Background/Purpose: Raynaud’s phenomenon (RP) affects approximately 10% of the US population. The high cost, lack of efficacy, and side effects of conventional medical therapies necessitates the need for complementary or alternative options.

Objective: A pilot, randomized control trial (RCT) of acupressure vs. patient education for the treatment of RP.

Methods:  A pilot single-center RCT of vasodilation acupressure, relaxation acupressure vs. RP education obtained from the Raynaud’s Association (control). Patients with either primary (N = 15) or secondary (N = 8) RP were randomized from January through April by block randomization to the 3 groups for an 8 week period. Patients randomized to acupressure were instructed on how to self-perform at home by a single investigator and a DVD was provided with instructions. The primary endpoint was a decrease in the severity, frequency and duration of RP. All patients kept a daily Raynaud’s diary, (recording the number and duration of attacks, pain, tingling and numbness on a 0-100 scale), and daily Raynaud’s condition score. At baseline and 8 weeks, EndoPAT was performed to determine endothelial function, and serum was collected for biomarker analysis (VEGF, tPA, sE-Selectin, BFGF, VCAM-1, ICAM). Data analysis was conducted using the last observation carried forward and paired statistical analyses were used to assess difference.  

Results: 23 patients were randomized and 9 discontinued prematurely (5 patients withdrew due to time restraints, 2 each for unrelated medical problems and lost to follow-up). Since there was no statistical difference between acupressure groups, they were combined and compared to the education group. 78% of patients were female, 96% were Caucasian, the mean age was 49.8 (SD=16) yrs; 5/16 patients in the acupressure group had secondary RP and 1/7 in the control group had secondary RP.. There was no statistical difference in the baseline characteristics between the acupressure groups vs. the control group. At the end of study, there were no statistical differences between the acupressure vs. education groups. However, there were trends in the patient reported severity of RP favoring acupressure groups (Table). In addition there were no significant differences in EndoPAT measurements or serum markers of vasculopathy. Sensitivity analysis using the completers showed similar results.

Table: Change from week 1 compared to week 8*

Variable	Group A+B	Control	P value
No of attacks Mean (SD)	N: 12 -6.3 (8.0)	N: 6 -7.2 (12.8)	1.0
Pain Mean (SD)	N: 12 -13.6 (30.1)	N: 6 9.6 (27.6)	0.12
Tingling Mean (SD)	N: 12 -5.3 (13.9)	N: 6 -1.2 (7.5)	0.64
Numbness Mean (SD)	N: 12 -10.5 (37.0)	N: 6 1.1 (22.1)	0.89
Average duration of attacks Mean (SD)	N:12 -9.2 (18.7)	N: 6 0.8 (11.2)	0.08
RCS average for difficulty Mean (SD)	N:12 -2.0 (2.4)	N: 5  -0.6 (2.9)	0.72
RCS average for pain Mean (SD)	N:12 -1.4 (2.0)	N: 5 -0.4 ( 3.0)	0.63
Endopat Mean (SD)	N: 14 -0.1 (0.4)	N: 7 -0.2 (0.8)	0.55
Patient VAS Mean (SD)	N: 16 -1.6 (2.2)	N: 7  -0.7 (2.0)	0.39
MD VAS Mean (SD)	N: 16 -2.1 (2.0)	N: 7  -1.9 (1.3)	1.0

*Using LOCF

Conclusion: Our pilot RCT showed that acupressure groups showed trends in improvement in symptoms associated with RP. However, there were no differences in the endothelial function and serum markers of vasculopathy. The parameters used to evaluate patients with RP have marked variability and supports the need for a composite measure to be developed for RP trials.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/acupressure-for-the-treatment-of-raynauds-phenomenon-a-pilot-randomized-controlled-trial/