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- A randomized controlled trial of acupuncture to treat functional constipation: design and protocol. [JOURNAL ARTICLE]
- BMC Complement Altern Med 2014 Oct 29; 14(1):423.
Functional constipation (FC) is a common gastrointestinal disorder (FGIDs) which has a major impact on the quality of life. Acupuncture is widely used as an alternative and complementary medicine (CAM) for FC, but the available evidence of its effectiveness is scarce. Therefore, we will perform a randomized controlled trial to determine whether acupuncture improves symptom and quality of life in FC patients more effectively than sham acupuncture or gastrointestinal prokinetic agent. This article will report the protocol of the trial.The current trial is a multicenter, randomized, three-arm controlled study undergoing in China. About 243 people who aged from 18 to 65 years with FC will be recruited in this study. These participants will be randomly allocated into three treatment groups, including electro-acupuncture (EA), Mosapride (M) and Mosapride & Sham Electro-acupuncture (MS) groups in a 1:1:1 ratio. Both the EA and sham EA receives 16 sessions of needling at Quchi (LI11) and Shangjuxu (ST37) during 4 weeks of treatment, and a follow-up period of 4 weeks. These groups will be compared on the primary outcomes of the number of times of defecation at baseline and 2, 4, 8 weeks after randomization. The secondary outcome measures include: stool consistency, intensity of defecating difficulty, MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), and the validated Patient Assessment of Constipation Quality of Life (PAC-QOL). These outcomes are measured at baseline and 2, 4 weeks after randomization, but SF-36 is measured at baseline and 4 weeks after randomization.This study will supply significant evidence for using acupuncture to treat FC, and will help us to observe whether it is a therapeutic effect rather than a placebo effect.
- Risk of Associated Conditions in Relatives of Subjects With Interstitial Cystitis. [JOURNAL ARTICLE]
- Female Pelvic Med Reconstr Surg 2014 Oct 27.
Urological chronic pelvic pain syndrome includes interstitial cystitis/painful bladder syndrome (IC/PBS), a chronic bladder pain condition of unknown etiology. Interstitial cystitis/painful bladder syndrome can co-occur with a number of associated conditions such as irritable bowel syndrome and fibromyalgia. The purpose of this study was to estimate the heritability of approximately 20 associated conditions in first-degree relatives (and if appropriate, second- and third-degree relatives) of patients with IC/PBS to identify shared genetic contributions for the disease combinations.We used the Utah Population Database, a unique population-based genealogical database that has been linked to electronic health records for the University of Utah Health Sciences Center back in 1994. Interstitial cystitis/painful bladder syndrome probands were identified by the International Classification of Diseases, Ninth Revision code for chronic interstitial cystitis and had genealogy information for 12 of their 14 immediate ancestors. We calculated excess risk of an associated condition in relatives of patients with IC/PBS using relative risk estimates.We identified 248 IC/PBS probands. We found that 2 associated conditions, myalgia and myositis/unspecified (fibromyalgia) as well as constipation, were in significant excess in the patients with IC/PBS themselves, their first-degree relatives, and their second-degree relatives. The excess risk among relatives between IC/PBS and these associated conditions also held in the converse direction. Excess risk of IC/PBS was observed in the first- and second-degree relatives in probands with myalgia and myositis/unspecified (fibromyalgia) and in probands with constipation.These results suggest that myalgia and myositis/unspecified (fibromyalgia) as well as constipation are likely to share underlying genetic factors with IC/PBS.
- Clinical characteristics of pediatric constipation in South jordan. [Journal Article]
- Pediatr Gastroenterol Hepatol Nutr 2014 Sep; 17(3):155-61.
Constipation is a common pediatric problem worldwide. This study aims to describe the clinical characteristics of pediatric constipation in south Jordan according to gender and age group.All patients with constipation managed at our pediatric gastroenterology service between September 2009 and December 2012 were included. Hospital charts were reviewed. Demographic data, clinical characteristics, and final diagnosis were recorded. Data were analyzed according to gender and the following age groups: infants, pre-school, school age, and adolescents.During the study period, 126 patients were enrolled. The number (percentage) of patients according to age were the following infants: 43 (34.1%), pre-school: 55 (43.7%), school age: 25 (19.8%), and adolescents: 3 (2.4%). Males made up 54.8% of the study population. There were no statistical gender differences in any age group. The most common symptom in all age groups was dry, hard stool. Infrequent defecation was found in almost one-half of the patients. Fecal incontinence was more common in school-aged children compared to pre-school-aged children and adolescents. Abdominal pain was seen in almost 40% of the constipated children. Abdominal pain was more prevalent in girls and older children. Fecal mass in the rectum was the most common physical finding, with constipated boys exhibiting higher rates. Functional constipation was the most common etiology.Clinical characteristics of constipation in children vary according to age group and gender. Older children had less frequent bowel motions, a longer duration of symptoms, and a higher prevalence of long-standing constipation compilations (fecal incontinence and abdominal pain).
- Prevalence of narcotic bowel syndrome in opioid abusers in iran. [Journal Article]
- Middle East J Dig Dis 2014 Oct; 6(4):208-13.
BACKGROUNDIn spite of the increasing trend in opioid abusers worldwide, the prevalence of narcotic bowel syndrome (NBS) is undetermined. We aimed to estimate the prevalence of NBS and other opioid bowel dysfunction (OBD) in opioid abusers in Kerman, southeast Iran. According to the best of our knowledge, this is the first study to assess the prevalence of NBS in opioid abusers.
METHODSBy referring to addiction treatment centers in Kerman city and in a cross-sectional study, 577 subjects with opium or opioid subtracts abuse were included in our study. A validated questionnaire was used for OBD assessment and diagnosis of NBS was made according to both the presence of chronic abdominal pain despite increasing the opioid dose and ruling out other causes of abdominal pain. SPSS software version 16 was used for data analysis. p value<0.05 was considered as statistically significant.
RESULTSConstipation, regurgitation, and heartburn were the most gastrointestinal complaints that were found in 132(22.9%), 123(21.3%) and 91(15.8%) subjects, respectively. Only 16(2.8%) participants fulfilled all the NBS criteria. Simultaneous use of non-narcotic sedative drugs increased the risk of NBS significantly (the odds ratio 3:1 and p=0.049).
CONCLUSIONNBS is not rare among opioid abusers and should be considered as a cause of chronic abdominal pain in this group.
- Self-reported pelvic organ prolapse surgery, prevalence, and nonobstetric risk factors: findings from the Nord Trøndelag Health Study. [JOURNAL ARTICLE]
- Int Urogynecol J 2014 Oct 28.
The aim of this study was to assess prevalence and risk factors of self-reported pelvic organ prolapse (POP) surgery in a Nordic county.We assessed cross-sectional data collection from participants in the Nord-Trøndelag Health Study in 2006-2008. All women in the county ≥30 years were eligible, of whom 20,285 (50.3 %) responded by completing questionnaires and attending screening stations. Outcome measures were self-reported POP surgery, age at survey, sociodemographic factors, and information on selected risk factors for POP: self-reported smoking, chronic obstructive pulmonary disease (COPD), asthma, constipation a decade prior, and measured body mass index (BMI). Descriptive statistics, Kaplan-Meier estimates, and multivariate logistic regression were used. Statistical significance was defined as p ≤ 0.01.POP surgery was reported by 1,123 (5.3 %) of all women: 0.7 % < age 40, 3.1 % between age 40 and 59, and 10.8 % age >60. Cumulative incidence by age 85 was 14.6 %; mean age at surgery was 51.6 [standard deviation 14.7]. After adjustment for sociodemographic and lifestyle factors, odds ratios (OR) with 99 % confidence intervals (CI) for reporting the need for POP surgery were marked constipation 1.83 (1.30-2.56), BMI categories above normal 1.58-1.64 (1.10-2.25), COPD 1.51 (1.06-2.16), occupation involving lifting compared with sitting 1.40 (0.98-2.01), and asthma 1.25 (0.98-1.59). Cigarette smoking was not significantly associated.Prevalence of self-reported POP surgery was high and increased with age. Constipation reported a decade prior, above-normal BMI, and COPD were significant nonobstetric risk factors.
- Neodymium yttrium-aluminium-garnet laser resection significantly improves quality of life in patients with malignant central airway obstruction due to lung cancer. [JOURNAL ARTICLE]
- Eur J Cancer Care (Engl) 2014 Oct 27.
Neodymium yttrium-aluminium-garnet (Nd : YAG) laser resection is one of the mostly used interventional pulmonology techniques for urgent desobstruction of malignant central airway obstruction (CAO). The major aim of this trial was to evaluate potential influence of Nd : YAG laser resection on overall quality of life (QoL) in patients with central lung cancer. Patients with malignant CAO scheduled for Nd : YAG laser resection were prospectively recruited in the trial. All patients were given European Organization for Research and Treatment, Quality of Life questionnaire (EORTC QLQ-30 v.3) before the procedure and approximately 2 weeks after the treatment. There were 37 male and 10 female patients, average age 54 ± 10 years. Most common tumour type was adenocarcinoma diagnosed in 51% of patients. Majority of patients were diagnosed in stage IIIB (53.2%) and stage IV (25.5%). Most common Eastern Cooperative Oncology Group performance status was 1 (72.3%). Nd : YAG laser resection significantly improved (P < 0.0001) QoL and overall health according to EORTC QLQ-30. However, in some of the questions dealing with nausea, vomiting, diarrhoea, constipation, family life, social activities and financial situation, we did not observe statistically significant improvement. Nd : YAG laser resection of malignant CAO significantly improves QoL and overall health in patients with lung cancer.
- Tolterodine extended release in the treatment of male oab/storage luts: a systematic review. [JOURNAL ARTICLE]
- BMC Urol 2014 Oct 27; 14(1):84.
Overactive bladder (OAB)/ storage lower urinary tract symptoms (LUTS) have a high prevalence affecting up to 90% of men over 80 years. The role of sufficient therapies appears crucial. In the present review, we analyzed the mechanism of action of tolterodine extended-release (ER) with the aim to clarify its efficacy and safety profile, as compared to other active treatments of OAB/storage LUTS.A wide Medline search was performed including the combination of following words: "LUTS", "BPH", "OAB", "antimuscarinic", "tolterodine", "tolterodine ER". IPSS, IPSS storage sub-score and IPSS QoL (International Prostate Symptom Score) were the validated efficacy outcomes. In addition, the numbers of urgency episodes/24 h, urgency incontinence episodes/24 h, incontinence episodes/24 h and pad use were considered. We also evaluated the most common adverse events (AEs) reported for tolterodine ER.Of 128 retrieved articles, 109 were excluded. The efficacy and tolerability of tolterodine ER Vs. tolterodine IR have been evaluated in a multicenter, double-blind, randomized placebo controlled study in 1529 patients with OAB. A 71% mean reduction in urgency incontinence episodes was found in the tolterodine ER group compared to a 60% reduction in the tolterodine IR (p < 0.05). Few studies evaluated the clinical efficacy of alpha-blocker/tolterodine combination therapy. In patients with large prostates (prostate volume >29 cc) only the combination therapy significantly reduced 24-h voiding frequency (2.8 vs. 1.7 with tamsulosin, 1.4 with tolterodine, or 1.6 with placebo). A recent meta-analysis evaluating tolterodine in comparison with other antimuscarinic drugs demonstrated that tolterodine ER was significantly more effective than placebo in reducing micturition/24 h, urinary leakage episodes/24 h, urgency episodes/24 h, and urgency incontinence episodes/24 h. With regard to adverse events, tolterodine ER was associated with a good adverse event profile resulting in the third most favorable antimuscarinic. Antimuscarinic drugs are the mainstay of pharmacological therapy for OAB / storage LUTS; several studies have demonstrated that tolterodine ER is an effective and well tolerated formulation of this class of treatment.Tolterodine ER resulted effective in reducing frequency urgency and nocturia and urinary leakage in male patients with OAB/storage LUTS. Dry mouth and constipation are the most frequently reported adverse events.
- Clozapine for treatment-resistant bipolar disorder: a systematic review. [JOURNAL ARTICLE]
- Bipolar Disord 2014 Oct 27.
To evaluate the efficacy and safety of clozapine for treatment-resistant bipolar disorder (TRBD).A systematic review of randomized controlled studies, open-label prospective studies, and retrospective studies of patients with TRBD was carried out. Interventions included clozapine monotherapy or clozapine combined with other medications. Outcome measures were efficacy and adverse drug reactions (ADRs).Fifteen clinical trials with a total sample of 1,044 patients met the inclusion criteria. Clozapine monotherapy or clozapine combined with other treatments for TRBD was associated with improvement in: (i) symptoms of mania, depression, rapid cycling, and psychotic symptoms, with many patients with TRBD achieving a remission or response; (ii) the number and duration of hospitalizations, the number of psychotropic co-medications, and the number of hospital visits for somatic reasons for intentional self-harm/overdose; (iii) suicidal ideation and aggressive behavior; and (iv) social functioning. In addition, patients with TRBD showed greater clinical improvement in long-term follow-up when compared with published schizophrenia data. Sedation (12%), constipation (5.0%), sialorrhea (5.2%), weight gain (4%), and body ache/pain (2%) were the commonly reported ADRs; however, these symptoms but did not usually require drug discontinuation. The percentage of severe ADRs reported, such as leukopenia (2%), agranulocytosis (0.3%), and seizure (0.5%), appeared to be lower than those reported in the published schizophrenia literature.The limited current evidence supports the concept that clozapine may be both an effective and a relatively safe medication for TRBD.
- Long-term evaluation of combined prolonged-release oxycodone and naloxone in patients with moderate-to-severe chronic pain: pooled analysis of extension phases of two Phase III trials. [JOURNAL ARTICLE]
- Neurogastroenterol Motil 2014 Oct 23.
While opioids provide effective analgesia, opioid-induced constipation (OIC) can severely impact quality of life and treatment compliance. This pooled analysis evaluated the maintenance of efficacy and safety during long-term treatment with combined oxycodone/naloxone prolonged-release tablets (OXN PR) in adults with moderate-to-severe chronic pain.Patients (N = 474) received open-label OXN PR during 52-week extension phases of two studies, having completed 12-week, double-blind, randomized treatment with oxycodone prolonged-release tablets (Oxy PR) or OXN PR. Analgesia and bowel function were assessed at each study visit using 'Average pain over last 24 h scale and Bowel Function Index (BFI), respectively. Treatment Satisfaction Questionnaire for Medication was assessed at study end only.Improvement in bowel function was particularly marked in patients who switched from Oxy PR in the double-blind phase to OXN PR during the extension phase, resulting in a clinically meaningful reduction (≥12 points) in BFI score: at the start of the extension phases, mean (SD) BFI score was 44.3 (28.13), and was 29.8 (26.36) for patients who had received OXN PR in the double-blind phase. One week later, BFI scores were similar for the two groups (26.5 [24.40] and 27.5 [25.60], respectively), as was observed throughout the following months. Fewer than 10% of patients received laxatives regularly. Mean 24-h pain scores were low and stable throughout the extension phases. No unexpected adverse events were observed.Pooled data demonstrate OXN PR is an effective long-term therapy for patients with chronic non-cancer pain, and can address symptoms of OIC. No new safety issues were observed which were attributable to the long-term administration of OXN PR.
- Phase I/II study with ruthenium compound NAMI-A and gemcitabine in patients with non-small cell lung cancer after first line therapy. [JOURNAL ARTICLE]
- Invest New Drugs 2014 Oct 25.
Background This phase I/II study determined the maximal tolerable dose, dose limiting toxicities, antitumor activity, the pharmacokinetics and pharmacodynamics of ruthenium compound NAMI-A in combination with gemcitabine in Non-Small Cell Lung Cancer patients after first line treatment. Methods Initial dose escalation of NAMI-A was performed in a 28 day cycle: NAMI-A as a 3 h infusion through a port-a-cath at a starting dose of 300 mg/m(2) at day 1, 8 and 15, in combination with gemcitabine 1,000 mg/m(2) at days 2, 9 and 16. Subsequently, dose escalation of NAMI-A in a 21 day schedule was explored. At the maximal tolerable dose level of this schedule an expansion group was enrolled of which 15 patients were evaluable for response. Results Due to frequent neutropenic dose interruptions in the third week, the 28 day schedule was amended into a 21 day schedule. The maximal tolerable dose was 300 and 450 mg/m(2) of NAMI-A (21 day schedule). Main adverse events consisted of neutropenia, anemia, elevated liver enzymes, transient creatinine elevation, nausea, vomiting, constipation, diarrhea, fatigue, and renal toxicity. Conclusion NAMI-A administered in combination with gemcitabine is only moderately tolerated and less active in NSCLC patients after first line treatment than gemcitabine alone.