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.

Epidemiology of substance and opium use among adult residents of Tehran; a comprehensive report from Tehran cohort study (TeCS).

BACKGROUND: The prevalence and burden of substance and opium use have increased worldwide over the past decades. In light of rapid population changes in Tehran, we aimed to evaluate the prevalence of opium and other substance use among adult residents in Tehran, Iran. METHOD: From March 2016 to March 2019, we utilized data from 8 296 participants in the Tehran Cohort Study recruitment phase (TeCS). We calculated the age-sex-weighted prevalence of substance use and the geographic distribution of substance use in Tehran. We also used logistic regression analysis to determine possible determinants of opium use. RESULT: We analyzed data from 8 259 eligible participants with complete substance use data and the average age of participants was 53.7 ± 12.75 years. The prevalence of substance use was 5.6% (95% confidence interval [CI]: 4.6- 7.1%). Substance use was more common in males than females (Prevalence: 10.5% [95% CI: 8.6- 12.6%] vs. 0.5% [95% CI: 0.2- 1.2%], respectively). The age-sex weighted prevalence of substance use was 5.4% (95% CI: 4.6-7.1%). Moreover, opium was the most frequently used substance by 95.8% of substance users. Additionally, we found that male gender (Odds ratio [OR]: 12.1, P < 0.001), alcohol intake (OR: 1.3, P = 0.016), and smoking (OR: 8.5, P < 0.001) were independently associated with opium use. CONCLUSIONS: We found that the prevalence of substance use in Tehran was 5.6%, and opium was the most frequently used substance. In addition, male gender, lower levels of education, alcohol, and tobacco consumption are the main risk factors for substance use in Tehran. Healthcare providers and policymakers can utilize our results to implement preventive strategies to minimize substance use in Tehran.

Association Between Incident Type 2 Diabetes and Opium Use: Mediation by Body Mass and Adiposity.

Opiates can affect glucose metabolism and obesity, but no large prospective study (to our knowledge) has investigated the association between long-term opium use, body mass index (BMI; weight (kg)/height (m)2), and incident type 2 diabetes mellitus (T2DM). We analyzed prospective data from 50,045 Golestan Cohort Study participants in Iran (enrollment: 2004-2008). After excluding participants with preexisting diseases, including diabetes, we used adjusted Poisson regression models to estimate incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for T2DM in opium users compared with nonusers, using mediation analysis to assess the BMI-mediated association of opium use with incident T2DM. Of 40,083 included participants (mean age = 51.4 (standard deviation, 8.8) years; 56% female), 16% were opium users (median duration of use, 10 (interquartile range), 4-20) years). During follow-up (until January 2020), 5,342 incident T2DM cases were recorded, including 8.5% of opium users and 14.2% of nonusers. Opium use was associated with an overall decrease in incident T2DM (IRR = 0.83, 95% CI: 0.75, 0.92), with a significant dose-response association. Most (84.3%) of this association was mediated by low BMI or waist circumference, and opium use did not have a direct association with incident T2DM (IRR = 0.97, 95% CI: 0.87, 1.08). Long-term opium use was associated with lower incidence of T2DM, which was mediated by low body mass and adiposity.

Use of integrative and complementary health practices by Brazilian population: results from the 2019 National Health Survey.

BACKGROUND: In 2006, Brazil implemented the National Policy on Integrative and Complementary Practices of the SUS. and in 2015, the Brazilian Ministry of Health issued a reinforcement to this policy to increase access to integrative and complementary health practices (ICHP). In this study, we described the prevalence of ICHP in Brazilian adults according to their sociodemographic characteristics, self-perceived health, and chronic diseases. METHODS: This is a nationally representative cross-sectional survey including 64,194 participants from the 2019 Brazilian National Health Survey. Types of ICHP were categorized according to their purposes: health promotion (Tai chi/Lian gong/Qi gong, yoga, meditation, and integrative community therapy) or therapeutic practices (acupuncture, auricular acupressure, herbal treatment and phytotherapy, and homeopathy). Participants were classified as non-practitioners and practitioners, who in turn were grouped according to use of ICHP in the last 12 months: only used health promotion practices (HPP); only used therapeutic practices (TP); used both (HPTP). Multinomial logistic regressions were performed to estimate the associations of ICHP with sociodemographic characteristics, self-perceived health status, and chronic diseases. RESULTS: Brazilian adults showed an ICHP use prevalence of 6.13% [95%CI = 5.75-6.54]. Compared to non-practitioners, women and middle-aged adults were more likely to use any ICHP. Afro-Brazilians were less likely to use both HPP and HPTP, whereas Indigenous people were more likely to use both HPP and TP. We found a positive gradient of association among participants with higher income and educational attainment and access to any ICHP. People from rural areas and those with negative self-perceived health were more likely to use TP. Participants with arthritis/rheumatism, chronic back problems, and depression were more likely to use any ICHP. CONCLUSIONS: We found that 6% of Brazilian adults reported using ICHP in the previous 12 months. Women, middle-aged individuals, chronic patients, people with depression, and wealthier Brazilians are more likely to use any type of ICHP. Of note, rather than suggesting to expand the offer of these practices in the Brazilian public health system, this study diagnosed Brazilians' behavior of seeking for complementary healthcare.

Evaluation of the prevalence of asthma and chronic obstructive pulmonary disease among opium users, and cigarette smokers and comparison with normal population in Kharameh: a cross-sectional study.

BACKGROUND: Recent studies have suggested that opium use may increase mortality from pulmonary diseases. However, there are limited comprehensive studies regarding the prevalence of Asthma and Chronic Obstructive Pulmonary Disease (COPD) among tobacco and opium users has been published. We aimed to determine the prevalence of respiratory disease among tobacco and opium users. METHODS: This cross-sectional study of tobacco and opium users and matched controls was conducted in the Kharameh Cohort, Fars, Iran. The prevalence of COPD and asthma, along with the participants demographical and spirometry data were examined. RESULTS: The average age of participants was 57 ± 8 years. Never smokers had a significant higher BMI (26.6 vs. 24.8), FEV1 (91% vs. 82%) and FVC (96% vs. 88%) values compared to participants with a positive smoking status. There was a statistical difference in the prevalence of COPD, asthma, and asthma COPD overlap (ACO) based on the participants smoking status, with the highest prevalence among opium and cigarette smokers, followed by opium users alone. Based on multivariate analysis, higher age, lower BMI, lower education than under diploma, cigarette smoking and opium use were significantly correlated with higher COPD prevalence; while lower age, cigarette smoking and opium use were significantly correlated with higher asthma prevalence. Illiterate participants had a significantly higher prevalence of COPD (23.6%), asthma (22%), and ACO (7.9%) among the educational groups. Regarding the prevalence of asthma, the higher socio-economic group had the lowest prevalence. CONCLUSIONS: Opium and tobacco users had a significantly higher prevalence of respiratory diseases, along with lower lung function tests based on spirometry evaluation.

Oral candidiasis and cigarette, tobacco, alcohol, and opium consumption in Rafsanjan, a region in the southeast of Iran.

BACKGROUND: We investigated the association between oral candidiasis prevalence and cigarette, tobacco, alcohol, and opium consumption in Rafsanjan, a region in the southeast of Iran. METHODS: This cross-sectional study was conducted using the data of Oral Health Branch of Rafsanjan Cohort Study (OHBRCS) as a part of the Rafsanjan Cohort Study (RCS). RCS included in Prospective Epidemiological Research Studies in IrAN (PERSIAN) was begun in 2015 in the Rafsanjan. A full-mouth examination was done by trained dental specialists. Oral candidiasis was diagnosed based on clinical examination. Information about cigarette, tobacco, and opium smoking and alcohol consumption were collected based on data from self-reported questionaries. Univariate and multivariate dichotomous logistics regression were used to assess the association between oral candidiasis and cigarette, tobacco, alcohol, and opium consumption. RESULTS: Among 8682 participants with mean age of 49.94 years, the prevalence of oral candidiasis was 7.94%. There was a direct association between cigarette smoking in current and former cigarette smokers with an increased odds of oral candidiasis (OR: 3.26, 95% CI: 2.46-4.33 and OR: 1.63, 95% CI: 1.18-2.25 respectively) in fully adjusted models. There was a dose-response relationship between the odds of oral candidiasis and dose (OR: 3.31, 95% CI: 2.38-4.60), duration (OR: 2.48, 95% CI: 2.04-3.95) and number (OR: 3.01, 95% CI: 2.02-4.50) of cigarette smoking in the 4th quartile compared to reference group. CONCLUSIONS: A dose-response relationship was shown between cigarette smoking and increased odds of oral candidiasis.

Acute angle closure glaucoma precipitated by homeopathic eyedrops containing Atropa belladonna.

Acute angle closure glaucoma is a sight-threatening condition that may lead to blindness. This is a case report of a woman who presented to the emergency department (ED) with acute angle closure glaucoma following use of an over-the-counter (OTC) homeopathic eye drop containing atropa belladonna (deadly nightshade). A 55-year-old woman presented to the ED with a 5-day history of left eye redness, swelling, tearing, and foreign-body sensation that had acutely worsened in the last two days. Her exam revealed mild left conjunctival injection with watery tearing and a hazy appearance of her left cornea. Fluorescein staining was negative, while tonometry revealed elevated intraocular pressure on the left, suggestive of acute angle closure glaucoma. She was urgently referred to ophthalmology. The etiology of the acute angle closure glaucoma was initially unclear however, with additional prompting, she revealed that two days prior she had started using homeopathic OTC eye drops. Inspection of the eyedrop's ingredients revealed that atropa belladonna was the primary ingredient and likely precipitated her isolated episode of acute angle closure glaucoma. A high level of clinical suspicion and focused ophthalmic exam including tonometry is essential to identify acute angle closure glaucoma in the ED. We present a case report of acute angle closure glaucoma associated with the use of homeopathic belladonna-containing eyedrops. Our report reinforces the necessity to perform thorough medication and supplement history given the prevalence of physiologically active substances available in OTC medications.

Comparative Evaluation of Homeopathic Therapy in the Treatment of Chronic Periodontitis.

CONTEXT AND OBJECTIVE: Periodontitis and type 2 diabetes (T2D) are chronic diseases generally treated with conventional therapies alone. The aim of this study was to compare the effects of homeopathy as an adjunct to conventional periodontal therapy in individuals with periodontitis and T2D. DESIGN: 85 individuals, age between 35 and 70 years, of both genders, participated in this randomized study; 70 patients were from the Institute of Endocrinology and Diabetes of Rio de Janeiro, Brazil. They were divided into 2 groups: G1, individuals with periodontitis without systemic conditions; and G-2, individuals with periodontitis and T2D. Both groups received homeopathic treatment and were evaluated in clinical and laboratory examinations. The medication used was chosen based on the similarity principle: Berberis 6CH, Mercurius Solubilis/Belladona /Hepar Sulfur and a Pyrogenium 200CH biotherapic. Medications were prescribed in diluted low ultra-diluted concentration doses for all signs and symptoms, while biotherapics were used for chronic stimulation. SETTING: The study was performed in Brazil by university research professors of homeopathy and periodontics. RESULTS: Both groups showed significant clinical and laboratory improvements during the study from baseline to 1 year with reductions in total cholesterol (total-C), triglycerides, glucose, glycated hemoglobin (A1cHb), uric acid and C-reactive protein (CRP). Statistical and descriptive analyses were performed. For most parameters, G1 performed better than G2 (P < .05). CONCLUSION: Homeopathy as an adjunct to periodontal treatment improves local and systemic clinics and can provide better health conditions for patients with or without T2D.

A comprehensive approach to complementary and alternative medicine usage among patients from a vascular department.

INTRODUCTION: Use of complementary and alternative medicine (CAM) therapies had been described in patients with disabling, chronic and painful conditions; these characteristics define the majority of vascular surgery (VS) entities. A lack of disclosure about CAM use from patients has been universally cited and may impact effective patient-doctor communication. Our primary objective was to describe CAM use, modalities, perceived benefits, safety, and associated factors among adult patients attending a VS outpatient clinic; we additionally explored patient's attitudes about CAM disclosure with their primary vascular surgeon. METHODS: This cross-sectional study invited 223 consecutive outpatients to an interview where the ICAM-Q (International Complementary and Alternative Medicine Questionnaire) and the PDRQ-9 (Patient-Doctor Relationship Questionnaire-9 items) were applied. In addition, sociodemographics, vascular disease and treatment-related information, comorbidity, and disease severity characteristics were obtained. Appropriated statistics was used; multiple logistic regression analysis identified factors associated to CAM use. All statistical tests were two-sided, and a p value ≤ 0.05 was considered significant. IRB approval was obtained. RESULTS: Patients recruited were primary females (69%) and had a median age of 65 years (54-75). Most frequent vascular diagnoses were chronic venous insufficiency (36.2%) and peripheral artery disease (26%). There were 104 (46.6%) patients who referred CAM use, primarily self-helped practices (96%), and use of herbal, vitamins, or homeopathic medicines (23.7%). Overall, the majority of the patients perceived CAM modalities helpful and 94.6% denied any adverse event. Female sex (OR: 1.768, 95% CI: 0.997-3.135, p = 0.051) and hospitalization during the previous year (OR: 3.173, 95% CI: 1.492-6.748, p = 0.003) were associated to CAM use. The majority of the patients (77%) agreed about CAM disclosure with their primary vascular surgeon; meanwhile, among CAM users, up to 54.9% did not disclose it, and their main reasons were "Doctor didn't ask" (32%) and "I consider it unnecessary" (16%). The patient-doctor relationship was rated by the patients with high scores. CONCLUSIONS: CAM use is frequent and perceived as safe and beneficial among VS outpatients; nonetheless, patients do not disclose CAM use with their primary vascular surgeons, and a wide range of reasons are given by the patients that prevent effective and open communication.

Homeopathic Treatment of Subclinical Hypothyroidism-A Series of 19 Cases.

BACKGROUND: Subclinical hypothyroidism (SCH) is a common clinical problem. Controversy surrounds the definition, clinical importance, and need for prompt diagnosis and treatment of the mild form of SCH. AIM: The aim of the study was to analyze the evolution of serum thyroid stimulating hormone (TSH) levels after a therapeutic homeopathic intervention in women older than 40 years with SCH. METHODS: This study is a retrospective series of 19 cases of SCH, with serum TSH levels between 5 and 10 mIU/L, treated exclusively with homeopathic medicines prescribed on an individualized basis. RESULTS: Nineteen patients were included according to the inclusion and exclusion criteria. Their mean age was 56 years, they were followed for a mean duration of 69 months, the mean number of serum TSH level measurements was 18, and the intervention was successful for 13 patients. CONCLUSION: The homeopathic therapeutic intervention was successful in 68% of the patients, with serum TSH levels back within the normal range (0.5-5.0 mIU/L).

Représentations et pratiques du jeûne et des régimes restrictifs pendant la chimiothérapie.

Introduction : The idea of therapeutic fasting with healing virtues is circulating among cancer patients. Our study aims to improve knowledge of this practice, which is contraindicated in France during chemotherapy, and to establish recommendations to facilitate exchanges between doctors and patients.Methods : Chemotherapy patients completed a self-questionnaire on diet, therapeutic fasting and alternative medicine. A subsample of patients intending to follow dietary restrictions were interviewed.Results : Among the 133 participants, more than half had changed their diet and/or had heard of therapeutic fasting. Twenty-one patients intended to fast or have dietary restrictions during chemotherapy. These were mainly women, with an average age of 56 years, being treated for breast cancer, using alternative medications. They had little interaction with the health care team but would have liked to have had some with their oncologist. Nine patients were interviewed. They had tested short fasting and/or a ketogenic diet to improve treatment efficacy, reduce side effects and/or gain more control over their management. They did not dare to talk about it with the oncologist but regretted their silence. They are often advised by naturopaths and have tested homeopathy to accompany their treatment.Conclusions : Patients explain that they want to put all the odds in their favor. They would like the medical profession to offer times for discussion on fasting, silence being perceived as potentially harmful.

Use of Complementary and Alternative Medicine in Patients with Primary Immunodeficiency: a Multicentric Analysis of 101 Patients.

The term complementary and alternative medicine (CAM) describes a broad spectrum of health care practices that are not an integral part of the conventional health care system. Many patients worldwide use CAM on their own initiative, often in combination with their conventional medical therapy. CAM use is attractive especially to patients with primary immunodeficiency, since they suffer from frequent infections and autoimmunity. Those are frequently addressed by CAM providers. The aim of this multicentric study was to collect information on the use of CAM by these patients and to define characteristics that are associated with the use of CAM. A total of 101 patients with primary immunodeficiencies at German hospitals were surveyed on their CAM use (further 14 patients rejected to participate). Multiple psychological tests (MARS-D, WHO-5, PHQ9, EFQ) were conducted to investigate variations among personality traits associated with CAM use. Additionally, clinical and sociodemographic patient data was collected. A total of 72% of patients used CAM to treat their primary immunodeficiency. The three most frequently used methods were physical exercise or fitness training (65%), dietary supplements (58%), and homeopathy (49%). Most patients did not discuss CAM use with their doctors, mostly because they felt that there was no time for it. CAM plays an important role for patients with primary immunodeficiency in a high-resource health care setting such as Germany. In clinical practice, doctors should create a platform to discuss needs that go beyond conventional therapy.

Blood lead concentration among oral/inhaled opium users: systematic review and meta-analysis.

Lead is a poisonous heavy metal with various known side effects. The effect of opium on raising blood lead concentration (BLC) has been investigated with no general agreement. In Iran, the number of lead poisoning cases has raised among the opium-addicted population. This systematic review and meta-analysis aim to combine the results of previous studies with the Iranian population to investigate the effect of opium on BLC. In this systematic review, PubMed/Medline, Web of Sciences, Embase, and Scopus were searched for studies using the Iranian population to compare the BLC of opium-addicted cases and non-addicted controls till January 2020. A random-effects model was used to pool the results. I-square test was used to assess the heterogeneity of the studies. The effect sizes were standardized mean differences (proxied by Hedges' g) followed by a 95% confidence interval. Of 417 initial articles, 13 studies met the inclusion criteria to be considered in the meta-analysis. The sample size of eligible studies ranged from 40 to 131 (mean 81.83, SD 27.6). All studies were focused on adults with mean age ranged from 33.5 to 65.15 years old (overall mean 49.0, SD 7.66). There were 13 studies included with 18 Hedges' g effect sizes. Using a random effect model, the pooled effect size was gw = 2.48 (95% CI: 1.58-3.39) and statistically significant in favor of opium-addicted participants. Moreover, heterogeneity was 96.6% (I2=96.6, Q(17) = 504.95, p < 0.001). For studies with large Hedges' g effect sizes (> 4) identified as outliers and removed from meta-analysis. The pooled Hedges' g effect size reduced to 1.39 (95% CI: 0.94-1.85), still highly significant in favor of higher levels of lead in the opium-addicted group. The funnel plot appeared symmetrical confirmed by Egger's test (t = 1.87, p = 0.088), indicating no publication bias present.

Evaluation of Individualized Homeopathic Treatment in Patients With Irritable Bowel Syndrome: A Pilot Study.

BACKGROUND: Some studies have suggested the efficacy of homeopathic treatment for irritable bowel syndrome (IBS). OBJECTIVE: The aim of this pilot study was to evaluate the efficacy of individualized homeopathic treatment in patients with IBS. METHODS: The study was carried out at the National Homeopathic Hospital of the Secretary of Health, Mexico City, Mexico and included 41 patients: 3 men and 38 women, mean age 54 ± 14.89 years, diagnosed with IBS as defined by the Rome IV Diagnostic criteria. Single individualized medicine was prescribed for each patient, taking into account all presenting symptoms, clinical history, and personality via repertorization using RADAR Homeopathic Software (archibel, Isnes, Belgium). The homeopathic drugs were used at fifty-millesimal (LM) potency per the Mexican Homeopathic Pharmacopoeia starting with 0/1 and increasing every month (0/2, 0/3, 0/6). Severity scales were applied at the beginning of treatment and every month for 4 months of treatment. The evaluation was based on comparing symptom severity scales during treatment. RESULTS: The results demonstrated that 100% of patients showed some improvement and 63% showed major improvement or were cured. The study showed a significant decrease in severity of symptom scores 3 months after treatment, with the pain score showing a decrease 1 month after treatment. The results highlight the importance of individualized medicine regimens using LM potency, although the early decrease in pain observed could also be due to the fact that Lycopodium clavatum and Nux vomica were the main homeopathic medicine prescribed, and these medicines contain many types of alkaloids, which have shown significant analgesic effects on pain caused by physical and chemical stimulation. CONCLUSION: This pilot study suggests that individualized homeopathic treatment using LM potencies benefits patients with IBS.

[Mental Distress and Resilience in Severe Somatic Diseases: An Analysis of Dyadic Relations]. / Psychische Belastung und Resilienz im Rahmen schwerer körperlicher Erkrankungen: eine Analyse dyadischer Zusammenhänge.

AIMS: In this article, we present 3 studies examining patients with current or previous severe physical illness and their partners with respect to dyadic concordance, gender and role differences in mental distress and resilience. METHODS: Study 1 included 55 patients and their partners on average 4.5 years after severe sepsis. Study 2 involved 49 patients with lung cancer, predominantly in advanced stage with metastases, and their partners. In study 3, 69 cancer patients with various tumor entities and tumor stages undergoing additional outpatient homeopathic treatment as well as their partners were examined. All studies used the Hospital Anxiety and Depression Scale (HADS) to measure mental distress and the short version of the Resilience Scale RS-13 to assess resilience as a personality trait. Results were meta-analytically pooled across the 3 studies. RESULTS: We found dyadic concordances between patient and partner in anxiety (r=0.29 [0.06; 0.48], I2=55%) and depression (r=0.44 [0.31; 0.55], I2=0%), but not in resilience. Gender differences emerged consistently across all three studies, both female patients and partners showed more severe anxiety symptoms than males (d=0.58 [0.26; 0.91], I2=0% for patients; d=0.53 [- 0.06; 1.12], I2=69% for partners). Results were heterogeneous for gender differences in depression and for role differences. Higher resilience scores were associated with lower mental distress both in patients and partners. There is some evidence that resilience has a protective effect for mental distress of the spouse. DISCUSSION AND CONCLUSION: Based on the results on dyadic concordance between patients and partners in mental distress somatic diseases should always be considered from a systemic perspective. Mental distress of both patients and partners requires special attention in psychosocial support, and partnership resources should be taken into account for coping with the disease.

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.

Prevalence and Likelihood Ratio of Six Objective Signs among Good Responders to Natrum muriaticum: Multi-centre Observational Assessment.

BACKGROUND: The reliability of homeopathic prescriptions may increase through resource to objective signs and guiding symptoms with significant positive likelihood ratio (LR). We estimated LR for six objective signs attributed to the homeopathic medicine Natrum muriaticum (Nat-m). METHODS: In this multi-centre observational assessment, we investigated the prevalence of six signs in the general patient population and among good responders to Nat-m in daily homeopathic practice. Next, we calculated LR for these six signs. RESULTS: Data from 36 good responders to Nat-m and 836 general population patients were compared. We found statistically significant positive LR (95% confidence interval) for signs such as lip cracks (1.94; 1.15 to 3.24), recurrent herpes (2.29; 1.20 to 4.37), hairline eruptions (2.07; 1.03 to 4.18), and dry hands (2.13; 1.23 to 3.69). CONCLUSIONS: Objective signs with significant positive LR might increase the reliability of homeopathic prescriptions. Further studies are warranted to confirm the validity of this approach.

Homeopathic Treatment of a Lower Leg Edema-A Case Report.

BACKGROUND: Homeopathy is frequently and successfully used in daily clinical practice, so there is a need for well-documented case reports that illustrate its effectiveness. For this reason, we present a case in which homeopathy was used to treat an ankle and lower leg for spontaneous acute swelling and redness. CASE REPORT: A 54-year-old man presented with recurrence of a swollen left ankle and lower leg, which had previously been treated by conventional medicine. After case taking, a homeopathic treatment with Apis mellifica 200c led to a fast improvement. The patient was free of symptoms within 24 hours and has remained so for 3 years. CONCLUSION: Homeopathic treatment with Apis mellifica led to a fast and long-lasting improvement of an acute ankle swelling and reddening that had recurred after conventional medical therapy of similar symptoms.

Individualized Homeopathic Medicines in Chronic Rhinosinusitis: Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS. METHODS: A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0-10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. RESULTS: Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. CONCLUSION: There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111-1210-7201].

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.