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H Nothnagel,1–3 M Brown Menard4,5, G Kvarstein,6 AJ Norheim,3 T Weiss,7 C Puta1,8, SD Mist,9 F Musial31Department of Sports Medicine and Health Promotion, Friedrich Schiller University Jena, Jena, Germany; 2Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany; 3Department of Community Medicine, The National Research Center for Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway; 4Crocker Institute, Kiawah Island, SC, USA; 5School of Integrative Medicine and Health Sciences, Saybrook University, Oakland, CA, USA; 6Pain clinic, University Hospital of Northern Norway, UiT The Arctic University of Norway, Tromsø, Norway; 7Department of Biological and Clinical Psychology, Friedrich Schiller University, Jena, Germany; 8Center for Interdisciplinary Prevention of Diseases related to Professional Activities, Friedrich Schiller University, Jena, Germany; 9Oregon Health & Science University, Portland, OR, USABackground: Recruitment and inclusion procedures in clinical trials are time critical. This holds particularly true for studies investigating patients with fluctuating symptom patterns, like those with chronic neck pain. In a feasibility study on neck pain, we found a clinically relevant decrease in pain ratings within the recruitment period. This paper analyses the phenomenon and gives recommendations for recruitment procedures in clinical trials on pain.Methods: Changes in pain intensity scores of 44 chronic neck pain patients (6 males and 36 females; mean age: 45.3±13.2 years) between the first telephone contact and baseline assessment were analyzed. Inclusion criterion was a mean pain intensity of ≥40 on a 0–100 numerical rating scale during the last three months. Statistical analyses were performed using ANOVA and parametric/non-parametric correlation coefficients.Results: Average pain intensity score decreased significantly from 60.3±13.3 at telephone interview to 38.1±21.7 at baseline assessment. This represents a relative change of 36.8%. A weak but significant negative correlation was found between number of days between assessments and pain rating differences. There was a positive correlation between change of pain intensity and the pain level at the first contact, indicating that the decreased pain ratings over time were also dependent on the initial pain rating.Conclusions: The clinically significant changes in pain intensity were weakly related to waiting time and moderately dependent on initial pain intensity, suggesting regression to the mean. The natural course of the disease and the Hawthorne effect are also discussed as contributing factors.Keywords: chronic neck pain, Hawthorne effect, natural course of the disease, regression to the mean, clinical trial, recruitment

Helen Nothnagel,1,2,* Christian Puta,1,3,* Thomas Lehmann,4 Philipp Baumbach,5 Martha B Menard,6,7 Brunhild Gabriel,1 Holger H W Gabriel,1 Thomas Weiss,8 Frauke Musial2 1Department of Sports Medicine and Health Promotion, Friedrich Schiller University, Jena, Germany; 2Department of Community Medicine, National Research Center in Complementary and Alternative Medicine, UiT, The Arctic University of Norway, Tromsø, Norway; 3Center for Interdisciplinary Prevention of Diseases Related to Professional Activities, 4Department of Medical Statistics, Computer Sciences and Documentation, Friedrich Schiller University, 5Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena, Germany; 6Crocker Institute, Kiawah Island, SC, 7School of Integrative Medicine and Health Sciences, Saybrook University, Oakland, CA, USA; 8Department of Biological and Clinical Psychology, Friedrich Schiller University, Jena, Germany *These authors contributed equally to this work Background: Quantitative sensory testing (QST) is a diagnostic tool for the assessment of the somatosensory system. To establish QST as an outcome measure for clinical trials, the question of how similar the measurements are over time is crucial. Therefore, long-term reliability and limits of agreement of the standardized QST protocol of the German Research Network on Neuropathic Pain were tested. Methods: QST on the lower back and hand dorsum (dominant hand) were assessed twice in 22 healthy volunteers (10 males and 12 females; mean age: 46.6±13.0 years), with sessions separated by 10.0±2.9 weeks. All measurements were performed by one investigator. To investigate long-term reliability and agreement of QST, differences between the two measurements, correlation coefficients, intraclass correlation coefficients (ICCs), Bland–Altman plots (limits of agreement), and standard error of measurement were used. Results: Most parameters of the QST were reliable over 10 weeks in healthy volunteers: Almost-perfect ICCs were observed for heat pain threshold (hand) and mechanical pain sensitivity (back). Substantial ICCs were observed for heat pain threshold (back), pressure pain threshold (back), mechanical pain sensitivity (hand), and vibration detection threshold (back and hand). Some QST parameters, such as cold detection threshold, exhibited low ICCs, but also very low variability. Generally, QST measures exhibited narrow limits of agreement in the Bland–Altman plots. Conclusion: The standardized QST protocol of the German Research Network on Neuropathic Pain is feasible to be used in treatment trials. Moreover, defining a statistically meaningful change is possible, which is a prerequisite for the use of QST in clinical trials as well as in long-term investigations of disease progression. Keywords: QST, healthy volunteers, test–retest reliability, intraclass correlations, Bland–­Altman plot, limits of agreement, standard error of measurement, minimum detectable difference

Background Many factors may play a role in the severity and progression of gastroesophageal reflux disease (GERD) since pathophysiology is multifactorial. Data regarding the progression of GERD are controversial: some reports of increased esophageal acid exposure (EAE) and mucosal damage were considered as evidence for a stable disease course, while others interprete these findings as disease progression. The aim of this study is to analyze a large patient-population with persisting symptoms indicative of GERD under protonpumpinhibitor-therapy and identify components characterizing disease severity and progression. Methods Patients with symptoms indicative of GERD were included in the study in a tertiary referral center (Frankfurt, Germany). All selected patients were under long-term protonpumpinhibitor-therapy with persistant symptoms. All patients underwent investigations to collect data on their physical status, EAE, severity of esophagitis, anatomical changes, and esophageal functional defects as well as their relation to the duration of the disease. Incidence over time was plotted as survival curves and tested with Log-rank tests for the four main disease markers. Multivariate modeling with COX-regression model was used to estimate the general impact of the four main disease markers on the time course of the disease. In order to elucidate possible causal relationships over time, a path analysis (structural equation model) was calculated. Results From the database with 1480 data sets, 972 patients were evaluated (542 males, 430 females). The mean age was 50.5 years (range18–89). The mean body mass index was 27.2(19–48). The mean time between the onset of symptoms and the diagnostic investigations was 8.2 years (1–50). A longer disease history for GERD was significantly associated with a higher risk for LES-incompetence. The mean duration from symptom onset to the time of clinical investigation was 9 years for patients with LES-incompetence (n  = 563), compared to a mean of 6 years for those with mechanically intact LES (n  = 95). A longer period from symptom onset to diagnostics was significantly associated with higher acid exposure. The pathway analysis was significant for the following model: 'history' (P  < 0.001➔LES-incompetence & Hiatal Hernia➔(p < 0,001)➔pH-score (P  < 0.001). Conclusion: LES-incompetence, the functional deterioration of the LES, and the anatomical alteration at the esophagogastric junction (Hiatal Hernia) as well as an increased EAE were associated with a long history of suffering from GERD. Path modeling suggests a causal sequence overtime of the main disease-parameters, tentatively allowing for a prediction of the course of the disease. [ABSTRACT FROM AUTHOR]

A large variety of foregut symptoms can occur in patients with gastroesophageal reflux disease (GERD), which can overlap with other disorders such as somatoform disorders and dyspepsia. Due to unclear diagnostic situations, these patients are often not adequately treated. The aim of this study was the evaluation of patients with foregut symptoms, referred for possible antireflux surgery, regarding their relationship with GERD and somatization tendencies based on control data from an unselected population. Symptom evaluation and somatization screening were initiated both in volunteers and in patients with foregut symptoms and GERD. Unselected volunteers from a village population were also evaluated by symptom analysis and for somatisation tendency. In addition, patients with foregut symptoms were diagnosed for GERD, and symptom analysis and psychodiagnostic evaluation were performed. There is no major significant difference in the symptom-spectrum in patients with foregut symptoms, whether they have a proven pathologic acid exposure fromGERD or not. The probability for the risk of somatization was 5.6% in the unselected population of nonpatient volunteers (n = 267). In patients with foregut symptoms (n = 750), the probability for the presence of somatoform tendencies was approximately 20%, independent whether these patients had a documented GERD or a normal esophageal acid exposure, implicating further diagnostic work-up for the selection of patients for antireflux surgery. There is a remarkable symptom load and variety in patients with GERD, in patients with foregut symptoms, and in an unselected population of volunteers. There is no difference in the risk for somatization between patients with foregut symptoms and those with documented GERD. Therapeutic decision making especially prior to antireflux surgery requires an awareness of mental and emotional challenges. [ABSTRACT FROM AUTHOR]

Background: There is evidence that acupuncture activates different spinal and supraspinal antinociceptive systems, but the specific modulatory effects on the sensory system have not been systematically investigated. In this study, we evaluated the immediate effects of different types of acupuncture on thermal, mechanical, and vibratory sensory thresholds. Methods: Twenty-four healthy volunteers (12 men and 12 women, mean age 33.1 years) received 3 different forms of acupuncture in a single-blinded crossover design; these included manual acupuncture, acupuncture with low-frequency electrical stimulation, and acupuncture with high-frequency electrical stimulation. The time between the interventions was 1 week. All forms of acupuncture were applied unilaterally in the leg at standard acupuncture points: spleen 6, spleen 9, stomach 36, and gallbladder 39. The effects of acupuncture were evaluated by systematic quantitative sensory testing (QST) immediately after each intervention. QST was performed on bilateral lower extremities, including thermal and mechanical perception and pain and vibratory thresholds. Results: The heat pain threshold was increased after manual acupuncture on the treated and untreated side compared with baseline. Low- and high-frequency electrostimulation led to a higher mechanical pain threshold on the treated side compared with baseline and manual acupuncture. The pressure pain threshold was increased by all forms of acupuncture on both sides, with individual changes from baseline ranging from 25 % to 52 %. Conclusions: There were congruent changes on QST after 3 common acupuncture stimulation methods, with possible unilateral as well as bilateral effects. [ABSTRACT FROM AUTHOR]

An abstract of the article "Adverse effects of homeopathy, what do we know? A systematic review," by T. Stub and colleagues is presented.

An abstract of the article "The effects of five sessions of cupping massage on chronic non-specific neck pain: A randomized controlled pilot study," by S. Schumann and colleagues is presented.

Background: The quality of homeopathic research studies is controversially discussed. In order to improve the overall assessment of homeopathic studies and subsequently facilitate evidence-based clinical decision-making, we aimed to combine methodological tools for scientific rigor with tools for external and model validity into one global tool., Method: Against the background of previous literature and the results of a preparatory survey, a first draft of a potential overarching tool was presented to an expert panel. Then, Delphi feedback rounds were conducted to elicit responses on the feasibility. The resulting preliminary tool was pilot-tested by five research experts on five randomly selected studies. After further optimization another five studies were assessed by the same experts and another three experts tested the second version. The ratings were tested for interrater-reliability using Gwet's AC2., Results: The appraisal tool comprises four domains. These are the assessment of risk-of-bias (1) using the Cochrane Tool, the studies' credibility (2) including the CONSORT statement and its extension on homeopathy, the study interventions' coherence (3) with homeopathic textbooks and previous research, and of the studies' clinical relevance (4). Each domain is assessed using a point system, which is then added up to an overall score. The instrument was evaluated as useful and "easy to apply" by the raters. The interrater reliability was 0.81 (95% CI 0.75 to 0.88) for five raters, and 0.64 (95% CI 0.49 to 0.79) for additional three raters in round 2, signifying good to moderate interrater reliability., Conclusion: We have developed an applicable and reliable assessment tool for homeopathic intervention studies. Using it in systematic reviews and meta-analyses will increase their scientific value., (S. Karger AG, Basel.)

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.

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.

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 standardise 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 between 11 and 15 treatments given once or twice a week., Conclusion: An expert consensus-based, semi-standardised 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 study provides a first point of departure for the implementation of a more standardised treatment approach. Moreover, since a recent meta-analysis concluded that more high-quality clinical studies on the topic are needed, this study provides a first standardised acupuncture treatment protocol for ED., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

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., (© 2023. The Author(s).)

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).