Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial

Abstract

Objectives To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care. Trial design A randomized, two-armed (1:1), parallel, placebo-controlled, double-blind, clinical trial is being performed to test the following hypotheses: H0: homeopathic medicines = placebo (null hypothesis) vs. H1: homeopathic medicines ≠ placebo (alternative hypothesis) for mild cases of COVID-19 in Primary Care. Participants Setting: Primary Care of São Carlos – São Paulo – Brazil. One hundred participants aged 18 years or older, with Influenza-like symptoms and a positive RT-PCR for SARS-CoV-2. Willingness to give informed consent and to comply with the study procedures is also required. Exclusion criterium: severe acute respiratory syndrome. Intervention and comparator Homeopathy: 1 globule of Natrum muriaticum LM2 diluted in 20 mL of alcohol 30% and dispensed in a 30 ml bottle. Placebo: 20 mL of alcohol 30% dispensed in a 30 ml bottle. Posology: one drop taken orally every 4 hours (6 doses/day) while there is fever, cough, tiredness, or pain (headache, sore throat, muscle aches, chest pain, etc.) followed by one drop every 6 hours (4 doses/day) until the fourteenth day of use. The bottle of study medication should be submitted to 10 vigorous shakes (succussions) before each dose. Posology may be changed by telemedicine, with no break in blinding. Study medication should be maintained during home isolation. According to the Primary Care protocol, the home isolation period lasts until the 10th day after the appearance of the first symptom, or up to 72 hours without symptoms. Main outcomes The primary endpoint will be time to recovery, defined as the number of days elapsed before all COVID-19 Influenza-like symptoms are recorded as mild or absent during home isolation period. Secondary measures are recovery time for each COVID-19 symptom; score of the scale created for the study (COVID-Simile Scale); medicines used during follow-up; number of days of follow-up; number of visits to emergency services; number of hospitalizations; other symptoms and Adverse Events during home isolation period. Randomisation The study Statistician generated a block randomization list, using a 1:1 ratio of the two groups (denoted as A and B) and a web-based tool (http://www.random.org/lists). Blinding (masking) The clinical investigators, the statistician, the Primary Care teams, the study collaborators, and the participants will remain blinded from the identity of the two treatment groups until the end of the study. Numbers to be randomised (sample size) One hundred participants are planned to be randomized (1:1) to placebo (50) or homeopathy (50). Trial Status Protocol version/date May 21, 2020. Recruitment is ongoing. First participant was recruited/included on June 29,2020. Due to recruitment adaptations to Primary Care changes, the authors anticipate the trial will finish recruiting on April 10, 2021. Trial registration COVID-Simile Study was registered at the University Hospital Medical Information Network (UMIN - https://www.umin.ac.jp/ctr/index.htm) on June 1st, 2020, and the trial start date was June 15, 2020. Unique ID: UMIN000040602. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study)

“…Three medical doctors (certified homeopaths), with over 25 years of clinical experience, had indicated that Natrum muriaticum LM2 was a homeopathically suitable remedy for COVID-19, as detailed in the published study protocol [9] .…”

“…This study aims to investigate the effectiveness and safety of the homeopathic medicine Natrum muriaticum LM2 in the treatment of mild cases of COVID-19 in a primary care setting. The rationale for selecting Natrum muriaticum LM2 is detailed in the published study protocol [9] .…”

Homeopathy as an Adjuvant to Standard Care in Moderate and Severe Cases of COVID-19: A Single-Blind, Randomized, Placebo-Controlled Study

“…Many trials on this front were ongoing at the time of drafting this manuscript. [19][20][21] In this study, individualized homeopathic treatment was given to all the participants of the experimental group (addon homeopathy, AoH), based on the totality of symptoms inclusive of not only clinical but also holistic or individualizing aspects such as thirst, appetite and frame of mind, wherever possible. In cases that were more severe, such as those in the ICU, it was difficult, however, to elicit their personalized symptoms.…”

COVID-19 rhapsody: Rage towards advanced diagnostics and therapeutic strategy

“…Moreover, homeopathic treatment is considered an individualized therapy for a definite and specific pathological outcomes. Therefore, homeopathic ultra-high diluted solution products, such as Aconitum napellus , Arsenicum album , Eupatorium perfoliatum , Gelsemium , or Ipecacuana , could help treat early pathogenesis, while Antimuonium tartaricum , Baptisia , or Camphor officinalis would be beneficial in later stages for both respiratory and systematic treatment [ 148 , 149 , 150 , 151 , 152 ].…”