A randomised study comparing the effectiveness of acupuncture or morphine versus the combination for the relief of dyspnoea in patients with advanced non-small cell lung cancer and mesothelioma.

BACKGROUND: Dyspnoea is one of the commonest symptoms of lung cancer. Opioids can reduce dyspnoea. This study investigates acupuncture for relief of breathlessness in lung cancer. METHODS: We performed a single-centre, randomised phase II study of 173 patients with non-small cell lung cancer or mesothelioma with dyspnoea score of ≥4 on visual analogue scale (VAS). Randomisation was to acupuncture alone (A), morphine alone (M) or both (AM). Acupuncture was administered at upper sternal, thoracic paravertebral, trapezius trigger points and LI4. Manubrial semi-permanent acupuncture studs were inserted and massaged when symptomatic. Arm A patients received rescue morphine. Primary end-point was proportion of patients achieving ≥1.5 improvement in VAS dyspnoea at 4 h. Measurements continued to day 14 and included VAS relaxation, line analogue rating (Lar) anxiety, hospital anxiety and depression and European Organisation for Research and Treatment of Cancer quality-of-life scores. RESULTS: Dyspnoea VAS improved ≥1.5 in 74%, 60% and 66% of arms A, M and AM, respectively, and was maintained in 45% at 2 weeks. There was no statistically significant difference between arms. VAS relaxation improved in arms A (1.06 points) and AM (1.48 points) compared to arm M (-0.19 points, p<0.001). At 7 d, the Lar anxiety score improved in arm A (1.5 points), arm AM (1.2 points) and arm M (no change, p=0.003). Fewer patients received at least one morphine dose in arm A compared with arm M or AM (21% versus 87% versus 87%, respectively, p<0.001). CONCLUSIONS: A, M and AM were effective in relieving dyspnoea. Acupuncture relieved anxiety and was morphine sparing, providing an alternative to morphine.

A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture.

BACKGROUND: Maintenance acupuncture is advocated by clinicians after successful clinic-based acupuncture. We aimed to assess the effectiveness of maintenance acupuncture in the management of cancer-related fatigue (CRF); treatment delivered by therapists or self-acupuncture/self-needling was compared with no maintenance treatment. METHODS: Breast cancer patients who participated in a randomized trial of acupuncture for CRF management (reported elsewhere) were re-randomized to receive an additional four acupuncturist-delivered weekly sessions; four self-administered weekly acupuncture sessions (self-needling); or no acupuncture. Primary outcome was general fatigue (Multidimensional Fatigue Inventory). Mood, quality of life and safety were also assessed. RESULTS: In total, 197 patients were re-randomized, with 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. Primary outcome scores were equivalent between the therapist-delivered acupuncture and self-acupuncture (P > 0.05). A non-significant trend in improving fatigue was observed at the end of 4 weeks in the combined acupuncture arms (P = 0.07). There was no impact on mood or quality of life of the further acupuncture sessions at 18 weeks beyond the improvement observed in initial trial. CONCLUSION: Self-acupuncture is an acceptable, feasible and safe maintenance treatment for patients with CRF. However, overall, maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture. TRIAL REGISTRATION NUMBER: NCT00957112.

A prospective randomised study to evaluate the effectiveness of standard 23 gauge fine needle, compared with a thinner 27 gauge needle for breast cytology.

The aim of this study was to determine whether a 27 gauge needle could be used to obtain adequate cytology with less discomfort to the patient. Two types of needles were compared-23 gauge (blue) needle versus 27 gauge very fine needle. The cytology specimen was assessed for quality in terms of adequacy for diagnosis. Ninety samples were randomised into this study. The quality of samples was similar in both groups; there was no statistical difference in the quality of samples obtained. The 27 gauge needle produced two inadequate samples (4.4%), whereas there were no inadequate samples with the 23 gauge needle. There was no statistical difference in the amount of blood on the slide between the two groups. The pain scores were significantly better with the finer needle (P=0.004). This study provides evidence that the 27 gauge FNAC is suitable for obtaining cytology in palpable breast lumps.

Evidence-based complementary medicine for palliative cancer care: does it make sense?

Complementary medicine is fast becoming an integral part of palliative cancer care. There is considerable debate as to whether such treatments require proof of effectiveness through randomized clinical trials or whether it may suffice that patients adopt them with apparent appreciation. We attempt to raise some of the arguments on both sides. The arguments include the logistical problems of conducting research in palliative care, ethical problems of placebo controls, methodological difficulties of standardizing treatments or quantifying subtle effects and the, often considerable, costs of clinical trials. We feel that neither those who argue against nor those who argue in favour of rigorous clinical trials are entirely wrong or entirely right. However, our final verdict is that an absence of rigorous science will critically hinder progress. This, in turn, would be to the detriment of future patients. Through discussing the strengths and weaknesses of both sets of arguments, both sides might learn valuable lessons.

Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding.

Evidence of effectiveness is increasingly used to determine which health technologies are incorporated into public health provision. Acupuncture is a popular therapy that has been shown to be superior to placebo in the treatment of nausea and dental pain, and promising for migraine and osteoarthritis of the knee. For many other conditions, such as chronic pain, in which acupuncture is often used, the evidence is either insufficient or negative. Misleading results may occur for a number of reasons. False negative results may arise from inadequate treatment schedules and inappropriate control interventions. This consensus document considers these issues with the aim of improving the design of efficacy trials of acupuncture in order that they are more likely to be conclusive and more meaningfully interpreted. Clinical trials of acupuncture must use an optimal form of treatment; this can be defined by examining standard texts, by surveying and consulting experts. There are a great many variables in treatment (such as point selection, form of stimulation) all of which need to be addressed in designing and reporting clinical trials. The control procedure is determined by the precise research question that is being addressed. For efficacy studies, in which the question is whether acupuncture has specific effects (i.e. is superior to placebo), sham forms of acupuncture appear the most appropriate method of controlling for needle penetration. A recent development of blunted, telescopic needles may represent a major advance. Such procedures may produce a therapeutic response so should preferably be recorded as 'sham' procedures rather than true 'placebo' controls. Blinding in clinical trials is an accepted means of reducing bias. Patient blinding in acupuncture studies can be achieved by sham procedures and its success should be measured. While practitioner blinding is difficult, though not impossible, blinding of the observer and the analyst should be considered as the ideal for all studies. A number of recommendations are made which aim to improve the quality of sham-controlled acupuncture studies.

Safety aspects of acupuncture in palliative care.

Acupuncture can mask symptoms of cancer and tumour progression. It is not safe to use such a therapy without full knowledge of the clinical stage of the disease, and the current status of orthodox therapy. Contraindications to acupuncture needling include an unstable spine, severe clotting disorder, neutropenia and lymphoedema. Whilst semi-permanent needles are used increasingly in symptom control and pain management they should not be used in patients with valvular heart disease or in vulnerable neutropenic patients. Acupuncture has an increasing role in support for pain and symptom management, but patients should not be advised to abandon conventional treatments in favour of complementary or alternative therapies alone, and should not have their hopes raised inappropriately, or have any guilt projected on to them for the cause of their cancer.

Are acupuncture points tender? A blinded study of Spleen 6.

OBJECTIVES: To explore the methodology for investigating the tenderness of acupuncture points, with particular reference to the hypothesis that the point Spleen 6 (SP6) is more tender in women than in men. DESIGN: Single-blind, observational study with volunteers. SETTING: University of Exeter, U.K. SUBJECTS: Student volunteers, 13 male and 13 female. OUTCOME MEASURES: Pressure thresholds at SP6, a control acupuncture point Stomach 36, and two nonacupuncture control sites in each leg were measured weekly for 4 weeks. RESULTS: No statistically significant differences were found between the pressure thresholds of SP6 in women and those in men. CONCLUSION: The present study provides no strong evidence to support the hypothesis that the acupuncture point SP6 is more tender in women and in men. Recommendations for further investigations are discussed.

Right phrenic nerve palsy as a complication of indwelling central venous catheters.

Five cases are reported of patients who developed a raised right hemidiaphragm while an indwelling central venous catheter was in situ. The patients were being treated with protracted venous infusions of chemotherapy for colorectal carcinoma. All five patients had a chest radiograph following insertion of the Hickman line which showed normal diaphragmatic positions. A mean of 93 days later (range 55-134 days) elevation of the right hemidiaphragm was noted in these patients on repeat chest radiographs. Two of the patients had a right phrenic nerve palsy demonstrated by magnetic stimulation of the nerve. The remaining three patients had paradoxical motion of the right hemidiaphragm on sonography, but were unable to undergo studies of phrenic nerve function before death from metastatic disease. It is suggested that right phrenic nerve palsy is a late complication of an indwelling central venous catheter.

A prospective analysis of 949 long-term central venous access catheters for ambulatory chemotherapy in patients with gastrointestinal malignancy.

We present a prospective analysis of the insertion complications and longevity of 949 cuffed, tunnelled central venous catheters used for ambulatory chemotherapy. Mean catheter life span was 121.8 days, 13.4% had complications at insertion, 17.7% had complications not necessitating removal and 18.6% had complications requiring removal. The more experienced operators had fewer complications inserting catheters (P < 0.0001). Late-onset shoulder pain occurred in 4.8% and was associated with an increased incidence of venous thrombosis (P < 0.0001) and infection (P = 0.06). Complications necessitating removal were not predicted by patient' age, site of insertion or malignancy, chemotherapy regimen, insertion platelet and fibrinogen counts, insertion complications, leucocyte count or cuff distance from the exist site. Catheters inserted with their tip in the superior vena cava were more at risk of removal (2.57 times) than those in the right atrium (P = 0.003).

A review of 560 Hickman catheter insertions.

Indwelling, cuffed, tunnelled, central venous (Hickman) catheters are increasingly being used for venous access and the administration of chemotherapy for oncological patients. This paper reviews the technical problems associated with the percutaneous insertion of these catheters and the complications arising from their use. Five hundred and sixty catheters were inserted; 31.3% had complications at insertion, most commonly precipitation of an arrhythmia (13.9%). Arterial puncture occurred in 3.8% and pneumothorax in 1.6%. Catheters remained in place for a median period of 91 days. Forty percent of catheters were removed electively on completion of treatment; 30.2% required removal because of complications, which included sepsis, migration, thrombosis and blockage. Twenty percent of patients died with their catheter in place, 8.5% were still in situ and 1.6% were removed because of patient non compliance. Sepsis remains the commonest, long term complication, with staphylococcus epidermidis being the organism isolated most frequently. There were no catheter-related deaths.

Acupuncture for the relief of cancer-related breathlessness.

The palliation of cancer-related breathlessness is challenging and complex. An open pilot study was conducted, exploring the safety and efficacy of acupuncture in 20 patients who were breathless at rest and whose breathlessness was directly related to primary or secondary malignancy. Sternal and LI4 acupuncture points were used. Outcome measures included pulse, respiratory rate, oxygen saturation and patient-rated visual analogue scales of breathlessness, pain, anxiety and relaxation. At each time point the mean values of the variables were calculated and compared to their pretreatment levels (Student's t-test). Seventy per cent (14/20) of patients reported marked symptomatic benefit from treatment; there were significant changes in VAS scores of breathlessness, relaxation and anxiety at least up to 6 hours post acupuncture which were measured to be maximal at 90 minutes (p < 0.005, p < 0.001, respectively). There was a significant reduction in respiratory rate, which was sustained for 90 minutes post acupuncture (p < 0.02). The therapeutic value of acupuncture in the management of breathlessness requires further evaluation.