Complications related to induced abortion: a combined retrospective and longitudinal follow-up study.

BACKGROUND: Induced abortion is one of the most common gynecological procedures in Sweden, but there is still little knowledge about the adverse effects. The aims of this study are to provide an overview of complications of medical and surgical abortions and to evaluate the impact of bacterial screening to prevent postabortal infections. METHODS: All women who underwent induced abortion at Skaraborg Hospital between 2008 and 2015 are included in the study. Bacterial screening for chlamydia, gonorrhea, mycoplasma, and bacterial vaginosis was performed prior to the abortions. Abortion complications, categorized as bleeding, infection, or incomplete abortion were assessed in women who came in contact with the gynecological clinic within 30 days after the procedure. RESULTS: A total of 4945 induced abortions were performed during the study period. Nearly all, 4945 (99.7%) were eligible for inclusion in the study. Medical abortions < 12 weeks were the most common procedure (74.7%), followed by surgical abortions (17.5%), and medical abortion > 12 weeks (7.8%). Complications were registered in 333 (6.7%) of all abortions. Among medical abortions < 12 weeks, the complication frequency increased significantly, from 4.2% in 2008 to 8.2% in 2015 (RR 1.49, 95% 1.04-2.15). An incomplete abortion was the most common complication related to medical abortions < 12 weeks. Of all women who tested positive for one or several bacteria at the screening and therefore received antibiotics, 1.4% developed a postabortal infection. Among those who tested negative at the screening, 1.7% developed infectious complications. CONCLUSIONS: The share of complications related to medical abortions < 12 weeks increased significantly during 2008-2015 without any evident cause. Women who tested positive for one or several bacteria upon screening and received antibiotics experienced almost an equal proportion of postabortal infections compared to women who tested negative upon screening. The screening process seems to fulfill its purpose of reducing the risk of infectious complications.

Effective connectivity in long-term EEG monitoring in preterm infants.

OBJECTIVE: Electroencephalogram (EEG) is commonly used to monitor brain activity in preterm neonates. Long-term EEG is used to predict outcomes by total band power. This study reports effective connectivity analyses in the fronto-parietal network in preterm infants. METHOD: Directed transfer functions (DTFs) were used in fully automated calculations of effective connectivity. Continuous eight-channel EEG recordings were performed for three full days starting at a median of 5.3h (2.5-11.2h) after birth. Analyses were performed using the channels Fp1, Fp2, P3 and P4. DTF were calculated every second in every connection and channel for all frequencies from 1 Hz to 30 Hz. The median connectivity was used in the connectivity assessment. RESULTS: Parieto-frontal connectivity was significantly higher (0.22) than fronto-parietal connectivity (0.05). There was a significant decrease in parieto-frontal connectivity between day one (0.18) and three. Conversely, there was a significant increase in fronto-parietal connectivity from day one to day three (0.07). CONCLUSION: Significant changes are seen in connectivity from day one to three, but there were no certain connectivity differences between gestational ages. SIGNIFICANCE: A rapid change in fronto-parietal connectivity was seen from day one to three which may indicate fast postpartum maturation.

The effect of blood glucose and pCO2 on spectral EEG of premature infants during the first three days of life.

BACKGROUND: Spectral EEG analysis using automated quantification of total absolute band power (tABP) expresses brain function. We hypothesized that pCO2 or blood glucose affects tABP during the critical first days of life in premature infants. OBJECTIVE: To use automated tABP quantification to determine whether EEG background activity in premature infants during the first 3 days of life is influenced by pCO2 or blood glucose levels. METHODS: Preterm infants, group 1 [gestational age (GA) = 24-27 weeks] and group 2 (GA = 28-30 weeks), underwent continuous EEG monitoring for 3 days after birth. Biochemical data were extracted from the observational datasheet used during monitoring. Blood samples were taken at the request of the attending physician. Statistical analyses were performed as repeated measurements using linear mixed models with a random intercept. The effect of time was treated as a fixed covariate and the GA groups as a fixed factor in all models. Continuous data were described using the mean ± SD or median and range, and categorical data were described using the number of patients and percentages unless otherwise indicated. RESULTS: There was an association between increased pCO2 and tABP and between increased blood glucose and tABP. Further, there were no differences in the responses between groups 1 and 2. CONCLUSION: Both hyperglycemia and hypercapnia showed a negative effect on brain activity decreasing tABP during the first 3 days of life in premature infants.

Automated spectral EEG analyses of premature infants during the first three days of life correlated with developmental outcomes at 24 months.

BACKGROUND: Spectral EEG analysis using automated quantification of total absolute band power (tABP) for long-term brain monitoring is reliable. We hypothesised that tABP during the first critical days of life could be a useful tool for predicting later developmental outcomes. OBJECTIVE: To determine whether measuring EEG background activity in premature infants with automated tABP quantification during the first 3 days of life correlated with their developmental outcomes at 24 months. METHODS: Preterm infants (group 1, gestational age, GA 24-28 weeks and group 2, GA 28-31 weeks) were continuously monitored by EEG for 3 days after birth. Their developmental outcomes were assessed using the Bayley-II and Peabody-2 developmental tests at 24 months. Their respective indices were calculated. Normal (index ≥85) and abnormal (index <85) outcomes were correlated with the tABP. RESULTS: In group 1, the tABP was significantly lower in the abnormal infants than in the normal infants. The specificity and negative predictive value were also high for all of the tests that were applied in this group. In group 2, there was no correlation between the tABP and developmental outcome. CONCLUSION: This study found that extremely premature infants with poor developmental outcomes had significantly lower tABP values in their first days of life compared to infants from the same group with normal outcomes. This method may be useful in predicting later outcomes in extremely premature infants and has the advantage of being automated.

Previous maternal infection protects offspring from enterovirus infection and prevents experimental diabetes development in mice.

AIMS/HYPOTHESIS: Enterovirus (e.g. Coxsackie B virus serotypes [CVBs]) infections may be associated with development of type 1 diabetes. Studies conducted in several European countries have, however, shown an inverse correlation between the incidence of type 1 diabetes and the prevalence of enterovirus infections. These findings could in part be explained by an extension of the poliovirus hypothesis, suggesting that the absence of maternally transferred antibodies protecting offspring from early infection increases the risk for diabetes development. Experimental evidence supporting this hypothesis in type 1 diabetes is, however, lacking. As maternally transferred protection from infection is a crucial component of the extended poliovirus hypothesis, we here tested the hypothesis that previously infected females transfer protection against infection and diabetes to offspring. METHODS: The induction of CVB-specific maternal antibodies and transfer of protection from virus infection, replication and development of virus-induced diabetes to offspring was assessed using NOD and Socs1-transgenic NOD mice. RESULTS: Infected mice produced neutralising antibodies to CVB. Offspring from infected females were positive for neutralising antibodies and were strongly protected from both infection and experimental diabetes. CONCLUSIONS/INTERPRETATION: Our study shows that maternally transferred antibodies protect offspring from enterovirus infection and virus-induced diabetes. This suggests that the absence of maternally provided protection increases the risk for severe outcomes after an enterovirus infection in offspring. Moreover, our findings may have implications for the design of prospective studies aimed at investigating the possible role of enterovirus infections in the aetiology of human type 1 diabetes.

Application of a computational model of vagus nerve stimulation.

OBJECTIVES: The most widely used and studied neurostimulation procedure for medically refractory epilepsy is vagus nerve stimulation (VNS) Therapy. The goal of this study was to develop a computational model for improved understanding of the anatomy and neurophysiology of the vagus nerve as it pertains to the principles of electrical stimulation, aiming to provide clinicians with a systematic and rational understanding of VNS Therapy. MATERIALS AND METHODS: Computational modeling allows the study of electrical stimulation of peripheral nerves. We used finite element electric field models of the vagus nerve with VNS Therapy electrodes to calculate the voltage field for several output currents and studied the effects of two programmable parameters (output current and pulse width) on optimal fiber activation. RESULTS: The mathematical models correlated well with strength-duration curves constructed from actual patient data. In addition, digital constructs of chronic versus acute implant models demonstrated that at a given pulse width and current combination, presence of a 110-µm fibrotic tissue can decrease fiber activation by 50%. Based on our findings, a range of output current settings between 0.75 and 1.75 mA with pulse width settings of 250 or 500 µs may result in optimal stimulation. CONCLUSIONS: The modeling illustrates how to achieve full or nearly full activation of the myelinated fibers of the vagus nerve through output current and pulse width settings. This knowledge will enable clinicians to apply these principles for optimal vagus nerve activation and proceed to adjust duty cycle and frequency to achieve effectiveness.

Reducing the bias of causality measures.

Measures of the direction and strength of the interdependence between two time series are evaluated and modified to reduce the bias in the estimation of the measures, so that they give zero values when there is no causal effect. For this, point shuffling is employed as used in the frame of surrogate data. This correction is not specific to a particular measure and it is implemented here on measures based on state space reconstruction and information measures. The performance of the causality measures and their modifications is evaluated on simulated uncoupled and coupled dynamical systems and for different settings of embedding dimension, time series length, and noise level. The corrected measures, and particularly the suggested corrected transfer entropy, turn out to stabilize at the zero level in the absence of a causal effect and detect correctly the direction of information flow when it is present. The measures are also evaluated on electroencephalograms (EEG) for the detection of the information flow in the brain of an epileptic patient. The performance of the measures on EEG is interpreted in view of the results from the simulation study.

Acute postoperative seizures after epilepsy surgery - a long-term outcome predictor?

OBJECTIVES: The prognostic value of acute postoperative seizures (APS) after epilepsy surgery is much debated. This study evaluated APS, defined as seizures in the first week post-surgery, as a predictor of long-term seizure outcome, and investigated the utility of other potential outcome predictors. MATERIALS AND METHODS: Medical records of 48 patients with temporal and extra-temporal epilepsy surgery were studied. Forty patients had lesional surgery. All had at least 2 year postoperative follow-up. RESULTS: At 2 year follow-up, 25 patients (53%) were seizure free. Univariate analysis showed that APS (P = 0.048), using ≥ six AEDs prior to surgery (P = 0.03), pathological postoperative EEG (P = 0.043) and female gender (P = 0.012) were associated with seizure recurrence. CONCLUSIONS: Univariate analysis indicate that APS, a high number of AEDs used prior to surgery, and pathological postoperative EEG are possible predictors of seizure recurrence after epilepsy surgery. Only gender retained significance in the multivariate analysis.

Variability in diagnosis of clue cells, lactobacillary grading and white blood cells in vaginal wet smears with conventional bright light and phase contrast microscopy.

OBJECTIVE: Study the reproducibility of wet smear interpretation of clue cells, lactobacillary grades and leukocyte dominance with conventional bright light and phase contrast microscopy. STUDY DESIGN: Sets of vaginal specimens were taken from unselected consecutive women attending an outpatient gynaecology clinic. Air-dried vaginal fluid on a microscope slide was rehydrated with isotonic saline before examination by six independent international investigators. Some investigators initially used a conventional bright light microscope, followed by phase contrast technique. RESULTS: Using phase contrast microscopy, an excellent inter-observer agreement was obtained among all investigators for clue cells detection (Kappa values from 0.69 to 0.94) and lactobacillary grades (Kappa 0.73-0.93). When conventional light microscopes were used, poor agreement was obtained for these criteria (Kappa index 0.37-0.72 and 0.80, respectively), but switching to phase contrast microscopy by the same investigators, improved Kappa to 0.83-0.85 and 0.88, respectively. The inter-observer agreement for estimation of the leukocyte/epithelial cell ratio (Kappa index 0.17-0.67) was poor, irrespective of the type of microscopy applied. Intra-observer agreement of clue cell detection and lactobacillary grading was also found to be excellent if phase contrast microscopy was used (Kappa 0.87-0.93), and poor with conventional bright light microscopy (Kappa 0.45-0.66). CONCLUSION: Clue cells and the lactobacillary grades are reliably identified by phase contrast microscopy in wet smears, with excellent intra- and inter-observer reproducibility agreement, and better than when simple bright light microscopy was used. Evaluation of leukocyte grading, on the other hand, was inconsistent among the different microscopists, irrespective of the type of microscope used. We propose to grade the leukocytes in a different way than searching for leukocyte dominance over epithelial cells, namely by counting them per high power field and per epithelial cell.

Predisposing factors for bacterial vaginosis, treatment efficacy and pregnancy outcome among term deliveries; results from a preterm delivery study.

BACKGROUND: Bacterial vaginosis (BV) during pregnancy is associated with an increased risk of preterm delivery but little is known about factors that could predict BV. We have analyzed if it is possible to identify a category of pregnant women that should be screened for BV, and if BV would alter the pregnancy outcome at term; we have also studied the treatment efficacy of clindamycin. METHODS: Prospective BV screening and treatment study of 9025 women in a geographically defined region in southeast Sweden. BV was defined as a modified Nugent score of 6 and above. Data was collected from the Swedish Medical Birth Register. Women allocated to treatment were supplied with vaginal clindamycin cream. The main outcome goals were to identify factors that could predict BV. RESULTS: Vaginal smears were consistent with BV criteria in 9.3%. Logistic regression indicates a significant correlation between smoking and BV (p < 0.001) and a greater prevalence of BV in the lower age groups (p < 0.001). We found no correlation between BV and history of preterm deliveries, previous miscarriages, extra-uterine pregnancies, infertility problems or reported history of urinary tract infections-factors that earlier have been associated with BV. Treatment with clindamycin cream showed a cure rate of 77%. Less than 1% of women with a normal vaginal smear in early pregnancy will develop BV during the pregnancy. There was no association between BV and the obstetric outcome among women who delivered at term. Women with BV, both treated patients and nontreated, had the same obstetric outcome at term as women with normal vaginal flora. CONCLUSION: BV is more than twice as common among smokers, and there is a higher prevalence in the younger age group. However these two markers for BV do not suffice as a tool for screening, and considering the lack of other risk factors associated with BV, screening of all pregnant women might be a strategy to follow in a program intended to reduce the number of preterm births.

Validation of the use of Pap-stained vaginal smears for diagnosis of bacterial vaginosis.

Papanicolaou-stained cervicovaginal smears (Pap smears) are used to screen for cervical cancer. Since there is a lack of consensus in published reports respecting the efficacy of Pap-stained smears in BV diagnostics, there is a need to validate their use for diagnosis of BV. Slides from the international BV00 workshop were Pap stained and independently analyzed by four investigators under a phase-contrast microscope. All workshop slides--whether Pap-stained, Gram-stained or rehydrated air-dried smears--were scored according to the same Nugent classification. The diagnostic accuracy of Pap smears for diagnosis of BV had a sensitivity of 0.85 and a specificity of 0.92, with a positive and negative predictive value of 0.84 and 0.93, respectively. The interobserver weighted kappa index was 0.86 for Pap-stained smears compared to 0.81 for Gram-stained smears, and 0.70 for rehydrated air-dried smears using the mean Nugent score as the criterion standard. Provided that the samples are taken from equivalent locations (the vaginal fornix) and analyzed according to the same scoring criteria, there is no discernable difference in the diagnostic accuracy of the three smear-staining methods. The Pap-stained vaginal smears can be used as a wholly adequate alternative to Gram-stained smears for BV diagnosis.

Is vagus nerve stimulation a treatment option for patients with drug-resistant idiopathic generalized epilepsy?

BACKGROUND: The value of vagus nerve stimulation (VNS) for treating patients with drug-resistant idiopathic generalized epilepsy (IGE) is not well documented. PATIENTS AND METHODS: Twelve patients (2 males, 10 females) with a mean age of 31 years (11-48 years) and with drug-resistant IGE had VNS implanted in the period 1995-2006. All had generalized seizures documented by video-electroencephalogram. Mean follow-up period was 23 months (9-54 months). RESULTS: There was a total seizure reduction of 61% (P = 0.0002). There was 62% reduction of generalized tonic-clonic seizures (P = 0.0020), 58% of absences (P = 0.0003) and 40% of myoclonic seizures (P = 0.0156). Eight patients were considered responders (>50% seizure reduction); two of these patients became seizure-free. Five out of seven patients with juvenile myoclonic epilepsy were responders. At the last follow-up visit, the patients had reduced the anti-epileptic drug (AED) usage from an average of 2.3 to 1.7 AED per patient (P = 0.0625). Two patients are currently being treated with VNS therapy only. Nine patients reported side effects, which were mostly mild and tended to diminish over time. CONCLUSION: Our results indicate that adjunctive VNS therapy is a favourable treatment option for patients with drug-resistant IGE. Rapid cycling seems worth trying in some of the non-responders.

Use of pH/whiff test or QuickVue Advanced pH and Amines test for the diagnosis of bacterial vaginosis and prevention of postabortion pelvic inflammatory disease.

BACKGROUND: Untreated bacterial vaginosis (BV) is a risk factor for postabortion pelvic inflammatory disease (PID). METHODS: Eight hundred and eight women who requested therapeutic abortion were consecutively examined for the presence of BV, using either pH/whiff test or QuickVue Advanced pH and Amines test. All patients who tested positive to BV were treated with clindamycin or metronidazole prior to abortion. RESULTS: Based on the wet smear examination, the incidence of BV was 21.6%. Positive pH and whiff test had a sensitivity of 53%, specificity of 98% and Kappa index 0.59 (n=239). Values for QuickVue Advanced pH and Amines test were 53%, 97%, and 0.58 respectively (n=508). The incidence of PID among all patients was 2.4% after pharmacological abortion and 4.9% after surgical abortion. Among the patients with microscopic presence of BV diagnosed positive by the pH/whiff test or QuickVue Advanced pH and Amines test and treated with antibiotics, no PID occurred. Patients with negative pH/whiff test or QuickVue pH and amines test who consequently did not receive preoperative antibiotics, but who later demonstrated microscopic presence of BV, had an incidence of 14.3% (5/35) postoperative PID compared to women with normal lactobacilli flora 4.3% (10/234) (OR 3.73; 95% CI 1.21-9.21). CONCLUSIONS: Although the pH/whiff test and QuickVue pH and Amines test failed to ascertain BV in almost half of the participants later found to have BV, we found that preabortal screening and subsequent treatment of those who test clinically positive does lower the incidence of postabortion PID.

Late miscarriage and preterm birth after treatment with clindamycin: a randomised consent design study according to Zelen.

OBJECTIVE: To screen for bacterial vaginosis (BV) and to investigate the effect of treatment with vaginal clindamycin in order to observe the effect on late miscarriage and delivery prior to 37 completed weeks (primary outcome). DESIGN: Randomised consent design for clinical trials according to Zelen. SETTING: Southeast region of Sweden. POPULATION: A total of 9025 women were screened in early pregnancy. METHODS: A total of 819 women with a Nugent score of 6 and above were considered to have BV and treated according to Zelen allocation. The incidence of late miscarriage and spontaneous (noniatrogenic) preterm birth was assessed. MAIN OUTCOME MEASURES: Late miscarriage and spontaneous preterm delivery before 37 weeks. RESULTS: Therapy with vaginal clindamycin had no significant impact on the incidence of spontaneous preterm delivery prior to 37 completed weeks; OR 0.90, 95% CI 0.40-2.02 (primary outcome variable). However, only 1 of 11 women in the treatment group versus 5 of 12 in the control group delivered prior to 33 completed weeks; OR 0.14, 95% CI 0.02-0.95. Treatment was associated with 32 days longer gestation for the 23 participants who had late miscarriage or spontaneous preterm birth (P= 0.024, Mann-Whitney U test) and significantly fewer infants had a birthweight below 2,500 g (secondary outcome). A follow up of infants born preterm 4 years postnatally indicated that extending gestational age did not increase the number of sequelae. CONCLUSIONS: Clindamycin vaginal cream therapy was associated with significantly prolonged gestation and reduced cost of neonatal care in women with BV. Early screening for BV and treatment with clindamycin saved approximately 27 euro per woman.

The value of multichannel MEG and EEG in the presurgical evaluation of 70 epilepsy patients.

OBJECTIVE: To evaluate the sensitivity of a simultaneous whole-head 306-channel magnetoencephalography (MEG)/70-electrode EEG recording to detect interictal epileptiform activity (IED) in a prospective, consecutive cohort of patients with medically refractory epilepsy that were considered candidates for epilepsy surgery. METHODS: Seventy patients were prospectively evaluated by simultaneously recorded MEG/EEG. All patients were surgical candidates or were considered for invasive EEG monitoring and had undergone an extensive presurgical evaluation at a tertiary epilepsy center. MEG and EEG raw traces were analysed individually by two independent reviewers. RESULTS: MEG data could not be evaluated due to excessive magnetic artefacts in three patients (4%). In the remaining 67 patients, the overall sensitivity to detect IED was 72% (48/67 patients) for MEG and 61% for EEG (41/67 patients) analysing the raw data. In 13% (9/67 patients), MEG-only IED were recorded, whereas in 3% (2/67 patients) EEG-only IED were recorded. The combined sensitivity was 75% (50/67 patients). CONCLUSION: Three hundred and six-channel MEG has a similarly high sensitivity to record IED as EEG and appears to be complementary. In one-third of the EEG-negative patients, MEG can be expected to record IED, especially in the case of lateral neocortical epilepsy and/or cortical dysplasia.

3T phased array MRI improves the presurgical evaluation in focal epilepsies: a prospective study.

BACKGROUND: Although detection of concordant lesions on MRI significantly improves postsurgical outcomes in focal epilepsy (FE), many conventional MR studies remain negative. The authors evaluated the role of phased array surface coil studies performed at 3 Tesla (3T PA MRI). METHODS: Forty patients with medically intractable focal epilepsies were prospectively imaged with 3T PA-MRI including high matrix TSE T2, fluid attenuated inversion recovery, and magnetization prepared rapid gradient echo. All patients were considered candidates for epilepsy surgery. 3T PA-MRIs were reviewed by a neuroradiologist experienced in epilepsy imaging with access to clinical information. Findings were compared to reports of prior standard 1.5T MRI epilepsy studies performed at tertiary care centers. RESULTS: Experienced, unblinded review of 3T PA-MRI studies yielded additional diagnostic information in 48% (19/40) compared to routine clinical reads at 1.5T. In 37.5% (15/40), this additional information motivated a change in clinical management. In the subgroup of patients with prior 1.5T MRIs interpreted as normal, 3T PA-MRI resulted in the detection of a new lesion in 65% (15/23). In the subgroup of 15 patients with known lesions, 3T PA-MRI better defined the lesion in 33% (5/15). CONCLUSION: Phased array surface coil studies performed at 3 Tesla read by an experienced unblinded neuroradiologist can improve the presurgical evaluation of patients with focal epilepsy when compared to routine clinical 1.5T studies read at tertiary care centers.

Bacterial vaginosis--a disturbed bacterial flora and treatment enigma.

The syndrome bacterial vaginosis (BV) is characterized by a disturbed vaginal microflora in which the normally occurring lactobacilli yield quantitatively to an overgrowth of mainly anaerobic bacteria. As BV is a possible cause of obstetrics complications and gynaecological disease--as well as a nuisance to the affected women--there is a strong impetus to find a cure. In BV treatment studies, the diagnosis criteria for diagnosis of BV vary considerably and different methods are used for cure evaluation. The design of study protocols varies and there is no consensus respecting a suitable time for follow-up visits. For the purpose of this review, available data were recalculated for 4-week post treatment cure rates. For oral metronidazole the 4-week cure rate was found not to exceed 60-70%. Treatment regimens with topical clindamycin or topical metronidazole have the same cure rates. It can thus be said that no sound scientific basis exists for recommending any particular treatment. There is no evidence of beneficial effects on BV engendered by partner treatment, or by addition of probiotics or buffered gel. Long-term follow-up (longer than 4 weeks) shows a relapse rate of 70%. With a primary cure rate of 60-70%, and a similar relapse rate documented in the reviewed literature, clinicians simply do not have adequate data for determining treatment or designing clinical studies. This is unfortunate since--apart from the obvious patient benefits--clinical studies can often serve as a guide for more basic studies in the quest for underlying disease mechanisms. In the case of BV there is still a need for continued basic studies on the vaginal flora, local immunity to the flora and host-parasite interactions as an aid when designing informative clinical studies.

Comparison of traditional Chinese acupuncture, minimal acupuncture at non-acupoints and conventional treatment for chronic sinusitis.

OBJECTIVES: To compare traditional Chinese acupuncture, minimal acupuncture at non-acupoints and conventional treatment for chronic sinusitis. DESIGN: A three-armed single blind randomised controlled study. SETTING: In an outpatient specialist clinic, we recruited 65 patients with symptoms of sinusitis >3 months and signs of sinusitis on computed tomography (CT). INTERVENTIONS: We randomised patients to one of three study arms: (1) 2-4 weeks of medication with antibiotics, corticosteroids, 0.9% sodium chloride solution, and local decongestants (n=21), (2) 10 treatments with traditional Chinese acupuncture (n=25), or (3) 10 treatments with minimal acupuncture at non-acupoints (n=19). OUTCOME MEASURES: Change in sinus soft tissue swelling on CT, symptoms of sinusitis, and health-related quality of life (HRQoL), using the two component summary scales of the Short Form 36 and a rating scale. RESULTS: In the conventional treatment group, sinus soft tissue swelling was reduced over 4 weeks (p=0.04), and HRQoL improved over 12 weeks (p=0.01-0.05). Pairwise comparisons of changes in total symptom score between the groups showed signs of a difference between conventional medication and sham over 4 weeks (p=0.06). CONCLUSION: Sinus soft tissue swelling was reduced in the conventional treatment group over 4 weeks, and HRQoL improved over 12 weeks. Only a non-significant difference in symptom score change over 4 and 12 weeks was shown between conventional medication and traditional Chinese acupuncture.