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.

Homoeopathic Treatment Of Psoriasis Using Fifty-Millesimal (LM) Potency: A Case Report.

Context: Psoriasis is a chronic, proliferative, and inflammatory skin disease related to the systemic manifestation of numerous organs. The typical lesion comprises red, scaly, sharply demarcated, indurated plaques, especially over the extensor surfaces and scalp. The degree and severity vary after some time and between people. Morphological variations are normal; both hereditary and environmental factors play important roles in etiology and pathogenesis.Psoriasis is very difficult to treat due to its chronicity. As a medical system, Homoeopathy treats both patients' physical ailments and overall wellness. The use of highly potentized homoeopathic anti-miasmatic intercurrent medicines will be very beneficial in dealing with this. Fifty-millesimal (LM) potency was a great discovery by Dr. Samuel Hahnemann. While treating numerous chronic illnesses, he was able to quickly relieve symptoms without any aggravation by using fifty-millesimal (LM) potency. Case Report: The present case report is of 24-year-old male patient having psoriasis for one year. This case report describes the homoeopathic management of psoriasis using fifty-millesimal (LM) potency. On the basis of presenting sign and symptoms, Arsenic Album 30C was prescribed with frequent repetitions after repertorisation. During follow-ups, Arsenic Album 1LM was prescribed in to accelerate the cure. Psoriasis is a chronic condition that tends to recur. To prevent the recurrence, Psorinum 1000C was prescribed as an intercurrent anti-miasmatic medicine in a single dose during the course of treatment. Psorinum is a nosode that was chosen for therapy since it is recommended when symptoms reappear and the best selected homoeopathic medicine is not very effective. Psorinum was prescribed in this case to clear the miasmatic obstruction because the Arsenic Album was only temporarily easing the complaints. Result: The patient has exhibited improvement in their mental state and quick alleviation from physical issues after receiving multiple doses of Arsenic Album 1LM and a single dose of Psorinum 1000C, all without their symptoms getting worse. The patient's condition was followed up on at every appointment for a considerable amount of time, and no new concerns had surfaced as of yet. Conclusion: This case report shows favourable results of homoeopathic medicine in fifty-millesimal (LM) potency. Therefore, it can be concluded that using fifty-millesimal (LM) potency of accurately selected homoeopathic medicine will shorten the cure process without the aggravation of symptoms. Further research studies are required to explore the efficacy of fifty-millesimal (LM) potency of homoeopathic medicine in treatment of chronic illnesses.

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.

Breast Abscess Healing with Homoeopathy: A Case Report.

Context: Breast abscess is the most common complication of acute bacterial mastitis usually referred to as pyogenic mastitis. It is usually encountered during lactation due to an infection with Staphylococcus aureus and streptococcal bacteria. These bacteria produce a severe inflammatory reaction leading to pus formation which is mainly treated by ultrasound-guided drainage or fine needle aspirations. We find that in this condition homoeopathic treatment can play an important role as it avoids such surgical procedures and helps in healing in a most gentle and rapid way. We report a successful single case study that opens up opportunities to take up more such cases to strengthen the results of this report. Case summary: A 23-year-old lactating mother came with complaints of pain and swelling with a collection of pus in the breast region and decreased breast milk secretion. Individualised homoeopathic medicine Silicea 200C was given to hasten suppuration and Belladonna 200C to treat inflammation.Thus, this case shows us how only few doses of medicine may be quickly helpful in managing a case of breast abscess without the need of any surgical procedures.

Homoeopathic Concept of Remedy Relationship And Its Utility in Management of Polycystic Ovarian Syndrome: A Case Report.

Polycystic ovarian syndrome (PCOS) is a common lifestyle disorder that has become a major international public health concern affecting young women of reproductive age. Homeopathy aims to provide an individual with optimal health on all levels-emotional, mental, physical and spiritual. Homeopathy's goal is to promote an individual's overall well-being rather than just treat symptoms. Dr. Boenninghausen's unique contribution to the promotion of scientific prescribing in homeopathic practice is the concept of remedy relationship and its reportorial analysis. Homeopathy takes into account a person's natural environment and lifestyle. Then, a homeopathic physician provides treatment that closely matches individual symptoms and recommends homeopathy remedies for the same. A 22-year-old female came into the homeopathic outpatient department (OPD) with complaints of irregular menses, pustular acne and constipation. An ultrasound of the abdomen and pelvis was done to confirm the diagnosis of POCS. Other investigations were performed, including thyroid function tests and hormonal assays, to rule out the presence of other disorders. The case was managed with homeopathic medicines, which were prescribed per Hahnemannian guidelines after referring relationship of remedies.

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

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

Determination of epidemiological characteristics of addicts treated in drug addiction clinics in Kabul.

According to the Afghanistan Ministry of Health, 3.5 million people use drugs, 2.4 million of which are regular users. In this cross-sectional study, it was aimed to determine epidemiological characteristics of addicts in a treatment center in Kabul. Eight hundred people were included. Statistical analysis was done with SPSS 22.0. The average age was 30.74 years, 88.9% were male, and 50.6% were married. Further, 35.9% have never been trained, 60.5% of participants were living in urban areas, 62.8% were refugees, 17.5% were unemployed, and 30.3% of them had monthly income below 147.1 USD. The average age of starting substance use was 19.9 years. "Friendship environment" was the leading reason to start (36.6%), followed by "reduce troubles" with 22.3%. The most preferred substance was cannabis (46.0%), followed by opium (25.3%) and heroin (17.0%). Heroin was the most commonly used substance lifelong (87.1%), followed by cannabis (66.3%) and opium (65.5%). When compared to individuals younger than 18, heroin use rates were 3.52 times higher in the 18-to-30 age range, 5.49 times higher in the 31-to-45 age range, and 1.86 times higher in urban residents than rural. Cannabis use was 12.24 times more among men than women, 2.79 times higher among divorced or widowed individuals than singles, 1.68 times higher among refugees than non-refugees, and 2.26 times higher among drug traffickers than non-traffickers. Opium use was 1.63 times higher for refugees than non-refugees and 3.24 times higher in those who worked in drug fields than those who did not. Periodic assessment of prevalence of drug use and the establishment of drug use monitoring systems are recommended.

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

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

Homeopathic Remedies in COVID-19: Prognostic Factor Research.

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

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

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

Comparative Effectiveness of the Homeopathic Preparation Traumeel S in Third Molar Extraction Surgery: A Preliminary Triple-Blind Clinical Trial.

BACKGROUND AND AIM: This preliminary study aimed to evaluate whether a homeopathic preparation (Traumeel S) might be a good option to control post-operative outcomes (pain, edema and trismus) associated with surgical removal of mandibular third molar teeth. The null hypothesis was that Traumeel S is not different from dexamethasone (gold standard) in controlling these post-operative inflammatory complications. METHODS: A randomized, "split-mouth", triple-blind clinical trial was conducted. Seventeen healthy patients with a mean age of 20.94 ( ± 5.83) years had their lower asymptomatic bilateral third molars removed. Patients were randomized to receive Traumeel S or dexamethasone pre-operatively by injection into the masseter muscle; each patient acted as his/her own control. At 24, 48, 72 hours and 7 days after the surgery, the pain was evaluated according to a visual analog scale, edema through linear measurements of the face, and trismus through the maximum buccal opening. Wilcoxon statistics or paired t-test were used, and a significance level of 95% was adopted. RESULTS: For pain, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone after 24 hours, 72 hours, and 7 days. For edema, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at all post-operative evaluations. For mouth opening, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at 72 hours and 7 days after third molar extraction. CONCLUSION: With the exception of some early post-operative findings, the null hypothesis is not rejected. Traumeel S might be a good alternative approach to dexamethasone for controlling pain, edema and trismus after third molar removal.

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

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

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

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

A novel, nonopiod-based treatment approach to men with urologic chronic pelvic pain syndrome using ultrasound-guided nerve hydrodissection and pelvic floor musculature trigger point injections.

INTRODUCTION: Urological chronic pelvic pain syndrome (UCPPS) represents a group of pain symptoms relating to patients with pelvic pain for which treatment is largely unsatisfactory. The objective of this study is to analyze the effects of a novel treatment strategy in males suffering from UCPPS. METHODS: This retrospective, institutional review board-approved study analyzed eight male patients aged 24 to 61 with UCPPS. All the patients had a trial of antibiotic therapy, NSAIDs, and pelvic floor physical therapy before the study. The Visual Analog scale (VAS) and Functional Pelvic Pain scale (FPPS) were collected pretreatment. While continuing physical therapy, patients underwent weekly ultrasound-guided pelvic floor trigger point injections to the iliococcygeus, pubococcygeus, and puborectalis with lidocaine 1%. Concomitantly, patients received peripheral nerve hydrodissection performed on the pudendal nerve and the posterior femoral cutaneous nerve. The first two injections combined 1% lidocaine with dexamethasone, while the next four injections consisted of 1% lidocaine with traumeel (a homeopathic, plant-derived anti-inflammatory medication). At the 6-week follow-up, each patient retook the VAS and FPPS. RESULTS: The mean age of our patients was 31.8 years and the average duration of symptoms of the UCPPS was 21 months. Pretreatment, the mean VAS was 3.3 (STD 1.7) and the mean VAS posttreatment was 1.8 (STD 1.4); P < .05; 95% CI, 0.73 to 2.27. The mean FPPS pretreatment was 11.0 (STD 8.0) and the mean FPPS posttreatment was 6.3 (STD 5.3); P < .05; 95% CI, 0.03 to 9.22. CONCLUSION: Our results show promise for a novel, nonopioid-based treatment for UCPPS.

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

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

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

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

Opium and risk of gastrointestinal cancer: a case-control study

Background/aim: Gastrointestinal (GI) cancers are among the most common cancers in the world. Many risk factors may increase the chance of developing GI cancers. In recent years, a number of epidemiological studies have reported evidence of carcinogenic effects of opium in humans. This study aimed to investigate the relationship between opium use and GI cancer. Materials and methods: This case-control study was performed on 95 patients with GI cancer and 190 healthy individuals (matched for age, sex, place of residence, and smoking) in Rafsanjan, Iran, in 2018. Diet information, as well as history of smoking, the use of hookah, opium, and its derivatives was collected using a checklist in interview sessions. Conditional logistic regression was performed to investigate the proposed relationship and to estimate odds ratios (OR). Results: After adjusting the confounding variables, the use of opium was significantly associated with an increased risk of GI cancer development (OR = 5.95, 95% CI: 2.4­14.9). Also, a dose-response association was found between the cumulative use of opium and the risk of GI cancers. Consumption of fruit and vegetables reduced the risk of developing GI cancers in opium users (OR = 4.9 and 4.7, respectively). Conclusion: Opium, in the form used among drug users in this area, can lead to an increased risk of GI cancers. Fruit and vegetables have a protective and modifying effect on the risk of GI cancer development caused by opium consumption.

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

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

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

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

Do sociodemographic characteristics associated with the use of CAM differ by chronic disease?

BACKGROUND: Complementary and alternative medicine (CAM) is oftenused to alleviate the discomfort, disability and pain involved in many chronic diseases. Besides this, females, middle-aged and higher educated people are also known to use CAM the most. This study explores whether the sociodemographic characteristics associated with CAM use differ by type of disease. METHODS: The following data were taken from the Belgian Health Interview Survey 2013 for the individuals aged 15+ years (n = 8942): sociodemographic characteristics, past 12-month diseases (using a list) and contact with a homeopath, chiropractor, acupuncturist and/or osteopath (CAM-therapists) in the past year. The association between CAM use and disease, controlled for gender, age, education and conventional medicine use, was assessed through logistic regressions. When interactions with the sociodemographic characteristics were found, stratified regressions were conducted. RESULTS: People with musculoskeletal diseases [odds ratio (OR) = 2.6], allergy (OR = 1.4) and severe headache (OR = 1.5) had higher odds of using CAM in the past year with statistical significance. For musculoskeletal diseases, the odds of using CAM was higher, with statistical significance, for every sociodemographic subclass. For allergy, CAM use was higher among men, people aged 45+ years and lower educated people, while for severe headache CAM use was higher among women, people aged 45+ years and higher educated people, all with statistical significance. CONCLUSIONS: Sociodemographic characteristics associated with CAM use differ by diseases. The role of CAM in disease management cannot be ignored. Making physicians aware for which disease CAM is used and by whom, may facilitate disease management.