Acupuncture for cancer pain: An umbrella review and a pilot pragmatic randomised controlled trial
Creators: name: HE, Yi Han
Publisher: name: RMIT University
Year: 2024
Subjects: classificationCode: 420803
subject: Traditional Chinese medicine and treatments

description: Pain is a distressing symptom experienced by around 70% of cancer patients, but is inadequately controlled in nearly 50% of these patients. Although the World Health Organization (WHO) analgesic ladder provides effective approaches to relieving cancer pain, addiction to analgesics and the side effects of pharmacological interventions pose critical challenges to pain management. Because pain is multidimensional, effective control mandates a comprehensive multidisciplinary approach, including non-pharmacological interventions.

Leading oncology organisations such as the American Society for Clinical Oncology and the National Comprehensive Cancer Network (NCCN®) have recommended acupuncture as a therapeutic option for managing cancer pain. Research on acupuncture for cancer pain has been growing but the findings are conflicting. The effectiveness and safety of acupuncture for cancer pain need critical evaluation, and therefore this project addresses this knowledge gap by summarising the current state of the evidence, addressing methodological gaps in the existing evidence, translating the available evidence into a clinical investigation and leading to the generation of new evidence. This PhD project comprised the following 3 parts:

<b>Part 1: Umbrella review of systematic reviews and reviews of randomised control trials and non-randomised studies</b>

A total of 23 systematic reviews (SRs), with or without meta-analysis, focusing on acupuncture and related therapies for cancer pain were included. The majority of the included SRs were considered as having relatively high reporting and methodological quality. With regard to the study outcomes, concerns about the considerable heterogeneity among primary studies were raised in all SRs, such as diverse study populations/patients, variety in acupuncture interventions, differences in comparators and variation in the outcome measurements. Twenty (20) randomised controlled trials (RCTs) were included in the SR and the majority (15 out of 20 studies) used electro/manual acupuncture, two used auricular acupressure, two used moxibustion alone, with the remaining study combining acupuncture with auricular acupressure as a complex intervention. Given the strong correlation between scales of pain assessment, the results measured by the visual analogue scale (VAS) were converted to the corresponding grade in the 11-point numerical rating scale (NRS, 0 points indicating no pain and 10 points indicating most severe pain). For example, a result of 40mm on the 100mm version of the VAS was recorded as 4 points for data synthesis. The results of the NRS, the converted VAS and the Brief Pain Inventory severity subscale were used in the meta-analysis to assess pain intensity. The primary meta-analyses were based on the results at the end of the treatment period of the included studies. In the RCTs of acupuncture, comparisons with sham acupuncture showed significant reductions in pain intensity mean difference [MD] -1.39 points [95% CI, -2.14 to -0.64 points]; I2= 81%, 7 studies, 398 participants) while comparisons with waitlist controls found improvements in pain intensity (MD -1.63 points [95% CI, -2.14 to -1.13 points], I2=0%, 3 studies, 255 participants). In the open-label studies of acupuncture combined with conventional analgesics, there were significant reductions in pain intensity in the acupuncture groups (MD -1.12 points [95% CI, -2.19 to -0.06 points], I2 =95%, 3 studies, 224 participants). For the RCTs of acupressure, there were significant reductions in pain intensity (MD -1.75 points [95% CI, -2.07 to -43 points], I2=64%, 2 studies, 106 participants). One study compared real moxibustion to sham moxibustion and showed that there were significant reductions in pain intensity (MD -1.28 points [95% CI -2.22 to -0.34 points], 1 study, 14 participants). For the study of moxibustion combined with conventional analgesics compared to conventional analgesics alone, there was a significant reduction in pain intensity (MD -1.45 points [95% CI -1.75 to -1.15 points], 1 study, 308 participants). For acupuncture combined with auricular acupressure, there was a significant reduction in pain intensity (MD -1.77 points [95% CI -2.64 to -0.90 points], 1 study, 60 participants).

Seventeen (17) non-randomised studies were also included and most of them allowed acupuncturists to choose acupuncture points according to the characteristics of the individuals and their symptoms, which would be consistent with clinical practice. From this point of view, the findings of the review of non-randomised studies may be relevant to inform the design of the clinical intervention in future randomised trials.

 2: Semi-standardised acupuncture protocol

The acupuncture protocol in the pilot pragmatic randomised controlled trial (pRCT) was developed following the comprehensive literature research reported in part 1. The most frequently used acupuncture points in the included RCTs of acupuncture for cancer pain were Hegu (LI4), Taichong (LR3), Zusanli (ST36), Sanyinjiao (SP6) and Yanglingquan (GB34). These points comprised the standardised section of the acupuncture protocol for the pilot clinical trial. Permission for the acupuncturist to partially tailor acupuncture points to the needs of each participant resembled real-life acupuncture practice and treatment protocols.

<b>Part 3: Pilot pragmatic randomised controlled trial</b>

With Human Ethics clearance, thirty (30) patients recruited at the Oncology Department of the Guangdong Provincial Hospital of Chinese Medicine (China) with moderate or severe pain were included and randomised to the adjunctive acupuncture group or to the control group. Both groups received routine pharmacotherapy for pain management, but the control group did not receive acupuncture. The duration of the treatment course was one week with a two-week follow-up. In total, 4 acupuncture sessions were administered, namely on days 1/2/4/6 of the treatment week. Pain intensity was measured by the NRS and the daily opioid dose was recorded.

There were no significant differences between groups in the mean scores for pain intensity and daily opioid consumption. The proportion of participants experiencing at least a 2-point reduction in NRS at the end of the treatment was 93.3% (n = 14/15) for the acupuncture group and 57.1% (n = 8/14) for the control group (RD: 36.1%, 95% CI [7.4-65.0%]; RR: 1.63, 95% CI [1.02-2.62]; P = 0.04). There were no serious adverse events (AEs) and no loss of participants during the treatment period.

This pilot study showed that adding acupuncture to routine analgesics for patients with moderate to severe cancer pain was feasible. The clinical effects of adding acupuncture as an adjunctive therapy should be further evaluated.