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Individualized Homeopathic Medicinal Products in the Treatment of Post-COVID-19 Conditions: A Double-Blind, Randomized, Placebo-Controlled, Feasibility Trial
Abstract
Objectives: Evidence suggests that post-coronavirus disease 2019 (COVID-19) is associated with reduced health-related quality of life, and up to 80% of those infected with COVID-19 may experience these symptoms. The objective of the present study was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in postCOVID-19 conditions. Design: Double-blind, randomized (1:1), two parallel arms, placebo-controlled, feasibility trial. Setting: D. N. De Homoeopathic Medical College & Hospital, Kolkata, West Bengal, India. Subjects: Sixty participants with post-COVID-19 conditions. Interventions: Group verum (n = 30; IHMPs plus concomitant care) versus group control (n = 30; placebos plus concomitant care). Outcome Measures: Feasibility issues; primary-post-COVID-19 symptoms checklist; secondary-Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen's d). Results: Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: -4.2, 95% CI -4.9 to -3.4, d = 2.854 and MYMOP-2 mean difference after 3 months: -2.2, 95% CI -2.8 to -1.7, d = 2.082, respectively. Natrum muriaticum (11.7%), Pulsatilla nigricans (10%), Rhus toxicodendron (8.3%), and Calcarea carbonica (8.3%) were the most frequently prescribed remedies. Conclusions: IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.
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This study investigates the relationship between long COVID and health-related quality of life (HRQOL) in patients discharged for 6 months. It included 192 patients with a history of severe COVID-19 and 192 patients with a history of non-severe COVID-19 patients that were selected through quota sampling methods from the Medical Care Monitoring Center (MCMC) of hospitals in Shiraz, Iran, in 2020. Phone-based interviews were conducted to collect data using the short form of the 12-item health-related quality of life (SF-12) questionnaire. Descriptive statistics, including mean (standard deviation) and frequency (percentage), were utilized. Statistical tests, such as the chi-squared test, independent samples t-test, Fisher’s exact test, and multiple linear regression models were performed. Statistical analysis was performed using SPSS software version 24, with a significance level of 0.05. Among 384 patients, 79.95% were married, with a mean age of 53.95 years. The majority of patients in both groups were male (57.81% in the severe group and 51.04% in the non-severe group). Patients with severe COVID-19 had significantly lower quality of life scores compared to those with non-severe COVID-19 (p < 0.001, 34.45 [SD = 6.59] versus 39.64 [SD = 5.07]). Furthermore, multiple linear regression analysis indicated that severe COVID-19 inducts a significant negative effect on HRQOL in patients after adjustment of confounders (p < 0.001, B = − 4.84). Patients with severe COVID-19 had lower HRQOL compared to those with a non-severe level. It is necessary to consider implementing policies aimed at providing social, psychological, or medical support to improve the HRQOL of patients with a history of severe COVID-19.
Background
Longer-term symptoms (long COVID) may be present in seemingly recovered patients for several months and can be debilitating.
Aim
To investigate the prevalence and type of symptoms in those with a prior COVID-19 diagnosis.
Methods
This prospective, longitudinal observational study commenced in July 2020 investigating the longer-term health impacts of COVID-19. Participants were recruited via public health units and media publicity. Surveys were completed upon enrolment, and at 1, 3, 6 and 12 months. Outcome measures included incidence of activity limitations and symptoms against health and vaccination status, age and gender.
Results
Overall, 339 participants were recruited. At 3 months after COVID-19, 66.8% reported symptoms, and 44.8% were still experiencing symptoms at 12 months. Fatigue was most common at every point (between 53.1% and 33.1%). Pain symptoms increased in relative prevalence over time, whereas respiratory/pulmonary-type symptoms decreased substantially after 3 months. Females and younger people were more likely to experience symptoms in the early stages of long COVID (P < 0.01) and those with more comorbidities in the latter stages (P < 0.001). Vaccination showed a statistically significant protective effect against symptoms (P < 0.01–0.001).
Conclusion
Long-term COVID-19 symptoms exist among recovered patients up to 12 months after contracting the virus. Fatigue is a primary contributor, while chronic pain became more problematic after 6 months. Vaccination was a factor in preventing long-term symptoms and aiding faster recovery from symptoms. Further work exploring additional contributors to symptom prevalence would assist in developing appropriate follow-up care.
Introduction
The effects of COVID-19 infection persist beyond the active phase. Comprehensive description and analysis of the post COVID sequelae in various population groups are critical to minimise the long-term morbidity and mortality associated with COVID-19. This analysis was conducted with an objective to estimate the frequency of post COVID sequelae and subsequently, design a framework for holistic management of post COVID morbidities.
Methods
Follow-up data collected as part of a registry-based observational study in 31 hospitals across India since September 2020–October 2022 were used for analysis. All consenting hospitalised patients with COVID-19 are telephonically followed up for up to 1 year post-discharge, using a prestructured form focused on symptom reporting.
Results
Dyspnoea, fatigue and mental health issues were reported among 18.6%, 10.5% and 9.3% of the 8042 participants at first follow-up of 30–60 days post-discharge, respectively, which reduced to 11.9%, 6.6% and 9%, respectively, at 1-year follow-up in 2192 participants. Patients who died within 90 days post-discharge were significantly older (adjusted OR (aOR): 1.02, 95% CI: 1.01, 1.03), with at least one comorbidity (aOR: 1.76, 95% CI: 1.31, 2.35), and a higher proportion had required intensive care unit admission during the initial hospitalisation due to COVID-19 (aOR: 1.49, 95% CI: 1.08, 2.06) and were discharged at WHO ordinal scale 6–7 (aOR: 49.13 95% CI: 25.43, 94.92). Anti-SARS-CoV-2 vaccination (at least one dose) was protective against such post-discharge mortality (aOR: 0.19, 95% CI: 0.01, 0.03).
Conclusion
Hospitalised patients with COVID-19 experience a variety of long-term sequelae after discharge from hospitals which persists although in reduced proportions until 12 months post-discharge. Developing a holistic management framework with engagement of care outreach workers as well as teleconsultation is a way forward in effective management of post COVID morbidities as well as reducing mortality.
Introduction: Growing evidence indicates that individuals recovering from COVID-19 may experience prolonged health consequences, resulting in notable morbidity even after the acute phase. Limited published literature exists concerning sequelae of COVID-19 among the Indian population. Therefore, we conducted this study at a subdistrict hospital (secondary level) in Haryana, aiming to estimate the prevalence of long COVID and its determinants.
Methods: This hospital-based study focused on outpatients who had a confirmed history of COVID-19, with a minimum of 28 days elapsed since the positive COVID-19 diagnostic test date. We administered a semi- structured questionnaire to gather sociodemographic information, a standardized symptom assessment checklist to identify long COVID symptoms, and the Patient Health Questionnaire (PHQ-9) to evaluate and grade depression severity. Additionally, we conducted pulmonary function tests, chest X-rays, complete blood counts, and kidney and liver function tests to assess the determinants of long COVID. STATA version 14 software (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP) was used for data analysis, and the bivariate and multivariate analyses (p-value <0.2 in bivariate analysis) were conducted to determine factors associated with long COVID.
Results: A total of 212 participants (male 53%) were recruited in this study. Among the long COVID symptoms, fatigue, body pain, cough, joint pain, and breathlessness were the most frequently reported symptoms among the study participants. The prevalence of long COVID was found to be 37.3% (95%CI: 30.7- 43.8%). In the multivariate model, depression (PHQ-9 scores) AOR-1.21 (95%CI:1.07-1.35) and severity of COVID-19 adjusted odds ratio (AOR)-2.22 (95%CI:1.05-4.69) came out to be statistically significant with long COVID.
Conclusion: Findings show alarming rates of long COVID symptoms persisting in nearly 37% of COVID-19- recovered individuals. Establishing tailored guidelines is crucial to mitigate burdens and complications and enhance the quality of life for those affected.
Background:
Shortly after the Coronavirus disease 2019 (COVID-19) pandemic, a considerable number of recovered patients reported persisting symptoms, especially neuropsychological manifestations, which were later named post-COVID syndrome (PCS). Immune dysregulation was suggested as one of the main mechanisms for PCS. Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) that is mostly used to treat depression, anxiety disorders, and obsessive-compulsive disorder, has been suggested as an anti-COVID drug due to its anti-inflammatory effects, mainly through the sigma-1 receptor. Therefore, we aimed to evaluate fluvoxamine's effect on PCS neuropsychiatric symptoms.
Method:
In this double-blind randomized clinical trial, we included confirmed mild to moderate COVID-19 outpatients using polymerase chain reaction (PCR) by an infectious disease specialist. The presence of severe COVID-19 symptoms was evaluated by the infectious disease specialist and included dyspnea, SpO2 < 94% on room air, PaO2/FiO2 < 300 mm Hg, a respiratory rate > 30 breaths/min, and lung infiltrates > 50%. Then we performed permuted block randomization and assigned patients 1:1 into two groups to either receive fluvoxamine 100 mg tablet or a placebo daily for 10 days. Eligible patients were evaluated after 12 weeks for the presence of fatigue, as the primary, and other PCS symptoms as secondary outcomes.
Results:
We screened a total of 486 patients from March to June 2022. After 12 weeks, 42 patients receiving fluvoxamine and 43 patients receiving Placebo were evaluated for PCS. Patients had a mean age of 38.5 ± 14.1 and 48% of them were women. Fatigue was significantly lower in the fluvoxamine group (p-value 0.026). No significant differences were observed in other symptoms.
Conclusion:
We concluded that taking fluvoxamine during active COVID-19 can reduce the chance of fatigue but the advantage of fluvoxamine was not observed for other symptoms. Further studies are necessary to confirm these preliminary results.
Beginning with the various strategies of the SARS-CoV-2 virus to invade our bodies and manifest infection, and ending with the recent long COVID, we are witnessing the evolving course of the disease in addition to the pandemic. Given the partially controlled course of the COVID-19 pandemic, the greatest challenge currently lies in managing the short- and long-term complications of COVID-19. We have assembled current knowledge of the broad spectrum of cardiovascular, pulmonary, and neuropsychiatric sequelae following SARS-CoV-2 infection to understand how these clinical manifestations collectively lead to a severe form of the disease. The ultimate goal would be to better understand these complications and find ways to prevent clinical deterioration.
Symptoms of long COVID were found in 38% of 170 patients followed median 22.6 months. Most prevalent symptoms were fatigue, affected taste and smell, and difficulties remembering and concentrating. Predictors for long COVID were older age and number of symptoms in the acute phase. Long COVID may take many months, maybe years to resolve.
Background:
Various symptoms have been associated with COVID-19, but little is known about the impacts of COVID-19 on the sensory system, risk factors, and the duration of symptoms. This study assesses olfactory, gustatory, hearing, and vestibular systems after COVID-19.
Methods:
This cross-sectional, single-center study involved 50 patients one to six months after COVID-19 and reports their patient records and the extent, onset, and duration of olfactory, gustatory, hearing, and balance disorders using questionnaires during and after COVID-19. Sensory symptoms were objectively studied using the following clinical tests after COVID-19 Sniffin' Sticks, taste tests, tone/speech audiometry, and video head impulse test.
Results:
Post-COVID-19-patients were suffering from olfactory and gustatory impairment for up to six months. According to the Dizziness Handicap Inventory, balance disorders were less noticed: Overall, about 40% of the patients during COVID-19 and nearly all patients recovered within six months. After COVID-19, clinical tests revealed that 75% were suffering from hyposomnia/anosmia, and 20% of all patients reported mild hypogeusia for up to six months. Vestibular disorders and hearing impairment rarely/did not occur. Females were significantly more affected by sensory impairments than males.
Conclusions:
COVID-19 particularly caused olfactory and gustatory impairment; balance disorders were present too; vestibular and auditory symptoms were negligible.
This cross-sectional study aimed to investigate the post-acute consequences of COVID-19. We conducted a self-administered questionnaire survey on sequelae, psychological distress (K6), impairments in work performance (WFun), and COVID-19–related experiences of stigma and discrimination in two designated COVID-19 hospitals in Hiroshima Prefecture, Japan, between August 2020 and March 2021. The prevalence of sequelae was calculated by age and COVID-19 severity. Factors independently associated with sequelae or psychological distress were identified using logistic regression analysis. Among 127 patients who had recovered from COVID-19, 52.0% had persistent symptoms at a median of 29 days [IQR 23–128] after COVID-19 onset. Among patients with mild COVID-19, 49.5% had sequelae. The most frequent symptoms were olfactory disorders (15.0%), taste disorders (14.2%), and cough (14.2%). Multivariate analysis showed that age was an independent risk factor for sequelae (adjusted odds ratios [AOR] for ≥ 60 years vs. < 40 years 3.63, p = 0.0165). Possible psychological distress was noted in 30.7% (17.9% of males and 45.0% of females). Female sex and the presence of sequelae were independent risk factors for psychological distress. Of all participants, 29.1% had possible impairments in work performance. Experiences of stigma and discrimination were reported by 43.3% of participants. This study revealed the significant impacts of Long COVID on health in local communities. A large-scale, long-term cohort study is desired.
Coronavirus disease 2019 (COVID-19) is a threat to patients not only because of its acute course, but also because of various complications occurring in the following period, that is, more than 28 days after the onset of acute infection. The present study identified a total of 121 patients hospitalized 29 or more days after the first positive result of a PCR test for SARS-CoV-2, of whom 98 patients were included in the study. Patients were divided into two groups by the time interval between the positive COVID-19 test result and hospitalization date. The time intervals were week 5–11 in an ongoing-COVID group (57.1% of patients) and 12 or more weeks in a post-COVID-group (42.9%). The most frequent reason for hospitalization was respiratory tract infection (58.2%). Pneumonia accounted for 77.2% of these cases. Other reasons for hospitalization were interstitial lung disease (22.4%), pulmonary embolism (8.2%), and sarcoidosis (6.1%). The study group was further divided according to the causes of hospitalization into subgroups with infections and other causes. In the group with infectious diseases, there was a shorter time period between PCR positivity and hospitalization and there were significantly more frequent non-respiratory complications. In the entire sample, the in-hospital mortality was 5.1%.
COVID-19 is the third deadly coronavirus infection of the 21st century that has proven to be significantly more lethal than its predecessors, with the number of infected patients and deaths still increasing daily. From December 2019 to July 2021, this virus has infected nearly 200 million people and led to over 4 million deaths. Our understanding of COVID-19 is constantly progressing, giving better insight into the heterogeneous nature of its acute and long-term effects. Recent literature on the long-term health consequences of COVID-19 discusses the need for a comprehensive understanding of the multisystemic pathophysiology, clinical predictors, and epidemiology to develop and inform an evidence-based, multidisciplinary management approach. A PubMed search was completed using variations on the term post-acute COVID-19. Only peer-reviewed studies in English published by July 17, 2021 were considered for inclusion. All studies discussed in this text are from adult populations unless specified (as with MIS-C). The preliminary evidence on the pulmonary, cardiovascular, neurological, hematological, multisystem inflammatory, renal, endocrine, gastrointestinal, and integumentary sequelae of shows that COVID-19 continues after acute infection. Interdisciplinary monitoring with holistic management that considers nutrition, physical therapy, psychological management, meditation, and mindfulness in addition to medication will allow for the early detection of post-acute COVID-19 sequelae symptoms and prevent long-term systemic damage. This review serves as a guideline for effective management based on current evidence, but clinicians should modify recommendations to reflect each patient's unique needs and the most up-to-date evidence. The presence of long-term effects presents another reason for vaccination against COVID-19.
Post-acute consequences of COVID-19, also termed long COVID, include signs and symptoms persisting for more than 12 weeks with prolonged multisystem involvement; most often, however, malnutrition is ignored.
Method:
The objective was to analyze persistent symptoms, nutritional status, the evolution of muscle strength and performance status (PS) at 6 months post-discharge in a cohort of COVID-19 survivors.
Results:
Of 549 consecutive patients hospitalized for COVID-19 between 1 March and 29 April 2020, 23.7% died and 288 patients were at home at D30 post-discharge. At this date, 136 of them (47.2%) presented persistent malnutrition, a significant decrease in muscle strength or a PS ≥ 2. These patients received dietary counseling, nutritional supplementation, adapted physical activity guidance or physiotherapy assistance, or were admitted to post-care facilities. At 6 months post-discharge, 91.0% of the 136 patients (n = 119) were evaluated and 36.0% had persistent malnutrition, 14.3% complained of a significant decrease in muscle strength and 14.9% had a performance status > 2. Obesity was more frequent in patients with impairment than in those without (52.8% vs. 31.0%; p = 0.0071), with these patients being admitted more frequently to ICUs (50.9% vs. 31.3%; p = 0.010). Among those with persistent symptoms, 10% had psychiatric co-morbidities (mood disorders, anxiety, or post-traumatic stress syndrome), 7.6% had prolonged pneumological symptoms and 4.2% had neurological symptoms.
Conclusions:
Obese subjects as well as patients who have stayed in intensive care have a higher risk of functional loss or undernutrition 6 months after a severe COVID infection. Malnutrition and loss of muscle strength should be considered in the clinical assessment of these patients.
Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm (n = 100) received the oral supplements for 14 days and the control arm (n = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients’ functional status and quality of life.
Background
A significant number of patients with COVID-19 experience prolonged symptoms, known as Long COVID. Few systematic studies have investigated this population, particularly in outpatient settings. Hence, relatively little is known about symptom makeup and severity, expected clinical course, impact on daily functioning, and return to baseline health.
Methods
We conducted an online survey of people with suspected and confirmed COVID-19, distributed via COVID-19 support groups (e.g. Body Politic, Long COVID Support Group, Long Haul COVID Fighters) and social media (e.g. Twitter, Facebook). Data were collected from September 6, 2020 to November 25, 2020. We analyzed responses from 3762 participants with confirmed (diagnostic/antibody positive; 1020) or suspected (diagnostic/antibody negative or untested; 2742) COVID-19, from 56 countries, with illness lasting over 28 days and onset prior to June 2020. We estimated the prevalence of 203 symptoms in 10 organ systems and traced 66 symptoms over seven months. We measured the impact on life, work, and return to baseline health.
Findings
For the majority of respondents (>91%), the time to recovery exceeded 35 weeks. During their illness, participants experienced an average of 55.9+/- 25.5 (mean+/-STD) symptoms, across an average of 9.1 organ systems. The most frequent symptoms after month 6 were fatigue, post-exertional malaise, and cognitive dysfunction. Symptoms varied in their prevalence over time, and we identified three symptom clusters, each with a characteristic temporal profile. 85.9% of participants (95% CI, 84.8% to 87.0%) experienced relapses, primarily triggered by exercise, physical or mental activity, and stress. 86.7% (85.6% to 92.5%) of unrecovered respondents were experiencing fatigue at the time of survey, compared to 44.7% (38.5% to 50.5%) of recovered respondents. 1700 respondents (45.2%) required a reduced work schedule compared to pre-illness, and an additional 839 (22.3%) were not working at the time of survey due to illness. Cognitive dysfunction or memory issues were common across all age groups (~88%). Except for loss of smell and taste, the prevalence and trajectory of all symptoms were similar between groups with confirmed and suspected COVID-19.
Interpretation
Patients with Long COVID report prolonged, multisystem involvement and significant disability. By seven months, many patients have not yet recovered (mainly from systemic and neurological/cognitive symptoms), have not returned to previous levels of work, and continue to experience significant symptom burden.
Funding
All authors contributed to this work in a voluntary capacity. The cost of survey hosting (on Qualtrics) and publication fee was covered by AA's research grant (Wellcome Trust/Gatsby Charity via Sainsbury Wellcome center, UCL).
The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improve
Background
SARS is not only an acute disease, but also leads to long-term impaired lung diffusing capacity in some survivors. However, there is a paucity of data regarding long-term CT findings in survivors after SARS. The aim of this study was to assess the changes in lung function and lung thin-section computed tomography (CT) features in patients recovering from severe acute respiratory syndrome (SARS), especially the dynamic changes in ground-glass opacity (GGO).
Material/Methods
Clinical and radiological data from 11 patients with SARS were collected. The serial follow-up thin-section CTs were evaluated at 3, 6, and 84 months after SARS presentation. The distribution and predominant thin-section CT findings of lesions were evaluated.
Results
The extent of the lesions on the CT scans of the 11 patients decreased at 6 and 84 months compared to 3 months. The number of segments involved on 84-month follow-up CTs was less than those at 6 months (P<0.05). The predominant thin-section CT manifestation at 84 months (intralobular and interlobular septal thickening) was different than that at 6 months, at which GGO was predominant.
Conclusions
During convalescence after SARS, GGO and intralobular and interlobular septal thickening were the main thin-section CT manifestation. Intralobular and interlobular septal thickening predominated over GGO at 84 months.
When homeopathy is tested in clinical trials, understanding and appraisal is likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed on 28 treatment- and provider-specific items that supplement the CONSORT (Consolidated Standards of Reporting Trials) Statement items 2, 3, 4, and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.
Introduction: The coronavirus disease (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%), Sulphur (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. Trial registration: CTRI/2022/03/041316
COVID-19, a disease caused by a novel coronavirus (SARS-CoV-2), is a major global threat that has turned into a pandemic. Despite the emergence of multiple vaccination alternatives and developing therapeutic options, dramatic short- and long-term clinical outcomes have been recorded with more than 250 million infected people and over 5 million deaths as of November 2021. COVID-19 presents various respiratory, cardiovascular, neuropsychiatric, musculoskeletal and kidney features during the acute phase; nevertheless, renal involvement in the post-infection period has recently been emphasized. The present review aims to evaluate the growing literature on kidney involvement in the SARS-CoV-2 infection along with clinical features reported both in the acute phase of the infection and in the post-acute COVID-19 period by assessing potential pathophysiological frameworks explaining such conditions. Chronic kidney disease and development of acute kidney injury (AKI) in the course of initial hospitalization are associated with high mortality and morbidity rates. Moreover, growing evidence suggests a decline in renal function in the 6-to-12-month follow-up period even in patients without any signs of AKI during the acute phase. Despite such concerns there are no guidelines regulating the follow-up period or therapeutic alternatives for such patient population. In conclusion, the burden of COVID-19 on the kidney is yet to be determined. Future prospective large scale studies are needed with long follow-up periods assessing kidney involvement via multiple parameters such as biopsy studies, urinalysis, measurement of serum creatinine and cystatin C, directly measured glomerular filtration rate, and assessment of tubular function via urinary β2-microglobulin measurements.
To ascertain the ability of a patient-generated outcome measure, the 'Measure Yourself Medical Outcome Profile' (MYMOP), to reflect the outcomes of consultations which patients consider are most important, as derived from qualitative interviews.
A qualitative study using a constant comparative method to analyse semistructured interviews which were then compared with the results of MYMOP questionnaires. A variable-orientated analysis was used to develop themes and a case-orientated analysis was used to develop narrative summaries called vignettes from the interviews. The MYMOP questionnaire was completed by the interviewees (n = 20), a minimum to twice and a maximum of nine times over a four-month period. The scores were displayed on individual MYMOP charts. For each individual, the outcome as measured by MYMOP was compared with the outcome data from the qualitative interviews. The interviewees were attending a variety of complementary practitioners in primary care.
The treatment effects which people described were encompassed by five themes: reduction in symptoms; reduction in disability; reduction in, or avoidance of, medication; gaining control and improving coping skills; and securing support and hope through the patient-practitioner relationship. The vignettes demonstrated how individuals identified and valued these various effects and weighed them up in evaluating the overall benefit of the treatment. Their MYMOP charts were able to measure some effects better than others.
The treatment effects, as quantified using MYMOP, accorded with those described by most patients at interview, but some important limitations were identified with MYMOP, particularly an underplaying of the importance of medication avoidance or medication reduction in this patient group. This dimension is lacking in most outcome questionnaires and has been included in a new version of MYMOP. This study also showed that qualitative interview data can help in evaluating the ability of outcome questionnaires to measure the treatment effects that particular patient groups consider most important.
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Advancing Understanding of Long COVID: Leveraging Patient Perspectives with the Symptom Burden Questionnaire
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