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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.

Background: Randomised controlled trials of acupuncture performed using sham interventions to control for the placebo effect have mostly used two types of sham techniques: techniques with minimal insertion of acupuncture needles with no additional stimulation (shallow needling control) and techniques with sham acupuncture devices that do not penetrate the skin (sham device control). To achieve successful blinding, sham device controlled acupuncture trials also use the acupuncture base unit in the verum acupuncture group, but in the shallow needling control trials this is not necessary for the verum acupuncture treatment. Objective: In this study, we analysed the estimated comparative effectiveness of these two verum acupuncture modalities in studies of acupuncture for menopausal hot flashes that used two types of sham control treatments. Methods: We conducted a network meta-analysis that included randomised controlled trials of acupuncture for hot flashes. Electronic databases, including Medline, Embase, Cochrane Library and AMED, were searched through March 2017. Data were extracted using a predefined data extraction tool by two independent reviewers. The risk of bias was assessed using the Cochrane risk of bias tool for randomised controlled trials. A five-node network meta-analysis was conducted based on the frequentist framework. Results: Eight studies were included in this review. From the network meta-analysis, we found that verum acupuncture in the shallow needling controlled trials was more effective than verum acupuncture in the sham device controlled trials (SMD −7.27, 95% CI−9.11 to −5.43). Significant heterogeneity and inconsistency were not observed among the included studies or the comparisons. Conclusions: From this preliminary analysis, we found that different types of verum acupuncture may have different effect sizes with respect to the severity of menopausal hot flashes.

Background Recently research on acupuncture for cancer related symptoms has significantly increased. To what extent have medical professionals recommended to use acupuncture in light of that evidence? Methods Evidence of effectiveness and safety was found by searching Pubmed for reviews to identify for what conditions and general results. Publications that recommend acupuncture in oncology were searched in the database of an ongoing general search for publications that recommend acupuncture. This database was developed by searching google for publications that recommend the use of acupuncture with the terms ‘name of symptom’ and ‘clinical practice guideline’ or ‘treatment guideline’. Results Acupuncture is moderately or weakly effective for 19 symptoms in patients with cancer and cancer survivors. Acupuncture is a safe therapy in cancer care if administered by trained acupuncturists. Acupuncture is targeted to improve symptoms associated with the cancer and different cancer treatments, not to treat the cancer itself. More than 350 publications by clinical practice guideline groups and expert groups, including public health statements made by national and government agencies recommended the use of acupuncture for 61 cancer related symptoms many with positive evidence of effectiveness. Conclusion The strength of evidence is weak for many indications, however the evidence for many standard therapies is either not very strong or if stronger, the incidence of adverse events is more, which makes acupuncture a treatment option despite the weak evidence. We have found evidence that many oncologists around the world have started to incorporate acupuncture into the treatment of various cancer related symptoms.

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., Plain language summary Ginseng for improving erectile function Review question Does ginseng help men’s ability to have erections? Background Many men have problems with gaining an erection. This can result in low self‐esteem, relationship issues and reduced quality of life. Medication and surgery can help with this problem, but studies also suggest that herbal supplements may help. We reviewed the literature to find out whether certain forms of ginseng, a popular root used in many countries, can help with erection problems. Study characteristics We included nine studies that compared the effects of ginseng against a placebo (dummy drug). These studies included 587 participants with mild to moderate difficulty in erection, aged 20 to 70 years old. All information we found was limited to a short follow‐up period of 12 weeks or fewer. Key results Compared to a dummy drug, ginseng may have a trivial effect on erectile function, as assessed by two questionnaires specially developed for this purpose. It may also have little to no effect on unwanted side effects. It may also have a trivial effect on men's satisfaction with intercourse based on responses to two specialized questionnaires. When men were simply asked whether their erections improved (without using a specialized questionnaire), the results of this systematic review show that ginseng may improve the ability to have intercourse. Certainty of evidence The certainty of evidence for most outcomes was low. This means that the true effect may be substantially different from what this review shows.

The objectives of this study were to assess the effects of ginseng on erectile dysfunction. We searched multiple electronic databases from their inceptions to 30 January 2021 without restrictions by language. We included randomized or quasirandomized controlled trials that evaluated the use of any type of ginseng as a treatment for erectile dysfunction compared to placebo or conventional treatment. The authors independently screened the literature, extracted data, assessed risk of bias, and rated the certainty of evidence (CoE) according to the GRADE approach. We included nine studies, and all compared ginseng to placebo. 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 (mean difference [MD] 3.52, 95% confidence interval [CI] 1.79 to 5.25; I2=0%; 3 studies; low CoE). 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 CoE). While 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 CoE), it may have a trivial effect on men's satisfaction with intercourse based on the Intercourse Satisfaction Domain of the IIEF-15 (MD 1.19, 95% CI 0.41 to 1.97; I2=0%; 3 studies; low CoE). No study reported quality of life as an outcome.

Background - Trials of acupuncture in the West began before textbooks about acupuncture were generally available. This placed trials at risk of possible faulty assumptions about the practice of acupuncture and adoption of problematic research assumptions and methods. Further, this lack of information has had an influence on the theories of developing a valid and reliable sham control treatment in clinical trials of acupuncture. This commentary explores these issues. Methods - Literature review focussing on the time line of developments in the field, developments of sham interventions and use thereof and knowledge of physiological effects of needling. Results - Early trials demonstrated a lack of knowledge about acupuncture. As the methodology of trials improved, new sham treatment methods were developed and adopted; however, the sham treatment methods were implemented without physiological studies exploring their potential physiological effects and without examining the broader practice of acupuncture internationally. Conclusions - Mistaken assumptions about the practice of acupuncture reinforced by paucity of physiological investigations are factors that led to use of inappropriate sham interventions for acupuncture trials. These not only lead to confusing or misleading trial results, they, as far as we can see underestimate the effects of acupuncture leading to bias against acupuncture. There are significant problems with sham interventions and how they are applied in trials of acupuncture. Further research is needed to explore the effects of this both for future trials and for interpreting existing evidence.

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.

Final publication is available from Mary Ann Liebert, Inc., publishers https://doi.org/10.1089/acm.2020.0032. Background: Acupuncture is one of the fastest developing evidence bases in Complementary Medicine and is one of the leading therapies included within integrative health care. This narrative review includes two separate parts: the first is about evaluation of the current evidence status in reviews on acupuncture and the second examines and gives examples of available recommendations on acupuncture in treatment guidelines from health care experts and public health organizations recommending acupuncture as a viable treatment in patients in palliative care. Methods: Electronic searches were performed in PubMed using the terms “acupuncture” + “palliative” and adding the term “safety” to find review articles documenting safety and evidence of effectiveness of acupuncture for treatment of symptoms in palliative care patients. Treatment guidelines that recommend use of acupuncture for symptom control in palliative care were found by searching through a database currently under construction by the lead author. Results: Acupuncture shows emerging evidence for 17 indications in palliative care. Examples were found and presented of publications recommending acupuncture for treatment of symptoms for patients in palliative care from Government, public health, oncology, and medical expert sources. The most publications are in oncology, but other conditions were found and a number were found in pediatric care. Conclusions: While the evidence for use of acupuncture to treat symptoms in palliative care patients is relatively weak, the evidence base is growing. Experts worldwide are also increasingly recommending acupuncture as a treatment for symptoms in palliative care. Since acupuncture is a safe, nonpharmacological treatment but with small, clinically significant effects, these recommended uses appear as pragmatic efforts to bridge the gap of treatment options available to this patient group.

Dear EditorI read with interest the paper by Xindong Qin et al. “Acupuncture for Recurrent Urinary Tract Infection in Women: A Systematic Review and Meta-Analysis.1 In this paper, under the heading “Interpretation” – they discuss possible mechanisms behind a potential effect of acupuncture. They are referring to one of my studies,2 but they are not discussing one of our study’s main finding. We found a correlation between fewer urinary tract infections and less measured volume of residual urine in the women treated with acupuncture. This change in residual urine did not occurred in the non-treated group. Residual urine or post voided volume measured by a Bladder Scan, and by a nurse, in a hospital setting, and she was blinded with regard to the participants group allocation. What is an empty Bladder? A paper by Haylen discuss this and a post-voided volume above 30 ml, in otherwise healthy women, has been regarded as one of many potential risk factors3. Interestingly all women in our study had at baseline more than 30 ml of residual urine.2 After 6 months control this was reduced to 18.2 mL in the acupuncture group while no change in the non-treated group (35.5 vs 38.8mL). Further, residual urine is recognized, and discussed as one of several potential risk factors for recurrent urinary tract infections in children 4 and healthy postmenopausal women. 5 Hence, with regard to post-voided volumes, I hope this can be included in future studies on acupuncture as a prophylactic treatment for recurrent urinary tract infections. Finally, a question to the authors,1 on page 6, you write: “None of the studies reported the secondary outcomes of urinary bacteria culture, WBCs of urine dipstick, kidney function, markers of kidney damage, health-related quality of life or healthcare costs.” However, our study 2 used a dipstick (Uricult) and we presented the number of infections with or without bacteriuria. Do I misunderstand, or do you mean the actual name of the bacteria found?Terje AlraekSchool of Health Sciences / NAFKAM, Department of Community Medicine,Kristiania University College / Faculty of Health Science, UiT The Arctic University of NorwayReferencesQin X, Coyle ME, Yang L, Liang J, Wang K, Guo X, Zhang AL, Mao W, Lu C, Xue CC, Liu X. Acupuncture for recurrent urinary tract infection in women: a systematic review and meta-analysis. BJOG 2020; https://doi-org.pva.uib.no/10.1111/1471-0528.16315Alraek T, Soedal LI, Fagerheim SU, Digranes A, Baerheim A. Acupuncture treatment in the prevention of uncomplicated recurrent lower urinary tract infections in adult women. Am J Public Health 2002;92:1609–11Haylen BT. The empty Bladder. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):237-9. doi: 10.1007/s00192-006-0111-0Hoebeke P, Van Laecke E, Van Camp C, Raes A, Van De Walle J. One thousand video-urodynamic studies in children with non-neurogenic bladder sphincter dysfunction. BJU International (2001), 87, 575–580Stamm WE, Raz R. Factors contributing to susceptibility of postmenopausal women to recurrent urinary tract infections. Clin Infect Dis. 1999 Apr;28(4):723-5. doi: 10.1086/515209.

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.

As positive evidence emerges for the use of an intervention to treat a health problem, the intervention gradually becomes incorporated into treatment guidelines (TGs) or clinical practice guidelines (CPGs) that are related to that health problem. To assess whether this general hypothesis can apply to acupuncture, 96 health problems were identified for which positive conclusions in systematic reviews and meta-analyses regarding the effectiveness of acupuncture have been made and then searched for TGs or CPGs that have recommended the use of acupuncture.Through August 31, 2017, searches were performed in relevant medical databases and Google using "treatment guideline," "clinical practice guideline," and the names of the 96 medical conditions as search terms. A "snow-balling" search approach was adopted. All positive recommendations were added into the registry.A total of 1311 publications were found that recommended using acupuncture published between 1991 and 2017. The number per year reached 50 in 2005 and 100 in 2009. In addition, 2189 positive recommendations were found for the use of acupuncture. Of these, 1486 were related to 107 pain indications and 703 were related to 97 nonpain indications. These recommendations were made by a wide range of groups, such as government health institutions, national guideline, and medical specialty groups. The recommendations came from around the world but were especially abundant in North America, Europe, and Australasia.Considerably more recommendations were found for the use of acupuncture than are known within the acupuncture or medical communities. A trend by year was also found; a rise in the number of positive statements about acupuncture was typically followed by a rise in the number of recommendations of acupuncture. Thus, the recommendations followed the emergent evidence for acupuncture. Better implementation plans need to be developed for the CPG/TG recommendations about acupuncture to be more effective/efficient.

Introduction The spectrum of cold injuries is very broad, and treatment is often difficult. This case report describes for the first time the successful treatment of frostbite sequel by acupuncture. Dynamic Infrared Thermography was used to monitor the effect of acupuncture. Case summary The patient was a 19 years old previously healthy, non-smoking, female patient. She had no previous history of cold injuries, no other injuries or medical problems, and was not taking any medication. During outdoor military training in February 2015 in the harsh North-Norwegian climate, she noticed that she began to lose feeling in her fingers that during the exercise turned into dark discoloration with blisters. She was diagnosed with a second degree frostbite on the fingertips of both hands. There was spontaneous recovery but when followed up at one year after the problem, she still complained of sensory-motor disturbances and hypersensitivity to cold. During the follow-up, she was examined by DIRT and offered off-label treatment with acupuncture. Local acupuncture points were used to enhance adjacent peripheral blood circulation. Acupuncture based on Traditional Chinese Medicine was added to these points according to the patient’s symptom of feeling cold in general. Acupuncture treatments were given once a week for 12 weeks. After treatment, the patient reported slightly less cold sensitivity. There was a clinical improvement in the control of micro-vascularization as shown in the thermographic examinations before and after treatment. Conclusion Acupuncture therapy might provide a potential novel and promising treatment for frostbite sequelae.

In these difficult times as the world continues to struggle with the Covid pandemic, it is quite amazing that Traditional Chinese Medicine (TCM) practitioners inside China were able to treat Covid infected patients as part of China's response to Covid. 1 Many groups are looking for successful treatments for Covid and its sequelae such as Long Covid. Publications about the potential role of acupuncture and Chinese TCM herbal medicine have been emerging since early 2020. While this is encouraging, there are a number of issues that we feel researchers and authors need to attend to if acupuncture, Chinese TCM herbal medicine are to gain recognition in treatment of Covid and Long Covid.

Background: Many patients have complex health complaints they attribute to dental amalgam. There is some evidence of symptom relief after removal of amalgam. Objective: The aims of this study were to assess the total symptom load in patients with all their amalgam fillings removed, and to investigate the self-reported improvement of health with regard to precautions taken under amalgam removal and time since removal. Methods: The survey was distributed to all members (n=999) of the Norwegian Dental patients association in 2011. The study participants returned the questionnaires anonymously by means of a pre-stamped envelope. The questionnaire asked for sociodemographic data, subjectively perceived health status, complaints persisting after amalgam removal and self-reported changes in symptoms after amalgam removal. Results: A total of 324 participants were included in the study. The majority of the participants reported improved health after amalgam removal, even though the mean degree of severity of complaints was still high. Exhaustion and musculoskeletal complaints were most severe, and reflects the fact that 38% of the participants reported poor to very poor current health. With regard to amalgam removal, associations between improved health, number of precautions applied, and time since removal were found. Conclusion: Most of the participants in this study reported improvement of health after amalgam removal even though they still suffered a high complaint load. Since absolute symptom load is a robust predictor for general health outcome and socioeconomic burden for society, a possible intervention, which enables patients to further improve their health status is desirable.

Clinical practice guidelines (CPGs) are an important tool for clinicians and health authorities to help select appropriate therapies for different patients and problems. While systematic reviews and meta-analyses look at best-available trial evidence, CPGs are less limited since they compare that best evidence to the same evidence for other therapies for the same condition, while at the same time including comparison of safety and cost-effectiveness of those therapies. Thus CPGs inform more about the clinical utility of a therapy within a broader health care context, still CPGs can be subject to bias in their inclusion and evidence-selection process. CPGs are influenced by many factors, including local political and socio-economic, in order to try to improve relevance for their target audience. Acupuncture, a traditional medical intervention that lies outside mainstream medicine, has been extensively investigated with emerging evidence for its effectiveness in many areas. The extent to which acupuncture is included in CPG development processes and recommended by CPGs is subject to many factors and is not well known within the acupuncture community. Many more recommendations for the use of acupuncture exist than previously thought, making it critical for the acupuncture community to become more informed about these recommendations and to try to improve implementation of the CPG recommendations in mainstream health care.

This is the accepted manuscript version. Published version is available at http://dx.doi.org/10.1016/j.ctim.2015.06.004 The registration of adverse events is important to identify treatment that might impose risk to patients. Homeopathic aggravation, a concept unique for homeopathy may impose a particular risk, as it is tolerant towards a worsening of the patients’ symptoms. The aim of this study was to explore the classification of patient reported reactions as homeopathic aggravations or adverse events. Design and setting In a cross sectional survey, patients were asked to register any reactions they had experienced 14 days after taking homeopathic remedies. Worsening of symptoms was classified as homeopathic aggravation if it was i) an increase of the patients’ existing symptoms ii) and/or a feeling of well-being that emerged 1-3 days after taking the remedy iii) and/or headache and/or fatigue accompanying these symptoms. Results A total of 26% of the participants reported worsening of symptoms. One third was classified as adverse events. Half of these were graded as minor and the other half as moderate according to the Common Terminology Criteria for Adverse Events. Two thirds were classified as homeopathic aggravations. Of these, 73% were classified as minor and 27% as moderate, giving a tendency towards milder severity for those classified as homeopathic aggravations (p=0.065). Conclusion Patients reported a substantial part of the short-term reactions after taking homeopathic remedy as a worsening of symptoms. These reactions were classified as mild and moderate. Hence, the risk connected to homeopathic treatment is minor. More studies are needed to confirm the existence of homeopathic aggravation and how to classify the concept in a clinically meaningful way.

Several systematic reviews suggest that acupuncture is effective for knee osteoarthritis (OA), and furthermore a safe and cost-effective treatment for this condition. A recent clinical practice guideline (CPG) from the National Institute for Health and Care Excellence (NICE), in the United Kingdom, recommended against the use of acupuncture on the grounds that the effect size (ES) in comparison with sham acupuncture is too small. Safety data were not considered in the review, in addition the levels of evidence for acupuncture against other recommended therapies were not compared. Consequently, it is argued that this NICE guideline has limitations that lead to several potential biases in its evaluation of acupuncture, which were not addressed correctly: (1) NICE's prior scoping process limited its review. (2) NICE introduced the method of developing recommendations based on the consideration of which interventions make "minimal important differences" of an ES of 0.5 or greater, rather than the statistical significance of the effect of an intervention when compared with an appropriate comparison. (3) Evidence that sham acupuncture is not physiologically inert and has some level of beneficial effect, hence artificially reducing the magnitude of the ES in comparison with sham. (4) The low adverse effects profile of acupuncture. (5) Evidence from trials comparing acupuncture with usual or standard care was not considered, nor was cost-effectiveness data. (6) Lack of the usual CPG "head-to-head" comparisons between interventions. If the same criteria and methods that have been applied to acupuncture were applied to other NICE-recommended therapies for knee OA, including patient centeredness, patient education, self-management and weight loss, nonsteroidal anti-inflammatory drug (NSAIDs), and cyclooxygenase-2 inhibitor (COX-2 inhibitors), these too would no longer be recommended and opiates would become the first line of drug prescription. Given the problems with sham acupuncture, perhaps now is the time to embrace pragmatic studies and employ comparative effectiveness studies instead.

An international brainstorming session on standardizing pattern identification (PI) was held at the Korea Institute of Oriental Medicine on October 1, 2013 in Daejeon, South Korea. This brainstorming session was convened to gather insights from international traditional East Asian medicine specialists regarding PI standardization. With eight presentations and discussion sessions, the meeting allowed participants to discuss research methods and diagnostic systems used in traditional medicine for PI. One speaker presented a talk titled "The diagnostic criteria for blood stasis syndrome: implications for standardization of PI". Four speakers presented on future strategies and objective measurement tools that could be used in PI research. Later, participants shared information and methodology for accurate diagnosis and PI. They also discussed the necessity for standardizing PI and methods for international collaborations in pattern research.

To explore the correlation between single acupoints used and the recurrence rate of cystitis among cystitis-prone women receiving acupuncture as a prophylactic treatment.In all, 58 cystitis-prone women were included in the analysis. Customised acupuncture treatments were given twice a week, over 4 weeks. The main effect parameter was the number of cystitis episodes during the 6-month observation time. Residual urine was measured at baseline, 2, 4 and 6 months using portable ultrasound equipment. Sympathetic and vagotone nerve activities were measured by using skin conductance and respiratory sinus arrhythmia, respectively.The main acupoints used for patients with Kidney (Shen) qi/yang deficiency were Shenshu (BL23), Taixi (KI3), Zhongji (CV3), Sanyinjiao (SP6) and Pangguangshu (BL28), compared with Taichong (LR3), CV3, BL28, Yinlingquan (SP9) and SP6 for Liver (Gan) qi stagnation, and SP6, CV3, BL28, Zusanli (ST36) and SP9 for Spleen (Pi) qi/yang deficiency patients. The combination BL23 and KI3 were used in 16 women, 13 of which were Kidney pattern related patients. When used, the number of symptomatic episodes were reduced to a third compared with what occurred in the 42 women where this combination was not used (3/16 vs. 28/42, P0.05). BL23 application correlated to a significant reduction in residual urine measured a few days after treatment. Patients with the pattern of Spleen qi/yang deficiency had an initial increase in residual urine after treatments.Treating Kidney pattern related patients with the combination of BL23 and KI3 resulted in far better outcome than other points/combination of points for other Chinese medicine diagnoses. The acupoint SP6 may be less indicated than previously assumed when treating cystitis-prone women prophylactically.

A symposium on pattern identification (PI) was held at the Korea Institute of Oriental Medicine (KIOM) on October 2, 2013, in Daejeon, South Korea. This symposium was convened to provide information on the current research in PI as well as suggest future research directions. The participants discussed the nature of PI, possible research questions, strategies and future international collaborations in pattern research. With eight presentations and an extensive panel discussion, the symposium allowed participants to discuss research methods in traditional medicine for PI. One speaker presented the topic, ‘Clinical pattern differentiation and contemporary research in PI.’ Two speakers presented current trends in research on blood stasis while the remaining five other delegates discussed the research methods and future directions of PI research. The participants engaged in in-depth discussions regarding the nature of PI, potential research questions, strategies and future international collaborations in pattern research.

Research into the diagnostic methods and patterns of traditional East Asian medical (TEAM) systems of practice such as acupuncture and herbal medicine face certain challenges due to the nature of thinking in TEAM and the subjective basis of judgments made in practice. The TEAM-based diagnosis can take into account various findings and signs such as the appearance of the tongue, palpable qualities of the radial pulses, palpable qualities and findings on the abdomen, the complexion of the patient and so on. Both diagnostic findings and the patterns of diagnosis cannot be assumed to have objective bases or to be causally related to the complaints of the patient. However, the diagnoses of TEAM based acupuncture and herbal medicine have tended to look at pictures of the whole patient and rather than focus on a particular symptom, they have looked across a myriad of signs and symptoms to decide or identify the 'pattern' of diagnosis according to the theory in question. Although open for selective and subjective biases each diagnosis pattern always comes with a prescribed treatment tailored to the pattern. Further, the same research requirements needed for the validation of the diagnoses are needed also for these clinical observations and judgments. Hence, it is necessary, albeit challenging for research on TEAM diagnoses to first address these issues before proceeding to more complex investigations such as the development of instruments for making diagnostic observations, instruments for forming diagnostic conclusions or studies investigating the physiological bases of the diagnostic patterns. Preliminary work has started and instruments have been made, but we suggest that any instrumentation must necessarily be first validated by matching of the calibrated or scaled observations or judgments to observations made and agreed upon by relevant experts. Reliability of all observations and judgments are needed before any other tool, technology or more advanced approach can proceed and also whenever the natural system of diagnosis-treatment is applied in clinical trials. In this paper the authors highlight the core problems and describe a step wise process for addressing them.

Introduction Pattern differentiation is a critical component for traditional Chinese medicine (TCM) diagnosis and treatment. However, the issue of whether pattern differentiation is appropriately applied in TCM interventional trials, including Chinese herbal medicine (CHM) interventions and non-herbal TCM interventions, is unclear. The aim of this study was to i) systematically review the current status of pattern differentiation used in WHO-registered clinical trials for different types of TCM interventions; and ii) provide suggestions for improving the use of pattern differentiation in future clinical trial design. Methods The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) database was searched for all TCM interventional trials registered up to 31 December 2017. In this systematic review trials with a TCM pattern differentiation in their design were included. Descriptive statistics were collated to demonstrate the characteristics of pattern differentiation applied for different TCM interventional trials. Results Among 2955 TCM interventional trials registered during 1999–2017, 376 (12.7%) trials included pattern differentiation. Of 376 trials, the use of pattern differentiation was identified in; –the title (30.6%), objective (50.5%), participants inclusion (100%), outcomes (43.6%) and study background (12.5%). Further, 85.4% reported the specific name of the TCM intervention, 10.6% provided the intervention’s targeted pattern, 83.8% reported the specific name of the TCM pattern, 7.2% presented diagnostic criteria for the pattern studied, and 19.1% adopted a pattern-related outcome as primary outcome for evaluation. Conclusion The reporting and application of pattern differentiation in TCM trials were inadequate and confusing, which was mainly due to lack of clarity regarding study design, objectives, diagnostic criteria and outcomes.

Published version. Source at http://doi.org/10.1007/s00520-016-3464-z. License CC BY 4.0. 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 nondisclosure of cancer-related information. This study found two additional circumstances that might lead to nondisclosure. 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.

Manuscript. Published version available in Complementary Therapies in Medicine 26 (2016) 146–163, doi 10.1016/j.ctim.2016.03.013 Objectives:Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients’ symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed.Design and setting:Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs).The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055participants were included. A subtotal of 39 studies was included in the additional meta-analysis.Results: A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86–1.14, I2= 54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high.Conclusion:Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine

The objective of this chapter is to provide an overview of the problems and solutions of randomized placebo-controlled trials in acupuncture. Studies examining how acupuncture might work cover a broad range of physiological systems, ranging from a single biochemical pathway to the whole biological system. Needling, touch, and pressure occur before skin penetration and then surface receptors/structures are stimulated by both shallow and deeper insertions with additional receptors are further stimulated by deeper insertions. This process raises important questions about the use of penetrating and non-penetrating sham acupuncture techniques and placebo effects. In clinical research the placebo treatment must be inert, and only when the provided randomization and blinding are properly used, a trial comparing the test treatment to the placebo treatment can be said as placebo-controlled. A placebo-controlled trial is an explanatory trial since it tests the known mechanisms associated with the treatment. But in hands-on therapies like acupuncture what can constitute a valid placebo control treatment? Are there predictable mechanisms by which acupuncture works suggesting which valid placebo can be used? Are there any sham acupuncture interventions that can constitute placebo treatments? Are they credible to be sham treatments? If they are not inert or credible, then how can we perform placebo-controlled trials on acupuncture? Are such trials possible? Many forms of sham acupuncture have been tried out in efforts to control placebo effects. In the ‘real’ or ‘test’ acupuncture the ‘real’ technique is applied to the ‘real’ acupoints. Thus, sham acupuncture involves varying the techniques of treatment and the locations of treatment. Given these two variables, three basic variations of sham acupuncture are possible. One of these could possibly act as a placebo control research model, provided that the sham techniques are clinically inert and the sites of their application are clinically inert. The other two models act to compare either treatment sites or treatment techniques. In the latter two models placebo can be held equal between treatment groups, but these models are not capable of acting as placebo-controlled trials. The second and third sham models are often used inadvertently as though they were capable of answering the same question as the first or were placebo-controlled clinical trials like the first. This chapter will give an overview on the current status and problems of placebo-controlled trials in acupuncture trials and suggest possible solutions. We can summarize the evidence: so far no sham acupuncture techniques are inert; they are also clinically effective; and no placebo-controlled trials of acupuncture have ever been performed. Given the evidence, we propose to stop performing sham acupuncture studies since they cannot achieve control for placebo effects. We propose a two-pronged approach to address the issues of mechanisms of action and effectiveness.

Background: Homeopathic aggravation is a temporary worsening of existing symptoms following the administration of a correct homeopathic prescription. The aim of this study was to explore and compose criteria that may differentiate homeopathic aggravations from adverse effects. Material and Methods: A qualitative approach was employed using focus group interviews. 2 interviews, with 11 experienced homeopaths, were performed in Oslo, Norway. The practitioners have practiced classical homeopathy over a period of 10–32 years. Qualitative content analysis was used to analyze the text data. The codes were defined before and during the data analysis. Results: We found that aggravations were subtle and multifaceted events. Moreover, highly skilled homeopaths are required to identify and report aggravations. Adverse effect may be defined as an ‘undesirable effect of a remedy’. This definition is pragmatic, flexible, and more in line with the holistic paradigm that the homeopaths represent. 8 criteria that distinguish aggravation from adverse effect were found. Highly sensitive persons hold a unique position regarding safety, as it is important to identify these patients in order to treat them correctly and avoid undesirable effects of the treatment. Conclusion: This study rigorously explored homeopaths’ views and experience on aggravation and adverse effects. The 8 criteria developed in this study may ensure patient safety and support therapists in identifying an ‘undesirable effect of a remedy’.

Aim of the study To assess the beneficial effects of acupuncture in patients with depression and to evaluate the report quality of acupuncture treatment for depression in randomized controlled trials and systematic reviews. Introduction Acupuncture has a long history of treating illnesses which we today in a biomedical context would understand and recognize as depression. Also in contemporary China and in the West patients are trying acupuncture as a treatment for depression. Randomized controlled trials have been conducted to investigate its efficacy. Materials and methods The following electronic databases were searched: the Cochrane Central Register for Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, PsycINFO and PUBMED. These searches ended in January 2009. In addition new searches were completed in Asian databases in February 2010. Standard guidelines were followed when the methodological quality of the RCTs were assessed, including CONSORT and the criteria in the Cochrane Handbook. Systematic reviews were evaluated using the PRISMA checklist. Results Four systematic reviews and 26 RCTs on acupuncture for treatment of depression were identified and included in this review. The methodological quality of the trial reports was generally low in terms of generation of the allocation sequence, allocation concealment, blinding and intention to treat. A significant beneficial effect was found for acupuncture in improvement of depression compared to pooled control measured by Hamilton Rating Scale for Depression (WMD −3.10, 95% CI −4.91 to −1.99, P = 0.0008). Subgroup analysis suggested that electro-acupuncture (WMD −0.68, 95% CI −1.49 to 0.13, P = 0.10) and TCM acupuncture (WMD 0.79, 95% CI −0.93 to 2.52, P = 0.37), were not statistically different from medication. Acupuncture was regarded as generally safe in the clinical trials included in this review. Conclusions Current evidence from this meta-analysis of randomized trials shows that acupuncture is effective in reducing severity of depression and that TCM- and electro acupuncture may have similar effect as current usual care. More rigorous trials are needed and long-term effects should be investigated if acupuncture is to be recommended for clinical use.

Introduction The multicentre, pragmatic, randomised controlled Acuflash study evaluated the effect of traditional Chinese medicine (TCM) acupuncture on postmenopausal vasomotor symptoms and health-related quality of life. It concluded that use of acupuncture in addition to self-care can contribute to a clinically relevant reduction of hot flushes and increased health-related quality of life. This article reports on the TCM syndrome diagnoses and acupuncture points used and their relation to the treatment response, and on treatment reactions and adverse events. Methods The acupuncture group (n = 134) received 10 acupuncture treatment sessions and advice on self-care; the control group (n = 133) received advice on self-care only. The study acupuncturists met the current membership criteria of the Norwegian Acupuncture Society, and had at least 3 years’ experience of practising TCM acupuncture. They were free to diagnose and select acupuncture points for each participant, after initial discussion. Results Fifty per cent of the participants in the acupuncture group were diagnosed with Kidney Yin Xu as their primary TCM syndrome diagnosis. No statistically significant differences were demonstrated between the syndrome groups regarding the distribution of responders and non-responders, nor regarding the change in health-related quality of life scores. A core of common acupuncture points (SP6, HT6, KI7, KI6, CV4, LU7, LI4, and LR3) were used in all the syndromes, and in addition multiple idiosyncratic points. Core point selection and frequency of use did not differ between responders and non-responders. No serious adverse events were reported. Conclusion Factors other than the TCM syndrome diagnoses and the point selection may be of importance regarding the outcome of the treatment.

This study compared the effectiveness of individualized acupuncture plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women.This study involved a multicenter, pragmatic, randomized, controlled trial with two parallel arms. Participants were postmenopausal women experiencing, on average, seven or more hot flashes per 24 hours during seven consecutive days. The acupuncture group received 10 acupuncture treatment sessions and advice on self-care, and the control group received advice on self-care only. The frequency and severity (0-10 scale) of hot flashes were registered in a diary. Urine excretion of calcitonin gene-related peptide was assessed at baseline and after 12 weeks. The primary endpoint was change in mean hot flash frequency from baseline to 12 weeks. The secondary endpoint was change in health-related quality of life measured by the Women's Health Questionnaire.Hot flash frequency decreased by 5.8 per 24 hours in the acupuncture group (n = 134) and 3.7 per 24 hours in the control group (n = 133), a difference of 2.1 (P0.001). Hot flash intensity decreased by 3.2 units in the acupuncture group and 1.8 units in the control group, a difference of 1.4 (P0.001). The acupuncture group experienced statistically significant improvements in the vasomotor, sleep, and somatic symptoms dimensions of the Women's Health Questionnaire compared with the control group. Urine calcitonin gene-related peptide excretion remained unchanged from baseline to week 12.Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women.

Objectives To determine the feasibility and acceptability of traditional Chinese medicine (TCM) acupuncture and pelvic floor muscle training (PFMT) in reducing symptoms and bothersomeness in women with mixed urinary incontinence (MUI); and to estimate the sample size for a full scale trial. Methods Thirty-four women with MUI were randomly assigned to either 12 sessions of TCM acupuncture, 12 sessions of PFMT, or to a waiting list control group. Outcome measures included an assessment of interest to participate in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with treatment. Clinical outcomes were assessed at baseline and 12 weeks, and included the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI SF), expectations of treatment effect, and adverse events. Results Recruitment was feasible and randomisation worked adequately by means of SurveyMonkey. SurveyMonkey does not permit stratification by ICIQ-UI SF baseline score. Fourteen of 22 women found the treatment options acceptable. The dropout rate was high, especially in the control group (6/12). Outcome forms were completed by 20 of 34 women. The median (IQR) changes of the ICIQ-UI SF scores in the acupuncture, physiotherapy, and waiting list group were 5.5 (2.3 to 6.8), 1.0 (−3.0 to 4.5), and 1.5 (−1.5 to 3.0), respectively, suggesting the need for a full scale trial. Conclusions Women with MUI were willing to participate in this study. There is a need for adjusting eligibility criteria. A sample size of 129 women, 43 in three arms, is required. No major adverse events occurred.

The aim of this study is to extract indicators that are associated with the heat/nonheat and excess/deficiency patterns in stroke pattern identification through the large-scale analysis of clinical data. Two experts, who had more than three years of clinical experience with stroke, independently performed the pattern identification. We analyzed indicators of clinical data with two doctors’ concurrent diagnoses on the patient’s pattern identification. To verify heat/nonheat and excess/deficiency patterns, which are the basic elements of pattern identification, we grouped 960 patients diagnosed as the fire-heat pattern, the Yin deficiency pattern, and the Qi deficiency pattern in to two groups, the heat/nonheat group and the excess/deficiency group. We then extracted significant indicators using univariate and multivariate analysis. As a result of the comparison of 65 indicators, we were able to extract 10 indicators for the heat pattern, 6 for the nonheat pattern, 9 for the excess pattern, and 10 for the deficiency pattern. Extracted indicators in this study can be used for pattern identification in the context of stroke. These are positive indicators from large-scale clinical studies and are greatly expected to be crucial discriminant indicators in individual pattern identification henceforth.

Dear Editor, We found the recent article by Liodden et al 1 to be interesting, especially due to the design and the subsequent permission of the ethics committee to allow this study to be performed in ‘the real world’. However, that discussion is not the aim of this letter. Our concern is that the authors conclude that “acupuncture may not be effective beyond placebo”, which we think is based on incorrect assumptions. Dundee, who pioneered the use of acupuncture for postoperative nausea and vomiting, found that the timing of the treatment is critical. Acupuncture must be administered before the anaesthetic (around the time of the pre-anaesthetic) rather than just before or after induction of anaesthesia.2 Reviewers have commented on this as a prerequisite for the effectiveness of the treatment, since it is thought that general anaesthesia can block the effect of acupuncture, as can the use of local anaesthetics.3 …

This article is based on two presentations held at Chinese medicine conference in Rothenburg (2013), Germany and at the 19th Anniversary of Korean Institute of Oriental Medicine (KIOM) International Symposium of Current Research Trends in Traditional Medicine — Pattern of Identification (2013). In designing clinical studies, it is a research question that leads to appropriate study design. However, they are mostly diagnostic procedures and techniques that are the key points to reflect the application of systems and methods in all forms of medicine — traditional East Asian medicine (TEAM) is no exception. The challenges within TEAM based on research reflect in different systems of medicine/theories such as traditional Japanese acupuncture, traditional Korean acupuncture and traditional Chinese acupuncture. This diversity of medical systems and methods applied in East Asia seems to have been fruitful within the different countries and traditional medicines have found their places within the respective countries health systems. The existing diversity, from a clinician’s point of view, may be viewed as a treasure when dealing with patients in the ‘real world’. On the other hand, this diversity seems to challenge the scientific mind worldwide, especially when it comes to research. Hence, there is a gap between clinical practice and research.

Summary Background There is no curative treatment for chronic fatigue syndrome (CFS). Traditional Chinese medicine (TCM) is widely used in the treatment of CFS in China. Objective To evaluate the effectiveness and safety of TCM for CFS. Methods The protocol of this review is registered at PROSPERO. We searched six main databases for randomized clinical trials (RCTs) on TCM for CFS from their inception to September 2013. The Cochrane risk of bias tool was used to assess the methodological quality. We used RevMan 5.1 to synthesize the results. Results 23 RCTs involving 1776 participants were identified. The risk of bias of the included studies was high. The types of TCM interventions varied, including Chinese herbal medicine, acupuncture, qigong, moxibustion, and acupoint application. The results of meta-analyses and several individual studies showed that TCM alone or in combination with other interventions significantly alleviated fatigue symptoms as measured by Chalder's fatigue scale, fatigue severity scale, fatigue assessment instrument by Joseph E. Schwartz, Bell's fatigue scale, and guiding principle of clinical research on new drugs of TCM for fatigue symptom. There was no enough evidence that TCM could improve the quality of life for CFS patients. The included studies did not report serious adverse events. Conclusions TCM appears to be effective to alleviate the fatigue symptom for people with CFS. However, due to the high risk of bias of the included studies, larger, well-designed studies are needed to confirm the potential benefit in the future.

Objective. The aim of this study is to evaluate the consistency of pattern identification (PI), a set of diagnostic indicators used by traditional Korean medicine (TKM) clinicians.Methods. A total of 168 stroke patients who were admitted into oriental medical university hospitals from June 2012 through January 2013 were included in the study. Using the PI indicators, each patient was independently diagnosed by two experts from the same department. Interobserver consistency was assessed by simple percentage agreement as well as by kappa and AC1statistics.Results. Interobserver agreement on the PI indicators (for all patients) was generally high: pulse diagnosis signs (AC1=0.66–0.89); inspection signs (AC1=0.66–0.95); listening/smelling signs (AC1=0.67–0.88); and inquiry signs (AC1=0.62–0.94).Conclusion. In four examinations, there was moderate agreement between the clinicians on the PI indicators. To improve clinician consistency (e.g., in the diagnostic criteria used), it is necessary to analyze the reasons for inconsistency and to improve clinician training.

SUMMARY. Background: Frequently recurrent acute cystitis in adult women is common in Western medicine. In prophylactic treatment, women are treated between attacks of acute cystitis to prevent recurrences.A recent study has shown that acupuncture seems effective for prophylaxis. Objectives:To describe the frequency of traditional Chinese medicine (TCM) syndromes found in females vulnerable to recurrent cystitis, and which symptoms most often form the basis for TCM diagnoses made in this condition. Methods: A descriptive study based on TCM diagnostic methods as used by experienced acupuncturists, and a questionnaire of symptoms used in TCM diagnostics. Results: Of 61 women with frequently recurring cystitis, 90% were diagnosed as having either a Spleen/Kidney yang xu/qi xu (54%), or a Liver qi stagnation (36%). Only 10% fell in other diagnostic groups. Of all symptoms noted, only three differed in frequency between the two main diagnostic groups: feeling cold (29/33 vs. 13/22, P

Purpose Homeopathy has few legal regulations acting as gatekeepers. The remedies may be in widespread use despite unclear mechanism of effect and safety assessment. Uncontrolled studies of homeopathic practise document consistently strong therapeutic effects and sustained patient satisfaction however, cases of adverse effects have also been reported. According to homeopathic theory transient worsening of patients symptoms (aggravations), are understood as a wanted reaction to the medication. To date, systematic information is lacking on how commonly adverse effects and homeopathic aggravations are reported in RCTs, observational studies and surveys.

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.

Background Throughout the world, patients with chronic diseases/illnesses use complementary and alternative medicines (CAM). The use of CAM is also substantial among patients with diseases/illnesses of unknown aetiology. Chronic fatigue syndrome (CFS), also termed myalgic encephalomyelitis (ME), is no exception. Hence, a systematic review of randomised controlled trials of CAM treatments in patients with CFS/ME was undertaken to summarise the existing evidence from RCTs of CAM treatments in this patient population. Methods Seventeen data sources were searched up to 13th August 2011. All randomised controlled trials (RCTs) of any type of CAM therapy used for treating CFS were included, with the exception of acupuncture and complex herbal medicines; studies were included regardless of blinding. Controlled clinical trials, uncontrolled observational studies, and case studies were excluded. Results A total of 26 RCTs, which included 3,273 participants, met our inclusion criteria. The CAM therapy from the RCTs included the following: mind-body medicine, distant healing, massage, tuina and tai chi, homeopathy, ginseng, and dietary supplementation. Studies of qigong, massage and tuina were demonstrated to have positive effects, whereas distant healing failed to do so. Compared with placebo, homeopathy also had insufficient evidence of symptom improvement in CFS. Seventeen studies tested supplements for CFS. Most of the supplements failed to show beneficial effects for CFS, with the exception of NADH and magnesium. Conclusions The results of our systematic review provide limited evidence for the effectiveness of CAM therapy in relieving symptoms of CFS. However, we are not able to draw firm conclusions concerning CAM therapy for CFS due to the limited number of RCTs for each therapy, the small sample size of each study and the high risk of bias in these trials. Further rigorous RCTs that focus on promising CAM therapies are warranted.