Raynauds Scleroderma Global Patients: Acupressure Is Not Effective For The Treatment Of Raynaud’s Phenomenon - Journal of Scleroderma and Related Disorders, Volume 2.

Acupressure Is Not Effective For The Treatment Of Raynaud’s Phenomenon.

Journal of Scleroderma and Related Disorders, Volume 2.

A randomized controlled trial of acupressure

for the treatment of Raynaud’s phenomenon:

the difficulty of conducting a trial

in Raynaud’s phenomenon.

Authors:

Heather Gladue, Veronica Berrocal, Richard Harris, Pei-Suen Tsou, Gautam Edhayan, Ray Ohara, Dinesh Khanna

Details of the above trial were published in the Journal of Scleroderma and Related Disorders, Volume 2.

The Article was accepted on March 31, 2016, and published online on July 23, 2016.

Here is a synopsis taken from the article:

ABSTRACT

Objective:

To examine the effect of acupressure on Raynaud’s phenomenon (RP) in a randomised controlled clinical trial (RCT) and to evaluate the difficulties of conducting an RP RCT.

Methods:

A pilot single-center RCT of acupressure versus targeted patient education was conducted for the treatment of RP. Patients with either primary (n = 15) or secondary (n = 8) RP were randomized in an 8-week study. The primary endpoints included a decrease in the frequency and duration of RP. Secondary endpoints included several serum biomarkers including endothelial dysfunction, Raynaud’s attack symptoms, Raynaud’s Condition Score, and patient and physician global assessments of RP. Primary data analysis was conducted using the last observation carried forward and t-tests or a Wilcoxon rank test was used to compare the two groups.

Results:

Twenty-three patients were randomized and seven discontinued prematurely. Seventy-eight percent of patients were female, 96% were Caucasian, and the mean age was 49.8 (SD = 16) years. No statistically significant differences were detected between the acupressure versus education groups in primary and secondary outcomes (p>0.05). Frequency of attacks decreased by 6.7 attacks (SD = 8.8) in the acupressure group versus 7.2 (SD = 12.8) in the education group (p = 0.96), and the duration of attacks decreased by 11.4 (SD = 19.9) minutes in the acupressure group versus an increase of 0.8 minutes (SD = 11.2) in the education group (p = 0.14). There were no adverse events noted in the RCT.

Conclusions:

This pilot study does not support efficacy of acupressure for RP.

Introduction

RP is a condition caused by an intermittent vasoconstriction of blood vessels in the extremities in response to cold or emotional stress. In the USA, it affects 2% to 11% of women and 1.5% to 8% of men. The burden of RP in the general population is quite high and can lead to loss of productivity and a reduced quality of life.

Currently used pharmacologic therapies for RP have only modest efficacy and can include calcium channel blockers, angiotensin II antagonists, alpha-1 adrenergic blockers, selective serotonin reuptake inhibitors, prostacyclins, nitrates, statins, botulin toxin, phosphodiesterase inhibitors, endothelin receptor antagonists and antioxidants.

Side effects of these therapies are common and efficacy is limited with the exception of calcium channel blockers and prostacyclins, which decrease the frequency and duration of attacks.

The high cost, lack of efficacy, and side effects of traditional medical therapies make other complementary treatments such as acupressure an attractive alternative.

Chinese acupuncture has been reported in a randomized controlled study of 3 primary Raynaud’s syndrome patients to decrease the frequency of RP attacks (n = 17) when compared to placebo (n=16, p<0.01). However, acupuncture needs to be administered by trained professionals, and usually requires an out of pocket expense. Alternatively, acupressure uses pressure to stimulate key areas based upon ancient Chinese medicine meridian theory.

The advantage of acupressure is that it can be taught to patients and be self-administered at home. As such, acupressure, may provide beneficial effects for the treatment of RP.

The purpose of this pilot single-center trial was to evaluate the feasibility and potential efficacy of standardized acupressure for improving circulation in RP. Among the outcome measures, we included published patient-reported measures such as frequency of RP, duration of RP attacks, patient assessment, attack symptoms (tingling, numbness and pain), and the Raynaud’s Condition Score (RCS), physician global assessment on a visual analogue score (VAS), serum biomarkers, and a measure of endothelial function (EndoPAT). We also explored a recently reported composite index in this trial.

Methods

Study design

Single center, unblinded, randomised controlled trial that was conducted over a period of 8 weeks and was approved by the University of Michigan Institutional Review Board. Two acupressure protocols were examined: one focusing on vasodilation (thus counteracting the vasospasm in RP), and the second focusing on relaxation.

The education (controlled) group received an education packet provided by the Raynaud’s Association.

Patients

Patients with both primary and secondary Raynaud’s were included and aged over 18.

Efficacy assessments

The primary outcomes were a decrease in the frequency and duration of RP attacks during week eight compared to the attacks during week one. Secondary assessments included RCS, RP pain, tinging and numbness, which collectively were combined into the parameter ‘attack symptoms’, physician and patient global assessment on a VAS, and EndoPAT. Serum markers included basic fibroblast growth factor (bFGF), vascular cell adhesion molecule -1 (VCAM-1), soluble-intercellular cell adhesion molecule-1 (slCAM-1), soluble-E-selectin (sE-selectin), tissue type plasminogen activator (tPA), procollagen type I N-terminal propeptide (PINP), and vascular endothelial growth factor (VEGF) were also assessed.

Adverse events

Patients did not experience any adverse evens from acupressure with no bruising or pain reported. There was a high drop-out rate approaching 30%, which is hypothesized to be due to the difficulty in patients keeping up the daily acupressure treatment or due to lack of efficacy.

Discussion

Identifying effective new treatments for RP patients has been hampered by the variability in clinical trial outcome measures used to assess efficacy. The variability and lack of standardized outcome measures has also made it difficult to compare different clinical trials as randomized controlled trials in RP often use different clinical outcome measures, resulting in conflicting outcomes in different trials. The variation in placebo response rates has made clinical trials inconclusive rendering the approval of new therapies for RP difficult despite anecdotal evidence of improvement.

The lack of reliable objective biomarkers or endpoints to predict efficacy has also pushed investigators to utlilize subjective endpoints that have high placebo response rates. Objective measures have been shown to be reliable and valid but are not always available for trials and there is a need for better outcome measures that can be incorporated into multicenter trials.

The results showed decreased endothelial function in the secondary RP group. It is unclear whether this lack of significance is due to a lack of efficacy or due to a lack of sensitivity to change in these tests that are used to detect the vascular changes attributed to RP.

Key Message

Acupressure is not effective for the treatment of Raynaud’s phenomenon.

- Outcome measures in Raynaud’s phenomenon have a high level of variability, making conclusive results difficult.

- A standardized composite index for RP or more reliable outcome measures are needed for multicenter trials.

Access the full article, here

April 2017.

To read my articles:

Rare Disease Day 2018, Research - Taking Part in Clinical Trials, Click here

March Autoimmune Disease Awareness Month 2018, Click here

Global patient video, Click here

Becoming a Patient Research Ambassador for the NIHR, Click here

If we only had more RESEARCH investment for Scleroderma, Raynaud's, Autoimmune Rare Disease, Click here

The Importance of Medical Research and Awareness to the Scleroderma, Raynaud's, Autoimmune Rare Disease patient, Click here

Scleroderma Awareness Month 2017 Patient Profiles Campaign, Click here

Scleroderma Awareness Month 2017 Patient Profiles Campaign Patient Index, Click here

The Pandora’s Box of the rare autoimmune disease Scleroderma, Raynaud's and Cancer, Click here

Key Event Dates 2018, Click here

Importance of an Early Diagnosis, Click here

Taking Part in Clinical Research Trials, Click here

The Importance of a Multi Disciplinary Medical ‘Dream Team’, Click here

Expert Specialist Centres, Click here

My Skin is Cured from Scleroderma, Click here

UK Guidelines for Managing and Treating Scleroderma, Click here

Fatigue, Click here

Mobility, Click here

Diet and nutrition, Click here

Raynaud's, Click here

World Scleroderma Day 29^th June 2016, Click here

World Scleroderma Day 29^th June 2017, Click here

Why Global Collaboration is important to the Rare Disease Patient, Click here

RARE DISEASE DAY:

The theme to this years Rare Disease Day is Research

Rare Disease Day 2018 – Research, Taking Part in Clinical Trials. Scleroderma, Raynaud's, Autoimmune Rare Disease, Click here

2016 Rare Disease Day Patient Voice

2016 Rare Disease UK Parliamentary Reception

2017 Rare Disease Day Flashback

2017 Rare Disease Day unmet clinical needs to the scleroderma patient

Rare Disease Day is a fantastic opportunity for the entire rare disease community to shine a spotlight on their reality, combining as one unified voice. Where, at least one commonality presides –

Medical Research provides the brightest light

for the illumination of the rare disease patients’ plight.

I highlighted other areas of medical research interest within Week 3 of my Patient Profiles Campaign for Scleroderma Awareness Month 2017.

VIDEO

INDEX

Although rare disease patients are few in number, eg. 2.5 million scleroderma patients worldwide, (the World Scleroderma Foundation), the commonalities and golden hallmark for each rare disease patient are the same:

Early Diagnosis

Expert Specialist Centres

Access to Innovative Medicines

Where MEDICAL RESEARCH investment is VITAL.

Research is the key. Abstracts from 2016 World Congress, Click here

Scleroderma Awareness Month Campaign 2016, Click here

Links

View video, here

Preamble - here

The Family Day at the Scleroderma Unit, The Royal Free Hospital is taking place on the 19^th May 2018. Browse the program, here

This year, I am celebrating 20 years of being a patient at this world leading expert specialist research centre.

Sept 2017

I am eternally grateful to the global scleroderma trail blazers Dame Prof Black and Prof Chris Denton, whose commitment and dedication to unlocking the scleroderma enigma, is nothing other than, superhuman.

I am truly humbled and inspired by their work ethic. I am wholly appreciative for Prof Denton’s continued medical expertise and support, especially during my barrister qualifying years, 1997 - 2004.

1^st March 2004, I qualified as a self employed practising barrister. Further to having been told in 1997, by my diagnosing doctor, that I was looking at a 15month prognosis.

I very much hope to utilise my professional skills and qualifications along with my patient experience, to help achieve the #SclerodermaFreeWorld dream, hoping to improve understanding and best practice, in the meantime.

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