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

Patients— and Physiotherapists— Belief in and Use of Acupuncture for Cancer-Related Symptoms

Background It is important to investigate attitudes to acupuncture, because therapists’ and patients’ expectations may affect the treatment outcome. Aim To explore the use of and belief in acupuncture among oncological physiotherapists and to explore patients’ interest in receiving acupuncture during cancer therapy and their belief in its effectiveness. Methods 522 patients (80% female, mean age 67 years) reported on their interest in receiving acupuncture for nausea during radiotherapy treatment; a subgroup (n=198) additionally disclosed their belief in the effectiveness of acupuncture. 117 Swedish oncological physiotherapists (96% female, mean age 48 years) answered a questionnaire regarding their use of and belief in acupuncture. Results Of the patients initiating cancer therapy, 359 (69%) were interested in receiving acupuncture. The patients believed acupuncture to be effective for pain (79%), nausea (79%) and vasomotor symptoms (48%). Of the 117 physiotherapists, 66 (56%) practised acupuncture. Physiotherapists generally believed in the effectiveness of acupuncture. For pain, 89% believed that acupuncture was effective and 42% of them practised it. Similar responses were noted for chemotherapy-induced nausea (86% and 38%, respectively) and vasomotor symptoms (80% and 28%, respectively). Younger physiotherapists and patients were more likely to believe in the effectiveness of acupuncture compared with older ones. Conclusions More than two thirds of patients with cancer were interested in receiving acupuncture during therapy. Patients and oncological physiotherapists believed that acupuncture was effective for cancer pain, nausea and vasomotor symptoms. Further studies of acupuncture for cancer-related symptoms and of the effect of patients’ and clinicians’ therapeutic relationships, including treatment expectations, would be welcome. </jats:sec

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

Understanding rationales for acupuncture treated individuals’ beliefs in acupuncture effects, to be able to maximize therapeutic results: A qualitative analysis

Objective: To investigate how individuals expressed rationales for their beliefs regarding efficacy of acupuncture. Methods: Qualitative data from participants of two different randomized sham-controlled trials, of relaxing (non cancer volunteers of the general population) or antiemetic (patients with cancer undergoing radiotherapy) effects of acupuncture was analyzed. Participants (n = 441) received genuine (n = 120 and n = 100) or sham (n = 121 and n = 100) (telescopic blunt sham-needle) relaxing or antiemetic acupuncture. The participants (n = 428; 97% response rate) expressed their belief regarding the efficacy of acupuncture, and n = 264 delivered qualitative rationales for their belief, analyzed using qualitative content analysis. Results: Of the 428 participants, 35 (8%) believed entirely that the acupuncture was effective, 209 (49%) believed much, 136 (32%) believed moderately, 39 (9%) believed a little, and 9 (2%) did not believe that the acupuncture was effective. Five categories and seven subcategories represented the meaning units of the central message of the rationales for the treatment belief. Participants with positive beliefs (believed entirely/much, n = 244) presented rationales related to: "Experienced positive effects", "Knowledge regarding effect-mechanisms of acupuncture", and "General trustworthiness of acupuncture". Participants with more negative beliefs (believed a little or not, n = 48) presented rationales related to: "Lack of feasibility of the acupuncture", "Varying effects", and "The effect is individual, not available for everybody". Conclusion: In order to strengthen acupuncture treated patients beliefs in the efficacy of acupuncture during clinical practice or research, acupuncture therapists may consider emphasizing these aspects in the therapeutic situation.</p

Emesis in patients receiving acupuncture, sham acupuncture or standard care during chemo-radiation: A randomized controlled study

Objective: To study nausea, vomiting and need for rescue antiemetics in patients receiving antiemetic acupuncture, sham acupuncture or standard care during concomitant chemotherapy during pelvic radiotherapy. Methods: In total, 68 patients participated (75% women, mean age 56 years, 53% had gynecological, 43% colorectal, and 4% other cancer types). Fifty-seven of them were blinded randomized to verum (n = 28) or sham (n = 29) acupuncture, median 10 sessions. During the study period of four weeks, the patients daily registered their nausea, vomiting and consumption of antiemetics. They were compared to a reference group (n = 11) receiving standard care only, who delivered these data once (after receiving mean 27 Gy radiotherapy dose). Results: More patients in the sham acupuncture group (17 of 20; 85%, p = 0.019, RR 1.81, CI 1.06-3.09) consumed antiemetics, compared to the verum acupuncture group (8 of 17; 47%). In the standard care group, 7 of 11 (63%) consumed antiemetics. The verum acupuncture treated patients experienced lower intensity of nausea than the other patients (p = 0.049). There was a non-significant tendency that more patients receiving either sham acupuncture or standard care experienced nausea (21 of 31; 68%) than patients receiving verum acupuncture (9 of 17; 53%: p = 0.074, RR 1.58, CI 0.91-2.74). Conclusion: Patients treated with verum acupuncture needed less antiemetics and experienced milder nausea than other patients. Our study was small and many analyses lacked statistical power to detect differences; we welcome further sham-controlled efficacy studies and studies regarding the role of non-specific treatment components for experiencing antiemetic effects of acupuncture.</p

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