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

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

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

Adherence to lifestyle recommendations among Norwegian cancer survivors and the impact of traditional and complementary medicine use: the Tromsø Study 2015-2016.

INTRODUCTION: Adherence to healthy lifestyle recommendations has positive effects on cancer outcomes yet adherence is low among cancer survivors. Differences in adherence between women and men, phase of survivorship, and other factors that might increase adherence, like the use of traditional and complementary medicine (T&CM), need to be explored. We aimed to study the adherence to national recommendations for a healthy diet (daily intake of ≥ 5 portions of fruit/vegetables), physical activity (150 min of moderate-intensity or 75 min of high-intensity/week), normal body mass index (BMI) (18.5-24.9 kg/m2), non-smoking, and low-risk alcohol consumption (women ≤ 10 g/day, men ≤ 20 g/day) among Norwegian cancer survivors and their associations with sex, the use of T&CM, and survivorship phase. METHODS: We used logistic regression, independent sample t-test, and chi-square test to study self-reported (diet, physical activity, smoking, alcohol consumption) and measured (BMI) adherence in 1530 cancer survivors (40 years and above, participating in the population-based Tromsø Study conducted in 2015-2016 (65% attendance). We dichotomized all assessed lifestyle recommendations (adherence = 1 point, non-adherence = 0 points), and created a score for every recommendation (0-5 points). Adherence to individual lifestyle recommendations and the use of T&CM as well as the phase of survivorship was adjusted for sex, age, income, and living with a partner. RESULTS: Adherence to recommendations was 7.5% for diet, 85.3% for physical activity, 30.5% for BMI, 89.3% for non-smoking, and 87.6% for alcohol consumption. In total 2.3% adhered to all five recommendations concurrently (mean score 2.96 [SD = 0.86]). Women adhered to more recommendations concurrently compared to men (3.03 [SD = 0.90] vs. 2.89 [SD = 0.80] points respectively, [p = .012]). In total, 31% reported the use of T&CM and there were no differences in adherence to individual lifestyle recommendations or concurrent adherence in overall T&CM use compared to non-use. Users of self-help techniques were more likely to adhere to the recommendations of diet (aOR 2.69, 95% CI 1.45-4.98) and physical activity (aOR 6.26, 95% CI 1.51-25.92). Users of traditional healers and users of more than one T&CM modality were less likely to adhere to the low-risk alcohol consumption recommendation, (aOR 0.32, 95% CI 0.13-0.77, and aOR 0.53, 95% CI 1.08-2.17, respectively) compared to T&CM non-users. Survivors with cancer previously (1162) had higher odds of adhering to the recommendation of diet (aOR 2.66, 95% CI 1.36-5.19) than survivors with cancer presently (n = 368), but not to other recommendations. CONCLUSION: The health of cancer survivors can be improved through adherence to lifestyle recommendations, yet our study found partial adherence among survivors in Norway, in accordance with findings from other countries. Although overall T&CM use was not associated with higher adherence to lifestyle recommendations, differences in adherence were seen among individual modalities like the use of self-help techniques and traditional healers. Our results suggest the need for intensified follow-up of lifestyle with attention to male survivors and diet among all survivors throughout the cancer survivorship continuum.

A Qualitative Study Among Healthcare Providers on Risks Associated With the Use of Supportive Care for Cancer Treatment-Related Symptoms in Children and Adolescents.

INTRODUCTION: Although more than 300 000 children and adolescents worldwide are diagnosed with cancer yearly, little research has been conducted investigating how healthcare providers consider risk and patient safety connected with supportive care (including complementary and alternative medicine [CAM]) in this age group. This study aimed to explore how different healthcare providers perceive and evaluate risk when patients combine supportive care and conventional medicine in clinical practice and how they communicate and inform parents about the use of these modalities. MATERIALS AND METHODS: In-depth semi-structured interviews were conducted with 22 healthcare providers with expertise in treating pediatric oncology patients from 5 countries. Systematic content analysis was conducted using Nvivo 1.61. RESULTS: The analysis resulted in 3 themes and 8 subthemes. Generally, participants were cautious about implementing unproven new modalities or therapies when recommending supporting care modalities to parents of children and adolescents with cancer. The most important criterion when recommending a modality was evidence for safety based on a risk/benefit evaluation. Negative interactions with conventional medicine were avoided by using the half-life of a drug approach (the time it takes for the amount of a drug's active substance in the body to reduce by half). For patients with severe symptoms, less invasive modalities were used (ear seeds instead of ear needling). To enhance safety, participants practiced open and egalitarian communication with parents. CONCLUSION: Healthcare providers reported using a variety of approaches to achieve a safe practice when parents wanted to combine supportive care and conventional cancer treatment. They emphasized that these modalities should be foremost safe and not become an extra burden for the patients. Providers highlighted patient-centered care to meet the individual's specific health needs and desired health outcomes. A lack of national and regional standardized training programs for supportive care in pediatric oncology was considered a hazard to patient safety.

Supportive care for cancer-related symptoms in pediatric oncology: a qualitative study among healthcare providers.

BACKGROUND: The aim of this study is to gain insight into the clinical experiences and perceptions that pediatric oncology experts, conventional healthcare providers, and complementary and alternative medicine (CAM) providers in Norway, Canada, Germany, the Netherlands, and the United States have with the use of supportive care, including CAM among children and adolescents with cancer. METHODS: A qualitative study was conducted using semi-structured in-depth interviews (n = 22) with healthcare providers with clinical experience working with CAM and/or other supportive care among children and adolescents with cancer from five different countries. Participants were recruited through professional associations and personal networks. Systematic content analysis was used to delineate the main themes. The analysis resulted in three themes and six subthemes. RESULTS: Most participants had over 10 years of professional practice. They mostly treated children and adolescents with leukemia who suffered from adverse effects of cancer treatment, such as nausea and poor appetite. Their priorities were to identify the parents' treatment goals and help the children with their daily complaints. Some modalities frequently used were acupuncture, massage, music, and play therapy. Parents received information about supplements and diets in line with their treatment philosophies. They received education from the providers to mitigate symptoms and improve the well-being of the child. CONCLUSIONS: Clinical experiences of pediatric oncology experts, conventional health care providers, and CAM providers give an understanding of how supportive care modalities, including CAM, are perceived in the field and how they can be implemented as adaptational tools to manage adverse effects and to improve the quality of life of children diagnosed with cancer and the families.

Clinical associations for traditional and complementary medicine use among norwegian cancer survivors in the seventh survey of the Tromsø study: a cross-sectional study.

BACKGROUND: Cancer survivors are a diverse group with varying needs that are patient-, disease-, and/or treatment-specific. Cancer survivors have reported supplementing conventional anti-cancer treatment with Traditional and Complementary Medicine (T&CM). Although female cancer survivors are reported to have more severe anticancer adverse effects, little is known about the association between anticancer treatment and T&CM use among Norwegian cancer survivors. The aims of this study are therefore to investigate (1) associations between cancer diagnosis characteristics and T&CM utilization and (2) associations between anticancer treatment and T&CM utilization among cancer survivors in the seventh survey of the Tromsø study. METHODS: Data was collected from the seventh survey of the Tromsø Study conducted in 2015-16 among all inhabitants of Tromsø municipality aged 40 and above (response rate 65%), where inhabitants received online and paper form questionnaires. Data from the data linkage to the Cancer Registry of Norway for cancer diagnosis characteristics was also used. The final study sample was made up of 1307 participants with a cancer diagnosis. Categorical variables were compared using Pearson's Chi-square test or Fisher's exact test while independent sample t-test was used to compare continuous variables. RESULTS: The use of T&CM the preceding 12 months was reported by 31.2% of the participants with natural remedies as the most reported modality of T&CM (18.2%, n = 238), followed by self-help practices of meditation, yoga, qigong, or tai chi, which was reported by 8.7% (n = 114). Users of T&CM were significantly younger (p = .001) and more likely to be female (p < .001) than the non-users, with higher use of T&CM among female survivors with poor self-reported health and being 1-5 years post-diagnosis. Lower use of T&CM was found among female survivors who received a combination of surgery with hormone therapy and those who received a combination of surgery with hormone therapy and radiotherapy. Similar usage was seen in male survivors, but not at a significant level. For both male and female survivors, T&CM was most frequently used by those with only one cancer diagnosis (p = .046). CONCLUSION: Our results indicate that the profile of the Norwegian cancer survivor who uses T&M is slightly changing compared to previous findings. Additionally, compared to male survivors, more clinical factors are associated with use of T&CM among female cancer survivors. These results should serve as a reminder to conventional health care providers to discuss the use of T&CM with patients across the entire cancer survivorship continuum to promote safe use, especially among female survivors.

Reflexology for acute rhinosinusitis - Results from a blinded, early-phase comparative trial.

BACKGROUND: Reflexology is commonly used as an adjunct to conventional treatment by patients with respiratory tract infections. The effect of reflexology needs to be tested in a full-scale randomized controlled study. Small early-phase trials can give an indication on whether full-size clinical trials are warranted. The objective of this study is to determine whether the study design is feasible in a full-scale study of reflexology as an add-on to usual care compared to usual care alone in acute rhinosinusitis, and further if there is a statistical indication of an effect of reflexology warranting a full-scale study. METHODS: 20 patients with symptoms compatible with acute rhinosinusitis, and an illness duration of 28 days or less were randomized to additional reflexology treatment along with usual medical care, or usual care alone. The patients scored how much each of 16 sinus-related symptoms bothered them in the past few days on a six-point scale (zero = no problem to five = severe problem). To determine if there is a statistical indication of an effect of reflexology warranting a full-scale study, the separation test was used. RESULTS: The methodology was considered feasible and could therefore be applied in a full-scale study of reflexology for acute rhinosinusitis. The mean reduction in symptom score from baseline to day two was 0.95 in the reflexology group and 0.78 in the control group. From baseline to day ten the mean reduction in symptom score was 2.12 in the reflexology group and 1.63 in the control group. A statistical indication of effect in a full-scale study in favor of reflexology was found from baseline to day ten but not from baseline to day two. CONCLUSIONS: The research methodology in this study could be used in a full-scale study of reflexology in acute sinusitis. The results from the separation test indicates an effect warranting a full-scale study of reflexology regarding effects in acute sinusitis ten days after treatment.

Prevalence of late and long-term effects of cancer (treatment) and use of complementary and alternative medicine in Norway.

BACKGROUND: The increasing number of patients surviving cancer leads to more people experiencing late and long term-effects from the disease and its treatment. Fatigue, sleep disorders, early menopause, pain, and nerve damage are commonly reported. Methods helping people to recover after cancer treatment are therefore essential. The aims of this study were threefold; (1) to determine the level of cancer patients suffering from late and long-term effects of cancer diagnosis and treatment in Norway, (2) explore complementary and alternative medicine (CAM) modalities used for managing these adversities, and (3) describe self-perceived benefits and harms of the CAM interventions. METHODS: The study was conducted in cooperation with the Norwegian Cancer Society (NCS) and consisted of an online cross-sectional study among members of the NCS user panel with present or previous cancer (n = 706). The study was carried out in September/October 2021 using a modified cancer-specific version of the International Questionnaire to Measure Use of Complementary and Alternative Medicine (I-CAM-Q). A total of 315 women and 153 men agreed to participate, resulting in a response rate of 67%. RESULTS: Most of the participants (83%) suffered from late and long-term effects of cancer treatment; mostly fatigue (59.2%), sleep disorder (41.5%), hot flashes (39.2%), nerve damage (polyneuropathy, 38.0%), and pain (36.6%) with a mean number of 5.1 different late and long-term effects. Late and long-term effects were positively associated with younger age and college/university education. Nearly half of the participants experiencing late and long-term effects (43%) reported having used CAM to treat these complaints. Most frequently used were self-help practices (26%) such as relaxation therapy (19%), yoga (14%) and meditation (13%), but also visits to CAM providers were reported by 22%. Herbal- and other natural remedies to treat late and long-term effects were used by 13%. A high percentage of CAM users reported self-perceived improvements of their symptoms (86% for self-help practices, 90% for visits to CAM providers). Few experienced adverse effects of the CAM treatment. CONCLUSION: A large proportion of cancer patients suffered from a wide range of late and long-term effects of cancer diagnosis and treatment, and they use CAM to treat these complaints to a rather high degree. Relaxation therapy, yoga, meditation, massage, and acupuncture were the most frequently used therapies regardless of complaint. The therapies used are generally considered to be both safe and beneficial for the respective complaint, indicating that the participants seem to be well informed about the choices they make.

The Development and Acceptability of a Wilderness Programme to Support the Health and Well-Being of Adolescent and Young Adult Cancer Survivors: The WAYA Programme.

Detailed descriptions of theory, structure, and activities with causal links to specified outcomes of wilderness programs are lacking. Addressing this gap, the present qualitative study gives a thorough description of the development of the Wilderness programme for Adolescent and Young Adult (AYA) cancer survivors (WAYA). WAYA is adapted to the individual needs of AYA cancer survivors. It was conceived around Næss's ecosophy and the Positive Health Model, and refined based on findings from a scoping review and patient/public involvement. Programme aims were to increase physical activity, self-confidence, personal growth, joy, safety within nature, meaningful relationships, and self-efficacy. The programme was an eight-day expedition followed three months later by a four-day base-camp. Activities included hiking, backpacking, kayaking, rock climbing, mindfulness and bushcrafting. Evaluation of the programme through focus group and individual interviews with 15 facilitators and 17 participants demonstrated that a diverse group of participants, challenging activities, and mindfulness-based practices were found to positively influence group bonding and the learning process. Furthermore, including an expedition and base-camp component was found to be beneficial in supporting the development of participants' own personal outdoor practices. In conclusion, this study demonstrated that the WAYA programme is safe and well accepted by AYA cancer survivors.

Safety and use of complementary and alternative medicine in Norway during the first wave of the COVID-19 pandemic using an adapted version of the I-CAM-Q; a cross-sectional survey.

BACKGROUND: The COVID-19 pandemic lockdown has had a profound impact on physical and mental well-being throughout the world. Previous studies have revealed that complementary and alternative medicine (CAM) is frequently used for, and can be potential beneficial for strengthening physical mental resilience. The aims of this study were therefore to determine the prevalence and reasons for use of CAM during the first wave of the COVID-19 pandemic among a representative sample of the Norwegian population, and further determine self-reported effects and adverse effects of the CAM modalities used. METHODS: Computer assisted telephone interviews using a COVID-adapted I-CAM-Q questionnaire were conducted with 1008 randomly selected Norwegians aged 16 and above using multistage sampling during April and May 2020 applying age and sex quotas for each area. Frequencies, Pearson's chi-square tests, Fisher exact tests, and independent sample t-test were used to identify the users of CAM, what they used, why they used it and whether they experienced effect and/or adverse effects of the modalities used, and further to describe differences in sociodemographic factors associated with CAM use. Cronbach's alpha tests were used to test for internal consistency in the different groups of CAM. Significance level was set to p < 0.05. RESULTS: The study revealed that two thirds of the respondents (67%) had used CAM within the first 3 months of the COVID-19 pandemic, in particular CAM modalities that did not involve a provider. Most used were natural remedies and dietary supplement (57%, mainly vitamins and minerals), but self-help practices like yoga and meditation were also widely used (24%). Women used CAM modalities significantly more than men (77% vs. 58%). Most of the respondents found the modalities they used beneficial, and few reported adverse effects of the treatments. CONCLUSIONS: A large proportion of the Norwegian population used CAM during the first wave of the COVID-19 pandemic with high satisfaction and few reported adverse effects. CAM was rarely used to prevent or treat COVID-19, but rather to treat a long-term health condition, and to improve well-being.

Impact of spiritual healing on moderate depression in adults: a study protocol of a pilot randomised controlled trial (RCT).

INTRODUCTION: Depression is a common mental disorder and the (global) leading cause of all non-fatal burden of disease worldwide. Currently, supported treatment for depression is antidepressant medication and different psychotherapeutic interventions. Many patients experience, however, adverse effects of antidepressant medication, while at the same time the access to psychotherapeutic interventions are limited. Many patients who suffer from depression turn to complementary medicine and among those modalities often spiritual healing. There is some evidence that consulting a spiritual healer can be beneficial for patients who suffer from depression, and that spiritual healing is associated with low risk. The aim of this protocol is to conduct a pilot randomised controlled trial (RCT) (spiritual healing as addition to usual care vs usual care alone) in preparation of a larger trial in adults with moderate depression, to examine feasibility and individuals' experience of spiritual healing. METHODS AND ANALYSIS: This study is a pilot RCT with two parallel groups. A total of 28 adult patients with moderate depression, diagnosed by the physician and according to the Montgomery and Åsberg Depression Rating Scale criteria will be randomised to spiritual healing in addition to usual care (n=14) or usual care alone (n=14). To determine if there is a statistical indication of an effect of healing warranting a full-scale study; the separation test will be used. To investigate participants' experience with spiritual healing, a qualitative study will be included using semistructured interviews. The data will be analysed based on a direct content analysis. ETHICS AND DISSEMINATION: This protocol was approved by regional committees for medical and health research ethics by the identifier (63692). The results will be disseminated through open-access, peer-reviewed publications, in addition to stakeholders' reporting and presenting at conferences. TRIAL REGISTRATION: Norwegian Centre for Research Data (845302) and clinicaltrials.gov (ID: NCT04766242).

Use of Complementary and Alternative Medicine in the context of cancer; prevalence, reasons for use, disclosure, information received, risks and benefits reported by people with cancer in Norway.

BACKGROUND: Research exploring the use of specific Complementary and Alternative Medicine (CAM) modalities by Norwegian cancer patients is sparse. The aims of this study were therefor to map the different CAM modalities cancer patients use and further investigate their rationale for use, communication about use, self-reported benefits and harms, and their sources of information about the different modalities. METHODS: In cooperation with the Norwegian Cancer Society (NCS), we conducted an online cross-sectional study among members of their user panel with present or previously cancer (n = 706). The study was carried out in September/October 2021 using a modified cancer-specific version of the International Questionnaire to Measure Use of Complementary and Alternative Medicine (I-CAM-Q). In total, 468 members, 315 women and 153 men, agreed to participate resulting in a response rate of 67.2%. The study was reported in accordance with the National Research Center in Complementary and Alternative Medicine's (NAFKAM) model of reporting CAM use. RESULTS: A large proportion of the participants (79%, n = 346) had used some form of CAM with a mean of 3.8 modalities each (range 1-17); 33% (n = 143) had seen a CAM provider, 52% (n = 230) had used natural remedies, while 58% (n = 253) had used self-help practices. Most of the participants used CAM to increase their quality of life, cope with the cancer disease or for relaxation/well-being (64%-94%), mostly with high satisfaction and low rates of adverse effects. Few used CAM to treat cancer or prevent it from spreading (16%, n = 55). The main information sources were health care providers (47%), the internet (47%), and family and friends (39%). More than half (59%) of the cancer patients discussed their use of at least one CAM modality with a physician. CONCLUSIONS: The results of this survey will provide health professionals with more in-depth insight into the patterns of CAM use by cancer patients and facilitate better-informed discussions with their patients. Considering the high use of CAM, reliable information provision supporting cancer care providers' knowledge and health literacy among patients as well as good communication are crucial. The cooperation between the NCS and NAFKAM provides an example of how to address these issues.

Safety of Complementary and Alternative Medicine (CAM) treatment among children and young adults who suffer from adverse effects of conventional cancer treatment: A systematic review.

BACKGROUND: Complementary and Alternative Medicine (CAM) is widely used around the world to treat adverse effects derived from cancer treatment among children and young adults. Parents often seek CAM to restore and maintain the child's physical and emotional condition during and after cancer treatment. OBJECTIVES: The objectives of this review were (i) to identify literature that investigates CAM use for treating adverse effects of conventional cancer treatment, (ii) to investigate the safety of the included CAM modalities, and (iii) to evaluate the quality of included studies. METHODS: Five scientific research databases were used to identify observational, quasi-experimental, and qualitative studies from January 1990 to May 2021. Included studies investigated the use of CAM to treat adverse effects of cancer treatment in childhood cancer. RESULTS: Fifteen studies were included in this review. Ten quasi-experimental, 3 observational studies (longitudinal/prospective), 2 qualitative studies, and 1 study with a quasi-experimental and qualitative arm were identified. Less than half (n = 6; 40%) of the studies included reported adverse effects for the CAM modality being studied. Among the studies that reported adverse effects, they were mostly considered as direct risk, as 13% reported mainly bleeding and bruising upon acupuncture treatment, and dizziness with yoga treatment. All adverse effects were assessed as minor and transient. CAM modalities identified for treating adverse effects of cancer treatment were alternative medical systems, manipulative and body-based therapies, biologically-based therapies, and mind-body therapies. CAM modalities were used to alleviate anxiety, pain, toxicity, prevent trauma, and improve health-related quality of life, functional mobility, and physical activity levels. All studies assessed scored 70% or above according to the Joanna Briggs Institute critical appraisal for study quality checklists. CONCLUSION: Most of the studies (58.3%) included in this review did not report adverse effects from CAM modalities used to treat adverse effects of cancer treatment in children and young adults. This lack of safety information is of concern because parents need to know whether the modality represents an extra burden or harm to the child. To improve awareness about safety in the field, a universal and uniform reporting system for adverse effects in CAM research is needed.

Complementary and alternative medicine modalities used to treat adverse effects of anti-cancer treatment among children and young adults: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Dealing with the symptom burden of cancer diagnosis and treatment has led parents to seek different self-management strategies including Alternative and Complementary Medicine (CAM). The aim of this study was to perform a systematic review and meta-analysis about the use and effect of CAM modalities to treat adverse effects of conventional cancer treatment among children and young adults. METHODS: Six scientific research databases were used to identify randomized controlled trials (RCTs) from 1990 to September 2020. Included studies investigated the use of CAM to treat cancer treatment related adverse effects in children and young adults compared to controls. RESULTS: Twenty RCTs comprising 1,069 participants were included in this review. The included studies investigated acupuncture, mind-body therapies, supplements, and vitamins for chemotherapy-induced nausea and vomiting (CINV), oral mucositis, and anxiety among children and young adults who underwent conventional cancer treatment. Seven studies (315 participants) were included in the meta-analysis. The overall effect of CAM (including acupuncture and hypnosis only) on chemotherapy-induced nausea and/or vomiting and controls was statistically significant with a standard mean difference of -0.54, 95% CI [-0.77, -0.31] I2 = 0% (p < 0.00001). There was a significant difference between acupuncture and controls (n = 5) for intensity and/or episodes of CINV with an SMD -0.59, 95% CI [-0.85, -0.33] (p < 0.00001). No significant difference was found between hypnosis and controls (n = 2) for severity or episodes of CINV with an SMD -0.41, 95% CI [-1.09, 0.27] I2 = 41% (p = 0.19). CONCLUSION: Current evidence from this meta-analysis of randomized controlled trials shows that CAM, including acupuncture and hypnosis only, is effective in reducing chemotherapy-induced nausea and vomiting in children and young adults. More rigorous trials and long-term effects should be investigated if acupuncture and hypnosis are to be recommended for clinical use.

Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies.

Background and objective: Andrographis paniculata (AP) is a traditionally used herbaceous plant, whose main active constituent is andrographolide. Andrographolide derivative medications and herbal preparations of AP are often used to treat respiratory tract infections. This study aims to systematically evaluate the safety of andrographolide derivative medications and herbal preparations of AP based on clinical studies. Methods: English and Chinese databases were searched for all types of clinical studies that reported adverse drug reactions (ADRs) and adverse events (AEs) of andrographolide derivative medications and herbal preparations of AP. The ADRs and AEs were classified according to manifestations, and graded according to severity. Single-rate meta-analysis was performed for ADR incidence using R software. Results: A total of 262 studies were included, including 125 randomized controlled trials, 23 non-randomized controlled trials, 6 case series, and 108 case reports. In 9490 participants using andrographolide derivative injections, 383 (4.04%) reported ADRs. Meta-analysis showed that the ADR incidence of three most frequently used injections of andrographolide derivatives (andrographolide sulfonate, potassium sodium dehydroandrographolide succinate, and potassium dehydroandrographolide succinate) were 5.48% [95% CI (4.47%, 6.72%)], 3.69% [95% CI (2.59%, 4.94%)] and 5.33% [95% CI (3.68%, 7.72%)], respectively, which may be slightly higher than the actual ADR incidence, because only studies that reported the occurrence of ADRs or AEs were included, but studies without ADR and AE were not included. The ADRs of andrographolide derivative injections were mainly gastrointestinal, skin and subcutaneous tissue disorders, and anaphylaxis. Fifty-five patients experienced life-threatening anaphylactic shock, three patients died, and the causation attributed to the andrographolide derivative injection. Other ADRs were mild, moderate or medically significant. Nine herbal preparations of AP were tested in 10 studies, and the reported ADRs were mainly mild to moderate gastrointestinal, skin and subcutaneous tissue disorders. Except for five patients using andrographolide derivative injections eventually died, most of the ADRs were alleviated after drug withdrawal and symptomatic treatment. Conclusions: The ADRs of andrographolide derivative medications are few, but can be life-threatening, mainly gastrointestinal, skin and subcutaneous tissue disorders, and anaphylaxis. Injections of andrographolide derivatives should be used with caution. Herbal preparations of AP are essentially safe. Systematic Review Registration: [website], identifier [registration number].

Conventional health care service utilization among cancer survivors that visit traditional and complementary providers in the Tromsø study: a cross-sectional study.

BACKGROUND: Traditional and complementary medicine (T&CM) is commonly used among cancer patients worldwide. Cancer patients in Norway mainly visit T&CM providers in addition to conventional health care services. It is not known how their utilization of T&CM providers influences their use of conventional health care services. The aim of this study was to investigate the difference between the utilization of conventional health care services among cancer survivors that visit T&CM providers and those that do not, and their associated factors. METHOD: Health care service utilization data were obtained from cancer survivors 40 years and above participating in the Tromsø Study: Tromsø 7 conducted in 2015-2016. Data were collected from self-administered questionnaires. Pearson chi-square tests, Fisher exact tests, t-test, and logistic regression were used, with the significance level considered at p < 0.05. RESULTS: Of 1553 individuals, 10% (n = 155) reported visiting T&CM providers in the past 12 months. As both cancer survivors visiting and not visiting T&CM providers were frequent users of conventional health care, no significant differences were found in the overall use of conventional health care (98.1vs.94.5%, p = .056). Users of T&CM providers were however more likely to visit physiotherapists (40.1% vs 25%, p < .001), emergency rooms (29.2% vs 16.5%, p < .001), chiropractors (17% vs 6%, p < .001), and psychologist/psychiatrist (8.9% vs 3.4%, p < .001). They also had more frequent visits to conventional health care (11.45 vs 8.31 yearly visits, p = 0.014), particularly to general practitioners (5.21 visits vs. 3.94 visits, p = .002). CONCLUSION: Results from this study show that visits to T&CM providers are associated with more visits to conventional health care services among cancer survivors. Further studies are needed to investigate the reasons for this high use behavior.

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

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

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

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

The impact of COVID-19 on complementary and alternative medicine providers: A cross-sectional survey in Norway.

BACKGROUND: The Norwegian authorities decided in March 2020 to implement a nationwide lockdown to prevent spread of the COVID-19 virus. The lockdown had vast socioeconomic consequences for the society. The aim of this study was to investigate how COVID-19 affected Complementary and Alternative Medicine (CAM) providers' practice, financial situation, recommendations to patients, and how they perceived their future practice as CAM providers. METHOD: Data were collected in this cross-sectional survey using a self-administrated electronic questionnaire. A total of 581 CAM providers completed the questionnaire, which was designed to describe consequences for CAM providers and their clinical practice caused by the nationwide lockdown. Descriptive statistics were carried out using frequency analyses to describe the demographics and consequences of the lockdown. Between group differences (gender and age) were analyzed using Pearson chi-square tests and Fisher's exact tests for categorical variables, and ANOVA tests and t-tests for continuous variables. Significance level was defined as p < 0.05 without adjustment for multiple comparisons. RESULT: During the nationwide lockdown of Norway, 38.4% of the respondents were able to provide CAM treatment to their patients. Of those, the majority (96.4%) had reorganized their clinical practice in accordance with COVID-19 hygiene regulations, offered video consultations (57.4%) or telephone consultations (46.6%). To manage financially during the lockdown, half of the providers spent their savings (48.7%). More than one third (35.1%) was supported by their partner, and 26.7% received compensation from the Norwegian state. A total of 26.3% of the CAM providers had other paid work that provided them with income. Nearly a fifth (18.6%) borrowed money from friends and family, changed their loan terms, or took out new bank loans. More than half (62.7%) expressed uncertainty about the future of their practice. CAM providers who had reorganized their practice to online consultations were more optimistic. CONCLUSION: The impact of COVID-19 on CAM providers was considerable. It adversely affected their clinical practice, financial situation, and view on their future practice. To ensure that the health needs of the Norwegian population regarding CAM use are met during pandemic times like COVID-19, it is recommended to support and train CAM providers in the development of online CAM services, as well as efficient implementation of infection prevention and control measures.

Use of complementary and alternative medicine in Norway: a cross-sectional survey with a modified Norwegian version of the international questionnaire to measure use of complementary and alternative medicine (I-CAM-QN).

BACKGROUND: In recent decades complementary and alternative medicine (CAM) has been widely used worldwide as well as in Norway, where CAM is offered mainly outside the national health care service, mostly complementary to conventional treatment and fully paid for by the patients. With few exceptions, previous research has reported on frequency and associations of total CAM use in Norway rather than on single therapies and products. Therefore, in this present study we will map the use of CAM more precisely, including types of services, products, and self-help practices and further include reasons for use and helpfulness of the specific therapies used based on a modified Norwegian version of the I-CAM-Q (I-CAM-QN). METHOD: Computer assisted telephone interviews using I-CAM-QN were conducted with 2001 randomly selected Norwegians aged 16 and above using multistage sampling in January 2019 with age and sex quotas for each area. Weights based on sex, age, education, and region corrected for selection biases, so that results are broadly representative of the Norwegian population. Descriptive statistics were carried out using Pearson's Chi-square tests and t-tests to identify group differences. RESULT: CAM use was reported by 62.2% of the participants during the prior12 months. Most participants had used natural remedies (47.4%), followed by self-help practices (29.1%) and therapies received from CAM providers (14.7%). Few of the participants had received CAM therapies from physicians (1.2%). Women were generally more likely to use CAM than men, younger people more likely than older, and participants with lower university education and income more likely than participants without university education, with higher university education and higher income. Mean number of visits per year to the different CAM providers ranged from 3.57 times to herbalists to 6.77 times to healers. Most of the participants found their use of CAM helpful. CONCLUSION: This study confirms that CAM is used by a considerable segment of the Norwegian population. We suspect that the number of participants reporting CAM use is greater when specific therapies are listed in the questionnaire as a reminder (as in the I-CAM-QN) compared to more general questions about CAM use. The CAM modalities used are mainly received from CAM providers operating outside public health care or administered by the participants themselves.

Communication and information needs about complementary and alternative medicine: a qualitative study of parents of children with cancer.

BACKGROUND: Many parents choose support such as Complementary and Alternative Medicine (CAM) for themselves and their children who have cancer. The aim of this paper is to describe, how parents who have children with cancer communicated with conventional health care providers about CAM, and what types and sources of information they would like to receive about CAM when the child was ill. METHOD: This focused ethnography draws from in-depth, semi-structured interviews conducted with 22 families in Norway with 24 adult participants (two couples), including two individuals who had had cancer themselves. Four domains were explored in the data analysis: the use of CAM, advice from laypeople about CAM, communication with conventional health care providers about CAM, and parents' information needs about CAM. RESULTS: Many of the participants had personal experiences with CAM before the child received the cancer diagnosis. The health care providers did not raise the question about CAM in the consultations. However, when the parents raised the question, they were mostly met in a positive way. The participants did not receive any information about CAM at the hospital, which they would have appreciated. Instead, they received recommendations about CAM from laypersons, which were mostly rejected, as the advice was not in line with their health values/philosophy. CONCLUSION: The reason participants did not disclose CAM use is that physicians did not ask them about it. However, positive communication about conventional treatment facilitated fruitful conversations about CAM. The participants wanted information about CAM from authoritative sources, primary from health care providers at the hospital and the Children's Cancer Society. They demand information about risks and benefits when using CAM as well as whether CAM can improve the immune system, fight the cancer, and improve the quality of life of the family. An evidence-based decision aid is warranted to enable health care providers and parents of children with cancer to make well-informed decisions about CAM.