Abstract
OBJECTIVE:
To assess the efficacy and safety of Neiguan (PC6) acupoint acustimulation in preventing chemotherapy-induced nausea and vomiting (CINV), especially for patients with guideline-inconsistent CINV prophylaxis (GICP) due to personal reasons
METHODS:
From January 2021 to December 2021, 373 patients suffered from solid malignancy were recruited according to the inclusion criteria. Complete response (no emesis and no rescue medication use) rate during the overall phase (0-120 h of each chemo-cycle) was the primary assessment of CINV control. The Functional Living Index-Emesis (FLIE) questionnaire was investigated among these patients as a secondary ‘quality of life’ objective to assess the impact of CINV on patients’ daily life by recording score of nausea and vomiting.
RESULTS:
With acustimulation of Neiguan (PC6) acupuncture point through a portable, noninvasive and user-friendly device, in terms of complete response rate and scores in nausea/vomiting by FLIE questionnaire, patients achieve a better outcome in highly emetogenic chemotherapy (HEC) induced CINV, especially GICP subgroup. Meanwhile, analysis also demonstrated this tendency existed in other patients with HEC/GCCP (guideline consistent CINV prophylaxis) and moderate emetogenic chemotherapy, although the difference was not significant.
CONCLUSION:
Considering advantages of Neiguan (PC6) acustimulation such as noninvasive, covered by medical insurance and few side effects, we believe it would be an ideal auxiliary tool in CINV control, especially in patients who receive highly emetogenic chemo-protocol and are reluctant to GCCP for economic reasons.
Keywords: acupuncture, acustimulation, tumor, chemotherapy-induced nausea and vomiting
1. INTRODUCTION
Chemotherapy-induced nausea and vomiting (CINV) are common side effects associated with chemotherapy,1 which has the potential to induce severe physiologic effects, electrolyte disturbances, dehydration, malnutrition and esophageal injury.2 These complications might cause treatment nonadherence, induce dose reduction, result in higher cost of care, and even affect prognosis of patients.3 Patients who have refractory CINV may refuse further treatment, require dose reductions, or seek alternative therapy options.4 Thus, prevention of CINV is critically important in reducing morbidity and total healthcare costs in patients underwent emetogenic chemotherapy. The prevention of CINV has improved dramatically over the past few decades, which is attributed to advances in understanding of emesis pathophysiology.5,6
International and national evidence-based antiemetic guidelines suggest a double or triple prophylaxis consisting of neurokinin-1 (NK1) receptor antagonist (RA), serotonin/5-HT3 RA and dexamethasone (DEX) prior to highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC)5,6 with the addition of olanzapine recommended in some guidelines for patients with anxiety.6 Despite these recommendations across guideline committees, multiple studies and surveys have suggested that adherence to these recommendations is still suboptimal.7,⇓-9 Besides, serious side effects of these antiemetic agents in high-risk patients such as headache, transient transaminase elevation, constipation and central nervous system effects have attracted increasing concern.10 In addition, China consists of multiple classes with stark difference in economic status. In many provincial health insurance policies, NK1 receptor RA has not been covered by reimbursement, which adding the financial burden on some patients. Thus, current status for CINV prevention still need to be improved.
Non-pharmacological techniques such as acupuncture, acustimulation, and acupressure have been investigated as alternatives or additional treatment in nausea and vomiting (NV). The efficacy of mild electrical stimulation using portable wrist bands to certain acupuncture point is reported in controlling NV by several articles.11,⇓,⇓,⇓,⇓-16 Among these acupuncture points, the most easily accessible one is located on the pericardial meridian and called Neiguan (PC6), which is also known as Nei Guan or G-JO.16 Somehow, controversy still exists whether acustimulation in acupuncture point is effective in controlling CINV.17,⇓-19 In a recent systematic review, authors confirmed electrostimulation at Neiguan (PC6) has an effect on controlling general emesis.19 Nevertheless, most articles included in this systematic review were published before 2005. From 2005 to present, antiemetic guidelines has progressed dramatically with emergence of several new drugs or agents with new intake approach like NK1 receptor RA,20 palonosetron (second-generation 5-HT3 receptor antagonist)21 and granisetron transdermal patch System (Sancuso).22 Thus, in this setting, the role of acustimulation as an adjunct to antiemetics is still needed to be discussed.
We conduct this retrospective study to investigate the potential role of acustimulation of Neiguan (PC6) acupuncture point, through Farosband, a reliable, noninvasive, user-friendly device, in CINV prevention under the setting of guideline-consistent CINV prophylaxis (GCCP).
2. MATERIALS AND METHODS
2.1 Study design
This was a retrospective, single-center, nonin-terventional study conducted at department of oncology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine between January 2021 to December 2021. Although this was a non-interventional study and did not influence the physician's routine treatment, ethical approval for the study was provided by the independent ethics committee, Sixth people's Hospital, Shanghai Jiaotong University. Informed and written consents were obtained from all patients or their advisers according to ethics committee guidelines.
2.2 Patients and antiemetic treatment
Data from patients with a variety of solid malignancy who underwent cycle 1 chemotherapy were collected and analyzed in this retrospective study. The chemotherapy protocol consisted of HEC and MEC agents according to NCCN guideline,6 with or without target therapy/immune checkpoint inhibitor. Data of patients were excluded if: (a) Experienced vomiting within 24 h before treatment, (b) Suffered from brain metastasis, intestinal obstruction, severe ascites or constipation. (c) Taking high dosage of morphine. (d) Receiving radiotherapy simultaneously.
Antiemetic drugs were administrated by clinician based on NCCN guideline.6 For the prevention of CINV associated with HEC, the prophylactic triple combination of a NK1 RA, 5-HT3 RA and DEX prior to chemotherapy was recommended. In patients treated with MEC, antiemetic prophylaxis with 5-HT3 RA plus DEX were advised.
Acustimulation of Neiguan (PC6) acupuncture point was administrated by patients’ own willing prior to chemotherapy. Generally speaking, the 2 metal electrodes of the device (FarosBand, Pharos Medical, Shanghai, China) were placed on the wrist skin of the dominant hand. The electrodes were placed precisely on the Neiguan (PC6) point. This point is located 2 to 3 cm proximal from the distal part of the wrist between the tendons of the musculus flexor carpi radialis and the musculus palmaris longus. Patients were told that they could adjust the intensity of the stimulation (five levels ranging from 10 to 35 mA) to whatever level they felt most comfortable. They were also told that emesis the wrist band could be worn on either wrist or alternated between wrists, and to wear the band continuously for five days, except when necessary to remove it to avoid immersion in water.
2.3 Outcome assessments and statistical analysis:
Data were collected from daily diaries recorded by patients from the start of chemotherapy on Day 1 through Day 5 (0-120 h) of each cycle of chemotherapy. Proportions of patients were calculated for the acute (Day 1), delayed (Days 2-5) and overall (Days 1-5) phases post-chemotherapy in Cycle 1 only to avoid psychological factor's effect such as anticipatory emesis on CINV.
Cycle 1 complete response (no emesis and no rescue medication use) rate during the overall phase was the primary assessment of CINV control and the primary objective of the study. Complete response rates were compared between patients with or without Neiguan (PC6) acustimulation using a χ 2 test for the overall population (primary objective) as well as subgroup analysis such as HEC/MEC and guideline-consistent/ inconsistent.
The Functional Living Index-Emesis (FLIE) questionnaire was included as a secondary ‘quality of life’ objective to assess the impact of CINV on patient's daily life.23 Score of nausea and vomiting was calculated and compared between patients with or without Neiguan (PC6) acustimulation using a t-test as well as subgroup analysis as mentioned above. The significance was defined at a 2-sided, P value of < 0.05. Statistical analysis was performed using the SPSS software, version 19.0 (SPSS Inc. Chicago, IL, USA).
3. RESULTS
3.1. Patients’ sample and characteristics
Data from 373 patients who were administrated intravenous chemotherapy in our institution was collected in this study. Generally speaking, of these patients, 227 were male, 146 were female, with a median age of 48. The vast majority of the malignancy type was bone and soft tissue sarcoma (46.9%) due to our institution's skillful specialization. Baseline characteristics were summarized in Table 1.
Table 1.
Patient characteristics [n (%)]
| Characteristic | Overall (n = 373) | HEC (n = 291) | MEC (n = 82) | |
|---|---|---|---|---|
| Gender | Male | 227 (60.8) | 182 (62.5) | 45 (54.8) |
| Female | 146 (39.2) | 109 (37.5) | 37 (45.2) | |
| Age (years) | Median | 48 | 43 | 59 |
| ECOG score | 0 | 242 (64.8) | 188 (64.6) | 54 (65.8) |
| 1 | 128 (34.3) | 102 (35) | 26 (31.7) | |
| 2 | 3 (0.9) | 1 (0.4) | 2 (2.5) | |
| Primary cancer (>5%) | Bone and soft tissue sarcoma | 175 (46.9) | 171 (58.7) | 4 (4.9) |
| Breast cancer | 25 (6.7) | 20 (6.9) | 5 (6.1) | |
| Lung cancer | 51 (13.7) | 51 (17.5) | ||
| Colorectal cancer | 47 (12.6) | 47 (57.3) | ||
| Gastric cancer | 19 (5.1) | 5 (1.7) | 14 (17.1) | |
| Others | 56 (15) | 44 (15.2) | 12 (14.6) | |
| Chemo-protocol | With target therapy/Immunotherapy | 81 (21.7) |
52 (17.9) | 29 (35.4) |
| Without target therapy/Immunotherapy | 292 (78.3) | 239 (82.1) | 53 (64.6) | |
| CINV prevention | Guideline consistent | 246 (65.9) | 166 (57.0) | 80 (97.5) |
| Guideline inconsistent | 127 (34.1) | 125 (43.0) | 2 (2.5) | |
| Neiguan (PC6) acustimulation | With PC6 acustimulation | 216 (57.9) | 172 (59.1) | 44 (53.6) |
| Without PC6 acustimulation | 157 (42.1) | 119 (40.9) | 38 (46.4) | |
Notes: MEC: moderate emetogenic chemotherapy; HEC: highly emetogenic chemotherapy; CINV: chemotherapy-induced nausea and vomiting; ECOG: Eastern Cooperative oncology Group. Summary of characteristics of patients was displayed as n (%).
In the overall study population, 65.9% of patients received guideline consistent CINV prevention (GCCP) treatment during the overall phase, while in the subsets of patients receiving HEC or MEC were 57% and 97.5%, respectively. In patients who receiving HEC and did not abide GCCP (n = 125), key inconsistency was absence of NK1 receptor RA (n = 122) mostly due to economic reason such as not covered by local medical insurance policy (n = 108) rather than concern about side effects (n = 14), according to surveys after discharge from hospital.
3.2. Neiguan (PC6) acustimulation’ role in CINV control
Factors between with or without Neiguan (PC 6) acus-timulation group was demonstrated in Table 2. In accordance with previous studies, patients with HEC and GCCP demonstrated better CINV control rate (70.4%, 117 out of 166) than those with HEC and GICP (56.8%, 71 out of 125). In patients with MEC, since majority of them received GCCP (97.5%), the subgroup analysis was not conducted.
Table 2.
Characteristics between with/without Neiguan (PC6) acustimulation [n (%)]
| Characteristic | Overall (n = 373) |
With acustimulation (n = 216) |
Without acustimulation (n = 157) |
|
|---|---|---|---|---|
| Gender | Male | 227 | 127 (55.9) | 100 (44.1) |
| Female | 146 | 89 (60.9) | 57 (39.1) | |
| Age (years) | Median | 48 | 44 | 58 |
| ECOG score | 0 | 242 | 130 (53.7) | 112 (46.3) |
| 1 | 128 | 86 (67.1) | 42 (32.9) | |
| 2 | 3 | 0 | 3 (100) | |
| Primary cancer (>5%) | Bone and soft tissue sarcoma | 175 | 139 (79.4) | 36 (20.6) |
| Breast cancer | 25 | 16 (64) | 9 (36) | |
| Lung cancer | 51 | 15 (29.4) | 36 (70.6) | |
| Colorectal cancer | 47 | 13 (27.6) | 34 (72.4) | |
| Gastric cancer | 19 | 7 (36.8) | 12 (63.2) | |
| Others | 56 | 26 (46.4) | 30 (53.6) | |
| Chemo-protocol | With target therapy/immunotherapy | 81 | 30 (37) | 51 (63) |
| Without target therapy/immunotherapy | 292 | 186 (63.6) | 106 (36.4) | |
Notes: summary of characteristics of patients was displayed as n (%).
Complete response rate was higher in patients with Neiguan (PC6) acustimulation (72.6%, 157 out of 216) than those without (63.6%, 100 out of 157), with no significant difference. These tendencies were also observed in patients with HEC chemo-protocol (116 out of 172, 69.1% with acustimulation versus 69 out of 119, 58% without) and with MEC chemo-protocol (38 out of 44, 86.3% with acustimulation versus 31 out of 38, 81.5% without), although the differences were not significant.
In subgroup analysis, we found that in patients with HEC chemo-protocol and guideline inconsistent CINV prevention (GICP) simultaneously, complete response rate was significantly higher with Neiguan (PC6) acustimulation (65.2%, 45 out of 69) than those without (46.4%, 26 out of 56), with a P-value < 0.05. This discrepancy had no obvious relationship with chemo-protocol since chemo-regimens composition were well balanced between subgroups (Table 3). This trend was also displayed in patients with HEC and GCCP, with a complete response rate of 71.8% in Neiguan (PC6)) acustimulation versus 68.2%, somehow, the discrepancy was not significant.
Table 3.
Chemotherapy protocols in GICP/HEC group (n)
| Chemo-regimens | With Neiguan (PC6) acustimulation (n = 69) |
Without Neiguan (PC6) acustimulation (n = 56) |
|---|---|---|
| Anthracycline | 19 | 12 |
| Cisplatin/carboplatin-based | 14 | 17 |
| Anthracycline/cisplatin Ifosfamide(≥2 g/m2) |
11 10 |
10 6 |
| VAC or AC | 13 | 10 |
| DTIC | 2 | 1 |
Notes: VAC: protocol with anthracycline, vincristine and cyclophosphamide; AC: protocol with anthracycline and cyclophosphamide; GICP: guideline-inconsistent CINV prophylaxis; HEC: highly emetogenic chemotherapy; CINV: chemotherapy-induced nausea and vomiting.
According to FLIE questionnaire, significantly differences was displayed in all patients receiving GCCP in scoring of nausea (16 ± 4) and vomiting (10 ± 3), compared to that with GICP (nausea: 21 ± 8, vomiting: 15 ± 8). This discrepancy remained obviously in patients with HEC, with a 16 ± 4 nausea score and a 11 ± 3 vomiting score compared with that of GICP (nausea: 21 ± 8, vomiting: 15 ± 9).
In patients with HEC, subgroup analysis demonstrated significantly lower scores in terms of nausea (17 ± 4) and vomiting (11 ± 3) with Neiguan (PC6) acustimulation in contrast with no acustimulation (nausea: 21 ± 8, vomiting: 19 ± 9). This variance existed significantly in HEC plus GICP, with a 17 ± 4 nausea score and a 11 ± 3 vomiting score in Neiguan (PC6) acustimulation subgroup compared with subgroup without (nausea: 26 ± 8, vomiting: 20 ± 10). With respect to subgroup HEC plus GCCP and MEC, no significant discrepancy was observed in terms of nausea/vomiting score with or without acustimulation.
4. DISCUSSION
The prevention of CINV is critically important in reducing morbidity and total healthcare costs in patients receiving emetogenic chemotherapy. Progress in antiemetic drugs have improved CINV control significantly. Our investigation reiterated that compliance the guideline would obviously improve the prevention status of CINV. Somehow, our study indicated that normative usage of GCCP is far from satisfaction, especially in patients with HEC protocol, which is consistent with prior studies.9,24,25 This discrepancy was mainly attributed to underutilization of NK1 RAs (97.6%), which was also consistent with other studies.25 Followed-up survey demonstrated that lack of reimbursement for NK1 RAs, a realistic and economic problem in China, was the main reason for patients’ refusal to accept this agent. An obvious counter-example is, administration of 5-HT3 RA (fee is covered by reimbursement) is accepted by majority of patients. The guideline also suggests other agent such as olanzapine as auxiliary in CINV control. Nevertheless, its potential side effects and lack of official approval in CINV control by SFDA limits its clinical application. Thus, supplements and improvements are still needed in CINV control, especially for cost-effective methods.
Several studies reported that Neiguan (PC6) acustimulation decreased incidence of CINV, which was confirmed in our study. With acustimulation of Neiguan (PC6) acupuncture point through a portable, noninvasive and user-friendly device, in terms of complete response rate and scores in nausea/vomiting by FLIE ques-tionnaire, patients could achieve a better outcome in HEC induced CINV, especially in those receiving GICP for subjective or objective reasons. Meanwhile, analysis also demonstrated this tendency remained in other patients with HEC/GCCP and MEC, although the difference was not significant. Given the advantage possessed by Neiguan (PC6) acustimulation such as noninvasive, covered by medical insurance and nearly no side effects, we believe it would be an ideal auxiliary tool in CINV control, especially in patients who receive HEC chemo-protocol and are reluctant to GCCP for personal reason.
Mechanism of Neiguan (PC6) acupuncture acustimulation in CINV control still remain unclear. In traditional Chinese medical theory, the meridian (or channel) system is a network of paths through which the life-energy known as “Qi” flows. Most of the acupoints are situated along the 12 major meridians and interact with their associated internal organs and other related internal structures. Stimulation of these acupoints, including Neiguan (PC6) would exert a positive effect. From molecular biology perspective, acustimulation stimulates afferent type 1 and 2 nervous tissues that send impulses to the spinal cord. This stimulus is transmitted via Aβ and C fibers, first to the spinal cord and then to the cortex. This stimulation induces endorphin release from endorphogenic cells and endorphins inhibit the chemoreceptor trigger zone. Second, mesencephalon and periaqueductal gray matter are stimulated with resultant enkephalin release. Stimulation of the hypotha-lamopituitary axis also induces release of β-endorphin and adrenocorticotropic hormone from the pituitary gland. Enkephalin, β-endorphin, and adrenocorticotropic hormone presumably exert their effects on emesis through modification of serotonin release.26,27
Owing to the retrospective nature of our analysis, there are several shortcomings in our study such as patient selection bias. For example, due to the treatment characteristic of our institution, patients suffered from bone and soft tissue sarcoma accounted for nearly half of the sample, which is inconsistent with the overall morbidity of this malignancy in China. And this patients selection also existed in PC 6 acustimulation subgroup (Table 2). Given that first-line chemo-agent in treating bone and soft tissue sarcoma were all highly emetogenic (anthracycline, high-dose methotrexate, cisplatin and ifosfamide), this selection bias further raise the proportion of HEC in our study. In addition, our investigation did not evaluate efficacy of Neiguan (PC6) acupuncture acustimulation on antitumor treatment which last more than 5 d like capecitabine, temozolomide, antibody-drug conjugate and targeted drugs. Furthermore, the molecular mechanism of Neiguan (PC6) acustimulation in CINV prevention was not investigated in this study. Despite those shortcomings mentioned, this study provides further evidence supporting Neiguan (PC6) stimulation as an alternative or supplemental modality for preventing CINV in daily clinical practice for patients in the setting of HEC and GICP, without the risk for potentially serious drug-induced side-effects.
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