Acupuncture as Complementary Treatment for Acute Tinnitus: A Randomized Controlled Pilot Study.

BACKGROUND: Up to now, tinnitus has been an almost non-treatable symptom affecting more than 18% of the population in industrialized countries. So far, there are only a few studies evaluating the effectiveness of acupuncture in tinnitus treatment, none of which include acute tinnitus (<3 months). The aim of this pilot study was to explore the feasibility of recruitment and adherence to acupuncture conducted according to the principles of traditional Chinese medicine in patients with acute idiopathic tinnitus and to assess effect sizes on subjective and objective outcomes within a randomized controlled design. PATIENTS AND METHODS: After randomization patients of the control group received usual care (n = 23), and patients of the intervention group (n = 25) received 4 additional acupuncture treatments in a 4- to 6-week period. Tinnitus severity was assessed by means of a visual analogue scale as well as standardized and validated tinnitus questionnaires (Tinnitus Functional Index and 12-item Mini Tinnitus Questionnaire) at baseline and 6 weeks after. These subjective parameters were completed by tone audiometry. Comparisons of the groups were carried out using the Wilcoxon-Mann-Whitney test. RESULTS: Both groups were comparable without significant differences in baseline values. All outcomes, except for the overall well-being, showed better improvements in the intervention group with clinically significant differences from baseline to end point. However, among the outcomes only the subjective change in tinnitus severity showed a significant group difference. No serious side effects were observed. CONCLUSION: The design of our pilot study was feasible in terms of recruitment, although patient adherence to treatment remained challenging. However, considering the small intergroup differences, procedures regarding the numbers of acupuncture sessions and the total period of the acupuncture treatment should be reconsidered. The results of this pilot study provide a good basis for future confirmatory trials.

Comparison of acupuncture on specific and non-specific points for the treatment of painful temporomandibular disorders: A randomised controlled trial.

BACKGROUND AND OBJECTIVE: The aim of this single-centre, two-arm, parallel-group, double-blinded, randomised controlled trial was to investigate the disputed specific effectiveness of acupuncture by comparing acupuncture on specific and non-specific points among patients with non-chronic, painful TMDs. METHODS: Following predefined eligibility criteria, 49 consecutive patients of both sexes were recruited to the study. All subjects were diagnosed with a non-chronic (Graded Chronic Pain Scale grade <3) painful TMD, as assessed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Patients were randomly assigned to group A (acupuncture on specific points) or group B (acupuncture on non-specific points) after the initial examination (T0). Both acupuncture treatment sessions were conducted by a trained dentist once a week for four weeks. The examination was repeated five weeks (T5) after T0 by one calibrated examiner who was unaware of the study groups. Characteristic pain intensity (CPI) was evaluated as the main outcome criterion and compared between times and treatment groups by means of non-parametric tests (significance level set at P = .05). Secondary outcomes comprised the maximum corrected active mouth-opening without pain (MAO); patients' expectations regarding acupuncture treatment and pain development; depressivity; and oral health-related quality of life (OHRQoL). RESULTS: A total of 41 patients (38 female) successfully completed the study (mean age: 40.17 ± 16.61). The two groups did not differ significantly at any time in terms of age and CPI. However, CPI was significantly (P < .05) lower at T5 than at T0 for both groups (29.66 and 30.35% lower in group A and group B, respectively). An increase in MAO was observed at T5 for both groups but was significant for group B only (P = .016). All patients had positive expectations of acupuncture therapy, and the two groups did not differ significantly at T5 with regard to the extent to which their expectations had been fulfilled by the treatment (P = .717). Comparison of T0 and T5 showed a statistically significant reduction of depressivity for group A (P = .0205), but no significant change for group B (P = .329). At T5, OHRQoL had improved significantly for both groups (group A, P = .018; group B, P < .001) compared with at T0. CONCLUSIONS: Acupuncture on both specific and non-specific points reduces the non-dysfunctional pain of TMD patients. The effect of acupuncture on painful TMD cannot be attributed to the specific point selection.

Long-term add-on therapy (compassionate use) with oral artesunate in patients with metastatic breast cancer after participating in a phase I study (ARTIC M33/2).

BACKGROUND: The antimalarial artesunate (ART), a semisynthetic derivative of artemisinin from the Chinese herb artemisia annua has remarkable anticancer properties in vitro and in vivo. Its excellent safety profile known from short-term therapy in malaria was confirmed in an open phase I trial (ARTIC M33/2) for dose-finding as add-on therapy for four weeks. PURPOSE: Patients with metastatic breast cancer, who had not experienced any clinically relevant adverse events (AE) during participation in ARTIC M33/2, were offered to continue ART as compassionate use (CU). Regular monitoring was continued in order to ensure adequate individual safety and tolerability and to collect information about long-term treatment with ART. Clinically relevant AEs or second progression of disease during ART were reasons for discontinuation of the add-on therapy. STUDY DESIGN: Compassionate use was offered open-label to participants of ARTIC M33/2. METHODS: Patients continued to take 100, 150 or 200 mg oral ART daily as add-on therapy to their guideline-based oncological therapy. Clinical and laboratory monitoring included audiological and neurological examination, ECG, NTproBNP and reticulocyte determination. Cumulative treatment days and cumulative ART doses encompass both the phase I study as well as the continued add-on treatment period (CU). RESULTS: Following the 4 ±â€¯1 weeks of the phase I trial, thirteen patients continued the add-on therapy as CU, resulting in a total of 3825 treatment days. In individual patients up to 1115 cumulative treatment days (37 months) and cumulative ART doses up to 167.3 g were reached. A total of 25 AEs grade ≥ 2 at least possibly related to ART long-term add-on therapy were documented, two, six and 17 in dose groups 100, 150 and 200 mg/d ART respectively. Six of these AEs were classified as grade 3, two in patients taking 150 and four in patients on 200 mg/d, none of them being probably or certainly related to ART. CONCLUSIONS: In thirteen patients with metastatic breast cancer up to 200 mg/d long-term oral ART (2.3-4.1 mg/kg BW/d) in up to 1115 cumulative treatment days (37 months) did not result in any major safety concerns.

Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial.

BACKGROUND: Adverse effects such as fatigue, pain, erythema, nausea and vomiting are commonly known in patients undergoing irradiation (RT) alone or in combination with chemotherapy (RCHT). Patients suffering from these symptoms are limited in their daily life and their quality of life (QOL) is often reduced. As addressed in several trials, acupuncture can cause amelioration of these specific disorders. Especially for pain symptoms, several groups have shown efficacy of acupuncture. To what extent the difference between traditional acupuncture (verum acupuncture) and false acupuncture (sham acupuncture) is in reducing side effects and improvement of QOL is not clear. METHODS/DESIGN: ROSETTA is a prospective randomized phase II trial (version 1.0) to examine the efficacy of traditional acupuncture in patients with RT-related side effects. In the experimental (verum) arm (n = 37) an experienced acupuncture-trained person will treat dedicated acupuncture points. In the control (sham) arm (n = 37) sham acupuncture will be performed to provide a blinded comparison of results. DISCUSSION: This is the first randomized prospective trial to evaluate the effect of traditional acupuncture on RT-related side effects such as fatigue and QOL. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02674646 . Registered on 8 December 2015.

Measurable impact of acupuncture on mucosal swelling of inferior turbinates: a prospective, randomized, controlled study.

CONCLUSIONS: Sham acupuncture turned out to be more effective than expected. The effect of acupuncture cannot be assessed by optical rhinometry (ORM). OBJECTIVES: In most cases nasal congestion is caused by hypertrophy of the inferior turbinate as a result of allergic and chronic rhinitis. Topical decongestants cause severe side effects. As a consequence, there is an increasing demand for alternative treatment options such as traditional Chinese medicine (TCM). METHODS: A total of 25 patients with nasal congestion due to hypertrophic inferior turbinate were recruited. The mucosal swelling status of the inferior turbinate was assessed by continuous ORM for 20 min. Patients were asked to score the severity of their nasal congestion on a visual analogue scale (VAS) before and 10 and 20 min after acupuncture. Specific verum acupuncture points related to nasal congestion were tested against non-specific control sham acupuncture points. RESULTS: Sham acupuncture improved VAS scores, whereas ORM measured an increase in nasal swelling. The ORM revealed a quicker onset of the effect of verum acupuncture on the nasal blood flow. Also, verum acupuncture reaches its maximum effect in a shorter time period, so that the net reaction time was much shorter. However, ORM could not prove a decongestant effect of verum acupuncture on inferior turbinate.

Pharmacogenomic determination of genes associated with sensitivity or resistance of tumor cells to curcumin and curcumin derivatives.

Curcuma longa L. has long been used as a medicinal plant in traditional Chinese medicine against abdominal disorders. Its active constituent curcumin has anti-inflammatory, chemopreventive and cytotoxic properties. In the present investigation, we have analyzed the cytotoxic activity of curcumin and four derivatives. Among these compounds, ethoxycurcumintrithiadiazolaminomethylcarbonate was the most cytotoxic one. The curcumin-type compounds were not cross-resistant to standard anticancer drugs and were not involved in ATP-binding cassette transporter-mediated multidrug resistance. A combined approach of messenger RNA-based microarray profiling, COMPARE analyses and signaling pathway analyses identified genes as determinants of sensitivity and resistance to curcumin and specific signaling routes involved in cellular response to curcumin. These genes may be useful as biomarkers to develop individualized treatment options in the future. From a nutritional point of view, it is a thriving perspective to further investigate whether C. longa may be used as a spice to improve cancer therapy.

Phytomedicine in otorhinolaryngology and pulmonology: clinical trials with herbal remedies.

Phytomedicine has become an important alternative treatment option for patients in the Western world, as they seek to be treated in a holistic and natural way after an unsatisfactory response to conventional drugs. Ever since herbal remedies have been introduced in the Western world, clinicians have raised concerns over their efficacy and possible side-effects. A PubMed (Medline) search was performed covering the last five years (01/07-04/12) and including 55 prospective clinical randomized control trials in the medical specialities Otorhinolaryngology and Pulmonology. In this review, we present evidence-based clinical data with herbal remedies and try to enlighten the question of efficacy and reliability of phytomedicine.

Cytotoxicity of Thymus vulgaris essential oil towards human oral cavity squamous cell carcinoma.

BACKGROUND: Oral cavity squamous cell carcinoma (OCSCC) accounts for 2% to 3% of all malignancies and has a high mortality rate. The majority of anticancer drugs are of natural origin. However, it is unknown whether the medicinal plant Thymus vulgaris L. (thyme) is cytotoxic towards head and neck squamous cell carcinoma (HNSCC). MATERIALS AND METHODS: Cytotoxicity of thyme essential oil was investigated on the HNSCC cell line, UMSCC1. The IC50 of thyme essential oil extract was 369 µg/ml. Moreover, we performed pharmacogenomics analyses. RESULTS: Genes involved in the cell cycle, cell death and cancer were involved in the cytotoxic activity of thyme essential oil at the transcriptional level. The three most significantly regulated pathways by thyme essential oil were interferon signaling, N-glycan biosynthesis and extracellular signal-regulated kinase 5 (ERK5) signaling. CONCLUSION: Thyme essential oil inhibits human HNSCC cell growth. Based on pharmacogenomic approaches, novel insights into the molecular mode of anticancer activity of thyme are presented.

Chemical Composition and antiproliferative activity of essential oil from the leaves of a medicinal herb, Levisticum officinale, against UMSCC1 head and neck squamous carcinoma cells.

BACKGROUND: Oral squamous cell carcinoma (OSCC) is a challenging disease with a high mortality rate. Natural products represent a valuable source for the development of novel anticancer drugs. We investigated the cytotoxic potential of essential oil from the leaves of a medicinal plant, Levisticum officinale (lovage) on head and neck squamous carcinoma cells (HNSCC). MATERIALS AND METHODS: Cytotoxicity of lovage essential oil was investigated on the HNSCC cell line, UMSCC1. Additionally, we performed pharmacogenomics analyses. RESULTS: Lovage essential oil extract had an IC50 value of 292.6 µg/ml. Genes involved in apoptosis, cancer, cellular growth and cell cycle regulation were the most prominently affected in microarray analyses. The three pathways to be most significantly regulated were extracellular signal-regulated kinase 5 (ERK5) signaling, integrin-linked kinase (ILK) signaling, virus entry via endocytic pathways and p53 signaling. CONCLUSION: Levisticum officinale essential oil inhibits human HNSCC cell growth.

Natural products derived from traditional chinese medicine as novel inhibitors of the epidermal growth factor receptor.

The epidermal growth factor receptor (EGFR) has become an important molecular target in cancer therapy. Various small molecules and therapeutic antibodies targeting EGFR family members have been developed during recent years and are established in clinical oncology. However, increasing clinical application of EGFR tyrosine kinase inhibitors has resulted in the development of resistance to EGFR-targeting drugs due to the selection of EGFR-mutated variants. This phenomenon forced the search for novel EGFR inhibitors with activity towards EGFR-mutant tumors. This review describes recent achievements in natural products derived from medicinal plants as novel EGFR inhibitors.

Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study.

BACKGROUND: Nasal congestion is one of the most common complaints dealt with in otorhinolaryngology. Side effects of decongestants are frequently seen in patients with chronic nasal congestion. This leads to an increasing demand of alternative treatments such as acupuncture. Future studies on acupuncture should aim at objectifying effects by both physical measuring and double blinding. Therefore, we were interested in whether these effects can potentially be measured as increase in nasal airflow (NAF) in ventus ("wind") disease of traditional Chinese medicine (TCM). METHODS: Twenty-four patients with a history of nasal congestion due to hypertrophic inferior turbinates or chronic sinusitis without polyposis were additionally diagnosed according to the Heidelberg model of TCM. They were asked to score the severity of their nasal congestion on a visual analog scale (VAS). The acupuncturist was blinded according to the Heidelberg blinding assay. NAF was measured by using active anterior rhinomanometry (ARM). Specific verum acupoints according to the Chinese medical diagnosis were tested against nonspecific control acupoints. VAS and NAF were scored and measured before and 15 and 30 minutes after acupuncture. RESULTS: Control acupuncture showed a significant improvement in VAS and a deterioration of NAF. Verum acupuncture showed highly significant improvements in VAS and NAF. In addition, verum acupuncture improved NAF and VAS significantly over time. CONCLUSION: Our control and verum acupoints fulfill the condition of a control and verum treatment, respectively. Measuring NAF by RRM and scoring VAS are possible and reflect acupuncture effects in vivo.

Additional use of acupuncture to NSAID effectively reduces post-tonsillectomy pain.

Post-tonsillectomy swallowing pain is a common and distressing side effect after tonsillectomy and thus of great clinical interest. Up until now, there is no randomized controlled patient- and observer-blinded study evaluating the efficacy of acupuncture against swallowing pain after tonsillectomy. We therefore compared the potency of specific verum acupuncture points related to a Chinese medical diagnosis in reducing postoperative swallowing pain with non-specific control points on the body as well as a non-acupuncture group who received standard medication only. The standardized pain therapy after tonsillectomy was orally administered nonsteroidal anti-inflammatory drugs (NSAID) (diclofenac 3 x 50 mg oral). The patients (n = 123) treated with NSAID were asked about their acute pain after taking a sip of water between the first and fifth postoperative day. Participants' pain was assessed using visual analog (VAS) [zero (0) for no pain up to ten (10) for the acute reported outset pain] before and 20 min, 1, 2 and 3 h after acupuncture treatment or standard pain medication, respectively. The functional assessment of diagnosis and treatment point-combination occurred by means of the "Heidelberg Model" of Traditional Chinese Medicine (TCM). Verum acupuncture lead to a significant additional pain relief. In comparison to the acupuncture, they also reported an average of 3 h duration of adequate pain-relief past taking the NSAID. This trial strongly supports a specific acupuncture scheme for the treatment of postoperative swallowing pain after tonsillectomy. It may particularly serve as an alternative pain treatment in case of NSAID intolerances.