Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial.

BACKGROUND: Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19. METHODS: All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202). RESULTS: A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001. CONCLUSIONS: NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies.

Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial.

OBJECTIVES: To investigate the potential efficacy of Nigella sativa (NS) oil supplementation on the outcomes of patients with mild Coronavirus Disease 2019 (COVID-19). TRIAL DESIGN: Prospective, two-arm, parallel-group, randomised (1:1 allocation ratio), open-label, controlled, exploratory phase II clinical trial of oral NS oil in patients with mild COVID-19. PARTICIPANTS: Inclusion Criteria: - Patients with mild COVID19 (defined as upper respiratory tract infection symptoms in the absence of clinical or radiological signs of pneumonia). - Adult (18 - 65 years old). - Written informed consent by the patient (or legally authorized representative) prior to initiation of any study procedures. - All patients should understand and agree to comply with planned study procedures. - Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) from throat swab. EXCLUSION CRITERIA: - Patients with pneumonia or severe illness requiring admission to intensive care unit. - Severe chronic kidney disease (i.e. estimated glomerular filtration rate [eGFR] < 30 mL / min ) or end stage renal disease requiring dialysis - Severe chronic liver disease (Alanine transaminase [AlT] or Aspartate transaminase [AST] > 5 times the upper limit of normal). - Pregnancy or breast feeding. - Anticipated transfer within 72 hours to another hospital that is not a study site. - Allergy to the study medication The trial is currently conducted on patients recruited from King Abdulaziz University Hospital, Jeddah, Saudi Arabia. INTERVENTION AND COMPARATOR: Intervention group: Nigella sativa oil (MARNYS® Cuminmar) 500 mg softgel capsules, one capsule orally twice daily for 10 days plus standard of care treatment (antipyretic, antitussive). Comparator group: standard of care treatment. MAIN OUTCOMES: Proportion of patients who clinically recovered (defined as 3 days of no symptoms) within 14 days after randomisation. RANDOMISATION: Patients will be randomly assigned to treatment or control groups in a 1:1 ratio using a computer-generated randomization scheme (Random permuted blocks of 10) developed using the web-based program: http://www.randomization.com . BLINDING (MASKING): No blinding. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Up to 200 eligible patients will be randomly assigned to either treatment or control groups. TRIAL STATUS: Protocol version 1, as of July 14, 2020. Recruitment was started on May 21, 2020. The intended completion date is December 31, 2020. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04401202 . Date of trial registration: May 26, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of 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.

Bronchiolitis obliterans organizing pneumonia: experience at three hospitals in Riyadh.

BACKGROUND: Because reports of bronchiolitis obliterans organizing pneumonia (BOOP) are lacking from the Middle East, we conducted a retrospective review of of all histopathologically proven cases of BOOP over a 10-year period at three tertiary care hospitals in Riyadh and describe the clinical features and outcome. METHODS: Charts at the three hospitals were searched using a specific code for BOOP or cryptogenic organizing pneumonia (COP). Lung specimens had to show histological proof of BOOP with a compatible clinical picture. Chest radiographs and high-resolution CT scans were reviewed. RESULTS: Twenty cases of biopsy-proven BOOP had well-documented clinical and radiographic data. There were 11 males and 9 females (mean age, 58 years; range, 42-78). The clinical presentation of BOOP was acute or subacute pneumonia-like illness with cough (85%), fever (70%) dyspnea, (85%) and crackles (80%). The most frequent radiological pattern was a bilateral alveolar infiltrate. The most common abnormality on pulmonary function testing (n=14) was a restrictive pattern (11 patients). Most patients (70%) had no underlying cause (idiopathic BOOP). Other associations included thyroid cancer, rheumatoid arthritis, syphilis and Wegner's granulomatosis. Ten patients (50%) had a complete response to steroids, 6 (30%) had a partial response and 3 (15.8%) with secondary BOOP had rapid progressive respiratory failure and died. CONCLUSION: The clinical presentation of BOOP in our patients is similar to other reported series. A favorable outcome occurs in the majority of cases. However, BOOP may occasionally be associated with a poor prognosis, particularly when associated with an underlying disease.

Cardiopulmonary exercise testing. An underutilized diagnostic tool in Saudi Arabia.

OBJECTIVE: To assess the use of cardiopulmonary exercise testing (CPET) in major hospitals and medical centers throughout the Kingdom of Saudi Arabia (KSA) and to seek information on the way CPET is conducted. METHODS: Self-reported questionnaires on the use of CPET were mailed during the fall of 2002 to 54 major public and private hospitals and medical centers throughout the KSA. The response rate was 64.2%. The returned questionnaires were coded and data were analyzed. RESULTS: The findings indicated that more than 85% of the sample was not employing CPET in their medical centers. However, all of the surveyed centers were regularly performing stress electrocardiogram tests. Approximately 21% of those medical centers who did not have CPET are planning to have it in the near future. The most frequent reasons for not conducting CPET were lack of equipment, lack of trained technicians and lack of training in interpreting test results. Moreover, the most important reasons for conducting the CPET were pulmonary problems, followed by cardiac disorders. Treadmill and leg ergometer were used most as an exercise mode. Bruce protocol as well as institution specific protocols were equally used during CPET. Finally, there appears a lack of local cardiorespiratory data, especially for healthy Saudi females at all ages as well as older male group. CONCLUSION: Cardiopulmonary exercise testing as a diagnostic tool for cardiopulmonary diseases was extremely underutilized in Saudi hospitals and medical centers. Much greater efforts are needed to raise the awareness among physicians on the usefulness of CPET.

Bronchiolitis obliterans organizing pneumonia.

Bronchiolitis obliterans with organizing pneumonia (BOOP) is now established as a distinct clinicopathologic entity, yet it may be overlooked by clinicians due to unfamiliarity and its non-specific presentation. It can be either idiopathic or associated with a variety of causes, such as infections, drugs, radiation or connective tissue diseases. A lung biopsy is needed to provide histopathologic confirmation. Usually prognosis is good, and the response to steroids may be dramatic, but occasionally BOOP may be fatal or runs a chronic relapsing course. This article is an updated review on current knowledge regarding BOOP.

Clinical spectrum of Swyer-James-Macleod syndrome in adults.

OBJECTIVE: The aim of this study is to describe the clinical and imaging features of Swyer-James-Macleod syndrome (SJMS) in 9 adults. METHODS: We reviewed the charts of 9 patients diagnosed with SJMS at the King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia over a 10 year period. RESULTS: The patients mean age was 38.1 years; males were more affected than females (7:2). Seven of the patients had symptoms referable to the chest and a similar number had compatible abnormalities on physical examination. The left lung was involved in all cases. Bronchiectasis was present in 7 (77.8%). Eight patients who underwent pulmonary function tests had combined defects. Two patients demonstrated significant reversibility. All patients had a stable course over at least before a 3 year follow-up period. CONCLUSION: Swyer-James-Macleod syndrome has a diverse manifestations in adults and can mimic other pulmonary disorders, which may lead to incorrect diagnosis and inappropriate therapy. The course is generally a stable one.

Rapidly growing mycobacterial pulmonary infection in association with severe gastroesophageal reflux disease.

Pulmonary infection due to rapidly growing mycobacteria (Runyan group IV) is uncommon and may be overlooked or misdiagnosed. Esophageal disorders have been recognized as a potential risk factor predisposing for this infection. A 35-year-old Sri Lankan patient, with severe gastroesophageal reflux disease and a hiatus hernia, contracted a pulmonary infection with Mycobacterium fortuitum-chelonae. He had severe airway obstruction and focal bronchiectasis, and responded to treatment with ciprofloxacin and clarithromycin. The case is reported to alert clinicians to the pathogenic potential of these organisms and to the prompt institution of appropriate chemotherapy once infection is recognized.

An audit of oxygen therapy on the medical ward in 2 different hospitals in Central Saudi Arabia.

OBJECTIVE: To study the use of oxygen therapy on the medical wards in 2 hospitals in Riyadh, Kingdom of Saudi Arabia. One was academic, King Khalid University Hospital and the other a community hospital, Riyadh Medical Complex. METHODS: This study was carried out over a one year period, 6 April 2000 through to 6 April 2001. Oxygen saturation was measured randomly by pulse oximetry in patients receiving oxygen therapy. Charts of the patients were inspected for relevant information related to oxygen therapy, including indications, dose, monitoring and documentation of the order. If oxygen saturation was >97% oxygen flow was reduced to maintain oxygen saturation between 92% and 94%. The potential savings by such reduction were calculated. RESULTS: A total of 108 patients were studied. The most frequent indications for oxygen therapy were hypoxemia and dyspnea. Arterial oxygen tension before starting oxygen was carried out for 78 patients (72.2%) and showed that the majority (60 patients, 76.9%) were hypoxemic arterial oxygen tension <= 65 mm Hg). The last documented arterial oxygen tension values after initiating oxygen were found in 79 patients (73.1%) and these were carried out at mean interval of 111 hours (range one-1200) before our assessment. Most patients (32 patients, 40.5%) had excessive values (>85 mmHg), 24 patients (30.4%) were hypoxemic (arterial oxygen tension <=65 mmHg) and only 23 patients (29.1%) had acceptable values (arterial oxygen tension > 65-85 mmHg). Our measurements also showed that arterial oxygen tension was excessive (>97%) in 59 patients (54.6%), adequate (>=92%-97%) in 44 patients (40.7%), and only a minority (5 patients, 4.6%) were hypoxemic (<92%). Oxygen dose could be reduced in 31 patients (28.7%) by a mean of 42% (range 18%-66%) and stopped in 38 patients (35%) while maintaining aterial oxygen tension between 92%-94%. Errors in oxygen prescription were more apparent in the non-academic setting (P<0.05%). CONCLUSION: Oxygen prescription was sub-optimal in both the academic and non-academic setting. The study highlights the need to adopt and evaluate cost-effective measures such as oxygen titration protocols using pulse oximetry, and physician education programs.

Chronic cough at a non-teaching hospital: Are extrapulmonary causes overlooked?

OBJECTIVE: To estimate the prevalence, assess the diagnostic approach and to identify specific causes and treatment response of chronic persistent cough (CPC) in consecutive adult patients attending the chest clinic at a non-teaching hospital in Riyadh, Saudi Arabia. METHODOLOGY: Chronic persistent cough was defined as cough persisting for more than 3 weeks. Patients were assessed clinically and investigated according to the suspected diagnosis. The specific causes were confirmed by appropriate investigations, as well as response to specific therapy. Improvement in cough following therapy was assessed subjectively by patients on a scale from 0 to 100%. RESULTS: Of 1332 patients seen in the chest clinic, 136 (10.2%; 95% confidence interval 8.6-11.8%) presented with CPC as the main complaint. One hundred patients (55% males) were assessed, after excluding 36 patients who were lost to follow up. The common presenting diagnoses (for the 81 patients who had previously consulted a physician) were upper respiratory tract infection (17.1%), asthma (15.9%), bronchitis (9.8%) and unknown in 30.8% of patients. Final diagnoses (as a sole or contributory cause) were established in 96% of patients and included rhinosinusitis (RS; 60%), asthma (26%), gastro-oesophageal reflux (GERD; 9%), postinfectious cough (8%) and bronchiectasis (5%). The agreement between the presenting and final diagnoses was generally poor, especially for extrapulmonary causes, which was as low as 5.3%. All patients, except for one, had complete or substantial improvement in the severity of cough. CONCLUSIONS: In a non-teaching hospital setting, CPC is a common benign disorder that rarely requires specialized investigations and is easily treated once the causes are identified. The multiplicity of causes and extrapulmonary triggers of CPC, particularly RS, are often overlooked. The principal causes in our series remain the same as in studies elsewhere, namely RS, asthma and GERD.

Evoked and event related potentials in chronic respiratory failure.

OBJECTIVE: To assess the value of brainstem auditory evoked potentials and event related evoked potential (3rd positive component of evoked related potentials with latency of 300 millisecond, in evaluating cognitive dysfunction in patients with chronic respiratory failure. METHODS: Thirty-two patients with chronic obstructive pulmonary disease and respiratory failure of mild to moderate severity, were assessed regarding their mental function, utilizing mini-mental state examination, arterial blood gases including PH, partial pressure of carbon dioxide, partial pressure of oxygen, and both brainstem auditory evoked potentials and event related evoked potential response. Twenty-five normal subjects, matched for age and sex, were also studied as a control group. The study was carried out during the year 1999 to 2000 in 3 hospitals; King Khalid University Hospital, King AbdulAziz University Hospital and Sahara Hospital, Riyadh, Kingdom of Saudi Arabia. RESULTS: There were significant delay of event related evoked potential response in patients compared with controls (P<0.05). No significant difference was noted for brainstem auditory evoked potentials and mini-mental state examination scores were within normal limits in 78% of patients. When event related evoked potential were analyzed in comparison with blood gases and mini-mental state examination, there was a clear moderate correlation with severity of hypoxemia (r = -0.697). Correlation was also noted, but to a lesser degree with partial pressure of carbon dioxide (r = 0.52) and PH (r = 0.53). There was no correlation with mini-mental state examination. CONCLUSION: The significant delay of event related evoked potential, which is considered the neuro-physiological correlate of cognition, points clearly to the presence of a certain degree of mental dysfunction in many of these patients, namely sub-clinical encephalopathy. These subtle changes commonly evade detection by conventional bed side test (mini-mental state examination), while detailed neuropsychological assessment is cumbersome and time consuming. So, event related evoked potential measurement may be an objective and practical test of subtle cognitive dysfunction in mild respiratory failure. Unfortunately, absolute event related evoked potential values may not be useful in individual patients, in view of its wide range. However, it is probably very helpful in the assessment of a group of subjects, such as trials of a new therapeutic modality. A follow-up study utilizing a larger group of patients, and formal neuropsychological mental assessment, will be expected to confirm and expand the present study`s conclusions.