Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up.

BACKGROUND: Integrative medicine is used frequently alongside chemotherapy treatment in pediatric oncology, but little is known about the influence on toxicity. This German, multi-center, open-label, randomized controlled trial assessed the effects of complementary treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1-18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients. METHODS: Intervention and control were given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients and additional on-demand treatment tailored to the intervention malignancy groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales. RESULTS: Data of 288 patients could be analyzed. Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow up. DISCUSSION: In this trial findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.

Postoperative Pain Therapy with Laser Acupuncture after Cesarean Section under Spinal Anesthesia: A Double-Blinded, Randomized, Placebo-Controlled Trial.

PURPOSE: The aim of our prospective, randomized, double-blind, placebo-controlled study was to investigate the effect of laser acupuncture on postoperative pain in women undergoing cesarean section. METHODS: 99 women (mean age 32 ± 5 years) scheduled for cesarean section under spinal anesthesia at Saarland University Hospital Medical Center, Homburg (Germany) were enrolled in this trial after giving written consent. Patients were randomized in two groups receiving a course of 3 treatments over 3 days with either active or placebo laser. Each acupuncture session treated Di-4 and Shen-men of both hands and ears. Primary outcome was defined as the pain severity at rest measured by Numeric Rating Scale (NRS) on the first postoperative day. Secondary outcome measures included analgesic consumption, time to mobilization, and length of stay. Treatment occurred on the operation day and on the following 2 days. Data were collected by a standardized questionnaire. RESULTS: From 95 included patients, 80 were analyzed. No statistical difference between both groups were observed for pain severity at rest on the first postoperative day after cesarean section (Mann-Whitney U test, p = 0.850, verum group [mean ± standard deviation]: 3.3 ± 2.1 vs. placebo group: 3.2 ± 1.9). Secondary outcome measures regarding analgesic consumption showed no difference in NSAID or opioid between treatment and placebo group. Laser acupuncture showed no effect on time to mobilization and length of stay. CONCLUSION: Our study could not demonstrate significant effects by the application of laser acupuncture on postoperative pain in women undergoing cesarean section.

[Progressive muscle relaxation in postoperative pain therapy]. / Progressive Muskelrelaxation in der postoperativen Schmerztherapie.

BACKGROUND: Early and optimal treatment of postoperative pain based on a multimodal treatment concept is very important so that subsequent chronification can be avoided. OBJECTIVES: This study investigated the influence of progressive muscle relaxation on the sensation of pain and the need for analgesics after orthopedic interventions. MATERIALS AND METHODS: This nonrandomized pilot study tested 104 patients in the Clinic of Orthopedics at the Saarland University Medical Center in Homburg, Germany. The patients underwent total endoprosthesis (TEP) of the or the knee or spine surgery (laminectomy), and they had the option of choosing to use the technique of progressive muscle relaxation. All patients completed a questionnaire on the first, fourth, and ninth postoperative day. Data were collected on the maximum and minimum intensity of pain, duration of strong pain, length of hospital stay, and use of pain medication. These were compared by means of t tests for the group with progressive muscle relaxation and the group without progressive muscle relaxation. RESULTS: No significant difference was observed between the two groups regarding pain sensation analgesic dosage. There was a tendency for the length of hospital stay to be shorter in the group with progressive muscle relaxation. CONCLUSION: The positive effect of progressive muscle relaxation cannot be confirmed on the basis of the study data. Owing to the varying study design and implementation as well as the inclusion of heterogeneous patient groups, no conclusion can be drawn at present regarding the effectiveness of progressive muscle relaxation in common practice; therefore, further research is necessary.

Photobiomodulation therapy in breast cancer-related lymphedema: a randomized placebo-controlled trial.

BACKGROUND: The aim of our study was to examine the effects of photobiomodulation therapy (PBMT) in the treatment of breast cancer-related lymphedema using a compactly designed treatment regime consisting of eight therapy sessions in combination with a cluster laser device covering a total area size of 78.54 cm² over the axillary. METHODS: Forty patients with unilateral lymphedema were enrolled in this double-blind, placebo-controlled trial in order to evaluate effects of PBMT on lymphedema-related pain, quality of life, grip strength and limb volume difference. Subjects received irradiation for ten minutes per session using a cluster laser covering a beam area of 78.54 cm². The applied energy was 384 Joules resulting in an energy density of 4.89 J/cm². RESULTS: Post-treatment, a 50% reduction in median pain scores and an increase in mean quality of life were observed. Mean grip strength was persistently higher after eight sessions of PBMT compared with pretreatment; however, no statistically significant intergroup differences (P > 0.05) were found over the time course. CONCLUSION: PBMT using a compactly designed treatment regime in combination with a cluster laser device did not significantly improve quality of life, pain scores, grip strength and limb volume over the time course.

Severe cyanide poisoning from an alternative medicine treatment with amygdalin and apricot kernels in a 4-year-old child.

BACKGROUND: The use of complementary and alternative medicine (CAM) is widespread in children with cancer and is poorly regulated. PATIENTS AND METHODS: Case report. RESULTS: We describe a case of severe cyanide poisoning arising from CAM use. A severely agitated, encephalopathic, unresponsive 4-year-old boy (initial Glasgow Coma Scale of 3) with a history of metastatic ependymoma was brought to our emergency department by ambulance services. Initial blood gas analysis demonstrated severe metabolic/lactic acidosis. On detailed questioning of the parents, the use of CAM including intravenous and oral "vitamin B 17" (amygdalin) and oral apricot kernel was reported. After administering sodium thiosulfate, rapid improvement in his medical condition with complete recovery without need for further intensive care treatment was seen. Serum cyanide level was markedly elevated. CONCLUSIONS: Cyanide poisoning can be the cause of severe encephalopathy in children receiving CAM treatment with substances containing cyanogenic glycosides.

Differences in use of complementary and alternative medicine between children and adolescents with cancer in Germany: a population based survey.

BACKGROUND: Use of complementary and alternative medicine (CAM) in children with cancer is common and probably increasing. However, data concerning differences between children and adolescents focusing on prevalence, reasons for use/non-use, costs, adverse effects, and socio-demographic factors are lacking. PROCEDURE: A population-based survey over a 1 year period with 497 participants was conducted. RESULTS: Of the 457 respondents (92%) 322 were children and 135 adolescents (>16 years of age) with malignancies. 31% reported CAM use from the time when being diagnosed, compared to an overall lifetime prevalence rate of 41% before cancer diagnosis. Among CAM users the most prevalent therapies were homeopathy, massage, anthroposophic medicine, acupuncture, and Bach flowers. The main reasons for use were to reduce therapy-related side effects, to strengthen the immune system, to achieve physical stabilization and to increase healing chances. Socio-demographic factors associated with CAM use were higher parental education and higher family income. A majority of CAM users (97%) would recommend CAM use. Most users (78%) informed a physician about CAM use. Side effects were rarely reported (5%), minor and self-limiting. CONCLUSIONS: The high prevalence rates seem to represent the parental or patients needs for additional treatment perceived as successful and devoid of side-effects. Clinical care and the physician-patient relation would profit from an enhanced understanding of CAM and a greater candidness towards the parental needs. Safety and efficacy - especially of CAM with high prevalence rates - should be studied in rigorous basic and clinical research.

Complementary and alternative medicine in paediatrics: a systematic overview/synthesis of Cochrane Collaboration reviews.

BACKGROUND: A high prevalence of complementary and alternative medicine (CAM) use has been documented in children with chronic illnesses. Conversely, evidence-based medicine is considered an important contributor in providing the best quality of care. METHODS: We performed a systematic overview/synthesis of all Cochrane reviews published between 1995 and 2012 in paediatrics that assessed the efficacy, and clinical implications and limitations of CAM use in children. Main outcome variables were: percentage of reviews that concluded that a certain intervention provides a benefit, percentage of reviews that concluded that a certain intervention should not be performed, and percentage of studies that concluded that the current level of evidence is inconclusive. RESULTS: A total of 135 reviews were included - most from the United Kingdom (29/135), Australia (24/135) and China (24/135). Only 5/135 (3.7%) reviews gave a recommendation in favour of a certain intervention; 26/135 (19.4%) issued a conditional positive recommendation, and 9/135 (6.6%) reviews concluded that certain interventions should not be performed. Ninety-five reviews (70.3%) were inconclusive. The proportion of inconclusive reviews increased during three, a priori-defined, time intervals (1995-2000: 15/27 [55.6%]; 2001-2006: 33/44 [75%]; and 2007-2012: 47/64 [73.4%]). The three most common criticisms of the quality of the studies included were: more research needed (82/135), low methodological quality (57/135) and small number of study participants (48/135). CONCLUSIONS: Given the disproportionate number of inconclusive reviews, there is an ongoing need for high quality research to assess the potential role of CAM in children. Unless the study of CAM is performed to the same science-based standards as conventional therapies, CAM therapies risk being perpetually marginalised by mainstream medicine.

Use of complementary and alternative medicine in healthy children and children with chronic medical conditions in Germany.

OBJECTIVES: Use of complementary and alternative medicine (CAM) in children is common and probably increasing. However little is known about differences between healthy and chronically ill children with a focus on prevalence, reasons for use/non-use, costs, adverse effects and socio-demographic factors. DESIGN: A questionnaire-based survey with 500 participants visiting the outpatient clinic of the University Children's Hospital Homburg, Germany was conducted over a 4-week period in 2004. Recruitment was stopped when 500 questionnaires were handed out in total. RESULTS: Of the 405 (81%) respondents (242 with chronic conditions, 163 healthy children incidentally visiting the hospital for minor ailments) 229 (57%) reported lifetime CAM use (59% with chronic conditions versus 53% healthy children). Among CAM users the most prevalent therapies were homeopathy (25%), herbal remedies (8%), anthroposophic medicine (7%), vitamin preparations (6%) and acupuncture (5%). The main reasons for use were to strengthen the immune system, physical stabilisation and to increase healing chances/maintain health. Socio-demographic factors associated with CAM use were tertiary education (mother: p=0.017; father: p>0.001), higher family income (p=0.001) and being Protestant (p=0.01). Expectations towards CAM were high and most parents would recommend certain CAM (94%). 79% of the users informed a physician about CAM use. Side effects were rarely reported (4%), minor and self-limiting. CONCLUSIONS: Clinical care and the physician-patient relation would benefit from an enhanced understanding of CAM and a greater candidness towards the parental needs. The safety and efficacy especially of CAM with high prevalence rates should be determined in rigorous basic and clinical researches.

Headache in children: update on complementary treatments.

Complementary and alternative medicine (CAM) is widely used by both physicians and patients with primary headache syndromes. Despite a considerable number of articles addressing CAM in primary headache syndromes, the overall evidence for CAM is still poor. The aim of this review was to give an overview of the current evidence of the main alternative therapies used in the treatment of primary headache syndromes of childhood. MEDLINE and Cochrane Library were systematically searched for articles dealing with complementary and alternative treatment or prophylaxis of headache and migraine published within the past 20 years.

Complementary and alternative treatment methods in children with cancer: A population-based retrospective survey on the prevalence of use in Germany.

INTRODUCTION: Few studies have been conducted to date on the prevalence of use of complementary and alternative treatment methods (CAMs) in paediatric oncology, and those that have been conducted are often not representative. We therefore decided to study a representative sample of children with cancer in the German population. PATIENTS AND METHODS: The study took the form of a retrospective survey amongst all parents whose children were first diagnosed with a disease covered by the German Childhood Cancer Registry in 2001. The primary objectives of the survey were to establish the prevalence of use of CAM and the factors related to its use. RESULTS: Of the 1595 questionnaires sent out, 1063 (67%) could be evaluated. 35% of the responders had used CAM. The most frequently used methods were homeopathy, dietary supplements and anthroposophic medicine including mistletoe therapy. Factors which increased the probability of using CAM were the previous use of CAM, higher social status and poor prognosis of the child's disease. The most frequently named reasons for use of CAM were physical stabilisation, strengthening the immune system and improving the chance of cure. Whilst the sources of information about CAM were in most cases not doctors, 71% of users had nevertheless spoken to a doctor about using CAM. The effects of the CAM perceived by the parents were for the most part positive. 89% of the users reported that they would recommend CAM to other parents. CONCLUSIONS: CAMs are administered alongside standard therapy to 35% of children with cancer in Germany, usually by the parents. Prospective studies on the effects and side-effects of the most frequently used methods are urgently needed, and paediatric oncologists should have sufficient knowledge of CAM to enable them to advise parents professionally and competently about these treatments, too.

Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial.

To investigate whether laser acupuncture is efficacious in children with headache and if active laser treatment is superior to placebo laser treatment in a prospective, randomized, double-blind, placebo-controlled trial of low level laser acupuncture in 43 children (mean age (SD) 12.3 (+/-2.6) years) with headache (either migraine (22 patients) or tension type headache (21 patients)). Patients were randomized to receive a course of 4 treatments over 4 weeks with either active or placebo laser. The treatment was highly individualised based on criteria of Traditional Chinese medicine (TCM). The primary outcome measure was a difference in numbers of headache days between baseline and the 4 months after randomization. Secondary outcome measures included a change in headache severity using a 10 cm Visual Analogue Scale (VAS) for pain and a change in monthly hours with headache. Measurements were taken during 4 weeks before randomization (baseline), at weeks 1-4, 5-8, 9-12 and 13-16 from baseline. The mean number of headaches per month decreased significantly by 6.4 days in the treated group (p<0.001) and by 1.0 days in the placebo group (p=0.22). Secondary outcome measures headache severity and monthly hours with headache decreased as well significantly at all time points compared to baseline (p<0.001) and were as well significantly lower than those of the placebo group at all time points (p<0.001). We conclude that laser acupuncture can provide a significant benefit for children with headache with active laser treatment being clearly more effective than placebo laser treatment.

Acupuncture against chemotherapy-induced nausea and vomiting in pediatric oncology. Interim results of a multicenter crossover study.

GOALS: In this multicenter crossover study, our aim was to evaluate the efficacy and acceptance of acupuncture as a supportive antiemetic approach during highly emetogenic chemotherapy in pediatric oncology. PATIENTS AND METHODS: Eleven children receiving several courses of highly emetogenic chemotherapy for treatment of solid tumors were included. Randomization allocated patients to start chemotherapy either with antiemetic medication plus acupuncture or antiemetic medication alone. During all study courses, patients continued to receive their programmed and additional antiemetic medication as needed. Acupuncture was given at day 1 of chemotherapy and at subsequent days on patient's demand. The amount of baseline and additional antiemetic medication during chemotherapy was documented. Patients maintained a daily diary of vomiting episodes and completed an evaluated nausea score at the end of every course. Their body weight was taken before and after a chemotherapy course. MAIN RESULTS: Twenty-two courses with or without acupuncture were compared. The benefits of acupuncture in adolescents with respect to the reduction of additional antiemetic medication were observed. Acupuncture enabled patients to experience higher levels of alertness during chemotherapy and reduced nausea and vomiting. Except for needle pain, no side effects were noted. Patient's acceptance of acupuncture was high. CONCLUSION: Our data indicate that acupuncture might reduce antiemetic medication and episodes of vomiting in pediatric oncology.