The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients

The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients in Jeddah, 2013, A Randomised Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Conventional treatment; Procedure: Wet cupping

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Western region
    • Jeddah, Western region, Saudi Arabia, 21589
      • King AbdulAziz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: 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.; Other Names: Anti-hypertension management; Procedure: 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.; Other Names: Hijama
ACTIVE_COMPARATOR: Conventional treatment; Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department	Other: 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.; Other Names: Anti-hypertension management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Systolic Blood Pressure After 4 Weeks	1 month
Diastolic Blood Pressure After 4 Weeks	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Collaborators: Joint Program of Family and Community Medicine, Jeddah, Saudi Arabia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (ESTIMATE): November 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 12, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 002 (University of CT Health Center)