|Year : 2022 | Volume
| Issue : 2 | Page : 306-311
A preliminary randomized, single-blinded, placebo-controlled clinical dose–response study to elucidate the effect of ongoing isometric contraction of muscles on the vital capacity of lungs on administering Blatta orientalis
Usha Kushwaha1, G Supriya1, Balakrishnan Nair2, Kathika Chattopadhyay3, Ashwini Nair4, Sanjay Vishwakarma1
1 Department of Physiology, Bakson Homoeopathic Medical College and Hospital, Noida, Uttar Pradesh, India
2 Faculty of Health and Environmental Sciences, Auckland University of Technology (AUT), Auckland, New Zealand
3 Department of Psychiatry, Bakson Homoeopathic Medical College and Hospital, Noida, Uttar Pradesh, India
4 Department of Materia Medica, Bakson Homoeopathic Medical College and Hospital, Noida, Uttar Pradesh, India
|Date of Submission||25-Mar-2022|
|Date of Decision||23-May-2022|
|Date of Acceptance||02-Jun-2022|
|Date of Web Publication||14-Nov-2022|
Auckland University of Technology, Auckland
Source of Support: None, Conflict of Interest: None
INTRODUCTION: Blatta orientalis is an indicated remedy for asthma and other chronic obstructive pulmonary diseases in homeopathic medicine. Preclinical studies indicate that B. orientalis shows anti-asthmatic properties in animals when induced with bronchospasm using acetylcholine through nonselective anticholinergic and antihistaminic activities. However, no studies have explored the changes in the vital capacity of the lungs on administering the homeopathic remedy, B. orientalis. It is shown that isometric contraction of pectoral muscles enhances the vital capacity of lungs by increasing ventilation and decreasing alveolar partial pressure of carbon dioxide. It can act as a valuable tool for monitoring the vital capacity of the lungs before and after administration of B. orientalis.
AIM: This preliminary research takes the first step toward exploring vital capacity through a randomized, placebo-controlled study elucidating the effects of ongoing isometric contraction of muscles on the vital capacity of lungs of healthy individuals on the administration of B. orientalis in different potencies. It aims to compare changes in the vital capacity of lungs in healthy participants during an acute bout of isometric contraction by handgrip dynamometer after administration of B. orientalis.
MATERIALS AND METHODS: Eighteen participants who fulfilled the inclusion criteria gave voluntary consent to participate in this research study. The research team measured the Tmax (measured by handgrip dynamometer) and the vital capacity (measured by a vitalograph) of these participants at the baseline. The participants were then placed into three-medicine arms to administer medicine orally: Arm 1 – B. orientalis Q, Arm 2 – B. orientalis 30C, and Arm 3 – placebo, following allocation of six participants in each medicine arm. Lottery method was used for grouping participants randomly to each medicine arm. The participants were numbered from 1 to 18 using the lottery method, and it was made sure that each arm had one male and five females to have similar gender distribution. The research team blindfolded the participants with a cloth bandage (dupatta) before categorizing them into different medicine arms. The team measured each participant's Tmax and vital capacity, and then administered one dose of the assigned medicine. The team measured the Tmax and vital capacity of the participants after 10 min of administering the medicine. The process was repeated after every 24 h for 3 consecutive days.
RESULTS: The effect of ongoing isometric contractions of the skeletal muscles on the vital capacity acted as a great tool to measure improvement in vital capacity. The vital capacity of the lungs was significantly decreased after oral administration of B. orientalis Q and B. orientalis 30C, whereas there was no significant effect found in the arm that received a placebo.
CONCLUSION: This preliminary study shows that B. orientalis decreases the vital capacity of lungs in healthy subjects and calls for further exploration of its action in higher potencies and with wider experimental parameters. Following the Law of Similimum, this inference also adds to the research scope on the potential of this homeopathic medicine in patients with restrictive lung diseases where the vital lung capacity gets significantly decreased.
Keywords: Anti-asthmatic, Blatta orientalis, isometric contraction, lung capacity, vital capacity
|How to cite this article:|
Kushwaha U, Supriya G, Nair B, Chattopadhyay K, Nair A, Vishwakarma S. A preliminary randomized, single-blinded, placebo-controlled clinical dose–response study to elucidate the effect of ongoing isometric contraction of muscles on the vital capacity of lungs on administering Blatta orientalis. BLDE Univ J Health Sci 2022;7:306-11
|How to cite this URL:|
Kushwaha U, Supriya G, Nair B, Chattopadhyay K, Nair A, Vishwakarma S. A preliminary randomized, single-blinded, placebo-controlled clinical dose–response study to elucidate the effect of ongoing isometric contraction of muscles on the vital capacity of lungs on administering Blatta orientalis. BLDE Univ J Health Sci [serial online] 2022 [cited 2023 Jun 8];7:306-11. Available from: https://www.bldeujournalhs.in/text.asp?2022/7/2/306/361180
The literature on homeopathy rightly recognizes the potential of Blatta orientalis for its quite distinctive therapeutic usefulness in respiratory illnesses. B. orientalis is an indicated remedy for asthma and other chronic obstructive pulmonary diseases (COPDs) 19. Preclinical studies suggest that B. orientalis shows anti-asthmatic properties in animals when induced with bronchospasm using acetylcholine through nonselective anticholinergic and antihistaminic activities. B. orientalis also showed anti-anaphylactic properties by stabilizing mast cells, lowering elevated IgE antibodies, and reducing eosinophils.
Nasal gel formulation of B. orientalis in milk aspiration induced eosinophilia in animals due to its strength in vivo inhibitory effects on IgE production and eosinophil granulocytes. The occurrence of dyspnea and asphyxia convulsions was delayed in guinea pigs treated with the drug due to decreased eosinophils and inhibition of IgE production. A study on the hemolymph of B. orientalis showed antibacterial activities against Staphylococcus aureus, Proteus mirabilis, Salmonella typhi, Pseudomonas aeruginosa, and Escherichia coli. The study reported that the chemical constituents of hemolymph were triazoles, thiophenes, secondary sulfonamide, vinyl halides, sulfinic acid, secondary amide, bromo compounds, cycloheptane, aldehyde/ketone group, and methylene groups. In asthmatic patients, these microorganisms can cause airway hyperresponsiveness and inflammation which can lead to increased bronchospasm.
The findings on an isometric contraction of pectoral muscles enhancing vital capacity and the ability of B. orientalis to treat respiratory illness like COPD have influenced the current research, paving a path toward a less explored area of investigating the ability of the medicine to treat respiratory diseases in humans. This finding expands the scope of current research, thus establishing this method of investigation as safe and non-invasive. This first step toward its exploration was taken by this preliminary study which attempted to elucidate the effects of ongoing isometric contraction of muscles on the vital capacity of lungs of healthy individuals on the administration of B. orientalis in different potencies through a randomized, placebo-controlled study. This preliminary single-blinded dose–response study also compared changes in the vital capacity of lungs in healthy participants during an acute bout of isometric contraction with the handgrip dynamometer after administration of B. orientalis Q and B. orientalis 30C.
Isometric contraction is the muscular contraction against resistance in which the muscles' significant physical shortening is observed when the muscle contracts against a strong spring during gripping. In such isometric contractions, this rise in tension is abrupt and commences early with a more extended period of contraction and gradual relaxation. Studies report that isometric handgrip exercises activate the autonomic nervous system to increase adrenaline, noradrenaline, and adrenomedullin in healthy individuals. These contractions increase individuals' heart rate and mean arterial blood pressure, modestly increasing their cardiac output. Isometric contraction of skeletal muscles causes a marked increase in ventilation with decreased alveolar partial pressure of carbon dioxide, thus acting as a valuable tool for increasing the vital capacity. Vital capacity is the air volume that an individual can breathe out by maximal expiratory effort after a maximum inspiration.
Studies have reported that higher levels of physical activities are associated with improved lung function in healthy adults and, therefore, found a positive association between physical activities and spirometric indices., This association attributes to the muscle strength of individuals, primarily measured by their handgrip strength, the force produced due to joint activities of the deep and superficial hand and forearm muscles during gripping. Handgrip strength test is an inexpensive, noninvasive, and objective indicator of an individual's health status and muscle strength, commonly used in studies to monitor isometric contractions. This tool can discriminate between the presence/absence of lung diseases and even between intermittent and moderate persistent asthma in children, therefore, used as a complementary tool in daily clinical practice to monitor asthma.
Based on a systematic review of the literature around B. orientalis, although studies have investigated the effectiveness of the medicine in the treatment of bronchial asthma, there is a dearth of studies on human beings that measure changes in vital capacity with ongoing isometric contraction on oral administration of this homeopathic medicine. In the current research, the team monitored the vital capacity of the lungs – before and after administering B. orientalis Q and B. orientalis 30C and compared them with placebo. The changes in vital capacity were measured with the aid of a noninvasive device called a vitalograph while the individual maintained an ongoing handgrip strength. This preliminary study explored B. orientalis capacity to improve the vital capacity of lungs and calls for its further exploration. It attempts to further expand on the potential of such homeopathic medicine in patients with diseases where the vital capacity of the lungs gets significantly affected.
| Materials and Methods|| |
The research was conducted on the campus of the Homoeopathic College. The research information was shared with 100 students present on the campus when the study was advertised. Twenty-seven out of 100 students showed interest in participating, 18 fulfilled the inclusion criteria, while 9 were excluded due to smoking habits, previous medication, and history of illnesses in the exclusion criteria. The 18 participants signed the consent form to get included in this research. These participants were healthy young adults between the age group of 18 and 25 years. It was assumed that young adults within this age range would have mature lungs and hence have normal vital lung capacity.
The health status for inclusion in the study was also determined based on their blood counts, urinalysis, and chest X-rays. The age, height, and arm circumference of participants were measured at baseline. Once found eligible, they were randomly divided into three arms with six participants for each arm. Each participant was given one number from 1 to 18 as a pseudonym [Table 1]. The participants were blinded by tying a piece of cloth (dupatta) around both their eyes. They were then allotted to one of the three investigational arms as described in the below sections. The study was conducted, and the measurements were taken on October 13, 2020, October 14, 2020, and October 15, 2020.
- Healthy participants from any gender
- Age group between 18 and 25 years
- Anthropometric upper arm circumference between 23.5 cm and 31 cm
- Willing to participate voluntarily and have signed consent.
- History of bronchial asthma
- History of emphysema
- History of space-occupying lesions of the chest
- History of lower respiratory tract infection in the past 6 months
- Participants who were ever diagnosed with coronavirus infection
- History of paralysis
- History of chronic bronchitis
- History of congenital heart disease
- History of rheumatic heart disease
- History of seizure disorders
- History of acute flaccid paralysis
- History of mental illness
- History of any visible limitation in either hand, surgery in hand or wrist in the last 3 months
- History of smoking in the past 1 year
- Not willing to participate in the study.
Investigational medicines and administration
The B. orientalis Q and B. orientalis 30C each of 30-ml sized bottles were purchased from a local homeopathic pharmacy. Placebo was constituted of “rectified spirit” with alcohol of 95% v/v. The placebo was also poured into a 30-ml glass vial with a similar dropper to the one used by the above brand to maintain dosage uniformity. Both investigational medicines and placebo will be referred to as “investigational medicines” in the following content.
Nonmedicated plain globules of no. 30 size prepared from pharmaceutical-grade cane sugar conforming to the pharmacopeia standards and quality control measures were used as a vehicle for preparing administrative doses that absorb alcohol uniformly. Three airtight vials of 1-dram size were used for the preparation and administration of doses. These vials were made up of 100% pharma grade, nonreactive, virgin plastic. The vials were labeled and color coded based on the medicine arms and kept separated.
Three-medicine arms were constituted as follows to administer the abovementioned two homeopathic medicines and one placebo – Arm 1 – B. orientalis Q, Arm 2 – B. orientalis 30C, and Arm 3 – placebo following random allocation of six participants into each medicine arm.
Three 1-dram vials were freshly prepared for each investigational arm following Hahnemann's method of medication using no. 30 globules. Around eight drops of the three investigational medicines were poured carefully into their respective vials using that moistened every globule in the space of 1 min at the Physiology Laboratory of Homoeopathic Medical College and Hospital, keeping necessary precautions in mind. Each investigational medicine was handled at different times and by different team members. They were fastened with differently colored caps, labeled, respectively, using a black sharpie, and kept separated for administration. From each investigational medicine, six globules were considered one standard dose.
The prepared 1-dram vials were labeled as below:
- Q representing bottle containing B. orientalis Q
- 30C representing bottle containing B. orientalis 30C
- S representing bottle containing placebo.
As discussed above, 18 participants who fulfilled the inclusion criteria gave voluntary consent to participate in this study. The research team measured the Tmax (mean compressing force of muscles) and the vital lung capacity of these participants at the baseline. Arm circumference and height of all participants were also measured to standardize the Tmax and vital lung capacities. The participants were then placed into three arms to administer medicines: Arm 1 – B. orientalis Q, Arm 2 – B. orientalis 30C, and Arm 3 – placebo, following random allocation of six participants into each medicine arm. The research team blindfolded the participants with a cloth bandage (dupatta) before categorizing them into different medicine arms. One dose of the assigned medicine was administered to each participant. [Table 1] shows the baseline data for the participants and the arms they were allocated to.
Measuring Tmax and vital capacity of lungs
The following process was used to measure the Tmax of each participant. A handgrip dynamometer for measuring Tmax was developed due to isometric contraction exercise. This device consists of two hollow metal tubes connected through a flexible metal strip. A graduated pressure scale between the two handles is used for directly recording the compressing force. The participants were requested to stand with arms at the sides with elbows slightly bent and hold a handgrip dynamometer in their dominant hand for a full grip. They were requested to squeeze the device once only. The research team recorded the compressing force or tension indicated on the device. This process was repeated after 1-min pause to exclude any fatigue in muscles. A mean of the two readings was considered their Tmax.
For measuring the vital lung capacity of participants, a vitalograph was used. This device is used in hospitals and sports medicine for measuring lung volume against time. It consists of a cylindrical chamber, having an outer container filled with water of 6-l capacity (corresponding to average lung capacity) in which a light metal gas bell floats. The bell is attached to a chain with a graduated pulley and a spring-mounted indicator needle. The movement of pulley indicates the volume of air presents in the bell. The participants were requested to sit comfortably, facing the vitalograph, and breath normally (quietly) for a minute. This process was followed by requesting them to inspire as deeply and as fully as possible, followed by expelling out all the air with maximum effort into the vitalograph through a mouthpiece. As the bell moved up, the pointer on the pulley indicated the volume of expired air. The participants were advised to make the forced expiration deep and quick but without haste. The research team took three readings at an interval of 5 min, and the mean of these measurements was considered the vital capacity of the lungs of each participant.
The research team measured the Tmax and vital lung capacity of the participants from 10 min of administering the investigational medicine [Table 2]. Each participant was blindfolded for 20 min at each step that required blinding for a total of 2 h approximately. The cloth bandages were removed only after the complete procedure for that day was over, and the investigational medicines were stored securely. The measurements of one participant were taken at one time, and the uniformity of the dose measurement time gap was ensured. The measurements were not shared with the participants, and they were advised to feel normal during the procedure. The idea was to avoid any kind of bias or intention to overdo or underdo during the measurement procedures. As the same devices were used for each participant, the devices were checked for recalibration requirements to the standard and recalibrated if needed to ensure an accurate reading. The process was repeated after 24 h for 3 consecutive days.
|Table 2: Changes in Tmax (x%v) and vital capacities (cm3) for all 3 days before and after administration of medicine and categorized into three medicine arms|
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This research involved a vitalograph in taking respiratory measurements, and among its components, mouthpieces have a significant risk of contamination. Hence, hygiene, disinfection, and infection control were of utmost importance for this study. The research team cleaned the mouthpiece and wiped other exposed parts of the device with alcohol after every use. The handgrip dynamometer was also wiped with alcohol after each participant's measurements.
The study followed the conditions laid down in the Declaration of Helsinki. Participation was voluntary, and informed consent was obtained from participants prior to the commencement of the study. The study followed the Guidelines for Good Clinical Practice, which are described in the documents by the International Conference on Harmonization and the European Central Council of Homeopaths (Guidelines for Homeopathic Provings). The hospital's Ethics Committee approved the study protocol, the approval number of which has been included.
A paired t-test was used to analyze the measurements of respiratory function parameters, before and after administering medicines for each investigational medicine arm. Analysis was done while keeping a 95% confidence interval (CI). For such samples, a 95% CI is effective when measuring the significance of differences between matched pairs of pre- and posttest readings for normal distributions using a paired t-test.
| Results|| |
As discussed in the methods section, 18 participants were randomly grouped into three medicine arms. Most participants were females (n = 15). The mean age was 21.7 years (range: 18–25, standard deviation: 2.04), and the median age was 22.5 years. The average height was 161.4 cm (males: 176 cm, females: 159 cm, overall range: 156–180, standard deviation: 6.6 cm), and the median height was 159 cm. The mean mid-arm circumference was 29.4 cm (males: 32.6, females: 28.8, overall range: 21–38, standard deviation: 3.8 cm), and the median circumference was 29 cm. The degree of skewness was higher for height measurements as the males were significantly taller than females. However, a normal distribution was observed for overall measurements of mid-arm circumferences. However, keeping the gender variations in mind, these readings depicted that the participants had minimum outliers during height measurements and met the inclusion criteria for a mid-arm circumference measurement of 23.5 cm to 31 cm – an average mid-arm circumference for this age group. Both arms had the same ratio of male and female gender which was 5:1.
The vital capacity and Tmax measurements were significantly lowered after administration of investigational medicines for both Arm 1 with B. orientalis Q and Arm 2 with B. orientalis 30C, whereas the participants in the placebo arm (Arm 3) did not show significant changes in their vital capacities or Tmax. The variations in vital capacity before and after oral administration of assigned medicine for each arm for successive 3 days are compared in [Figure 1]. The figure clearly indicates that the participants who were administered B. orientalis showed a significant decrease in their vital capacities.
|Figure 1: Daily cumulative variations of vital capacities (in cm3) for participants in each arm after administration of assigned medicine. Initial days are indicated with a darker shade|
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Another surprising finding was that most of the figures remained below zero in terms of variation of vital capacity after administration of investigational medicines, while not much difference was seen in the placebo arm. The scatter diagram shown in [Figure 2] indicates the difference in vital capacity after administering B. orientalis. The values that are less than zero indicate a significant reduction in vital capacities in participants in the investigation medicine arms. These values are indicated in [Table 2], which also details the randomization of participants and their respective readings of Tmax and vital capacities. Similar findings were observed with Tmax measurements, where the readings were highly significant in Arm 1 and 2 while least significant in the placebo arm. From these findings, it can be interpreted with ease that the medicine has reduced the vital capacity of lungs of the participants in B. orientalis arms.
|Figure 2: Scatter plot for the variations in vital capacities (in cm3) after administering investigational medicines for all 3 days put together|
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As stated earlier, for all statistical tests, the degree of freedom was 5, with a CI of 95%. Post hoc tests showed [Table 3] that a decrease in vital capacity with ongoing isometric contraction was significantly higher after administration of B. orientalis Q and 30C both in all 3 days. The test revealed no significant difference in the placebo arm. Comparing Q and 30C potencies of B. orientalis, an overall higher significance was seen for the effects for 30C potency (P = 0.0003 Day 1, 0.0005 Day 2, and 0.003 Day 3) while B. orientalis Q also showed a significant effect on all 3 days (P = 0.0077 Day 1, 0.0001 Day 2, and 0.0008 Day 3)
|Table 3: Post hoc tests indicating a higher significance in Arms 1 and 2 compared to placebo|
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| Discussion|| |
The team carried out this research to investigate the prediction of changes in the vital capacity of lungs during acute bouts of isometric contraction after administration of B. orientalis Q, 30C and placebo (non-medicated cane sugar globules) in healthy young adults. This study showed that oral administration of B. orientalis in Q and 30C potency decreases Tmax and vital capacity of lungs in subsequent 3 days. No such increase or decrease relationship was found in Tmax and vital capacity of lungs on oral administration of placebo. The evaluation of vital capacity of lungs suggested that B. orientalis 30C had a significantly higher mean lung capacity than B. orientalis Q. Therefore, vital capacity with ongoing isometric contraction parameters assessed was significantly reduced with oral administration of B. orientalis Q and 30C.
The statistical dissimilarities could be attributed to factors such as smaller sample size, increased age, and high sedentary state of participants. The shorter age range (18–25 years) of the participants may have limited the generalizability of our findings. The participants selected for this study were well-informed individuals who may be aware of keywords used in the study. However, blinding was used to avoid bias from the participants while no prompts or names of the medicine were mentioned or shared with the participants. Furthermore, factors such as physical activity and ethnicity that influence lung function were not evaluated in this study. The research team strongly believes that the practical implications and benefits of this study are more valuable than these limitations as it provides the groundwork indication that B. orientalis would increase the vital capacity of patients with respiratory illnesses.
Homeopaths have been using potentized B. orientalis to treat cases of bronchial asthma characterized by suffocation with marked accumulation of mucus. This was proved accidentally in 1890 by a patient who happened to drink tea in which beetle had been infused. Bronchial asthma is a chronic inflammatory disorder of the airway under the classification of obstructive respiratory diseases. The vital capacity may be standard or decreased in obstructive lung diseases, whereas vital capacity is decreased in restrictive lung diseases. The respiratory performances result from coordinated modulation of the autonomic nervous system by inputs from exercising muscles, joints, respiratory centers, and cardiovascular centers. The stimulation of sympathetic fibers results in activation of dilator fibers in bronchial muscles with constriction of pulmonary blood vessels. This results in the dilation of the bronchus, hence allowing more expansion of lungs during breathing.
In addition, isometric contraction activates the sympathetic nervous system, which results in the dilation of the bronchial tree, hence increasing vital capacity. The knowledge that B. orientalis improves vital capacity expands the scope of research to expand its usability and potential in treating restrictive lung diseases where vital capacity is significantly decreased. In obstructive lung diseases, vital capacity of lungs remains same or slightly reduced, whereas in restrictive lung diseases, it is significantly decreased. It goes back to what has been mentioned in the aphorism 47 of the organon of medicine that “medicinal agents have an absolute unconditional power” to derange a person's health and thus the physician must judiciously choose the artificial morbific agent (medicine) that conformably does this process as it takes place in nature. Therefore, the current study helps the prescribing parameters of B. orientalis as a treatment for restrictive lung diseases. Such a physiological effect can help to correlate the role of B. orientalis to enhance the sympathetic nervous system resulting in vital capacity; however, its further exploration warrants more research in this area.
| Conclusion|| |
This randomized, single-blinded, placebo-controlled dose–response study has elucidated the effect of ongoing isometric contraction of muscles on the vital capacity of lungs on administering B. orientalis Q and 30C while also comparing them with each other. This study helps to expand the knowledge of the usability of B. orientalis as a homeopathic medicine. The findings imply that B. orientalis Q and 30C decrease Tmax and vital capacity of lungs in normal healthy participants. Further studies with a bigger sample size are recommended to validate the outcome and usability in interstitial lung diseases.
The authors acknowledge Dr. SPS Bakshi, CMD, Dr. C. P. Sharma, Principal, all the supporting staff, and the student participants of Bakson Homoeopathic Medical College and Hospital, Greater Noida, Uttar Pradesh.
Financial support and sponsorship
This study was financially supported by the Bakson Homoeopathic Medical College and Hospital, Greater Noida, Uttar Pradesh, India.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]