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1.
Homeopathy ; 112(3): 184-197, 2023 08.
Article in English | MEDLINE | ID: mdl-36442593

ABSTRACT

OBJECTIVES: This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19). METHODS: The study was a randomized, single-blind, prospective, placebo-controlled clinical trial set in the clinical context of standard care. INTERVENTION: Patients of either sex, admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were recruited and then randomly divided into two groups to receive either individualized homeopathic medicines or placebos, in addition to the standard treatment of COVID-19. OUTCOME MEASURES: The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test. RESULTS: In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences. CONCLUSION: The study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.


Subject(s)
COVID-19 , Homeopathy , Humans , COVID-19/therapy , SARS-CoV-2 , Prospective Studies , Single-Blind Method , Double-Blind Method , Treatment Outcome
2.
Homeopathy ; 103(4): 224-31, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25439038

ABSTRACT

INTRODUCTION: The decision to treat subclinical hypothyroidism (SCH) with or without autoimmune thyroiditis (AIT) in children, presents a clinical dilemma. This study was undertaken to evaluate the efficacy of individualized homeopathy in these cases. METHODS: The study is an exploratory, randomized, placebo controlled, single blind trial. Out of 5059 school children (06-18 years) screened for thyroid disorders, 537 children had SCH/AIT and 194 consented to participate. Based on primary outcome measures (TSH and/or antiTPOab) three major groups were formed: Group A - SCH + AIT (n = 38; high TSH with antiTPOab+), Group B - AIT (n = 47; normal TSH with antiTPOab+) and Group C - SCH (n = 109; only high TSH) and were further randomized to two subgroups-verum and control. Individualized homeopathy or identical placebo was given to respective subgroup. 162 patients completed 18 months of study. RESULTS: Baseline characteristics were similar in all the subgroups. The post treatment serum TSH (Group A and C) returned to normal limits in 85.94% of verum and 64.29% of controls (p < 0.006), while serum AntiTPOab titers (Group A and B) returned within normal limits in 70.27%of verum and 27.02%controls (p < 0.05). Eight children (10.5%) progressed to overt hypothyroidism (OH) from control group. CONCLUSION: A statistically significant decline in serum TSH values and antiTPOab titers indicates that the homeopathic intervention has not only the potential to treat SCH with or without antiTPOab but may also prevent progression to OH.


Subject(s)
Homeopathy , Hypothyroidism/complications , Isoantibodies/therapeutic use , Thyroiditis, Autoimmune/drug therapy , Thyrotropin/blood , Adolescent , Child , Female , Humans , India , Male , Single-Blind Method , Thyroiditis, Autoimmune/complications , Treatment Outcome
3.
Complement Med Res ; 31(1): 1-9, 2024.
Article in English | MEDLINE | ID: mdl-38008074

ABSTRACT

INTRODUCTION: The coronavirus disease 2019 (COVID-19) is leading to unknown and unusual health conditions that are challenging to manage. Post-COVID-19 fatigue is one of those challenges, becoming increasingly common as the pandemic evolves, as it impairs the quality of life of an individual. This trial attempts to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults. METHODS: A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences. RESULTS: Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups. CONCLUSION: IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.EinleitungDie Coronainfektion (COVID-19) zieht unbekannte und ungewöhnliche gesundheitliche Probleme nach sich, deren Management oft eine Herausforderung darstellt. Das gilt unter anderem für Ermüdung nach einer COVID-19-Erkrankung, die mit zunehmender Dauer der Pandemie immer häufiger auftritt und die Lebensqualität der Betroffenen beeinträchtigt. In dieser Studie wird versucht, vorläufige Belege für die Wirksamkeit individualisierter homöopathischer Mittel (IHM) im Vergleich zu Placebo zur Behandlung von Ermüdung nach COVID-19 bei Erwachsenen zu identifizieren.MethodenEine einfach verblindete, randomisierte, placebokontrollierte Parallelgruppenstudie von 3 Monaten Dauer wurde im ambulanten Bereich des Calcutta Homoeopathic Medical College and Hospital in Indien durchgeführt. 60 Teilnehmer erhielten nach Randomisierung im Verhältnis 1:1 entweder IHM (n = 30) oder identisch aussehendes Placebo (n = 30). Die primäre und die sekundäre Zielgröße waren die Fatigue Assessment Scale (FAS) und das Outcome in Relation to Impact on Daily Living (ORIDL) für bis zu 3 Monate, jeweils monatlich gemessen. Vergleichende Analysen wurden an der Intent-to-treat-Population durchgeführt, um Unterschiede zwischen den Gruppen zu erkennen.ErgebnisseGruppenunterschiede bei der primären (FAS gesamt: F1, 58 = 14,356; p < 0.001) sowie der sekundären Zielgröße (ORIDL: F1, 58 = 210,986; p < 0.001) nach 3 Monaten sprachen für die IHM gegenüber Placebo. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%) und Thuja occidentalis (10%) waren die am häufigsten indizierten Mittel. In beiden Gruppen wurden keine Schädigungen, unbeabsichtigten Wirkungen, homöopathischen Verschlechterungen oder jegliche schwerwiegenden unerwünschten Ereignisse beobachtet.SchlussfolgerungDie IHM erzielten signifikant bessere Effekte als Placebo in der Behandlung von Post-COVID-Ermüdung bei Erwachsenen. Definitive, belastbare Studien können eingeleitet werden, um diese Befunde zu bestätigen.


Subject(s)
COVID-19 , Materia Medica , Adult , Humans , COVID-19/therapy , India , Quality of Life , Single-Blind Method , Sulfur
4.
PLoS One ; 18(11): e0292783, 2023.
Article in English | MEDLINE | ID: mdl-37967089

ABSTRACT

BACKGROUND & OBJECTIVES: No definite treatment is known for COVID-19 till date. The objective of this study is to assess the efficacy of customized Homoeopathic medicines, when used as an add-on treatment to Standard of Care (SOC), in patients suffering from moderate to severe COVID-19 infection. METHODS: This was a randomized, controlled, single-blind, parallel-group trial where 214 COVID19-positive patients were screened for moderate and severe cases of COVID-19. Adjuvant homoeopathic medicines were given in the treatment group and SOC was given to both groups. The duration of oxygen support was compared as the primary outcome. Subjects were followed for 28 days or till the end-point of mechanical ventilation/ death. RESULTS: Of 129 subjects included, 57 and 55 were severe; and 8 and 9 were moderate cases in Homoeopathy and SOC arms, respectively. In all, 9 (15.2%) participants in Homoeopathy and 20 (32.2%) participants in SOC arms eventually expired (p<0.05). Oxygen support was required for 9.84±7.00 and 14.92±7.549 days in Homoeopathy and SOC arms, respectively (p<0.005). Subjects receiving Homoeopathy (12.9±6.days) had a shorter hospitalization stay than in SOC (14.9±7.5 days). Homoeopathy arm (10.6±5.7 days) also showed statistically significant mean conversion time of of Realtime-Polymerase Chain Reaction (RT-PCR) from positive to negative than the SOC arm (12.9±5.6 days). The mean score of Clinical Outcome Ordinal Scale (COOS) was lower in the Homoeopathy arm. Laboratory markers [Interleukins (IL)-6, C-reactive protein (CRP), Neutrophils-Lymphocytes ratio (NLR)]were normalized earlier in Homoeopathy arm. CONCLUSION: Homoeopathy, as add-on therapy with SOC for COVID-19 management, demonstrates a reduction in mortality and morbidity, by reduced requirement of oxygen and hospitalization. Some laboratory markers are normalized at an earlier time. Hence, there is overall control over the disease. Registry: The study was registered on the http://ctri.nic.in/Clinicaltrials website under identifier number: CTRI/2020/12/029668 on 9th December 2020.


Subject(s)
COVID-19 , Homeopathy , Humans , COVID-19/therapy , SARS-CoV-2 , Single-Blind Method , Biomarkers , Oxygen , Treatment Outcome
5.
Homeopathy ; 101(1): 38-43, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22226313

ABSTRACT

BACKGROUND: Modern management of haemophilia patients is expensive: 90% of expenditure is on clotting factor concentrates. Any intervention which reduces the need for clotting factor concentrates in these patients without compromising the quality of life is of interest. AIMS AND OBJECTIVES: To investigate the effectiveness of individualised homeopathic medicines in reducing the requirement of factor concentrates in haemophilia patients. MATERIALS AND METHODS: In a single blind placebo controlled cross over trial 28 consecutive persons with haemophilia (PWH) with severe (24) or moderately severe (4) disease received standard management with placebo homeopathy for 1 year and active homeopathic treatment in the subsequent year with the same conventional management. There was no wash out period. They received standard managements for any acute emergency during the study period. Development of inhibitor during the study period was a withdrawal criterion. Sample size for the trial was calculated as 24 PWH. Transfusion requirements, bleeding scores, pain scores were evaluated blind by independent experts. Homeopathic medicines were selected by experienced homeopathic physicians depending on clinical condition of the patient. Chi-squared and paired t tests were used in statistical analysis. RESULTS: 28 patients were recruited. Homeopathic medicines improved frequency of bleeding, extent of bleeding, blood products consumed and pain scores (P<0.0001). There was also significant improvement in well being. Plasma levels of clotting factors did not change. No patients developed inhibitors during the study there were no dropouts. CONCLUSION: Individualised homeopathic medicines may have an important supportive role in the management of PWH, where blood products and factor concentrates are not easily available. Larger, perhaps multicentric trials are warranted.


Subject(s)
Hemophilia A/drug therapy , Homeopathy , Materia Medica/administration & dosage , Adolescent , Blood Coagulation Factors/drug effects , Child , Cross-Over Studies , Female , Hemophilia A/blood , Hemophilia A/pathology , Humans , Male , Pain Measurement , Severity of Illness Index , Single-Blind Method , Treatment Outcome
6.
Altern Ther Health Med ; 17(1): 16-21, 2011.
Article in English | MEDLINE | ID: mdl-21614940

ABSTRACT

BACKGROUND: Pulpa dentis D30 (PD: dental pulp of the calf, prepared in a homeopathic D30 potency) has been used in acute reversible pulpitis for pain relief and to avoid or postpone invasive dental treatment. PRIMARY STUDY OBJECTIVE: To study short-term clinical outcomes of PD therapy for acute reversible pulpitis in routine dental practice. METHODS/DESIGN: Prospective, observational, open-label, single-arm cohort study. SETTING: Eleven dental primary care practices in Germany. PARTICIPANTS AND INTERVENTION: Thirty-two patients starting monotherapy with PD for acute reversible pulpitis without visible or radiological abnormalities. PD was applied as 1-mL submucous injections into the mucobuccal fold, repeated daily as needed. PRIMARY OUTCOME MEASURES: Avoidance of invasive dental treatment (pulp capping, root canal therapy, tooth extraction) and remission of pain, measured on a 0-10 point scale (partial remission: reduction by > or =3 points; complete remission: reduction from > or =4 points to 0-1 points) during the 10-day follow-up period. RESULTS: Median pain duration was 14.0 days. The patients received a median of two PD applications (range 1-7). A total of 81% (n=26/32) of patients did not require invasive dental treatment, and 19% (n= 6) had root canal therapy. Remission status was evaluable in 24 patients. Of these, 63% (n = 15/24) achieved pain remission, 58% (n = 14) remitted without invasive dental treatment (complete remission: n=12, partial remission: n=2), and 29% (n= 7) had a close temporal relationship between PD and remission (ratio "time to remission after first PD application vs pain duration prior to first PD application" <1:10). CONCLUSION: In this study of PD for acute reversible pulpitis, 58% of evaluable patients achieved pain remission without invasive dental treatment. The open-label pre-post design does not allow for conclusions about comparative effectiveness. However, more than one-fourth of evaluable patients remitted with a close temporal relationship between the first PD application and pain remission, suggesting a causal relationship between therapy and remission.


Subject(s)
Dental Care/methods , Homeopathy/methods , Pain Management , Pulpitis/therapy , Acute Disease , Adult , Animals , Cattle , Cohort Studies , Dental Pulp , Female , Humans , Male , Middle Aged , Pain/etiology , Pain Measurement , Prospective Studies , Pulpitis/complications , Single-Blind Method , Treatment Outcome , Young Adult
7.
Homeopathy ; 100(4): 220-7, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21962196

ABSTRACT

BACKGROUND: Ultra High Dilutions (UHD) are diluted beyond the Avogadro limit with dynamization (dilution with succussion). The process of anuran amphibian metamorphosis is controlled by thyroid hormones, including the resorption of the tadpole tail. METHODS: A randomized and blinded study was performed to investigate the influence of triiodothyronine (T3) 5·10(-24)M (10cH) on apoptosis induced by T3 100 nM in Rana catesbeiana tadpoles' tail tips, in vitro. Explants were randomized to three groups: control: no T3 in pharmacological or UHD dose; test: T3 100 nM and challenged with T3 10cH (UHD); positive control: T3 100 nM, treated with unsuccussed ethanol. The apoptotic index and the area of explants of test and control groups at the first and final day of the experiment were compared by t-test. RESULTS: There was no difference in tail tip area between test and control groups, but a significantly higher (p<0.01) index of apoptosis in explants of the test group. CONCLUSION: This data suggest that T3 10cH modifies the effect of T3 at pharmacological dose, opening new perspectives for further studies and investigation of the dose-effect curve.


Subject(s)
Apoptosis/drug effects , Models, Biological , Triiodothyronine/administration & dosage , Animals , Homeopathy , Metamorphosis, Biological , Rana catesbeiana , Random Allocation , Single-Blind Method , Solutions , Tail , Triiodothyronine/chemistry
8.
Urol Res ; 38(3): 205-9, 2010 Jun.
Article in English | MEDLINE | ID: mdl-19997722

ABSTRACT

Most of the drugs administered to stone patients appear to be inappropriate and doing more harm than good to the patients. The objective of this paper is to identify the prevalence of blind chemotherapy among the stone patients and find out the real indication for the drugs administered. Patients who attended the stone clinic for the first time were interviewed to find out what drugs they had been taking before the attendance at the stone clinic. 350 patients consuming specific drugs relevant to stone formation at least for a period of 15 days were selected for a detailed assessment. The type of drug consumed, the dose, the duration, the side effects, compliance rate and effect on stone disease were assessed. The biochemical profile of the patients was assessed to identify the role of the therapeutic modalities utilised. Conclusions regarding the utility of drugs in the process of stone formation were made. The values were compared with those of patients not on medication and considering laboratory standards. Of the 350 patients studied, 96 patients were consuming potassium citrate in different doses, 50 were consuming allopurinol, 44 cystone, 27 potassium citrate + magnesium, 25 calcury, 24 rowatinex, 21 ayurvedic drugs, 17 dystone, 17 homeopathic medicines and 17 other drugs. The longest duration of compliance was for cystone-2.5 years. All other drugs were stopped by the patients themselves due to recurrence of symptoms. As much as 93% of the patients did not feel that there was any significant relief of symptoms. The side effects which prompted the patients to stop medicine were gastro intestinal upset, particularly with potassium citrate, rowatinex and potassium citrate + magnesium combination. The relevant biochemical changes noted were increased urinary citrate levels in patients consuming potassium citrate alone or in combination with magnesium. Serum uric acid was within normal limits in patients consuming allopurinol. Urine uric acid levels were also lower in patients on allopurinol. It is concluded that most of the drugs administered blindly were neither indicated nor beneficial for the patients. Metabolic correction has to be based on proper metabolic assessment.


Subject(s)
Antimetabolites/therapeutic use , Diuretics/therapeutic use , Kidney Calculi/drug therapy , Urolithiasis/drug therapy , Humans , Potassium Citrate/therapeutic use , Single-Blind Method , Urolithiasis/prevention & control
9.
Homeopathy ; 98(1): 40-4, 2009 Jan.
Article in English | MEDLINE | ID: mdl-19135958

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of Ignatia homeopathic 30C in management of oral lichen planus (OLP). METHODS AND MATERIALS: In this single blind randomized control clinical trial, 30 consecutive patients with oral lesions consistent clinically and histologically with erosive and/or atrophic OLP were recruited. The patients were randomly divided into two groups to receive Ignatia or placebo. They were treated for 4 months. RESULTS: Mean lesion sizes and mean pain measures differed between control and treatment groups favouring Ignatia (p<0.05). CONCLUSION: Our results suggest that Ignatia has a beneficial effect in treatment of OLP in selected patients.


Subject(s)
Homeopathy , Lichen Planus, Oral/therapy , Adult , Aged , Female , Humans , Lichen Planus, Oral/pathology , Male , Middle Aged , Prospective Studies , Single-Blind Method
10.
Homeopathy ; 98(3): 137-41, 2009 Jul.
Article in English | MEDLINE | ID: mdl-19647206

ABSTRACT

OBJECTIVE: The objectives of this study were to clinically determine the efficacy of individualised homeopathy in the treatment of minor recurrent aphthous ulceration (MiRAU). DESIGN & INTERVENTION: A randomized, single blind, placebo-controlled clinical trial of individualised homeopathy. One hundred patients with minor aphthous ulcer were treated with individualised homeopathic medicines or placebo and followed up for 6 days. Patients received two doses of individualised homeopathic medicines in the 6C potency as oral liquid at baseline and 12 h later. Pain intensity and ulcer size were recorded at baseline during and at the end of the trial (mornings of days 4 and 6). RESULT: All 100 patients completed treatment. Between group differences for pain intensity and ulcer size were statistically significant at day 4 and at day 6 (P<0.05). No adverse effects were reported. CONCLUSION: The results suggest that homeopathic treatment is an effective and safe method in the treatment of MiRAU.


Subject(s)
Homeopathy/methods , Pain/drug therapy , Phytotherapy/methods , Stomatitis, Aphthous/drug therapy , Adult , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Pain/etiology , Single-Blind Method , Stomatitis, Aphthous/complications , Treatment Outcome
12.
Complement Ther Med ; 13(2): 91-100, 2005 Jun.
Article in English | MEDLINE | ID: mdl-16036166

ABSTRACT

BACKGROUND: Various investigators have observed significant effects of highly diluted histamine on human basophil degranulation in vitro, compared to corresponding water controls. However, active and inactive dilution levels differed in most studies. OBJECTIVE: We aimed to reproduce former studies with flow-cytometry using rigorously controlled experimental conditions to minimise confounding factors. METHODS: In seven independent experiments, basophils of the same human donor were incubated with diluted histamine (up to 10(-34)M) or water controls and activated with anti-IgE antibodies. Basophil activation was determined by using bi-colour flow-cytometry. Experiments were blinded and performed with a randomised arrangement of the solutions on microtiter-plates. RESULTS: Histamine at the dilutions 10(-2)M and 10(-22)M was associated with a significant inhibition of basophil degranulation (p=0.018, Wilcoxon signed rank test) of 23.1% and 5.7%, respectively, if compared to "diluted" water treated in an identical manner. However, if all controls were pooled, only histamine 10(-2)M had a significant effect. Significant effects were seen for row numbers of the microtiter plates. CONCLUSION: We were not able to confirm the previously reported large effects of homeopathic histamine dilutions on basophil function of the examined donor. Seemingly, minor variables of the experimental set up can lead to significant differences of the results if not properly controlled.


Subject(s)
Basophil Degranulation Test/methods , Basophils/drug effects , Histamine/pharmacology , Homeopathy , Dose-Response Relationship, Drug , Flow Cytometry , Histamine/administration & dosage , Humans , In Vitro Techniques , Single-Blind Method
13.
Thromb Haemost ; 77(2): 262-6, 1997 Feb.
Article in English | MEDLINE | ID: mdl-9157578

ABSTRACT

Studies measuring the fibrin degradation product D-Dimer (DD) using enzyme-linked immunosorbent assays (ELISA) in patients with venographically proven deep venous thrombosis (DVT) suggest that it is possible to exclude DVT when DD level is below a certain cut-off level. However, ELISA methods are time-consuming and not available in all laboratories. Different rapid latex-agglutination assays have been investigated, but their sensitivity is considerably lower. In the present study we compared the value of four novel latex DD tests (Tinaquant, Minutex, Ortho and SimpliRed) and one rapid ELISA (VIDAS) to a classical ELISA DD assay (Organon Mab Y18) in 132 patients suspected of DVT. The VIDAS, a new quantitative automated ELISA, had a sensitivity of 100% and a negative predictive value of 100% for both proximal and distal DVT at a cut-off level of 500 ng/ml. The Tinaquant assay, a new quantitative latex method, had a sensitivity of 99% and a negative predictive value of 93% for both proximal and distal DVT at a cut-off level of 500 ng/ml. For proximal DVT only, both assays had a sensitivity and negative predictive value of 100%. VIDAS and Tinaquant correlated well with ELISA (correlation of r = 0.96 and r = 0.98 respectively). Sensitivities of the semi-quantitative latex assays Minutex, Ortho and SimpliRed were considerably lower (77%, 51% and 61% respectively). These results suggest that VIDAS and Tinaquant may be used instead of ELISA DD in the exclusion of DVT. Tinaquant can be performed within 20 min and VIDAS within 35 min. Both assays might be used as a routine screening test and should be evaluated in large clinical management studies.


Subject(s)
Enzyme-Linked Immunosorbent Assay , Fibrin Fibrinogen Degradation Products/analysis , Latex Fixation Tests , Thrombophlebitis/diagnosis , Adult , Aged , Aged, 80 and over , Feasibility Studies , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Sensitivity and Specificity , Single-Blind Method , Thrombophlebitis/blood
14.
Altern Ther Health Med ; 6(2): 58-66, 2000 Mar.
Article in English | MEDLINE | ID: mdl-10710804

ABSTRACT

The acknowledged early adoption of placebo controls in drug trials by homeopaths is currently thought to have been derived from prior external attempts to discredit the system. This claim is reexamined in the light of a comprehensive literature search for 19th-century homeopathic therapeutic trials and provings using placebo. Single-blind placebo controls, still used today, are shown to have originated independently within homeopathy's own disciplinary matrix before the first external evaluations. They are the most likely source for later placebo-controlled crossover and parallel group experiments by homeopaths.


Subject(s)
Homeopathy/history , Placebos/history , Controlled Clinical Trials as Topic/history , History, 19th Century , History, 20th Century , Humans , Single-Blind Method
15.
J Altern Complement Med ; 1(2): 145-60, 1995.
Article in English | MEDLINE | ID: mdl-9395611

ABSTRACT

This article describes and discusses five placebo-controlled randomized studies investigating the immunomodulatory activity of preparations containing extracts of Echinacea in healthy volunteers. A total of 134 (18 female and 116 male) healthy volunteers between 18 and 40 years of age were studied. Two studies tested intravenous homeopathic complex preparations containing Echinacea angustifolia D1 (study 1) and D4 (study 5). Two studies (2 and 3a) tested oral alcoholic extracts of roots of E. purpurea, one study an extract of E. pallida roots (study 3b), and one study an extract of E. purpurea herb (study 4). Test and placebo preparations were applied for four (study 5) or five (studies 1-4) consecutive days. The primary outcome measure for immunomodulatory activity was the relative phagocytic activity of polymorphonuclear neutrophil granulocytes (PNG), measured in studies 1 and 2 with a microscopic method and in studies 3, 4, and 5 with two different cytometric methods. The secondary outcome measure was the number of leukocytes in peripheral venous blood. Safety was assessed by a screening program of blood and other objective parameters as well as by documentation of all subjective side effects. In studies 1 and 2 the phagocytic activity of PNG was significantly enhanced compared with placebo [maximal stimulation 22.7% (95% confidence interval 17.5-27.9%) and 54.0% (8.4-99.6%), respectively], while in the other studies no significant effects were observed. Analysis of intragroup differences revealed significant changes in phagocytic activity during the observation periods in five test and three control groups. Leukocyte number was not influenced significantly in any study. Side effects due to the test preparations could not be detected. Our studies provide evidence for immunomodulatory activity of the homeopathic combination tested in study 1 and the E. purpureae radix extract tested in study 2. The negative results of the other three studies are difficult to interpret due to the different methods for measuring phagocytosis, the relevant changes in phagocytic activity within most placebo and treatment groups during the observation period, and the small sample sizes. Future studies should be performed on patients rather than healthy volunteers and use standardized or chemically defined monopreparations of Echinacea.


Subject(s)
Adjuvants, Immunologic/standards , Anti-Inflammatory Agents, Non-Steroidal/immunology , Granulocytes/drug effects , Homeopathy/standards , Leukocyte Count/drug effects , Neutrophils/drug effects , Phagocytosis/drug effects , Plant Extracts/immunology , Adjuvants, Immunologic/chemistry , Adolescent , Adult , Anti-Inflammatory Agents, Non-Steroidal/chemistry , Chemistry, Pharmaceutical , Double-Blind Method , Echinacea , Female , Flow Cytometry , Humans , Male , Plant Extracts/chemistry , Single-Blind Method
16.
Neurol India ; 48(1): 37-42, 2000 Mar.
Article in English | MEDLINE | ID: mdl-10751812

ABSTRACT

A prospective, randomised, single blind study was conducted to evaluate and compare the intracranial pressure (ICP) and cardiovascular effects of pipecuronium (PPC) and pancuronium (PNC) in 20 patients undergoing supratentorial surgery. Patients were randomly divided into two groups. Patients in Group I (n = 10) received pancuronium (0.1 mg kg(-1)) and in Group II (n = 10) pipecuronium (0.07 mg kg(-1)) for intubation. Intracranial pressure (ICP), heart rate (HR), systolic, diastolic and mean arterial pressures (SAP, DAP, MAP), central venous pressure (CVP), nasopharyngeal temperature and arterial blood gases (ABG) were monitored at the following time periods: before induction (0 minutes); 3 minutes after thiopentone and muscle relaxant; immediately after intubation; and 4, 6, 8, 10, 20 and 30 minutes following intubation. The rise in intracranial pressure at intubation was significantly greater in group I (21.10+/-3.97 torr, 122.59%) when compared to group II patients (1.80+/-0.70 torr, 10.04%) (p<0.0 1). Cardiovascular parameters also showed a significantly greater degree of rise in group I when compared to group II patients. Heart rate increased by 29+/-6.32 beats min(-1) (33.52%) and systolic arterial pressure by 11.60+/-7.37 torr (9.47%) in group I. These parameters did not change significantly in group II. No significant alterations were observed in the other measured parameters in either of the two groups.


Subject(s)
Hemodynamics/drug effects , Intracranial Pressure/drug effects , Neuromuscular Nondepolarizing Agents/therapeutic use , Pancuronium/therapeutic use , Pipecuronium/therapeutic use , Supratentorial Neoplasms/physiopathology , Adolescent , Adult , Female , Humans , Male , Middle Aged , Prospective Studies , Single-Blind Method
17.
Can Vet J ; 43(8): 601-3, 2002 Aug.
Article in English | MEDLINE | ID: mdl-12170834

ABSTRACT

A commercial homeopathic remedy and a placebo were administered orally as individual agents to 18 dogs with atopic dermatitis. The pruritus was reduced by less than 50% in only 2/18 dogs; 1 of these dogs was receiving the homeopathic remedy, the other was receiving the placebo. One dog vomited after administration of the homeopathic remedy.


Subject(s)
Dermatitis, Atopic/veterinary , Dog Diseases/drug therapy , Materia Medica/therapeutic use , Administration, Oral , Animals , Dermatitis, Atopic/drug therapy , Dogs , Female , Male , Materia Medica/adverse effects , Pruritus/drug therapy , Pruritus/veterinary , Single-Blind Method , Treatment Outcome , Vomiting/chemically induced , Vomiting/veterinary
18.
Zhongguo Zhong Xi Yi Jie He Za Zhi ; 17(7): 414-6, 1997 Jul.
Article in Zh | MEDLINE | ID: mdl-10322862

ABSTRACT

OBJECTIVE: To observe the effects of Tongxinluo capsule (TXLC) in treating angina pectoris (AP) caused by coronary heart disease (CHD) and evaluate its safety. METHODS: Randomized single-blind controlled design were adopted. Three hundred and forty two patients were treated with TXLC (4 capsules, three times daily), and 150 patients in the control group done with Shuxin oral liquor (SXOL, 20 ml, two times daily). After 4 weeks of treatment, the data of AP, ECG, main symptoms, total effects were collected and evaluated. RESULTS: TXLC appeared to be more effective than SXOL for patients with mild, moderate, severe AP (P < 0.01), except with mild stomach discomfort for a few patients, TXLC has no side effect and toxicity. CONCLUSION: TXLC is an effective drug in treating AP and has no side effects and toxicity.


Subject(s)
Angina Pectoris/drug therapy , Drugs, Chinese Herbal/therapeutic use , Materia Medica/therapeutic use , Adult , Aged , Female , Humans , Male , Middle Aged , Single-Blind Method
19.
Complement Ther Clin Pract ; 19(4): 246-50, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24199982

ABSTRACT

BACKGROUND AND OBJECTIVE: Homeopathic medicine (HM) in the treatment of Chronic Periodontitis (CP) aims to restore the vital energy balance of the patient allowing the body to heal itself. Thus, the aim of this study was to evaluate the additional benefits of HM as an adjunctive to conventional periodontal treatment (CPT). MATERIALS AND METHODS: After sample size calculation, sixty individuals of both genders, and ages varying between 35 and 70 years old, 40 with chronic periodontitis (CP group - CPG) and 20 without CP (Healthy Group - HG) participated in this "Single-Blind Randomized Controlled Clinical Trial". The CP patients were divided into two groups: one was submitted only to CPT (CP Control Group - CPT-C) and the other group was submitted to CPT and HM, according to the similia principle (CP Test Group - CPTT). Assessments were made at baseline and after 90 days of treatments. The local and systemic responses to the treatments were evaluated by clinical and laboratory parameters, respectively. Data were analyzed by parametric and nonparametric tests. The level of significance was 5%. RESULTS: At baseline, CP patients presented higher values of LDL cholesterol and blood glucose than HG individuals. After the treatment, all the systemic parameters evaluated decreased in CP patients, except LDL and HDL Cholesterol in CPT-C, and HDL Cholesterol in CPT-T. There was a statistical gain in clinical attachment level only in CPT-T (+0.51 mm) after 90 days; however, there was a reduction in probing depth, in the level of visible plaque and in the bleeding on probing, in both CP groups (CPT-C and CPT-T) after 90 days. CONCLUSION: The findings of this 3-month follow-up study concluded that H M, as an adjunctive to CPT, can provide additional benefits in the treatment of CP.


Subject(s)
Blood Glucose/metabolism , Cholesterol, HDL/blood , Cholesterol, LDL/blood , Chronic Periodontitis/drug therapy , Homeopathy , Materia Medica/therapeutic use , Periodontal Index , Adult , Aged , Chronic Periodontitis/blood , Dental Plaque , Female , Follow-Up Studies , Humans , Male , Middle Aged , Single-Blind Method
20.
Article in English | MEDLINE | ID: mdl-22654210

ABSTRACT

To disclose a quackery called "revitalisation of tired water by hydronic technology", scientific experiments have been conducted with drinking water kept in "ordinary, everyday-use" drinking glasses and so-called 'informed' glasses, a patent-protected product supposed to have an effect on the "structure, vitality and memory of water". Drinking "informed" water is claimed to have a wide range of positive revitalising health effects (blue informed glass), to facilitate weight loss (red informed glass) and to have a stress-relieving action (green informed glass). Allegedly, by the use of the "orgon methodology", information is coded into the glass, which action is additionally enforced by the addition of the "magic life" symbol - a specially designed energy condenser which, together with the selected information, is permanently introduced into the liquid contained in the glass. Since the manufacturer claimed the products to have a broad bactericidal action, regardless of the external conditions and completely independent from additional factor that would lead to the activation of the system, the efficacy of the informed drinking glass was tested using standardised, microbiological tests. Respecting the principle of a single-blind test for each of 5 samples of each type of the informed glass, growth reduction factor (RF) (difference log cfu/ml - colony per unit/ml of control glass and log cfu/ml of each informed glass) was determined after 0,2,4,6 and 8 h in spring water experimentally contaminated with standardised ATCC strains of two types of bacteria and one yeast. The results showed a statistically significant bactericidal action of the blue informed glass with all strains-Enterococcus faecalis (RF 0.62/0.76), Salmonella enteritidis (RF 0.87/0.97), and Candida albicans (RF 0.5/0.60) - as opposed to the red and green glasses where this effect was negligible (RF < 0.1). However, when the tests were repeated in complete darkness, none of the three informed glasses showed any bactericidal action. The obtained results indicate a fraud: bactericidal effect is rather a result of photocatalytic action of a hidden component used on purpose in the production of glass or subsequently applied by the use of nanotechnology (possibly antimony trioxide or titanium oxide) than of the so-called "orgon and hydronic technology".


Subject(s)
Anti-Bacterial Agents/pharmacology , Antifungal Agents/pharmacology , Candida albicans/drug effects , Enterococcus faecalis/drug effects , Quackery , Salmonella enteritidis/drug effects , Colony Count, Microbial , Color , Consumer Product Safety , Drinking Water/microbiology , Glass , Humans , Microbial Sensitivity Tests , Nostrums , Rejuvenation , Single-Blind Method
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