Homeopathy: statistical significance versus the sample size in experiments with Toxoplasma gondii

2021 ◽  
Vol 10 (36) ◽  
pp. 115-118
Author(s):  
Érika Cristina Ferreira ◽  
Paula Fernanda Massini ◽  
Caroline Felicio Braga ◽  
Ricardo Nascimento Drozino ◽  
Neide Martins Moreira ◽  
...  

Introduction: Toxoplasmosis is a zoonosis that represents a serious public health problem, caused by Toxoplasma gondii, which affects 20-90% of the world human population [1,2]. It is a serious problem especially when considering the congenital transmission due to congenital sequels. Treatment with highly diluted substances is one of the alternative/complementary medicines most employed in the world [3,4]. The current ethical rules regarding the number of animals used in animal experimental protocols with the use of more conservative statistical methods [5] can not enhance the biological effects of highly diluted substances observed by the experience of the researcher. Aim: To evaluate the minimum number of animals per group to achieve a significant difference among the groups of animals treated with biotherapic T. gondii and infected with the protozoan regarding the number of cysts observed in the brain. Material and methods: A blind randomized controlled trial was performed using eleven Swiss male mice, aged 57 days, divided into two groups: BIOT-200DH - treated with biotherapic (n=6) and CONTROL - treated with hydroalcoholic solution 7% (n=7).The animals of the group BIOT-200DH were treated for 3 consecutive days in a single dose 0.1ml/dose/day. The animals of BIOT – 200DH group were orally infected with 20 cysts of ME49-T. gondii. The animals of the control group were treated with cereal alcohol 7% (n=7) for 3 consecutive days and then were infected with 20 cysts of ME49 -T. gondii orally. The biotherapic 200DH T. gondii was prepared with homogenized mouse brain, with 20 cysts of T. gondii / 100μL according to the Brazilian Homeopathic Pharmacopoeia [6] in laminar flow. After 60 days post-infection the animals were killed in a chamber saturated with halothane, the brains were homogenized and resuspended in 1 ml of saline solution. Cysts were counted in 25 ml of this suspension, covered with a 24x24 mm coverglass, examined in its full length. This study was approved by the Ethics Committee for animal experimentation of the UEM - Protocol 036/2009. The data were compared using the tests Mann Whitney and Bootstrap [7] with the statistical software BioStat 5.0. Results and discussion: There was no significant difference when analyzed with the Mann-Whitney, even multiplying the "n" ten times (p=0.0618). The number of cysts observed in BIOT 200DH group was 4.5 ± 3.3 and 12.8 ± 9.7 in the CONTROL group. Table 1 shows the results obtained using the bootstrap analysis for each data changed from 2n until 2n+5, and their respective p-values. With the inclusion of more elements in the different groups, tested one by one, randomly, increasing gradually the samples, we observed the sample size needed to statistically confirm the results seen experimentally. Using 17 mice in group BIOT 200DH and 19 in the CONTROL group we have already observed statistical significance. This result suggests that experiments involving highly diluted substances and infection of mice with T. gondii should work with experimental groups with 17 animals at least. Despite the current and relevant ethical discussions about the number of animals used for experimental procedures the number of animals involved in each experiment must meet the characteristics of each item to be studied. In the case of experiments involving highly diluted substances, experimental animal models are still rudimentary and the biological effects observed appear to be also individualized, as described in literature for homeopathy [8]. The fact that the statistical significance was achieved by increasing the sample observed in this trial, tell us about a rare event, with a strong individual behavior, difficult to demonstrate in a result set, treated simply with a comparison of means or medians. Conclusion: Bootstrap seems to be an interesting methodology for the analysis of data obtained from experiments with highly diluted substances. Experiments involving highly diluted substances and infection of mice with T. gondii should be better work with experimental groups using 17 animals at least.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4899-4899
Author(s):  
William F. Clark ◽  
A. Keith Stewart ◽  
Gail A. Rock ◽  
Marion Sternbach ◽  
David M. Sutton ◽  
...  

Abstract In myeloma, plasma exchange (PE) has been suggested to prevent rapidly progressive kidney failure by reducing exposure to nephrotoxic light chains. We carried out a randomized controlled multi-centre trial comparing PE or no PE in 104 patients of whom 101 met the inclusion, exclusion criteria and 4 were lost to follow-up. We compared baseline characteristics as well as renal outcomes and performed a futility analysis to determine the sample size necessary for potential statistical significance for the changes noted. Thirty-nine patients were randomized to the control group and 58 to the PE group with a 6-month follow-up. The baseline characteristics of these 2 groups were similar including serum creatinine, dialysis dependence, age, gender, serum calcium, serum albumin, 24 -hour urine for protein levels and Durie-Salmon myeloma staging. Thirteen (33.3%) of the control group and 19 (33.3%) of the PE group died within 6 months of follow up. Ten patients (31%) in the control and 10 patients (21%) in the PE arm were dialysis dependent at 6 months. Seven patients (47%) came off dialysis in the control and 13 patients (59%) in the PE arm with the mean number of dialysis days from 0–6 months being 45.7±67.6 in the control versus 29.2±56.1 in the PE arm at 6 months. The mean serum creatinine in the control group was 314.6±256.1 μmol/L versus 215.4±215.3 μmol/L in the PE group and the composite end point of death, dialysis or serum creatinine >254 μmol/L occurred in 12 (30.8%) in the control and 11 (19.3%) in the PE arm. The futility analysis to indicate the per group sample size necessary to achieve statistical significance at 6 months for the difference we observed was infinite for cumulative mortality, 805 for dialysis dependence, 2418 for coming off dialysis, 321 for number of dialysis days, 132 for creatinine difference of 100 μmol/L and for the composite outcome of death, dialysis or creatinine>354 μmol/L, 737. We did not observe a statistically significant difference in mortality or renal morbidity for PE versus no PE in patients with myeloma and rapidly progressive kidney failure.


2021 ◽  
Vol 10 (36) ◽  
pp. 158-162
Author(s):  
Caroline Felicio Braga ◽  
Gislaine Janaína Sanchez Falkowski ◽  
Neide Martins Moreira ◽  
Denise Lessa Aleixo ◽  
Silvana Marques de Araújo

Introduction: Toxoplasmosis is a zoonosis that represents a serious public health problem, worldwide distributed. Pregnant women are part of the most risky group due to congenital sequels. The necessity of a preventive treatment for congenital infections is of great importance [1] Biotherapics, highly diluted medicines prepared with T. gondii according to the Brazilian Homeopathic Pharmacopoeia [2], is an important prevention strategy, ensuring a safe and cheap approach to protozoan infections [3]. However, little is known about the effects of different potencies and treatment schedules. Aim: To evaluate the effect of biotherapic 200DH in mice infected with Toxoplasma gondii. Material and methods: The study was approved by the Ethics Committee for Animal Experimentation of the Universidade Estadual de Maringá – Protocol n° 036/2009. Fourteen mice were used – swiss male aged 57 days divided into two groups according to the treatment (or its diluent biotherapic): BIOT-200DH and Control (cereal alcohol-7%). The biotherapic was prepared with homogenized mouse brain (20 cysts of T.gondii/100μL-average 242 bradyzoites / cyst), according to the Brazilian Homeopathic Pharmacopoeia in laminar flow. The experiment was performed as a blind randomized controlled trial. The animals were treated for 3 days immediately prior to infection. The treatment schedule was of 0.1mL/single dose/ day, by gavage. Animals aged 57 – 59 days were treated with biotherapic and were clinically evaluated. The animals were orally infected at the age of 60 days (20 cysts ME49-T. gondii). Within18-21 days of infection the clinical parameters were evaluated. On the 55th day of infection the eye fundus was Examined (Ophthalmoscope Welch Allyn ®) and the intraocular pressure was measured (Tonometer TONO-PEN ® XL). After 60 days of post-infection the animals were killed in a chamber saturated with halothane, the brains were homogenized and resuspended in 1 ml of saline solution. The cysts were counted according to a rate of 25 mL of suspension, covered with 24x24 mm glass, examined in its full length. Results and discussion: The number of brain cysts was compared among groups using the Mann-Whitney test with 5% of significance. Although there was no significant difference among the groups (p =0.2943), the results are interesting: the number of cysts - average ± standard deviation –was of the 4.5 ± 3.3 in the BIOT-200DH group and of 9.7 ± 12.8 in the control group. It is necessary to emphasize the great variability within the control group expressed by the standard deviation. Likewise, there was no significant difference among the average of intraocular pressure observed in the control group (8.9 ± 3.8) and the group BIOT-200DH (8.0 ± 2.6). Regarding fundoscopy, the control group presented 57.14% of the animals without changes and 42.86% with discreet subretinal hemorrhage. While in the BIOT-200DH group, 50% of the animals showed no change and 50% showed discreet subretinal hemorrhage. Compared with the results from the use of other biotherapic T. gondii potencies [4], these results indicate that mice infected with the protozoan reacted better to the potency 200DH, Although mortality. This better response may the chronic aspect of the infection and/ or the characteristics of host-parasite relationship in the infection with T. gondii that involves alterations in the central nervous system. Conclusion: The highly diluted biotherapic 200DH T. gondii caused mortality in one animal in group however caused no significant difference other clinical and parasitological parameters evaluated although there was a decrease of parasitism brain of mice infected with the protozoan compared to control group.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Aneta Bac ◽  
Magdalena Wróbel ◽  
Katarzyna Ogrodzka-Ciechanowicz ◽  
Edyta Michalik ◽  
Anna Ścisłowska-Czarnecka

Abstract The assessment of the six-week influence of Kinesio Taping combined with a rehabilitation on selected ultrasonography measurements, the level of disability, and the quality of life in patients with rotator cuff lesions. 60 participants were randomly assigned into a taping group (KT combined with a six-week rehabilitating protocol) and a control group (only rehabilitation protocol). In all patients the following assessments were performed twice: USG, UEFI and NHP questionnaires. In the examination of the subacromial space and the subacromial bursa in the taping group, no statistical significance was observed. A statistically significant change in the thickness of the muscles was obtained only for the thickness of the infraspinatus in the taping group. A statistically significant change was obtained in the assessment of tendinopathy only for the supraspinatus muscle in both groups. Within both groups a statistically significant difference was observed in the average UEFI and NHP scores; however, the differences in the scores obtained between the groups were not statistically significant. The use of KT with a rehabilitation program did not yield statistically significantly better results in the improvement of selected shoulder region indicators, the function of the upper limb and the quality of life.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yong-Jun Tang ◽  
Li-Li Xie ◽  
Xiang-Rong Zheng ◽  
Chen-Tao Liu ◽  
Xia Wang

AbstractOur aim was to detect type 2 innate lymphoid cells (ILC2s)-related cytokines of infants with bronchiolitis by using Elisa, Liquidchip technology and RT-PCR and investigated its correlation with bronchiolitis. We recruited 26 infants with bronchiolitis and 20 healthy infants as control from Xiangya Hospital. Compared to the control group, the serum levels of interleukin-5 (IL-5) [41.99 (21.11) vs 25.70 (19.64)], IL-9 [27.04 (37.51) vs 8.30 (0.54)], IL-13 [184.05 (132.81) vs 121.75 (176.13)], IL-33 [83.70 (46.69) vs 11.23 (55.31)] and thymic stromal lymphopoietin (TSLP) [31.42 (5.41) vs 28.76 (2.56)] were significantly increased in infants with bronchiolitis (P < 0.05), while the level of IgE had no significant difference between the two groups [19.05 (14.15) vs 14.85 (20.2), P > 0.05]. The mRNA expression of IL-17RB (9.83 ± 0.35 vs 9.19 ± 0.58), TSLP (16.98 ± 2.12 vs 15.07 ± 2.25), retinoid acid receptor related orphan receptor α (7.18 ± 0.71 vs 5.46 ± 1.09) and trans-acting T-cell-specific transcription factor 3 (4.86 ± 0.66 vs 4.19 ± 0.90) were significantly increased in infants with bronchiolitis versus the control group (P < 0.05), while there was no statistical significance for suppression of tumorigenicity 2 (5.59 ± 0.68 vs 5.41 ± 0.87, P > 0.05). Our findings suggested that ILC2s possibly play a specific role in immunopathology of bronchiolitis.


2018 ◽  
Vol 6 (9) ◽  
pp. 1627-1632
Author(s):  
Shirali Kharamin ◽  
Mohammad Malekzadeh ◽  
Arash Aria ◽  
Hamide Ashraf ◽  
Hamid Reza Ghafarian Shirazi

BACKGROUND: Cardiovascular disease is the most prevalent public health problem on a worldwide scale, and ischemic heart disease accounts for approximately one-half of these events in high-income countries. One of the most important risk factors for this disease is mental and psychological especially stressful experiences. AIM: This research was established to compare emotional processing, as a key factor in stress appraisal, between IHD patients and people with no cardiovascular disease. METHODS: Using simple sampling, fifty patients were selected from people who diagnosed as IHD in the hospital and referred for treatment after discharging care and treatment. Control group participants were selected as control group peoples, using neighbourhood controls selection. The Emotional Processing Scale was filled by all members of the two groups. RESULTS: There were significant differences between the two groups on the EPS-25 total scores, as well as on emotional processing dimensions of signs of unprocessed emotion, unregulated emotion; avoidance and impoverished. Also, there was no significant difference between the two groups in the dimension of Suppression. The final step of regression revealed a β of 10.15 and 1.05 for AVO and IEE subscales respectively. CONCLUSION: The result showed that patients with IHD are using more negative emotional processing styles.


Author(s):  
Devika Perumal ◽  
Divya Selvaraju

Background: The choice of suture material for repair of episiotomy or perineal laceration is largely of one’s personal preference. Chromic catgut was widely used in most institutions. It now appears that chromic catgut is associated with more postpartum discomfort and hence chromic catgut has been largely replaced by synthetic absorbable materials like polyglactin and polyglycolic acid.Methods: The study was conducted in Institute of Social Obstetrics and Government Kasturba Gandhi Hospital, Chennai. This is a prospective, comparative study involving two groups. The use of a rapidly absorbing form of synthetic absorbable suture material, in the repair of episiotomy or perineal laceration in 100 patients during the study period February 2012 to July 2012, were simultaneously compared with the traditional natural absorbable suture material.Results: With the use of rapidly absorbing polyglactin 910, there was a significant reduction (p=0.000) in the short-term pain, 19 compared to 80 in the control group. With regard to wound dehiscence and the need for resuturing, there was statistically significant difference in the control group (15%) compared to the study group (0%). There was no statistical significance between the two groups in terms of dyspareunia (12.4% vs 10.7%).Conclusions: Fast-absorbing form of Polyglactin seems to be effective in reducing some of the morbidity associated with perineal repair following childbirth. There was significant reduction in the short-term pain and the need for analgesia. The incidence of wound dehiscence was markedly reduced.


2021 ◽  
Author(s):  
Eslam Moradi Asl ◽  
Abedin Saghafipour ◽  
Amir Hamta ◽  
Zahra Taheri-Kharameh ◽  
Malek Abazari ◽  
...  

Abstract Background Head lice are a main public health problem and the most important human ectoparasites and the use of pediculicides is the most common way to control it. One of the possible causes of treatment failure is the lack of improper application of pediculicide. The aim of this study was to assess the effect of education on efficacy of 1% permethrin or 4% dimeticone lotion to treat head lice infestation. Methods This quasi-experimental study was performed on 100 people infected with head lice in comprehensive urban health centers of Ardabil (intervention group) and 400 people of East Azerbaijan and West Azerbaijan (control group) provinces from April to March 2019. The data collection tool included demographic questionnaire and examination evidence recording sheet in terms of presence of hits or adult lice. Results The outcome of treatment included elimination of head lice infestation on days 7, and in the case of recurrence, it was considered on days 14 and 30 after treatment. Data were analyzed using R software and Generalized Estimating Equation method. GEE analysis showed there is significant difference in evaluating head lice over time. Conclusion Participants who received the training intervention (OR = 3.29; CI 95%: 2.21–4.88) were more likely to have a successful treatment than control group. In the case of providing proper training on the use of pediculicides and observing hygiene tips to patients with pediculosis, could help to successful treatment of pediculosis.


2019 ◽  
Vol 7 (1) ◽  
pp. 88-91 ◽  
Author(s):  
Valentina Tofiloska ◽  
Maria Krstevska ◽  
Ana Daneva-Markova ◽  
Viktorija Jovanovska

BACKGROUND: Postmenopausis is a period that begins one year after the last menstrual period. Abnormal uterine bleeding could be of different origins. AIM: This study aimed to determine the association of serum estrogen hormone levels and obesity with the occurrence of endometrial bleeding in post-menopausal women. MATERIAL AND METHODS: Prospective clinical study involving 120 postmenopausal patients treated at the University Clinic for Gynecology and Obstetrics-Skopje, divided into two groups: control and study. The control group consisted of 40 postmenopausal patients without endometrial bleeding, hospitalised and operated due to urogenital pathology. The study group consisted of 80 patients with endometrial bleeding who were divided into three subgroups according to the thickness of the endometrium: from 5-8 mm, 8-11 mm and above 11 mm. In all subjects, estradiol and BMI was determined. RESULTS: Estradiol levels were statistically higher in the study group compared to control while statistically significant difference among the three subgroups according to the thickness of the endometrium about the levels of estradiol in blood is not found. About BMI, the results showed that there was no statistical significance between the two examined groups. CONCLUSION: Patients with endometrial bleeding have increased levels of estradiol and are at increased risk of endometrial cancer about controls, the likelihood of endometrial cancer significantly increases by 1,108 times.


2020 ◽  
Vol 4 (4) ◽  
Author(s):  
Yannan Sun

 Objective: Investigate the effectiveness of nursing risk management in the care of critically ill patients in the respiratory unit. Methods: Among the critically ill respiratory patients admitted to our hospital between May 2019 and April 2020, 78 patients were randomly selected and divided into an observation group and a control group, each consisting of 39 patients. In the observation group, a nursing risk management model was implemented, i.e., patients' clinical symptoms were observed at any time to monitor their treatment satisfaction and the effectiveness of their care and routine care was implemented for the control group. Results: The heart rate, respiratory rate, and pH of patients in the observation group were more stable than those in the control group, and their respiratory status was better, with differences in data. There was also significant statistical significance (P<0.05). The incidence of patient-provider disputes, unplanned extubation, and unplanned events were lower in the observation group compared to the control group, and their data difference was statistically significant (P<0.05). The treatment satisfaction as well as the total effective rate of patients in the observation group was also much higher than that of the control group, and there was also a statistically significant difference in the data (P<0.05). Conclusion: The nursing risk management model has a significant therapeutic effect in the care of critically ill respiratory patients. Therefore, it is worth popularizing to use in the clinical nursing of respiratory critical patients.


2021 ◽  
Author(s):  
Michaela Kaiserova ◽  
Monika Chudackova ◽  
Hana Prikrylova Vranova ◽  
Katerina Mensikova ◽  
Anetta Kastelikova ◽  
...  

Background: Various cerebrospinal fluid (CSF) biomarkers are studied in Parkinson’s disease (PD) and atypical parkinsonian syndromes (APS). Several studies found reduced 5-hydroxyindoleacetic acid (5-HIAA), the main serotonin metabolite, in PD. There is little evidence regarding its levels in APS. Methods: We measured 5-HIAA in the CSF of 90 PD patients, 16 MSA patients, 26 progressive supranuclear palsy (PSP) patients, 11 corticobasal degeneration (CBD) patients, and 31 controls. We also compared the values in depressed and non-depressed patients. Results: There was a statistically significant difference in CSF 5-HIAA in PD and MSA compared to the control group (median in PD 15.8 µg/l, in MSA 13.6 µg/l vs. 24.3 µg/l in controls; P=0.0008 in PD, P=0.006 in MSA). There was no statistically significant difference in CSF 5-HIAA in PSP and CBD compared to the control group (median in PSP 22.7 µg/l, in CBD 18.7 µg/l vs. 24.3 µg/l in controls; P= 1 in both PSP and CBD). CSF 5-HIAA levels were lower in PD patients with depression compared to PD patients without depression (median 8.34 vs. 18.48, P<0.0001). Conclusions: CSF 5-HIAA is decreased in PD and MSA. The CSF 5-HIAA levels in PSP and CBS did not differ from those of the control group. There was a tendency toward lower CSF 5-HIAA in MSA than in PD, however, the results did not reach statistical significance. These results may be explained by more severe damage of the serotonergic system in synucleinopathies (PD, MSA) than in tauopathies (PSP, CBS).


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