Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study.

STUDY QUESTION: What is the efficacy and safety of long-term treatment (up to 2 years) with relugolix combination therapy (CT) in women with moderate to severe endometriosis-associated pain? SUMMARY ANSWER: For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis; after an initial decline of <1%, the mean bone mineral density (BMD) remained stable with continued treatment. WHAT IS KNOWN ALREADY: Endometriosis is a chronic condition characterized by symptoms of dysmenorrhea, non-menstrual pelvic pain (NMPP), and dyspareunia, which have a substantial impact on the lives of affected women, their partners, and families. SPIRIT 1 and 2 were phase 3, randomized, double-blind, placebo-controlled studies of once-daily relugolix CT (relugolix 40 mg, oestradiol 1 mg, norethisterone acetate 0.5 mg) in premenopausal women (age 18-50 years) with endometriosis and moderate-to-severe dysmenorrhea and NMPP. These trials demonstrated a significant improvement of dysmenorrhea, NMPP, and dyspareunia in women treated with relugolix CT, with minimal decline (<1%) in BMD versus placebo at 24 weeks. STUDY DESIGN, SIZE, DURATION: Patients participating in this open-label, single-arm, long-term extension (LTE) study of the 24-week SPIRIT pivotal studies (SPIRIT 1 and 2) received up to an additional 80 weeks of once-daily oral relugolix CT treatment between May 2018 and January 2023. PARTICIPANTS/MATERIALS, SETTING, METHODS: Premenopausal women with confirmed endometriosis and moderate to severe dysmenorrhea and NMPP who completed the 24-week pivotal studies (SPIRIT 1 and 2 trials; Giudice et al., 2022) and who met all entry criteria were eligible to enrol. Two-year results were analysed by treatment group based on original randomization in pivotal studies: relugolix CT, delayed relugolix CT (relugolix 40 mg monotherapy for 12 weeks, followed by relugolix CT), or placebo→relugolix CT (placebo for 24 weeks followed by relugolix CT). The primary endpoints of the LTE study were the proportion of dysmenorrhea and NMPP responders at Week 52 and Week 104/end-of-treatment (EOT). A responder was a participant who achieved a predefined, clinically meaningful reduction from baseline in Numerical Rating Scale (NRS) scores (0 = no pain, 10 = worst pain imaginable) for the specific pain type with no increase in analgesic use. The predefined clinically meaningful threshold for dysmenorrhea was 2.8 points and for NMPP was 2.1 points. Secondary efficacy endpoints included change from baseline in Endometriosis Health Profile-30 (EHP-30) pain domain scores, a measure of the effects of endometriosis-associated pain on daily activities (function), NRS scores for dysmenorrhea, NMPP, dyspareunia, and overall pelvic pain, and analgesic/opioid use. Safety endpoints included adverse events and changes in BMD. MAIN RESULTS AND THE ROLE OF CHANCE: Of 1261 randomized patients, 1044 completed the pivotal studies, 802 enrolled in the LTE, 681 completed 52 weeks of treatment, and 501 completed 104 weeks of treatment. Demographics and baseline characteristics of the extension population were consistent with those of the original randomized population. Among patients randomized to relugolix CT at pivotal study baseline who continued in the LTE (N = 277), sustained improvements in endometriosis-associated pain were demonstrated through 104 weeks. The proportion of responders at Week 104/EOT for dysmenorrhea and NMPP was 84.8% and 75.8%, respectively. Decreases in dyspareunia and improvement in function assessed by EHP-30 pain domain were also sustained over 2 years. At Week 104/EOT, 91% of patients were opioid-free and 75% of patients were analgesic-free. Relugolix CT over 104 weeks was well tolerated with a safety profile consistent with that observed over the first 24 weeks. After initial least squares mean BMD loss <1% at Week 24, BMD plateaued at Week 36 and was sustained for the duration of 104 weeks of treatment. Efficacy and safety results were generally consistent in women in the placebo→relugolix CT and delayed relugolix CT groups. LIMITATIONS, REASONS FOR CAUTION: The study was conducted as an open-label study without a control group over the 80 weeks of the extension period. Of the 802 patients who were enrolled in this LTE study, 681 patients (84.9%) and 501 patients (62.5%) of patients completed 52 and 104 weeks of treatment, respectively. In addition, there currently are no comparative data to other hormonal medications. Finally, a third (37.4%) of the study population terminated participation early. WIDER IMPLICATIONS OF THE FINDINGS: In conclusion, relugolix CT offers an additional option to help address an important unmet clinical need for effective, safe, and well-tolerated medical treatments for endometriosis that can be used longer-term, reducing the need for opioids and improving quality of life. The findings from this study may help support the care of women with endometriosis seeking longer-term effective medical management of their symptoms. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by Myovant Sciences GmbH (now Sumitomo Pharma Switzerland GmbH). C.M.B. reports fees from Myovant, grants from Bayer Healthcare, fees from ObsEva, and Chair of ESHRE Endometriosis Guideline Group (all funds went to the University of Oxford); N.P.J. reports personal fees from Myovant Sciences, during the conduct of the study, personal fees from Guerbet, personal fees from Organon, personal fees from Roche Diagnostics; S.A.-S. reports personal fees from Myovant Sciences, personal fees from Bayer, personal fees from Abbvie, personal fees from UpToDate; J.S.P., and R.B.W. are employees and shareholders of Myovant Sciences; J.C.A.F. and S.J.I. are shareholders of Myovant Sciences (but at time of publicaion are no longer employess of Myovant Sciences); M.S.A. and K.W. have no conflicts to declare; V.M. is a consultant to Myovant; L.C.G. reports personal fees from Myovant Sciences, Inc and Bayer. The authors did not receive compensation for manuscript writing, review, and revision. TRIAL REGISTRATION NUMBER: NCT03654274.

[Complementary and supplementary procedures in the treatment of headache]. / Komplementäre und ergänzende Verfahren in der Kopfschmerztherapie.

In Germany, headache is one of the illnesses that most frequently leads to health impairments and to consultation with physicians. Even in children, headache is often associated with restricted activities of daily life. Nevertheless, the level of care for headache disorders is disproportionate to the medical needs. As a result, patients regularly use complementary and supportive therapeutic procedures. This review shows the procedures currently used for primary headache in childhood and adulthood, the methodological approaches and existing scientific evidence. The safety of the therapeutic options is also classified. These methods include physiotherapy, neural therapy, acupuncture, homeopathy, phytotherapy and the intake of dietary supplements. For children and adolescents with headaches, there are studies in the field of dietary supplements for coenzyme Q10, riboflavin, magnesium and vitamin D, which indicate specific effects in the reduction of headaches.

Fibromyalgia: A Report of 2 Cases Treated With Homeopathy.

Fibromyalgia is a chronic condition that is characterized by widespread pain and a multitude of other symptoms, including fatigue, sleep disturbances, cognitive dysfunction, stiffness, and depressive episodes. Fibromyalgia is most common in women, though it can occur in men as well. It most often starts in middle adulthood but can occur in the teen years and in old age. Fibromyalgia has also been termed central pain amplification disorder, meaning the volume of pain sensation in the brain is turned up too high. This study has been conducted to evaluate the role of homeopathic treatment in fibromyalgia, a chronic pain disorder which a physician may come across fairly commonly in their practice. Homeopathy has demonstrated great efficacy in mitigating the symptoms of widespread pain, sleep disturbance, and fatigue, which are the most commonly reported symptoms of fibromyalgia.

Polycystic Ovarian Syndrome Treated with Individualized Homeopathy: A Case Report.

Introduction: Polycystic ovarian syndrome (PCOS) is a polygenic, multifactorial, syndromic disorder with reproductive, endocrine, and metabolic dysfunction seen in reproductive aged women (12-45 years). The exact cause is not known may involve increased luteinizing hormone, increased insulin levels, and a defect in androgen synthesis. The symptoms include anovulation, irregular menses, and hyperandrogenism. It is clinically manifested by hirsutism, acne, and androgenic alopecia. Health care practitioners continue to seek a cure for PCOS as it is increasing in frequency and is one of the major causes of anovulatory infertility. Methods: The case was recorded in the gynaecological department at the Homoeopathic Medical College and Research Centre. An 18- year-old female patient with PCOS was treated with individualised homeopathy (iHOM) medicine between 26th September 2019 and 26th November 2020. During the follow-up visits, treatment outcomes were assessed. To assess whether the changes were due to homoeopathic medicine, an assessment using the modified Naranjo criteria was performed. Results: Over an observational period of 1 year, beneficial result from iHOM medicine was seen. This treatment method can be used by the physicians in the treatment of PCOS as a complementary health practice. Conclusion: Considering the multi-factorial aetiology of PCOS, iHOM medicine with lifestyle modification is helpful in treating PCOS.

Efficacy of Cyclical Prescription in Homoeopathic Management of Polycystic Ovary Disease: A Case Report.

Polycystic ovarian disease is a very common condition affecting women of reproductive age. Homoeopathy believes in a holistic approach and, when prescribed, can correct hormonal imbalances, regulate ovulation, and deal with associated complaints, as well as help to cure the condition from its root cause. A case of a 17-year-old female came into the Homoeopathic outpatient department with complaints of irregular menses and hyperpigmented patches on her back. Hormonal assay and thyroid function tests were done to rule out other disorders, and ultrasound of the abdomen and pelvis was done to confirm the diagnosis of polycystic ovarian disease. In this case Sulphur, Calcarea Carb, and Lycopodium were prescribed in a cyclical manner and proved to be beneficial.

Non-invasive Resolution of Pathological Ovarian Masses with Homeopathic Treatment-A Case Series.

BACKGROUND: Ovarian masses may be either physiological or pathological. Physiological ovarian masses are non-neoplastic. Pathological masses grow more than 7 cm and persist beyond 3 months; they do not resolve spontaneously, and invasive surgery with removal of reproductive organs is the conventional treatment. It usually results in further co-morbidities and hampers the quality of life of the patient. OBJECTIVES: This case series of pathological left ovarian masses demonstrates the role of homeopathic treatment in each of two multiparous women where the right ovary was surgically removed previously for similar pathology and in an adolescent girl with increased tumor marker CA-125. METHODS: Three cases of women with pathological ovarian masses in the left ovary, and advised invasive surgery by attending gynecologists, were treated with homeopathic medicines at the outpatient department of the National Homeopathy Research Institute in Mental Health, Kottayam, Kerala, from 2017 to 2020. Each case was followed up with clinical and ultrasonographic evidence and reported according to the criteria set out in the HOM-CASE guidelines. RESULT: Complete resolution of the ovarian masses was observed in all three cases, evidenced by ultrasonography, with normalizing CA-125 values also observed in the case of endometrial cyst. The patients improved within 4 to 15 months of treatment using Thuja and other individualized homeopathic medicines. The MONARCH score was calculated as +7/13, +9/13, and +9/13 for the three cases, respectively, indicating a positive causal attribution of homeopathy in the resolution of these pathological ovarian masses. CONCLUSION: This case series suggests that individualized homeopathy, and notably Thuja, can be useful in the treatment of pathological ovarian masses.

Health and Immune Boosting Techniques of General Adult Pakistani Population: A KAP Study.

OBJECTIVE: To discover Pakistani adult population's perception about their general health, immune status and knowledge regarding immunity, and to highlight their efforts to improve it. METHODS: The knowledge-attitude-practice study was conducted from January to May 2021, after approval ethics review committee of the Islamic International Medical College, Rawalpindi, Pakistan, and comprised individuals of either gender from the community aged 18 years or more and not suffering from any physical disability or mental illness. Data was collected using a pre-tested, self-administered questionnaire that was disseminated through online platforms. The collected data was analysed using SPSS 25. RESULTS: All the 455(100%) individuals approached responded to the questionnaire. The mean age of the subjects was 22.6±7.579 years. There were 256(56.3%) female respondents, 283(62.2%) were aged 20-21 years, and 359(78.9%) hailed from the Sindh province. Most participants perceived their general health as 'good' 197(43.3%). The immune system function was reported 'good' by 200(44%), and the perception of general knowledge of immunity was reported 'good' by 189(41.5%) subjects. Inverse relationships were identified between stress levels and self-perceived health, and between receiving effective homeopathic treatment and 'very good' self-perceived immune status (p<0.05). People willing to take non-obligatory vaccines had a positive opinion about their self-perceived knowledge on immunity that produced a direct relationship (p<0.05). CONCLUSIONS: The findings provide a framework of practices that should be promoted to improve health status of adult population in Pakistan.

A systematic review of clinical and laboratory findings of lead poisoning: lessons from case reports.

Lead is one of the most toxic heavy metals in the environment. The present review aimed to highlight hazardous pollution sources, management, and review symptoms of lead poisonings in various parts of the world. The present study summarized the information available from case reports and case series studies from 2009 to March 2020 on the lead pollution sources and clinical symptoms. All are along with detoxification methods in infants, children, and adults. Our literature compilation includes results from 126 studies on lead poisoning. We found that traditional medication, occupational exposure, and substance abuse are as common as previously reported sources of lead exposure for children and adults. Ayurvedic medications and gunshot wounds have been identified as the most common source of exposure in the United States. However, opium and occupational exposure to the batteries were primarily seen in Iran and India. Furthermore, neurological, gastrointestinal, and hematological disorders were the most frequently occurring symptoms in lead-poisoned patients. As for therapeutic strategies, our findings confirm the safety and efficacy of chelating agents, even for infants. Our results suggest that treatment with chelating agents combined with the prevention of environmental exposure may be an excellent strategy to reduce the rate of lead poisoning. Besides, more clinical studies and long-term follow-ups are necessary to address all questions about lead poisoning management.

Individualised Homeopathic Treatment of Acne-An Analysis of 83 Patients.

BACKGROUND: Acne is a common disorder of the pilosebaceous follicle. The face, back and chest are usually involved. It leads to significant diminution in quality of life. Numerous treatments are documented in therapeutic guidelines. Naturopathic approaches have been proposed in some, but the role of homeopathy is not examined. METHODS: In this study, 83 patients treated for acne with individualised homeopathic medicine alone were reviewed. Most had received conventional acne treatment, with limited success prior to presentation for homeopathy. Each patient was prescribed a single homeopathic medicine and followed up at 6- to 8-week intervals. The individualisation process resulted in 17 different medicines being used in this group. Photographic documentation was obtained per patient, with informed consent. Patients were classified as mild (comedonal acne with no papules or pustules), moderate (inflammatory and non-inflammatory lesions) and severe (predominantly inflammatory lesions: pustules, cysts, nodules). Results of treatment were recorded as remission (decrease in new lesion number, duration and intensity), failure to respond, and lost to follow-up (LTF). RESULTS: The average age of patients was 21.5 years (range 11-45 years). The F:M ratio was 55 (66.3%):28 (33.7%). Average pre-treatment duration was 5.5 years (0.25-22 years). Seven (8.4%) patients had mild acne, 37 (44.6%) moderate, and 39 (47%) severe acne. There were 13 (15.7%) LTFs, two (2.4%) failed to respond, and 68 (81.9%) went into remission. Average time to remission was 1.9 months (range 1.5-6 months), with no relapses or side-effects. The most commonly prescribed medicines were Lycopodium (38.6%), Palladium (15.7%) and Platinum (12.1%). CONCLUSION: Individualised homeopathy may be useful for acne therapy. The most useful medicines appeared to be Lycopodium, Palladium and Platinum, though 17 different medicines were used in this study, underscoring the value of individualisation of therapy, a key characteristic of homeopathy.

Homeopathic Remedies in COVID-19: Prognostic Factor Research.

BACKGROUND/OBJECTIVE: Coronavirus disease 2019 (COVID-19) is a new disease; its clinical profile and natural history are evolving. Each well-recorded case in homeopathic practice is important for deciding the future course of action. This study aims at identifying clinically useful homeopathic remedies and their prescribing symptoms using the prognostic factor research model. METHODS: This was an open-label, multi-centric, observational study performed from April 2020 to July 2020 at various public health care clinics. The data were collected prospectively from clinical practice at integrated COVID-19 care facilities in India. Good-quality cases were selected using a specific set of criteria. These cases were analyzed for elucidating prognostic factors by calculating the likelihood ratio (LR) of each frequently occurring symptom. The symptoms with high LR values (>1) were considered as prescribing indications of the specific remedy. RESULTS: Out of 327 COVID-19 cases reported, 211 met the selection criteria for analysis. The most common complaints were fatigue, sore throat, dry cough, myalgia, fever, dry mouth and throat, increased thirst, headache, decreased appetite, anxiety, and altered taste. Twenty-seven remedies were prescribed and four of them-Arsenicum album, Bryonia alba, Gelsemium sempervirens, and Pulsatilla nigricans-were the most frequently used. A high LR was obtained for certain symptoms, which enabled differentiation between the remedies for a given patient. CONCLUSION: Homeopathic medicines were associated with improvement in symptoms of COVID-19 cases. Characteristic symptoms of four frequently indicated remedies have been identified using prognostic factor research, findings that can contribute to accurate homeopathic prescribing during future controlled research in COVID-19.

Homeopathic Treatment in Patients with Polycystic Ovarian Syndrome: A Case Series.

BACKGROUND AND OBJECTIVES: Polycystic ovary syndrome (PCOS) is a common heterogeneous endocrine disorder in women of reproductive age. It is characterized by various clinical presentations such as ovulatory dysfunction, polycystic ovaries, and hyperandrogenism. Considering the side effects associated with conventional treatment and the patients who fail to respond to these measures, there is a demand for a complementary therapy that would alleviate symptoms of PCOS without side effects. Homeopathy is a complementary system of medicine that has been successfully used in different disease conditions, including PCOS. A case series of PCOS is hereby presented, to demonstrate some positive results of individualized homeopathic treatment. METHODS: Seven cases of young women with PCOS were treated with individualized homeopathic medicines. Each case was followed up with clinical and ultrasonographic evidence and was reported according to the criteria set out in the HOM-CASE guidelines. The assessment of causal attribution of homeopathic treatment effect was carried out using the Modified Naranjo Criteria. RESULTS: Marked improvement was observed in all seven cases of PCOS. The irregular menstrual cycles and other associated symptoms became normal, along with a resolution of cysts in ovaries as evidenced by ultrasonography. All cases improved within 4 to 12 months of treatment. The Modified Naranjo Criteria total score was +9/13 for each case, which indicates a positive causal attribution of homeopathy in relieving the symptoms of PCOS. CONCLUSION: This case series suggests a significant role of individualized homeopathic medicines in PCOS by regularizing the menstrual cycle along with the resolution of cysts and associated symptoms.

Data Collection during the COVID-19 Pandemic: Learning from Experience, Resulting in a Bayesian Repertory.

BACKGROUND: A novel pandemic disease offered the opportunity to create new, disease-specific, symptom rubrics for the homeopathic repertory. OBJECTIVE: The aim of this study was to discover the relationship between specific symptoms and specific medicines, especially of symptoms occurring frequently in this disease. MATERIALS AND METHODS: Worldwide collection of data in all possible formats by various parties was coordinated by the Liga Medicorum Homeopathica Internationalis. As the data came in, more symptoms were assessed prospectively. Frequent analysis and feedback by electronic newsletters were used to improve the quality of the data. Likelihood ratios (LRs) of symptoms were calculated. An algorithm for combining symptom LRs was programmed and published in the form of an app. The app was tested against 18 well-described successful cases from Hong Kong. RESULTS: LRs of common symptoms such as 'Fatigue' and 'Headache' provided better differentiation between medicines than did existing repertory entries, which are based only on the narrow presence or absence of symptoms. A mini-repertory for COVID-19 symptoms was published and supported by a web-based algorithm. With a choice of 20 common symptoms, this algorithm produced the same outcome as a full homeopathic analysis based upon a larger number of symptoms, including some that are traditionally considered more specific to particular medicines. CONCLUSION: A repertory based on clinical data and LRs can differentiate between homeopathic medicines using a limited number of frequently occurring epidemic symptoms. A Bayesian computer algorithm to combine symptoms can complement a full homeopathic analysis of cases.

Analysis of Homeopathic Genus Epidemicus for COVID-19 Patients in Spain.

BACKGROUND: Homeopathy has had documented success treating epidemics in the last two centuries. We aimed to obtain a clear homeopathic clinical picture of coronavirus disease 2019 (COVID-19) and postulate the genus epidemicus of the disease in order to inform and enhance future treatment and prophylaxis options. METHODS: We conducted a prospective case series study, collecting data from 19 homeopaths in Catalonia, Spain, from patients who presented with fever and/or cough and/or breathlessness and/or confirmed COVID-19 infection or close contact with a confirmed case. We included 107 patients, and data were recorded through a checklist questionnaire on the day of the case analysis and at day 10-15 after commencing treatment. Symptoms were collected and analyzed with the help of homeopathic repertories. RESULTS: A total of 103 cases were mild or moderate; four were severe. The severe cases were excluded from the analysis and the 103 mild and moderate cases were analyzed and a clear overall clinical picture with mental, general, and particular symptoms was achieved. Eighty-eight cases had a complete recorded follow-up. The most prescribed medicines were Bry, Ars, Phos and Gels, whilst those with the best rates of good response were Sulph, Puls and Bry. Time to full recovery after homeopathic treatment ranged from 3.5 to 14.4 days, depending on the medicine used. The potency 200c was associated with faster rates of full recovery and a lesser need to change remedy. CONCLUSION: We have defined the symptomatic homeopathic characteristics of mild and moderate COVID-19 in Spain and established a set of medicines that might be useful to consider as effective genus epidemicus.

Risk evaluation of the use of complementary and alternative medicines in cancer.

INTRODUCTION: Cancer patients use complementary and alternative medicines (CAM) to improve their well-being. Little is known about real risks. OBJECTIVE: To highlight 3 different types of axes: 1/cancer patients' perceptions concerning CAM; 2/misinformation/miscommunication about CAM; 3/CAM toxicity (direct toxicity, CAM-anticancer drugs, CAM-cancer interactions). METHOD: A questionnaire was proposed to cancer patients for 2 months. The CAM toxicity was analyzed if patients documented their drugs and CAM. RESULTS: Eighty-five patients responded: 72/85 were taking≥1CAM. In total, 95% patients were satisfied. There was an increasing CAM intake after cancer diagnosis. One hundred and seventeen different CAM were identified (63 herbs, 24 essential oils, 28 food supplements, 2 homeopathic specialities). Only 30/85 were aware CAM could interact with anticancer drugs. No other type of risk was perceived. INFORMATION SOURCES: 43/85 Internet, 38/85 general practitioner, 38/85 community pharmacist, 32/85 entourage, 25/85 other patients, 22/85 oncologist. In total, 81.3% questioned healthcare professionals (HCP) about CAM. Twelve patients noticed HCP lacked knowledge regarding CAM. The toxicity analysis was carried out for 24 patients who consumed 1 to 24CAM. In total, 133CAM were reported, including 87 different CAM. For only 43CAM/87, studies were found. All patients presented≥1risk: 14 at risk of CAM-cancer interactions, 15 of CAM-anticancer drug interactions, 21 of CAM direct toxicities. CONCLUSION: Many CAM are used by patients. The diagnosis of cancer favors their use. The risks are manifold: low perception of risk that can be induced by CAM, diverse and insecure sources of information and many potential toxicities that are not scientifically documented.

A cross-sectional study of errors in physicians orders' of antiseizure medications among people with epilepsy from rural India.

AIMS: To enumerate and classify errors in physicians' orders of antiseizure medications (ASMs) to people with epilepsy presenting to neurology clinic. METHODS: This cross-sectional study was conducted in the neurology clinic of a teaching hospital catering to a predominantly rural population. People in whom a diagnosis of epilepsy was confirmed and who presented for the first time with a prior prescription for antiseizure medication/s were included. Their immediate previous prescriptions were assessed for errors, enumerated and classified according to WHO guidelines for prescription writing. RESULTS: Hundred prescriptions of 334 patients screened were analyzed. The number of ASMs prescribed to a participant was 2 ±â€¯0.6 (mean ±â€¯SD). We identified a mean of 5 ±â€¯4 (median: 3; range: 1-7) errors in each order. These included superscription errors, e.g., missing information on seizure control and frequency (n = 90, 90%), generic name (n = 62, 62%), patient identifiers (n = 57, 57%), prescribers' identifiers (n = 29, 29%) and diagnosis or indication for prescribing the medication/s (n = 55, 55%). The most common inscription and subscription errors were dosing errors (22%) and pharmaceutical form errors (20%) followed by omission (13%), duplication (13%), substitution (12%), commission (9%) and frequency errors (8%). Errors were more common among prescriptions provided by primary-care and Ayurvedic, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) physicians compared to specialists (P < 0.05). CONCLUSIONS: Errors are common among medication orders provided by non-specialist and specialist physicians. Primary care and AYUSH are more liable to make errors underscoring the need to educate them in basic epilepsy treatment.

Efficacy of Homeopathy in Addition to a Multidisciplinary Intervention for Overweight or Obesity in Mexican Adolescents: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Current recommendations for treating obesity in adolescence include a comprehensive approach (nutritional, behavioral, and exercise). Calcarea carbonica ostrearum (CCO) is a homeopathic medicine usually prescribed in obese individuals, but its effects on weight and body fat are not completely known. OBJECTIVE: The aim of this study will be to evaluate the efficacy of homeopathic CCO, in addition to a multidisciplinary intervention (diet, motivational support, and exercise program), on body fat and weight in obese adolescents. METHODS/DESIGN: A randomized, placebo-controlled, double-blind, parallel-group, superiority trial with 3-month study duration will be undertaken. The study will be conducted in a public research hospital in Mexico City, Hospital Juárez de México, in the outpatient services of homeopathy and sports medicine. Eighty non-diabetic adolescents, 12 to 19 years old, who are overweight or obese, will be included. The primary outcome: change in body fat percentage at week 12. The secondary outcomes: change in mean total weight, total body mass index, fat mass index, waist-hip ratio, lean muscle mass, fasting glucose, insulin, insulin resistance, lipid profile, score of Center for Epidemiologic Studies Depression Scale Revised (CESD-R) and score of Screen for Child Anxiety-Related Emotional Disorders (SCARED) at week 12. Efficacy data will be analyzed in the intention-to-treat sample. To determine the difference in the outcomes between groups at baseline and week 12, data will be analyzed using Student's t-test. DISCUSSION: This is the first randomized controlled trial aimed to determine the fat-reducing efficacy in obese adolescents of a homeopathic medicine, CCO, given in addition to a multidisciplinary intervention, compared with placebo plus the same intervention. It is an attempt to support scientific evidence in homeopathy for one of the most common chronic diseases, which causes high mortality due to its complications. CLINICALTRIALS. GOV IDENTIFIER: NCT03945396: https://clinicaltrials.gov/ct2/show/NCT03945396?term=homeopathy+for+obesity+in+Mexican+adolescents&rank=1.

The use of home remedies and complementary health approaches in endometriosis.

RESEARCH QUESTION: Conventional treatments are often associated with adverse effects and endometriosis pain symptoms may reoccur despite treatment. Consequently, many women use complementary health approaches (CHA) and home remedies (HR) to relieve their pain. The aim of this study was to examine the frequency and the subjectively perceived efficacy of CHA/HR use by women affected by endometriosis. DESIGN: Retrospective evaluation using medical charts and a questionnaire. Women recruited in hospitals and in self-help groups were asked about the use of 'topical heat', 'repose/relaxation', 'movement/massages', 'homeopathy/phytotherapy', 'acupuncture/traditional Chinese medicine (TCM)' and 'kinesiology/physiotherapy'. RESULTS: From a total of 574 women with a confirmed diagnosis of endometriosis, 359 (62.5%) applied some form of CHA/HR. Women suffering from fatiguing disease symptoms more often selected alternative therapies (odds ratio [OR] 3.14, 95% confidence interval [CI] 1.39-7.11, P = 0.006) compared with women without these characteristics. Furthermore, women dissatisfied with healthcare provided by their treating physician, more frequently (OR 2.30, 95% CI 1.19-4.45, P = 0.013) chose the aforementioned alternative strategies. CONCLUSION: As conventional therapies may not be sufficiently effective, women's needs should be closely examined, and individual treatment options should be discussed and initiated by clinicians to provide the best comprehensive treatment possible for endometriosis.

Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine therapy in localized breast cancer patients? A multicenter randomized placebo-controlled phase III trial.

PURPOSE: Endocrine therapy (ET) used to reduce the risk of recurrence in hormone receptor-expressing disease (75% of breast cancers) is associated with worsening of climacteric symptoms with a negative impact on quality of life (QoL). Homeopathy might allow a better management of hot flushes (HF). METHODS: In this multicenter randomized double-blind placebo-controlled phase III study ( ClinicalTrials.gov NCT01246427), we enrolled ≥ 18 years old women with histologically proven non metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients should not be scheduled for chemotherapy or radiotherapy, and had no associated pathology known to induce HF. After a 2- to 4-week placebo administration, we randomly assigned (1:1) patients with HFS ≥ 10 using an interactive web-based centralized platform to BRN-01 homeopathic medicine complex (Actheane®) in arm A or Placebo (Arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. Primary endpoint was assessed at 4-week post-randomization, as the variation between pre- and 4w-HFS. Secondary endpoints included HFS variation between pre- and 8w-HFS, compliance and tolerance assessed 8 weeks after randomization, and QoL and satisfaction assessed at 4- and 8-week post-randomization. RESULTS: Two hundred ninety-nine patients were included, and 138 (46.2%) randomized (A, 65; P, 73). Median 4w-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different. However, 4w-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4w-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470). CONCLUSIONS: The efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.

Complementary and alternative medicine use in adults with autism spectrum disorder in Germany: results from a multi-center survey.

BACKGROUND: Complementary and Alternative Medicine (CAM) is widely used both in the general population and for the treatment of somatic and psychiatric disorders. Studies on CAM use among patients with autism spectrum disorder (ASD) have so far only focused on children and adolescents. The aim of this study was to investigate patterns of CAM use among adults with ASD. METHODS: A questionnaire survey concerning current and lifetime use of CAM was distributed to adults with ASD between November 2015 and June 2016. Participants diagnosed by experienced clinicians using the current diagnostic gold standard were recruited from four ASD outpatient clinics in Germany. Questionnaire data was then linked to supplementary clinical data. RESULTS: The final sample consisted of 192 adults (response: 26.8%) with a mean age of 31.5 years (80% male; diagnoses: Asperger's syndrome (58%), childhood autism (27%), atypical autism (12%)). 45% of the respondents stated that they were currently using or had used at least one CAM modality in their life. Among the participants with lifetime CAM use, almost half had used two or more different types of CAM. Alternative medical systems (e.g. homeopathy, acupuncture) were most frequently used, followed by mind-body interventions (e.g. yoga, biofeedback, animal assisted therapy). Overall, 20% of respondents stated that they would like to try at least one listed CAM modality in the future. CONCLUSIONS: This is the first study on CAM use in adults with ASD, demonstrating considerable CAM use in this population. Given the popularity of CAM, patients should be informed about the effectiveness and potentially dangerous side effects of CAM treatments, as evidence for the majority of CAM methods in ASD is still limited.

Rethinking ADHD intervention trials: feasibility testing of two treatments and a methodology.

Attention deficit hyperactivity disorder (ADHD) is a lifelong condition associated with considerable costs. The long-term effectiveness and acceptability of treatments to improve outcomes remains in doubt. Long-term trials are needed comparing interventions with standard care and each other. The Sheffield Treatments for ADHD Research (STAR) project used the Trials within Cohorts (TwiCs) approach. A cohort of children with ADHD was recruited and outcomes collected from carers and teachers. A random selection was offered treatment by homoeopaths (hom) or nutritional therapists (NT). Their outcomes (Conners Global ADHD Index) were compared with those not offered interventions. The feasibility of the methods and interventions was assessed. The TwiCs approach was feasible with modifications. 144 participants were recruited to the cohort, 83 offered treatment, 72 accepted, and 50 attended 1+ appointments. Results according to carers assessments at 6 months were as follows: t = 1.08, p = .28 (- 1.48, 4.81) SMD .425 (hom); t = 1.71, p = .09 (- .347, 5.89), SMD = .388 (NT). Teachers' responses were too few and unstable. No serious treatment adverse events occurred.Conclusion: the STAR project demonstrated the feasibility of the TwiCs approach for testing interventions for children with ADHD. What is Known: • Attention deficit hyperactivity disorder (ADHD) is a lifelong condition associated with considerable costs to ADHD stakeholders. Children are at risk of negative outcomes and in need of pre-emptive strategies • The long-term effectiveness and acceptability of recommended treatments to improve outcomes remains in doubt What is New: • A small-scale test of the design demonstrated that the Trials within Cohorts (TwiCs) approach is feasible and can make a useful contribution regarding testing the effectiveness of interventions for children with ADHD to improve long-term negative outcomes • Treatment by homoeopaths and nutritional therapists may offer novel opportunities to improve outcomes.