Maternal Antibiotic Exposure and the Risk of Developing Antenatal Depressive Symptoms.

Background: Antenatal depression is common and has significant consequences. The literature suggests that antibiotic exposure may be associated with depression. Many individuals are exposed to antibiotics during pregnancy. Further investigation of the association between antenatal antibiotic use and the development of depression during pregnancy is needed. Methods: A national prospective observational cohort study of pregnant individuals was undertaken using an online survey, completed during the third trimester. Antenatal depressive symptoms (ADSs) were defined as having an Edinburgh Postnatal Depression Scale score of ≥13 and/or receiving a clinical diagnosis of depression. Results: One in six individuals (16.5%, n = 977) experienced ADSs during their pregnancy, of whom 37.9% received a depression diagnosis. There was no relationship between antibiotic use and the development of ADSs. Four factors were identified as significant independent predictors of ADSs: personal history of depression, severe nausea and vomiting causing an inability to eat, emotional abuse from an intimate partner within the prior 12 months, and not having a university degree. Conclusions: Antenatal antibiotic use was not associated with the development of ADSs. Given the high incidence of undiagnosed depression, new strategies and models of care that prioritise individuals with risk factors may be required to optimise antenatal care.

Maternal Antibiotic Exposure and the Risk of Developing Antenatal or Postpartum Depressive Symptoms: The Maternal Experience Study Protocol.

Limited epidemiological evidence suggests a link between antibiotic use and developing depression. This study seeks to investigate this association in depth, using a cohort of pregnant individuals. The primary aim is to explore any association between the use of antibiotics during pregnancy and the development of antenatal depressive symptoms up to the third trimester, as well as the use of antibiotics during pregnancy and within 12 months postpartum and the development of postpartum depressive symptoms. A national prospective, observational, longitudinal cohort study has been designed to examine these relationships. A sample size of 1500 pregnant individuals has been sought for this study, assuming 10 potential predictor variables (including antibiotic use) in the final multiple logistic regression model and allowing for a 30% drop-out rate. The development of depressive symptoms is considered either a diagnosis by a medical doctor and/or a scoring 13 or higher on the Edinburgh Postnatal Depression Scale. Data will be collected during the third trimester and at 6 weeks, 6 months, and 12 months postpartum. These surveys include variables previously identified as associated with antenatal and postpartum depression (e.g., level of social support, experience of intimate partner abuse, and obstetric complications), as well as antibiotic and probiotic use. This study will provide an update on the prevalence of the symptoms of depression during pregnancy and postpartum and its associated risk factors. It will also, for the first time, comprehensively explore the potential association between antibiotic use during pregnancy and up to 12 months postpartum and the development of depressive symptoms.

Exploring Criteria for the Translation of Traditional Knowledge Within Contemporary Clinical Practice, Research, Policy, and Education: A Stakeholder Forum.

Background: The 2018 Declaration of Astana identifies traditional knowledge (TK) as one of the drivers for strengthening primary health care systems through the use of technology (traditional medicines) and knowledge and capacity building (traditional practitioners). While TK underpins both traditional practice and the use of traditional medicines, facilitating the use of TK in contemporary health care systems has been difficult to achieve. The aim of this study was to identify key factors related to the translation of TK into contemporary settings to help establish tools to support the knowledge translation process. Methods: This study used World Café methodology to collect the observations, ideas, and perspectives of experts who use TK in their practice. These experts (n = 9) were from a variety of contexts, including clinical practice, research, education, policy, and consumer advocacy, participated in the 1-day event. Data were collected into NVivo 12 software and analyzed using inductive-deductive thematic analysis. Results: Thematic analysis identified five themes: the need to define the elements required for critical evaluation of sources of TK as evidence, the importance of applying a tradition-centric lens when translating TK for contemporary use, the need to bridge gaps between TK and its contemporary applications, the value of critically evaluating the TK translation process itself, and the recognition of traditions as living systems. Taken together, the themes showed holistic interpretation of the translation process that incorporates critical analysis of the TK itself and accountable, transparent, and ethical processes of translation that consider safety, socioeconomical and intellectual property impacts of TK in contemporary use. Conclusions: Stakeholders identified TK as a valid and important source of evidence that should guide practice in a range of contemporary settings (e.g., policy and clinical practice), and outlined important consideration for critiquing, evaluating, communicating, and using TK within these settings.

Investigating the association between the symptoms of women with Fibromyalgia, Digestive function, and markers of the microbiota of the Gastrointestinal Tract (The FIDGIT Study): study protocol.

BACKGROUND: Fibromyalgia a common idiopathic condition affecting around 1.4% of adults globally. Its signature symptom is chronic widespread pain, with a constellation of somatic and psychological symptoms. Fibromyalgia is associated with significant reductions in quality of life, yet to date there is no biochemical marker for its diagnosis. Previous studies have indicated a strong association with gastrointestinal dysfunction, and more recently, alterations to the gut microbiome. No studies have examined the inter-relationship between fibromyalgia, gastrointestinal dysfunction, and the microbiome. This prospective observational case-controlled study will gather data on gastrointestinal function, dietary intake, fermentation patterns of ingested carbohydrates, and symptoms commonly associated with fibromyalgia. These will be evaluated alongside human gene expression and metatranscriptomic analysis of the oral and faecal microbiome. METHODS: Adult women aged ≥18 years diagnosed with fibromyalgia and/or meeting ACR 2016 criteria, and healthy family or age-matched controls will be recruited from the community. From consenting participants, we will collect detailed survey information and samples of blood, urine, stool, saliva, and breath. DISCUSSION: This is the first prospective study examining interactions between digestive function, human gene expression, and the gut microbiome together with general, and fibromyalgia-specific, symptoms experienced by New Zealand women. This exploration will allow an in-depth understanding of clinically relevant factors that are associated with fibromyalgia and will guide further research and contribute to improved management of this poorly understood condition. TRIAL REGISTRATION: The study was approved by the New Zealand Health and Disability Committee (HDEC) (ref: 20/CEN/197) and registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR), registration number ACTRN12620001337965. Written consent will be obtained after providing participants with detailed information about the procedures. Access to data will be restricted to the immediate research team, and all samples and survey data will be deidentified and coded before analysis.

Antibiotic use and the development of depression: A systematic review.

OBJECTIVE: Increasingly, disruption of the gastrointestinal ecosystem is thought to be involved in the pathogenesis of several medical conditions, including depression. Antibiotics can induce substantial changes in the gastrointestinal microbiota and several lines of evidence suggest that antibiotics exposure may increase the risk of developing depression. This systematic review examined this potential association. METHODS: PubMed, Ovid EMBASE, CINAHL, and PsychINFO databases, as well as unpublished resources, were searched for studies in humans published from 2000 onwards. The studies needed to consider the connection between antibiotic exposure (either alone or in combination with other antibiotics and medications) and the development of depressive symptoms and/or disorders (in isolation to other psychological conditions). RESULTS: Nine studies met the eligibility criteria. All were observational in nature. The studies were conducted in different age groups with various indications for receiving antibiotics. Together, these relatively low-quality studies suggest a potential association between antibiotic exposure and subsequent development of depression symptoms. Specifically, studies from the United Kingdom and Sweden indicate that the risk of depression is increased by at least 20%, with the former (over 1 million participants) reporting an increased risk with the number of courses and agents used, that persists with a slow decline over the ten years following exposure. CONCLUSIONS: The inherent limitations associated with the studies' methodologies make a reliable conclusion difficult. While the risk of antimicrobial resistance may prohibit large randomised clinical trials in healthy individuals, future placebo-controlled trials with antibiotics-based protocols (e.g. for acne) should explore their effect on mental health.

International prevalence of consultation with a naturopathic practitioner: a systematic review and meta-analysis.

OBJECTIVES: Naturopathy is a traditional medicine system informed by codified philosophies and principles, and an emphasis on non-pharmacologic therapeutic interventions. While naturopathy is practised by approximately 75 000-100 000 000 naturopathic practitioners in at least 98 countries, little is known about the international prevalence of history of consultation with a naturopathic practitioner. This study reports a systematic review and meta-analysis of studies describing the global prevalence of history of consultation with a naturopathic practitioner by the general population. SETTING: The included literature was identified through a systematic search of eight databases between September and October 2019, as well as the grey literature. PARTICIPANTS: Studies were included if they reported the prevalence rate of consultations with a naturopathic practitioner by the general population. INTERVENTIONS: Survey items needed to report consultations with a naturopathic practitioner as defined in the country where data was collected, and not combine naturopathic consultations with other health services or only report consulations for illness populations. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary measures used for the analysis was consultations in the previous 12 months. Other prevalence timeframes were reported as secondary measures. METHODS: Meta-analysis of prevalence data was conducted using random effects models based on individual countries and WHO world regions. RESULTS: The literature search identified eight manuscripts summarising 14 studies reporting prevalence for inclusion in the review. All included studies had a low risk of bias. Meta-analysis of the included studies by world region found the 12-month prevalence of history of naturopathy consultations ranged from 1% in the Region of the Americas to 6% in the European and Western Pacific Regions. CONCLUSIONS: There are up to sixfold differences in the prevalence of naturopathy consults over 12 months between and within world regions, which may be driven by a range of policy, legislative and social factors. PROSPERO REGISTRATION NUMBER: CRD42020145529.

Polycystic Ovary Syndrome: An Evolutionary Adaptation to Lifestyle and the Environment.

Polycystic ovary syndrome (PCOS) is increasingly recognized as a complex metabolic disorder that manifests in genetically susceptible women following a range of negative exposures to nutritional and environmental factors related to contemporary lifestyle. The hypothesis that PCOS phenotypes are derived from a mismatch between ancient genetic survival mechanisms and modern lifestyle practices is supported by a diversity of research findings. The proposed evolutionary model of the pathogenesis of PCOS incorporates evidence related to evolutionary theory, genetic studies, in utero developmental epigenetic programming, transgenerational inheritance, metabolic features including insulin resistance, obesity and the apparent paradox of lean phenotypes, reproductive effects and subfertility, the impact of the microbiome and dysbiosis, endocrine-disrupting chemical exposure, and the influence of lifestyle factors such as poor-quality diet and physical inactivity. Based on these premises, the diverse lines of research are synthesized into a composite evolutionary model of the pathogenesis of PCOS. It is hoped that this model will assist clinicians and patients to understand the importance of lifestyle interventions in the prevention and management of PCOS and provide a conceptual framework for future research. It is appreciated that this theory represents a synthesis of the current evidence and that it is expected to evolve and change over time.

A narrative review of the role of gastrointestinal dysbiosis in the pathogenesis of polycystic ovary syndrome.

Diet-induced gastrointestinal dysbiosis has been hypothesized to play a significant role in stimulating an increase in gastrointestinal permeability and activating systemic inflammation in women with polycystic ovary syndrome (PCOS). We reviewed the current proof-of-concept studies on the proposed mechanism of dysbiosis in the pathogenesis of PCOS. A literature search was performed to identify articles on changes in the intestinal microbiome (dysbiosis) and increased intestinal mucosal permeability involving lipopolysaccharide (LPS), LPS-binding protein (LPS-BP), and zonulin. We also searched for systematic reviews and meta-analyses that synthesized the results of studies on the therapeutic effects of prebiotics, probiotics, or synbiotics in women with PCOS. Our search was confined to human studies between 2012 and 2021 using the PubMed, Scopus, and Cochrane databases. Thirty-one studies met the inclusion criteria (14 microbiota, 1 LPS, 1 LPS-BP, 1 LPS and LPS-BP, 5 zonulin, 9 systematic reviews). Our analysis revealed that most studies reported reduced alpha diversity and dysbiosis in women with PCOS. Preliminary studies suggest that LPS, LPS-BP, and zonulin may be involved in the pathophysiology of increased intestinal permeability. Treatment of PCOS with prebiotics, probiotics, and synbiotics appears to have a range of beneficial effects on metabolic and biochemical profiles. This review highlights the need for continued research into the pathophysiological mechanisms of dysbiosis and the clinical efficacy of prebiotics, probiotics, and synbiotics in women with PCOS.

Effects of a high-prebiotic diet versus probiotic supplements versus synbiotics on adult mental health: The "Gut Feelings" randomised controlled trial.

Background: Preliminary evidence supports the use of dietary interventions and gut microbiota-targeted interventions such as probiotic or prebiotic supplementation for improving mental health. We report on the first randomised controlled trial (RCT) to examine the effects of a high-prebiotic dietary intervention and probiotic supplements on mental health. Methods: "Gut Feelings" was an 8-week, 2 × 2 factorial RCT of 119 adults with moderate psychological distress and low prebiotic food intake. Treatment arms: (1) probiotic supplement and diet-as-usual (probiotic group); (2) high-prebiotic diet and placebo supplement (prebiotic diet group); (3) probiotic supplement and high-prebiotic diet (synbiotic group); and (4) placebo supplement and diet-as-usual (placebo group). The primary outcome was assessment of total mood disturbance (TMD; Profile of Mood States Short Form) from baseline to 8 weeks. Secondary outcomes included anxiety, depression, stress, sleep, and wellbeing measures. Results: A modified intention-to-treat analysis using linear mixed effects models revealed that the prebiotic diet reduced TMD relative to placebo at 8 weeks [Cohen's d = -0.60, 95% confidence interval (CI) = -1.18, -0.03; p = 0.039]. There was no evidence of symptom improvement from the probiotic (d = -0.19, 95% CI = -0.75, 0.38; p = 0.51) or synbiotic treatments (d = -0.03, 95% CI = -0.59, 0.53; p = 0.92). Improved anxiety, stress, and sleep were noted in response to the prebiotic diet while the probiotic tentatively improved wellbeing, relative to placebo. No benefit was found in response to the synbiotic intervention. All treatments were well tolerated with few adverse events. Conclusion: A high-prebiotic dietary intervention may improve mood, anxiety, stress, and sleep in adults with moderate psychological distress and low prebiotic intake. A synbiotic combination of high-prebiotic diet and probiotic supplement does not appear to have a beneficial effect on mental health outcomes, though further evidence is required. Results are limited by the relatively small sample size. Clinical trial registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372753, identifier ACTRN12617000795392.

Hydrogen-methane breath testing results influenced by oral hygiene.

The measurement of hydrogen-methane breath gases is widely used in gastroenterology to evaluate malabsorption syndromes and bacterial overgrowth. Laboratories offering breath testing provide variable guidance regarding oral hygiene practices prior to testing. Given that oral dysbiosis has the potential to cause changes in breath gases, it raises concerns that oral hygiene is not a standard inclusion in current breath testing guidelines. The aim of this study was to determine how a pre-test mouthwash may impact hydrogen-methane breath test results. Participants presenting for breath testing who had elevated baseline gases were given a chlorhexidine mouthwash. If a substantial reduction in expired hydrogen or methane occurred after the mouthwash, breath samples were collected before and after a mouthwash at all breath sample collection points for the duration of testing. Data were evaluated to determine how the mouthwash might influence test results and diagnostic status. In 388 consecutive hydrogen-methane breath tests, modifiable elevations occurred in 24.7%. Administration of a chlorhexidine mouthwash resulted in significantly (p ≤ 0.05) reduced breath hydrogen in 67% and/or methane gas in 93% of those consenting to inclusion. In some cases, this modified the diagnosis. Mean total gas concentrations pre- and post-mouthwash were 221.0 ppm and 152.1 ppm (p < 0.0001) for hydrogen, and 368.9 ppm and 249.8 ppm (p < 0.0001) for methane. Data suggest that a single mouthwash at baseline has a high probability of returning a false positive diagnosis. Variations in gas production due to oral hygiene practices has significant impacts on test interpretation and the subsequent diagnosis. The role of oral dysbiosis in causing gastrointestinal symptoms also demands exploration as it may be an underlying factor in the presenting condition that was the basis for the referral.

A systematic review of the association between fibromyalgia and functional gastrointestinal disorders.

BACKGROUND: Fibromyalgia and functional gastrointestinal disorders (FGID) including irritable bowel syndrome (IBS) are common conditions presenting in clinical settings and are more prevalent in women. While the relationship between IBS and fibromyalgia has been demonstrated, a review of the prevalence of the broader group of FGID in adults with fibromyalgia has not been undertaken. The aim of this review was to systematically review the published literature, identifying the comorbidity of FGID in people with fibromyalgia, and to discuss the clinical implications, limitations of current research and areas of interest for future research. METHODS: Medline, Embase, CINAHL and Web of Science were searched during June 2019. Results were screened for original research articles meeting established criteria for identification of FGID in adults diagnosed with fibromyalgia. RESULTS: A total of 14 studies involving 1340 adults with fibromyalgia, 363 healthy controls and 441 adults with other pathologies were included in this review. Only 1 of the 14 studies included surveyed the full range of FGID . Functional gut disorders were matched to Rome II criteria for reporting and comparison. In addition to increased abdominal pain and functional bloating or gas, IBS of mixed-pattern and constipation-types appear to be more prevalent than diarrhoea-predominant IBS in adults with fibromyalgia. CONCLUSION: This review confirms previous reports that IBS is common in people living with fibromyalgia and suggests that IBS-mixed and constipation types predominate. An association with a range of FGID other than IBS is suggested, but data are limited. Research exploring the association between fibromyalgia and functional gastrointestinal dysfunction beyond IBS are warranted.

Integrative physiology and traditional naturopathic practice: Results of an international observational study.

BACKGROUND: Naturopathy is one of seven distinct traditional medical systems acknowledged by the World Health Organization. Naturopathic principles and philosophies encourage a focus on multiple body systems during case-taking and the design of treatments. Little is known about whether such teaching translates into practice. This study aimed to characterise naturopathic practice as it relates to the identification of multiple physiological systems in the diagnosis and treatment of patients. METHODS: A cross sectional study was conducted in collaboration with the World Naturopathic Federation. A survey capturing clinical diagnostic and treatment considerations for up to 20 consecutive patients was administered to naturopaths in 14 countries. RESULTS: Naturopaths (n = 56) were mostly female (62.5%), aged between 36 and 45 years (37.5%), in practice for 5-10 years (44.6%), and consulting between 11 and 20 patients per week (35.7%). Participants completed the survey for 851 patient cases. Naturopaths reported a greater number of physiological systems relevant to clinical cases where the patients were working age (18-65 years) (IRR 1.3, p = .042), elderly (65 years and over) (IRR 1.4, p = .046), or considered by the naturopath to have a chronic health condition (IRR 1.2, p = .003). The digestive system was weakly associated with patients based on chronicity of the health complaint (V = .1149, p = .004), or having a musculoskeletal complaint (V = .1067, p = .002) autoimmune pathophysiology (V = .1681, p < .001), and considered relevant in respiratory (V = .1042, p = .002), endocrine (V = .1023, p = .003), female reproductive (V = .1009, p = .003), and integumentary (V = .1382, p < .001) systems. CONCLUSION: Naturopaths across the world adopt an integrative physiological approach to the diagnosis and treatment of chronic and complex health care complaints..

Consumer Reports of "Keto Flu" Associated With the Ketogenic Diet.

Background: The ketogenic diet (KD) is a high-fat, low-carbohydrate diet that limits glucose and results in the production of ketones by the liver and their uptake as an alternative energy source by the brain. KD is an evidence-based treatment for intractable epilepsy. KD is also self-administered, with limited evidence of efficacy, for conditions including weight loss, cognitive and memory enhancement, type II diabetes, cancer, neurological and psychiatric disorders. A commonly discussed side effect of KD in media and online forums is "keto flu," a cluster of transient symptoms generally reported as occurring within the first few weeks of KD. This study aimed to characterize the pattern of symptoms, severity and time course of keto flu as related by users of online forums. Method: Online forums referring to "keto flu," "keto-induction," or "keto-adaptation" in the URL were identified in Google. Passages describing personal experiences of keto flu were categorized manually with reference to pattern of symptoms, severity, time course, and remedies proposed. Results: The search criteria identified 75 online forums, 43 met inclusion criteria and contained 448 posts from 300 unique users. Seventy-three made more than one post (mean 3.12, range 2-11). Descriptors of personal experience of keto flu, reported by 101 of 300 users, included 256 symptom descriptions involving 54 discrete symptoms. Commonest symptoms were "flu," headache, fatigue, nausea, dizziness, "brain fog," gastrointestinal discomfort, decreased energy, feeling faint and heartbeat alterations. Symptom reports peaked in the first and dwindled after 4 weeks. Resolution of keto flu symptoms was reported by eight users between days 3 and 30 (median 4.5, IQR 3-15). Severity of symptoms, reported by 60 users in 40 forums, was categorized as mild (N = 15), moderate (N = 23), or severe (N = 22). Eighteen remedies were proposed by 121 individual users in 225 posts. Conclusions: Typically, individual posts provided fragmentary descriptions related to the flow of forum conversations. A composite picture emerged across 101 posts describing personally experienced symptoms. User conversations were generally supportive, sharing remedies for keto flu reflecting assumptions of physiological effects of KD.

Determining the association between fibromyalgia, the gut microbiome and its biomarkers: A systematic review.

BACKGROUND: The association between fibromyalgia and irritable bowel syndrome is well-established. Alterations in the composition and diversity of the gut microbiome in irritable bowel syndrome have been reported, however, this association is poorly understood in fibromyalgia. Our aim was to summarise the research reporting on the gastrointestinal microbiome and its biomarkers in people with fibromyalgia. METHODS: A systematic review of published original research reporting on the gastrointestinal microbiota and its biomarkers in adults with a diagnosis of fibromyalgia was undertaken. RESULTS: From 4771 studies, 11 met our inclusion criteria and were separated into four main groups: papers reporting Helicobacter pylori; other gut bacterial markers; metabolomics and other biomarkers, which included intestinal permeability and small intestinal bacterial overgrowth. CONCLUSION: The results suggest there is a paucity of quality research in this area, with indications that the gut microbiota may play a role in fibromyalgia within the emerging field of the gut-musculoskeletal axis. Further investigations into the relationship between the gut microbiota, gut dysfunction and fibromyalgia are warranted.

A systematic review and quality assessment of case reports of adverse events for borage (Borago officinalis), coltsfoot (Tussilago farfara) and comfrey (Symphytum officinale).

Symphytum officinale (comfrey), Tussilago farfara (coltsfoot) and Borago officinalis (borage) have long histories of therapeutic use, but their safety has been questioned due to the presence of unsaturated pyrrolizidine alkaloids (PAs). The evidence base underlying these concerns relies in part on case reports. This systematic review assesses these case reports for their reliability to inform this debate. METHOD: Study selection was restricted to case reports describing possible pyrrolizidine alkaloid related harm and ingestion of comfrey, coltsfoot or borage. An extensive search of academic databases was conducted. Papers meeting the criteria were critically appraised. RESULTS: The search resulted in 11 appropriate case reports, none of which involved borage. Nine reports were assessed for causality and indicated some degree of association between the material ingested and the adverse event. Lack of unequivocal identification of the species ingested compromised attribution and was a significant source of uncertainty. Three levels of identity confusions were found; misidentification or substitution at the level of the whole herb; omission of appropriate botanical identification and attribution of a specific PA to either comfrey or coltsfoot when it is a constituent found in other plants of established toxicity. CONCLUSION: These cases are an unreliable body of evidence on which to draw conclusions about the safety of the oral consumption of Symphytum officinale and Tussilago farfara. Toxicological studies based on oral ingestion of phytochemically-complex preparations of these herbs may be the most accurate methodology for assessing clinical risk.

Western herbal medicines in the treatment of irritable bowel syndrome: A systematic review and meta-analysis.

OBJECTIVE: To evaluate the efficacy of Western herbal medicines in the treatment of irritable bowel syndrome (IBS). DESIGN: A computer-based search of MEDLINE, EMBASE, CINAHL, AMED, GreenFILE, Health Source: Nursing/Academic Edition, and the Cochrane Library was conducted. A hand-search of the bibliographies of relevant papers and previous meta-analyses and reviews was also undertaken. Trials were included in the review if they were double-blind and placebo-controlled investigating the effects of Western herbal medicines on IBS-related symptoms or quality of life. There were no language restrictions. Eligibility assessment and data extraction were performed by two independent researchers. For herbal medicines where there was more than 1 trial of similar design, data were synthesised using relative risk of symptoms improving using the random effects model. RESULTS: Thirty-three trials were identified that met all eligibility criteria. Seventeen of these evaluated peppermint essential oil, fifteen other Western herbal medicines, and one trial evaluated peppermint oil in one arm and aniseed essential oil in the other arm. Eighteen different herbal preparations were evaluated in these trials. Data suggests that a number of Western herbal medicines may provide relief of IBS symptoms. Meta-analyses suggest that peppermint essential oil is both efficacious and well-tolerated in the short-term management of IBS. Aloe vera and asafoetida also demonstrated efficacy in reducing global IBS symptoms in meta-analyses. The herbal formulas STW 5, STW 5-II and Carmint, along with Ferula assa-foetida, Pimpenella anisum oil, the combination of Curcumin and Foeniculum vulgare oil, and the blend of Schinopsis lorentzii, Aesculus hippocastanum, and peppermint essential oil also demonstrated efficacy in rigorously-designed clinical trials. CONCLUSION: A number of Western herbal medicines show promise in the treatment of IBS. With the exception of peppermint essential oil, Aloe vera, and asafoetida, however, none of the positive trials have been replicated. This lack of replication limits the capacity to make definitive statements of efficacy for these herbal medicines.

Biofeedback for treatment of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a prevalent condition that currently lacks highly effective therapies for its management. Biofeedback has been proposed as a therapy that may help individuals learn to exert conscious control over sympatho-vagal balance as an indirect method of symptom management. OBJECTIVES: Our primary objective was to assess the efficacy and safety of biofeedback-based interventions for IBS in adults and children. SEARCH METHODS: We searched the Cochrane Inflammatory Bowel Disease (IBD) Group Specialized Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Allied and Complementary Medicine Database (AMED) from inception to 24 July 2019. We also searched reference lists from published trials, trial registries, device manufacturers, conference proceedings, theses, and dissertations. SELECTION CRITERIA: We judged randomized controlled trials to be eligible for inclusion if they met the Association for Applied Psychophysiology and Biofeedback definition of biofeedback, and if they compared a biofeedback intervention to an active, sham, or no-treatment control for the management of IBS. DATA COLLECTION AND ANALYSIS: Two authors independently screened trials for inclusion, extracted data, and assessed risk of bias. Primary outcomes were IBS global or clinical improvement scores and overall quality of life measures. Secondary outcome measures were adverse events, assessments of stool frequency and consistency, changes in abdominal pain, depression, and anxiety. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (CI). For continuous outcomes, we calculated the mean difference (MD) and 95% CI. We used GRADE criteria to assess the overall certainty of the evidence. MAIN RESULTS: We identified eight randomized trials with a total of 300 adult participants for our analysis. We did not identify any trials in children. Four trials assessed thermal biofeedback. One trial assessed rectosigmoidal biofeedback. Two trials assessed heart rate variability biofeedback. Two trials assessed electrocutaneous biofeedback. Comparators were: no treatment (symptom monitoring group; three studies), attention control (pseudomeditation; two studies), relaxation control (one study), counseling (two studies), hypnotherapy (one study), standard therapy (one study), and sham biofeedback (one study). We judged all trials to have a high or unclear risk of bias. Global/Clinical improvement The clinical benefit of biofeedback plus standard therapy compared to standard therapy alone was uncertain (RR 4.20, 95% CI 1.40 to 12.58; 1 study, 20 participants; very low-certainty evidence). The same study also compared biofeedback plus standard therapy to sham biofeedback plus standard therapy. The clinical benefit in the biofeedback group was uncertain (RR 2.33, 95% CI 1.13 to 4.80; 1 study, 20 participants; very low-certainty evidence). The clinical benefit of heart rate biofeedback compared to hypnotherapy was uncertain when measured with the IBS severity scoring system (IBS-SSS) (MD -58.80, 95% CI -109.11 to -8.49; 1 study, 61 participants; low-certainty evidence). Compared to counseling, the effect of heart rate biofeedback was unclear when measured with a composite symptom reduction score (MD 7.03, 95% CI -51.07 to 65.13; 1 study, 29 participants; low-certainty evidence) and when evaluated for clinical response (50% improvement) (RR 1.09, 95% CI 0.48 to 2.45; 1 study, 29 participants; low-certainty evidence). The clinical benefit of thermal biofeedback used in a multi-component psychological intervention (MCPI) compared to no treatment was uncertain when measured with a composite clinical symptom reduction score (MD 30.34, 95% CI 8.47 to 52.21; 3 studies, 101 participants; very low-certainty evidence), and when evaluated as clinical response (50% improvement) (RR 2.12, 95% CI 1.24 to 3.62; 3 studies, 101 participants; very low-certainty evidence). Compared to attention control, the effects of thermal biofeedback within an MCPI were unclear when measured with a composite clinical symptom reduction score (MD 4.02, 95% CI -21.41 to 29.45; 2 studies, 80 participants; very low-certainty evidence) and when evaluated as clinical response (50% improvement) (RR 1.10, 95% CI 0.72 to 1.69, 2 studies, 80 participants; very low-certainty evidence). Quality of life A single trial used overall quality of life as an outcome measure, and reported that both the biofeedback and cognitive therapy groups improved after treatment. The trial did not note any between-group differences, and did not report any outcome data. Adverse events Only one of the eight trials explicitly reported adverse events. This study reported no adverse events in either the biofeedback or cognitive therapy groups (RD 0.00, 95% CI -0.12 to 0.12; 29 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: There is currently not enough evidence to assess whether biofeedback interventions are effective for controlling symptoms of IBS. Given the positive results reported in small trials to date, biofeedback deserves further study in people with IBS. Future research should include active control groups that use high provider-participant interaction, in an attempt to balance non-specific effects of interventions between groups, and report both commonly used outcome measures (e.g. IBS-SSS) and historical outcome measures (e.g. the composite primary symptom reduction (CPSR) score) to allow for meta-analysis with previous studies. Future studies should be explicit in their reporting of adverse events.

Lessons from Outside and Within: Exploring Advancements in Methodology for Naturopathic Medicine Clinical Research.

INTRODUCTION: Naturopathy is a mixture of both traditional and complementary medicine. It incorporates a broad set of health care practices that may or may not be traditional to that country or conventional medicine and are not fully integrated into the dominant health care system. Research required to evaluate or substantiate naturopathic medicine may not fall under the testing of randomized clinical trials, which opens up discussions on what is the best practice for research in naturopathic medicine. DISCUSSION: Not only do advances in health research methodology offer important opportunities to progress naturopathic research, there are also areas where the unique characteristics of naturopathic philosophy and practice can impact other areas of health research. Some of the new advances in health research methodology involve whole-system research, pragmatic trials, template for intervention description and replication protocols for complex interventions, patient-centered care models, and the pragmatic-explanatory continuum indicator summary tool for designing pragmatic trials. Discussion and critique of these health-related methodologies shows that these research methods are more suited for the philosophy and treatment options that naturopathy is based on. CONCLUSIONS: Successful implementation of naturopathic research methodologies, and translation and dissemination of research will require a substantial paradigm shift in which naturopathic practitioners adopt a greater level of responsibility for developing an evidence base for naturopathic medicine.