The Nonpenetrating Telescopic Sham Needle May Blind Patients with Different Characteristics and Experiences When Treated by Several Therapists

Background. Little is known which factors influence the blinding in acupuncture studies. Aim. To investigate if blinding varied between patients with different characteristics receiving verum or sham acupuncture. Methods. We randomised cancer patients to verum (n = 109) or sham acupuncture (n = 106) with a nonpenetrating telescopic sham needle for nausea. Level of blinding was compared between different sub-groups of patients using Bang's blinding index (BI) ranged −1 to 1 (−1 = all state the opposite treatment, 1 = all identify treatment). Results. Most patients in the verum (74 of 95; 78%, BI 0.72) and the sham (68 of 95; 72%, BI −0.60). acupuncture group believed they had received verum acupuncture. The probability for a patient to believe he/she received verum acupuncture was related to the received needling type (P = .003) and to the patient's belief in received treatment effects (P = .008). Hospital (P = .425), therapist (P = .434), previous acupuncture experience (P = .578), occurrence of nausea (P = .157), gender (P = .760), and age (P = .357) did not affect blinding. Conclusions. Blinding was successfully achieved irrespective of age, gender, acupuncture experience, treatment effect, or in which hospital or by which therapist the patient received treatment. Patients with higher belief in the effect of the treatment were more likely to believe they had received verum acupuncture

Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care

Background: It is not known whether or not delivering acupuncture triggers mechanisms cited as placebo and if acupuncture or sham reduces radiotherapy-induced emesis more than standard care. Methodology/Principal Findings: Cancer patients receiving radiotherapy over abdominal/pelvic regions were randomized to verum (penetrating) acupuncture (n = 109; 99 provided data) in the alleged antiemetic acupuncture point PC6 or sham acupuncture (n = 106; 101 provided data) performed with a telescopic non-penetrating needle at a sham point 2-3 times/week during the whole radiotherapy period. The acupuncture cohort was compared to a reference cohort receiving standard care (n = 62; 62 provided data). The occurrence of emesis in each group was compared after a mean dose of 27 Gray. Nausea and vomiting were experienced during the preceding week by 37 and 8% in the verum acupuncture group, 38 and 7% in the sham acupuncture group and 63 and 15% in the standard care group, respectively. The lower occurrence of nausea in the acupuncture cohort (verum and sham) compared to patients receiving standard care (37% versus 63%, relative risk (RR) 0.6, 95 % confidence interval (CI) 0.5-0.8) was also true after adjustment for potential confounding factors for nausea (RR 0.8, CI 0.6 to 0.9). Nausea intensity was lower in the acupuncture cohort (78% no nausea, 13% a little, 8% moderate, 1% much) compared to the standard care cohort (52% no nausea, 32% a little, 15% moderate, 2% much) (p = 0.002). The acupuncture cohort expected antiemetic effects from their treatment (95%). Patients who expected nausea had increased risk for nausea compared to patients who expected low risk for nausea (RR 1.6; Cl 1.2-2.4). Conclusions/Significance: Patients treated with verum or sham acupuncture experienced less nausea and vomiting compared to patients receiving standard care, possibly through a general care effect or due to the high level of patient expectancy.Original Publication:Anna Enblom, Mats Lekander, Mats Hammar, Anna Johnsson, Erik Onelov, Martin Ingvar, Gunnar Steineck and Sussanne Börjeson, Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care, 2011, PLOS ONE, (6), 3, .http://dx.doi.org/10.1371/journal.pone.0014766Licensee: Public Library of Science (PLoS)http://www.plos.org

Nausea and vomiting in patients receiving acupuncture, sham acupuncture or standard care during radiotherapy

Background and aim: Many patients with cancer experience emesis (nausea and vomiting) during radiotherapy. The overall aim of this thesis was to improve the situation for patients with risk for emesis during radiotherapy, by evaluating emesis in patients receiving verum (genuine) acupuncture, sham (simulated) acupuncture or standard care during radiotherapy. Methods: In study I, a cross-sectional sample (n=368) treated with radiotherapy over various fields answered a study-specific questionnaire. In study II, 80 healthy volunteers were randomized to receive needling with verum acupuncture or non-penetrating telescopic sham needles by one of four physiotherapists. In study III, 215 patients were randomly allocated to verum (n=109) or non-penetrating telescopic sham (n=106) acupuncture during their entire radiotherapy period over abdominal or pelvic fields. The same 215 patients were also included in study IV. They were compared to 62 patients irradiated over abdominal or pelvic fields, selected from study I. Results: In study I, the weekly prevalence of nausea was 39 % in all radiotherapy-treated patients and 63 % in abdominal or pelvic irradiated patients. Age younger than 40 years and previous experience of nausea in other situations were characteristics associated with an increased risk for nausea. Of the 145 nauseous patients, 34 % considered their antiemetic treatment as insufficient. Patients with nausea reported lower level of quality of life compared to patients free from nausea. In study II, most individuals needled with verum (68 %) or sham (68 %) acupuncture could not identify needling type, and that blinding result varied from 55 to 80 % between the four therapists. In study III, nausea was experienced by 70 % (mean number of days=10.1) and 25 % vomited during the radiotherapy period. In the sham group 62 % experienced nausea (mean number of days=8.7) and 28 % vomited. Ninety five percent in the verum and 96 % in the sham group believed that the treatment had been effective for nausea. In both groups, 67 % experienced other positive effects, on relaxation, mood, sleep or pain-reduction, and 89 % were interested in receiving the treatment again. In study IV, the weekly prevalence of nausea and vomiting was 38 and 8 % in the verum group, 37 and 7 % in the sham group and 63 and 15 % in the standard care group. The nausea difference between the acupuncture and the standard care cohort was statistically significant, also after overall adjustments for potential confounding factors. The nausea intensity in the acupuncture cohort was lower compared to the standard care cohort (p=0.002). Patients who expected nausea had increased risk for nausea compared to patients who expected low risk for nausea (Relative risk 1.6). Conclusions and implications: Nausea was common during abdominal or pelvic field irradiation in patients receiving standard care. Verum acupuncture did not reduce emesis compared to sham acupuncture, while reduced emesis was seen in both patients treated with verum or sham acupuncture. Health-care professionals may consider identifying and treating patients with increased risk for nausea in advance. The telescopic sham needle was credible. Researchers may thus use and standardize the sham procedure in acupuncture control groups. The choice of performing acupuncture during radiotherapy cannot be based on arguments that the specific characters of verum acupuncture have effects on nausea. It is important to further study what components in the acupuncture procedures that produce the dramatic positive but yet not fully understood antiemetic effect, making it possible to use those components to further increase quality of care during radiotherapy

Type and frequency of side effects during PC6 acupuncture : observations from therapists and patients participating in clinical efficacy trials of acupuncture

BACKGROUND: Many therapists practise PC6 acupuncture for emesis (nausea and vomiting) during pregnancy, different cancer therapies, palliative care, after surgery, or to induce relaxing effects in general. Knowledge of side effects is central to shared decision-making.AIM: To describe the type and frequency of side effects and the level of needle-induced pain during PC6 acupuncture.METHODS: We included 1298 PC6 acupuncture treatments, delivered to 221 participants (77% women, mean age 52.5, range 18-91 years). The subjects had received genuine PC6 acupuncture, in one of two previous randomised controlled trials, aimed at inducing antiemetic (n=100, with 100 providing data on side effects and 94 on needle-induced pain, respectively) or relaxing (n=121, with 120 providing data) effects. Side effects during and after the acupuncture treatments were registered in structured treatment protocols and study diaries.RESULTS: No serious complications occurred. Side effects during the acupuncture sessions included minor bleeding in 5.0%, tiredness in 4.9%, numbness in 4.5% and dizziness in 1.4% of the 1298 treatments. After treatment, the mean proportions of participants reporting side effects each week were: tiredness 25.8%; feeling cold 17.8%; dizziness 9.7%; sweating 9.3%; haematoma 8.8%; and soreness at the needling sites 4.3%. Participants perceived the needling to be not painful (47.4% of participants), or mildly (39.1%), moderately (11.6%) or very painful (1.4%).CONCLUSIONS: Few side effects occurred and those that did were mild. Nearly 90% found PC6 acupuncture to be not painful or only mildly painful. Healthcare professionals may consider the observed levels of side effects when informing patients about side effects of PC6 acupuncture

Experiences of incontinence and pelvic floor muscle training after gynaecologic cancer treatment

The purpose of the present study is to describe how gynaecological cancer survivors (GCS) experience incontinence in relation to quality of life, their possibilities for physical activity and exercise and their perceptions and experiences of pelvic floor muscle training. This qualitative interview content analysis study included 13 women (48-82 age) with urinary (n = 10) or faecal (n = 3) incontinence after radiation therapy (n = 2), surgery (n = 5) and surgery and radiation therapy (n = 6) for gynaecological cancer, 0.5-21 years ago. Symptoms related to incontinence and restrictions in daily activities reduced physical quality of life. Emotions related to incontinence reduced psychological quality of life and social and existential quality of life, due to restrictions in activity and feelings of exclusion. Practical and mental strategies for maintaining quality of life were described, such as always bringing a change of clothes and accepting the situation. Possibilities for sexual and physical activity as well as exercise were also restricted by incontinence. The women had little or no experience of pelvic floor muscle training but have a positive attitude towards trying it. They also described a lack of information about the risk of incontinence. The women were willing to spend both money and time on an effective treatment for their incontinence. Nine out of 10 were willing to spend at least 7 h a week. GCS experienced that incontinence reduced quality of life and limited possibilities for sexual and physical activity as well as exercise. Coping strategies, both practical and emotional, facilitated living with incontinence. The women had a positive attitude towards pelvic floor muscle training. Lack of information had a negative impact on their way of dealing with the situation.Funding Agencies|Swedish Cancer Society; Kamprad Family Foundation for Entrepreneurship, Research and Charity; Linkoping University; Region Ostergotland; FORSS (The Research Council of Southeast Sweden)</p

Emesis and gastrointestinal problems during radiotherapy A comparison of performance of daily activities between patients experiencing nausea and patients free from nausea

Purpose of the research To describe the experiences of nausea vomiting and gastrointestinal problems during radiotherapy and to compare patients experiencing nausea with patients not experiencing nausea regarding performance in daily activities sleeping and eating capacity Methods and sample A cross-sectional sample of 131 Swedish radiotherapy patients answered a questionnaire regarding the preceding week of radiotherapy Mean age was 63 years (standard deviation 12 1) and 56% were women The radiotherapy fields were breast (35%) abdomen/pelvis (15%) prostate/bladder (21%) head/neck (10%) and other (8%) Key results The patients experiencing nausea within the observed week (n = 31) had compared to the patients not experiencing nausea (n = 100) lower ability in daily activities in general (p = 0 001) in shopping (p = 0 014) walking (p = 0 007) and social interaction (p = 0 007) Of the patients with nausea 48% had seldom woken up rested and 34% were not able to eat as much as they used to Corresponding figures for nausea free patients were 27% (not significant ns) and 16% (ns) Six (5%) experienced vomiting 15 (12%) diarrhoea 23 (18%) constipation and 52 (40%) any gastrointestinal symptoms Forty seven (90%) were negatively bothered by the experienced gastrointestinal symptoms Conclusions The fourth of patients experiencing nausea during radiotherapy had lower ability to perform daily activities than the three quarters of patients who were free from nausea Few patients vomited while 40% experienced gastrointestinal symptoms during the observed week of radiotherapy This implies that health care professionals could consider identifying nauseous patients that possibly need support in nausea-reduction and in daily activities during radiotherapy (c) 2009 Published by Elsevier Lt

Preparedness to Implement Physical Activity and Rehabilitation Guidelines in Routine Primary Care Cancer Rehabilitation : Focus Group Interviews Exploring Rehabilitation Professionals Perceptions

To explore primary care professionals perceptions of physical activity and other cancer rehabilitation practice in cancer survivors, investigating the preparedness to implement guidelines regarding cancer rehabilitation. We collected qualitative data through seven semi-structured focus group interviews with 48 rehabilitation professionals, with mean 9 years of experience in primary care rehabilitation (32 physiotherapists, 15 occupational therapists, and 1 rehabilitation assistant) in a primary care setting. Data was analyzed using content analysis. Primary care rehabilitation professionals expressed limited experience of cancer survivors, experienced lack of knowledge of cancer-related disability, and had doubts concerning how to treat cancer survivors. They also experienced uncertainty about where to find collaboration and support in the healthcare system outside their own rehabilitation clinic. There is a need to combine different implementation strategies to tackle multiple barriers for effective cancer survivor rehabilitation in primary care, to boost individual rehabilitation professionals knowledge and self-efficacy, to clarify roles and responsibilities for cancer rehabilitation across levels of care, and to develop and strengthen organizational bridges to provide adequate access to rehabilitation for cancer survivors.Funding Agencies|County Council of Ostergotlands funding of research time, Local Research Council of Western County Council of Ostergotland, and Research Council of Southeast Sweden</p

Reduced Need for Rescue Antiemetics and Improved Capacity to Eat in Patients Receiving Acupuncture Compared to Patients Receiving Sham Acupuncture or Standard Care during Radiotherapy.

Objective. To evaluate if consumption of emesis-related care and eating capacity differed between patients receiving verum acupuncture, sham acupuncture, or standard care only during radiotherapy. Methods. Patients were randomized to verum (n = 100) or sham (n = 100) acupuncture (telescopic blunt sham needle) (median 12 sessions) and registered daily their consumption of antiemetics and eating capacity. A standard care group (n = 62) received standard care only and delivered these data once. Results. More patients in the verum (n = 73 of 89 patients still undergoing radiotherapy; 82%, Relative Risk (RR) 1.23, 95% Confidence Interval (CI) 1.01-1.50) and the sham acupuncture group (n = 79 of 95; 83%, RR 1.24, CI 1.03-1.52) did not need any antiemetic medications, as compared to the standard care group (n = 42 out of 63; 67%) after receiving 27 Gray dose of radiotherapy. More patients in the verum (n = 50 of 89; 56%, RR 1.78, CI 1.31-2.42) and the sham acupuncture group (n = 58 of 94 answering patients; 62%, RR 1.83, CI 1.20-2.80) were capable of eating as usual, compared to the standard care group (n = 20 of 63; 39%). Conclusion. Patients receiving acupuncture had lower consumption of antiemetics and better eating capacity than patients receiving standard antiemetic care, plausible by nonspecific effects of the extra care during acupuncture.Funding agencies: Swedish Cancer Society; Region of Ostergotland; University of Linkoping; Cancer Rehabilitation Foundation; Swedish Institute of Health Research; Vardal Foundation for Healthcare Sciences and Allergy Research; Osher Center for Integrative Research, Karolin</p

Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle?

A control treatment in acupuncture research must be credible, regardless if the needting is performed by one or by several therapists. Objective: To investigate if individuals could identify whether neediing had been given with an acupuncture needle or a sham needle and if the therapist influenced this ability. Design: Eighty individuals were randomized to one single needling given by one of four physiotherapists using either an invasive needle or a non-penetrating telescopic sham needle. Results: An equal proportion of individuals, 27 (68%), in the acupuncture group and the sham group answered incorrectly or was not sure at ail regarding needling type but the proportion varied between the therapists from 55 to 80% (ns). Bang's blinding index was 0.20 (95% CI 0.03-0.36) in the acupuncture group and 0.10 (95% Cl 0.09-0.29) in the sham group (interpretation: 20 and 10% identified needling type beyond statistical chance). Acupuncture was on a four-grade scale rated as median "mildly painful" and sham as "not painful'' (ns). Pain ratings varied from median "not" to "mildly painful'' in the therapists (p=0.01). Conclusions: Two thirds of individuals needled by acupuncture as well as sham could not identify needling type and only 10-20% of the individuals were unblinded beyond chance. The therapists, not the needling type, influenced how painful the needling was perceived. Implications: To achieve blinding success in acupuncture efficacy studies using the sham needle, the needling procedure must be strictly standardized in order to minimize differences between the therapists. (c) 2008 Elsevier Ltd. Atl, rights reserved