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Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum ( n  = 30; IHMs plus concomitant care) versus control ( n  = 30; placebos plus concomitant care). Outcome measures: Primary-Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary-Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: all of them were measured at baseline, and every month, up to 3 months. Results: Intention-to-treat sample ( n  = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p  < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI ( p  = 0.044), SFI ( p  = 0.080), and RMPDQ scores ( p  = 0.134), but were significant for SF-MPQ ( p  = 0.007) and OLBPQ ( p  = 0.036). Gnaphalium polycephalum ( n  = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings. Clinical Trial Registration Number: CTRI/2020/10/028617.

This study aimed to assess the effectiveness and safety of intravesical instillation treatment of Kangfuxin liquid (KFL) combined with thrombin and epidermal growth factor (EGF) for radiation-induced hemorrhagic cystitis (HC) in patients with cervical cancer. A total of 34 patients with radiation-induced HC of grade 2-4 were treated with intravesical instillation of KFL combined with thrombin and EGF until the complete disappearance of hematuria and lower urinary tract symptoms (LUTS). Gentamicin was added if white blood cells were detected and bacterial culture was positive in the urine. All patients were followed up for 2 years to evaluate the clinical efficacy and safety of the treatment regimen. Patients with and without recurrent hematuria (n = 3, 9% and n = 31, 91%, respectively) were completely recovered from hematuria and LUTS by intravesical instillation treatment for 6-22 days. No adverse event was reported during the treatment and the 2-year follow-up for all patients. Thus, intravesical instillation of KFL combined with thrombin and EGF is an effective and safe therapeutic regimen for radiation-induced HC of grade 2-4 in patients with cervical cancer.

Background: In recent years, the incidence of ulcerative colitis (UC) is on the rise, and most of them are young adults. As the peak of the disease overlaps with the childbearing age, it has a great impact on the fertility of female patients. We, therefore, conduct a randomized and controlled trial to evaluate the efficacy and safety of mesalazine enteric-coated tablets combined with Kangfuxin Liquid (KFX) enema for the child-bearing period female with active UC., Methods: In this randomized controlled study, a total of 236 eligible patients will be assigned to the experimental group (n = 118) or the control group (n = 118) in a 1:1 ratio. The control group will be taken mesalazine enteric-coated tablets combined with placebo enema and the experimental group will be taken mesalazine enteric-coated tablets combined with KFX enema. Participants will receive 8 weeks of intervention treatment and 3 months of maintenance treatment before pregnancy. The primary assessment is the Mayo score. Secondary outcomes include mucosal healing, faecal calprotectin (FC), Inflammatory Bowel Disease Quality (IBDQ), and pregnancy outcome., Discussion: This study will provide evidence regarding the efficacy and safety of KFX enema used before pregnancy on halting active UC, reducing the relapse rate during pregnancy, improving pregnancy outcome, and the quality of life., Trial Registration: Chinese Clinical Trials Register identifier, ChiCTR2000039161, registered on October 20, 2020., Competing Interests: The authors have no conflicts of interests to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Kangfuxin (KFX), a well-known Chinese patent medicine which extracted from Periplaneta americana, is widely used as an adjuvant in the treatment of peptic ulcers (PUs) with proton pump inhibitors (PPIs) such as rabeprazole, in China. However, no clear consensus has been reached on the efficacy for PU treatment., Methods: We searched in 7 electronic databases to find randomized controlled trials (RCTs) completed before May 31, 2020 to explore the clinical efficiency of KFX plus rabeprazole in the treatment of PU. Risk ratio (RR) corresponding to 95% confidence interval (CI) was calculated to estimate the outcomes. Publication bias was assessed by both Egger's and Begg's tests. Statistical analyses were performed using RevMan 5.4 and Stata version 10.0., Results: Twenty-five RCTs, comprising 2555 PU patients, were included in this study. Meta-analysis showed that, when compared with rabeprazole-based treatment alone, KFX plus rabeprazole significantly improved the healing rate (RR = 1.34, 95% CI 1.25-1.44) and overall response rate of ulcers (RR = 1.16, 95% CI 1.13-1.20), alleviated the clinical symptoms of PU (RR = 1.14, 95% CI 1.08-1.21), and reduced the recurrence of PU (RR = 0.38, 95% CI 0.24-0.61) without an increase in the occurrence of adverse events (RR = 0.92, 95% CI 0.66-1.28)., Conclusion: Our study suggests that KFX combined with rabeprazole showed positive therapeutic effects and is safe for treating PU, which may provide more reliable evidence for the clinical use of KFX in the treatment of PU.

BACKGROUND The aim of this study was to analyze the clinical application of cortex phellodendri compound fluid (CPCF) in the treatment of diabetic foot ulcers. MATERIAL AND METHODS From January 2012 to December 2015, a total of 720 cases of diabetic foot ulcers (DFU) were randomly assigned into an experimental group (n=540) that was treated by CPCF and a control group (n=180) that was treated by a Kangfuxin solution (KFS). After 4 weeks of treatment, their ulcer area, serum growth factor, clinical total effective rate, and incidence of adverse events were assessed. RESULTS There were 720 patients who completed the trial. The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05). There was no significant difference in the adverse events rates between the 2 groups. CONCLUSIONS CPCF external treatment of diabetic foot ulcer can promote ulcer healing and increase the concentration of growth factors, and it is safe and reliable.

The pharmacokinetics of Chinese materia medica (PCMM) has made a great contribution to investigations of the in vivo process of various components in Chinese materia medica (CMM), intending to provide useful information for clinical guidance related to CMM. However, some issues are worthy of further consideration, and current PCMM studies face a substantial challenge. First, high-dosage administration is prevalent in PCMM studies, and the obtained results might be meaningless and inappropriate for guiding the clinical application of CMM, as they deviate from clinical practice. Improvements in instrument sensitivity have not reduced the prevalence of high-dosage administration. In addition, the selection of components for detection in PCMM studies is usually uncertain, lacking sufficient scientific support, especially for components without clarified bioactivities. Therefore, the scientific value of current PCMM studies is limited. We believe that these abnormalities can be attributed to the poor recognition of the characteristics of CMM and the improper application of research approaches from Western medicines. Currently, the more pressing key scientific issues for CMM should be clinical effectiveness, quality control and bioactivity discovery, which are closely related to its own characteristics and are beneficial to its modern developments., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interests., (Copyright © 2020 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

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., (© 2020 The Authors. Brain and Behavior published by Wiley Periodicals, Inc.)

Context: Kangfuxin (KFX) is widely used for the treatment of gastric and duodenal ulcer; however, more research is needed to determine the protective mechanisms of KFX in ameliorating gastric ulcer. Objective: To investigate the efficacy and potential mechanism of Kangfuxin liquid (KFX) in water-immersion and restraint stress (WIRS)-induced gastric ulcer. Materials and methods: Seventy rats were randomly divided into seven groups ( n  = 10) as follows: the control group (normal saline, i.g.), the model group (normal saline, i.g.), the KFX groups (2.5, 5 and 10 mL/kg, i.g.), the omeprazole group (20 mg/kg, i.p.) and Sanjiuweitai Granules group (1850 mg/kg, i.g.). The WIRS model was applied to induce stress ulcers after 7 days of drug administration. Afterwards, rats were sacrificed at 10 h induced by WIRS. Results: Pre-treatment with KFX (5,10 mL/kg) could effectively reduce the area of gastric ulcers and improve the pathological changes of ulcerated tissue. Moreover, KFX (5,10 mL/kg) increased the prostaglandin E2 (52%) and cyclooxygenase-1 (30%) levels, and improved malondialdehyde (54%), superoxide dismutase (58%), catalase (39%), and nitric oxide (11%) and TNF-α (9%), IL-6 (11%), MMP-9 (54%) and MMP-2 (53%) of ulcer tissue. Furthermore, pre-treatment with KFX dramatically increased IGF-1, PTEN, and Akt protein expression. Conclusions: Our results suggest that KFX has protective effects on WIRS-induced gastric ulcer via inflammatory reactions, oxidative stress inhibition, and pro-survival action, which were the results of activating the IGF-1/PTEN/Akt signalling pathway. Our results provide evidence of KFX for treating gastric ulcer.

The wound healing effects of pharmaceutic preparations of Periplaneta americana, Kangfuxin liquid, have been widely utilized in clinics. However, its wound repair efficacy is limited due to short retention capability on cutaneous wound location. Herein, Periplaneta americana extract (PAE), which showed pro-fibrogenic and pro-angiogeneic effects, was embedded into hydrogel film (PAE/Film) by solution cast method by blending polyvinyl alcohol, hydroxypropyl chitosan and carbomer at the weight ratio of 78/6/3, with glycerol as plasticizer. PAE/Film exhibited smooth, flexible, and excellent swelling ability (WVTR of 2464 ± 31.5 g/m 2 /day), characterized by scanning electron microscopy, Fourier transform infrared spectroscopy, and differential scanning calorimetry, meting the condition of ideal wound dressing. The superior wound healing capacity of PAE/Film was demonstrated that it significantly accelerated wound healing process in vivo in both full-thickness skin defect and scald wounded models. Compared to saline, blank vehicle (drug-free) and free PAE group, PAE/Film could accelerate wound healed, promote re-epithelialization and collagen deposition by means of TGF-β/Smad signal pathway activation. Taken together, this novel hydrogel film-loading PAE would be a useful pharmaceutic candidate for acute cutaneous wound health care., (Copyright © 2019. Published by Elsevier B.V.)

Rationale: Methotrexate (MTX) is an antimetabolite of folic acid, which is used for management of ectopic pregnancy. MTX-related toxicity may include cutaneous mucosal damage, bone marrow suppression, gastrointestinal disorders (gastritis, diarrhea, hematitis), liver and kidney function damage, pulmonary toxicity, cardiac toxicity, and nerve toxicity. However, it is not usual for vulvar edema induced by low-dose methotrexate., Patient Concerns: In this case report, we described a patient with severe vulvar edema and oral cavity ulceration and scalp ulceration induced by low-dose MTX treatment for ectopic pregnancy. Her presenting complaints were pain in the vulva, oral cavity, and scalp., Diagnoses: The patient was diagnosed based on clinical findings for MTX toxic reactions., Interventions: Vulva was disinfectioned with iodide and Kangfuxin solution, her mouth was rinsed with mouthwash. Three compound glycyrrhizin tablets were orally administered (3 times/day). After 10 days, the broken skin and mucous membrane healed., Outcomes: The vulvar edema and oral cavity ulceration and scalp ulceration healed., Lessons: Our study demonstrated that even low-dose MTX can be induced skin and mucosal injury, patients and doctors should timely detection of drug toxicity reactions, immediately rescue, prompt discontinuation of medication, and symptomatic treatment to avoid accidental occurrence.

Lamb farming is generally a secondary activity for farmers, and many breeding systems suffer from management failures that impair production. One reason for decline in performance is enteritis, usually affecting newborn lambs. Enteritis can be fatal, especially in dairy herds. Generally, lambs are fed sucrose or unprocessed milk from sheep or cow that is heated and fed to animals two or three times a day in baby bottles. However, on most farms, milk temperature differs among feeds, as often the process of alteration among diet adaptations is deficient, contributing to enteritis and consequent diarrhea. Therefore, the objective of the present study was to verify the administration of the homeopathic product (Dia 100 ® ) in newborn and bottle-fed lambs, in order to prevent or minimize the occurrence of diarrhea. We studied 60 lambs, divided into two groups with ten repetitions each (n = 30) and during the nursing period (1-45 days of life). Animals in the treated group received the homeopathic product (36 g) orally divided into three doses (1, 7 and 14 days of life). We measured weight gain, mortality, bacterial counts (Escherichia coli and total coliforms) in feces, hematological analysis (leukocytes, hematocrit, hemoglobin and erythrocytes) and biochemical analyses (glucose, triglycerides, cholesterol, albumin, globulin, urea and total protein) at four time-points. There were no differences in weight gain between groups (P > 0.05); however, there was a higher mortality rate in the control group (13%) than in the treated group (6%). E. coli counts were significantly higher in the stools of control group lambs on days 15 and 45 of the experiment (P < 0.05). Total leukocyte counts were greater in treated animals due to greater numbers of lymphocytes on day 15 of the experiment (P < 0.05). In the treated group, we found higher serum levels of total protein, urea (day 15), globulin and triglycerides (days 15 and 30). In the period of administration of the homeopathic product, there was substantial and significant reduction of cases of diarrhea (up to day 14); however, after this period, there were no difference between groups. Based on these results, we concluded that the homeopathic product had moderate efficacy in terms of control of diarrhea. The treated lambs made better use of nutrients, contributing to the development of their immune responses., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Primary tooth eruption in infants is associated with a range of local and systemic symptoms although this remains a subject of much debate. In addition, data are limited on the role of physicians in managing infant teething, and on the benefit of homeopathic treatments., Methods: We conducted an observational, multicenter, prospective survey evaluating teething symptoms, and symptom course following routine medical management by French pediatricians in 597 infants aged from 3 to 24 months. We also examined the response to treatment with routinely prescribed teething medications; the homeopathic agent, Camilia® and topically applied gingival agents (Delabarre® or Dolodent®)., Results: Most infants (96.6%) had buccogingival symptoms and 93.3% had at least one general symptom. Fever (≥38 °C) was reported in 15.2% of infants. For teething, 212 infants were prescribed Camilia®, 172 a gingival solution (Delabarre® or Dolodent®) and 213 received Camilia® along with a gingival agent. Infants prescribed both a homeopathic and a gingival treatment had a significantly higher number of symptoms at presentation compared with those prescribed a single agent. There were no significant differences in symptom course across these three treatment groups. Systemic analgesics/antipyretics were prescribed in 68.8% of cases. Parent satisfaction with medical management and prescribed treatments was high., Conclusions: Teething is frequently associated with transient local and systemic upset in infants and is a significant concern to parents. Camilia® provides a similar benefit to topical therapy, and is frequently used by pediatricians in France.

Background: Homeopathic vaccines are licensed in many countries but scientific data to support their use are sparse. The goal of this study was to compare the antibody response of homeopathic and conventional vaccines and placebo in young adults. We hypothesized that there would be no significant difference between homeopathic vaccines and placebo, while there would be a significant increase in antibodies in those received conventional vaccines., Methods: A randomized blinded placebo-controlled trial was conducted where 150 university students who had received childhood vaccinations were assigned to diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines. The primary outcome was a ≥ two-fold increase in antibodies from baseline following vaccination as measured by ELISA. Participants, investigators, study coordinator, data blood drawers, laboratory technician, and data analyst were blinded., Results: None of the participants in either the homeopathic vaccine or the placebo group showed a ≥ two-fold response to any of the antigens. In contrast, of those vaccinated with Tdap, 68% (33/48) had a ≥ two-fold response to diphtheria, 83% (40/48) to pertussis toxoid, 88% (42/48) to tetanus, and 35% (17/48) of those vaccinated with MMR had a response to measles or mumps antigens (p < 0.001 for each comparison of conventional vaccine to homeopathic vaccine or to placebo). There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo., Conclusions: Homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated., Trial Registry: NCT 02825368., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Homeopathy has been widely used to treat side effects of chemotherapy. The n-of-1 design is a single-patient trial method to study a clinical condition that is either short lived and reversible or is chronic and stable. The n-of-1 design requires a washout/reset period. The feasibility of performing an n-of-1 study in homeopathy has not previously been tested., Methods: A feasibility n-of-1 trial of individualized homeopathic treatment for fatigue in a single adult undergoing chemotherapy administered periodically was performed. For each matched pair of treatments, the participant was randomly allocated either placebo or verum for the period between treatments. For the subsequent treatment period, the opposite allocation was given. Participant and practitioner were blinded to the allocation. Ongoing conventional treatments were permitted. The ability to recruit and retain was monitored and changes in fatigue and quality of life were measured using two validated outcome measures., Results: Sixty-eight patients were assessed between February 2014 and February 2015. Four patients were eligible for the study and one consented to participate. The participant enrolled in the study for six cycles of chemotherapy and completed all treatment and outcome measures. There was no improvement under homeopathic treatment compared to placebo. There were multiple confounding events such as conventional medication changes and an adverse event unrelated to therapy., Conclusion: Adequate recruitment was not feasible in this setting. The n-of-1 study design is feasible in this population from the perspective of the ability to complete the trial. No conclusion on the efficacy of homeopathy for this individual can be made. It is unclear as to whether multiple treatments of chemotherapy would be an appropriate clinical situation in which to apply the n-of-1 trial methodology. Future studies should pilot adaptations to this study design., Competing Interests: None., (The Faculty of Homeopathy.)

Background: Contact dermatitis (CD) is a frequently occurring medical condition, for which Vinca minor (VM) is one of the recommended homeopathic medicines. However, the symptoms indicating this medicine have not yet been assessed systematically. Likelihood ratio (LR), based on Bayesian statistics, may yield better estimation of a medicine's indication than the existing method of entry of symptoms into materia medica and repertories., Methods: We investigated LRs of four CD symptoms of VM: (1) great sensitiveness of skin, with redness and soreness from slightest rubbing; (2) weeping eczema with foul, thick crusts; (3) itching amelioration in open air; and (4) CD of scalp. An observational, prospective, patient-outcome study was conducted in five different practice settings on 390 CD patients over 18 months using three outcomes-Glasgow Homeopathic Hospital Outcome Scale (GHHOS), Scoring Atopic Dermatitis (SCORAD), and Dermatology Life Quality Index (DLQI), assessed at baseline, after 3 and 6 months. The LR of each of the four symptoms was estimated as per the patient-rated outcomes on GHHOS., Results: Seventy-four VM and 316 non-VM cases were analyzed. Estimated LRs were as follows: symptom 1, 1.29 (95% confidence interval [CI]: 0.65 to 2.60); symptom 2, 1.48 (95% CI: 0.80 to 2.74); symptom 3, 1.70 (95% CI: 0.94 to 3.07); symptom 4, 1.36 (95% CI: 0.74 to 2.51). There were statistically significant reductions in SCORAD and DLQI scores over 3 and 6 months., Conclusion: There was insufficient evidence to attribute any of the four assessed symptoms clearly to VM. Though non-significant, a high LR was observed for "itching amelioration in open air" (symptom 3). Symptoms in the homeopathic materia medica for VM are perhaps over-represented. More research of this nature is warranted., Competing Interests: We declare no conflict of interest. The study was performed as PhD thesis of the corresponding author., (The Faculty of Homeopathy.)

Recurrent aphthous ulcer (RAU) is a common and frequently occurring disease in the Department of Stomatology. The clinical manifestations are localized ulcer of oral mucosa, and the ulcer mask is self limiting and easy to recur. In this paper, by adopting the randomized study method, the author study the effect of oral ulcer powder combined with traditional Chinese drugs on patients with recurrent aphthous ulcer, and analyze its effect on inflammatory factor. Kangfuxin liquid combined with oral ulcer powder helps reduce recurrent aphthous ulcer patients the levels of inflammatory factors, improve the symptoms of pain. The recurrence rate of the patients in the observation group for 6 months was 12.8%, which was significantly lower than that of the control group (31.42%). The difference was statistically significant (P<0.05). At the same time, the average TNF-a, IL-1 and IL-6 water in the observation group were significantly lower than that of the control group, proving that the treatment regimen could reduce the inflammatory response.

Context • Pertussis cough (whooping cough) is distressing due to the intensity and chronicity of its cough. No specific drugs are available that can alleviate the cough's intensity or significantly shorten its duration. Homeopathic medicines are used for a wide variety of medical conditions, including cough. Objective • The study investigated the benefits of homeopathic medicines for whooping cough, to alleviate the cough's intensity and to shorten its duration. Design • The current study was a case series of patients with whooping cough. Setting • The study took place at one of the suburban hospital clinics of the Ann & Robert H. Lurie Children's Hospital of Chicago (Chicago, IL, USA). Participants • Participants were 20 patients aged 21 mo to 20 y, of whom 11 were female and 18 were male, who visited the hospital clinic for treatment of the chronic cough that is characteristic of whooping cough. The details of the cases of 3 representative participants are highlighted in the text. Intervention • The 3 representative patients all received 1 dose weekly of a 30c dilution of homeopathic pertussinum and a 6c dilution of homeopathic Drosera 3 times daily. The homeopathic medicines most often used for the other participants were the same doses of pertussinum and Drosera. Outcome Measures • Verbal feedback from patient or family were obtained at the follow-up visits. Results • The intensity and duration of participant's coughs were alleviated within days to 1 wk in most cases. Conclusions • Homeopathic medicines can alleviate the intensity or reduce the duration of whooping cough, with no adverse effects.

Background: Among the post-immunization adverse events, especially of Diphtheria-Pertusis-Tetanus (DPT), fever is a common systemic reaction. There is anecdotal support for the use of the homeopathic medicine Arsenicum album in preventing post-vaccination fever. The investigators intended to evaluate its efficacy in preventing febrile episodes following vaccination., Methods: In the community medicine out-patient of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India, between August 2014 and January 2017, a double-blind, randomized, placebo-controlled trial was conducted on 120 children (verum: 60, placebo: 60) who presented for the 2nd and 3rd dose of DPT-HepB-Polio vaccination and reported febrile episodes following the 1st dose. Intervention used was Arsenicum album 30cH 6 doses or placebo (indistinguishable from verum), thrice daily for two subsequent days. Parents were advised to report any event of febrile attacks within 48h of vaccination, either directly or over telephone., Results: The groups were comparable at baseline. Children reporting fever after the 2nd dose was 29.8% and 30.4% respectively for the homeopathy group and control group respectively [Relative Risk (RR)=1.008] with no significant difference (P=0.951) between groups. Again after the 3rd dose, children reporting fever were 31.5% and 28.3% respectively for the homeopathy group and control group respectively (RR=0.956) with no significant difference (P=0.719) between groups., Conclusion: Empirically selected Arsenicum album 30cH could not produce differentiable effect from placebo in preventing febrile episodes following DPT-HepB-Polio vaccination. [Trial registration: CTRI/2017/02/007939]., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Scopo della presente trattazione è promuovere la consapevolezza del pediatra nei confronti della sintomatologia legata alla dentizione nei bambini con il supporto delle evidenze più significative reperibili nella letteratura scientifica. Dopo la caratterizzazione dei disturbi più comuni, con la relativa incidenza e durata nella popolazione pediatrica, e del ruolo dell'infiammazione saranno definiti i limiti delle terapie attualmente disponibili. Saranno quindi illustrate le prerogative di un medicinale omeopatico, Camilia® (Boiron, Francia), che interviene sull'infiammazione locale e sistemica e sulla composita fenomenologia correlata al processo di dentizione, con il vantaggio di un'azione multifunzionale ed efficace e l'assenza di effetti indesiderati o rischi di interazione con altri farmaci.

Ethnopharmacological Relevance: What are the minimum methodological and conceptual requirements for an ethnopharmacological field study? How can the results of ethnopharmacological field studies be reported so that researchers with different backgrounds can draw on the results and develop new research questions and projects? And how should these field data be presented to get accepted in a scientific journal such as the Journal of Ethnopharmacology? The objective of this commentary is to create a reference that covers the basic standards necessary during planning, conducting and reporting of field research., Materials and Methods: We focus on conducting and reporting ethnopharmacological field studies on medicinal plants or materia medica and associated knowledge of a specific people or region. The article highlights the most frequent problems and pitfalls, and draws on published literature, fieldwork experience, and extensive insights from peer-review of field studies., Results: Research needs to be ethical and legal, and follow local and national regulations. Primary ethnopharmacological field data need to be collected and presented in a transparent and comprehensible way. In short this includes: 1) Relevant and concise research questions, 2) Thorough literature study encompassing all available information on the study site from different disciplines, 3) Appropriate methods to answer the research questions, 4) Proper plant use documentation, unambiguously linked to voucher specimens, and 5) Qualitative and quantitative analyses of the collected data, the latter relying on use-reports as basic units., Conclusion: Although not exhaustive, we provide an overview of the necessary main issues to consider for field research and data reporting including a list of minimal standards and recommendations for best practices. For methodological details and how to correctly apply specific methods, we refer to further reading of suggested textbooks and methods manuals., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Esophageal variceal bleeding is a common lethal complication of cirrhosis. Endoscopic injection sclerotherapy (EIS) is one of the major endoscopic approaches for treating esophageal variceal bleeding. However, complications may occur after EIS, which mainly include retrosternal discomfort/pain, dysphagia, re-bleeding, esophageal ulcer, esophageal strictures, and esophageal perforation, etc. In this article, we reported a 36-year-old male who developed esophageal ulcer related bleeding after EIS. Currently, there is no consensus on the treatment strategy for esophageal ulcer-related bleeding after EIS. In the present case, the following treatment strategy may be effective for ulcer related bleeding. The first step is to inhibit gastric acid secretion and reduce portal pressure by intravenous infusion of esomeprazole and somatostatin, respectively. The second is local hemostasis by oral norepinephrine and lyophilizing thrombin powder. The third is to protect digestive tract mucosa by oral Kangfuxin Ye and aluminum phosphate.

This study was designed to evaluate the gastroprotective effect of Kangfuxin (KFX), a Chinese patent medicine constituent isolated from American cockroach, on ethanol-induced gastric ulcer in mice and to elucidate the potential mechanisms of the effect involved. According to the results, mice treated with alcohol appeared obvious gastric mucosal injury, while treatment with Cimetidine (a positive control) and KFX significantly relieved the damage, along with decreased oxidative stress and apoptosis indexes. Subsequently, we conducted a label-free quantitative proteomic (LFQ) and found that NF-κB and PI3K/AKT signaling pathway participated in gastroprotective effect of KFX. Furthermore, Western blot analysis revealed that KFX treatment inhibited the expression of TNF-α, IL-1β, greatly reduced the phosphorylation level of IκB and repressed the nuclear translocation of NF-κB p65, which demonstrated that KFX inhibited the activation of NF-κB pathway. Meanwhile, the PI3K/AKT pathway was also involved in regulating the anti-inflammation effect. These findings define for the first time that the gastroprotective effects of KFX against gastric ulcer can be attributed to its role in NF-κB inhibition., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Ethnopharmacological Relevance: Oviductus ranae (OR) is a traditional animal-based Chinese medicine, which has been listed in the Chinese Pharmacopoeia since 1985 edition. Although its medicinal application has been widely acknowledged, there is little available information on its potential toxicity., Aim of the Study: The aim of this study was to investigate the acute, sub-acute, and genetic toxicities of OR., Materials and Methods: In acute toxicity evaluation, OR was administered orally to mice at doses of 2.5, 5.0, 10.0, and 20.0g/kg BW for one time. Mortality, clinical signs, and body weight were observed for 14 days after treatment. In sub-acute toxicity evaluation, OR was administered orally to rats once a day for 28 consecutive days at doses of 1.75, 3.50, and 7.00g/kg BW. Animals were observed for general behaviors, mortality, food intake, and body weight changes. At the end of treatment, relative organ weight, pathology, hematological and biochemical parameters were monitored. In genotoxicity evaluation, bacterial reverse mutation assay (Ames test) was performed by treating OR with four different Salmonella typhimurium strains at doses of 8, 40, 200, 1000, and 5000μg/plate without or with S-9 mix, respectively. The genotoxicity of OR was also evaluated by micronucleus and sperm malformation assays in mice at doses of 2.5, 5.0, and 10.0g/kg BW, respectively., Results: The results of acute toxicity study showed that the LD 50 value of OR is higher than 20.0g/kg BW in mice. Death and abnormal clinical symptoms were not found during the period of experiment. In sub-acute toxicity, we found that the no-observed-adverse-effect levels (NOAEL) of OR in rats is up to 7.00g/kg BW. No statistically significant or toxicologically relevant defferences in body weight, food intake, relative organ weight, pathology, hematological and biochemical parameters were observed, when compared with control group. Results of Ames test, micronucleus and sperm malformation assays indicated that OR has no mutagenicity in vitro at a limited dose of 5000μg/plate, and dose not induce micronuclei and sperm malformation in mice at the dose of up to 10.0g/kg BW in mice., Conclusions: In conclusion, OR is a tranditional Chinese medicine with high safety., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Objective: To evaluate the effects of homoeopathic ultrahigh dilutions of Aconitum napellus in Baker's yeast-induced fever in rabbits., Methods: Rabbits were divided into 4 groups and each group contained 6 rabbits. Baker's yeast suspension (20%) was injected subcutaneously. After fever induction, paracetamol and homoeopathic ultrahigh dilutions (A. napellus 200c and 1 000c) were given orally. Rectal temperature was measured with digital thermometer hourly., Results: Fever was induced in all the rabbits after 4 hours of Baker's yeast administration. A. napellus 200c and 1000c significantly reduced the temperature (P < 0.05). In positive control, temperature decrease was more significant (P < 0.001)., Conclusion: The above findings indicate the effectiveness of ultrahigh dilutions of A. napellus in Baker's yeast-induced fever in rabbits. However, the effects were slower and less significant than standard medicine. Moreover, future research is required to know their mechanism of reducing temperature.

The objective of the present study was to evaluate the effectiveness of the application of homeovox for the combined treatment of small vocal cord nodules and acute laryngitis in the professional voice users. A total of 40 subjects presenting with dysphonia were examined after they were divided into two study groups and two groups of comparison depending on the nosological form of the pathological condition. The subjects comprising the study groups were given traditional therapy in the combination with the intake of homeovox whereas the patients included in the two groups of comparison received the traditional treatment alone. The outcome of the treatment was evaluated on days 1, 5, and 10 after the initiation of therapy based on the analysis of the changes in the videoendostroboscopic picture of the larynx and the acoustic characteristics obtained by the computer-assisted analysis of the voice. The analysis of the results of the combined treatment has demonstrated the statistically significant differences in some acoustic parameters of the voice between the subjects with small vocal cord nodules and acute laryngitis belonging to the study groups and the groups of comparison. It is concluded that the introduction of homeovox in the combined treatment of the patients presenting with the small nodules in the vocal cords and acute catarrhal laryngitis accelerates the recovery of the acoustic characteristics of the voice within various periods after the onset of the treatment in comparison with the patients treated with the use of traditional therapy alone.

Silicosis is an occupational pulmonary fibrosis caused by inhalation of silica (SiO 2 ) and there are no ideal drugs to treat this disease. Earthworm extract (EE), a natural nutrient, has been reported to have anti-inflammatory, antioxidant, and anti-apoptosis effects. The purpose of the current study was to test the protective effects of EE against SiO 2 -induced pulmonary fibrosis and to explore the underlying mechanisms using both in vivo and in vitro models. We found that treatment with EE significantly reduced lung inflammation and fibrosis and improved lung structure and function in SiO 2 -instilled mice. Further mechanistic investigations revealed that EE administration markedly inhibited SiO 2 -induced oxidative stress, mitochondrial apoptotic pathway, and epithelial-mesenchymal transition in HBE and A549 cells. Furthermore, we demonstrate that Nrf2 activation partly mediates the interventional effects of EE against SiO 2 -induced pulmonary fibrosis. Our study has identified EE to be a potential anti-oxidative, anti-inflammatory, and anti-fibrotic drug for silicosis.

The purpose of this study was to evaluate the effect of two administration methods of a biostimulatory homeopathic complex (Convert H ® ) on the production of fresh and lyophilized venom of rattlesnakes (Crotalus durissus) under intensive captivity conditions. Sixty snakes were subjected to treatment following a randomized block design. The effects of sex and size were controlled for. Thirteen consecutive extractions were performed over 21 months. The first factor considered in the experiment was the origin of mice used as prey: a conventional colony (A1) or the Convert H colony (A2; mice receiving the homeopathic complex in water at 1%). The type of water given to snakes was the second factor: pure (B1) or amended with 5% of Convert H ® (B2). The experiment was structured in a factorial 2 × 2 design combining mouse and water types (A1B1, A1B2, A2B1, and A2B2). No consistent treatment effects on fresh venom production (mL) were observed when the experimental groups were compared with controls (A1B1). However, production of lyophilized venom (mg) was significantly higher (p < 0.05) in A2B2 animals than in controls in eight of 13 extractions performed, and also in aggregate. The results revealed that production of lyophilized venom, measured over multiple extractions, can be increased by administering the homeopathic complex simultaneously to rattlesnakes and prey., (Copyright © 2016 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.)

Background: Phials containing high dilutions of homeopathic remedies are commonly utilized in diagnostic tools in combination with electro acupuncture measuring electrical conductivity of the skin. The present research aimed to elucidate the interaction of the homeopathic remedy and the human organism., Method: The study protocol included the transition of a healthy subject to a diseased state utilizing a sub-harmful dose of a toxin. Subsequently, the subject was exposed to a homeopathic or placebo remedy in a closed glass phial and electrical conductivity was measured in open as well as in blind trials. A total of 229 data were collected from open trials and 750 data from blind trials., Result: The experimental data showed that homoeopathic remedies in closed glass phials may influence the electrical skin conductivity. The results of the blind trials differed considerably from those of the open trials. The percentage of correctly identified (verum and placebo) phials in the open trials (85%) was statistically different from those in the blind trials (65%). In both types of trials, however, the difference between the sealed phials containing the homeopathic medicine and the placebo was statistically significant. The results of measurements are directly linked to the way in which the tester holds the electrode in one hand and the subject's finger in the other, while putting pressure on the electrode., Conclusion: It was concluded that the tester's muscle tone is the intermediary in unconsciously selecting which phial influenced him in his specific contact with the subject., (Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.)

Placebos are allegedly used widely in general practice. Surveys reporting high level usage, however, have combined two categories, 'pure' and 'impure' placebos. The wide use of placebos is explained by the high level usage of impure placebos. In contrast, the prevalence of the use of pure placebos has been low. Traditional pure placebos are clinically ineffective treatments, whereas impure placebos form an ambiguous group of diverse treatments that are not always ineffective. In this paper, we focus on the impure placebo concept and demonstrate problems related to it. We also show that the common examples of impure placebos are not meaningful from the point of view of clinical practice. We conclude that the impure placebo is a scientifically misleading concept and should not be used in scientific or medical literature. The issues behind the concept, however, deserve serious attention in future research.

Background: Deriving clinical indications for the HIV nosode by conducting a double-blind, placebo-controlled homeopathic pathogenetic trial (HPT) with the aim to introduce a new nosode to the profession., Method: The HPT was conducted in 22 volunteers, 15 of which received HIV nosode in 30c potency pills, while 7 received identical placebo pills orally, once a week, for 4 weeks. The volunteers' symptoms during initial 7 days of run-in period were noted. All symptoms for both groups produced during run-in period were excluded from final analysis. Informed consent form, approval by Ethics Committee, laboratory investigations as well as safety and ethical measures were provided. The volunteers were trained to write data in prescribed diaries, and the data were analyzed., Results: The HPT of the HIV nosode exhibited qualitatively distinct symptoms, which can be applied in clinical practice. Number of symptoms reported in verum group was 130, in placebo group 60. Quantitative pathogenetic index was 0.285 in verum group, 0.238 in placebo group; qualitative pathogenetic index was 0.1402 in the verum group as compared to placebo (0.0907). Safe use was documented., Conclusion: This study brought in guiding symptoms, which will help the profession to employ this nosode in practice., (© 2015 S. Karger GmbH, Freiburg.)

Gastroparesis is a chronic disorder of abnormal gastric motility causing considerable suffering. We describe two cases of gastroparesis which were treated by methods which were not part of routine conventional therapy, but which, nevertheless, led to significant clinical improvement. In the first case, the patient suffered from gastroparesis following a vagal injury while undergoing a lung transplant. During his illness a mega-bezoar formed, a well-described complication of gastroparesis. After conservative measures failed, and in order to avoid a surgical intervention that carried considerable risk under the circumstances, a successful trial consisting of imbibing large amounts of "Coca Cola" and acupuncture was initiated. The bezoar dissolved completely and considerable improvement of the patient's gastric motility was achieved. In the second case, the patient was a young woman suffering from idiopathic gastroparesis, which responded well to treatment with tricyclic antidepressants. Due to her intention to become pregnant, this treatment was discontinued and she was admitted to receive homeopathic treatment. After two failed attempts in finding the right homeopathic remedy to replace the conventional treatment, the third remedy (Sepia) used brought dramatic improvement in her general condition and her dyspepsia. Today, over two years after her successful homeopathic treatment, she is in the middle of her second pregnancy, without any treatment and free of complaints. These two cases are examples of simple solutions for seemingly complicated and complex conditions alleviated by an integration of conventional and complementary/alternative medicine.

Background: The homeopathic complex HomeoAqua Mega 3(®) was designed to stimulate fish liver function resulting in enhanced lipid metabolism and improved overall performance. The effect of the complex in fatty acid compounds in the muscle tissues and the performance of Nile tilapia (O. niloticus) were evaluated., Methods: A control diet with 40 mL of alcohol solution (30° Gay Lussac (GL) alcohol) per kg of feed and another diet with 40 mL/kg of the homeopathic complex were analysed in sex-reversed juvenile male Nile tilapia with mean initial weights of 89.54 g (±7.97) and 89.74 g (±8.83) and initial total mean lengths of 16.93 cm (±0.56) and 16.85 cm (±0.56) for the control and homeopathy-treated fish, respectively. Overall, 200 fish were distributed into 10 water tanks, with 20 specimens in each 600 L tank, they were kept for 63 days. Monitoring of the water's physical and chemical parameters was performed. Additionally, the percentage chemical composition and the composition of the muscle tissue fatty acids were determined, and fish performance was evaluated., Results: No significant differences (p > 0.05) were found between treatments with regard to the water's physical and chemical parameters, moisture, ashes, proteins of the Nile tilapia muscular tissue and mean rates of total weight and length of the animals in the final period of the assay. The total lipid (TL) rates of the tilapia muscle tissue were 1.133 ± 0.2% at the start (control and homeopathy) and 0.908 ± 0.14% (control) and 0.688 ± 0.14% (homeopathy) at the end of the experiment (p < 0.06). The sum total of the SFAs (saturated fatty acids) was 338.50 ± 0.15 at the start (control and homeopathy) and 271.49 ± 0.34 mg/g of the TLs for the control and 226.12 ± 0.77 mg/g of TL for the homeopathy at the end of the experiment (p < 0.05). The n-6/n-3 ratio was also lower for the homeopathy-treated fish (8.45 ± 0.40) compared with the control fish (9.60 ± 0.14), (p < 0.05) at the end of the 63-day period., Conclusion: Nile tilapia juveniles that received the HomeoAqua Mega-3(®) in their diets had a decrease in the TL rates, mainly for the SFAs, and the n-6/n-3 ratio, compared with the control group, without any changes in the animal performance during the experimental period., (Copyright © 2014 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.)

Acute otitis media (AOM) is one of the most common pediatric diseases; almost all children experience at least one episode, and a third have two or more episodes in the first three years of life. The disease burden of AOM has important medical, social and economic effects. AOM requires considerable financial assistance due to needing at least one doctor visit and a prescription for antipyretics and/or antibiotics. AOM is also associated with high indirect costs, which are mostly related to lost days of work for one parent. Moreover, due to its acute symptoms and frequent recurrences, AOM considerably impacts both the child and family's quality of life. AOM prevention, particularly recurrent AOM (rAOM), is a primary goal of pediatric practice. In this paper, we review current evidence regarding the efficacy of medical treatments and vaccines for preventing rAOM and suggest the best approaches for AOM-prone children.

Background: Homeopathic Pathogenetic Trials (HPTs) are a pillar of homeopathy, a key source of the symptoms characteristic of a particular homeopathic medicine. Homeopaths choose homeopathic medicines by comparing these remedy pictures with the symptoms the patient is presenting. Thus, recognition of these symptom sets underpins the clinical practice of homeopathy., Objective: To test whether HPTs generate consistent and recognisable sets of symptoms in consecutive trials., Design: Practising homeopaths, blinded to the homeopathic medicine under investigation, were given the set of symptoms generated during an unpublished HPT and asked to identify the homeopathic medicine used., Homeopathic Trial Substance: Ozone, prepared by homeopathic method to the ultramolecular dilution of 30c (10(-60) dilution), was chosen at random from twenty potential medicines., Results: Seven practising homeopaths were asked to make three guesses as to the identity of the remedy. Initially from the full list of possible remedies (N = 2372). Two of the seven homeopaths guessed the identity of the remedy correctly (p < 0.0001). Subsequently, when their choice of possible medicines was restricted to a list of 20, the same two homeopaths selected the correct medicine, however none of the other practising homeopaths did so (p = 0.2)., Discussion: The selection of the correct homeopathic medicine from the unrestricted list (N = 2372 medicines) by two homeopaths is noteworthy given that the homeopathic medicine used during the HPT was diluted well beyond Avogadro's number and would not be expected to produce any detectable or recognisable symptomatology. Possible reasons why the remaining five homeopaths did not guess correctly are discussed., Conclusion: The results show that practising homeopaths may be able to correctly identify a homeopathic medicine from the set of symptoms generated during an HPT. This suggests that such symptom pictures generated by taking an ultramolecular homeopathic medicine are recognisable and specific to the substance taken. Since identification of the remedy was based on past HPT information held in the materia medica, this demonstrates that HPT-generated symptom pictures are reproducible, thus validating the HPT methodology. These promising preliminary findings warrant replication; possible improvements to the trial design to be incorporated in future studies were identified., (Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.)

Background: Gelsemium sempervirens L. (Gelsemium s.) is a traditional medicinal plant, employed as an anxiolytic at ultra-low doses and animal models recently confirmed this activity. However the mechanisms by which it might operate on the nervous system are largely unknown. This work investigates the gene expression of a human neurocyte cell line treated with increasing dilutions of Gelsemium s. extract., Methods: Starting from the crude extract, six 100 × (centesimal, c) dilutions of Gelsemium s. (2c, 3c, 4c, 5c, 9c and 30c) were prepared according to the French homeopathic pharmacopoeia. Human SH-SY5Y neuroblastoma cells were exposed for 24 h to test dilutions, and their transcriptome compared by microarray to that of cells treated with control vehicle solutions., Results: Exposure to the Gelsemium s. 2c dilution (the highest dose employed, corresponding to a gelsemine concentration of 6.5 × 10(-9) M) significantly changed the expression of 56 genes, of which 49 were down-regulated and 7 were overexpressed. Several of the down-regulated genes belonged to G-protein coupled receptor signaling pathways, calcium homeostasis, inflammatory response and neuropeptide receptors. Fisher exact test, applied to the group of 49 genes down-regulated by Gelsemium s. 2c, showed that the direction of effects was significantly maintained across the treatment with high homeopathic dilutions, even though the size of the differences was distributed in a small range., Conclusions: The study shows that Gelsemium s., a medicinal plant used in traditional remedies and homeopathy, modulates a series of genes involved in neuronal function. A small, but statistically significant, response was detected even to very low doses/high dilutions (up to 30c), indicating that the human neurocyte genome is extremely sensitive to this regulation.

For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To investigate the effects of cinobufagin on the apoptosis in U-2OS osteosarcomas cells (U-2OS cells) and explore its potential mechanism., Methods: The cytostatic effects of cinobufagin (10, 20, 50, 100, 200, and 400 nmol/L) on U-2OS cells were evaluated by MTT assay at 24, 48, and 72 hours after culture; simple U-2OS cells served as control group. The impact of cinobufagin (100 nmol/L) on the apoptosis in U-2OS cells was determined by flow cytometry at 48 hours after culture, which were treated with cinobufagin (experimental group) or with cinobufagin plus Z-VAD-FMK (control group), and simple U-2OS cells served as blank control group. The Caspase-3 activity was measured by Caspase-3 activity assay kit at 48 hours after culture, which were treated with cinobufagin (20, 50, and 100 nmol/L), and simple U-2OS cells served as control group. The expression of apoptosis signal pathway related proteins in U-2OS cells treated with cinobufagin were detected by Western blot at 48 hours after culture, which were treated with cinobufagin (20, 50, and 100 nmol/L), and simple U-2OS cells served as control group., Results: The results of MTT assay showed that cinobufagin inhibited the proliferation of U-2OS cells in a dose- and time-dependent manners. At each time point, the growth rate of U-2OS cells was significantly reduced with the increasing cinobufagin concentration, and as time prolonged, the growth rate of U-2OS cells behaved the same way in the same group. There were significant differences among different time points and groups (P < 0.05). The apoptotic rate of experimental group (46.87% +/- 11.23%) was significantly higher than that of the control group (2.34% +/- 0.98%) and blank control group (1.04% +/- 0.25%) (P < 0.05). The Caspase-3 activity in 20, 50, and 100 nmol/L groups were 1.14 +/- 0.32, 1.31 +/- 0.41, and 1.92 +/- 0.54, respectively, which were significantly higher than that in control group (P < 0.05). Compared with 20and 50 nmol/L groups, 100 nmol/L group significantly increased the Caspase-3 activity in U-2OS cells (P < 0.05). Compared with the control group, the expressions of cleaved Caspase-3, cleaved Caspase-9, and Bax were obviously up-regulated; the Bcl-2 expression was down-regulated; and the ratio of Bax/Bcl-2 was increased in different cinobufagin-treated groups (P < 0.05). The same tendency was seen in different cinobufagin-treated goups, showing significant differences among groups (P < 0.05)., Conclusion: Cinobufagin can inhibite the proliferation of U-2OS cells, and induce cell apoptosis. The potential mechanism of cinobufagin-induced apoptosis may be related to the mitochondria-mediated pathway.

Objective: To study the therapeutic effects of Bufonis Venenum on L7212 leukemia and the potential mechanism., Methods: L7212 leukemia model mice were randomly divided into four groups: model group, low and high dose Bufonis Venenum groups and chemotherapy group. Normal mice were treated as control group. Mice were injected intraperitoneally for 10 days continually. The body weight, survival time, peripheral blood leukocyte, hepatic and splenic indexes, bone marrow leukocyte and T lymphocyte were observed and determined., Results: Body weight of L7212 leukemia model group mice were decreased significantly. Compared with other groups, high dose Bufonis Venenum group's weight loss was the least. Bufonis Venenum groups survived longer than L7212 model group. Compared with model group, high dose Bufonis Venenum group's liver index was higher (P < 0.05). After inoculation for 1 day, leukocyte count as well as percentage of leukemic cells within five groups had no significant difference (P > 0.05). Compared with the model group, after inoculation for 10 days, leukocyte count in Bufonis Venenum groups and the chemotherapy group were significantly reduced (P < 0.05). Percentage of leukemia cells in blood and bone marrow in high dose Bufonis Venenum group was significantly decreased (P < 0.05). Compared with model group, CD3+ and CD4+ in Bufonis Venenum groups and the chemotherapy group were increased, CD8+ was decreased, but had no significant difference (P > 0.05)., Conclusion: Bufonis Venenum has therapeutic effects on the L7212 leukemia by inducing apoptosis and improving immune system.

Background: An open-label pilot study of individualized homeopathy for attention deficit hyperactivity disorder (ADHD) was conducted to assess the potential for future studies with a focus on the feasibility of the recruitment plan and outcome measure schedules; identification of any group characteristics of participants who respond significantly to the therapy; and establishing the length of time required for an improvement in ADHD symptoms., Patients and Methods: Participants (aged 6-16) were recruited through community advertisement and outreach. Participants completed 1 screening and 9 individualized homeopathic follow-up consultations. ADHD symptoms were assessed using the Conners 3 - Parent Questionnaire administered at each consultation. The pre- and post-study difference in Conners Global Index - Parent (CGI-P) T-score was evaluated for each participant. Baseline data of those who showed a statistically significant improvement (responders) were compared to those who did not (non-responders)., Results: 35 participants were enrolled over 11 months. 80% completed all 10 consultations in a median of 12.1 months. 63% had a statistically significant improvement in the primary outcome, first occurring after a mean of 4.5 visits. Overall scores for participants completing at least 2 data points decreased from a baseline median of 85.5 to 74.0 (p < 0.001, CI 95%). There were no significant baseline differences between responders and non-responders. No serious adverse events related to the therapy were reported., Conclusion: The change in the median CGI-P T-score from baseline to the end of this open-label pilot study was statistically significant. The research methods are feasible. Future studies are warranted., Trial Registration: NCT01141634., (© 2014 S. Karger GmbH, Freiburg.)

Background: In order to further improve the methodology and quality of data collection in homeopathic drug provings (HDP), there is a need for a minimum standardised HDP protocol. The objective of the present study was to test the feasibility of this type of protocol., Materials and Methods: The study protocol embraced a multi-centre, randomised, double-blind, placebo-controlled trial with 2 parallel groups. It was approved by an ethics review committee. During the pre-approval phase, discordances between the regulatory and homeopathic requirements for the protocol were checked and solutions found. The study medication was Potentilla anserina. 6 participants received verum and 4 placebo. The resulting symptom list will be published elsewhere. The procedure was accepted by all participants., Results: Three important issues were addressed: the requirement to keep all participants blinded; the adverse events reporting to regulatory authorities; and the necessity of a placebo control group. Other issues that need further investigations were identified, e.g. sample size, observation period and dosage regimen., Conclusions: A minimum protocol of a HDP is feasible. All important design elements of HDP could be solved in discussions with the respective regulatory authorities, and participating homeopaths accepted the procedure., (© 2014 S. Karger GmbH, Freiburg.)

Objective: To explore the effect of retinociacdi (RA) combined extracts from Testudinis Carapacis et Plastri(PTE) on proliferating in MSCs and its mechanism., Methods: Transfected PGL3-ID1 using the calcium phosphate co-precipitation method in rat MSCs. PTE combined with RA and retinociacdi receptor inhibitor(Ro41) acted on transfected MSCs with respective concentrations of 10(-6), 10(-7) and 10(-8) mol/L. Luciferase activity measurement was used to detect the activity of RAR and IDI 36 h later. PTE acted on MSCs 36 h,3 d and 7 d for respective concentrations of 1, 3, 30 and 100 microg/mL,then collected cells to detect RAR with RT-PCR. PTE combined with RA for 10(-7) mol/L and Ro41 for 10(-6) mol/L respectively on MSCs for 36 h,and then collected cells to detect RAR and ID1 with RT-PCR., Results: PTE promoted expression of ID1 on MSCs. When combined with RA, the promotion effect became greater and it promoted expression of RAR at the same time; When inhibited RA using Ro41, the promotion of IDI was weaken by PTE., Conclusion: RA promotes expression of IDI on MSCs, PTE regulates proliferation and differentiation of MSCs by expression of nuclear receptor RAR.

Objective: To compare the inhibitory effects of fresh gecko crude extract and its hydrolysate on H22 transplanted tumor in mice., Methods: The content of soluble nitrogen (SN-TCA index) was used to determine the degree of enzymolysis. The hydrolysate of gecko was obtained from fresh gecko crude extract by pepsin and papain hydrolyzing. H22 transplanted tumor mouse models were established and divided into negative group, positive group,crude extract group and hydrolysate group., Results: The inhibition rate of the H22 tumor-bearing mice was 29.17%, 48.99% respectively for the crude extract group and the hydrolysate group. The inhibition rate of hydrolysate group and the negative group were significantly different (P < 0.05). The spleen and thymus index for the crude extract group and the hydrolysate group didn't show different compared with the negative group., Conclusion: The crude extract of the fresh gecko and the hydrolysate can inhibit the growth of the H22 transplanted tumor. The enzymolysis by pepsin and papain can increase the antitumor activity of the crude extract of fresh gecko.

The present study examines the efficacy of a homeopathic dry cow prophylaxis in a randomized, placebo controlled case-control field trial. The study was conducted in 24 Brown Swiss farms in the Engadine (Swiss mountain region). The effect of the used homeopathic substances were combined with antibiotics in justified cases. At drying off and in the 3rd and 5th week of lactation the udders were clinically examined and quarter milk samples were taken for bacteriological and cytological analysis. In addition, milk recording data of the first 6 milk testing were included in the evaluations. The used homeopathic prophylaxis at drying off did not show any effect in the incidence of dry cow mastitis and mastitis in the first 120 days of lactation. However, at day 21 post partum significantly fewer animals in the verum group showed a bacteriological finding of a major pathogen, but more animals in this group suffered from a secretion disorder. It has been shown that at the 6th milk test pp significantly more animals of the verum group had a somatic cell count below 100'000 cells/ml than the control group.

Ethnopharmacological Relevance: Lignosus rhinocerus (Tiger Milk mushroom) is distributed in South China, Thailand, Malaysia, Indonesia, Philippines and Papua New Guinea. In Malaysia, it is the most popular medicinal mushroom used by the indigenous communities to relieve fever, cough, asthma, cancer, food poisoning and as a general tonic. In China, this mushroom is an expensive traditional medicine used to treat liver cancer, chronic hepatitis and gastric ulcers. The sclerotium of the mushroom is the part with medicinal value. This rare mushroom has recently been successfully cultivated making it possible to be fully exploited for its medicinal and functional benefits. The present study was carried out to evaluate the chronic toxicity of the sclerotial powder of Lignosus rhinocerus cultivar (termed TM02), its anti-fertility and teratogenic effects as well as genotoxicity., Materials and Methods: Sprague Dawley rats (10 rats/group/sex) were fed orally with 250, 500 and 1000 mg/kg of sclerotial powder of TM02. The sclerotial powder was orally administered once daily and consecutively for 180 days. At the completion of the oral feeding period, analysis of hematological and clinical biochemical parameters, urine profiles, organ weight as well as histopathological analysis were carried out. The effect of the sclerotial powder on fertility and its possible teratogenicity were examined by feeding rats orally with 100 mg/kg sclerotial powder consecutively for 7-8 weeks. Genotoxicity was evaluated by Ames test using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 uvrA., Results: The results showed that oral administration of the sclerotial powder of the Lignosus rhinocerus cultivar at daily dose of up to 1000 mg/kg for 180 days had no adverse effect on the general clinical observations, body weight, hematology, clinical biochemistry, urinalysis, absolute organ weight as well as relative organ weight, nor induced histological changes in the organs. Oral administration of 100 mg/kg sclerotial powder of the Lignosus rhinocerus for 7-8 weeks did not affect the fertility of the rats nor induce teratogenic effect on their offspring. Lignosus rhinocerus sclerotial powder up to 5000 μg/plate in the presence and absence of metabolic activation did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used., Conclusion: Our results showed that the no-observed-adverse-effect level (NOAEL) dose of the sclerotial powder of Lignosus rhinocerus in 180-day chronic toxicity study is more than 1000 mg/kg. Oral feeding of the sclerotial powder at 100mg/kg did not induce adverse effect on rats' fertility nor causing teratogenic effect on their offspring. In the reverse mutation Ames test, the sclerotial powder at all tested concentration did not show any genotoxicity., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: Homeopathic drug proving is a basic concept in homeopathy. This study aimed to record symptoms produced by a homeopathic drug compared with placebo., Methods: This multicentre, randomised, double-blind, placebo-controlled phase 1 trial consisted of a 7-day run-in period, a 5-day intervention period and a 16-day post-intervention observation period. Subjects, investigators and statisticians were blinded for intervention groups and identity of the homeopathic drug. Subjects in the intervention group received Okoubaka aubrevillei (potency C12) and subjects in the placebo group received the optically identical sucrose globules. Dosage in both groups was five globules taken five times per day over a maximum period of 5 days. Subjects documented the symptoms they experienced in a semistructured online diary. The primary outcome parameter was the number of characteristic proving symptoms compared with placebo after a period of 3 weeks. Characteristic symptoms were categorised using content analysis. Secondary outcome parameters were the qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms was quantitatively analysed on an intention-to-treat basis using analyses of covariance with the subject's expectation and baseline values as covariates., Results: Thirty-one subjects were included (19 Okoubaka and 12 placebo). Data for 29 participants could be analysed. No significant differences in number of characteristic symptoms in both groups were observed between Okoubaka (mean±standard deviation 5.4±6.0) and placebo (4.9±5.6). The odds ratio for observation of a characteristic symptom was 1.11 (95% confidence interval 0.4 to 3.05, P=0.843). Females and subjects expecting a higher number of symptoms at baseline or feeling more sensitive to homeopathic drugs experienced more characteristic symptoms regardless of allocation. The qualitative analysis showed an inter-coder reliability of 0.69 (95% confidence interval 0.62 to 0.76). The qualitative comparison of symptom profiles was inconclusive., Conclusions: Combined results of qualitative and quantitative methods did not result in a significant difference of characteristic proving symptoms between O. aubrevillei C12 and placebo. The qualitative comparison of the symptom profiles leaves some open questions. The nocebo effect might be a plausible explanation for most of the phenomena observed in this trial., Trial Registration: ClinicalTrials.gov: NCT01061229.