reference
XUedong an, Lina M, Ping X, et al. Effects of Shengmai Yin (生脉饮) on lung and cardiac function in convalescent patients with cardiopulmonary symptoms of coronavirus disease 2019: a randomized, double-blind, multicenter control study.J Tradit Chin Med.2023; 43 (1): 140-145.
Study goal
To evaluate the safety and effectiveness of Shengmai Yin using a visual analogue scale (VAS) for cardiopulmonary symptoms in convalescent patients with Covid-19
Key to take away
The Shengmai Yin formula can be a simple and beneficial measure to improve the quality of life of convalescent patients with Covid-19, especially when it comes to alleviating the patients' chest discomfort symptoms.
design
Randomized, double -blind, multicenter, controlled study
Participant
The study involved 200 convalescent Covid-19 patients with cardiopulmonary symptoms in three medical centers: 100 patients in the experimental group (men=41; women=59) and 100 patients in the control group (men=31; women=69). Of these, 192 patients completed the study (98 in the experimental group and 94 in the control group).
Inclusion criteria: no fever for at least 72 hours, clinical remission of respiratory problems, significant improvement in both lungs in thorax computer tomography (CT) and 2 negative throat smears for Sars-Cov-2-RNA at least 24 hours. Additional criteria: (a) 2 to 3 symptoms or at least 1 symptom with a vas score larger than 4; (b) 2 to 4 weeks since dismissal from the hospital; (c) at the age of 18 to 70; and (d) signed declaration of consent.
Exclusion Criteria: (a) Patients with difficulty taking oral medications due to underlying diseases; (b) underlying diseases affecting survival (uncontrolled cardiac, pulmonary, renal, digestive, hematological, neuropsychiatric or immunological diseases; metabolic diseases; malignancies; severe malnutrition); (c) allergic predisposition, allergies to the medications included in the treatment plan; (d) pregnancy or breastfeeding; (e) mental illness, altered mental status, communication deficiencies or lack of self-awareness and (f) participation in other clinical trials.
intervention
The patients took 10 ml Shengmai Yin (Tong Ren Tang Technologies Co.) three times a day for 2 weeks.
Evaluated study parameters
Researchers assessed the following symptoms using the VAS, which were scored from 0 to 10 depending on severity at 0, 1, and 2 weeks:
- Kurzatmigkeit,
- Hidrosis,
- Brustbeschwerden,
- Herzklopfen und
- trockener Husten.
Primary end point rated
The researchers defined a reduction in the VAS by 30 % or more as effective. As curative, they defined a reduction in the VAS to 0.
Most important knowledge
The Shengmai Yin treatment was effective in relieving breast complaints (P= 0.008). After 2 weeks there was no significant difference in shortness of breath, hididosis, palpitations and dry cough.
transparency
Investigators identified no disclosures or study funding sources.
Effects and restrictions for practice
Shengmai San is a popular formula of traditional Chinese medicine (TCM) that contains three ingredients:Radix Ginseng,,Radix OphiopogonisAndFructus schisandrae. It can be administered as a liquid (Shengmai Yin, which was used in this study), Shengmai capsule or granulate or through a modern application of the formula as intravenous infusion (used in China). It is a Qi and Yin tonic and is often given patients in the recovery phase if they are weakened by a serious illness to get back to strength. Shengmai means "restore or generate pulse" and is intended to improve the strength and quality of the pulse of the patient, which reflects a general improvement in their condition and vitality.
Shengmai formulas have shown considerable advantages in cardiovascular and respiratory diseases and were discussed in detail in the literature.1.2Some of his effects include positive advantages in heart failure,3dilated cardiomyopathy,4 and improvedRespiratory function in chronic obstructive pulmonary disease (COPD).5The diverse research behind Shengmai Yin makes it a logical choice for the treatment of Covid-19 patients who have, among other things, significant burden on both cardiovascular and respiratory functions.
A higher dosage may have improved the result.
The study lasted two weeks and analyzed patients' responses in five areas:Shortness, hydrosis, breast complaints, palpitations and dry cough. Only breast complaints showed a statistically significant improvement compared to the self-reported VAS score. No major side effects were found. Several reasons can be responsible for the fact that only one of five symptoms improved, including: dosage, type of administration, study time, comorbidities and surveillance parameters.
A higher dosage could have improved the result. The patients in this study received 10 ml of the formula three times a day over a period of 2 weeks, which corresponds to a total dose of 30 ml per day. In another small study with patients with dilatative cardiomyopathy, a 20 ml formula was used twice a day for a total dose of 40 ml per day. This study resulted in increased stress tolerance and improved left -wing ventricular contractility in patient population.
The type of administration and combination with other therapies can also play a role in the result. In the past, a study time of only two weeks was carried out, but these studies used an intravenous preparation of the formula, which avoided a ridge-pass effect in the body. Oral therapies usually need more time to achieve the destinations.
In a small study with 20 patients with COPD, those who were treated with an intravenous preparation of the Shengmai formula for a total of 14 days showed an improved breathing function.5Shengmai injections after acute myocardial infarction have also shown promise when combined with conventional therapies. Although caution is warranted regarding the methodology and small sample size of the studies, the review nevertheless showed a trend towards lower mortality rates during hospitalization and a reduction in the incidence of heart failure, shock and reinfarction.6
We have seen clinically how different the severity of Covid-19 is with different people. While the study excluded certain life -threatening impending conditions that impair survival, many factors are not taken into account in this study that can play a role when the illness and recovery progresses. Some of these factors are related to the virus itself, for example with the severity of infections caused by various tribes of SARS-COV-2 infections. Some factors are related to host and environmental factors: lifestyle, nutrition, activity level, habits, genetics, status of body composition, vitamin D status, underlying chronic diseases, co-factors and environmental factors such as climate and air pollution as well as cultural factors and socio-economic factors.7
Overall, this study supports short-term, safe use of Shangmai Yin as a quality of life intervention in convalescent Covid-19 patients. Further studies that use quantifiable clinical tools, such as: Other studies, such as laboratory and imaging studies measuring cardiovascular, respiratory and immune responses, would be helpful to demonstrate further effectiveness of the formula in a clinical setting.