Clinical trial NCT01987583: The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients
Official title: The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
Collaborators: name: Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia
First posted: 2013-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure After 4 Weeks
timeFrame: 1 month
measure: Diastolic Blood Pressure After 4 Weeks
timeFrame: 1 month
Secondary outcomes:
measure: Incidence of Wet Cupping Side Effects in Intervention Group
timeFrame: 1 month
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
state: Western region
Study officials:
affiliation: Ministry of Health
name: Nouran A Aleyeidi, Resident Community Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: National Guard Health Affairs, King Abdulaziz Medical City
name: Khaled Aseri, Consultant Community Medicine
role: STUDY_DIRECTOR
References:
citation: Aleyeidi NA, Aseri KS, Matbouli SM, Sulaiamani AA, Kobeisy SA. Effects of wet-cupping on blood pressure in hypertensive patients: a randomized controlled trial. J Integr Med. 2015 Nov;13(6):391-9. doi: 10.1016/S2095-4964(15)60197-2.