Post Marketing Efficacy and Safety Study of BOHECO Peace (Full Spectrum Hemp Leaf Extract Based Ayurvedic Proprietary Medicine) for the Management of Pain

Shameen Salim; Neeraj Kumar Patel; Jahan Peston Jamas

doi:http://dx.doi.org/10.21760/jaims.7.5.2

Introduction: The use of Hemp leaf-based medicines is being developed at an exponential rate with more and more studies and research carried out to assess the efficacy of the drug in various illnesses including management of pain. Materials and Methods: 50 patients who had been on the full spectrum hemp leaf based ayurvedic proprietary medicine manufactured by Bombay Hemp Company, Mumbai, India for pain were selected for the study. Separate structured multiple-choice questionnaires were used for the assessment of safety and efficacy of BOHECO’s PEACE manufactured by BOHECO. Results: In Overall effect of management of Pain, out of 50 participants, 47 responses were received in which, 3 patients (6.4%) reported complete remission of the pain, 28 patients (59.5%) reported marked improvement, 15 patients (31.9%) were getting moderate Improvement and one patient (2.1%) reported mild improvement. Out of 15 patients who reported adverse events, most reported AEs were dry mouth in 12 patients which is a common response of the body to hemp leaf-based medicine, mild euphoria in 3 patients, somnolence in 2 patients, sedation in 2 patients and anxiety in 1 patient. The mild AEs reported were self-limiting without any medical intervention. Conclusion: Full Spectrum Hemp leaf extract based Ayurvedic proprietary medicine sold under the brand name BOHECO PEACE used for the management of pain has been observed to be effective and safe for long term use. It is observed to have reduced chronic pain with no serious adverse reactions at prescribed doses.

Corresponding Author

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Shameen Salim, Chief Medical Officer, CareAyu Private Limited, Mangaram Pandalam, PO Pathanamthitta, Kerala, India.
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Shameen Salim, Neeraj Kumar Patel, Jahan Peston Jamas, Post Marketing Efficacy and Safety Study of BOHECO Peace (Full Spectrum Hemp Leaf Extract Based Ayurvedic Proprietary Medicine) for the Management of Pain. J Ayu Int Med Sci. 2022;7(5):6-11.
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Manuscript Received

Review Round 1

Review Round 2

Review Round 3

Accepted

2022-04-30

2022-05-02

2022-05-09

2022-05-16

2022-05-22

Conflict of Interest

Funding

Ethical Approval

Plagiarism X-checker

Note

Nil

Yes

17%

Introduction

Pain have become significant health problems in the world causing social burden and personal disability. It demands the development of a permanent solution or a long-term management with minimal side effects. The use of hemp leaf-based medicines is being developed at an exponential rate with more and more studies and research carried out to assess the efficacy of the drug in various illnesses including management of pain. However, it raises the demand for assessment of its safety in the long term.^[1]

Pain is generally defined as a highly unpleasant physical sensation caused by illness or injury. This sensation is caused by a group of receptors in the central and peripheral nervous systems called the pain pathway.^[2] The use of pain as a tool for assessing the physical and mental health of a person dates to the attempt of our ancestors to understand human health and diseases. Over the ages, the definition of pain has changed from being just a symptom to understanding pain as a protective mechanism of the body which serves no useful purpose other than destruction after a specific period of time.^[3] The idea of pain itself as a disease rather than a symptom is being debated in the scientific community as the definition of disease is “an impairment of the normal state of the living animal or plant body or one of its parts that interrupts or modifies the performance of the vital functions”.^[4] However, management of chronic pain due to incurable or terminal illness and permanent tissue damage has been a challenge to modern day physicians when it comes to the question of side effects.

The last two years witnessed the emerging developments in the legalization of hemp-based medications in many countries, including India, following the conceptualization of endocannabinoid system.^[7] hemp has a long history of medicinal uses due to its main components that are found in higher concentrations, identified as Δ9 tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). Among them, Δ9 tetrahydrocannabinol (Δ9-THC) is identified as the psychoactive component, which is a potential treatment for Pain and Sleep, and cannabidiol (CBD) has been identified as a potential treatment for pain and mental stress.^[8],[9] Having proven the efficacy, the safety remains the next most important concern, as the indications of these medicines sometimes demand long-term usage.

Materials and Methods

A retrospective observational analysis through a patient survey with the help of a questionnaire was carried out. We developed questionnaires to assess the broad characteristics of patients using Hemp/Cannabis Leaf based medicines. The survey consisted of structured questions answered by either yes/no or multiple-choice responses specifically designed for patients taking pain and stress medications separately. Questions focused on several key domains, like perceived efficacy, and adverse drug reactions, along with side benefits.

Data Source: Patient database created by doctor’s team at CareAyu. Further patient consent form was collected before starting the survey.

Sample size: 50 patients who had been on a prescription-based product, BOHECO PEACE (Full Spectrum Hemp leaf extract based Ayurvedic proprietary medicine) manufactured by BOHECO were selected irrespective of age, gender, or the underlying care.

Selection criteria: The cases were selected irrespective of Age, Gender, Acute or Chronic conditions and Underlying causes. All the patients with no physical or mental disability to fill up the questionnaire were selected. The only inclusion criteria considered was the past or current use of BOHECO PEACE for Pain management.

Assessment criteria: A purely subjective grading with a 10-point Likert scale derived from the commonly used Numeric rating Scale of 1-10,

was done for the assessment of efficacy of Pain, and no other subjective or objective clinical parameters were used.

Voluntary reporting of adverse events was encouraged during the survey where the patient was given a list of common side effects to select from and a column for reporting any unidentified adverse reactions.

The probable side effects included in the questionnaire for reporting were dry mouth, somnolence, euphoria, sedation, and anxiety.

Table 1: 10-point scale on Pain Management

Improvement	Grading
No Improvement	0
Mild Improvement	1-3
Moderate Improvement	4-6
Marked Improvement	7-9
Complete Remission	10

Statistical Analysis

A statistical analysis of the data collected from the 50 patients using BOHECO PEACE was done using Chi Square test to look for relevant correlations by using Phi and Cramer's V to understand the strength of association. To maintain the sample size, an average value was counted as response while tabulating the data.

Results and Discussion

Age Group: The age group distribution of subjects was 21-30 (34%), 31-40 (22%), 41-50 (16%), 51-60 (14%) and remaining were >60 years. (Fig. 1)

Time administration of Medicine: 41 patients amounting to 82% preferred using the medicine at night whereas only 2 patients (4%) preferred day and 7 patients (14%) preferred both day and night. (Fig. 2)

No of drops prescribed: About 21 patients (42%) were taking 3-6 drops daily, 18 patients (36%) were taking 2-3 drops and 11 patients (22%) were taking 6-12 drops. (Fig. 3)

Pain relief in chronic conditions: 18 patients (38.3%) strongly agreed that the medicine provides relief in chronic cases, 28 patients (59.6%) agreed that medicine provides pain relief in chronic conditions and only 1 patient (2.1%) did not agree that medicine provides pain relief in chronic conditions. (Fig. 4)

Pain relief grading: Out of 47 responses received, 12 patients (25.5%) selected a grade 8 to represent their pain relief, another 12 patients (25.5%) selected a grade of 7. 10 patients (21.3%) selected grade 6 and 5 patients (10.6%) selected grade 5, 3 patients (6%) selected grade 10, 4 patients (8%) selected grade 9 and only one patient (2%) selected grade 1. (Fig. 5)

Reduction in frequency of the pain: Out of 46 responses, 35 patients (76.08%) reported reduction in frequency of the pain whereas, 11 patients (23.9%) reported no reduction in frequency of the pain. (Fig. 6)

Pain reverting back on withdrawal of medicine: Out of 47 responses, 32 Patients (68.1%) felt that the pain reverted on stopping the medicine whereas 15 Patients (31.9%) didn't feel that the pain reverted on stopping the medicine.

Reduction of nausea and vomiting associated with chronic terminal illness: Among the 3 patients out of 50 participants, who had nausea and vomiting, 1 patient strongly agreed, 1 patient agreed, and 1 patient (33%) disagreed that the medicine helped in reducing nausea and vomiting associated with the illness they have or the treatments they are following. (Fig. 7)

Enhances mood: Out of 48 responses received, 26 patients (54.1%) strongly agreed, 17 patients (35.4%) agreed that the medicine enhances mood and only 5 patients (10.4%) disagreed that the medicine enhances mood. (Fig. 8)

Stimulates appetite: Out of 48 responses received, 18 patients (37.5%) strongly agreed that the medicine stimulates appetite, 8 patients (16.6%) agreed that the medicine stimulates appetite whereas 22 patients (45.8%) disagreed that the medicine stimulates appetite. (Fig. 9)

Wake up refreshed: Out of 49 responses, 37 patients (75.5%) agreed that they wake up refreshed with no difficulty after having the medicines at night in prescribed doses; only 12 patients (24.5%) disagreed that they could wake up refreshed after having the medicine at night. (Fig. 10)

Side effects observed: Out of 50 patients, 19 patients (38%) reported that the medicine has side effects whereas 31 patients (62%) reported no side effects or adverse reactions during the medicine. (Fig. 11)

Adverse reactions

No of patients

Dry eyes

Constipation and headache

Burning micturition and blisters

Disturbed sleep

Pain in inguinal region

Tinnitus

Conclusion

Full Spectrum Hemp leaf extract based Ayurvedic proprietary medicine sold under the brand name BOHECO PEACE, used for the management of pain has been observed to be effective and safe for long term use.

It is observed to have reduced pain with no serious adverse reactions at prescribed doses.

Acknowledgement

The current study was sponsored by Bombay Hemp Company, India. The authors acknowledge the kind support received from the team members.

Disclosure Statement

The current study is an observational study without any clinical interventions. Therefore, CTRI registration has not been carried out as per the CTRI guidelines.

Reference