Supportive cancer care: is integrative oncology the future?

PURPOSE OF REVIEW: Nearly half of cancer patients use complementary therapies alongside the conventional cancer treatment. This clinical reality is a challenge for the medical team mainly to guarantee patient's safety. The evolution from Supportive Care to Integrative oncology is taking shape. RECENT FINDINGS: Integrative oncology, a new field in cancer care, combines conventional supportive care and validated complementary approaches. The first part of this review is to highlight the process of validation of one of the most popular complementary medicines among European cancer patients: homeopathy. It seems to be a well tolerated and useful complementary approach in integrative cancer care. The second part shows through the example of stage IV lung cancer the transition from conventional supportive care to integrative oncology with a benefit for their quality of life and survival. SUMMARY: The future of supportive cancer care seems to lead towards a move from coexistence of conventional care and complementary approaches to a combination of both in integrative oncology. This would require new skills among caregivers, specific academic training and adapted studies. Further research is needed to highlight the benefits in the specific field of integrative cancer care.

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.

Medicinal grade opium tincture for severe diarrhea: effect revisited in observational study.

PURPOSE OF REVIEW: Chronic diarrhea is a common disorder that interferes with normal daily activities and results in poor quality of life. Fecal urgency and incontinence often necessitate clinical consultation, but the pathophysiological mechanisms are difficult to differentiate in a clinical setting. Therefore, drugs targeting the opioid receptors, such as diphenoxylate and loperamide, are typically used, as they reduce both gut motility and secretion. RECENT FINDINGS: For severe diarrhea, morphine-containing extemporaneous opium tincture drops have recently been reprofiled to a pharmaceutical. The drug is indicated for severe diarrhea in adults when other antidiarrheals do not give sufficient fecal emptying control. The pronounced effect is due to the liquid formulation with rapid onset as a drug dissolution step is avoided. A recent prospective, noninterventional study (CLARIFY) of patients treated with opioid drops demonstrates a rapid and sustained therapeutic effect. Tolerance does not develop for the antidiarrheal effect and no dependence was observed after discontinuation. SUMMARY: This mini-review discusses the use of opium derivates for treatment of diarrhea, with an emphasis on opium drops as a new medicinal grade opium for the use as additional treatment of severe diarrhea, emphasizing its mechanism of action and evaluation of the risk-benefit ratio in the clinical setting.

Opium tincture has anti-propulsive effects in patients with chronic diarrhea: a randomized, placebo-controlled, and cross-over trial.

OBJECTIVE: Chronic diarrhea affects approximately 5% of the population. Opioids inhibit gastrointestinal motility, and opium tincture has shown anti-propulsive effects in healthy, but no controlled studies of its clinical efficacy exist. We aimed to investigate the anti-propulsive and central nervous system (CNS) effects of opium tincture in patients with chronic diarrhea. MATERIALS AND METHODS: The study was a randomized, double-blinded, placebo-controlled, cross-over trial in subjects with chronic diarrhea refractory to standard treatment. Participants received opium tincture or placebo during two intervention periods, each lasting seven days. Bowel movements were recorded daily, and gastrointestinal transit time was investigated with the wireless motility capsule system. Gastrointestinal symptoms, health-related quality of life, and CNS effects (pupil size, reaction time, memory, and general cognition) were also investigated, along with signs of addiction. RESULTS: Eleven subjects (mean age: 45 ± 17 years, 46% males) with a median of 4.7 daily bowel movements were included. The number of daily bowel movements was reduced during opium tincture treatment to 2.3 (p = 0.045), but not placebo (3.0, p = 0.09). Opium tincture prolonged the colonic transit time compared to placebo (17 h vs. 12 h, p < 0.001). In both treatment arms, there were no changes in self-reported gastrointestinal symptoms, health-related quality of life, or CNS effects, and no indication of addiction was present. CONCLUSION: Opium tincture induced anti-propulsive effects in patients with chronic diarrhea refractory to standard treatment. This indicates that opium tincture is a relevant treatment strategy for selected patients with chronic diarrhea. Moreover, no evidence of opioid-induced sedation or addiction was found.Trial Registration Number: NCT05690321 (registered 2023-01-10).

Qualitative evaluation of the acceptability and feasibility among healthcare professionals and patients of an ART multi-cycle treatment planning and continuation intervention prototype.

STUDY QUESTION: Is it possible to design an ART Treatment Planning and Continuation Intervention (TPCI) that is considered acceptable and feasible to patients and healthcare professionals (HCPs)? SUMMARY ANSWER: HCPs and patients responded positively to the TPCI prototype and perceived it as an acceptable intervention to support patients to stay engaged with planned treatment, but some concerns were raised about the feasibility of using it in practice. WHAT IS KNOWN ALREADY: People discontinue ART due to its psychological burden. Digital tools to support people undergoing ART are available but typically focus only on practical support rather than psychological support. Research about treatment continuation and multi-cycle planning indicates that cognitive factors (expectations, intentions, efficacy beliefs) should be targets of interventions designed to help patients engage with and continue treatment to meet their personal treatment plans and goals. However, it is not known whether this form of psychological support would be acceptable for HCPs and patients or feasible to implement in practice. STUDY DESIGN, SIZE, DURATION: Qualitative cognitive interviews with HCPs and patients (May 2021). Patients were eligible if they had had a consultation to start a first/repeat stimulated IVF/ICSI cycle in the 8 weeks prior to recruitment, were aged 18 or older (upper age limit of 42 years for women) and fluent in English. Eligible HCPs were those employed by a fertility clinic who were responsible for delivering treatment planning consultations to patients. PARTICIPANTS/MATERIALS, SETTING, METHODS: HCPs and patients were asked to think aloud while being exposed to and exploring the TPCI in one-to-one online cognitive interviews. The TPCI was designed to reduce treatment discontinuation via cognitive factors namely formation and maintenance of multi-cycle ART intentions and efficiency of decision-making during treatment, and continuation of treatment after an unsuccessful cycle (when recommended). To impact cognitive factors the TPCI comprised of two components: an expectation management and reasoning checklist for HCPs to use during planning consultations (TPCI Checklist) and a multi-feature cognitive support mobile application (TPCI App) for patients to use prior to and during treatment. After participants thought aloud while being exposed to the TPCI prototype (both components) they were asked open questions concerning their perceptions of the core components and activities on eight acceptability dimensions (e.g. acceptability, demand, integration). Interviews lasted between 40 and 90 min, were recorded, transcribed verbatim and analysed using thematic analysis. MAIN RESULTS AND THE ROLE OF CHANCE: Thirteen HCPs and 13 patients participated in 25 online interviews. Thematic analysis using inductive and deductive coding generated 180 codes, grouped into 22 categories and synthesized into 9 themes. The themes showed that HCPs and patients provided positive feedback about the TPCI, perceiving it as a needed, acceptable and potentially effective way to forewarn patients of the possible need for multiple cycles, to provide patients with a sense of patient-clinic collaboration and support, and to bolster treatment intentions, all of which were perceived to contribute to reduced treatment discontinuation. HCPs perceived implementation of the TPCI Checklist to be challenging in its current length due to time pressures and clinic workload. Suggestions for enhancing the TPCI Checklist and App were provided, but none required critical changes to its core components or activities. LIMITATIONS, REASONS FOR CAUTION: All patients were women recruited from social media websites, mainly associated with patient support groups, who may be highly committed to their fertility treatment. HCPs were predominantly from private fertility clinics. WIDER IMPLICATIONS OF THE FINDINGS: The findings suggest there is demand for digital support geared towards motivational aspects of undergoing ART. The TPCI is an acceptable support tool to meet that need according to HCPs responsible for delivering planning consultations and patients undergoing fertility treatment. Future research is needed to develop the prototype and examine the feasibility of implementation of the TPCI in clinics. STUDY FUNDING/COMPETING INTEREST(S): This research was financially supported by Merck Serono Ltd, an affiliate of Merck KGaA, Darmstadt, Germany. 'Merck KGaA, Darmstadt, Germany reviewed the manuscript for medical accuracy only before journal submission. The authors are fully responsible for the content of this manuscript, and the views and opinions described in the publication reflect solely those of the authors' J.B. reports personal fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, Organon JJC, Ferring Pharmaceuticals A/S, research grant from Merck Serono Ltd, grants from ESHRE outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app. S.G. reports consultancy fees from TMRW Life Sciences and Ferring Pharmaceuticals A/S, speaker fees from Access Fertility, SONA-Pharm LLC, Meridiano Congress International and Gedeon Richter. C.H. declares no conflicts of interest. TRIAL REGISTRATION NUMBER: N/A.

Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome†.

STUDY QUESTION: What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? SUMMARY ANSWER: International evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. WHAT IS KNOWN ALREADY: The 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from six continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low to low quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, evidence quality was low and evidence-practice gaps persist. STUDY DESIGN, SIZE, DURATION: The 2023 International Evidence-based Guideline update reengaged the 2018 network across professional societies and consumer organizations, with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation-II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength and diversity and inclusion were considered throughout. PARTICIPANTS/MATERIALS, SETTING, METHODS: This summary should be read in conjunction with the full Guideline for detailed participants and methods. Governance included a six-continent international advisory and management committee, five guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health and other experts, alongside consumers, project management, evidence synthesis, statisticians and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and five face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across five guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council (NHMRC). MAIN RESULTS AND THE ROLE OF CHANCE: The evidence in the assessment and management of PCOS has generally improved in the past five years, but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpins 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include: i) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm and inclusion of anti-Müllerian hormone (AMH) levels as an alternative to ultrasound in adults only; ii) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; iii) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care and shared decision making to improve patient experience, alongside greater research; iv) maintained emphasis on healthy lifestyle, emotional wellbeing and quality of life, with awareness and consideration of weight stigma; and v) emphasizing evidence-based medical therapy and cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION: Overall, recommendations are strengthened and evidence is improved, but remains generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. WIDER IMPLICATIONS OF THE FINDINGS: The 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the Guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S): This effort was primarily funded by the Australian Government via the National Health Medical Research Council (NHMRC) (APP1171592), supported by a partnership with American Society for Reproductive Medicine, Endocrine Society, European Society for Human Reproduction and Embryology, and European Society for Endocrinology. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). HJT and AM are funded by NHMRC fellowships. JT is funded by a Royal Australasian College of Physicians (RACP) fellowship. Guideline development group members were volunteers. Travel expenses were covered by the partnering organizations. Disclosures of interest were strictly managed according to NHMRC policy and are available with the full guideline, technical evidence report, peer review and responses (www.monash.edu/medicine/mchri/pcos). Of named authors HJT, CTT, AD, LM, LR, JBoyle, AM have no conflicts of interest to declare. JL declares grant from Ferring and Merck; consulting fees from Ferring and Titus Health Care; speaker's fees from Ferring; unpaid consultancy for Ferring, Roche Diagnostics and Ansh Labs; and sits on advisory boards for Ferring, Roche Diagnostics, Ansh Labs, and Gedeon Richter. TP declares a grant from Roche; consulting fees from Gedeon Richter and Organon; speaker's fees from Gedeon Richter and Exeltis; travel support from Gedeon Richter and Exeltis; unpaid consultancy for Roche Diagnostics; and sits on advisory boards for Roche Diagnostics. MC declares travels support from Merck; and sits on an advisory board for Merck. JBoivin declares grants from Merck Serono Ltd.; consulting fees from Ferring B.V; speaker's fees from Ferring Arzneimittell GmbH; travel support from Organon; and sits on an advisory board for the Office of Health Economics. RJN has received speaker's fees from Merck and sits on an advisory board for Ferring. AJoham has received speaker's fees from Novo Nordisk and Boehringer Ingelheim. The guideline was peer reviewed by special interest groups across our 39 partner and collaborating organizations, was independently methodologically assessed against AGREEII criteria and was approved by all members of the guideline development groups and by the NHMRC.

Complementary and Integrative Medicine in Pancreatic Cancer.

PURPOSE OF REVIEW: Pancreatic cancer has high mortality and morbidity rates, associated with the issues of typically late diagnosis and the limited effectiveness of current treatments. Patients tend to experience multiple symptoms that can include anxiety, fear, depression, fatigue, weakness, peripheral neuropathy, and abdominal pain, which reduce quality of life (QoL) and may compromise the treatment continuum. Many of those symptoms are amenable to complementary and integrative medicine (CIM) therapies as a part of supportive and palliative care. This article reviews research findings on the beneficial effect of use of CIM modalities in regard to pancreatic cancer, with emphasis on pancreatic ductal adenocarcinoma (PDAC). RECENT FINDINGS: Given the often-poor prognosis of the disease, patients with PDAC often seek integrative therapies to help manage the disease itself, to provide support through cancer treatment and its symptoms, and to provide emotional stress relief. Data is accumulating in the past few years on the potential benefits of CIM to the management of pancreatic cancer symptoms and treatment side effects, in order to augment supportive care. This data reveal that nutrition counselling; digestive enzyme therapy; microbiome support; dietary supplements; lifestyle interventions (physical activity and circadian health/sleep hygiene) appear to improve QoL of these patients through reduced symptom burden and meeting psychological needs, such as distress and fatigue. Acupuncture, mindfulness, yoga, reflexology, massage, and homeopathy may also contribute to symptom reduction, both physical and psychological, in all stages of the disease. There is supporting evidence that some CIM modalities may alleviate side effects and symptoms related to pancreatic cancer and its treatment, suggesting that practitioners might consider integrating these modalities in certain situations encountered in the treatment of pancreatic cancer. Further investigation is needed to define the optimal integration of CIM into the treatment and supportive care of patients affected by pancreatic cancer.

Schizophrenia and Homoeopathy: A Review.

Context: Schizophrenia is a mental condition that is affecting approx. 1.0 percent of the worldwide population, with devastating consequences for affected individuals and their families. Homoeopathy could be an effective alternative mode of treatment and can minimize the consequences of it. Objective: This study is done to have a brief review of the condition of Schizophrenia and to evaluate the role of Homoeopathy as an alternative mode of treatment in patients suffering from this condition. Design: The research team performed a narrative review by searching Pubmed, IJRH, ISOR-JDMS, WHO, and Medscape databases. Reference books related to medicine and homoeopathy were also reviewed. The search used the keywords like Schizophrenia, Homoeopathy, psychiatry, hallucinations, paranoia, ICD-10, DSM-5, etc. Setting: This study is conducted at Faculty of Homoeopathic Sciences in Jayoti Vidyapeeth Women's University. Results: Schizophrenia alters the thinking, feeling and behavior of affected person and is presented in form of delusion, hallucination with social withdrawal. Homoeopathy can be an alternative mode of treatment to not only help in improving this condition but also treat the same. There are not much studies that has been conducted to evaluate the role of Homoeopathy in schizophrenia. Out of few, one study has suggested improvement in the symptoms of paranoid schizophrenia using Brief Psychiatric Rating Scale (BPRS) score system. Conclusions: Schizophrenia is a psychiatric condition not only affecting routine of daily of life but also the Quality of life. Homoeopathy is a non-toxic, gentle, permanent treatment which is based on totality of symptoms (TOS) and individualization. In the process of construction of TOS and individualization, more importance is given to mental symptoms. As again pschizophrenia is a psychiatric condition which affects the mental process of patient, Homoeopathy can be used as an effective method of treatment but to establish the efficacy of it, more studies including randomized controlled trials are suggested.

A Case Report of Alopecia Areata Treated With Individualized Homoeopathy.

Introduction: Hair is regarded as an essential part of human identity, and losing it has a negative effect on many facets of one's quality of life. Alopecia areata (AA) is a chronic, non-scarring hair loss of the scalp or body hair. It is believed to be an autoimmune disorder where the body cannot recognize its own cells, resulting in the subsequent destruction of the hair follicles. The efficacy of the available treatment is not adequate and remission of hair follicles is unpredictable. However, individualized homoeopathy (iHOM) has shown great results in treating AA. Methods: At the Dermatological Department of D.Y. Patil Homoeopathic Medical College & Research Center, India, an 11-year-old female patient diagnosed with Alopecia areata was treated homeopathically from July 2021 to November 2021. During the follow-up visits, the outcome was assessed. To assess whether the changes were due to homoeopathic medicine, an assessment using the modified Naranjo criteria was performed. Results: Over an observation period of 5 months, beneficial result from iHOM medicine was seen, and so can be used by physicians in treating Alopecia Areata as a complementary health practice. Conclusion: Considering the multi-factorial etiology of Alopecia Areata, iHOM medicine and the auxillary line of treatment are effective in treating Alopecia Areata.

Efficacy of Constitutional Prescription in Homoeopathic Management of Psoriasis: Case Report.

Psoriasis is a chronic inflammatory disease which has multisystem involvement, predominantly skin and joints. It affects quality of life and leads to psychological distress in patients leading to poor self-esteem and depression, ultimately affecting interpersonal relationships. Homoeopathy believes in a holistic approach and, when prescribed on a constitutional basis, helps to cure the condition from its root cause. A diagnosed case of psoriasis in a 23-year-old male came into the Homoeopathic OPD with complaints of psoriatic patches on the face and scalp. Routine investigations were done to rule out other disorders. In this case, Sulphur was prescribed on a constitutional basis and proved to be beneficial. Considering the extent of psoriasis in this patient, the Homoeopathic approach relieved the case in a short period of time with prolonged treatment response, suggesting that this may represent the ideal cure in Homoeopathy.

Molecular and Epigenetic Aspects of Opioid Receptors in Drug Addiction and Pain Management in Sport.

Opioids are substances derived from opium (natural opioids). In its raw state, opium is a gummy latex extracted from Papaver somniferum. The use of opioids and their negative health consequences among people who use drugs have been studied. Today, opioids are still the most commonly used and effective analgesic treatments for severe pain, but their use and abuse causes detrimental side effects for health, including addiction, thus impacting the user's quality of life and causing overdose. The mesocorticolimbic dopaminergic circuitry represents the brain circuit mediating both natural rewards and the rewarding aspects of nearly all drugs of abuse, including opioids. Hence, understanding how opioids affect the function of dopaminergic circuitry may be useful for better knowledge of the process and to develop effective therapeutic strategies in addiction. The aim of this review was to summarize the main features of opioids and opioid receptors and focus on the molecular and upcoming epigenetic mechanisms leading to opioid addiction. Since synthetic opioids can be effective for pain management, their ability to induce addiction in athletes, with the risk of incurring doping, is also discussed.

Menopause: Questions and Answers for Improving Homeopathic Clinical Practice.

BACKGROUND: Medical attention for menopausal women is frequently delivered by health care providers (general practitioners, gynecologists or homeopathic physicians) who are not specialized in post-reproductive care. Homeopathy has been used for treating menopausal complaints for more than two centuries. Therefore, it is important to improve clinical knowledge in this field among homeopathic physicians. Nowadays, there is a special interest in the study of menopause-related chronic conditions due to the impact on women's quality of life. The aim of this review is to address the important key points of the menopause, clinical assessment, and available tests for evaluating menopausal women, as well as some general topics regarding homeopathic clinical practice for menopause. METHODS AND RESULTS: A literature search regarding menopause and current guidelines and recommendations was performed. To be practical and concise, the information is presented in the form of questions and answers. Currently, there is an international classification of woman's reproductive aging that can be useful for clinical and research purposes in homeopathy. A comprehensive homeopathic approach is mandatory for evaluating women with a healthy menopause, but also for those experiencing co-morbidities. In an integrative health care system, several assessment resources can be incorporated into the homeopathic consultations. Clinical and laboratory examinations for detecting metabolic disorders (dyslipidemia, insulin resistance, diabetes and hypertension, among others), mood disorders, cognitive impairment and osteoporosis are available in many clinical settings. Screening for gynecological cancers is an international recommendation at this stage. All data obtained from homeopathic consultations would help to integrate well-documented case reports. This would give the possibility to generate hypotheses to design high-quality clinical research. CONCLUSION: Improving homeopathic clinical practice for menopause is useful for both clinical and research purposes. The international recommendations for evaluating menopausal women should be incorporated in homeopathic clinical practice, mainly in clinical settings where homeopathy is integrated in outpatient services.

Homeopathic Products as a Complementary Dietary Additive for Pigs in their Growing and Finishing Phases.

BACKGROUND: Homeopathic products (HP) have been proposed for the prevention of disease and as a complementary dietary additive in pig farming, with resulting improved performance and quality of life of the animals and with benefits for food safety. The aim of this study was to assess the addition of HP to pig feed and its effects on growth performance, dietary protein utilization, nutrient digestibility, meat quality, and economic feasibility. METHODS: A total of 80 male pigs, body weight 32.8±2.3kg, were allocated in a randomized design, with two treatments of 10 replications and four animals per experimental unit. Treatments were composed of a control diet (CD) or CD+HP (Finalvitaplus+Figotonus, 1.1kg/ton feed of each product). The outcome measures used were growth performance (body weight gain) and feed efficiency (body weight gain per unit of feed consumed), efficiency of dietary protein utilization (blood urea nitrogen), nutrient digestibility (apparent digestibility coefficient and apparent nutrient digestibility), meat quality (including pH, temperature, color, liquid loss by cooking and thawing, intramuscular fat and meat tenderness), and economic feasibility (cost of the diets). RESULTS: There was no effect (p >0.05) of treatments on growth performance of the pigs, though the group that received HP showed an 8.93% greater feed efficiency than the control group (p=0.077). The animals in the control group had a 14.37% higher blood urea nitrogen concentration in the finishing I phase (70-100kg body weight) compared with those fed HP (p=0.028), indicating lower protein utilization in the controls. There was comparative improvement in digestibility coefficient and in nutrient digestibility in pigs fed HP in the growing-finishing phase (p <0.05). There was no differential effect of treatments on meat quality or economic feasibility (p >0.05). CONCLUSION: The addition of HP to the diet of growing-finishing pigs produced some improvement in their dietary protein utilization, nutrient digestibility and feed efficiency, though it did not affect their growth performance, meat quality or economic feasibility.

Double-Blind, Randomized, Placebo-Controlled Trial of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults: A Replication Trial with 6 Months' Follow-up.

BACKGROUND: Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD. METHODS: In this double-blind, randomized, placebo-controlled trial of 6 months' duration (n = 60), adult patients were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) - all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample. RESULTS: After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (-18.1; 95% confidence interval, -24.0 to -12.2), favoring IHMs against placebos (F 1, 52 = 14.735; p <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: F 1, 52 = 0.019; p = 0.891; DLQI: F 1, 52 = 0.692; p = 0.409). CONCLUSION: IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.

A Case of Recurrent Urinary Tract Infection Successfully Treated during Homeopathic Supportive Care in Oncology.

INTRODUCTION: A 32-year-old patient with colon cancer consulted for homeopathic supportive care (HSC). She had also suffered from recurrent urinary tract infections (RUTIs) for 20 years. Could homeopathy treat these two very different issues with the same medicine? THE PATIENT'S MAIN CONCERNS: Though the main reason for the consultation was a fear of the side effects of chemotherapy, the presence of Escherichia coli-induced RUTIs affected the patient's quality of life. INTERVENTIONS AND OUTCOMES: The repertory listing highlighted Pulsatilla as the patient's homeopathic constitutional medicine. It was prescribed both for HSC and also for RUTI. In association with Arsenicum album and Nerves, Pulsatilla enabled a good tolerance to chemotherapy, with rapid recovery from peripheral neuropathies. In combination with Colibacillinum, Pulsatilla provided relapse-free curing of the RUTIs. The MOdified NARanjo Criteria for Homeopathy (MONARCH) Inventory score was +9. CONCLUSION: The one individual's two different clinical complaints were treated with a constitutional homeopathic medicine, Pulsatilla, which covered the whole case. However, in HSC, the use of the constitutional remedy alone is rarely sufficient: it was reinforced by individualised symptomatic medication, organotherapy and isotherapy. For RUTI, isopathic and tubercular miasmatic treatments were each helpful. For both complaints, individualised homeopathy gave rapid, long-lasting and effective results.

Individualized Homeopathic Medicines in Treatment of Hyperuricemia: Evaluation by Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Hyperuricemia (HU) is a major health issue in India and across the globe. It increases the disease burden and hampers quality of life. This study was aimed at exploring the effects of individualized homeopathic medicines (IHMs) against placebo in the treatment of HU. METHODS: This double-blind, randomized, placebo-controlled trial was conducted on 60 patients suffering from HU in the outpatient department of D. N. De Homoeopathic Medical College and Hospital, Kolkata. Each patient received either IHMs or identical-looking placebos, along with advice on dietary modifications irrespective of codes. Serum uric acid (SUA) level was the primary outcome measure; the HU quality of life questionnaire (HUQLQ) and the Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) were the secondary outcomes; all measured at baseline, and every month, up to 3 months. Group differences were examined by two-way (split-half) repeated-measures analysis of variance after adjusting for baseline differences. Significance level was set at p ≤0.05, two-tailed. RESULTS: The intention-to-treat sample (n = 58) was analyzed. Between-group differences in SUA levels (F 1, 56 = 13.833, p <0.001), HUQLQ scores (F 1, 56 = 32.982, p <0.001) and MYMOP-2 profile scores (F 1, 56 = 23.873, p <0.001) were statistically significant, favoring IHMs against placebos, with medium to large effect sizes. Calcarea carbonica and Pulsatilla nigricans were the most frequently prescribed medicines. No serious adverse events were reported from either of the groups. CONCLUSION: IHMs showed significantly better results than placebos in reducing SUA levels and improving quality of life in patients suffering from HU. TRIAL REGISTRATION: CTRI/2019/10/021503; UTN: U1111-1241-1431.

Individualized Homeopathic Medicines as Adjunctive Treatment of Pediatric Epilepsy: A Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Epilepsy, one of the most common neurological diseases, contributes to 0.5% of the total disease burden. The burden is highest in sub-Saharan Africa, central Asia, central and Andean Latin America, and south-east Asia. Asian countries report an overall prevalence of 6/1,000 and that in India of 5.59/1,000. We examined whether individualized homeopathic medicines (IHMs) can produce a significantly different effect from placebos in treatment of pediatric epilepsy in the context of ongoing standard care (SC) using anti-epileptic drugs (AEDs). METHODS: The study was a 6-month, double-blind, randomized, placebo-controlled trial (n = 60) conducted at the pediatric outpatient department of a homeopathic hospital in West Bengal, India. Patients were randomized to receive either IHMs plus SC (n = 30) or identical-looking placebos plus SC (n = 30). The primary outcome measure was the Hague Seizure Severity Scale (HASS); secondary outcomes were the Quality of Life in Childhood Epilepsy (QOLCE-16) and the Pediatric Quality of Life inventory (PedsQL) questionnaires; all were measured at baseline and after the 3rd and 6th month of intervention. The intention-to-treat sample was analyzed to detect group differences and effect sizes. RESULTS: Recruitment and retention rates were 65.2% and 91.7% respectively. Although improvements were greater in the IHMs group than with placebos, with small to medium effect sizes, the inter-group differences were statistically non-significant - for HASS (F 1, 58 = 0.000, p = 1.000, two-way repeated measures analysis of variance), QOLCE-16 (F 1, 58 = 1.428, p = 0.237), PedsQL (2-4 years) (F 1, 8 = 0.685, p = 0.432) and PedsQL (5-18 years) (F 1, 47 = 0.000, p = 0.995). Calcarea carbonica, Ignatia amara, Natrum muriaticum and Phosphorus were the most frequently prescribed medicines. No serious adverse events were reported from either of the two groups. CONCLUSION: Improvements in the outcome measures were statistically non-significantly greater in the IHMs group than in the placebos group, with small effect sizes. A different trial design and prescribing approach might work better in future trials. TRIAL REGISTRATION: CTRI/2018/10/016027.

Uptake of Recommendations for Posttreatment Cancer-Related Fatigue Among Breast Cancer Survivors.

BACKGROUND: Physical activity (PA) and psychosocial interventions are recommended management strategies for cancer-related fatigue (CRF). Randomized trials support the use of mind-body techniques, whereas no data show benefit for homeopathy or naturopathy. METHODS: We used data from CANTO (ClinicalTrials.gov identifier: NCT01993498), a multicenter, prospective study of stage I-III breast cancer (BC). CRF, evaluated after primary treatment completion using the EORTC QLQ-C30 (global CRF) and QLQ-FA12 (physical, emotional, and cognitive dimensions), served as the independent variable (severe [score of ≥40/100] vs nonsevere). Outcomes of interest were adherence to PA recommendations (≥10 metabolic equivalent of task [MET] h/week [GPAQ-16]) and participation in consultations with a psychologist, psychiatrist, acupuncturist, or other complementary and alternative medicine (CAM) practitioner (homeopath and/or naturopath) after CRF assessment. Multivariable logistic regression examined associations between CRF and outcomes, adjusting for sociodemographic, psychologic, tumor, and treatment characteristics. RESULTS: Among 7,902 women diagnosed from 2012 through 2017, 36.4% reported severe global CRF, and 35.8%, 22.6%, and 14.1% reported severe physical, emotional, and cognitive CRF, respectively. Patients reporting severe global CRF were less likely to adhere to PA recommendations (60.4% vs 66.7%; adjusted odds ratio [aOR], 0.82; 95% CI, 0.71-0.94; P=.004), and slightly more likely to see a psychologist (13.8% vs 7.5%; aOR, 1.29; 95% CI, 1.05-1.58; P=.014), psychiatrist (10.4% vs 5.0%; aOR, 1.39; 95% CI, 1.10-1.76; P=.0064), acupuncturist (9.8% vs 6.5%; aOR, 1.46; 95% CI, 1.17-1.82; P=.0008), or CAM practitioner (12.5% vs 8.2%; aOR, 1.49; 95% CI, 1.23-1.82; P<.0001). There were differences in recommendation uptake by CRF dimension, including that severe physical CRF was associated with lower adherence to PA (aOR, 0.74; 95% CI, 0.63-0.86; P=.0001) and severe emotional CRF was associated with higher likelihood of psychologic consultations (aOR, 1.37; 95% CI, 1.06-1.79; P=.017). CONCLUSIONS: Uptake of recommendations to improve CRF, including adequate PA and use of psychosocial services, seemed suboptimal among patients with early-stage BC, whereas there was a nonnegligible interest in homeopathy and naturopathy. Findings of this large study indicate the need to implement recommendations for managing CRF in clinical practice.

Menopause is more than Hot Flashes: What is Missing in Homeopathic Research? A Narrative Review.

BACKGROUND: Menopausal complaints are frequently treated with homeopathy in daily practice worldwide. Recently, vasomotor symptoms have been understood to have implications as predictors of other important and long-term outcomes, causing increased risk of mortality and/or disability. METHODS: A comprehensive search of the literature was conducted to investigate whether homeopathic treatments for menopausal women with vasomotor symptoms have a positive effect on other important health outcomes associated with menopause, such as cardiovascular disease, neurocognitive impairment, metabolic and mood disorders, or osteoporosis. RESULTS: Though observational studies have shown encouraging results in reducing the severity and frequency of hot flashes in women treated with homeopathy, few randomized controlled trials have shown positive results. In most of the studies using homeopathy, the primary outcome is reduction in the frequency and severity of hot flashes, and other menopausal complaints are assessed secondarily as a part of the symptoms evaluated in the menopausal scales. Quality of life improves with homeopathic treatments for hot flashes, but there is scarce evidence of the effect of homeopathy on other health outcomes associated with menopause. Limited evidence exists in the case of menopausal women treated with individualized homeopathy for depression and metabolic disorders. CONCLUSION: A more comprehensive approach for treating menopause in routine homeopathic practice constitutes a valuable opportunity to increase knowledge and high-quality research in this field. Future homeopathic research for menopause should be focused on well-designed, double-blind, placebo-controlled, randomized trials as well as on pragmatic trials to show whether homeopathic treatments for vasomotor symptoms can also improve outcomes that are well-known to increase the risk of mortality and/or disability.

Efficacy of Individualized Homeopathic Medicines in Treatment of Acne Vulgaris: A Double-Blind, Randomized, Placebo-Controlled Trial.

BACKGROUND: Acne is estimated to affect 9.4% of the global population, making it the 8th most prevalent disease worldwide. Acne vulgaris (AV) is among the diseases that directly affect quality of life. This trial evaluated the efficacy of individualized homeopathic medicines (IHM) against placebo in AV. METHODS: In this double-blind, randomized, placebo-controlled trial conducted at the National Institute of Homoeopathy, India, 126 patients suffering from AV were randomized in a 1:1 ratio to receive either IHM (verum) in centesimal potencies or identical-looking placebo (control). The primary outcome measure was the Global Acne Grading System score; secondary outcomes were the Cardiff Acne Disability Index and Dermatology Life Quality Index questionnaires - all measured at baseline and 3 months after the intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. RESULTS: Overall, improvements were greater in the IHM group than placebo, with small to medium effect sizes after 3 months of intervention; however, the inter-group differences were statistically non-significant. Sulphur (17.5%), Natrum muriaticum (15.1%), Calcarea phosphorica (14.3%), Pulsatilla nigricans (10.3%), and Antimonium crudum (7.1%) were the most frequently prescribed medicines; Pulsatilla nigricans, Tuberculinum bovinum and Natrum muriaticum were the most effective of those used. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. CONCLUSION: There was non-significant direction of effect favoring homeopathy against placebo in the treatment of AV. TRIAL REGISTRATION: CTRI/2018/11/016248; UTN: U1111-1221-8164.