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.

Effectiveness of Homeopathic Medicines as Add-on to Institutional Management Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized Placebo-Controlled Trial.

BACKGROUND: Acute encephalitis syndrome (AES) is endemic to certain parts of India, with limited treatment options. In our initial exploratory comparative observational study of 151 patients with AES, there was significantly reduced mortality with adjunctive homeopathy compared to institutional management protocol (IMP). The present randomized placebo-controlled trial brings more statistical rigor to this research program. METHODS: This study was conducted at a pediatric unit from 2013 to 2015. Children aged > 6 months and ≤ 18 years and receiving IMP were randomized to receive adjunctive homeopathy (n = 325) or placebo as control (n = 323). The primary effectiveness analysis was based on Glasgow Outcome Scale (GOS). Morbidity was assessed using the Liverpool Outcome Score for Assessing Children at Follow-up. Analysis was by intention to treat. RESULTS: A total of 612 children were analyzed (Homeopathy [H] = 304; Control [C] = 308). The primary outcome, GOS, differed significantly between H and C groups. There was 14.8% death/neuro-vegetative state in the H group compared to 29.8% in the C group. Relative risk was 0.49 (95% confidence interval [CI]: 0.36 to 0.68), with absolute risk reduction of 15.0% (95% CI: 8.6 to 21.6%). Number needed to treat to prevent one additional death/neuro-vegetative state was 6.6 (95% CI: 4.6 to 11.6). Proportional-odds analysis also revealed a greater effect in the H group: odds ratio, 0.40 (95% CI: 0.27 to 0.60). The most frequently used medicines were Belladonna (n = 116), Stramonium (n = 33), Arsenicum album (n = 25), Sulfur (n = 18), Opium (n = 17), and Nux vomica (n = 10). CONCLUSION: Adjunctive homeopathic medicines may improve clinical outcomes associated with AES. Further randomized and controlled studies, using double-blinded trial design, are recommended to discover if the current findings may be corroborated.

Serum concentrations of TNF-α and its soluble receptors during psychotherapy in German soldiers suffering from combat-related PTSD.

BACKGROUND: Changes in serum concentrations of tumor necrosis factor-α (TNF-α) and its soluble receptors (sTNF-R) p55 and p75 have been shown to be associated with various psychiatric treatments. SUBJECTS AND METHODS: Before and after treatment, serum levels of TNF-α, sTNF-R p55 and sTNF-R p75 were measured in 38 German soldiers who had been deployed abroad and suffered from combat-related post-traumatic stress disorder (PTSD). Patients were randomized either to inpatient psychotherapy (N=21) including eye movement desensitization and reprocessing (EMDR) or to outpatient clinical management (N=17). Symptoms of PTSD were measured using the Post-traumatic Stress Diagnostic Scale (PDS). RESULTS: The PDS score significantly decreased across time in both groups. Serum concentrations of TNF-α increased, while sTNF-R p55 and sTNF-R p75 levels decreased significantly. After the treatment period, we could not detect any significant difference regarding TNF-α, sTNF-R p55 or sTNF-R p75 levels between the inpatient psychotherapy group and the outpatient clinical management control group. CONCLUSIONS: This relatively small clinical study suggests that specific inpatient psychotherapy but also non-specific supportive outpatient treatment for PTSD are associated with changes in the TNF-α system. This may represent an immunological effects or side effects of psychotherapy.

Is There a Role for Homeopathy in Cancer Care? Questions and Challenges.

Patients with cancer commonly use complementary and integrative medicine, including homeopathy. Homeopathy has grown in popularity with the public but is viewed with skepticism by medical academia and is still excluded from conventionally prescribed treatments. In recent years, homeopathy has been used in cancer care in Europe and other countries worldwide. This use raised the question if there is any benefit in utilizing this type of care with cancer patients. The purpose of this manuscript is to explore the evidence related to the benefit of homeopathy in cancer care. Limited research has suggested that homeopathic remedies appear to cause cellular changes in some cancer cells. In animal models, several homeopathic remedies have had an inhibitory effect on certain tumor development. Some clinical studies of homeopathic remedies combined with conventional care have shown that homeopathic remedies improve quality of life, reduce symptom burden, and possibly improve survival in patients with cancer. The findings from several lab and clinical studies suggest that homeopathy might have some beneficial effect in cancer care; however, further large, comprehensive clinical studies are needed to determine these beneficial effects. Although additional studies are needed to confirm these findings, given the low cost, minimal risks, and the potential magnitude of homeopathy's effects, this use might be considered in certain situations as an additional tool to integrate into cancer care.

[THE APPLICATION OF ANTIHOMOTOXIC DRUG PREPARATIONS IN THE COMPLEX TREATMENT IN PATIENTS WITH NEUROLOGICAL MANIFESTATIONS OF LUMBAR OSTEOCHONDROSIS].

The expediency of application homeosyniatry by preparations of Traumel S and Placenta Compositum after the offered chart in relation to a complex with classic acupuncture and in relation to the group of the generally accepted treatment has been proved in complex treatment patients with reflex syndromes of lumbar osteochondrosis. A similar conclusion was done after the statistically reliable (P < 0.05) dynamics of parameters of endogenous intoxication, liperoxydation and antioxydant systems of the protection (by the level of katalase, superoxyddismutase, SH-groups, ceruloplasmine).

Interim results of a randomised controlled trial of homeopathic treatment for irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a chronic condition for which there is no consensus on the optimum treatment. Gastroenterology problems are some of the most common conditions treated by homeopaths, yet few trials have explored the effectiveness of individualised homeopathic treatment for IBS. A three-armed trial was conducted which compared: usual care, homeopathic treatment plus usual care and supportive listening plus usual care. The primary outcome was change in irritable bowel symptom severity score between baseline and 26 weeks, calculated using ANCOVA. An interim ANCOVA adjusted for baseline IBS severity, age and employment status found no statistically significant difference between the three arms. However, a post-hoc test comparing homeopathic treatment plus usual care to usual care alone found a statistically significant difference in favour of homeopathic treatment. In addition, 62.5 percent of patients in the homeopathic treatment arm (compared to 25.0 percent of those in the usual care arm), achieved a clinically relevant change in irritable bowel symptom severity score, which indicates a promising effect for homeopathic treatment, though these results should be interpreted with caution due to the low number of participants in the study.

Neonatal opiate withdrawal and rooming-in: a retrospective analysis of a single center experience.

AIM: To evaluate our treatment of neonatal abstinence syndrome (NAS), our experience with rooming-in of opiate-dependent mothers and to examine the influence of rooming-in on short term outcome of infants exposed to opiates in utero. METHOD: Retrospective analysis of maternal and perinatal data of newborn infants with NAS treated between 2004 and 2011 in a level 3 academic children's hospital in a German metropolis. Therapy of NAS and duration of therapy, length of hospital stay and costs were considered in particular. FINDINGS: Data of 77 newborns with NAS were analysed. 84.6% of infants were treated with tincture of opium (79.2% rooming-in, 88.7% no rooming-in). Infants with rooming-in (n=24) had a 17% shorter median duration of therapy [27.0 d (IQR 24.0-38.5), no rooming-in (n=53) 32.5 d (IQR 25.0-54.5)] and shorter median length of hospital stay [33.0 d (IQR 28.0-48.0), no rooming-in 41.5 d (IQR 30.3-54.5)]. Demographic data was comparable between newborns and mothers with or without rooming-in. Costs were median 13 457 € (IQR 8 967-17 494)/patient [rooming-in: 9 547 € (IQR 7 024-16 135), no rooming-in: 14 486 € (IQR 9 479-19 352)]. CONCLUSIONS: Rooming-in in NAS should be encouraged to shorten duration of therapy and length of hospital stay and thereby reduce costs. No major problems arose in the care of the infants with NAS when parents stayed with their infants but close monitoring of the newborn and strict instruction of parents are required.

Complementary and alternative medicines use by Scottish women with breast cancer. What, why and the potential for drug interactions?

BACKGROUND: Despite the increased use of complementary and alternative medicine (CAM) by breast cancer patients, there is little published information regarding CAM use in the Scottish breast cancer population. METHODS: A questionnaire comprising five sections--demographics; perceived health status, prescribed medicines; use, indications, satisfaction and expenditure on CAMs; attitudes towards and factors associated with CAM use; and attitudinal statements--was issued to patients attending the Aberdeen Breast Clinic. RESULTS: A total of 453 questionnaires were distributed and 360 (79.5%) returned. Respondents were prescribed a mean of 3.2 medicines (95% CI 2.83-3.47). With regard to CAM use, 33.1% of respondents reported current use, 36.4% prior use, and 30.6% reported never having used CAMs. The key indications for use were general well being, boosting immune system and cancer prophylaxis, with high levels of satisfaction reported. The strongest association for CAM use was use by friends and family and higher educational attainment (p < 0.001). Supplements with estrogenic activity, such as soya or red clover, were taken by 29% of respondents. Herbs (echinacea, pomegranate, peppermint, chamomile, grapefruit, garlic, ginseng) that have the potential to interact with adjuvant endocrine therapies (tamoxifen, anastrazole, letrozole, exemestane) were being taken by 38% of treated patients. CONCLUSION: The level of CAM use by Scottish breast cancer patients is similar to that reported from other countries, although there are marked differences in the type, nature and frequency of specific CAM therapies. Higher patient education level and use by family and friends were significantly associated with CAM use. The high level of use of potentially disease modifying or interacting herb supplements may be of concern.

[Antihomotoxic therapy in patients with inflammatory and dystrophic salivary gland diseases].

Traumeel S was used as monotherapy for salivary glands inflammatory and dystrophic disorders. The study showed the drug to be especially efficient by exacerbation of the recurrent disease but the results were poor by indolent disease and on the latter stages of dystrophic disorder. Traumel S may be recommended to be used in combined therapy for salivary glands inflammatory and dystrophic disorders treatment.

[Effectiveness and safety of a homeopathic drug combination in the treatment of chronic low back pain. A double-blind, randomized, placebo-controlled clinical trial]. / Wirksamkeit und Sicherheit eines homöopathischen Komplexpräparates bei chronischen Rückschmerzen. Doppelblinde, randomisierte, placebokontrollierte, klinische Studie.

BACKGROUND: The homeopathic drug combination Lymphdiaral Basistropfen is established in the treatment of edema and swellings. This is the first time the effectiveness and safety was investigated in the treatment of chronic low back pain. METHODS: The study is a randomized, double-blind, placebo-controlled trial. From December 2003 to May 2007 248 patients aged 18 to 75 years were screened, 228 were randomized, 221 started therapy, in 192 the progress was measured (103 verum vs. 89 placebo), 137 completed the study (72 verum vs. 65 placebo). They received 10 drops of verum or placebo solution three times daily for 105 days additionally to an inpatient complex naturopathic treatment. RESULTS: The hannover functional ability questionnaire score (primary outcome measure) tends to increase in the intention-to-treat-analysis (verum: 6.6 vs. placebo: 3.4; p = 0.11) and increases significantly in the per-protocol-analysis (verum: 9.4 vs. placebo: 4.1; p = 0.029). The treatment was well tolerated (92.9% vs. 95.4%). The incidence of adverse reactions and serious adverse reactions was similar in both treatment groups. CONCLUSIONS: This first randomized, double-blind, placebo-controlled trial shows, that the homeopathic drug combination can improve the treatment of chronic low back pain.

[On conservative management of cicatricial eyelid malpositions].

Methods of conservative and complex rehabilitation of patients with cicatricial eyelid malpositions are proposed. Conservative treatment included developed regimen of antihomotoxic agents, different techniques of graduated extension of scar tissues, special eyelid exercises. In complex management conservative treatment was provided along with surgery, in some cases botulinum toxin A was administered. Duration, time and priorities were determined.

Complementary and alternative medicine in sarcoma patients treated in an Italian sarcoma center.

BACKGROUND: Bone and soft-tissue sarcoma are rare tumors. Complementary and alternative medicine (CAM) is often used in cancer patients however limited data are available in sarcoma patients. The aim of the present study is to explore the use of CAM in patients with bone and soft-tissue sarcoma. METHODS: Patients in follow-up visit for high grade bone or soft-tissue sarcoma at the Rizzoli outpatient clinic from September 1, 2014, to December 31, 2015, were asked, after written consent, to fill out a questionnaire with items pertaining to sociodemographic factors and their use of CAM before, during, or after chemotherapy. RESULTS: Four hundred and sixty-nine participated to the survey: 409 were adults and 60 were <18 years old. The percentage of use of CAM in adults was 44.7% and in minors 38.3%. The most common type of CAM was vitamins and minerals, followed by phytotherapy and homeopathy. The majority of patients used CAM after the sarcoma diagnosis. None used CAM alone instead of conventional chemotherapy. Benefits from use of CAM were reported by 75% of patients (some benefit in 53% plus high benefit in others 22%) and side effects in 6.7%. A significant correlation was found with CAM use and female gender, young age (18-44) and higher education. Disclosure to the oncologist was 56% and 69% to their family doctors. CONCLUSIONS: This study shows that CAM use is frequent among adults and pediatric patients with bone and soft tissue sarcoma as in other cancer patients. Moreover, the profile of these Italian CAM consumers in sarcoma patients is similar to other studies. Patients disclosure to their oncologist or physician about the use of CAM was similar to other Italian studies, but higher compared to other international studies.

Characteristics of cancer patients using homeopathy compared with those in conventional care: a cross-sectional study.

BACKGROUND: There are only few studies on cancer patients who are treated in complementary and alternative medicine clinics and comparing them with patients in conventional care. We will present the comparison of characteristics of two patient cohorts: one was treated in a homeopathic cancer care clinic and one was treated in a conventional oncology care (CC) outpatient clinic. PATIENTS AND METHODS: Six-hundred and forty-seven patients were included in this cross-sectional cohort study and had to fill in questionnaires [health-related quality of life (QoL) (Functional Assessment of Cancer Therapy-General Scale), depression and anxiety (Hospital Anxiety and Depression Scale), fatigue (Multidimensional Fatigue Inventory) and expectancies toward treatment]. Clinical data were extracted from medical records. This study presents the comparison of both cohorts. RESULTS: Patients in the homeopathy cohort are younger, better educated and more often employed than patients in the CC cohort. The most pronounced differences indicate longer disease histories and different diagnostic and clinical pretreatment variables. Despite the clinical differences, QoL as well as anxiety, depression and fatigue was similar in both the groups. CONCLUSIONS: Homeopathic treatment is sought by cancer patients at a different phase during the course of the disease, which has particular implications for research. However, expectancies toward the benefit of the treatment as well as QoL data are similar.

Chronic pelvic pain.

Though there are myriad etiologies of CPP, common therapeutic targets include inflammation, somatic dysfunction, and psychological disturbances. Inflammation may be addressed not only with dietary changes including nutritional and botanical supplements but also with mind-body therapies. Somatic dysfunction may respond to manipulative therapies provided by osteopaths, naturopaths, chiropractors, and some physical therapists. Therapists may also offer visceral, craniosacral, myofascial, and other whole-body therapies, as can highly trained massage therapists and bodyworkers. Mental health care may be key in many cases. Integrative medicine heralds the return to a sense of the human being's intrinsic capacity for healing, incorporating the vitalism of many of the therapies' origins (traditional Chinese medicine, indigenous medicine, ayurveda, osteopathy, chiropractic, etc) with the gains made by a more reductionistic tradition. Given the complexity and wide variation of etiologies and symptoms of CPP, using an integrative approach may offer expanded therapeutic solutions. We must expand our capacity to listen to each patient-with ears, eyes, mind, heart, and hands. Each treatment plan may then be tailored to the unique history and perspective that lie within the individual. Doing so requires the essential elements of time, skill, and love.

A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome.

INTRODUCTION: Chronic pain and fatigue are the main symptoms of postpoliomyelitis syndrome (PPS). This study aimed to evaluate the efficacy and safety of an anthroposophic multimodal treatment for chronic pain in PPS outpatients. METHODS: A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial was designed to compare four groups (n = 48): groups A and B received daily active experimental transdermal gel (ETG) or placebo gel (PTG), respectively; groups C and D received weekly external therapies, art therapies, and neurofunctional reorganization, plus either daily ETG or PTG, respectively. The pain symptoms were evaluated through a visual analogue scale (VAS), the McGill questionnaire, and thermography. Quality of life and resilience were evaluated by the WHOQOL-BREF and Antonovsky sense of coherence questionnaires applied at baseline and after the interventions. RESULTS: No related adverse events occurred, and 10% of the patients reports dysphagia improvement. In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035). However, following the week-to-week evolution of pain with the concomitant use of the ETG, this significant pain reduction occurred earlier from the 4th week and continued to decrease (p = .016, d = 1.369). In the group that received the complete multimodal treatment, the greatest significant benefit in increasing quality of life occurred in the physical domain and elevation in resilience with an emphasis on meaning and comprehension domains. CONCLUSIONS: The anthroposophic multimodal treatment group presented both safety and efficacy as an analgesic in the groups that received the nonpharmacological therapies, much earlier when associated with the ETG. The multimodal approach corresponded to the pattern of better efficacy for both pain reduction and improvement in quality of life and resilience.

[Application of antihomotoxic preparations in complex treatment of early inflammatory complications, occurring after gastrointestinal operations].

Anastomositis and abdominal cavity infiltrate constitutes the most frequent early inflammatory complications, occurring after gastrointestinal operations. The informativity of diagnostic methods of these complications, the volume and efficacy of conservative curative procedures were shown. Introduction of antihomotoxic preparations in complex of treatment measures, in part, of Traumeel C, Lymphomyosot, Mucosa compositum C, Echinacea compositum C had promoted the efficacy raising and the shortening of the treatment duration of these complications.

[The complex approach to treatment of pain syndrome of cervical vertebral osteochondrosis].

The article deals with an investigation of therapeutic efficiency combined with applications of biological preparations and special medical-improving gymnastic exercises at treatment of a vertebral cervical osteochondrosis on the one hand, traditional means on the other hand. 76 patients aged 31-62 have taken part in the given research. The basic group was made by 47 patients and the control group - by 29. The patients of the basic group applied a special complex of medical-improving gymnastic exercises, and also paravertebral injections of biological preparations Traumeel S, Neuralgo-Rheum-Injeel. The patients of the control group received traditional therapy of a vertebral osteochondrosis. Injections of Voltaren (Diclofenac) intramuscularly, MIG400 (Ibuprophen) tablets, phonophorez with Indometacin ointment, a traditional complex of physiotherapy exercises. Duration of the treatment in all groups has made 28 days. Obtained data testify that by the end of treatment full knocking over of a pain syndrome in the basic group is noted at 71,2 % of patients, in control group only in 41,4 % of patients the pains have completely disappeared in a cervical spine. Thus, therapy by biological preparations in a combination to a complex of special medical-improving gymnastic exercises allows to reduce terms of knocking over of sharp clinical displays of an osteochondrosis of a cervical spine, to raise efficiency of restoration of sensitive, vascular, muscular-tonic frustration, and also allows to avoid neuro-surgical intervention at patients with hernias interspine disks.

The IMCO scheme as a tool in developing team-based treatment for people with multiple sclerosis.

BACKGROUND: The Danish Multiple Sclerosis Society (a patient organization) has initiated a research-based bridge-building and integrative treatment project to take place from 2004 to 2010 at a specialized MS hospital. The background for initiating the project was an increasing use of alternative treatment documented among persons with multiple sclerosis (PwMS). From PwMS there has been an increasing demand upon The Danish Multiple Sclerosis Society to initiate the project. OBJECTIVE: The overall purpose of the project is to examine whether collaboration between 5 conventional and 5 alternative practitioners may optimize treatment results for people who have multiple sclerosis (MS). The specific aim of this paper is to present tools used in developing collaboration between the conventional and alternative practitioners. MATERIALS AND METHODS: Two main tools in developing collaboration between the practitioners are described: (1) the planning and conduction of 4 practitioner-researcher seminars in the prephase of the project before recruiting patients with MS; and (2) the IMCO scheme (which is an abbreviation of Intervention, Mechanism, Context, and Outcomes). This tool was developed and used at practitioner-researcher seminars to make visible the different practitioners' treatment models and the patient-related treatment courses. RESULTS: Examples of IMCO schemes filled in by the medical doctor and the classical homeopath illustrate significant differences in interventions, assumptions concerning effect mechanisms, and awareness of contexts facilitating and inhibiting the intervention to generate the outcomes expected and obtained. CONCLUSIONS: The IMCO schemes have been an important tool in developing the team-based treatment approaches and to facilitate self-reflection on the professional role as a health care provider. We assume that the IMCO scheme will be of real value in the development of effective treatment based on collaboration between conventional and alternative practitioners.