Hypertension
Conditions
Brief summary
This research proposal is submitted to fulfill the requirement of the PHD degree of Community Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi Arabia. Background: Cupping is an ancient treatment remedy that has been used for many centuries in many parts of the world. In the Middle East, Wet cupping Hijama is still a popular treatment because of its religious background. Despite of that, it still has little scientific evidence that proves its efficacy. Many hijama healers claim that they have observed dramatic improvement in Blood pressure control of hypertension patients. Not many studies support that. This study should help to prove or disprove this hypothesis. Objectives: * To determine the efficacy of wet cupping on blood pressure among high blood pressure patients. * To assess the incidence of wet cupping side effects in the intervention group. Methods: The study design is a randomised controlled trial. There will be an intervention group of high blood pressure patients who will perform hijama in addition to their usual management, and a control group of high blood pressure patients who will receive their usual anti-hypertension management only. There will be 8 weeks follow up period. After that, data entry, analysis and interpretation will take place. Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients
Interventions
PROCEDUREWet cupping
Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
OTHERConventional treatment
According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital.
Sponsors
Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* High BP at the time of the study (SBP 140 mmHg or more and/or DBP 90mmHg or more). For patients with DM, high BP is defined as SBP 130 mmHg or more and/or DBP 85mmHg or more. * Age between 19 and 65 years old. * Males and females
Exclusion criteria
* Grade III Hypertension (SBP 180 mmHg or more and/or DBP 110 BP or more). * Patients with very high added risk,according to the Saudi Hypertension management guidelines. By excluding the patient who have associated clinical conditions which are: cerebrovascular disease, heart disease, renal disease, peripheral vascular disease and advanced retinopathy. * Patients with secondary hypertension. * Pregnant women. * If the patient performed dry cupping, wet cupping or acupuncture during the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic Blood Pressure After 4 Weeks | 1 month |
| Diastolic Blood Pressure After 4 Weeks | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Wet Cupping Side Effects in Intervention Group | 1 month | * Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session. * Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session. |
Countries
Saudi Arabia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wet Cupping and Conventional Treatment Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.
Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.
Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital. | 40 |
| Conventional Treatment Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department
Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Wet Cupping and Conventional Treatment | Conventional Treatment | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 9.4 | 54 years STANDARD_DEVIATION 9.5 | 53 years STANDARD_DEVIATION 9.4 |
| Baseline Diastolic Blood Pressure | 85 mmHg STANDARD_DEVIATION 7.9 | 86 mmHg STANDARD_DEVIATION 10.7 | 86 mmHg STANDARD_DEVIATION 9.3 |
| Baseline Systolic Blood Pressure | 152 mmHg STANDARD_DEVIATION 10.7 | 156 mmHg STANDARD_DEVIATION 11.3 | 154 mmHg STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 56 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Diastolic Blood Pressure After 4 Weeks
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wet Cupping and Conventional Treatment | Diastolic Blood Pressure After 4 Weeks | 82 mmHg | Standard Deviation 9.9 |
| Conventional Treatment | Diastolic Blood Pressure After 4 Weeks | 81 mmHg | Standard Deviation 12.2 |
Primary
Systolic Blood Pressure After 4 Weeks
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wet Cupping and Conventional Treatment | Systolic Blood Pressure After 4 Weeks | 140 mmHg | Standard Deviation 17.7 |
| Conventional Treatment | Systolic Blood Pressure After 4 Weeks | 149 mmHg | Standard Deviation 18.5 |
Secondary
Incidence of Wet Cupping Side Effects in Intervention Group
* Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session. * Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session.
Time frame: 1 month