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).

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.

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 .

Ginseng for erectile dysfunction.

BACKGROUND: Dietary supplements with ginseng, or ginseng alone, are widely used for a broad range of conditions, including erectile dysfunction. Ginseng is particularly popular in Asian countries. Individual studies assessing its effects are mostly small, of uneven methodological quality and have unclear results. OBJECTIVES: To assess the effects of ginseng on erectile dysfunction. SEARCH METHODS: We conducted systematic searches on multiple electronic databases, including CENTRAL, MEDLINE, Embase, CINAHL, AMED, and loco-regional databases of east Asia, from their inceptions to 30 January 2021 without restrictions on language and publication status. Handsearches included conference proceedings. SELECTION CRITERIA: We included randomized or quasi-randomized controlled trials that evaluated the use of any type of ginseng as a treatment for erectile dysfunction compared to placebo or conventional treatment. DATA COLLECTION AND ANALYSIS: Two authors independently classified studies and three authors independently extracted data and assessed risk of bias in the included studies. We rated the certainty of evidence according to the GRADE approach. MAIN RESULTS: We included nine studies with 587 men with mild to moderate erectile dysfunction, aged from 20 to 70 years old. The studies all compared ginseng to placebo. We found only short-term follow-up data (up to 12 weeks).  Primary outcomes Ginseng appears to have a trivial effect on erectile dysfunction when compared to placebo based on the Erectile Function Domain of the International Index of Erectile Function (IIEF)-15 instrument (scale: 1 to 30, higher scores imply better function; mean difference [MD] 3.52, 95% confidence interval [CI] 1.79 to 5.25; I² = 0%; 3 studies; low certainty evidence) assuming a minimal clinically important difference (MCID) of 4.  Ginseng probably also has a trivial effect on erectile function when compared to placebo based on the IIEF-5 instrument (scale: 1 to 25, higher scores imply better function; MD 2.39, 95% CI 0.89 to 3.88; I² = 0%; 3 studies; moderate certainty evidence) assuming a MCID of 5. Ginseng may have little to no effect on adverse events compared to placebo (risk ratio [RR] 1.45, 95% CI 0.69 to 3.03; I² = 0%; 7 studies; low certainty evidence). Based on 86 adverse events per 1000 men in the placebo group, this would correspond to 39 more adverse events per 1000 (95% CI 27 fewer to 174 more). Secondary outcomes Ginseng may improve men's self-reported ability to have intercourse (RR 2.55, 95% CI 1.76 to 3.69; I² = 23%; 6 studies; low certainty evidence). Based on 207 per 1000 men self-reporting the ability to have intercourse in the placebo group, this would correspond to 321 more men (95% CI 158 more to 558 more) per 1000 self-reporting the ability to have intercourse. Ginseng may have a trivial effect on men's satisfaction with intercourse based on the Intercourse Satisfaction Domain of the IIEF-15 (scale: 0 to 15, higher scores imply greater satisfaction; MD 1.19, 95% CI 0.41 to 1.97; I²=0%; 3 studies; low certainty evidence) based on a MCID of 25% improvement from baseline. It may also have a trivial effect on men's satisfaction with intercourse based on item 5 of the IIEF-5 (scale: 0 to 5, higher scores imply more satisfaction; MD 0.60, 95% CI 0.02 to 1.18; 1 study; low certainty evidence) based on a MCID of 25% improvement from baseline. No study reported quality of life as an outcome. We found no trial evidence to inform comparisons to other treatments for erectile dysfunction, such as phosphodiesterase-5 inhibitors. We were unable to conduct any predefined subgroup analyses. AUTHORS' CONCLUSIONS: Based on mostly low certainty evidence, ginseng may only have trivial effects on erectile function or satisfaction with intercourse compared to placebo when assessed using validated instruments. Ginseng may improve men's self-reported ability to have intercourse. It may have little to no effect on adverse events. We found no trial evidence comparing ginseng to other agents with a more established role in treating erectile dysfunction, such as phosphodiesterase-5 inhibitors.

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.

Correction to: Complementary and alternative medicine for treatment of atopic eczema in children under 14 years old: a systematic review and meta-analysis of randomized controlled trials.

ᅟ.

Complementary and alternative medicine for treatment of atopic eczema in children under 14 years old: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Due to limitations of conventional medicine for atopic eczema (AE), complementary and alternative medicine (CAM) is widely used as an alternative, maintaining, or simultaneous treatment for AE. We aimed to evaluate the beneficial and harmful effects of CAM for children with AE under 14 years old. METHODS: We searched for randomized trials on CAM in 12 Chinese and English databases from their inception to May 2018. We included children (< 14 years) diagnosed with AE, who received CAM therapy alone or combined with conventional medicine. We extracted data, and used the Cochrane "Risk of bias" tool to assess methodological quality. Effect was presented as relative risk (RR) or mean difference (MD) with 95% confidence interval (CI) using RevMan 5.3. RESULTS: Twenty-four randomized controlled trials involving 2233 children with AE were included. Methodological quality was of unclear or high risk of bias in general. The trials tested 5 different types of CAM therapies, including probiotics, diet, biofilm, borage oil, and swimming. Compared to placebo, probiotics showed improved effect for the SCORAD index (MD 9.01, 95% CI 7.12-10.90; n = 5). For symptoms and signs such as itching, skin lesions, CAM combined with usual care was more effective for symptom relief ≥95% (RR 1.47, 95% CI 1.30-1.68; n = 8), and for ≥50% symptoms improvement (RR 1.34, 1.25-1.45; n = 9) compared to usual care. There was no statistic significant difference between CAM and usual care on ≥95% improvement or ≥ 50% improvement of symptoms. However, swimming, diet and biofilm showed improvement of clinical symptoms compared with usual care. At follow-up of 8 weeks to 3 years, CAM alone or combined with usual care showed lower relapse rate (RR 0.38, 0.28-0.51, n = 2; RR 0.31, 0.24-0.40, n = 7; respectively) compared to usual care. Twelve out of 24 trials reported no occurrence of severe adverse events. CONCLUSIONS: Low evidence demonstrates that some CAM modalities may improve symptoms of childhood AE and reduce relapse rate. Safety remains unclear due to insufficient reporting. Further well-designed randomized trials are needed to confirm the potential beneficial effect and to establish safety use.

What circumstances lead to non-disclosure of cancer-related information in China? A qualitative study.

BACKGROUND: Withholding information from cancer patients is a common practice in many Asian countries, including China, Japan, and Singapore, as well as in some Western countries, such as Spain, Greece, and Italy. Much research has investigated why doctors withhold information from cancer patients generally, both in the West and the East, but little research has been done on specifically why Chinese doctors withhold such information. METHODS: Three focus group interviews were conducted with a total of 16 oncologists in China. The interviews were recorded, transcribed, and translated. Qualitative data were analyzed using systematic text condensation. RESULTS: The result of this study revealed numerous circumstances that can lead to non-disclosure of cancer-related information. Many of these circumstances have been described in previous studies about non-disclosure in other countries. We found two additional circumstances that have not been described in previous literature and might therefore expand our current knowledge about this phenomenon; they are contradiction between laws and fear for personal safety. CONCLUSION: Numerous circumstances can lead to non-disclosure of cancer-related information. This study found two additional circumstances that might lead to non-disclosure. The findings of this study suggest further assessment and clarification about the laws that govern doctor-patient communication and that action should be taken to ensure safe working environments for Chinese oncologists.

Use of complementary and alternative medicine in patients with health complaints attributed to former dental amalgam fillings.

BACKGROUND: The dental filling material amalgam is generally well tolerated. However, a small proportion of dental patients experience health complaints which they attribute to amalgam. The symptom pattern is often similar to patients with medically unexplained physical symptoms (MUPS) and the health complaints may persist after amalgam removal. Among patients with MUPS, the use of complementary and alternative medicine (CAM) seems to be high. The aim of this survey was to describe the prevalence and range of CAM use among people with health complaints attributed to dental amalgam fillings in which the health problems persist after the removal of all amalgam fillings. Specific attention was paid to (1) self-reported effects of CAM, (2) differences in CAM use dependent on self-reported health, and (3) gender differences in self-reported CAM use. METHODS: A survey was distributed to all members of The Norwegian dental patient association (NDPA) (n = 999), the response rate was 36.4%. The anonymous questionnaire asked for socio-demographic data, health complaints related to former amalgam fillings, subjectively perceived health status, symptoms, and experience with therapeutic interventions, mostly from the spectrum of CAM. Only participants who had all their fillings removed, which was the vast majority, were analysed. RESULTS: A total of 88.9% of included respondents had used at least one CAM modality, with a higher proportion of men (95.7%) compared to women (86.2%, p = 0.015). The most frequently used therapies were dietary supplements, vitamins and minerals recommended by a therapist (used by 66.7%) followed by self-prescribed dietary supplements, vitamins and minerals (59.0%), homeopathy (54.0%), acupuncture (48.8%) and special diets (47.5%). Use of CAM was similar for participants reporting normal to good health compared to participants reporting poor health. For all but two CAM modalities, the self-reported treatment effect was better in the group reporting normal to good health compared to the group reporting poor health. CONCLUSIONS: CAM was widely used by participants in our study, a finding similar to findings from studies of MUPS patients. To date, health problems associated with the use of dental amalgam is not an accepted diagnosis in the healthcare system. Consequently, people suffering from such complaints experience a lack of adequate treatment and support within conventional health care, which might have contributed to the high number of CAM users in this study.

An Acupuncture Protocol for the Treatment of Erectile Dysfunction: 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 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.

The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: A systematic review and network meta-analysis.

Objective: In sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis. Methods: Ten databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated. Results: A total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate. Conclusion: For knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.

Publication status and reporting quality of case reports on acupuncture-related adverse events: A systematic reviews of case studies.

Introduction: Case reports on acupuncture-related adverse events (AEs) have been consistently published in the literature. This review aims to assess the current publication status of case reports on acupuncture-related AEs and evaluate their reporting quality in order to identify areas for improvement. Methods: This study is a systematic review (SR) of case reports. Studies describing cases for acupuncture-related AEs between 2010 and 2023 (until July) were searched in PubMed, Embase, and local databases (China and Korea), as well as by hand-searching references included in published relevant SRs. A bibliometric analysis was conducted to examine the publication trends of the included literature. The appropriateness of the acupuncture described in the cases, the causality assessment between AEs and acupuncture treatment, and the presence of necessary items from the CAse REport guidelines (CARE) checklist were narratively analyzed. Results: A total of 169 case reports were included in this review. Over the past decade, an average of 12 case reports on acupuncture-related AEs were published annually. However, only 38.2% of the articles provided sufficient information to determine the appropriateness of the acupuncture treatment used in the reported cases, and considerable numbers of the included case reports did not suggest enough information for the assessment of a causal relationship. The majority of cases did not report the timeline (n = 164), patient perspectives (n = 157), and informed consent (n = 121) items from the CARE checklist. Discussion: Acupuncture-related AEs persist in being frequently reported in the literature. Nonetheless, the information concerning acupuncture and causality assessment within these publications is still found to be insufficient. The development of reporting guidelines for future case reports on acupuncture-related AEs is anticipated to promote an academic environment conducive to more comprehensive reporting.

Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain: A Systematic Review and Network Meta-Analysis.

Importance: When sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is conducted either at the same points that are used for the acupuncture group or at nonindicated points. Objective: To assess whether the outcome of sham acupuncture varies according to the needling points in sham-controlled trials of acupuncture for chronic nonspecific low back pain (CLBP) as an example. Data sources: Searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database were conducted on February 12, 2023. Study selection: Randomized clinical trials (RCTs) assessing the outcomes of acupuncture in sham acupuncture-controlled or waiting list-controlled trials on CLBP were included. Data extraction and synthesis: Two researchers independently extracted data on study characteristics and outcomes and assessed quality. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the acupuncture group, referred to as sham acupuncture therapy (verum) (SATV) or at different points, referred to as sham acupuncture therapy (sham) (SATS). Clinical similarity, transitivity, and consistency tests were conducted, followed by a random-effects frequentist network meta-analysis (NMA). Main outcomes and measures: The primary outcome was pain, and the secondary outcome was back-specific function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMD) with 95% CIs. The risk of bias was assessed using the Cochrane risk of bias tool, and the certainty of evidence for findings was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Ten RCTs involving 4379 participants were included. In comparison with SATS, acupuncture was significantly associated with improvements in both pain (SMD, -0.33; 95% CI, -0.52 to -0.15) and function outcomes (SMD, -0.13; 95% CI, -0.25 to -0.02); however, there were no differences between acupuncture and SATV. In comparison with SATS, SATV was significantly associated with better pain (SMD, -0.45; 95% CI, -0.88 to -0.03) and function outcomes (SMD, -0.30; 95% CI, -0.56 to -0.05). The risk of bias that could affect the interpretation of the results was usually low, and the certainty of evidence was moderate to low. Conclusions and relevance: In this NMA, sham acupuncture needling at the same points as those in acupuncture was not a true placebo control for assessing the efficacy of acupuncture for CLBP and might underestimate the outcome of acupuncture in clinical settings.

Using Acupuncture for Adjunct Treatment for Cancer-Related Fatigue in Breast Cancer Patients Is Practicable. Reply to Hu et al. Is Acupuncture an Ideal Adjunctive Treatment for Cancer-Related Fatigue? Comment on "Choi et al. Acupuncture for Managing Cancer-Related Fatigue in Breast Cancer Patients: A Systematic Review and Meta-Analysis. Cancers 2022, 14, 4419".

We are grateful for the relevant comments by Hu et al. [...].

Different Outcomes According to Needling Point Location Used in Sham Acupuncture for Cancer-Related Pain: A Systematic Review and Network Meta-Analysis.

Numerous acupuncture studies have been conducted on cancer-related pain; however, its efficacy compared to sham acupuncture remains controversial. We confirmed whether the outcome of acupuncture differs according to the needling points of sham acupuncture for cancer-related pain. We searched 10 databases on 23 May 2023 to screen acupuncture trials using sham acupuncture or waiting list as controls for cancer-related pain. Sham acupuncture was classified into two types, depending on whether the needling was applied at the same locations as verum acupuncture (SATV) or not (SATS). A network meta-analysis (NMA) was performed on the basis of a frequentist approach to assess pain severity. Eight studies (n = 574 participants) were included in the review, seven of which (n = 527 participants) were included in the NMA. The pain severity was not significantly different between SATV and verum acupuncture, but verum acupuncture significantly improved pain severity compared to SATS. The risk of bias affecting the comparisons between the verum and sham acupuncture was generally low. Previous acupuncture trials for cancer-related pain showed differing outcomes of sham and verum acupuncture, depending on the needling points of sham acupuncture. The application of SATV cannot be considered a true placebo, which leads to an underestimation of the efficacy of verum acupuncture.

Mapping of systematic reviews on traditional medicine across health conditions: a protocol for a systematic map.

INTRODUCTION: Traditional medicine (TM) is an important part of healthcare either as the main healthcare system or as a complement to conventional medicine. The effectiveness of TM has been assessed in clinical trials that have been synthesised into thousands of systematic reviews (SRs). This study is commissioned by the World Health Organization (WHO) and is aimed at providing a systematic map of SRs of TM interventions across health conditions, as well as identifying gaps in the research literature in order to prioritise future primary research. METHODS AND ANALYSIS: This is the protocol for a systematic map of SRs reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). We will search 17 electronic databases to identify SRs of TM. The literature search covers the last 5 years, from January 2018 to December 2022. At least two independent reviewers will perform the database search, screening of eligible SRs, data extraction and quality assessments using the A MeaSurement Tool to Assess Systematic Reviews (AMSTAR 2). The characteristics and extent of SRs will be analysed according to disease classification, and type of TM intervention, and visualised by means of (interactive) graphical maps. ETHICS AND DISSEMINATION: Ethical approval is not required as this is a systematic map of published studies. The findings of the study will be disseminated through online-available maps, presentations and scientific publications. PROSPERO REGISTRATION NUMBER: CRD42023416355.

The Red flag! risk assessment among medical homeopaths in Norway: a qualitative study.

BACKGROUND: Homeopathy is widely used, and many European physicians practice homeopathy in addition to conventional medicine. Adverse effects in homeopathy are not expected by homeopaths due to the negligible quantities of active substances in a remedy. However, we questioned if homeopathic aggravation, which is described as a temporary worsening of existing symptoms following a correct homeopathic remedy, should be regarded as adverse effects or ruled out as desirable events of the treatment. In order to improve knowledge in an unexplored area of patient safety, we explored how medical homeopath discriminate between homeopathic aggravations and adverse effects, and how they assessed patient safety in medical practice. METHOD: A qualitative approach was employed using focus group interviews. Two interviews with seven medical homeopaths were performed in Oslo, Norway. The participants practiced homeopathy besides conventional medicine. Qualitative content analysis was used to analyze the text data. The codes were defined before and during the data analysis. RESULTS: According to the medical homeopaths, a feeling of well-being may be a criterion to distinguish homeopathic aggravations from adverse effects. There was disagreement among the participants whether or not homeopathic treatment produced adverse effects. However, they agreed when an incorrect remedy was administrated, it may create a disruption or suppressive reaction in the patient. This was not perceived as adverse effects but a possibility to prescribe a new remedy as new symptoms emerge. This study revealed several advantages for the patients as the medical homeopaths looked for dangerous symptoms which may enhance safety. The patient was given time and space, which enabled the practitioner to see the complete picture. A more comprehensive toolkit gave the medical homeopaths a feeling of professionalism. CONCLUSION: This explorative study investigated how Medical Homeopaths understood and assessed risk in their clinical practice. A feeling of well-being emerging soon after taking the remedy was the most important criterion for discriminating between Homeopathic Aggravations and Adverse Effects in clinical practice. The Medical Homeopaths used the view of both professions and always looked for red flag situations in the consultation room. They combined knowledge from two treatment systems which may have advantages for the patient. These tentative results deserve further research efforts to improve patient safety among users of homeopathy. For further research we find it important to improve and develop concepts that are unique to homeopathy in order to validate and modernize this medical practice.