Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica / 中国结合医学杂志

Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.

Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study) / 中西医结合学报

BACKGROUND@#Different homeopathic approaches have been used as supportive care for coronavirus disease 2019 (COVID-19) cases, but none has been tested in a clinical trial.@*OBJECTIVES@#To investigate the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19.@*DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS@#A randomized, double-blind, two-armed, parallel, single-center, placebo-controlled clinical trial was conducted from June 2020 to April 2021 in São-Carlos, Brazil. Participants aged > 18 years, with influenza-like symptoms and positive result from a real-time polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home-isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo.@*OUTCOME MEASURES@#The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures.@*RESULTS@#Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.@*CONCLUSION@#Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.@*TRIAL REGISTRATION@#UMIN Clinical Trials Registry ID: JPRN-UMIN000040602.

Weight gain and control of endo- and ectoparasites of beef heifers treated with allopathic, herbal and homeopathic drugs / Ganho de peso e controle de endo e ectoparasitas de novilhas de corte tratadas com medicamentos alopáticos, fitoterápicos e homeopáticos

The aim of this study was to evaluate the efficacy of herbal, homeopathic and allopathic treatments for parasites in beef heifers during two experimental cycles of 318 and 313 days. Treatments: NC - negative control (untreated); HH - treated with homeopathic preparation Homeo bovis Parasitário®; PC - (positive control) - treated with 10% moxidectina® and an acaricide formulation of cypermethrin, chlorpyrifos and piperonyl butoxide®; HF ­ treated with homeopathic preparation Fator C&MC®; and FN - treated with neem cake (torta de neem®) and with neem oil (óleo de neem®). Parasite egg count (EPG), horn fly (Haematobia irritans) and tick (Rhipicephalus (Boophilus) microplus) assessment and animal weighting were performed at 28-day intervals. Blood samples were collected at the first cycle to assess the immune response. Horn fly infestation was not affected by any treatment (P>0.05). The mean number of ticks, which was low in both cycles, was lower (P<0.05) in the first cycle in animals that received PC treatment. In both experimental cycles, the mean EPG of the PC-treated animals was lower (P<0.05) than the animals receiving other treatments. Treatments had no effect on the immune response (P>0.05). The animals treated with allopathic drugs were 22 to 30 kg heavier (P<0.05) than untreated animals or animals treated with alternative drugs.

O objetivo do trabalho foi avaliar a eficácia de tratamentos fitoterápicos, homeopáticos e alopáticos contra ecto e endoparasitas na recria de novilhas, em dois ciclos experimentais subsequentes de 318 e 313 dias. Tratamentos: CN - controle negativo - não tratado; tratamento HH - tratado com homeopático Homeo bovis Parasitário®; tratamento CP ­ controle positivo ­ tratado com moxidectina 10%® e uma formulação acaricida contendo cypermetrina, clorpirifós e butóxido de piperonila®; tratamento HF - tratado com homeopático Fator C&MC® e tratamento FN - tratados com torta de neem® e com óleo de neem®. A contagem de ovos nas fezes (OPG), a infestação por Haematobia irritans, Rhipicephalus (Boophilus) microplus e pesagem dos animais foram realizadas em intervalos de 28 dias. No primeiro ciclo foi coletado sangue para avaliar a resposta imume. A infestação por mosca-dos-chifres não foi influenciada por nenhum dos tratamentos (P>0,05). Nos dois ciclos o número médio de carrapatos foi baixo e apenas no primeiro foi menor (P>0.05) no tratamento CP em relação aos demais. A média de OPG no tratamento CP foi mais baixa que nos demais tratamentos nos dois ciclos experimentais (P<0,05). Não houve efeito de tratamentos na resposta imune. Os animais do tratamento CP ganharam entre 22 a 30 kg de peso vivo a mais (P<0,05) que os não tratados ou tratados com medicamentos alternativos.

Homeopathic drugs Natrum sulphuricum and Carcinosin prevent azo dye-induced hepatocarcinogenesis in mice.

The study was undertaken to examine whether Carcinosin-200 (Car-200) could provide additional ameliorative effect, if used intermittently with Natrum sulphuricum-30 (Nat Sulph-30) against hepatocarcinogenesis induced by chronic feeding of p-dimethylaminoazobenzene (p-DAB) and phenobarbital (PB) in mice (Mus musculus). Mice were randomly divided into seven sub-groups: (i) normal untreated; (ii) normal + succussed alcohol; (iii) p-DAB (0.06%) + PB (0.05%); (iv) p-DAB + PB + succussed alcohol, (v) p-DAB + PB + Nat Sulph-30, (vi) p-DAB + PB + Car-200, and (vii) p-DAB + PB + Nat Sulph-30 + Car-200. They were sacrificed at 30, 60, 90 and 120 days for assessment of genotoxicity through cytogenetical end-points like chromosome aberrations, micronuclei, mitotic index and sperm head anomaly and cytotoxicity through assay of widely accepted biomarkers and pathophysiological parameters. Additionally, electron microscopic studies and gelatin zymography for matrix metalloproteinases (MMPs) were conducted in liver at 90 and 120 days. Results showed that administration of Nat Sulph-30 alone and in combination with Car-200 reduced the liver tumors with positive ultra-structural changes and in MMPs expression, genotoxic parameters, lipid peroxidation, -glutamyl transferase, lactate dehydrogenase, blood glucose, bilirubin, creatinine, urea and increased GSH, glucose-6-phosphate dehydrogenase, superoxide dismutase, catalase, glutathione reductase activities and hemoglobin, cholesterol, and albumin levels. Thus, intermittent use of Car-200 along with Nat Sulph-30 yielded additional benefit against genotoxicity, cytotoxicity, hepatotoxicity and oxidative stress induced by the carcinogens during hepatocarcinogenesis.

Hepatoprotective activity of six polyherbal formulations in paracetamol induced liver toxicity in mice.

Background & objective: Polyherbal formulations available with a wide range of indications like protective to liver, appetite and growth promoters, gastrointestinal and hepatic regulator, as treatment for hepatic dysfunction, for hepatic regeneration as well as liver stimulant and tonic. Despite the widespread use, there is a lack of scientifi c evidence on their effi cacy and safety. This study was undertaken to evaluate the hepatoprotective activity of six commercially available formulations, namely Liv 52, Livergen, Livokin, Octogen, Stimuliv and Tefroliv in acute liver toxicity in mice model induced by paracetamol (PCM). Methods: Swiss albino mice of either sex were used, divided in 28 groups with six in each group. The dose of the polyherbal formulations was calculated from human dose (20 ml/day) using a standard conversion table. They were given as pretreatment (2.60 ml/kg/day) for 7 days by oral route twice a day prior to PCM administration. Hepatotoxicity was induced by administering a single oral dose of PCM (500 mg/kg bw) on day 8. The study parameters were conducted on day 9. The biochemical parameters included liver enzyme levels alanine tranaminases (ALT), aspartate transaminases (AST) and alkaline phosphatase (ALP). The pharmacological and pathological parameters were phenobarbitone sleeping time and macroscopic and microscopic changes of liver tissues respectively. Results: PCM toxicity signifi cantly increased ALT, AST and ALP (321.00 ± 87.93, 273.17 ± 45.68, 257.50 ± 17.64 IU/l vs normal control, 33.33 ± 0.61, 89.33 ± 9.50, 152.17 ± 11.40 IU/l respectively, P<0.05), prolonged phenobarbitone induced sleeping time (from 277.50 ± 8.04 min to 335.83 ± 7.00 min, P<0.05). When PCM higher dose (1g/kg p.o. single dose) was used, the liver tissue, in macroscopic appearance, showed extensive necrosis associated with haemorrhages. Low dose (500 mg/kg p.o. single dose) showed punctate haemorrhagic necrosis of liver tissue. In the microscopic studies, PCM induced toxicity showed haemorrhages, fatty changes and necrosis. The pretreatment in low doses (2.6 ml/kg/day) with liquid formulations of Liv 52 and Livergen reversed the PCM induced liver toxicity. At higher doses (5.2 ml/ kg/day), all the six herbal formulations conclusively showed marked benefi cial effects in the studied pharmacological, biochemical and histological parameters. Interpretation & conclusion: The present fi ndings demonstrated the effi cacy of polyherbal liquid formulations at two dose levels in PCM induced hepatotoxicity in mice. However, it suggests that a dose adjustment may be necessary to optimize the effects in clinical settings.

Caracterização de uma população de mulheres com quadro clínico de incontinência urinária sob o ponto de vista homeopático: relato de um estudo prospectivo / Characterization of a female population with a clinical diagnosis of urinary incontinence undes a homeopathic point of view: a prospectene study

No presente estudo, 120 mulheres com sintomas de incontinência urinária foram avaliadas urodinamicamente e submetidas à anamnese homeopática. Como seria de se esperar, a grande maioria delas (82) apresentava um quadro de incontinência urinária aos esforços confirmado pelo estudo urodinâmico. Analisada a totalidade sintomática dessas pacientes, os remédios homeopáticos mais encontrados seguindo uma ordem decrescente de freqüência foram: Natrum muriaticum (50), Pulsatilla nigricans (21), Causticum (10), Arsenicum album (6), Ignatia amara, Lycopodium, Calcarea carbonica e Hepar sulphur. As pacientes diagnosticadas com urge-incontinência ou hiper-atividade vesical apresentavam na sua grande maioria um perfil Sepia sucus. E as pacientes com incontinência urinária mista via de regra desenvolviam inicialmente sintomas de urgência seguidos de urge-incontinência, para apenas meses e até mesmo anos mais tarde relatarem perda urinária aos esforços. O estudo revela ainda que a maior parte dessas pacientes apresentava outras comorbidades associadas ao quadro de incontinência urinária, sugerindo ser este um processo complexo, envolvendo uma desorganização da energia vital do organismo com repercussão em diversos órgãos até a localização no órgão de choque final, no caso dessas pacientes, o aparelho urogenital e bexiga urinária. Os resultados deste estudo incentivam a novas pesquisas no campo clínico para um melhor entendimento e maior utilização da homeopatia como terapia adjuvante no tratamento da incontinência urinária.

Efficacy of stimuliv, an indigenous compound formulation, against hepatotoxicity of antitubercular drugs--a double blind study.

Anti-tubercular drugs are known to cause hepatotoxicity, which may lead to noncompliance to drug therapy. Stimuliv, an indigenous compound formulation, is reported to be useful in liver disorders. Efficacy of prophylactic administration of stimuliv against anti-tubercular drugs-induced hepatotoxicity was studied in this double blind randomized clinical trial. One hundred and forty-five newly diagnosed patients of tuberculosis were included in the study. Out of these, sixty three patients were treated with stimuliv (2 tablets thrice daily), sixty received the placebo, while twenty-two dropped out of the study. The patients were assessed clinically and biochemically at two-week intervals over a period of two months. In stimuliv-treated group, the incidence and severity of hepatotoxicity was significantly less (p < 0.05) as compared to placebo-treated group. In addition, patients treated with stimuliv had better appetite and weight gain. Stimuliv treatment may be recommended in newly diagnosed adult patients of tuberculosis.

Traditional Chinese materia medica: a retrospect and prospect

For thousands of years, traditional medicine and remedies have been practed and used in the fight against disease in China. They have proved to be valuable and the distillate of vast historical experience based on field-tested human experiments, long-term observations and clinical trials. The Chinese people belive that traditional medicine is consistent with theirown culture. Endowed with a unique theoretical system and provided outstanding clinical results, traditional Chinese medicine continues to play an important role in helping the Chinese nation flourish. The recent study of traditional medicinal plants in Chine has given us confidence that what was recorded in ancient medical literature through empirical observations is indeed still coindicent with the concepts of modern chemistry, pharmacology and medicine. The task of revealing what is valid and efficacious should be retained, and what is mythic and invalid should be discarded in traditional Chinese medicine may require scientific research lasting for several generations. Therfore, multidisciplinary cooperation and international collaboration in this field would be essential. Systematic coordination of work in traditional medicine by word organizations, national governments, private foundations and individual scientists is a requisite as well.