Einar Kristian Borud

The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial

Objective: This study compared the effectiveness of individualized acupuncture plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women. Methods: This study involved a multicenter, pragmatic, randomized, controlled trial with two parallel arms. Participants were postmenopausal women experiencing, on average, seven or more hot flashes per 24 hours during seven consecutive days. The acupuncture group received 10 acupuncture treatment sessions and advice on self-care, and the control group received advice on self-care only. The frequency and severity (0-10 scale) of hot flashes were registered in a diary. Urine excretion of calcitonin gene-related peptide was assessed at baseline and after 12 weeks. The primary endpoint was change in mean hot flash frequency from baseline to 12 weeks. The secondary endpoint was change in health-related quality of life measured by the Womens Health Questionnaire. Results: Hot flash frequency decreased by 5.8 per 24 hours in the acupuncture group (n = 134) and 3.7 per 24 hours in the control group (n = 133), a difference of 2.1 (P < 0.001). Hot flash intensity decreased by 3.2 units in the acupuncture group and 1.8 units in the control group, a difference of 1.4 (P < 0.001). The acupuncture group experienced statistically significant improvements in the vasomotor, sleep, and somatic symptoms dimensions of the Womens Health Questionnaire compared with the control group. Urine calcitonin gene-related peptide excretion remained unchanged from baseline to week 12. Conclusions: Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women.

The Acupuncture on Hot Flashes Among Menopausal Women study: observational follow-up results at 6 and 12 months

Objective: The previously published Acupuncture on Hot Flashes Among Menopausal Women study compared the effectiveness of individualized acupuncture treatment plus self-care versus self-care alone on hot flashes and health-related quality of life in postmenopausal women. This article reports on the observational follow-up results at 6 and 12 months. Methods: The Acupuncture on Hot Flashes Among Menopausal Women study was a pragmatic, multicenter randomized controlled trial with two parallel arms, conducted in 2006 to 2007. The 267 participants were postmenopausal women experiencing, on average, 12.6 hot flashes per 24 h. The acupuncture group received 10 individualized acupuncture treatments during 12 weeks and advice on self-care, whereas the control group received only advice on self-care. Hot flash frequency and intensity (0-10 scale) and hours of sleep per night were registered in a diary. Health-related quality of life was assessed by the Womens Health Questionnaire. Results: From baseline to 6 months, the mean reduction in hot flash frequency per 24 hours was 5.3 in the acupuncture group and 5.0 in the control group, a nonsignificant difference of 0.3. At 12 months, the mean reduction in hot flash frequency was 6.0 in the acupuncture group and 5.8 in the control group, a nonsignificant difference of 0.2. Differences in quality-of-life scores were not statistically significant at 6 and 12 months. Conclusion: The statistically significant differences between the study groups found at 12 weeks were no longer present at 6 and 12 months. Acupuncture can contribute to a more rapid reduction in vasomotor symptoms and increase in health-related quality of life in postmenopausal women but probably has no long-term effects.

Perioperative acupuncture and postoperative acupressure can prevent postoperative vomiting following paediatric tonsillectomy or adenoidectomy: a pragmatic randomised controlled trial

Objective To investigate the effectiveness of acupuncture and acupressure as supplements to standard treatment for postoperative vomiting in children undergoing tonsillectomy and/or adenoidectomy. Methods A pragmatic, open, block-randomised controlled trial. The results were analysed according to the intention-to-treat principle. The study was conducted without extra resources in a normal setting at the day-surgery department of Lovisenberg Diakonale Hospital in Oslo. 154 children with an American Society of Anesthesiologists grade 1–2, weighing at least 10 kg, were included. Children with concomitant gastrointestinal diseases, emesis or antiemetic treatment <24 h preoperatively, rash or local infection over the actual acupuncture points were excluded together with patients whose parents’ informed consent could not be obtained. The intervention group received acupuncture at pericardium 6 bilaterally, at a depth of approximately 0.7 cm with a median of 21 min during anaesthesia, followed by acupressure wristbands for 24 h and standard treatment. The control group received standard treatment. The primary end point was the occurrence of vomiting or retching during 24 h postoperatively. Results Children in the acustimulation group experienced less retching and vomiting than the control group—46.8% versus 66.2% (p=0.015). The effect of acustimulation was specifically pronounced in girls and children aged 1–3 years. Conclusion This trial indicates the effectiveness of acustimulation as an adjunct to standard treatment. The results should encourage and promote the implementation of acustimulation for postoperative vomiting in children undergoing adenoidectomy or tonsillectomy.

The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH) study: A study protocol of an ongoing multi-centre randomised controlled clinical trial

BackgroundAfter menopause, 10–20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints.Methods/DesignThe study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate.The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments.DiscussionThe study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Womens Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.

The acupuncture treatment for postmenopausal hot flushes (Acuflash) study: traditional Chinese medicine diagnoses and acupuncture points used, and their relation to the treatment response

Introduction The multicentre, pragmatic, randomised controlled Acuflash study evaluated the effect of traditional Chinese medicine (TCM) acupuncture on postmenopausal vasomotor symptoms and health-related quality of life. It concluded that use of acupuncture in addition to self-care can contribute to a clinically relevant reduction of hot flushes and increased health-related quality of life. This article reports on the TCM syndrome diagnoses and acupuncture points used and their relation to the treatment response, and on treatment reactions and adverse events. Methods The acupuncture group (n = 134) received 10 acupuncture treatment sessions and advice on self-care; the control group (n = 133) received advice on self-care only. The study acupuncturists met the current membership criteria of the Norwegian Acupuncture Society, and had at least 3 years’ experience of practising TCM acupuncture. They were free to diagnose and select acupuncture points for each participant, after initial discussion. Results Fifty per cent of the participants in the acupuncture group were diagnosed with Kidney Yin Xu as their primary TCM syndrome diagnosis. No statistically significant differences were demonstrated between the syndrome groups regarding the distribution of responders and non-responders, nor regarding the change in health-related quality of life scores. A core of common acupuncture points (SP6, HT6, KI7, KI6, CV4, LU7, LI4, and LR3) were used in all the syndromes, and in addition multiple idiosyncratic points. Core point selection and frequency of use did not differ between responders and non-responders. No serious adverse events were reported. Conclusion Factors other than the TCM syndrome diagnoses and the point selection may be of importance regarding the outcome of the treatment.

Menopausal problems and acupuncture

Hot flushes are common and distressing in postmenopausal women. Treatment with oestrogens carries significant health risks. The current hypothesis for their mechanism involves a narrowing of the thermoneutral zone, which may be counteracted by interventions that increase oestrogen, endorphin or serotonin levels, or decrease noradrenalin levels. Acupuncture has several mechanisms with the potential to reduce hot flush frequency and severity. This article reviews the current clinical trial literature. Sixteen studies are included in the review. Three studies comparing acupuncture with no specific therapy show that acupuncture treatment leads to a reduction of around 50% in hot flush frequency. There were seven comparisons between acupuncture and other therapy: three showed acupuncture to have a significantly smaller effect on frequency than oestrogen therapy, two found a similar effect to relaxation, one found a significantly greater effect than the food supplement oryzanol, and one was unclear. Out of seven studies that compared acupuncture with some other form of needle penetration, whether superficial or deep and whether on or off acupuncture points, five showed no effect, one showed an effect on frequency, and another on severity but not frequency. These studies provide little support for a point specific effect of acupuncture in this condition. Two studies compared acupuncture with non-penetrating, blunt needles: one was significantly positive for flush severity but not frequency, and the other showed no effect. In conclusion, the results from all studies are in agreement with the hypothesis that acupuncture needling relieves hot flushes. There are few data however supporting the hypothesis that the effect of acupuncture is point specific. Future research should investigate whether there is a biological effect of needling on hot flushes or not, whether tailored treatment is superior to standardised treatment, and ways of delivering treatment that causes least discomfort and least cost.

Selecting acupuncture treatment for hot flashes: a Delphi consensus compared with a clinical trial.

OBJECTIVES A treatment protocol was required for a trial of traditional Chinese acupuncture for menopausal hot flashes (ACUFLASH). A study that aimed to generate a consensus of the opinions of expert practitioners was set up, though the trial commenced before the process had been completed. This article reports on the consensus process, and compares the syndromes and treatments generated by expert consensus with those actually used in the clinical trial. DESIGN A panel of 10 experts was included in an e-mail Delphi process. The experts were asked to suggest the syndromes they would expect to be diagnosed most frequently in women with menopausal hot flashes. They were asked to list the symptoms they would use to diagnose the individual syndromes, and the points they would use to treat them. RESULTS After six rounds of the Delphi process, consensus was achieved on eight syndromes, and on about five indicative symptoms for each syndrome, and five to eight acupuncture points for treatment. The clinicians in the ACUFLASH trial used five syndromes, four of which matched the consensus. The points used by the two groups overlapped by 28%. CONCLUSIONS Eight (8) of 10 international acupuncture experts were able to reach consensus on the syndromes, symptoms, and treatment of postmenopausal women with hot flashes. The syndromes were similar to those used by practitioners in the ACUFLASH clinical trial, but there were considerable differences between the acupuncture points. This difference is likely to be the result of differences in approach of training schools, and whether it is relevant for clinical outcomes is not well understood.

Acupuncture versus usual care for postoperative nausea and vomiting in children after tonsillectomy/adenoidectomy: a pragmatic, multicenter, double-blinded, randomized trial

Objectives To investigate the effect of a standardised acupuncture on nausea and vomiting in children after tonsillectomy with or without adenoidectomy when possible placebo effects were precluded. Methods A pragmatic, multicentre, double-blinded, randomised controlled trial. The study was conducted over 10 months in 2012–2013 at three ambulatory clinics. Two hundred and eighty-two children, age 1–11 years, American Society of Anesthesiologists grade ≤II, were included. To equalise expectancy effects, all parents were told that their child would receive acupuncture. However, children were randomly allocated to perioperative bilateral needling acupuncture at PC6, depth 7 mm, mean time 17 min (SD 5–45) during anaesthesia plus usual care, or to usual care only. The regional ethics committee approved this approach. Primary endpoints were nausea and vomiting 24 h postoperatively. Results This study did not demonstrate any effect of acupuncture (95% CI) compared with standard care. The overall vomiting in the acupuncture and usual-care groups was 44.2% and 47.9%, respectively. Nausea was experienced by 31.7% in the acupuncture group and by 32.6% in the usual-care group. The test power was acceptable for comparisons of vomiting. Conclusions The findings suggest that when controlling for possible placebo effects standardised PC6 acupuncture needling during anaesthesia without further stimulation of PC6 is not effective in reducing nausea and vomiting in children after tonsillectomy with or without adenoidectomy. Future studies should investigate acupuncture treatment which balances adequate dose and technique and a feasible, child-friendly acupuncture treatment. Trial Registration Number ClinicalTrials.gov NCT01729052.

Cancer risk and all-cause mortality among Norwegian military United Nations peacekeepers deployed to Kosovo between 1999 and 2011

OBJECTIVE Media reports of leukaemia and other cancers among European United Nations (UN) peacekeepers who served in the Balkans, and a scientific finding of excess Hodgkin lymphoma among Italian UN peacekeepers who served in Bosnia, suggested a link between cancer incidence and depleted uranium (DU) exposure. This spurred several studies on cancer risk among UN peacekeepers who served in the Balkans. Although these studies turned out to be negative, the debate about possible cancers and other health risks caused by DU exposure continues. The aim of the present study was to investigate cancer incidence and all-cause mortality in a cohort of 6076 (4.4% women) Norwegian military UN peacekeepers deployed to Kosovo between 1999 and 2011. METHODS The cohort was followed for cancer incidence and mortality from 1999 to 2011. Standardised incidence ratios for cancer (SIR) and mortality ratios (SMR) were calculated from national rates. RESULTS Sixty-nine cancer cases and 38 deaths were observed during follow-up. Cancer incidence in the cohort was similar to that in the general Norwegian population. No cancers in the overall cohort significantly exceeded incidence rates in the general Norwegian population, but there was an elevated SIR for melanoma of skin in men of 1.90 (95% confidence interval [CI] 0.95-3.40). A fivefold increased incidence of bladder cancer was observed among men who served in Kosovo for ≥ 1 year, based on 2 excess cases (SIR=5.27; 95% CI 1.09-15.4). All-cause mortality was half the expected rate (SMR=0.49; 95% CI 0.35-0.67). CONCLUSION Our study did not support the suggestion that UN peacekeeping service in Kosovo is associated with increased cancer risk.

The Women's Health Questionnaire (WHQ): A psychometric evaluation of the 36‐item Norwegian version

The Womens Health Questionnaire (WHQ) was designed specifically to study possible changes that occur during menopause. The purpose of this study was to perform a psychometric evaluation of the Norwegian version of the WHQ by examining the factor structure and construct validity of the instrument. Data used for the evaluation were collected at baseline of the ACUFLASH study, a randomized, controlled clinical trial that evaluated the effect of acupuncture treatment on menopausal symptoms. Altogether, 267 women with a very high frequency of hot flushes were included in the study. Some deficiencies in the WHQ questionnaire were observed when applied to this sample, including an unclear factor structure, low alpha values for some dimensions, and a strong floor effect in the vasomotor symptoms dimension. The total scale score appears reliable, but care should be taken when interpreting some of the subscales.