Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer: A Multicenter Randomized Clinical Trial.

Importance: Patients with head and neck cancer who undergo radiotherapy can develop chronic radiation-induced xerostomia. Prior acupuncture studies were single center and rated as having high risk of bias, making it difficult to know the benefits of acupuncture for treating radiation-induced xerostomia. Objective: To compare true acupuncture (TA), sham acupuncture (SA), and standard oral hygiene (SOH) for treating radiation-induced xerostomia. Design, Setting, and Participants: A randomized, blinded, 3-arm, placebo-controlled trial was conducted between July 29, 2013, and June 9, 2021. Data analysis was performed from March 9, 2022, through May 17, 2023. Patients reporting grade 2 or 3 radiation-induced xerostomia 12 months or more postradiotherapy for head and neck cancer were recruited from community-based cancer centers across the US that were part of the Wake Forest National Cancer Institute Community Oncology Research Program Research Base. Participants had received bilateral radiotherapy with no history of xerostomia. Interventions: Participants received SOH and were randomized to TA, SA, or SOH only. Participants in the TA and SA cohorts were treated 2 times per week for 4 weeks. Those experiencing a minor response received another 4 weeks of treatment. Main Outcomes and Measures: Patient-reported outcomes for xerostomia (Xerostomia Questionnaire, primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General) were collected at baseline, 4 (primary time point), 8, 12, and 26 weeks. All analyses were intention to treat. Results: A total of 258 patients (201 men [77.9%]; mean [SD] age, 65.0 [9.16] years), participated from 33 sites across 13 states. Overall, 86 patients were assigned to each study arm. Mean (SD) years from diagnosis was 4.21 (3.74) years, 67.1% (n = 173) had stage IV disease. At week 4, Xerostomia Questionnaire scores revealed significant between-group differences, with lower Xerostomia Questionnaire scores with TA vs SOH (TA: 50.6; SOH: 57.3; difference, -6.67; 95% CI, -11.08 to -2.27; P = .003), and differences between TA and SA (TA: 50.6; SA: 55.0; difference, -4.41; 95% CI, -8.62 to -0.19; P = .04) yet did not reach statistical significance after adjustment for multiple comparisons. There was no significant difference between SA and SOH. Group differences in Functional Assessment of Cancer Therapy-General scores revealed statistically significant group differences at week 4, with higher scores with TA vs SOH (TA: 101.6; SOH: 97.7; difference, 3.91; 95% CI, 1.43-6.38; P = .002) and at week 12, with higher scores with TA vs SA (TA: 102.1; SA: 98.4; difference, 3.64; 95% CI, 1.10-6.18; P = .005) and TA vs SOH (TA: 102.1; SOH: 97.4; difference, 4.61; 95% CI, 1.99-7.23; P = .001). Conclusions and Relevance: The findings of this trial suggest that TA was more effective in treating chronic radiation-induced xerostomia 1 or more years after the end of radiotherapy than SA or SOH. Trial Registration: ClinicalTrials.gov Identifier: NCT02589938.

Randomized, placebo-controlled trial of K1 acupoint acustimulation to prevent cisplatin-induced or oxaliplatin-induced nausea.

BACKGROUND: Greater than 70% of patients with cancer experience chemotherapy-induced nausea and vomiting. In the current study, the authors examined the effects of electrostimulation of the K1 acupoint located on the sole of the foot because it is believed to have the potential to control chemotherapy-induced nausea and vomiting. METHODS: In this trial, 103 patients diagnosed with primary or metastatic liver cancer were recruited before transcatheter arterial infusion (TAI) of cisplatin or oxaliplatin and randomized to either group A (51 patients who were treated with the antiemetic tropisetron and acustimulation at the K1 acupoint for 20 minutes approximately 1 to 2 hours before TAI on the first day and then daily for the subsequent 5 days) or group B (52 patients who were treated with tropisetron and electrostimulation at a placebo point on the heel). The rate, intensity, and duration of nausea and vomiting were collected at baseline and then daily for 5 days after TAI. Quality of life was assessed daily using the MD Anderson Symptom Inventory and the EuroQoL scale. RESULTS: No differences were found between groups A and B with regard to the incidence and degree of nausea or vomiting on day 1 or the following 5 days. Patients in group A had better EuroQoL scores compared with patients in group B (72.83 in group A vs 65.94 in group B; P =.04) on day 4 but not on the other days. No group differences were noted at any time point for MD Anderson Symptom Inventory scores. CONCLUSIONS: Electrostimulation of K1 combined with antiemetics did not result in initial prevention of cisplatin-induced or oxaliplatin-induced nausea or vomiting.

Generalized depletion of free nerve endings and decrease of cutaneous nervous innervation in streptozotocin-induced painful and painless diabetic rats.

BACKGROUND: The loss of peripheral nerve fiber is evident in chronic painful diabetic neuropathy. However, the correlation between peripheral fiber loss and the genesis of pain is unclear. Using the streptozotocin-induced diabetic rat model and focusing on free nerve endings, we attempted to investigate the peripheral changes that elicit pain syndromes in diabetes. METHODS: Diabetes was induced in rats using 75 mg/kg streptozotocin, while controls received saline solution. "Painful" rats with thermal or mechanical hypersensitivity and "painless" rats (without significant threshold changes) were enrolled. The peripheral nerve endings were immunostained using protein gene product 9.5 in footpad skin sections. The peripheral nerve densities in each behavior group were calculated and averaged. RESULTS: A progressive loss of protein gene product 9.5-blotted nerve fibers was noted after diabetes was induced and as the duration of hyperglycemia proceeded. Painful and painless diabetic rats have similar histological nerve fiber loss including depleted epidermal free nerve endings. CONCLUSION: The results indicated that there are undiscovered pathological changes that are sensitizing the injured nerve fiber in periphery.

Electro-acupuncture to prevent prolonged postoperative ileus: a randomized clinical trial.

AIM: To examine whether acupuncture can prevent prolonged postoperative ileus (PPOI) after intraperitoneal surgery for colon cancer. METHODS: Ninety patients were recruited from the Fudan University Cancer Hospital, Shanghai, China. After surgery, patients were randomized to receive acupuncture (once daily, starting on postoperative day 1, for up to six consecutive days) or usual care. PPOI was defined as an inability to pass flatus or have a bowel movement by 96 h after surgery. The main outcomes were time to first flatus, time to first bowel movement, and electrogastroenterography. Secondary outcomes were quality of life (QOL) measures, including pain, nausea, insomnia, abdominal distension/fullness, and sense of well-being. RESULTS: No significant differences in PPOI on day 4 (P = 0.71) or QOL measures were found between the groups. There were also no group differences when the data were analyzed by examining those whose PPOI had resolved by day 5 (P = 0.69) or day 6 (P = 0.88). No adverse events related to acupuncture were reported. CONCLUSION: Acupuncture did not prevent PPOI and was not useful for treating PPOI once it had developed in this population.

Acupuncture for radiation-induced xerostomia in patients with cancer: a pilot study.

BACKGROUND: This pilot study evaluated if acupuncture can alleviate radiation-induced xerostomia among patients with cancer. Secondary objectives were to assess the effects of acupuncture on salivary flow and quality of life (QOL). METHODS: Nineteen patients received acupuncture twice a week for 4 weeks. RESULTS: Xerostomia inventory (XI) and patient benefit questionnaire (PBQ) scores were significantly better after acupuncture on weeks 4 and 8 than at baseline (XI: p = .0004 and .0001; PBQ: p = .0004 and .0011, respectively). For QOL at weeks 4 and 8, there was a significant difference for questions related to head/neck cancer (p = .04 and .006, respectively). At week 8, there was a significant difference in physical well-being (p = .04). At weeks 5 and 8, there were significant differences in the total score (p = .04 and .03, respectively). CONCLUSIONS: Acupuncture was effective for radiation-induced xerostomia in this small pilot study. Further research is needed.

Effects of changes in alveolar ventilation on isoflurane arterial blood concentration and its uptake into the human body.

We investigated whether minute alveolar ventilation affects isoflurane concentration in arterial blood and uptake of isoflurane into the body. Thirty female patients scheduled to undergo elective gynecological surgery were randomly assigned to one of three groups: i.e. hyperventilation, normal ventilation and hypoventilation. Inspiratory (CIiso) and end-tidal (CEiso) concentrations of isoflurane were measured by infrared analysis, and arterial blood isoflurane concentration (Aiso) was analyzed by gas chromatography. Cardiac index was measured by Doppler ultrasonography. The body uptake of isoflurane was determined by multiplying alveolar ventilation by the gradient of CIiso-CEiso. Aiso was highest in the hyperventilation group (significant), followed by the normal ventilation and hypoventilation groups, during the 40-min study. During the first 10 min of the study, the slope of the Aiso-over-time curve was highest in the hyperventilation group, followed by the normal ventilation group and the hypoventilation group. During the second half of the study (20-40 min), the slope Aiso-over-time curve did not differ among the three groups. Changes in ventilation affected the concentration of isoflurane in arterial blood but did not significantly alter the uptake of it during the last 20 min of the study. The change of alveolar ventilation altered the speed of functional residual capacity wash-in by isoflurane, which was the integral factor influencing Aiso and body uptake of isoflurane.