week (MD = 0.87, P < 0.001). There was no significant difference in the Bristol stool scale score between the two groups in the fourth week (MD = 0.40, P = 0.08), but significant differences were observed in the eighth week (MD = 0.40, P = 0.03). A significant reduction in patient assessment of constipation quality of life (PAC-QOL) score were observed in the EA group during treatment (SMD = -0.83, P < 0.001). No serious adverse events were reported.ConclusionsEA had favorable effects on CSFC, and the longer the treatment duration was, the better was the effect, but the effect showed a certain period of validity. However, the results may be influenced by the clinical heterogeneity of acupuncture points, depth of needling, intensity, and frequency of EA.     

The effects of connective tissue manipulation and Kinesio Taping on chronic constipation in children with cerebral palsy: a randomized controlled trial

Purpose: The aim of this study was to investigate the effects of connective tissue manipulation (CTM) and Kinesio Taping^® (KT) on constipation and quality of life in children with cerebral palsy (CP).

Method: This study was designed as a randomized controlled trial. Forty children diagnosed with chronic constipation based on Rome III criteria were randomly assigned to CTM group [6 females, 7 males; 8 y 6?mo (SD = 3y 4?mo)], KT group [7 female, 7 male; 8y 7?mo (SD =3y 5?mo)] or control group [6 female, 7 male; 8y 3?mo (SD = 3y 6?mo)]. All patients were assessed with 7-day bowel diaries, Bristol Stool Form Scale (BSFS), Visual Analog Scale (VAS), and Pediatric Quality of Life Inventory (PEDsQL). Kruskal-Wallis, Wilcoxon’s signed-rank, and Mann–Whitney U tests were used to determine intra-group and inter-group differences. The level of significance was p?Results: Among the CTM, KT, and control groups, there were statistically significant differences regarding the changes in defecation frequency (2.46, 3.00, 0.30, ES 1.16, p?p?=?0.003), BSFS (1.84, 2.14, 0.07, ES 0.91, p?p?p?Conclusions: This study revealed that CTM and KT seem equally effective physiotherapy approaches for the treatment of pediatric constipation and these approaches may be added to bowel rehabilitation program.

• Implications for rehabilitation

• CTM and KT have similar effectiveness in alleviating the constipation-related symptoms and improving quality of life in children with CP.

• CTM and KT can be integrated into bowel rehabilitation programs.

• Considering the characteristics of patients, these treatment options can be used as an alternative of each other by physiotherapists.

     

Naloxegol (Movantik®) Provides Rapid and Sustained Improvement of Opioid-Induced Constipation Symptoms Irrespective of Opioid Dose

AimNaloxegol (Movantik), an oral peripherally acting mu-opioid receptor antagonist has demonstrated rapid relief of opioid-induced constipation (OIC) in patients with chronic non-cancer pain in two phase 3 trials (KODIAC 4/5; NCT01309841/NCT01323790). This analysis aims to characterize the OIC symptom burden and evaluate the efficacy of naloxegol in treating symptoms of OIC based on daily opioid dosages. This is the first naloxegol analysis based on a lower opioid dose cutoff of 100 MEU/day.MethodsData were pooled from the KODIAC 4/5 intent-to-treat populations (N=1337). Subjects treated with placebo (PBO) and naloxegol (12.5mg, 25mg) QD were evaluated based on opioid dose ranges (lower dose, ≤100mg; higher dose, >100mg MEU/day). OIC symptoms assessed include number of spontaneous bowel movements (SBM/wk), complete evacuation (CSBM), straining (scale 1=not at all, 5=extreme) and stool consistency (Bristol Stool Scale: 1=hard, 7=watery).ResultsBaseline OIC symptom burden (SBM/wk, CSBM/wk, straining, stool consistency) was similar between lower (n=764) and higher (n=567) opioid dose subgroups. Naloxegol (12.5mg, 25mg) provided significant improvement vs PBO in SBMs/wk in the lower and higher opioid dose subgroups; ≤100 MEU (mean SBM/wk: 2.41, 2.91 vs 1.99, respectively; p<0.05) and ˃100 MEU (mean SBM/wk: 2.81, 3.53 vs 2.05, respectively; p< 0.05). A significant improvement in CSBMs/wk vs PBO was demonstrated in the lower dose subgroup for naloxegol 25mg (mean CSBM/wk: 1.48, 1.97 vs 1.38; p=0.54 and p<0.05, respectively) and in the higher dose subgroup for both naloxegol regimens (mean CSBM/wk: 1.90, 2.36 vs 1.20, respectively; p<0.05). In both dose subgroups, rapid symptom improvement in SBM, CSBM and stool consistency were seen within the first week with naloxegol (p<0.05).ConclusionsRegardless of opioid dose, naloxegol (12.5mg, 25mg) provided rapid and sustained improvement of clinically relevant OIC symptoms. These data suggest that all patients should routinely be assessed for OIC, as lower opioid doses often induce constipation.     

Assessment of reporting completeness in acupuncture studies on patients with functional constipation using the STRICTA guidelines

ObjectiveTo evaluate the completeness of reporting of acupuncture interventions in trials for functional constipation (FC) following the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines.MethodsWe searched eight databases for all published trials, including clinical trials, pilot/feasibility studies, observational studies, and case studies, for acupuncture in patients with FC up to June 31, 2021. The completeness of reporting was evaluated using the STRICTA guidelines.ResultsFinally, 99 studies were included and analysed based on the latest STRICTA guidelines. Out of the 17 analysed STRICTA sub-items, only five were found to be appropriately reported in more than 90% of the trials, while five were completely reported in less than 30%.ConclusionsThe reporting completeness of acupuncture trials for FC in accordance with STRICTA guidelines is moderate, with poor guideline adherence for several items. Clinical trial reports should be further improved in accordance with STRICTA guidelines to enhance the completeness of evidence. There is also a need to explore the underlying reasons as to why the authors did not report these items and to develop strategies for improving guideline compliance.     

Comparison of Connective Tissue Manipulation and Abdominal Massage Combined With Usual Care vs Usual Care Alone for Chronic Constipation: A Randomized Controlled Trial

ObjectiveThe aim of the present study was to determine and compare the effects of connective tissue manipulation (CTM) and abdominal massage when combined with usual care on the symptoms of constipation and quality of life (QoL) immediately following a 4-week treatment in patients suffering from chronic constipation.MethodsA total of 60 patients with chronic constipation were randomly assigned to CTM, abdominal massage, or control groups. Connective tissue manipulation and abdominal massage were conducted at 5 sessions a week for 4 weeks. Each session was approximately 15 to 20 minutes. The severity of constipation by the Constipation Severity Instrument, symptoms of constipation by a bowel diary and Bristol Stool Scale, and QoL by patient assessment of QoL questionnaire were evaluated at baseline and at the end of 4 weeks.ResultsThere were significant differences in the changes in constipation severity (P < .001), symptoms of constipation (P ≤ .001), and QoL (P < .001) among the 3 groups. However, based on pair-wise analysis, there were no significant differences in the changes of the severity and symptoms of constipation and QoL between the CTM and abdominal massage groups (P > .05).ConclusionThe findings of the present study revealed that compared to usual care alone, the combination of usual care and CTM or abdominal massage may be more beneficial for chronic constipation. However, the superiority of CTM or abdominal massage was not observed. Further high-quality studies with long-term follow-up are needed to investigate the optimal massage therapy program in patients with chronic constipation.     

Nonrandomized Clinical Trial of the Effectiveness of a Laxative Treatment Protocol to Time of First Bowel Movement After Uterine Artery Embolization Procedure: A Pilot Study

PurposeThe purpose of this pilot study was to determine the efficacy of a proactive laxative protocol for constipation prevention in patients undergoing uterine artery embolization (UAE).DesignA nonrandomized clinical trial.MethodsA nonrandomized trial study design was piloted using a convenience sample of 35 patients undergoing UAE in the course of 1 year.FindingsThere was a statistically significant difference (P < .0001) in time of first bowel movement after UAE when patients followed a proactive laxative protocol. A combination of senna and stool softener taken twice a day for 2 days preoperatively was associated with a shorter time to first bowel movement postoperatively.ConclusionsThis pilot study supports the benefits of a proactive laxative protocol in helping achieve procedural recovery uncomplicated by constipation in patients undergoing UAE.     

Effects of Elobixibat,an Inhibitor of Ileal Bile Acid Transporter,on Glucose and Lipid Metabolism: A Single-arm Pilot Study in Patients with T2DM

PurposeThe ileal bile acid transporter inhibitor elobixibat was recently approved in Japan for use in the treatment of patients with chronic constipation. Elobixibat has been associated with increased plasma glucagon-like peptide 1 level through Takeda G protein receptor 5, which is a membrane receptor of bile acids. The present study assessed the metabolic effects of elobixibat in patients with type 2 diabetes mellitus (T2DM)-related constipation.MethodsIn this single-arm pilot study, 21 patients with T2DM and constipation were administered elobixibat 10 mg/d for 12 weeks (period 1). The primary end point was the change in hemoglobin (Hb) A_1c at week 12. Secondary end points included physical parameters; constipation symptoms; and blood parameters, such as low-density lipoprotein cholesterol (LDL-C), arachidonic acid (AA), and fatty acid fractions. Thereafter, the study participants chose whether to continue therapy for an additional 12 weeks (period 2), at which point HbA_1c and lipid levels were reevaluated. Safety information, including adverse events, discontinuation and interruption of the drug, was collected at each visit during the trial.FindingsPeriod 1: the levels of HbA_1c, LDL-C, and AA were significantly reduced after administration of elobixibat for 12 weeks (–0.2%, –21.4 mg/dL, and –16.1 µg/dL, respectively; P = 0.016, P < 0.001, and P = 0.010). Period 2: at week 24, the change from baseline in HbA_1c was significantly greater among those who continued elobixibat treatment than in those who discontinued after 12 weeks (–0.23% vs +0.21%; P = 0.038). No serious or severe adverse events were observed.ImplicationsElobixibat may benefit patients with T2DM by improving glucose metabolism and lowering serum LDL-C and AA levels, in addition to ameliorating constipation. This single-arm pilot study was of a small sample size. The findings provide a basis for designing a larger-scale study to confirm the effects of elobixibat on glucose and lipid metabolism. (UMIN Clinical Trials Registry identifier: UMIN000045508; https://www.umin.ac.jp/ctr/index.htm)     

A Longitudinal Study of Predictors of Constipation Severity in Oncology Outpatients With Unrelieved Pain

ContextAlthough constipation is a common symptom in oncology patients, it often goes unrecognized and untreated. In addition, little is known about characteristics associated with interindividual differences in constipation severity.ObjectivesTo describe prevalence, characteristics, and management of constipation; evaluate interindividual differences in constipation severity over 10 weeks; and identify demographic, clinical, and symptom characteristics associated with higher constipation severity scores.MethodsIn this prospective, longitudinal study, 175 oncology patients with unrelieved pain were recruited from eight outpatient cancer settings in the U.S. Patients completed demographic and symptom questionnaires at enrollment. Constipation severity was evaluated over 10 weeks using the Constipation Assessment Scale (CAS). Hierarchical linear modeling was used to identify characteristics associated with higher CAS scores.ResultsAt enrollment, 70.1% of the patients reported constipation [i.e., CAS score of >2; mean CAS score: 3.72 (±3.11)]. While over the first week of the study patients used one to two constipation treatments per day, a large amount of interindividual variability was found in CAS scores. Higher percentage of days with no bowel movement, higher number of constipation treatments, higher state anxiety scores, and higher analgesic side effects scores were associated with higher CAS scores at enrollment. Higher percentage of days with no bowel movement was associated with interindividual differences in the trajectories of constipation.ConclusionOur findings underscore the high prevalence of and large amount of interindividual variability in constipation severity. The characteristics associated with worse CAS scores can assist clinicians to identify high-risk patients and initiate prompt interventions.     

Acupuncture for Breathlessness in Advanced Diseases: A Systematic Review and Meta-analysis

ContextNonpharmacological approaches are effective strategies for difficult to palliate breathlessness. Although acupuncture is effective for dyspnea in early-stage chronic obstructive pulmonary disease (COPD), little is known about its effects in patients with advanced (non)malignant diseases.ObjectivesThe objective of this study was to identify and examine the evidence of acupuncture on breathlessness in advanced malignant and nonmalignant diseases.MethodsSystematic literature review of randomized controlled trials of acupuncture and acupressure searched in five databases. Included were adult participants with at least 25% having advanced diseases such as cancer or COPD with severe breathlessness. Primary outcome was severity of dyspnea on Visual Analogue Scale or Borg Scale. Secondary outcomes included quality of life, function, and acceptability. Data were pooled using a random effects model of standardized mean differences.ResultsTwelve studies with 597 patients (347 COPD, 190 advanced cancer) were included. For breathlessness severity, significant differences were obtained in a meta-analysis (10 studies with 480 patients; standardized mean difference (SMD) = −1.77 [95% CI −3.05, −0.49; P = 0.007; I² = 90%]) and in a subgroup analysis of using sham acupuncture control groups and a treatment duration of at least three weeks (6 studies with 302 patients; SMD = −2.53 [95% CI −4.07, −0.99; P = 0.001; I² = 91%]). Exercise tolerance (6-minute walk test) improved significantly in the acupuncture group (6 studies with 287 patients; SMD = 0.93 [95% CI 0.27, 1.59; P = 0.006; I² = 85%]). In four of six studies, quality of life improved in the acupuncture group.ConclusionAcupuncture improved breathlessness severity in patients with advanced diseases. The methodological heterogeneity, low power, and potential morphine-sparing effects of acupuncture as add-on should be further addressed in future trials.     

Bowel function during pain therapy with oxycodone/naloxone prolonged-release tablets in patients with advanced cancer

Background: The World Health Organization (WHO) step‐III opioids are often required right from the start of pain therapy in order to achieve sufficient symptom control. Bowel dysfunction, particularly constipation, is one of the most frequent and persistent side effects of opioid therapy, and it is known to cause considerable distress in many patients. The aim of the study was to evaluate whether patients with advanced cancer and moderate to severe cancer pain will benefit from treatment with oxycodone/naloxone prolonged‐release tablets (OXN), with particular regard to constipation. Material and methods: In this exploratory, non‐randomised, open‐label, mono‐centre study we evaluated the bowel function in palliative care patients treated with OXN. During the treatment phase patients were titrated up to an adequate pain control. The Bristol Stool Form Scale (BSFS) (type 1–7) and Bowel Function Index (BFI) (0–100) were used to assess consistency and frequency of bowel movements. Global patient satisfaction was assessed with Patient Global Impression of Change Scale (PGIC) (1–7). Statistics: mean ± SD, significance p < 0.05. Results: Twenty‐six patients [10 male patients (38.5%)] were included; mean age 70.6 ± 14.0 years, length of stay 22.6 ± 21.2 days. At admission all patients had opioid‐induced constipation. During the observation period of 14 days the daily mean dose of OX was 36.2 ± 17.2 mg and of N 15.4 ± 5.3 mg. In five cancer patients pain control was not sufficient under the approved maximum total daily dose of 40/20 mg OXN; therefore switching to hydromorphone. BFI improved significantly in 21 patients (72.4 ± 17.0 vs. 36.8 ± 13.4) (p < 0.0001); stool consistency (BSFS) improved from type 2.0 ± 0.7 to 4.9 ± 1.0 (p < 0.0001). PGIC at discharge was 1.9 ± 0.8. Discussion: Patients with OXN treatment throughout the whole study phase showed a clinically relevant improvement in pain intensity and bowel function as well as increased satisfaction. Well‐known disadvantages of laxative treatment might be spared or even circumvented under OXN treatment, if appropriate.     

Acupuncture and moxibustion for endometriosis: A systematic review and analysis

ObjectivesThis study aimed to examine the effect of acupuncture on symptoms and health-related quality of life in patients with endometriosis.MethodsNine biomedical databases were searched to April 2022 to identify randomized controlled trials of acupuncture and/or moxibustion used alone or as adjunct to guideline-recommended pharmacotherapy for the treatment of endometriosis. One reviewer extracted data and another verified the data. A random effects model was used to calculate mean differences.ResultsFifteen trials involving 1018 patients met the inclusion criteria, but diversity in comparisons and outcome measures prevented meta-analysis. Compared to sham acupuncture, manual acupuncture was more effective at reducing dysmenorrhea VAS pain score (mean difference [MD] − 2.40, 95 % CI [− 2.80, − 2.00]; moderate certainty evidence), pelvic pain VAS score (MD − 2.65, 95 % CI [− 3.40, − 1.90]; high certainty evidence) and dyspareunia VAS scores (MD − 2.88, [− 3.83, − 1.93]), lessened the size of ovarian cyst (MD − 3.88, 95 % CI [− 7.06, − 0.70]), and improved quality of life. Compared to conventional therapy, manual acupuncture plus conventional therapy and warm needle alone resulted in greater improvements in quality of life than conventional therapy. Among the six studies that reported safety, fewer adverse events were reported in participants who received acupuncture or moxibustion.ConclusionsLow to moderate certainty evidence from single studies showed that manual acupuncture may improve pain-related symptoms and quality of life; however, there is insufficient evidence on the overall effectiveness of acupuncture and moxibustion for endometriosis.     

Description of analytical method and clinical utility of measuring serum 7-alpha-hydroxy-4-cholesten-3-one (7aC4) by mass spectrometry

BackgroundImbalance of bile acids (BA) homeostasis in the gastrointestinal tract can lead to chronic diarrhea or constipation when BA in the colon are in excess or low, respectively. Since both disturbances of bowel function can result from other etiologies, identifying BA imbalance is important to tailor treatment strategies. Serum concentrations of 7-alpha-hydroxy-4-cholesten-3-one (7aC4), a precursor in bile acid synthesis, reflect BA homeostasis. Here we describe a method to accurately measure serum 7aC4 and evaluate the clinical utility in patients with diarrhea or constipation phenotypes.MethodsSerum 7aC4 is measured after acetonitrile protein precipitation using C18 liquid chromatography, tandem mass spectrometry, and deuterium-labeled 7aC4 internal standard. Assay performance including linearity, precision, and accuracy was assessed using waste serum samples. The reference interval was established in healthy individuals without BA-altering conditions or medications. Clinical performance was assessed in patients with irritable bowel syndrome.ResultsThe method precisely and accurately measured 7aC4 in human serum from 1.4–338 ng/mL with no ion suppression or interference from related 7-keto-cholesterol. Central 95th percentile reference interval was 2.5–63.2 ng/mL. Lower serum 7aC4 was found in patients with constipation with sensitivity/specificity of 79%/55% compared to healthy controls. Higher 7aC4 was found in patients with bile acid diarrhea (BAD) compared to those without BAD with sensitivity/specificity of 82%/53%.ConclusionsWe have developed a sensitive and precise assay for measuring the concentration of 7aC4 in serum. The assay can be used to screen for diarrhea caused by bile acid malabsorption.     

The efficacy of Tung’s acupuncture for sex hormones in polycystic ovary syndrome: A randomized controlled trial

BackgroundPolycystic ovary syndrome (PCOS) is a common and heterogeneous endocrine disorder in reproductive-age women. Tung's acupuncture, a Traditional Chinese Medicine (TCM) treatment, is widely used for PCOS in East Asia, but evidence on its efficacy is rare. The aim of this RCT study was to examine whether the Tung’s acupuncture could be a complementary treatment method for PCOS.MethodsA total of 60 PCOS patients were randomly assigned to a Tung's acupuncture group (n = 30) or a cyproterone acetate/ethinylestradiol (CPA/EE) group (n = 30). Each participant received treatments for 12 weeks to assess the short-term treatment efficacy and then followed up for another 12 weeks to assess the long-term treatment efficacy. The primary outcome examined was change in the ratio of luteinizing hormone (LH) to follicle-stimulating hormone (FSH); the secondary outcomes examined were changes in body mass index (BMI), LH, FSH, total testosterone (TT), ovarian volume, polycystic ovary number and menstrual frequency.ResultsBoth groups showed significant reductions in the LH/FSH ratio, LH and TT after 12-week treatment (p < 0.001) and 12-week follow-up (p < 0.05). No significant differences existed between the two groups (p > 0.05). Both groups showed significant improvement in BMI, menstrual frequency and polycystic ovary number after 12-week treatment (p < 0.05).ConclusionCompared with CPA/EE, Tung’s acupuncture showed no better improvement on LH/FSH ratio for PCOS although it could reduce the ratio. Tung's acupuncture might have some effect on long-term weight control and menstruation frequency. Further studies addressing this study’s limitations are recommended.     

Emesis in patients receiving acupuncture,sham acupuncture or standard care during chemo-radiation: A randomized controlled study

ObjectiveTo study nausea, vomiting and need for rescue antiemetics in patients receiving antiemetic acupuncture, sham acupuncture or standard care during concomitant chemotherapy during pelvic radiotherapy.MethodsIn total, 68 patients participated (75% women, mean age 56 years, 53% had gynecological, 43% colorectal, and 4% other cancer types). Fifty-seven of them were blinded randomized to verum (n = 28) or sham (n = 29) acupuncture, median 10 sessions. During the study period of four weeks, the patients daily registered their nausea, vomiting and consumption of antiemetics. They were compared to a reference group (n = 11) receiving standard care only, who delivered these data once (after receiving mean 27 Gy radiotherapy dose).ResultsMore patients in the sham acupuncture group (17 of 20; 85%, p = 0.019, RR 1.81, CI 1.06–3.09) consumed antiemetics, compared to the verum acupuncture group (8 of 17; 47%). In the standard care group, 7 of 11 (63%) consumed antiemetics. The verum acupuncture treated patients experienced lower intensity of nausea than the other patients (p = 0.049). There was a non-significant tendency that more patients receiving either sham acupuncture or standard care experienced nausea (21 of 31; 68%) than patients receiving verum acupuncture (9 of 17; 53%: p = 0.074, RR 1.58, CI 0.91–2.74).ConclusionPatients treated with verum acupuncture needed less antiemetics and experienced milder nausea than other patients. Our study was small and many analyses lacked statistical power to detect differences; we welcome further sham-controlled efficacy studies and studies regarding the role of non-specific treatment components for experiencing antiemetic effects of acupuncture.     

Impact of Femoropopliteal Bypass Surgery on the Survival and Amputation Rate of End-Stage Renal Disease Patients with Critical Limb Ischemia

Abstract Background and Purpose:  The appropriate medical approach to treat patients with end-stage renal disease (ESRD) and critical limb ischemia (CLI) is still controversial. The goal of this study was to investigate the survival rate of ESRD patients with foot ulcers who underwent femoropopliteal bypass surgery versus patients who did not receive any major surgical interventions. Patients and Methods:  A 5-year Kaplan-Meier survival analysis of 99 ESRD subjects with foot ulcers, stage IV, recruited in the authors' single-center study between 1997 and 2005, was performed. 27 patients underwent bypass surgery because of meeting standard eligibility criteria for this procedure, and 72 patients received only conventional treatment due to their poorer vascular condition. Patients were censored upon major amputation during the observation period. Start of the observation was date of ulcer diagnosis. Results:  Survival rate was 16.2% (standard error [SE], 0.08) in the bypass group versus 18.6% (SE, 0.06) in the non-bypass group (p = 0.92; log-rank test). Median time to bypass surgery was 0.36 years (range, 0–2.65 years) after ulcer diagnosis. Six patients of 27 (22.2%) were censored due to major amputation in the bypass group versus 25 patients of 72 (34.7%) in the non-bypass group. Conclusion:  These results may suggest that bypass surgery in ESRD patients with foot ulcers as treatment of CLI is not the appropriate surgical approach, since this procedure does not seem to cause a better survival than in patients who could not undergo revascularization surgery because of their poorer overall vascular condition.      

Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial

BackgroundShoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome.ObjectiveTo decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture.MethodRandomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0–35 points).ResultsA total of 68 participants were included in the analysis (TA, n = 35; SA, n = 33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported.ConclusionsThe use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services.     

Assessment of anti-inflammatory efficacy of acupuncture in patients with inflammatory bowel disease: A systematic review and meta-analysis

BackgroundInflammation has a significant role in the onset and progression of inflammatory bowel disease (IBD). Increasing attention has been paid to the use of acupuncture in IBD patients; however, its regulatory effects on inflammatory factors in IBD still require validation. Here, we systematically evaluated the effects of acupuncture on inflammatory factors in IBD patients.MethodsEight electronic databases were searched for studies that met the inclusion criteria. After evaluating the quality of the studies selected by two reviewers, the meta-analysis was performed to assess the efficacy of acupuncture in IBD patients and the impact on inflammatory factors (TNF-α, IL-1, IL-8 and IL-10).ResultsFour randomized controlled trials with a total of 228 patients satisfied the inclusion criteria. Acupuncture has a positive therapeutic impact on IBD (MD = 1.22, 95% CI [1.07, 1.39], P = 0.003). Moreover, it regulates the levels of TNF-α (MD =−60.58, 95% CI [−100.30, −20.89], P = 0.003), IL-8 (MD =−56.40, 95% CI [−60.02, −52.14], P < 0.00001) and IL-10 (MD =35.96, 95% CI [11.02, 60.91], P = 0.005) in IBD patients. However, the P value of meta-analysis in IL-1 great than 0.05.(MD =−27.90, 95% CI [−97.82, 42.02], P = 0.11).ConclusionAcupuncture has a positive therapeutic impact on IBD and can effectively regulate inflammatory factors in IBD patients. TNF-α, IL-8 and IL-10 are more appropriate inflammatory indicators for clinically evaluating the anti-inflammatory response in the blood of IBD patients by acupuncture.     

Effects of anterior cruciate ligament reconstruction on patellofemoral joint stress and lower extremity biomechanics at 12 weeks post-surgery and at time of return to sport in adolescent females

BackgroundThe purpose of this study was to examine kinematic and kinetic differences associated with patellofemoral pain after anterior cruciate ligament reconstruction between limbs at 12-week post-surgery and at time of return to sport.MethodTwenty-four adolescent females completed 5 consecutive single leg squats on each limb at 12-weeks post-surgery and again during their RTS assessment. Peak knee extension moment, peak hip adduction angle, and patellofemoral joint stress at 45 degrees of knee flexion were calculated. Separate two by two repeated measures ANOVA were performed.FindingsThere was a significant interaction (limb × time) for knee extension moment (p < 0.001). Surgical limb knee extension moment was significantly less than the non-surgical limb at return to sport (p < 0.001). At 12-weeks the surgical limb was significantly less than non-surgical limb (p < 0.001), additionally the surgical limb was significantly greater at time of return to sport than at 12 weeks (p < 0.001). There was a significant main effect of limb for hip adduction angle (p = 0.002). Surgical limb was significantly greater than non-surgical limb (Surgical = 9.84 (SE 1.53) degree, non-surgical = 4.79 (SE 1.01) degree). There was also a main effect of time and limb for patellofemoral joint stress. Return to sport was significantly greater than 12 weeks and the surgical limb was significantly less than non-surgical limb (Surgical = 4.93 (SE 0325) MPa, Nonsurgical = 5.29 (SE 0.30) MPa).InterpretationThe surgical limb of participants following ACL-R demonstrated variables that have been associated with the development of patellofemoral pain.     

The effectiveness and safety of acupuncture treatment on sciatica: A systematic review and meta-analysis

BackgroundSciatica results from primary or secondary damage to the sciatic nerve in the lumbar or gluteal region. The first option for sciatica is analgesics, but their therapeutic effect and safety in long-term use are questionable. On the other hand, acupuncture has recently been recognized as a complementary and alternative medicine (CAM) to conventional medicine, and studies on its effectiveness and safety have been actively conducted.ObjectiveTo systematically compare acupuncture with analgesics in terms of effect, safety, and durability in the treatment of sciaticaMethodsThis review was performed in accordance with Cochrane Handbook for Systematic Reviews of Interventions Version 6.2. Four databases were searched for this review: Wangfang, the Korean Traditional Knowledge Portal (KTKP), PubMed, and EBSCOhost. The primary outcome measures in the review were total effective rate (TER), visual analog scale (VAS) score and pain threshold, and the secondary ones were adverse effects (AEs) and relapse rates. Risk ratio (RR) for TER and mean difference (MD) for VAS score and pain threshold were used as statistics for the meta-analysis of effectiveness, along with associated 95 % confidence intervals (CIs) and P-values. AEs and relapse rates were used for the safety and durability of the interventions. Version 2 of the Cochrane risk-of-bias assessment tool for randomized trials (RoB 2) was used for the methodological quality of randomized controlled trials (RCTs) included in the review.ResultsThe synthesized TER of 28 RCTs involving 2707 participants was significantly higher in the acupuncture group compared to the analgesic group (RR [95 % CI] = 1.20 [1.16, 1.24], P < 0.001). The synthesized VAS score of 7 RCTs involving 589 participants was significantly reduced in the acupuncture group compared to the analgesic group (MD [95 % CI] = − 1.78 [− 2.44, − 1.12], P < 0.001). In 5 RCTs involving 311 participants, the synthesized pain threshold was significantly elevated in the acupuncture group compared to the analgesic group (MD [95 % CI] = 0.93 [0.64, 1.22], P < 0.001). Additionally, adverse effects (AEs) and relapse rates of RCTs in the review were lower in the acupuncture group compared to the analgesic group.ConclusionIn this systematic review, acupuncture treatment was significantly effective and safe compared to analgesics in sciatica. In the future, studies with a rigorous study design are required to increase the validity of the effectiveness and safety of acupuncture treatment for sciatica.