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Cureus Dec 2021Functional dyspepsia is a common gastrointestinal disorder characterized by postprandial fullness or early satiety and epigastric burning or pain in the absence of... (Review)
Review
Functional dyspepsia is a common gastrointestinal disorder characterized by postprandial fullness or early satiety and epigastric burning or pain in the absence of organic disease. Acotiamide is a novel prokinetic motility drug being used in functional dyspepsia. Databases like PubMed, PubMed Central, Embase, and Scopus were searched for studies comparing the use of acotiamide and placebo for people with functional dyspepsia. Quantitative synthesis was performed using RevMan 5.4 (Cochrane, London, United Kingdom). The improvement in symptoms of functional dyspepsia after treatment was higher in people treated with acotiamide than placebo, although not statistically significant (OR, 1.48; 95% CI, 0.93 to 2.35; n = 1697; I = 59%). Among the commonly reported adverse effects, namely, raised in serum prolactin (OR 1.02, 95% CI 0.64 to 1.61; n = 1709; I = 44%), raised in alanine transaminase (OR 1.27, 95% CI 0.70 to 2.33; n = 1709; I = 0%), and raised in serum bilirubin (OR, 0.98; 95% CI, 0.52 to 1.87; I = 0%) did not differ between two groups. Acotiamide seems to be a promising agent in functional dyspepsia. However, further larger studies are needed to evaluate the role of acotiamide in functional dyspepsia.
PubMed: 35070565
DOI: 10.7759/cureus.20532 -
Antioxidants (Basel, Switzerland) Dec 2021Treating oxidative stress through antioxidant therapy has been considered an appealing strategy in the management of male infertility. However, evidence regarding the... (Review)
Review
Treating oxidative stress through antioxidant therapy has been considered an appealing strategy in the management of male infertility. However, evidence regarding the toxicity of antioxidant therapy is controversial. We summarized the available clinical evidence on the toxicity associated with the use of antioxidants in infertile males. A systematic review was performed in March 2021. We included randomized controlled trials evaluating the incidence of adverse events in male patients with infertility receiving antioxidant therapy. Thirteen studies involving 1999 male patients were identified. Antioxidant supplementation in patients with male factor infertility was associated with a statistically significantly increased risk of nausea (Odds Ratio: 2.16, 95% Confidence Interval: 1.05-4.43, = 0.036), headache (Odds Ratio: 3.05, 95% Confidence Interval: 1.59- 5.85 = 0.001), and dyspepsia (Odds Ratio: 4.12, 95% Confidence Interval: 1.43-11.85, = 0.009) compared to a placebo. Treatment discontinuation due to adverse events was not significantly higher in patients taking antioxidants compared to a placebo (Odds Ratio: 2.29, 95% Confidence Interval: 0.76-6.88, = 0.139). When antioxidant supplementation is considered, a more accurate risk/benefit analysis is warranted.
PubMed: 35052594
DOI: 10.3390/antiox11010089 -
Cureus Dec 2021is a Gram-negative microorganism that causes chronic dyspepsia, gastritis, mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric adenocarcinoma. Various... (Review)
Review
is a Gram-negative microorganism that causes chronic dyspepsia, gastritis, mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric adenocarcinoma. Various antibiotic regimens are employed to eradicate it; however, antibiotic resistance has skyrocketed in recent years, resulting in a reduction in eradication rates. As a result, numerous novel therapeutic approaches are being adopted in clinical practice, and probiotics are being extensively investigated. Probiotics are living bacteria that, when consumed, offer many medicinal advantages that may be accomplished by altering the amount or activity of gut flora. Their beneficial influence on gut health, immune system modulation, and cancer therapy is the subject of extensive investigation. This is owing to their perceived safety and simplicity of use. The primary objective of this review is to learn about and investigate the function of probiotics in the eradication of , either alone or in conjunction with traditional treatments. Data have been collected from PubMed, PubMed Central, Medline, Cochrane, and Google Scholar, and relevant articles have been chosen following the PRISMA guidelines. Our search resulted in 2489 records, of which 123 full-text articles were screened for eligibility. Two reviewers independently performed the quality appraisal of 16 relevant articles, and ultimately 11 high-quality studies are included in this review. In conclusion, probiotic monotherapy does not have a significant effect on the eradication rates of , but in conjunction with standard treatment regimens, there was mild improvement in the eradication rates but a significant reduction of side effects due to antibiotics.
PubMed: 35047301
DOI: 10.7759/cureus.20483 -
Gut Jan 2022Functional dyspepsia (FD) is a chronic disorder that is difficult to treat. may contribute to its pathophysiology. A Cochrane review from 2006 suggested that...
OBJECTIVE
Functional dyspepsia (FD) is a chronic disorder that is difficult to treat. may contribute to its pathophysiology. A Cochrane review from 2006 suggested that eradication therapy was beneficial, but there have been numerous randomised controlled trials (RCTs) published since. We evaluated impact of eradication therapy on both cure and improvement of FD, as well as whether any benefit was likely to arise from eradication of .
DESIGN
We searched the medical literature through October 2021 to identify RCTs examining efficacy of eradication therapy in -positive adults with FD. The control arm received antisecretory therapy or prokinetics, with or without placebo antibiotics, or placebo alone. Follow-up was for ≥3 months. We pooled dichotomous data to obtain a relative risk (RR) of symptoms not being cured or symptoms not improving with a 95% CI. We estimated the number needed to treat (NNT).
RESULTS
Twenty-nine RCTs recruited 6781 . -positive patients with FD. Eradication therapy was superior to control for symptom cure (RR of symptoms not being cured=0.91; 95% CI 0.88 to 0.94, NNT=14; 95% CI 11 to 21) and improvement (RR of symptoms not improving=0.84; 95% CI 0.78 to 0.91, NNT=9; 95% CI 7 to 17). There was no significant correlation between eradication rate and RR of FD improving or being cured (Pearson correlation coefficient=-0.23, p=0.907), but the effect was larger in patients with successful eradication of than with unsuccessful eradication (RR=0.65; 95% CI 0.52 to 0.82, NNT=4.5, 95% CI 3 to 9). Adverse events (RR=2.19; 95% 1.10 to 4.37) and adverse events leading to withdrawal (RR=2.60; 95% CI 1.47 to 4.58) were more common with eradication therapy.
CONCLUSION
There is high quality evidence to suggest that eradication therapy leads to both cure and improvement in FD symptoms, although the benefit is modest.
PubMed: 35022266
DOI: 10.1136/gutjnl-2021-326583 -
Journal of Clinical Medicine Oct 2021Functional gastrointestinal disorders (FGID) are common among children and may cause a significant symptom burden. The Rome criteria are symptom-based guidelines for the... (Review)
Review
Functional gastrointestinal disorders (FGID) are common among children and may cause a significant symptom burden. The Rome criteria are symptom-based guidelines for the assessment of FGID among children and adults. The aim of this systematic review was to estimate the prevalence of FGID utilizing the revised Rome IV criteria. Nine health databases were searched. The inclusion criteria were: prospective FGID prevalence data using the Rome IV criteria for children up to 18 years, and the exclusion criteria were: cohorts with known gastrointestinal or organic conditions. The data were presented as a percentage of children experiencing at least one FGID, as well as in individual categories. The searches identified 376 papers, with 20 included in the final analysis, providing a pooled cohort of 18,935 children. The median prevalence of FGID for children aged up to four years was 22.2% (range 5.8-40%), and aged four-eighteen years was 21.8% (range 19-40%). The most common FGID for children aged 0-12 months was infant regurgitation, the most common FGID for those aged 13-48 months were functional constipation and cyclic vomiting, and, for those aged over four years, functional constipation, functional dyspepsia, and irritable bowel syndrome. This reported overall incidence of FGID may be used as a benchmark of normative data among the general population and comparative data for those with comorbid disease.
PubMed: 34768604
DOI: 10.3390/jcm10215087 -
The Cochrane Database of Systematic... Sep 2021This is an updated version of a Cochrane Review previously published in 2019. Catamenial epilepsy describes worsening seizures in relation to the menstrual cycle and may... (Review)
Review
BACKGROUND
This is an updated version of a Cochrane Review previously published in 2019. Catamenial epilepsy describes worsening seizures in relation to the menstrual cycle and may affect around 40% of women with epilepsy. Vulnerable days of the menstrual cycle for seizures are perimenstrually (C1 pattern), at ovulation (C2 pattern), and during the luteal phase (C3 pattern). A reduction in progesterone levels premenstrually and reduced secretion during the luteal phase is implicated in catamenial C1 and C3 patterns. A reduction in progesterone has been demonstrated to reduce sensitivity to the inhibitory neurotransmitter in preclinical studies, hence increasing risk of seizures. A pre-ovulatory surge in oestrogen has been implicated in the C2 pattern of seizure exacerbation, although the exact mechanism by which this surge increases risk is uncertain. Current treatment practices include the use of pulsed hormonal (e.g. progesterone) and non-hormonal treatments (e.g. clobazam or acetazolamide) in women with regular menses, and complete cessation of menstruation using synthetic hormones (e.g. medroxyprogesterone (Depo-Provera) or gonadotropin-releasing hormone (GnRH) analogues (triptorelin and goserelin)) in women with irregular menses. Catamenial epilepsy and seizure exacerbation is common in women with epilepsy. Women may not receive appropriate treatment for their seizures because of uncertainty regarding which treatment works best and when in the menstrual cycle treatment should be taken, as well as the possible impact on fertility, the menstrual cycle, bone health, and cardiovascular health. This review aims to address these issues to inform clinical practice and future research.
OBJECTIVES
To evaluate the efficacy and tolerability of hormonal and non-hormonal treatments for seizures exacerbated by the menstrual cycle in women with regular or irregular menses. We synthesised the evidence from randomised and quasi-randomised controlled trials of hormonal and non-hormonal treatments in women with catamenial epilepsy of any pattern.
SEARCH METHODS
We searched the following databases on 20 July 2021 for the latest update: Cochrane Register of Studies (CRS Web) and MEDLINE Ovid (1946 to 19 July 2021). CRS Web includes randomised controlled trials (RCTs) or quasi-RCTs from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including Cochrane Epilepsy. We used no language restrictions. We checked the reference lists of retrieved studies for additional reports of relevant studies.
SELECTION CRITERIA
We included RCTs and quasi-RCTs of blinded or open-label design that randomised participants individually (i.e. cluster-randomised trials were excluded). We included cross-over trials if each treatment period was at least 12 weeks in length and the trial had a suitable wash-out period. We included the following types of interventions: women with any pattern of catamenial epilepsy who received a hormonal or non-hormonal drug intervention in addition to an existing antiepileptic drug regimen for a minimum treatment duration of 12 weeks.
DATA COLLECTION AND ANALYSIS
We extracted data on study design factors and participant demographics for the included studies. The primary outcomes of interest were: proportion seizure-free, proportion of responders (at least 50% decrease in seizure frequency from baseline), and change in seizure frequency. Secondary outcomes included: number of withdrawals, number of women experiencing adverse events of interest (seizure exacerbation, cardiac events, thromboembolic events, osteoporosis and bone health, mood disorders, sedation, menstrual cycle disorders, and fertility issues), and quality of life outcomes.
MAIN RESULTS
Following title, abstract, and full-text screening, we included eight full-text articles reporting on four double-blind, placebo-controlled RCTs. We included two cross-over RCTs of pulsed norethisterone, and two parallel RCTs of pulsed progesterone recruiting a total of 192 women aged between 13 and 45 years with catamenial epilepsy. We found no RCTs for non-hormonal treatments of catamenial epilepsy or for women with irregular menses. Meta-analysis was not possible for the primary outcomes, therefore we undertook a narrative synthesis. For the two RCTs evaluating norethisterone versus placebo (24 participants), there were no reported treatment differences for change in seizure frequency. Outcomes for the proportion seizure-free and 50% responders were not reported. For the two RCTs evaluating progesterone versus placebo (168 participants), the studies reported conflicting results for the primary outcomes. One progesterone RCT reported no significant difference between progesterone 600 mg/day taken on day 14 to 28 and placebo with respect to 50% responders, seizure freedom rates, and change in seizure frequency for any seizure type. The other progesterone RCT reported a decrease in seizure frequency from baseline in the progesterone group that was significantly higher than the decrease in seizure frequency from baseline in the placebo group. The results of secondary efficacy outcomes showed no significant difference between groups in the pooled progesterone RCTs in terms of treatment withdrawal for any reason (pooled risk ratio (RR) 1.56, 95% confidence interval (CI) 0.81 to 3.00, P = 0.18, I = 0%) or treatment withdrawals due to adverse events (pooled RR 2.91, 95% CI 0.53 to 16.17, P = 0.22, I = 0%). No treatment withdrawals were reported from the norethisterone RCTs. The RCTs reported limited information on adverse events, although one progesterone RCT reported no significant difference in the number of women experiencing adverse events (diarrhoea, dyspepsia, nausea, vomiting, fatigue, nasopharyngitis, dizziness, headache, and depression). No studies reported on quality of life. We judged the evidence for outcomes related to the included progesterone RCTs to be of low to moderate certainty due to risk of bias, and for outcomes related to the included norethisterone RCTs to be of very low certainty due to serious imprecision and risk of bias.
AUTHORS' CONCLUSIONS
This review provides very low-certainty evidence of no treatment difference between norethisterone and placebo, and moderate- to low-certainty evidence of no treatment difference between progesterone and placebo for catamenial epilepsy. However, as all the included studies were underpowered, important clinical effects cannot be ruled out. Our review highlights an overall deficiency in the literature base on the effectiveness of a wide range of other hormonal and non-hormonal interventions currently being used in practice, particularly for those women who do not have regular menses. Further clinical trials are needed in this area.
Topics: Adolescent; Adult; Anticonvulsants; Epilepsy; Fatigue; Female; Humans; Menstruation; Middle Aged; Randomized Controlled Trials as Topic; Seizures; Young Adult
PubMed: 34528245
DOI: 10.1002/14651858.CD013225.pub3 -
Archives of Iranian Medicine Jul 2021Dyspepsia is a highly prevalent gastrointestinal problem. The present study was carried out to assess the prevalence of dyspepsia in Iran. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dyspepsia is a highly prevalent gastrointestinal problem. The present study was carried out to assess the prevalence of dyspepsia in Iran.
METHODS
The present study was registered at PROSPERO with the code CRD42019148610. It was carried out based on MOOSE and reporting was performed according to the PRISMA protocol. Systematic search of the literature was performed in July 2019 on international databases of PubMed/Medline, Web of Science (ISI), Cochrane Library, EBSCO, CINAHL, EMBASE, Scopus, Science Direct, and local databases as well as the Google Scholar search engine. Heterogeneity was evaluated using I2 and Chi-square tests. All analyses were done using Comprehensive Meta-Analysis software.
RESULTS
Overall, 14 studies with a sample size of 54,118 subjects entered in this meta-analysis. The prevalence of dyspepsia in Iran was 14.6% (95% CI: 9.6-21.7). Large heterogeneity was detected among studies (I2=99.62%, <0.001). The prevalence of dysmotility-like, ulcer-like, and unspecified dyspepsia was estimated to be 9.7% (95% CI: 4.9-18.4), 12.1% (95% CI: 5.2-25.7) and 17.0% (95% CI: 7.8-33.4), respectively. The prevalence of dyspepsia in Iranian men and women was found at 11.1% (95% CI: 6.3-18.8) and 17.8% (95% CI: 10.0-29.7), respectively.
CONCLUSION
The prevalence of dyspepsia in Iran is relatively high. However, it is lower than global estimates.
Topics: Databases, Factual; Dyspepsia; Humans; Iran; Prevalence
PubMed: 34488322
DOI: 10.34172/aim.2021.80 -
Frontiers in Medicine 2021We aimed to critically evaluate the effectiveness and safety of acupuncture as an add-on therapy to conventional Western medication (WM) and assess the quality of...
We aimed to critically evaluate the effectiveness and safety of acupuncture as an add-on therapy to conventional Western medication (WM) and assess the quality of evidence (QoE) of these findings. A total of 12 English, Korean, and Chinese databases were searched on December 18, 2020. Randomized controlled trials (RCTs) assessing the effectiveness of acupuncture as an add-on therapy to conventional WM for functional dyspepsia (FD) were included. The primary outcome was the symptom score of FD. The risk of bias of the included studies and QoE were evaluated using the Cochrane Collaboration's risk of bias tool and Grading of Recommendations, Assessment, Development, and Evaluation method, respectively. A total of 22 RCTs were included. The total and individual FD symptom scores were significantly improved in the acupuncture combined with WM groups compared with the WM alone groups, except for in one study. The Nepean dyspepsia index score and total effective rate mostly improved significantly in the acupuncture group, regardless of the WM used and acupuncture type. FD-related biomarkers, such as ghrelin and gastrin levels, showed mixed results. The acupuncture group showed a significantly lower recurrence rate after 3-6 months of follow-up than the WM alone group. There were no differences in the incidence of adverse events between the two groups. The included studies generally had low methodological quality. The QoE for the main findings was generally very low to moderate. Limited evidence suggests that acupuncture has the potential to improve FD treatment in combination with conventional WM. Furthermore, the methodological quality of the included studies and QoE of the main findings were generally low. Therefore, RCTs with a rigorous methodology, including sham acupuncture and multiethnic subjects, should be performed. OSF registries [https://osf.io/mxren], PROSPERO [CRD42021226608].
PubMed: 34381798
DOI: 10.3389/fmed.2021.682783 -
Journal of Gastroenterology and... Nov 2021The therapeutic effect of acupuncture treatments (AT) on functional gastrointestinal disorders (FGIDs) is contentious. A meta-analysis was conducted to assess the... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The therapeutic effect of acupuncture treatments (AT) on functional gastrointestinal disorders (FGIDs) is contentious. A meta-analysis was conducted to assess the efficacy and safety of acupuncture for FGIDs.
METHODS
The Cochrane Library, EMBASE, PUBMED, Web of Science, Wanfang Database, China National Knowledge Infrastructure, and VIP Database were searched through December 31, 2019 with no language restrictions. Risk ratio (RR) with 95% confidence interval (CI) was calculated to determine the improvement in symptom severity after treatment.
RESULTS
A total of 61 randomized controlled trials (RCTs) on FGIDs were included. The pooled results illustrated the following: compared to pharmacotherapy (RR 1.13, 95% CI 1.09-1.17), placebo acupuncture (RR 1.69, 95% CI 1.37-2.08), no specific treatment (RR 1.86, 95% CI 1.31-2.62), and AT as an adjuvant intervention to other active treatments (RR 1.25, 95% CI 1.21-1.30), AT had more favorable improvements in symptom severity; sub-group analysis results classified according to functional dyspepsia, irritable bowel syndrome, and functional constipation also supported this finding; and the incidence of adverse events was lower in AT than in other treatments (RR 0.75, 95% CI 0.56-0.99).
CONCLUSIONS
This meta-analysis found that AT was significantly associated with relief of FGIDs symptoms; however, the evidence level was moderate or low. Further data from rigorously designed and well powered RCTs are needed to verify the effectiveness and safety of AT as a FGIDs treatment.
PROSPERO PROTOCOL NUMBER
CRD42020169508.
Topics: Acupuncture Therapy; Constipation; Dyspepsia; Gastrointestinal Diseases; Humans; Irritable Bowel Syndrome; Randomized Controlled Trials as Topic
PubMed: 34342044
DOI: 10.1111/jgh.15645 -
Integrative Medicine Research Jun 2021Dyspepsia represents a symptom domain rather than a diagnostic condition and covers a wide range of complex, underlying pathophysiologies that are not well understood.... (Review)
Review
BACKGROUND
Dyspepsia represents a symptom domain rather than a diagnostic condition and covers a wide range of complex, underlying pathophysiologies that are not well understood. The review explores comparative effectiveness interventions for the treatment of symptomatic dyspepsia along a pragmatic-explanatory continuum. The aim is to identify relevant design characteristics applicable to future upper gastrointestinal comparative effectiveness research employing integrative medicine.
METHODS
Medline, CINAHL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) and WHO Clinical Trials were systematically searched until January 2019. Included articles were original research with two or more comparative intervention arms for the primary outcome; relief of symptomatic dyspepsia. Evaluation of the studies was conducted using the pragmatic-explanatory continuum indicator summary (PRECIS-2) tool.
RESULTS
Thirty-six articles were included in the review. A total of 68 Patient Reported Outcome Measurements (PROMs), utilizing 50 different formats were deployed across the studies. The appraisal process revealed eligibility, flexibility in adherence, flexibility in delivery and organization domains further aligned towards an explanatory design.
CONCLUSION
This review identified three design characteristics relevant for future comparative effectiveness research for the treatment of upper gastrointestinal disorders in a community setting. Extensive exclusion eligibility criteria limited the generalization of comparative effectiveness study results by removing sub-groups of the target populations more at risk of dyspeptic symptoms. The requirement for entry endoscopy was found to be common and not always pragmatically justifiable. Development of validated PROMs appropriate for a generic application to upper gastrointestinal disorders would be advantageous for future comparative effectiveness research within integrative medicine.
PubMed: 34258220
DOI: 10.1016/j.imr.2020.100663