It’s widely assumed that complementary medicine has a “softer” evidence base than orthodox medicine – that is, in one respect, an evidence base of clinical trials with relatively small numbers of trial participants. This is true.
Clinical trials of orthodox medical interventions often involve hundreds of thousands of people and cost many millions of dollars to carry out and there’s a good reason why this occurs – there’s enormous money to be made from new drugs, particularly anti-cancer drugs, and clinical trials that prove the efficacy of a new drug virtually guarantee good sales revenue.
Rituximab for example, a drug that’s mainly prescribed for non-Hodgkin’s lymphoma and first approved for sale in 1997, as at 2017 had accumulated sales of 93.7 billion US dollars1. The cost of setting up large clinical trials, particularly for the manufacturers of CAM medicines such as homeopathics, is simply beyond their financial capacity. As a result, what’s conducted are relatively small trials but, this does not diminish their usefulness and what follows are examples of recent work in this area.
- Tay-Teo K, et al. Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Companies. JAMA Netw Open. 2019;2(1):e86875.
- Mehra P. Usefulness of homeopathy in essential hypertension: an exploratory interventional trial. Int J High Dilution Res.2015;14(1):16-19.1. 30 people with stage 1 or 2 essential hypertension were subjected to repertory analysis, were prescribed individualised homeopathic medicine and were followed up every 15 days (stage 2) or every month for up to 1 year (stage 1). Improvement was defined as changes in hypertension guideline (JNC VII) stages and improvement of the participants’ general condition.
The main outcome was changes in the blood pressure, and the secondary outcome was presence of metabolic syndrome. The data were analysed using statistical software SPSS version 16 and the Wilcoxon signed rank test was applied. 16 (53.33%) cases showed marked improvement, 8 (26.67%) moderate improvement, 3 (10%) no improvement and 3 (10%) dropped out. Homeopathic Arsenicum album, Natrum muraticum, Nux vomica, Causticum and Lycopodium clavatum were found to be useful in the management of essential hypertension. The difference in the systolic and diastolic blood pressure before and after treatment was statistically significant (p<0.001). Metabolic syndrome was present in 46.67% of the cases.
- Mourao LC, et al. Homeopathy and Levels of Ca++Salivary in the Prevention of Dental Caries. Int J High Dilution Res. 2019;18(2):02-02. In this randomised controlled multi-centre study, 48 children with a high rate of dental caries, submitted to dental treatment, without the preventive application of fluoride topical and specific food guidelines were divided randomly into 2 groups according to the medication experienced: GI –Calcarea Carbonica 6C; Calcarea phosphorica 6C; Calcarea fluorica 6C, in the dose of 3 daily drops for 15 days a month for 3 months. GII –Upward scales of Calcarea Carbonica 6C; Calcarea phosphorica 6C; Calcarea fluorica 6C, in the dose of 3 daily drops, in the first month. Calcarea Carbonica 9C; Calcarea phosphorica 9C; Calcarea fluorica 9C, in the dose of 3 daily drops, in the second month. Calcarea Carbonica 12C; Calcarea phosphorica12C; Calcarea fluorica12C, in the dose of 3 daily drops, in the third month. The salivary Ca + + levels were measured before the administration of the first dose and monthly, for 3 consecutive months. The calcium (mg/dl) salivary indices were determined by optical emission spectrometry (ICP-OES). The results were submitted to statistical analysis with Student T-Test (significance with P < 0.05) and analysis of variance Shapiro-Wilk normality test. The averages of calcium increase under the action of homeopathic medicinal products: Calcarea Carbonica, Calcarea Phosphorica and Calcarea Fluorica,in this study, did not differ in G I and G II and in both groups the increase in salivary calcium level was statistically significant to 0.5%.
- Gupta J, et al. Management of early years of simple and mucopurulent chronic bronchitis with pre-defined homeopathic medicines–a Prospective Observational Study with 2-Years Follow-Up. Int J High Dilution Res. 2019;18(3-4):47-62. 532 people with simple and muco-purulent chronic bronchitis (SMCB) were enrolled as per the inclusion and exclusion criteria. 14 pre-defined homeopathic medicines were shortlisted for prescription after repertorising the pathological symptoms of SMCB. Outcomes were assessed through the chronic bronchitis symptom scale (CBSS) andFEV1/ FVC ratio with spirometry for over a period of two years. The appearance of any change (relief/ worse)/ status quo was immediately followed by placebo/ change in dilution/ change in remedy. Statistical analysis was done using SPSS version 20. Data was analysed based on the intention to treat principle using the last observation carry forward method. Mean CBSS score reduced from 29.86±4.5 at baseline to 12.33±7.6 at completion of 2 years. Repeated measures ANOVA, at time points 0 (baseline), 3, 6, 9, 12 ,15, 18, 21 and 24 months, showed significant reduction in CBSS scores [Wilk’s Lambda 0.104, F=564, df 524; p=00001]. The FEV1 and FEV1/FVC was maintained within normal limits. 86% prescriptions included Lycopodium, Arsenicum album, Pulsatilla, Phosphorus, Stannum metallicum, Calcarea carbonica, Silicea, or Bryonia alba.
- Brands M, et al. Outcomes and effects of homeopathic treatment of malaria in Kenya, a multi-centre study. Int J High Dilution Res. 2020;19(1-2):02-25. In 3 studies authors documented the homeopathic treatment of malaria: in a retrospective qualitative study, a prospective single arm study, and a comparison between one cohort receiving homeopathic treatment and the other receiving the anti-malarial drug, artemether. In the qualitative retrospective study (2014) (n=54), authors related typical malaria and individual symptoms, with remedy prescriptions and affected organs. Principal Component Analysis (PCA) showed, that specific remedies were prescribed for patterns of affected organs. In the prospective study (2014) (n=70),the primary outcome was the parasitological status at the first follow up (median 8 days), secondary outcome was the quality of life measure with Outcome Related to Impact on Daily Life. In the third study, of the group (n=79) (b) exposed to homeopathy, n=6 (a) were still parasite-positive after one week, in the control (co-artem) group of n=35 (c) no patient was positive (d). The odds ratio was 5.8068 (95% CI 0.3183 –105.8794), with z = 1.187 and P = 0.2352. The difference was not statistically significant; homeopathic remedies and co-artem tablets had similar effect for uncomplicated malaria in that region. Co-morbidity was treated with different remedies.
- Mohan GR, et al. Evaluation of Homoeopathic Treatment Approach in Depressive Disorders of Hyderabad Urban Population of Age Group 15–30 Years: A Prospective, Non-comparative, Open-Label Observational Study. Homœopathic Links. 2019;32(04):224-9. 175 people presenting with symptoms of depressive disorders were treated with homeopathy based on individualisation. Hamilton depression rating scale (HAM-D) was used to assess the treatment. The assessment parameters were- marked improvement- 75% and above; moderate improvement- 50% and above; mild improvement- 25%. A significant difference (p = 0.0001, p < 0.05) in the mean scores of HAM-D using paired t-test was observed at the end of the study; marked improvement was seen in 39 cases; moderate improvement was seen in 76; mild improvement was seen in 34 cases; no improvement was seen in 26 cases. Remedies such as Ignatia, Nat mur, Nux vomica, Staphysagria, Arsenicum album and Lycopodium were found to have a positive role.
- Kundu N, et al. Homeopathic Treatment of Rheumatoid Arthritis: An Open, Observational Trial. Homœopathic Links. 2019;32(04):216-23. 44 patients suffering from rheumatoid arthritis were prescribed individualised homeopathic medicines and assessed over 4 months of treatment. Disease Activity Score-28 (DAS28) and Rheumatoid Arthritis Disease Activity Index (RADAI) were used as the primary and secondary outcome measures respectively. There were statistically significant reductions in both DAS28 score (6.8 ± 1.0 vs. 6.1 ± 1.2; mean reduction 0.7, 95% CI: 0.4–0.9, p < 0.001) and RADAI score (6.6 ± 1.8 vs. 5.2 ± 1.9; mean reduction 1.4, 95% CI: 1.0–1.9, p < 0.001) over 4 months of individualised homeopathic treatment.
In Vitro Research
- Pinto SAG, et al. Study of the effects of Silicea terra and Zincum metallicum in various dilutions on the oxidative activity of macrophages in vitro. Int J High Dilution Res. 2018;17(1):19. Authors assessed the homeopathic medicines Silicea terra and Zincum in 6C, 30C and 200C homeopathic potencies in an in vitro experimental model to determine their effects on the interaction between RAW 264.7 macrophages and BCG (Bacillus Calmette-Gueérin). They measured oxidative activity through measurement of hydrogen peroxide and nitrite/nitrate in the cell culture supernatant after 24 hours of treatment. The tests were performed in duplicate, and the data were analysed by means one-way ANOVA. The results show no effect on nitric oxide (NO) production, but reduction of hydrogen peroxide production (p≤ 0.001) after treatment with the vehicle (30% alcohol). Such reduction was reversed with treatments Silicea terra 30C and Zincum metallicum 30C (p≤ 0.001). Treatment with Silicea terra 200C induced significant reduction of hydrogen peroxide production, even when compared to the vehicle (p≤ 0.005). Taken together, the results indicate that only treatment of BCG-challenged macrophages with Silicea terra 200C was able to significantly reduce the oxidative activity of these cells after 24 hours of incubation.
- Cardoso TN, et al. In vitro interaction between murine carcinoma cells and macrophages after treatment with Carbo animalis. Int J High Dilution Res. 2018;17(1):13. Authors analysed the interaction of macrophages with murine breast cancer cells (4T1) after treatment with Carbo animalis in different homeopathic dilutions: 6C, 30C and combination 30C + 6C (MIX). All dilutions and vehicles were physically and chemically analysed for conductance and composition of microparticles in suspension by means of energy-dispersive x-ray spectroscopy (EDX). Exposure of macrophages co-cultured with 4T1 cells to treatments over a period of 48 hours led to the following significant changes: 1) reduction of TNF-alpha production in co-cultures compared to simple macrophage culture, indicating an inhibitory effect of the tumour on macrophage activity; b) higher expression of pseudopodia and IL-6 production after exposure to all treatments; c) increase of the cell number per microscopic field, increase in the interaction (cell-cell contact) between macrophages and 4T1cells and increase in production of GM-CSF, IL-12p40 and MCP-1 after treatment with Carbo animalis 6C; d) increase of VEGF production in cells treated with Carbo animalis 30C. There was no change in nitric oxide production with any treatment. Physical-chemical analysis of the drugs revealed a significant increase in the conductivity of Carbo animalis 30C and MIX samples compared to the vehicle (30% alcohol). The microparticles exhibited an extremely diverse composition, including Na, Si, Cl, F, Pb, S, Ca, Mg, Al, K, Nb, B and Be . Only Carbo animalis 6C exhibited boron and beryllium with frequency above 50% per particle, and this drug induced the most significant changes on the macrophage-tumour interaction.
- Scardoeli B, et al. High Dilution in Leukopenia treatment in five Dogs. Int J High Dilution Res. 2022; 21(1):17-17. This reports on the homeopathic treatment of 5 dogs between 3 and 5 years old, presenting with leukopenia. The homeopathic treatment was chosen, using Echinacea angustifolia due to its immunostimulant and immunomodulatory actions, which evolution was analysed by blood tests. The same protocol was made for all of the patients, including 4 globules of Echinacea angustifolia 6C orally, every 12 hours for 30 days. The first dog attended on 07/21/2021, presented 4,000 leukocytes, which increased to 6,800 on 08/17/2021. The second patient attended on 12/07/2021 presented 4,700 leukocytes, increasing to 6,800 on 01/25/2022. The third patient attended on 08/24/2021 presented 5,400 leukocytes, which increased to 6,800 on 10/15/2021. The fourth patient presented 4,300 leukocytes on 01/13/2022, increasing to 5,500 on 02/11/2022. The fifth patient presented on12/12/2021 4,600 leukocytes, increasing to 8,400 on 02/03/2022. Therefore, the average of the first collection was 3,681 leukocytes and in the second there was an increase to 6,860 leukocytes (T-test, p= 0,0167).
- LCCA de Vilhena Moraes, et al. Increase in growth of eucalyptus seedlings with application of homeopathic preparations. Int J High Dilution Res. 2018;17(3-4):58-62. This study assessed the interaction between the homeopathic preparations and the development of Eucalyptus urophylla S. T. Blake seedlings. Applications were made once daily and preparations utilised were Phosphorus, Calcarea carbonica, Kali muriaticum, Magnesia carbonica, all in potencies 3C and12C and the controls were water and alcohol 3C. Parameters of seedling quality were measured in different times during the experiment, up to the end. Kali mur 12C promoted increased root length of approximately 55% compared to the water control. Phosphorus 3C differed from other treatments considering the total green mass. Phosphorus 3C and Kali mur 12C increased the root growth, in relation to controls. The responses obtained with the application of Phosphorus 3C indicate the viability of its agronomic use to increase of the root capacity of absorbing elements, as much as necessary for the plant growth.