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DOAJ Open Access 2024
Unveiling the Immunostimulatory Potential of Rhus Toxicodendron in Immunocompromised Balb/C Mice Induced with Cyclophosphamide

Vara Prasad Saka, Narasimha Kumar G. V., Bharat Kumar Reddy Sanapalli et al.

This study investigated how <i>Rhus toxicodendron</i> (RT) (6C, 30C, and 200C) can boost the immune system of BALB/c mice that were given cyclophosphamide (CPM), which is an anticancer drug that weakens the immune system. RT, known for its historical use in traditional homeopathic remedies, has demonstrated immunomodulatory and anti-inflammatory effects in various experimental models. To test the immune-boosting effects of RT, CPM (80 mg/kg) was given intraperitoneally to mice on days 4, 8, and 12 of the study but not to the normal control group. CPM-induced immunosuppression led to significant decreases in red blood cell (RBC), white blood cell (WBC), and hemoglobin (Hb) levels, and reduced spleen and thymus indices. Phagocytic activity, cytokine concentrations, and spleen architecture were also adversely affected. RT treatment, particularly at 200C, significantly ameliorated these effects, improving RBC, WBC, and Hb levels. Furthermore, RT partially prevented CPM-induced atrophy of immune organs. Treatment positively influenced cytokine production at both the protein and mRNA levels, restoring immune balance. Histopathological results confirmed that RT stimulated the immune system. The cells were more stable, and the white pulp in the spleen was arranged in a regular pattern. These findings suggest that RT may serve as an adjunctive immunostimulant therapy for conditions characterized by immunosuppression. However, further investigations in other immunocompromised states must validate these results before considering human clinical trials.

DOAJ Open Access 2023
Therapy and Prevention of Noise Fears in Dogs—A Review of the Current Evidence for Practitioners

Stefanie Riemer

Noise fears represent the most common behavioural problem in dogs. This manuscript provides an overview of diverse approaches for alleviating fear of noises in dogs and the supporting evidence. In the treatment of noise fears, both short-term solutions to prevent trauma or the deterioration of fear during unavoidable noise events and longer-term training need to be considered. Environmental management, the provision of incentives (food/play) during noise exposure, and, when indicated, anxiolytic medication, can safeguard dogs’ welfare during noise events. Most “alternative” products (such as nutraceuticals, herbal remedies, pheromones, homeopathy, Bach flowers, and essential oils) are unlikely to be sufficient as monotherapy for noise fears, whereas there is good evidence for the efficacy of several anxiolytic medications. In the longer term, counterconditioning to real-life noises, relaxation training, and desensitisation/counterconditioning using noise recordings have been shown to improve fear of noises in dogs. Preventative training appears to be highly effective in preventing the development of noise fears in puppies and adult dogs.

Veterinary medicine, Zoology
DOAJ Open Access 2021
Association of menstrual pattern with lifestyle factors among female medical students

Garima Namdev, Sabiha Naz

Introduction: Menstrual disorders are more frequently observed among young females, especially medical students nowadays. Various lifestyle factors such as frequent consumption of fast foods, dietary habits, physical exercise, and yoga practicing play a very great role in alteration of menstruation pattern. All of these variables are affected by weight gain which is determined by body mass index (BMI), which itself affect menstrual pattern. Aims and Objectives: The aim of this study was to determine the association of menstrual pattern with lifestyle factors and BMI among medical students. Materials and Methods: A cross-sectional observational study was done among sixty undergraduate female medical students with the help of pretested and predesigned questionnaire consisting of menstrual pattern, premenstrual syndrome (PMS), and dysmenorrhea along with details about lifestyle factors. Anthropometric measurements such as weight, height, and BMI were also taken. Chi-square test was applied to test the association between menstrual pattern and lifestyle factors. Results: Out of total, 60% of students had regular cycle, 63% had dysmenorrhea, and 75% possess PMS. Majority of obese (65.2%) students had irregular cycle and 52.1% suffered from dysmenorrhea. Maximum 91% and 77.4% of students had regular cycle practicing yoga and physical exercise, respectively, whereas 86.2% of students suffered from PMS among those not exercising regularly. All of these findings were found statistically significant. Conclusion: More than half of students possess regular cycle. Overweight and obesity were found to be associated with irregular menstrual cycle and dysmenorrhea. Lifestyle factors such as yoga practicing, frequent consumption of fast foods, and regular physical exercise affect menstrual pattern in the present study.

Nursing, Homeopathy
DOAJ Open Access 2021
Cardiovascular benefits of Momordica charantia in cholesterol-fed Wistar rats

Silvanus Olu Innih, Ikechi Gerald Eze, Kingsley Omage

Abstract Background Momordica. charantia is popularly used as a medicinal herb in ethnomedicine for the management of cardiovascular diseases. In this study, we evaluated the beneficial effects of the ethanolic extract of M. charantia (Linn.) in experimentally induced cardiovascular disorders using cholesterol-fed Wistar rat. Methods Seventy-two experimental rats were randomly assigned into nine 9 groups of 8 rats each and treated as follows: Rats in group A (control) were given distilled water only; Rats in group B were given 30 mg/kg of cholesterol dissolved in coco-nut oil (cholesterol solution); Rats in group C were given cholesterol solution and 100 mg/kg Atorvastatin; Rats in group D were given 250 mg/kg of M. charantia and cholesterol solution; Rats in group E were given 500 mg/kg of M. charantia and cholesterol solution; Rats in group F were given 250 mg/kg. M. charantia; Rats in group G were given 500 mg/kg M. charantia; Rats in group H were given 1 ml of coconut oil; Rats in group I were given 100 mg/kg of Atorvastatin. Results Mean LDL-cholesterol was significantly (P < 0.05) lower in groups F, E and H as compared with the control groups. Histological analysis of the heart and aortic branch of the experimental rats show that cholesterol administration induced myocardial degeneration, vascular ulceration and stenosis in the aorta and heavy perivascular infiltrates of inflammatory cells. However, these deleterious effects were ameliorated upon treatment with Momordica charantia and Atorvastatin as compared with the control groups. Conclusion Our findings indicate the possible cardiovascular benefits of M. charantia.

Medicine, Homeopathy
DOAJ Open Access 2020
The utility of crab shell powder in the treatment of rickets

Ri Gon, Mi-Ra Pak, Ok-Son Ri et al.

Purpose: To estimate the effect of treatment for rickets by crab shell powder (CSP). Objects and Methods: We supplied children with rickets with calcium lactate and CSP and observed the serum concentrations of calcium, phosphorus, alkaline phosphatase (ALP) in preadministration and postadministration. Results: Postadministration serum concentrations of calcium, phosphorus, and ALP increased significantly compared to preadministration in both groups (P < 0.05), but significance between two groups is not recognized. Conclusion: The effective ratio of calcium lactate and CSP in the treatment for rickets has no difference, but CSP markedly decreased the incidence of concomitant disorders compared with calcium lactate.

Nursing, Homeopathy
DOAJ Open Access 2020
Nitrobenzene-induced hormonal disruption, alteration of steroidogenic pathway, and oxidative damage in rat: protective effects of Vernonia amygdalina

Johnson O. Oladele, Oyedotun M. Oyeleke, Oluwaseun T. Oladele et al.

Abstract Background Infertility is a global health burden which affect more than 15% of couples’ population. An impaired hormonal balance, oxidative stress and alteration in the physiological function of the reproductive organ are factors leading to infertility. The present study investigated the protective role of methanolic leaf extract of Vernonia amygdalina (MLVA) against Nitrobenzene-induced oxidative testicular damage and hormonal imbalance in rats. Thirty sexually active male wistar rats were sorted into five groups, each group containing six rats. Group I received distilled water while 100 mg/kg bw of Nitrobenzene was administered to groups (II, III, IV and V) to induce testicular damage and hormonal imbalance. Group III and IV were treated with oral administration of 200 mg/kg bw and 400 mg/kg bw of MLVA respectively and group V with vitamin E for 14 days. Results Nitrobenzene-treated rats showed significant (P < 0.05) decrease in the body weight gain, testis and epididymis weights. However, upon administration of MLVA or vitamin E, these changes were significantly reversed in Nitrobenzene-treated rats. Also, Nitrobenzene significantly (P˂0.05) induced endocrine disruption as shown by decreased activities level of serum Thyroid stimulating hormone (TSH), luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin, testosterone, triiodothyronine (T3), and tetraiodothyronine (T4). Administration of Nitrobenzene also induced oxidative damage as shown by increased level of testicular lipid peroxidation (MDA), and decreased levels of glutathione (GSH). Histological studies of the testes revealed mild congestion of interstitial vessels and oedema in rats administered Nitrobenzene only. Conclusion Taken together, MLVA obliterated the adverse effects of Nitrobenzene on the antioxidant enzymes, markers of testicular oxidative damage, endocrine and testicular structure in rats.

Medicine, Homeopathy
DOAJ Open Access 2020
<i>Artemisia absinthium</i> L.—Importance in the History of Medicine, the Latest Advances in Phytochemistry and Therapeutical, Cosmetological and Culinary Uses

Agnieszka Szopa, Joanna Pajor, Paweł Klin et al.

<i>Artemisia absinthium</i>—wormwood (Asteraceae)—is a very important species in the history of medicine, formerly described in medieval Europe as “<i>the most important master against all exhaustions</i>”. It is a species known as a medicinal plant in Europe and also in West Asia and North America. The raw material obtained from this species is <i>Absinthii herba</i> and <i>Artemisiae absinthii aetheroleum.</i> The main substances responsible for the biological activity of the herb are: the essential oil, bitter sesquiterpenoid lactones, flavonoids, other bitterness-imparting compounds, azulenes, phenolic acids, tannins and lignans. In the official European medicine, the species is used in both allopathy and homeopathy. In the traditional Asian and European medicine, it has been used as an effective agent in gastrointestinal ailments and also in the treatment of helminthiasis, anaemia, insomnia, bladder diseases, difficult-to-heal wounds, and fever. Today, numerous other directions of biological activity of the components of this species have been demonstrated and confirmed by scientific research, such as antiprotozoal, antibacterial, antifungal, anti-ulcer, hepatoprotective, anti-inflammatory, immunomodulatory, cytotoxic, analgesic, neuroprotective, anti-depressant, procognitive, neurotrophic, and cell membrane stabilizing and antioxidant activities. <i>A. absinthium</i> is also making a successful career as a cosmetic plant. In addition, the importance of this species as a spice plant and valuable additive in the alcohol industry (famous absinthe and vermouth-type wines) has not decreased. The species has also become an object of biotechnological research.

DOAJ Open Access 2020
In Vitro Antioxidant Activities of the Aqueous and Methanolic Stem Bark Extracts of (Schum.)

Gervason Moriasi MSc, Anthony Ireri PhD, Mathew Piero Ngugi PhD

Oxidative stress has been recognized as a key driver of many ailments affecting humankind. Free radicals attack biologically important biomolecules, impairing their functioning, thereby initiating and exacerbating diseases. As a comeback, antioxidant therapies have been proposed as novel approaches to ameliorating oxidative stress–associated diseases including chronic ones. Antioxidants are thought to employ multifaceted and multitargeted mechanisms that either restore oxidative homeostasis or prevent free radical buildup in the body, which overwhelm the endogenous defenses. Plants have been used for many ages across time to manage human diseases, and have a host of antioxidant phytocompounds. Piliostigma thonningii is traditionally used for the management of inflammation, malaria fever, rheumatism, and insanity, among other diseases caused by a disturbed redox state in the body. In this study, in vitro antioxidant activities of the methanolic and aqueous stem bark extracts of P. thonningii were evaluated using the in vitro antilipid peroxidation, the 1,1-diphenyl-2-picryhydrazyl (DPPH) free radical scavenging, and the ferric reducing antioxidant power assay methods. The obtained results revealed remarkable antioxidant activities of the studied plant extracts as evidenced by the low IC 50 and EC 50 values. These antioxidant activities could be due to the presence of antioxidant phytochemicals like flavonoids, carotenoids, tannins, and phenols, among others. Therefore, the therapeutic potency of this plant could be due to its antioxidant properties. This study recommends in vivo antioxidant efficacy testing of the studied plant extracts, as well as isolation and characterization of bioactive antioxidant compounds that are potent against oxidative stress.

Other systems of medicine, Homeopathy
DOAJ Open Access 2020
Acid Uric 3× Tablet: Standardization and pharmacological evidence of uric acid use as anti-gout medicine

Ayisha Shaukat, Khalid Hussain, Nadeem Irfan Bukhari et al.

Context: Despite being a causative agent of gout, uric acid is used as an anti-gout medicine in homeopathy without reported scientific evidence, and such highly diluted medicines lack the exact amount of active ingredient per dose, which is mandatory for pharmacological evaluation. Aims: To determine active contents per tablet and evaluate anti-gout and anti-inflammatory activities of Acid Uric 3× Tablet, a homeopathic anti-gout medicine. Methods: A simple RP-HPLC method was developed and validated for the determination of uric acid in Acid Uric 3× Tablet. The standardized tablet was then investigated for anti-gout activity using xanthine oxidase inhibition and potassium oxonate-induced hyperuricemia in rats models. The tablet was also investigated for anti-inflammatory activity employing both in vitro and in vivo models. Results: The developed HPLC method was found to be simple, sensitive and precise. Acid Uric 3× Tablet was found to contain 250 µg uric acid/tablet. This medicine inhibited xanthine oxidase activity (IC50 = 12.42 μg/mL) and lowered the serum uric acid in tablet-treated rats (1.02 mg/dL) as compared to toxic group (4.87 mg/dL). The tablet also showed anti-inflammatory activity in heat-induced protein denaturation (IC50 = 4.6 ± 1.0 µg/mL), anti-proteinase (IC50 = 4.64 ± 1.0 µg/mL), heat-induced RBC hemolysis (IC50 = 12.39 ± 1.5 µg/mL) and hypotonicity-induced hemolysis (IC50 = 11.31 ± 1.0 µg/mL). Moreover, significant anti-inflammatory activity was found in the carrageenan-induced rat-paw edema model at a dose of 0.132 mg/kg. Conclusions: The findings of the study indicate that the developed HPLC method may be used to standardize Acid Uric 3× Tablet and provide scientific evidence of lowering uric acid level.

Therapeutics. Pharmacology, Pharmacy and materia medica
DOAJ Open Access 2018
Development of a module to successfully implement competency-based medical education program in an institute

Saurabh Rambiharilal Shrivastava, Prateek Saurabh Shrivastava, Jegadeesh Ramasamy

Medical education aims to train students in such a way that they are empowered to meet the health needs of the population. Competency-based medical education (CBME) aims to ensure that the student acquires the desired competencies to meet the needs of people in a community and even addresses the constraints attributed to the conventional medical education. Institutes with an active CBME program in place, but in novice stages, have an immense need to sensitize the faculty or the postgraduate students about the different domains of CBME. Having a module, which is designed in a systematic and structured manner, can prove to be a wonderful tool to carry out the sensitization session. The overall process of preparation of a module goes through the stages of needs assessment, designing of the module, and finally the development of a module. To conclude, the presence of a structured module built on the comprehensive needs assessment can help an institute to successfully implement CBME within their setup.

Nursing, Homeopathy
DOAJ Open Access 2018
Feasibility of Homeopathic Treatment for Symptom Reduction in an Integrative Oncology Service

Noah Samuels MD, Yakov Freed MD, Rony Weitzen MD et al.

Background: Homeopathy has the potential to reduce symptoms related to cancer treatment. The present study examined the feasibility of a homeopathic consultation and treatment program, provided as part of an integrative oncology service. Methods: The electronic medical files of patients undergoing a homeopathic consultation in an integrative oncology service clinic were examined retrospectively. Adherence to the homeopathic treatment regimen and perceived response to the treatment were evaluated. Results: The files of 124 patient (34 males, 90 females) were examined, of which two-thirds reported acquiring and self-administering the homeopathic remedy as prescribed, and nearly three-quarters reporting a beneficial effect. Adherence to the homeopathic treatment regimen was greatest among patients attending a second visit, as opposed to having only telephone/e-mail follow-up ( P < .005). An association was found between a perceived beneficial effect of treatment with attending a follow-up visit ( P = .04), female gender ( P = .02), younger age ( P = .048), diagnosis of breast cancer ( P = .014), and current radiation treatment (vs chemotherapy; P = .003). Patients reporting chemotherapy-induced peripheral neuropathy were also more likely to report a beneficial effect ( P = .004), as were female patients reporting hot flashes ( P = .005) and those referred by an oncologist ( P = .046). No adverse effects were attributed to the homeopathic treatment. Conclusions: Homeopathy can be successfully incorporated within a supportive care integrative oncology service. In addition to demographic and cancer-related characteristics, as well as symptoms, patients attending a second visit (vs only telephone/e-mail follow-up) were more likely to adhere to and perceive a beneficial effect from the homeopathic regimen.

Neoplasms. Tumors. Oncology. Including cancer and carcinogens
DOAJ Open Access 2018
The Distinction of Hot Herbal Compress, Hot Compress, and Topical Diclofenac as Myofascial Pain Syndrome Treatment

Jurairat Boonruab PhD, Netraya Nimpitakpong MD, Watchara Damjuti PhD

This randomized controlled trial aimed to investigate the distinctness after treatment among hot herbal compress, hot compress, and topical diclofenac. The registrants were equally divided into groups and received the different treatments including hot herbal compress, hot compress, and topical diclofenac group, which served as the control group. After treatment courses, Visual Analog Scale and 36-Item Short Form Health survey were, respectively, used to establish the level of pain intensity and quality of life. In addition, cervical range of motion and pressure pain threshold were also examined to identify the motional effects. All treatments showed significantly decreased level of pain intensity and increased cervical range of motion, while the intervention groups exhibited extraordinary capability compared with the topical diclofenac group in pressure pain threshold and quality of life. In summary, hot herbal compress holds promise to be an efficacious treatment parallel to hot compress and topical diclofenac.

Other systems of medicine, Homeopathy
DOAJ Open Access 2017
African locust bean (Parkia biglobosa, Jacq Benth) leaf extract affects mitochondrial redox chemistry and inhibits angiotensin-converting enzyme in vitro

Kayode Komolafe, Afolabi C. Akinmoladun, Titilope R. Komolafe et al.

Abstract Background Parkia biglobosa leaf has popular ethnomedicinal use in tropical Africa. However, little is known about its molecular biological effects. This study sought to investigate the in vitro antioxidant activity, angiotensin-I-converting enzyme (ACE) inhibition and effects of aqueous-methanolic extract of P. biglobosa leaf (PBE) on mitochondrial membrane potential and reactive oxygen species (ROS) generation. Methods Antioxidant activity was determined by extract’s DPPH. (1,1-diphenyl-2-picrylhydrazyl radical), ABTS.+ [2,2′-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) diammonium salt radical cation] scavenging ability, reducing property and propensity to inhibit lipid peroxidation induced by prooxidants (FeSO4/sodium nitroprusside, SNP) in isolated rat tissue preparations. Determination of angiotensin-converting enzyme (ACE) inhibition was based on the hydrolysis of N-hippuryl-His-Leu hydrate (HHL) by the enzyme. Subsequently, the effects of PBE on toxicant-induced mitochondrial ROS formation and basal membrane potential (∆Ψm) were determined by 2′, 7′-dichlorodihydrofluorescin (DCFH) oxidation and safranine fluorescence respectively. Results PBE significantly reduced ferric ions (P < 0.001), scavenged DPPH (EC50 = 98.33 ± 1.0 μg/mL) and ABTS (EC50 = 45.30 ± 0.1) radicals, with moderate Fe2+- chelating effect (40%). In rat liver and brain homogenates respectively, PBE prevented membrane peroxidation induced by FeSO4 (EC50: 75.87 ± 2.1 μg/mL and 89.34 ± 2.5 μg/mL) and SNP (EC50: 28.10 ± 1.6 μg/mL and 17.25 ± 0.78 μg/mL). The extract’s inhibition of ACE (IC50 = 51.30 ± 5.1 μg/mL) and mild depolarization of isolated liver mitochondria membrane potential were concentration-dependent. Finally, PBE was more effective than catechin in attenuating calcium and SNP-induced surge in mitochondrial ROS generation. Conclusion Parkia biglobosa leaf exhibits considerable ACE inhibitory effect, antioxidant activity and affects mitochondrial redox chemistry. These present findings also justify the ethnobotanical applications of the plant in the indigenous system of medicine.

Medicine, Homeopathy
DOAJ Open Access 2017
The Current Studies of Education for a Traditional and Complementary Medicine in Malaysia

Yun Jin Kim PhD

The aim of this study is to understand the current tradition and complementary medicine (T&CM) education in Malaysia. We referred to literature regarding to traditional medicine education in Malaysia, and collected the information via website or interview with faculty of T&CM in universities/colleges and Division of T&CM, Ministry of Health, Malaysia. T&CM education in Malaysia has been following China’s T&CM systems for 50 years. Currently, Division of T&CM, Ministry of Health; and Ministry of Higher Education has approved 11 institutions to offer T&CM education. Students may major in Chinese herbal medicine, acupuncture, or other T&CM subjects. Generally, clinical training programs in China, Taiwan, or Australia include substantial proportion of clinical training. We report on the general information of T&CM education in Malaysia. This result would be the first-stage information for the establishment of a strategy regarding the enhancement of T&CM education in Malaysia.

Other systems of medicine, Homeopathy
DOAJ Open Access 2017
Survey on the use of Homeopathy among Pediatricians of the Italian Federation of Pediatric Physicians (FIMP) [Article in English and Italian] • [Indagine sull’utilizzo dell’Omeopatia tra i Pediatri della Federazione Italiana Medici Pediatri (FIMP)]

Gianfranco Trapani, Tiziana Di Giampietro, Luisella Zanino et al.

ENGLISH TEXT: The use of Complementary Alternative Medicine (CAM), and more specifically of Homeopathy, is common among the pediatric population in Italy. In order to verify the attitude of family pediatricians (pediatri di famiglia) towards the use of Homeopathy, a survey has been carried out among 5,399 (number of doctors who received the questionnaire) family pediatricians enrolled in the Italian Federation of Pediatric Physicians (Federazione Italiana Medici Pediatri, FIMP) by means of an online questionnaire. The response has been significant (1,252 questionnaires have been filled in, corresponding to 23.19% of the total submitted) and has highlighted that 29.4% of the pediatricians who took part in the survey use homeopathic medicine to cure their patients. The study has also analyzed several other parameters related to the use of Homeopathy, including age and pediatric education, most commonly treated diseases, pharmaceutical forms and possible adverse effects. ITALIAN TEXT: L’impiego delle Medicine Complementari e Al­ter­native (Complementary Alternative Medicine, CAM), e più spe­cifica­men­te dell’Omeopatia, è comune tra la popolazione pediatrica in Italia. Allo scopo di verificare l’attitudine dei pediatri di famiglia nei confronti dell’utilizzo dell’Omeopatia, è stata condotta un’indagine, tramite un questionario online, tra i 5.399 (numero di medici che ha ricevuto il questionario) pediatri di famiglia appartenenti alla Federazione Italiana Medici Pediatri (FIMP). Il riscontro è stato significativo (1.252 questionari, corrispondenti al 23,19% di quelli inviati, sono stati compilati ) ed ha evidenziato che il 29,4% dei pediatri che hanno risposto all’indagine utilizza la medicina omeopatica per curare i propri pazienti. Lo studio ha anche analizzato alcuni altri para­metri correlati all’impiego dell’Omeopatia, inclusi l’età e la formazione dei pediatri, le patologie più frequentemente trattate, le forme farmaceutiche utilizzate e i possibili effetti avversi.

Medicine, Pediatrics
DOAJ Open Access 2016
Bovine Mastitis in Cuba. Review article

Amado Ruiz Gil , Joan Peña Rodríguez , Dianys Remón Díaz

Mastitis is the main disease affecting dairy cattle. Reducing it is one of the most important tasks Cuban cattle raising has today. Hence, it is essential to know the national background, and related research contribution. The literature shows that the frequency of mastitis caused by wellknown pathogens has declined; whereas mastitis caused by minor pathogens is more frequent. Research on the incidence of mastitis should be done in the eastern part of the country. The economic losses associated to the disease, antimicrobial sensitivity of the microorganisms involved, and the differences between mechanical and manual milking must be further researched as well. Somatic cell count must also be extended to the rest of the country. Milking routine and hygiene should be improved, increased production of medication to control mastitis, and implementation of research on natural products and alternative treatments must be encouraged (homeopathy and Eucalyptus). A program to control bovine mastitis would be useful, based on recent research done in Cuba, including several products made in the country. Updated international methods to fight the disease are based on state of the art methodologies.

Animal culture
DOAJ Open Access 2015
Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial.

Emma Del Carmen Macías-Cortés, Lidia Llanes-González, Leopoldo Aguilar-Faisal et al.

<h4>Background</h4>Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.<h4>Methods/design</h4>A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).<h4>Results</h4>After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.<h4>Conclusion</h4>Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.<h4>Trial registration</h4>ClinicalTrials.gov NCT01635218.<h4>Protocol publication</h4>https://clinicaltrials.gov/ct2/show/NCT01635218 [corrected].

Medicine, Science

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