Assessment of pain between sedated and unsedated colonoscopy: Double-blind randomized clinical trail.

BACKGROUND: Colonoscopy plays a vital role for the diagnosis and treatment of colonic diseases but can be associated with anxiety and discomfort or pain. We tested whether unsedated colonoscopy impacts quality indicators and investigated predictors of pain during colonoscopy. MATERIALS AND METHODS: This randomized controlled trial was performed on candidates for elective colonoscopy at AL Zahra Hospital, Isfahan at 2018-2019. Balanced block randomization was used to allocate 275 cases into two groups. At finally, 124 patients in case and 122 patients in control group enrolled in analysis. Patients in the sedation group received midazolam with/out pethidine before colonoscopy. Pain intensity in rectal examination (PIREX), preprocedural anxiety, pain intensity during colonoscopy, hemodynamics, duration of colonoscopy, polyp detection rate, cecal intubation rate, bloating within 24 h after colonoscopy, and willingness to repeat colonoscopy were assessed and compared between two groups. RESULTS: Compared to the group with sedation, cecal intubation time was shorter and bloating was less frequent (7% vs. 16%, P = 0.02) in the unsedated group. There was no difference between the two groups regarding polyp detection rate, cecal detection rate, and willingness to repeat colonoscopy. Pain during rectal examination was significantly associated with pain during colonoscopy (P < 0.001, 95% confidence interval; 0.5-1.3). CONCLUSION: The assessment of pain intensity during rectal examination may help to identify patients who can benefit from sedation during colonoscopy. Colonoscopy with sedation does not seem to have a negative impact on colonoscopy quality indicators, and may even reduce cecal intubation time and bloating following procedure.

Autonomic Modulation of Cardiac Activity Across Levels of Sleep Depth in Individuals With Depression and Sleep Complaints.

OBJECTIVE: We assessed mean heart rate (HR) and HR variability (HRV) across wake, rapid eye movement (REM) sleep, and non-REM (NREM) sleep, and across varying levels of NREM sleep depth in individuals with depression and sleep complaints. METHODS: Retrospective polysomnographic data were obtained for 25 individuals diagnosed as having depression (84% female; mean age = 33.8 ± 12.2 years) and 31 mentally healthy controls (58.1% female; mean age = 37.2 ± 12.4 years). All were free of psychotropic and cardiovascular medication, cardiovascular disease, and sleep-related breathing disorders. HR and time-domain HRV parameters were computed on 30-second electrocardiography segments and averaged across the night for each stage of sleep and wake. RESULTS: Compared with the control group, the depression group had higher HR across wake, REM, and all levels of NREM depth (F(1,51) = 6.3, p = .015). Significant group by sleep stage interactions were found for HRV parameters: SD of normal-to-normal intervals (SDNN; F(2.1,107.7) = 4.4, p = .014) and root mean square differences of successive R-R intervals (RMSSD; F(2.2,113.5) = 3.2, p = .041). No significant group difference was found for SDNN or RMSSD during wake (all, p ≥ .32). However, compared with the control group, the depression group had significantly lower SDNN in REM (p = .040) and all NREM stages (all p ≤ .045), and lower RMSSD during NREM 2 (p = .033) and NREM 3 (p = .034). CONCLUSIONS: This study suggests that the abnormalities in autonomic cardiac regulation associated with depression and sleep problems are more prominent during sleep, especially NREM sleep, than during wake. This may be due to abnormalities in parasympathetic modulation of cardiac activity.

Effect of Vitamin D Therapy on Sexual Function in Women with Sexual Dysfunction and Vitamin D Deficiency: A Randomized, Double-Blind, Placebo Controlled Clinical Trial.

PURPOSE: We investigated the effect of vitamin D therapy on sexual function in women with low vitamin D levels and sexual dysfunction. MATERIALS AND METHODS: We performed this randomized, double-blind, placebo controlled trial in women 18 to 45 years old with sexual dysfunction, defined as a FSFI (Female Sexual Functioning Index) score less than 26.55, and serum 25[OH]D less than 30 ng/ml. Participants received an intramuscular injection of 300,000 IU cholecalciferol or a placebo at baseline and then after 4 weeks. Sexual function was evaluated with the FSFI at baseline, and 4 and 8 weeks. The serum level of 25[OH]D was measured and depression symptoms were evaluated by the BDI (Beck Depression Inventory) at baseline and 8 weeks. RESULTS: A total of 38 women in each group completed the study. Serum 25[OH]D levels increased only in the cholecalciferol group by a mean ± SD of 14.4 ± 3.2 ng/ml (p <0.001). The FSFI score was higher in the intervention group at study week 4 (19.6 vs 16.3, p = 0.002) and week 8 (25.0 vs 17.1, p <0.001). The BDI score was significantly decreased only in the cholecalciferol group by a mean of -21.0 ± 12.3 (p <0.001). The effect of treatment on sexual function was independent of its effect on depression symptoms. CONCLUSIONS: Vitamin D therapy in women with sexual dysfunction and vitamin D deficiency can improve sexual function. This effect does not seem to be mediated by an improvement in depression symptoms.

Premedication with benzodiazepines for upper gastrointestinal endoscopy: Comparison between oral midazolam and sublingual alprazolam.

BACKGROUND: Premedication with orally administered benzodiazepines is effective in reducing anxiety and discomfort related to endoscopic procedures. We evaluated the efficacy and safety of oral midazolam in comparison to sublingual alprazolam as premedication for esophagogastroduodenoscopy (EGD). MATERIALS AND METHODS: Adult candidates for diagnostic EGD received either oral midazolam (7.5 mg in 15 cc apple juice) or sublingual alprazolam (0.5 mg) 30 min before EGD. Procedural anxiety and pain/discomfort were assessed using 11-point numerical rating scales. Patients' overall tolerance (using a four-point Likert scale) and willingness to repeat the EGD, if necessary, were also assessed. Blood pressure, heart rate, and arterial oxygen saturation were monitored from medication to 30 min after the procedure. RESULTS: Patients experienced a similar reduction in procedural anxiety after medication with oral midazolam and sublingual alprazolam; mean (standard deviation [SD] of 1.86 [1.63] and 2.02 [1.99] points, respectively, P = 0.91). Compared to oral midazolam, pain/discomfort scores were lower with sublingual alprazolam; mean (SD) of 4.80 (3.01) versus 3.68 (3.28), P = 0.024. There was no significant difference between the two groups in patients' tolerance, willingness to repeat the procedure, or hemodynamic events. CONCLUSION: Oral midazolam and sublingual alprazolam are equally effective in reducing EGD-related anxiety; however, EGD-related pain/discomfort is lower with alprazolam. Both benzodiazepines are equally safe and can be used as premedication for patients undergoing diagnostic EGD.

No association between serum adenosine deaminase activity and disease activity in Crohn's disease.

BACKGROUND: Adenosine deaminase activity is proposed as a marker of inflammation in some inflammatory conditions. AIMS: To investigate the association of serum adenosine deaminase activity and disease activity in Crohn's disease patients. METHODS: In a cross-sectional study, 30 consecutive known cases of Crohn's disease (15 with active disease and 15 in remission) referring to a university hospital in Tehran (Iran) and 15 age- and gender-matched healthy controls were studied. Disease activity was assessed using the Crohn's disease activity index (cutoff >150). Total serum adenosine deaminase activity, C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin were evaluated in patients. Serum adenosine deaminase activity was measured in controls. RESULTS: Mean age of the patients was 36.8 ± 12.6 years, and 56.7 % were male. Serum adenosine deaminase activity in patients with active disease, patients in remission, and controls was 12.3 ± 5.9, 14.6 ± 6.2, and 11.9 ± 6.4 U/L, respectively (P = 0.458). Compared with patients in remission, those with active disease had higher erythrocyte sedimentation rate (40.4 ± 30.6 vs. 16.9 ± 16.0 mm/h, P = 0.014) and higher frequency of positive C-reactive protein (66.6 vs. 13.3 %, P = 0.004) and positive fecal calprotectin tests (86.6 vs. 33.3 %, P = 0.004). Serum adenosine deaminase activity was not correlated with erythrocyte sedimentation rate (r = 0.05, P = 0.761) and was not different between patients with positive and negative C-reactive protein (12.2 ± 5.4 vs. 14.2 ± 6.5 U/L, P = 0.393) and fecal calprotectin tests (11.7 ± 5.3 vs. 16.0 ± 6.5 U/L, P = 0.063). CONCLUSIONS: In patients with Crohn's disease, serum adenosine deaminase activity is not associated with clinical disease activity or with other inflammation markers and cannot be suggested as an inflammation marker.

Vitamin D Deficiency Associated with Disease Activity in Patients with Inflammatory Bowel Diseases.

BACKGROUND: Evidence exists on the association between vitamin D deficiency and inflammatory bowel diseases (IBD). AIMS: To investigate whether vitamin D level is associated with disease activity and quality of life in IBD patients. METHODS: This cross-sectional study was conducted on known adult IBD patients referred to an outpatient clinic of gastroenterology in Isfahan city, Iran. Disease activity was evaluated using the Simplified Crohn's Disease Activity Index and Simple Clinical Colitis Activity Index. Quality of life was assessed with the Short-Inflammatory Bowel Disease Questionnaire. Serum 25[OH]D was measured using the radioimmunoassay method. Vitamin D deficiency and insufficiency were defined as concentration of <50 and 50-75 nmol/L, respectively. RESULTS: Studied subjects were 85 ulcerative colitis and 48 Crohn's disease patients (54.1% females) with mean age of 42.0 ± 14.0 years. Vitamin D deficiency and insufficiency were present in 52 (39.0%) and 24 (18.0%) patients, respectively. Thirty patients (22.5%) had active disease who, compared with patients in remission, had more frequent low vitamin D levels (80 vs. 50.4%, P = 0.005). Quality of life was not different between patients with low and those with normal vitamin D levels (P = 0.693). In the logistic regression model, low vitamin D was independently associated with active disease status, OR (95% CI) = 5.959 (1.695-20.952). CONCLUSIONS: We found an association between vitamin D deficiency/insufficiency and disease activity in IBD patients. Prospective cohorts and clinical trials are required to clarify the role of vitamin D deficiency and its treatment in clinical course of IBD.

Premedication with sublingual or oral alprazolam in adults undergoing diagnostic upper gastrointestinal endoscopy.

BACKGROUND AND STUDY AIM: Diagnostic esophagogastroduodenoscopy (EGD) is uncomfortable for most patients. We determined the efficacy of alprazolam, administered orally or sublingually, as premedication for sedation during EGD. PATIENTS AND METHODS: Adult EGD candidates were randomly allocated to four groups (n = 55, each group) and received alprazolam (0.5 mg) sublingually or orally, placebo sublingually or orally at 30 minutes before EGD. Main outcome measures included procedure-related anxiety and pain/discomfort (assessed using 11-point numeric scales), patient overall tolerance (assessed using a 4-point Likert scale), need for intravenous sedation, and willingness to repeat the EGD if necessary. RESULTS: Patients experienced greater reduction in anxiety score after medication with sublingual alprazolam (mean 2.25, standard deviation [SD] 1.73) compared with sublingual placebo (mean 0.10, standard error [SE] 0.15]; P < 0.001) and oral alprazolam (0.63, SE 0.14; P < 0.001). Also, pain/discomfort scores were lower with sublingual alprazolam compared with sublingual placebo (3.29, SE 0.29 vs. 4.16, SD 1.86; P = 0.024), and with oral alprazolam compared with oral placebo (3.48, SD 1.69 vs. 5.13, SD 2.39; P  < 0.001). Patient overall tolerance was better with sublingual alprazolam than with sublingual placebo (P = 0.005) or with oral alprazolam (P = 0.009). Regarding intravenous sedation, there was no difference between sublingual alprazolam and sublingual placebo (10.9 % vs. 10.9 %; P = 0.619) or between oral alprazolam and oral placebo (9.0 % vs. 12.7 %; P = 0.381). Willingness to repeat the procedure was greater with sublingual alprazolam than with sublingual placebo (50.9 % vs. 30.9 %; P = 0.026). CONCLUSIONS: Sublingual alprazolam is an effective premedication for sedation during EGD. It reduces anxiety and pain/discomfort related to EGD and increases patient tolerance and willingness to repeat the EGD if necessary. CLINICAL TRIAL REGISTRATION: NCT01949038 ClinicalTrials.gov.

P wave duration and dispersion in Holter electrocardiography of patients with obstructive sleep apnea.

PURPOSE: The underlying mechanisms of the association between obstructive sleep apnea (OSA) and atrial fibrillation (AF) remained unclear. We investigated P wave parameters as indicators of atrial conduction status among OSA patients. METHODS: We studied 42 untreated OSA patients, categorized into mild (6), moderate (18), and severe (18) OSA based on the apnea/hypopnea index (AHI) and 18 healthy controls. Twenty-four-hour Holter electrocardiography was applied to measure P wave parameters including P wave duration and P wave dispersion; difference between the maximum (P-max) and minimum (P-min) measured P wave duration. RESULTS: Mean P wave duration ranged from 110.2 ± 9.3 ms in mild OSA patients to 121.1 ± 15.4 ms in severe OSA patients and was 113.4 ± 10.0 ms in controls with no significant difference among the groups, P = 0.281. P wave dispersion and P-max were significantly longer in those with moderate OSA (68.0 ± 9.3 and 154.2 ± 9.3 ms) and those with severe OSA (71.6 ± 13.7 and 157.2 ± 13.3 ms) than controls (52.6 ± 15.3 and 142.1 ± 15.4 ms), P < 0.05. AHI was significantly correlated with P-max (r = 0.407, P = 0.012) and P wave dispersion (r = 0.431, P = 0.008). With linear regression analysis controlling for age, gender, and BMI, the AHI was independently associated with P wave dispersion (ß = 0.482, P = 0.002). CONCLUSIONS: Using Holter monitoring for measurement of P wave parameters, this study showed an association of OSA with prolonged P-max and P wave dispersion. These results indicate that patients with OSA have disturbances in atrial conduction associated with OSA severity. Repeating this study in a larger sample of patients is warranted.

Seropositivity of cytomegalovirus in patients with recurrent pregnancy loss.

BACKGROUND: Some evidence has shown a relationship between human cytomegalovirus (CMV) infection and pregnancy loss. However, whether recurrent or latent CMV infection or altered immune response to CMV is related to recurrent pregnancy loss (RPL) is unclear. We evaluated CMV infection and avidity of antibodies to CMV in women with RPL. MATERIALS AND METHODS: This case-control study was conducted on 43 women with RPL referred to a clinical immunology out-patient clinic in Isfahan (Iran), and 43 age-matched multiparous women without history of abortion as control subjects. Patients and controls were evaluated for anti-CMV IgG and IgM antibodies and IgG avidity index (AI) using the enzyme linked immunosorbent assay method. Student's t-test and Chi-square test were used to analyze the data. RESULTS: One case (2.3%) of positive anti-CMV IgM was detected in each group. Anti-CMV IgG positivity was more frequent in patients than in controls (90.6% vs. 69.8%, P = 0.014), but there was no difference between the two groups in anti-CMV IgG AI (79.4 ± 11.4 vs. 80.1 ± 10.2, P = 0.781). IgG titer was significantly higher in seropositive cases with RPL than seropositive controls (5.18 ± 1.99 vs. 2.00 ± 0.81, P < 0.001). CONCLUSION: We found that previous exposure to CMV was significantly higher in patients with RPL than the control group. However, no association was found between IgG AI and RPL. Further investigations are needed to find whether latent CMV infection starts an indirect process of autoimmune etiology in RPL or women with RPL have recurrent or reactivation of CMV infection.

Multistrain probiotic and lactulose in the treatment of minimal hepatic encephalopathy.

BACKGROUND: Some evidence has shown benefits of probiotics in the management of minimal hepatic encephalopathy (MHE). We evaluated the efficacy of a multistrain probiotic compound, alone and in combination with lactulose, in the treatment of MHE. MATERIALS AND METHODS: This study has two parts. First, consecutive adult patients with MHE were randomized to receive lactulose (30-60 mL/day) + probiotic (200 million colony forming units of seven bacteria species/day) (Gp-LPr) or lactulose + placebo (Gp-L). In second part, a non-randomized group of patients received probiotic alone (Gp-Pr). Medication duration was for 2 weeks and patients were followed-up for another 8 weeks. Improvement in MHE status was assessed by psychometric hepatic encephalopathy score (PHES). Development of overt encephalopathy, hospitalization, and death were considered as secondary outcomes. RESULTS: Sixty patients (80% male, mean age 38.4 ± 9.6 years) completed the intervention. PHES significantly improved after medication in all the three groups (Gp-LPr: -3.8 ± 3.9 to -1.6 ± 3.0; Gp-L: -4.8 ± 4.1 to -1.6 ± 2.9; and Gp-Pr: -4.9 ± 3.7 to -2.1 ± 2.5, P < 0.001). After 8 weeks follow-up, improvement was maintained in Gp-LPr and Gp-Pr, but there was deterioration in those who did not receive probiotics (Gp-L: PHES score reversed to -4.8 ± 4.2). Two patients (one each in Gp-L and Gp-Pr) experienced overt encephalopathy. One patient was hospitalized due to worsening of ascites (Gp-LPr) and one due to spontaneous bacterial peritonitis (Gp-L). Side effects were mild and not significantly different among the groups. CONCLUSION: Lactulose and probiotics are effective for the treatment of MHE; however, probiotics, but not lactulose, have long-term effects. More studies are required before suggesting probiotics for the standard treatment of MHE.

Impact of healthcare interventions on distress following acute musculoskeletal/orthopaedic injury: a scoping review of systematic reviews.

BACKGROUND: Musculoskeletal injuries can cause distress, and distress is associated with delayed recovery. Numerous interventions have been developed to facilitate recovery from injury, and several systematic reviews evaluate the efficacy of these interventions for reducing psychological distress. OBJECTIVES: This scoping review aims to map the synthesised evidence for the relationship between treatment interventions and distress-related outcomes following acute injury. The objectives were (1) to describe the types of interventions that have been evaluated in relation to distress-related outcomes following accidental injury, (2) to examine the scope of distress-related outcomes that have been measured in relation to these interventions and (3) to explore the range of clinical professions that deliver these interventions. DESIGN: We searched nine electronic databases and grey literature (to 21 April 2022). We included any systematic review reporting on the relationship between interventions delivered in the time following injury and distress-related outcomes. Data relevant to the specific objectives of this scoping review were extracted and described using narrative synthesis. RESULTS: From 8412 systematic reviews imported for screening, 8266 unique records were screened. 179 were selected for full-text review. 84 systematic reviews were included in the study. Interventional types were pharmacological, psychological, exercise based, physical/manual therapies, virtual reality based, multimodal and workplace based. Interventions were delivered digitally, face to face and using virtual reality by a variety of healthcare professionals, including doctors, nurses, psychologists and physiotherapists. The most frequently reported distress-related variables included anxiety, depression, post-traumatic stress disorder diagnosis. CONCLUSION: A wide range of interventions may help to mitigate distress following acute accidental musculoskeletal or orthopaedic injury. Even interventions that were not designed to reduce distress were found to improve distress-related outcomes. In view of the important role of distress in recovery from injury, it is recommended that distress-related variables are measured as core outcomes in the evaluation of treatments for acute injuries.

A digital health intervention to support patients with chronic pain during prescription opioid tapering: a pilot randomised controlled trial.

Introduction: Recent changes in opioid prescribing guidelines have led to an increasing number of patients with chronic pain being recommended to taper. However, opioid tapering can be challenging, and many patients require support. Objectives: We evaluated the feasibility, acceptability, and potential efficacy of a codesigned digital health intervention to support patients with chronic pain during voluntary prescription opioid tapering. Methods: In a pilot randomised controlled trial, participants received a psychoeducational video and 28 days of text messages (2 SMS/day) in addition to their usual care (intervention) or usual care alone (control). The feasibility, acceptability, and potential efficacy of the intervention were evaluated. The primary outcome was opioid tapering self-efficacy. Secondary outcomes were pain intensity and interference, anxiety and depression symptom severity, pain catastrophising, and pain self-efficacy. Results: Of 28 randomised participants, 26 completed the study (13 per group). Text message delivery was high (99.2%), but fidelity of video delivery was low (57.1%). Most participants rated the messages as useful, supportive, encouraging, and engaging; 78.5% would recommend the intervention to others; and 64.2% desired a longer intervention period. Tapering self-efficacy (Cohen d = 0.74) and pain self-efficacy (d = 0.41) were higher, and pain intensity (d = 0.65) and affective interference (d = 0.45) were lower in the intervention group at week 4. Conclusion: First evidence supports the feasibility, acceptability, and potentially efficacy of a psychoeducational video and SMS text messaging intervention to support patients with chronic pain during voluntary prescription opioid tapering. Definitive trials with longer intervention duration are warranted.

The effects of multistrain probiotic compound on bismuth-containing quadruple therapy for Helicobacter pylori infection: a randomized placebo-controlled triple-blind study.

BACKGROUND: Evidence has shown benefits of single-strain probiotics for Helicobacter pylori eradication. We investigated the effects of adding a multistrain probiotic compound on bismuth-containing quadruple therapy for H. pylori infection. MATERIALS AND METHODS: Adult patients with peptic ulcer disease and confirmed H. pylori infection (n = 180) were randomized to receive bismuth-containing quadruple therapy (omeprazole, bismuth subcitrate, amoxicillin, and clarithromycin) plus a probiotic compound or placebo for 2 weeks. The probiotic compound contained seven bacterial species including Lactobacillus and Bifidobacterium strains and Streptococcus thermophiles. Eradication of H. pylori was assessed 4 weeks after medication by (13) C urea breath test. Other outcomes were dyspepsia symptoms, therapy-related adverse effects, and patient's tolerance. RESULTS: Eighty-four patients in the probiotic and 86 in the placebo group completed the trial. With per-protocol (intention to treat) analysis, H. pylori was eradicated in 82.1% (76.6%) of the probiotic and 84.8% (81.1%) of the placebo group, p = .392 (0.292). Symptoms were significantly improved with similar trends in both groups. Regarding the adverse effects, diarrhea was less frequent (2.2 vs 11.1%, p = .016), while abdominal pain was more frequent (10 vs 2.2%, p = .029) in the probiotic group. The two groups were similar in treatment tolerance (p = .851). CONCLUSIONS: In overall, our studied multistrain probiotic compound has not beneficial effects in the treatment of H. pylori infection. It might be related to the low dosage of our probiotic regimen and/or high frequency of upper gastrointestinal adverse effects which in turn could decrease the eradication efficacy.

The psychometric properties of the persian migraine-specific quality of life questionnaire version 2.1 in episodic and chronic migraines.

BACKGROUND: Migraine-specific quality of life (MSQ) is a valid and reliable questionnaire. Linguistic validation of Persian MSQ questionnaire, analysis of psychometric properties between chronic and episodic migraine patients, and capability of MSQ to differentiate between chronic and episodic migraines were the aims of this study. METHOD: Participants were selected from four different neurology clinics that were diagnosed as chronic or episodic migraine patients. Baseline data included information from MSQ v. 2.1, MIGSEV, SF-36, and symptoms questionnaire. At the third week from the baseline, participants filled out MSQ and MIGSEV. Internal consistency (Cronbach alpha) and test-retest reproducibility (intraclass correlation coefficients) were used to assess reliability. Convergent and discriminant validities were also assessed. RESULTS: A total of 106 participants were enrolled. Internal consistencies of MSQ among all patients, chronic and episodic migraines, were 0.92, 0.91, and 0.92, respectively. Test-retest correlation of MSQ dimensions between visits 1 and 2 varied from 0.41 to 0.50. Convergent, item discriminant, and discriminant validities were approved. In all visits MSQ scores were lower in chronic migraine than episodic migraine; however, the difference was not statistically significant. CONCLUSION: Persian translation of MSQ is consistent with original version of MSQ in terms of psychometric properties in both chronic and episodic migraine patients.

Comparison of Lactobacillus Sporogenes plus mineral oil and mineral oil alone in the treatment of childhood functional constipation.

BACKGROUND: Functional constipation is one of the most prevalent childhood gastrointestinal disorders. We evaluated effects of adding a probiotic to mineral oil in the treatment of functional constipation in children. MATERIALS AND METHODS: This controlled trial was conducted on 60 children (2 to 14 years old) with functional constipation (Rome III criteria). Children were allocated to receive the synbiotic (Lactol®, composed of Lactobacillus Sporogenes, 1 Tab/20 kg/d) plus mineral oil (Paraffin 1 ml/kg/d) or the mineral oil alone for two months. Symptoms of constipation including defecation frequency, stool form, strain and pain at defecation, incomplete evacuation and soiling were assessed and compared before and after the intervention. After the treatment period, the two groups were also compared with regards to subjective global assessment of improvement. RESULTS: After the treatment, stool frequency increased in both groups (P < 0.001), with greater increase in synbiotic + mineral oil group (P = 0.001). Frequency of hard/very hard stool and frequency of painful defecation decreased similarly in both groups (P < 0.001). Straining at defecation, incomplete evacuation, and soiling decreased in both groups (P < 0.001), but more decrease was seen in the synbiotic + mineral oil group (P < 0.05). Finally, there was a better global improvement in the synbiotic + mineral oil group (P < 0.05). No severe side-effects were observed in any group. CONCLUSION: Adding the synbiotic Lactol® (containing Lactobacillus Sporogenes) to mineral oil can increase the improvement in the constipation symptoms of children without specific side-effects.

Text messaging intervention to support patients with chronic pain during prescription opioid tapering: protocol for a double-blind randomised controlled trial.

INTRODUCTION: Increases in pain and interference with quality of life is a common concern among people with chronic non-cancer pain (CNCP) who are tapering opioid medications. Research indicates that access to social and psychological support for pain self-management may help people to reduce their opioid dose without increasing pain and interference. This study evaluates the efficacy of a text messaging intervention designed to provide people with CNCP with social and psychological support for pain self-management while tapering long-term opioid therapy (LTOT) under the guidance of their prescriber. METHODS AND ANALYSIS: A double-blind randomised controlled trial will be conducted. Patients with CNCP (n=74) who are tapering LTOT will be enrolled from across Australia. Participants will continue with their usual care while tapering LTOT under the supervision of their prescribing physician. They will randomly receive either a psychoeducational video and supportive text messaging (two Short Message Service (SMS) per day) for 12 weeks or the video only. The primary outcome is the pain intensity and interference assessed by the Pain, Enjoyment of Life and General Activity scale. Secondary outcomes include mood, self-efficacy, pain cognitions, opioid dose reduction, withdrawal symptoms, and acceptability, feasibility, and safety of the intervention. Participants will complete questionnaires at baseline and then every 4 weeks for 12 weeks and will be interviewed at week 12. This trial will provide evidence for the efficacy of a text messaging intervention to support patients with CNCP who are tapering LTOT. If proven to be efficacious and safe, this low-cost intervention can be implemented at scale. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Northern Sydney Local Health District (Australia). Study results will be published in peer-reviewed journals and presented at scientific and professional meetings. TRIAL REGISTRATION NUMBER: ACTRN12622001423707.

A digital health intervention to support patients with chronic pain during prescription opioid tapering: a pilot randomised controlled trial.

Introduction: Recent changes in opioid prescribing guidelines have led to an increasing number of patients with chronic pain being recommended to taper. However, opioid tapering can be challenging, and many patients require support. Objectives: We evaluated the feasibility, acceptability, and potential efficacy of a co-designed psycho-educational video and SMS text messaging intervention to support patients with chronic pain during prescription opioid tapering. Methods: A pilot randomised controlled trial was conducted. In addition to their usual care, participants in the intervention group received a psycho-educational video and 28 days of text messages (two SMS/day). The control group received usual care. The feasibility, acceptability, and potential efficacy of the intervention were evaluated. The primary outcome was opioid tapering self-efficacy. Secondary outcomes were pain intensity and interference, anxiety and depression symptom severity, pain catastrophising, and pain self-efficacy. Results: Of 28 randomised participants, 26 completed the study (13 in each group). Text message delivery was 99.2% successful. Most participants rated the messages as useful, supportive, encouraging, and engaging, 78.5% would recommend the intervention to others, and 64% desired a longer intervention period. Tapering self-efficacy (Cohen's d = 0.74) and pain self-efficacy (d = 0.41) were higher and pain intensity (d = 0.65) and affective interference (d = 0.45) lower in the intervention group at week 4. Conclusions: It is feasible, acceptable, and potentially efficacious to support patients with chronic pain during prescription opioid tapering with a psycho-educational video and SMS text messaging intervention. A definitive trial has been initiated to test a 12-week intervention.

Exhausted Heart Rate Responses to Repeated Psychological Stress in Women With Major Depressive Disorder.

Past research links depression and blunted cardiac vagal reactivity to chronic stress. Yet, to our knowledge no experiment investigates heart rate (variability) responses to a repeated laboratory stressor in patients with depression. Repeated exposure may provide valuable information on stress reactivity in depression. Fifty-nine women (30 inpatients diagnosed with depression and 29 matched controls) underwent two consecutive runs of a mental arithmetic stress paradigm consisting of one baseline and two exposures to control, stress, and recovery phases of 5 min each, in a case-control design. Subjective stress and electrocardiography were recorded. Variance of heart rate (HR) and root mean square of successive RR interval differences (RMSSD) were analyzed using linear mixed models. Overall, physiological parameters (HR and RMSSD) and subjective stress showed a strong group effect (all p < 0.001). In both groups, subjective stress and HR increased in response to stress, but the subjective stress levels of patients with depression did not return to baseline levels after the first stressor and for the remainder of the experiment (all p < 0.004 compared to baseline). Patients' HR reactivity responded oppositely: while HR recovered after the first stress exposure, no reactivity was observed in response to the second exposure. These findings may suggest that the often-reported blunted HR/HRV response to stressors results from exhaustion rather than an incapacity to react to stress. The altered HR reactivity could indicate allostatic (over-) load in depression.

Effects of Early Repolarization on Electrocardiography and Long-Term Cardiovascular Outcomes: A 15-Year Population-Based Cohort Study.

Background: We aimed to investigate the association between persistent early repolarization (ER) in healthy individuals and long-term cardiovascular events and mortality rates in a large cohort study. Methods: Demographic characteristics, medical records, 12-lead electrocardiograms (ECGs), and laboratory data were retrieved and analyzed from the Isfahan Cohort Study. The participants were followed up biannually via telephone interviews and 1 live structured interview in between until 2017. Individuals who had ER in all their ECGs were considered persistent ER cases. Study outcomes were cardiovascular events (unstable angina, myocardial infarction, stroke, and sudden cardiac death), cardiovascular-related mortality, and all-cause mortality. The independent t test, the χ2 test, the Mann-Whitney U test, and the Cox regression models were used for statistical analyses. Results: The study population consisted of 2696 subjects (50.5% female). Persistent ER was found in 203 subjects (7.5%), with a higher frequency in men (6.7% vs 0.8%; P<0.001). Cardiovascular events, cardiovascular-related mortality, and all-cause mortality occurred in 478 (17.7%), 101 (3.7%), and 241 (8.9%) individuals, respectively. After controlling for known cardiovascular risk factors, we found an association between ER and cardiovascular events (adjusted hazard ratio [95% confidence interval] =2.36 [1.19-4.68], P=0.014), cardiovascular-related mortality (4.97 [1.95-12.60], P=0.001), and all-cause mortality (2.50 [1.11-5.58], P=0.022) in women. No significant association was found between ER and any study outcomes in men. Conclusion: ER is common in young men with no apparent long-term cardiovascular risks. In women, ER is relatively rare, but it could be associated with long-term cardiovascular risks.

Evaluating acceptability and feasibility of a mobile health intervention to improve self-efficacy in prescription opioid tapering in patients with chronic pain: protocol for a pilot randomised, single-blind, controlled trial.

INTRODUCTION: Opioid medications are no longer recommended as long-term therapy for chronic non-cancer pain, and many patients are advised to reduce or discontinue opioid medications. Many patients report difficulties in tapering opioid medications, necessitating supporting interventions. This protocol describes a pilot randomised controlled trial (RCT) to investigate the acceptability, feasibility and potential efficacy of a mobile health intervention to improve the opioid tapering self-efficacy of patients with chronic non-cancer pain. METHODS AND ANALYSIS: The trial will be a single-blind (clinician, data collector and statistician-blinded) pilot RCT with two parallel arms. Forty adult patients with chronic non-cancer pain who are voluntarily reducing their prescribed opioid medications under medical guidance will be recruited from two tertiary pain clinics (Start date 25 August 2021). Participants will be randomly assigned to an intervention or control group. Both groups will receive usual care, including multidisciplinary pain management. In addition to usual care, the intervention group will receive a short informational and testimonial video about opioid tapering and will receive two specifically text messages per day for 28 days. The intervention is codesigned with patients and clinicians to provide evidence-based informational, motivational and emotional support to patients with chronic pain to taper opioid medications. Feasibility of the intervention and a future definitive RCT will be evaluated by measuring patient acceptability, delivery of the intervention, rates and reasons of exclusions and drop-outs, completion rates and missing data in the study questionnaires, and obtaining estimates for sample size determination. Potential efficacy will be evaluated by comparing changes in opioid tapering self-efficacy between the two groups. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Northern Sydney Local Health District (Australia). Study results will be published in peer-reviewed journals and presented at scientific and professional meetings. TRIAL REGISTRATION NUMBER: ACTRN12621000795897.