Health complaints before and at one and five years after removal of dental amalgam restorations - data from a prospective cohort study in Norway.

OBJECTIVE: Health complaints attributed to dental amalgam fillings comprise both intraoral and general health complaints. There are data suggesting that patients with medically unexplained physical symptoms (MUPS) attributed to amalgam fillings show improvement in symptoms after removal of all amalgam fillings. However, data indicating changes of specific health complaints are limited. This study evaluated the changes of health complaints after removal of amalgam restorations in patients with health complaints attributed to dental amalgam fillings. METHOD: Patients with MUPS attributed to dental amalgam (Amalgam cohort) had all their amalgam fillings removed. The participants indicated an intensity of 11 local and 12 general health complaints on numeric rating scales before the treatment and at follow-up after 1 and 5 years. The comparison groups comprising a group of healthy individuals and a group of patients with MUPS without symptom attribution to dental amalgam did not have their amalgam restorations removed. RESULTS: In the Amalgam cohort, mean symptom intensity was lower for all 23 health complaints at follow-up at 1 year compared to baseline. Statistically significant changes were observed for specific health complaints with effect sizes between 0.36 and 0.68. At the 5-year follow-up, the intensity of symptoms remained consistently lower compared to before the amalgam removal. In the comparison groups, no significant changes of intensity of symptoms of health complaints were observed. CONCLUSION: After removal of all amalgam restorations, both local and general health complaints were reduced. Since blinding of the treatment was not possible, specific and non-specific treatment effects cannot be separated.

An acupuncture protocol for the treatment of erectile dysfunction (ED) - a Delphi-process.

INTRODUCTION: Erectile Dysfunction (ED) is a widespread disorder, and the worldwide incidence is rapidly increasing. Acupuncture, an intervention out of the spectrum of Traditional Chinese Medicine (TCM) has a long tradition as treatment for ED. Nonetheless, a best practice treatment protocol is currently missing. A recent systematic review and meta-analysis confirmed a huge diversity of acupuncture treatments for ED and concluded that there is an urgent need to standardize acupuncture treatment for ED. Consequently, the authors conducted a Delphi process with the aim to achieve an expert consensus as a basis for the development of a best practice protocol. METHODS: The Delphi process consisted of four rounds of questionnaires with closed and open-ended questions. Eleven acupuncture experts participated. The therapeutic aim was defined as "to achieve an erection sufficient for sexual satisfaction". RESULTS: Consensus was achieved on 24 acupoints corresponding to 12 TCM syndromes. The syndromes were KI Yang xu, KI Yin xu, KI Qi xu, Ki and HT not harmonised, LR Qi Stagnation, LR Qi stagnation and Heat, Liver Blood xu, Liver Blood xu and Liver Qi stagnation, Damp-heat sinking to the lower Jiao5, HT and GB Qi xu, SP xu and HT Blood xu, Yin xu. The suggested optimal dose was between11-15 treatments given once or twice a week. CONCLUSION: An expert consensus-based, semi-standardized best practice treatment protocol for the treatment of ED was developed. Moreover, the Delphi process also revealed inconsistencies as to which signs and symptoms constitute a TCM syndrome. Further Delphi studies including a broader range of experts from various acupuncture traditions are needed to establish further agreement. Nonetheless, the best practice protocol introduced in this paper provides a first point of departure for the implementation of a more standardized treatment approach. Moreover, since a recent meta-analysis concluded that more high-quality clinical studies on the topic are needed, this paper provides a first standardized acupuncture treatment protocol for ED.

General practitioners' role in safeguarding patients with dementia in their use of dietary supplements. A qualitative study.

OBJECTIVE: The use of dietary supplements (DS) may cause harm through direct and indirect effects. Patients with dementia may be particularly vulnerable. This study aims to explore general practitioners' (GPs') experiences with DS use by these patients, the GPs perceived responsibilities, obstacles in taking on this responsibility, their attitudes toward DS, and suggestions for improvements to safeguard the use of DS in this patient group. DESIGN: Qualitative individual interview study conducted February - December 2019. Data were analysed using systematic text condensation. SETTING: Primary healthcare clinics in Norway. SUBJECTS: Fourteen Norwegian GPs. FINDINGS: None of the informants were dismissive of patients using DS. They were aware of the possible direct risks and had observed them in patients. Most GPs showed little awareness of potential indirect risks to patients with dementia who use DS. They acknowledged the need for caretaking of these patients. Although there were differences in practice styles, most of the GPs wished to help their patients safeguarding DS use but found it difficult due to the lack of quality assurance of product information. Furthermore, there were no effective ways for the GPs to document DS use in the patients' records. Several suggestions for improvement were given by the GPs, such as increased attention from GPs, inclusion of DS in the prescription software, and stricter regulatory systems for DS from the authorities. CONCLUSION: The GPs had initially little awareness of this safety risk, but there were differences in practice style and attitudes towards DS. The GPs did not perceive themselves as main responsible for safe use of DS in patient with dementia. The most important reason to disclaim responsibility was lack of information about the products. One suggestion for improvement was better integration of DS in patients' medical record.

Currently, little is known about general practitioners (GPs) caretaking of patients with dementia who use dietary supplements (DS). Our study showed that:The GPs in this study showed little awareness of the potential safety risk that DS use may represent for patients with dementia.Several obstacles in the treatment setting and in the regulation of DS make it difficult for the GPs to assume full responsibility for patients with dementia who use DS.Lack of evidence about DS safety and effect adds to professional uncertainty and may cause frustration or reluctance to address the issue.

Quality of life in benign colorectal disease-a review of the assessment with the Gastrointestinal Quality of Life Index (GIQLI).

BACKGROUND AND PURPOSE: The Gastrointestinal Quality of Life Index (GIQLI) is an instrument for the assessment of quality of life (QOL) in diseases of the upper and lower GI tract, which is validated in several languages around the world. The purpose of this literature review is the assessment of the GIQLI in patients with benign colorectal diseases. Reports on GIQLI data are collected from several institutions, countries, and different cultures which allows for comparisons, which are lacking in literature. METHODS: The GIQL Index uses 36 items around 5 dimensions (gastrointestinal symptoms (19 items), emotional dimension (5 items), physical dimension (7 items), social dimension (4 items), and therapeutic influences (1 item). The literature search was performed on the GIQLI and colorectal disease, using reports in PubMed. Data are presented descriptively as GIQL Index points as well as a reduction from 100% maximum possible index points (max 144 index points = highest quality of life). RESULTS: The GIQLI was found in 122 reports concerning benign colorectal diseases, of which 27 were finally selected for detailed analysis. From these 27 studies, information on 5664 patients (4046 female versus 1178 male) was recorded and summarized. The median age was 52 years (range 29-74.7). The median GIQLI of all studies concerning benign colorectal disease was 88 index points (range 56.2-113). Benign colorectal disease causes a severe reduction in QOL for patients down to 61% of the maximum. CONCLUSIONS: Benign colorectal diseases cause substantial reductions in the patient's QOL, well documented by GIQLI, which allows a comparison QOL with other published cohorts.

Mercury, silver and selenium in serum before and after removal of amalgam restorations: results from a prospective cohort study in Norway.

OBJECTIVE: A prospective cohort study on changes of health complaints after removal of amalgam restorations was carried out at the request of the Norwegian Directorate of Health. The aim was to provide and evaluate experimental treatment to patients with health complaints attributed to dental amalgam fillings. METHODS: Patients (n = 32) with medically unexplained physical symptoms (MUPS), which were attributed to dental amalgam restorations had all their amalgam restorations removed and replaced with other dental restorative materials. Samples of blood were collected before and 1 year after removal of the fillings, and concentration of inorganic mercury (I-Hg), methylmercury (MeHg), silver (Ag) and selenium (Se) in serum was determined by inductively coupled plasma-sector field mass spectrometry. The comparison groups (one with MUPS but without attribution to amalgam [n = 28] and one group of healthy individuals [n = 19]) received no treatment. The participants responded to questionnaires at baseline and at follow-up after 1 and 5 years. RESULTS: Concentration of I-Hg and Ag in serum decreased significantly after removal of all amalgam restorations. Concentration of MeHg and Se in serum were not changed. Intensity of health complaints was significantly reduced after amalgam removal, but there were no statistically significant correlations between exposure indicators and health complaints. CONCLUSIONS: Removal of all amalgam restorations is followed by a decrease of concentration of I-Hg and Ag in serum. The results support the hypothesis that exposure to amalgam fillings causes an increase of the daily dose of both I-Hg and Ag. Even though intensity of health complaints decreased after removal of all amalgam restorations there was no clear evidence of a direct relationship between exposure and health complaints. Trial registration: The project is registered at Clinicaltrials.gov (NCT01682278).

Interventions for osteoarthritis pain: A systematic review with network meta-analysis of existing Cochrane reviews.

Objective: To conduct a network meta-analysis comparing all treatments for osteoarthritis (OA) pain in the Cochrane Library. Design: The Cochrane Library and Epistemonikos were searched for randomized controlled trials (RCTs) about treatments for hip and knee OA. We constructed 17 broad categories, comprising drug treatments, exercise, surgery, herbs, orthotics, passive treatments, regenerative medicine, diet/weight loss, combined treatments, and controls. In addition to a full network analysis, we compared the direct/indirect effects, and studies with shorter-/longer follow-up. CINeMA software was used for assessing confidence in network meta-analysis estimates. Results: We included 35 systematic reviews including 445 RCTs. There were 153 treatments for OA. In total, 491 comparisons were related to knee OA, less on hip OA, and only nine on hand OA. Six treatment categories showed clinically significant effects favoring treatment over control on pain. "Diet/weight loss" and "Surgery" had effect sizes close to zero. The network as a whole was not coherent. Of 136 treatment comparisons, none were rated as high confidence, six as moderate, 13 as low, and 117 as very low. Conclusions: Direct comparison of different available treatment options for OA is desirable, however not currently feasible in practice, due to heterogeneous study populations and lack of clear descriptions of control interventions. We found that many treatments were effective, but since the network as a whole was not coherent and lacked high confidence in the treatment comparisons, we could not produce a ranking of effects.

Gastrointestinal Quality of Life in Gastroesophageal Reflux Disease: A Systematic Review.

BACKGROUND: The Gastrointestinal Quality of Life Index (GIQLI) is a well-established instrument for the assessment of quality of life (QOL) in gastrointestinal (GI) diseases. The purpose of this literature review was to investigate QOL by means of GIQLI in patients with gastroesophageal reflux disease (GERD) prior to any interventional therapy. There are several reports on GIQLI data; however, comparisons from different countries and/or different GERD cohorts assessing the same disease have to date not been conducted. METHODS: The GIQLI uses 36 items around 5 dimensions (GI symptoms [19 items], emotional dimension [5 items], physical dimension [7 items], social dimension [4 items], and therapeutic influences [1 item]). A literature search was conducted on the application of GIQLI in GERD patients prior to interventional therapy using reports in PubMed. Data on the mean GIQLI as well as index data for the 5 dimensions as originally validated were extracted from the published patient cohorts. A comparison with the normal healthy control group from the original publication of the GIQLI validation conducted by Eypasch was performed. Data are presented descriptively as GIQLI points as well as a reduction from 100% maximum possible index points (max 144 index points = highest QOL). RESULTS: In total, 77 abstracts from studies using the GIQLI on patients with GERD were identified. After screening for content, 21 publications were considered for further analysis. Ten studies in GERD patients comprised complete calculations of all dimensions and were included in the analysis. Data from 1,682 study patients were evaluated with sample sizes ranging from 33 to 568 patients (median age of 789 females and 858 males: 51.8 years). The median overall GIQLI for the patient group was 91.7 (range 86-102.4), corresponding to 63.68% of the maximum GIQLI. The dimensions with the largest deviation from the respective maximum score were the physical dimension (55% of maximum) followed by the emotional dimension (60% of maximum). In summary, the GIQLI level in GERD cohorts was reduced to 55-75% of the maximum possible index. CONCLUSIONS: Severe GERD causes substantial reductions in the patient's QOL. The level of GIQLI can carry between different studied GERD cohorts from different departments and countries. GIQLI can be used as an established tool to assess the patient's condition in various dimensions.

Is amalgam removal in patients with medically unexplained physical symptoms cost-effective? A prospective cohort and decision modelling study in Norway.

There are many patients in general practice with health complaints that cannot be medically explained. Some of these patients attribute their health complaints to dental amalgam restorations. This study examined the cost-effectiveness of the removal of amalgam restorations in patients with medically unexplained physical symptoms (MUPS) attributed to amalgam fillings compared to usual care, based on a prospective cohort study in Norway. Costs were determined using a micro-costing approach at the individual level. Health outcomes were documented at baseline and approximately two years later for both the intervention and the usual care using EQ-5D-5L. Quality adjusted life year (QALY) was used as a main outcome measure. A decision analytical model was developed to estimate the incremental cost-effectiveness of the intervention. Both probabilistic and one-way sensitivity analyses were conducted to assess the impact of uncertainty in costs and effectiveness. In patients who attribute health complaints to dental amalgam restorations and fulfil the inclusion and exclusion criteria, amalgam removal is associated with modest increase in costs at societal level as well as improved health outcomes. In the base-case analysis, the mean incremental cost per patient in the amalgam group was NOK 19 416 compared to the MUPS group, while mean incremental QALY was 0.119 with a time horizon of two years. Thus, the incremental costs per QALY of the intervention was NOK 162 680, which is usually considered cost effective in Norway. The estimated incremental cost per QALY decreased with increasing time horizon, and amalgam removal was found to be cost saving over both 5 and 10 years. This study provides insight into the costs and health outcomes associated with the removal of amalgam restorations in patients who attribute health complaints to dental amalgam fillings, which are appropriate instruments to inform health care priorities.

Validity and responsiveness of GHC-index in patients with amalgam-attributed health complaints.

OBJECTIVE: Many patients have medically unexplained physical symptoms (MUPS); some of them attribute their health complaints to dental amalgam fillings. The aim of this study was to assess the validity and responsiveness of General Health Complaints index (GHC-index) for measuring the symptom load in MUPS patients compared to the widely used symptom outcome measure, Giessen Subjective Complaints List (GBB-24). METHODS: Three outcome measures - GHC-index, GBB-24, and Munich Amalgam Scale (MAS) - were administered at baseline and 12 months after removal of all dental amalgam restorations. The validity and responsiveness of these symptom measures were tested against external anchors: bodily distress syndrome (BDS), SF-36 vitality, and visual analogue scale (VAS). We tested both convergent and known group validities. We also examined the predictive validity and responsiveness to changes for each instrument. RESULTS: All the main outcome measures showed evidence of convergent and known group validities. The GHC-index, GBB-24 and MAS were all able to detect the anticipated differences in BDS and Energy. But the GBB-24 was more efficient in discriminating the BDS compared with the GHC-index (relative efficiency: RE = 0.69; 95% CI: 0.41-0.96) and MAS (RE = 0.59; 95% CI: 0.32-0.86). Each main outcome variable revealed good predictive validity for vitality (standardized coefficient: b ≈ 0.71 and R2 ≈ 0.50). Moderate to high sensitivity to change over time was demonstrated, with GHC-index performing better. CONCLUSION: The GHC-index is a valid and responsive instrument for assessing symptom load in MUPS patients attributing their health complaints to amalgam fillings and undergoing amalgam removal.

Adverse effects in homeopathy. A systematic review and meta-analysis of observational studies.

BACKGROUND: Almost all health care interventions have the potential to be associated with risk to patient safety. Different terminologies are used to define treatment induced risk to patient safety and a common definition is the term adverse effect. Beyond the concept of adverse effect and specific to homeopathy is the concept of homeopathic aggravation. Homeopathic aggravation describes a transient worsening of the patients' symptoms, which is not understood as an adverse effect. In order to ensure patient safety within a homeopathic treatment setting, it is important to identify adverse effects, as well as homeopathic aggravations, even though it may be challenging to distinguish between these two concepts. To date there is an obvious lack of systematic information on how adverse effects and homeopathic aggravations are reported in studies. This systematic review and meta-analysis focuses on observational studies, as a substantial amount of the research base for homeopathy are observational. METHOD: Eight electronic databases, central webpages and journals were searched for eligible studies. The searches were limited from the year 1995 to January 2020. The filters used were observational studies, human, English and German language. Adverse effects and homeopathic aggravations were identified and graded according to The Common Terminology Criteria for Adverse Effects (CTCAE). Meta-analysis was performed separately for adverse effects and homeopathic aggravations. RESULTS: A total of 1,169 studies were identified, 41 were included in this review. Eighteen studies were included in a meta-analysis that made an overall comparison between homeopathy and control (conventional medicine and herbs). Eighty-seven percent (n = 35) of the studies reported adverse effects. They were graded as CTCAE 1, 2 or 3 and equally distributed between the intervention and control groups. Homeopathic aggravations were reported in 22,5% (n = 9) of the studies and graded as CTCAE 1 or 2. The frequency of adverse effects for control versus homeopathy was statistically significant (P < 0.0001). Analysis of sub-groups indicated that, compared to homeopathy, the number of adverse effects was significantly higher for conventional medicine (P = 0.0001), as well as other complementary therapies (P = 0.05). CONCLUSION: Adverse effects of homeopathic remedies are consistently reported in observational studies, while homeopathic aggravations are less documented. This meta-analysis revealed that the proportion of patients experiencing adverse effects was significantly higher when receiving conventional medicine and herbs, compared to patients receiving homeopathy. Nonetheless, the development and implementation of a standardized reporting system of adverse effects in homeopathic studies is warranted in order to facilitate future risk assessments.

Consultations with health care providers and use of self-management strategies for prevention and treatment of COVID-19 related symptoms. A population based cross-sectional study in Norway, Sweden and the Netherlands.

OBJECTIVES: The present study was initiated to determine consultations with health care providers and use of self-management strategies for prevention or treatment of COVID-19 related symptoms in countries with a full lockdown (Norway), a partial lockdown (the Netherlands) and no lockdown (Sweden) during the first three months of the COVID-19 pandemic, and if such use correlates with worries of being infected by COVID-19 disease. DESIGN: Data were collected in collaboration with Ipsos A/S in April-June 2020. An adapted version of the International Questionnaire to measure use of Complementary and Alternative Medicine (I-CAM-Q) was used with the categories "for prevention of COVID-19" and "to treat COVID-19-related symptoms" added. Data were collected among a representative sample in Norway, Sweden and the Netherlands using data assisted telephone interviews (Norway, n=990 and Sweden, n=500), and an online survey (the Netherlands, n=1004). Total response rate was 30%. RESULTS: Very few consulted a health care provider with the intention to treat or prevent COVID-19 (1.2% and 1.0% respectively) with medical doctors mostly visited (1.0% and 0.9% respectively). Similarly, the use of self-management strategies to prevent or treat COVID-19 was low (3.4% and 0.2% respectively); most commonly used for prevention of COVID-19 were vitamins and minerals (2.8%). Consultations with health care providers and use of self-management strategies for prevention of COVID-19 were positively associated with worries of being infected with COVID-19. CONCLUSIONS: The COVID-19 pandemic does not seem to have evoked a large-scale difference in behavior related to consultations with health care providers or the use of self-management strategies in any of the three countries.

Home care service employees' contribution to patient safety in clients with dementia who use dietary supplements: a Norwegian survey.

OBJECTIVE: To explore home care services (HCS) employees' professional experiences with the use of dietary supplements (DSs) in their clients with dementia. We also investigated their attributed professional responsibility concerning this use and their attitudes toward DSs in general. Differences between nurses and nurse assistants were investigated. DESIGN: A cross-sectional survey with self-administered questionnaires. SETTING: Home care services in six Norwegian municipalities in the period August-December 2016. SUBJECTS: A total of 231 (64% response rate) HCS employees; 78 nurses and 153 nurse assistants (auxiliary nurses and employees without formal education).Main outcome measures: Health care employees' experiences with patient safety in clients with dementia who use DSs. RESULTS: Fifty per cent were concerned that clients with dementia might harm their health due to DS use. Thirty-one per cent reported having intervened in order to reduce the risk. Seventy-one per cent preferred to administer DSs to clients with dementia rather than leaving this responsibility to the clients. The respondents placed the responsibility for patient safety in clients with dementia using DSs mainly with the general practitioners, while they ascribed themselves and pharmacies a medium level of responsibility. There were only minor difference between nurses and nurse assistants, and no difference in attitudes towards DSs. CONCLUSION: Employees in HCS were concerned about the DS use in clients with dementia. Moreover, almost one-third had intervened to improve clients' patient safety. The majority indicated that HCS should administer DSs rather than the clients with dementia themselves.KEY POINTSTo our knowledge, this is the first study investigating the role of home care services with regard to patient safety in clients with dementia who use dietary supplements (DSs).•Home care service employees worried about patient safety related to DS use in clients with dementia.•Home care service employees attributed to themselves medium responsibility to ensure the safe use of DSs in these clients.•Lack of knowledge was the most important reason why home care service employees did not recommend DSs to clients.

Validity and responsiveness of EQ-5D-5L and SF-6D in patients with health complaints attributed to their amalgam fillings: a prospective cohort study of patients undergoing amalgam removal.

BACKGROUND: Evidence of health utility changes in patients who suffer from longstanding health complaints attributed to dental amalgam fillings are limited. The change in health utility outcomes enables calculating quality-adjusted life-year (QALY) and facilitates the comparison with other health conditions. The purpose of this study was to estimate the validity and responsiveness of the EQ-5D-5L and SF-6D utilities following removal of dental amalgam fillings in patients with health complaints attributed to their amalgam fillings, and examine the ability of these instruments to detect minimally important changes over time. METHODS: Patients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, were recruited to a prospective cohort study in Norway. Two health state utility instruments, EQ-5D-5L and SF-6D, as well as self-reported general health complaints (GHC-index) and visual analogue scale (EQ-VAS) were administered to all patients (n = 32) at baseline and at follow-up. The last two were used as criteria measures. Concurrent and predictive validities were examined using correlation coefficients. Responsiveness was assessed by the effect size (ES), standardized response mean (SRM), and relative efficiency. Minimally important change (MIC) was examined by distribution and anchor-based approaches. RESULTS: Concurrent validity of the EQ-5D-5L was similar to that of SF-6D utility. EQ-5D-5L was more responsive than SF-6D: the ES were 0.73 and 0.58 for EQ-5D-5L and SF-6D, respectively; SRM were 0.76 and 0.67, respectively. EQ-5D-5L was more efficient than SF-6D in detecting changes, but both were less efficient compared to criteria-based measures. The estimated MIC of EQ-5D-5L value set was 0.108 and 0.118 based on distribution and anchor-based approaches, respectively. The corresponding values for SF-6D were 0.048 and 0.064, respectively. CONCLUSIONS: In patients with health complaints attributed to dental amalgam undergoing amalgam removal, both EQ-5D-5L and SF-6D showed reasonable concurrent and predictive validity and acceptable responsiveness. The EQ-5D-5L utility appears to be more responsive compared to SF-6D. Trial registration The research was registered at ClinicalTrials.gov., NCT01682278. Registered 10 September 2012, https://clinicaltrials.gov/ct2/show/NCT01682278 .

Removal of dental amalgam restorations in patients with health complaints attributed to amalgam: A prospective cohort study.

BACKGROUND: The Norwegian Ministry of Health and Care Services initiated a project including experimental treatment for patients with health complaints attributed to amalgam restorations. OBJECTIVE: The aim was to evaluate changes of general health complaints in patients who participated in the project and had all amalgam restorations removed. METHODS: The project was designed as a prospective cohort study and organised by the Dental Biomaterials Adverse Reaction Unit in Bergen, Norway. The dental treatment was provided by the patient's local dentist. The main target group consisted of patients with medically unexplained physical symptoms, attributed to dental amalgam restorations (Amalgam cohort). The primary comparison group consisted of patients with medically unexplained physical symptoms without attribution to dental amalgam restorations (MUPS cohort). Primary outcome was self-reported general health complaints (GHC index) at follow-up 12-months after completed amalgam removal. RESULTS: In the Amalgam cohort, a significant reduction of GHC index from 43.3 (SD 17.8) at baseline to 30.5 (SD 14.4) at follow-up (mean reduction 12.8, SD 15.9; n = 32; P < .001) was observed. The change scores for GHC index indicated that the reduction of complaints was significantly higher (P = .004) in the Amalgam cohort compared with the MUPS cohort (mean reduction 1.2, SD 12.3, n = 28). After adjustment for age, gender, education and baseline GHC index, the mean adjusted difference was -8.0 (95% confidence interval from -15.4 to -0.5; P = .036). CONCLUSION: In a group of patients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, removal of amalgam restorations was followed by a significant reduction of health complaints.

Combining psychotherapy with craniosacral therapy for severe traumatized patients: A qualitative study from an outpatient clinic in Norway.

BACKGROUND: Craniosacral therapy (CST) is an established complementary modality for several health complaints. A clinic for psychosomatics in Norway has included CST into a multimodal treatment approach for severely traumatized patients. The aim of this study was to investigate and describe the indications for the use of craniosacral therapy within trauma therapy. Specifically, to explore treatment philosophy, criteria for improvement, treatment aims, and the evaluation of the risk profile of the multimodal treatment approach. METHODS: Semi-structured individual interviews (n = 8) and one focus group interview were conducted with the therapists at the Clinic for Psychosomatics, Hospital of Southern Norway, Kristiansand, Norway. The text data were transcribed verbatim, and the analysis of the material was conducted according to conventional and direct content analysis. RESULTS: The therapists at the clinic applied a holistic treatment approach, based on their understanding of mind and body as one entity. To access emotions and traumata, they used a mixture of different treatment techniques. The therapists experienced patients with severe bodily symptoms as being less cognitively present and attributed this to the symptoms craving most mental resources. The craniosacral therapists' specific aims and task within the multimodal trauma therapy was to ease these physical complaints, so that cognitive and emotional resources could be utilized for therapy. The psychotherapists found that emotions and traumata were more accessible after CST. The general treatment goals were to increase symptom tolerance levels and to enable better self-care. Furthermore, the ability to transform negative behaviors and develop positive alternatives were considered to be signs of improvement. CONCLUSION: The study participants considered that patients with complex traumas, including post-traumatic stress disorder, seemed to benefit from this multimodal treatment approach and appreciated its' holistic treatment philosophy, including craniosacral therapy. With regard to patient safety, the study participants recommended that craniosacral therapy for severely traumatized patients should only be provided in cooperation with psychotherapists, or other highly qualified health personnel working in specialized institutions.

Clinical Presentation of Gastroesophageal Reflux Disease: A Prospective Study on Symptom Diversity and Modification of Questionnaire Application.

INTRODUCTION: Symptoms occurring in gastroesophageal reflux disease (GERD) such as heartburn, regurgitation, thoracic pain, epigastric pain, respiratory symptoms, and others can show a broad overlap with symptoms from other foregut disorders. The goal of this study is the accurate assessment of symptom presentation in GERD. METHODS: Patients with foregut symptoms were investigated for symptoms as well as endoscopy and gastrointestinal-functional studies for presence of GERD and symptom evaluation by standardized questionnaire. Questionnaire included a graded evaluation of foregut symptoms documenting severity and frequency of each symptom. The three types of questionnaires include study nurse solicitated, self-reported, and free-form self-reported by the patient. RESULTS: For this analysis, 1,031 GERD patients (572 males and 459 females) were enrolled. Heartburn was the most frequently reported chief complaint, seen in 61% of patients. Heartburn and regurgitation are the most common (82.4/58.8%, respectively) in overall symptom prevalence. With regard to modification in questionnaire technique, if patients fill in responses without prompting, there is a trend toward more frequent documentation of respiratory symptoms (up to 54.5% [p < 0.01]), fullness (up to 93.9%), and gas-related symptoms (p < 0.001). Self-reported symptoms are more diverse (e.g., throat-burning [12%], mouth-burning [9%], globus [6%], dyspnea [9%], and fatigue [7%]). CONCLUSIONS: GERD symptoms are commonly heartburn and regurgitation, but overall symptom profile for patients may change depending on the type of questionnaire.

Acupuncture for the Treatment of Pain - A Mega-Placebo?

Several control conditions, such as penetrating sham acupuncture and non-penetrating placebo needles, have been used in clinical trials on acupuncture effects in chronic pain syndromes. All these control conditions are surprisingly effective with regard to their analgesic properties. These findings have fostered a discussion as to whether acupuncture is merely a placebo. Meta-analyses on the clinical effectiveness of placebo revealed that placebo interventions in general have minor, clinically important effects. Only in trials on pain and nausea, including acupuncture studies, did placebo effects vary from negligible to clinically important. At the same time, individual patient meta-analyses confirm that acupuncture is effective for the treatment of chronic pain, including small but statistically significant differences between acupuncture and sham acupuncture. All acupuncture control conditions induce de qi, a distinct stimulation associated with pain and needling which has been shown to be a nociceptive/pain stimulus. Acupuncture therefore probably activates the pain matrix in the brain in a bottom-up fashion via the spino-thalamic tract. Central nervous system effects of acupuncture can be modulated through expectations, which are believed to be a central component of the placebo response. However, further investigation is required to determine how strong the influence of placebo on the attenuation of activity in the pain matrix really is. A meta-analysis of individual participant functional magnetic imaging data reveals only weak effects of placebo on the activity of the pain network. The clinical acupuncture setting is comprised of a combination of a distinct neurophysiological stimulus, the needling stimulus/experience, and a complex treatment situation. A broader definition of placebo, such as that proposed by Howick (2017) acknowledges a role for expectation, treatment context, emotions, learning, and other contextual variables of a treatment situation. The inclusion of particular treatment feature as a definitional element permits a contextual definition of placebo, which in turn can be helpful in constructing future clinical trials on acupuncture.

Prevalence, and health- and sociodemographic associations for visits to traditional and complementary medical providers in the seventh survey of the Tromsø study.

BACKGROUND: Patient-centered culturally sensitive health care (PC-CSHC) has emerged as a primary approach to health care. This care focuses on the cultural diversity of the patients rather than the views of the health care professionals. PC-CSHC enables the patient to feel comfortable, respected, and trusted in the health care delivery process. As users of traditional and complementary medicine (T&CM) rarely inform their conventional health care providers of such use, the providers need to identify the users of T&CM themselves to avoid negative interaction with conventional medicine and to be able to provide them with PC-CSHC. Since the patterns of traditional medicine (TM) use are different to those of complementary medicine (CM), the aim of this study was to investigate the prevalence, and the health- and sociodemographic associations for visits to TM- and CM providers in an urban population. METHOD: The data were collected through two self-administrated questionnaires from the seventh survey of the Tromsø Study, a population-based cohort study conducted in 2015-2016. All inhabitants of Tromsø aged 40 or above were invited (n = 32,591) and n = 21,083 accepted the invitation (response rate 65%). Pearson chi-square tests and one-way ANOVA tests were used to describe differences between the groups whereas binary logistic regressions were used for adjusted values. RESULTS: The results revealed that 2.5% of the participants had seen a TM provider, 8.5% had seen a CM provider whereas 1% had visited both a TM and a CM provider during a 12-month period. TM users tended to be older, claim that religion was more important to them, have poorer economy and health, and have lower education compared to CM users. We found that more than 90% of the participants visiting T&CM providers also used conventional medicine. CONCLUSION: A considerable number of the participants in this study employed parallel health care modalities including visits to conventional, traditional, and complementary medicine providers. To offer patient-centered culturally sensitive health care that is tailored to the patients' treatment philosophy and spiritual needs, conventional health care providers need knowledge about, and respect for their patients' use of parallel health care systems.