Acupuncture for pancreatic cancer pain: a randomized, placebo-controlled, blinded trial
Andrew J. Vickers, Ghassan Abou-Alfa, Eileen O'Reilly, Sarah Lilly, Barrie R. Cassileth Memorial Sloan-Kettering Cancer Center
Pancreatic cancer pain
• Care of pancreatic cancer predominately palliative
• 80% of patients have pain on presentation • 90% of patients with end-stage disease have moderate to severe pain
Acupuncture for pancreatic cancer pain: pilot study at MSKCC
• 10 patients with stage III or IV pancreatic cancer • Single acupuncture treatment • Pain scores fell from 6.8 / 10 immediately before treatment to 2.6 / 10 immediately afterwards. • Mean improvement was 4.2 points (95% C.I. 2.2, 6.2)
Randomized trial: objectives
1. To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo 2. To determine the duration of acupuncture effects
Design of randomized trial: patients
• Patients with pancreatic cancer
• Baseline pain of 3 or greater on a 0 – 10 scale • Pain due to cancer
Design of randomized trial: interventions
• Study of acupuncture for pancreatitis suggested effect of acupuncture may be short term • Acupuncture needles: one session
– Immediate effect of acupuncture
• Semi-permanent needles (“studs”): one week
– Sustain acupuncture effect – Stimulated by patient or caregiver
Handle
Needle Plastic ring
Placebo needle
After “insertion”
Acupuncture
Placebo
Ashi points
Ashi points
Design of trial: follow-up
• Pain: Numerical rating scale (0 – 10)
• “Pain right now”
– 1 hour and immediately before treatment – 30 and 60 minutes after treatment
• “Average pain in last 24 hours”
– 1 hour before treatment
– Daily for six days
• Opiate use (mm morphine equivalents)
Participant flow
• Target accrual: 60 patients
• 186 patients identified • 124 ineligible
– 99 insufficient pain scores
• 48 no consent • 14 randomized • Trial closed early
Results
Prior to treatment Immediately after treatment
2.9 (SD 2.2)
During one week followup
Acupuncture
5.2 (SD 1.8)
4.8 (SD 2.4)
Placebo
5.4
5.0
5.7
(SD 2.7)
(SD 3.3)
(SD 2.6)
0
1
2
3
4
5
6
7
8
0
24
48
72
96
120
Hours after treatment
Differences between groups
• For immediate effect:
– 2.0 points (95% C.I. -1.1, 5.2; p=0.18)
• During one-week follow-up:
– 1.7 points lower (95% C.I. -1.1, 4.5; p=0.2)
• All post-treatment pain scores (unplanned analysis)
– Differences between groups approached statistical significance (p=0.072).
Conclusions
• Trial not feasible at a tertiary referral center
– earlier stages of disease
– on active therapy
– pain is well controlled
• We recommend a similar study in patients with end-stage disease, perhaps in a hospice setting.
Acupuncture for pancreatic cancer pain: a randomized, placebo-controlled, blinded trial
Thank you
Acupuncture for pancreatic cancer pain: a randomized, placebo-controlled, blinded trial
Thank you