Comparison of Efficacy and Safety of a Bevacizumab Biosimilar, in Combination with Chemotherapies, in Nonresectable Metastatic Colorectal Cancer and in Advanced Nonsquamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study.

Ranjith K.The objective of this study was to compare the efficacy, safety, pharmacokinetics, and immunogenicity of a proposed bevacizumab biosimilar (DRL_BZ) with the innovator Avastin (reference medicinal product [RMP]) in patients with nonresectable metastatic colorectal cancer (mCRC) over a period of 9 months and advanced nonsquamous non-small cell lung cancer (NSCLC) over 6 months. The study was planned as a randomized, double-blind trial. In part A, a total of 117 mCRC patients were intended to receive 5 mg/kg of bevacizumab every 2 weeks along with mFOLFOX6 chemotherapy for a maximum of 18 cycles. In part B, 60 NSCLC patients were to receive 15 mg/kg of bevacizumab every 3 weeks along with pemetrexed and carboplatin for the initial four cycles, followed by pemetrexed for another four cycles. The primary endpoint was the progression-free survival rate at 6 months (PFS6) in both subparts. The anticipated sample size was 106 evaluable mCRC patients to achieve 85% statistical power for concluding noninferiority with a margin of half the difference (18.8%) between DRL_BZ and Avastin, along with a pilot study involving 60 evaluable NSCLC patients. Safety comparison included assessing adverse events (AEs), infusion reactions, and lab abnormalities. Immunogenicity comparison involved the incidence of antidrug antibodies (ADAs) and neutralizing antibodies (NAbs). Pharmacokinetic comparison was planned after the first and fourth dosing cycles of treatment in 24 NSCLC patients. The PFS6 for mCRC patients treated with DRL_BZ and RMP was 57.8% and 50% respectively, with a difference in efficacy of 7.8 (-8.7, 23.7). The PFS9 was 31.1% and 22.9%, with a difference of 8.2% (-6.9%, 22.9%). The objective response rate (ORR) for DRL_BZ and RMP was 28.8% and 22.4%, while the disease control rate (DCR) was 44.2% and 37.9% respectively. For NSCLC patients, the PFS6 was 44% and 45%, showing a difference of -1.0 (-4.2, 22.1). The ORR was 41.4% and 48.1%, and the DCR was 62.1% and 63%. The frequency, type, and severity of AEs were similar in both indications. Blood levels during the first and fourth dosing cycles exhibited comparable values. All NSCLC patients tested negative for ADA, while no mCRC patients on DRL_BZ tested positive for ADA. Low incidences of ADA (8%) and NAbs (4.0%) were reported in patients on RMP. Overall, the efficacy, safety, immunogenicity, and pharmacokinetic parameters of DRL_BZ and RMP were found to be comparable. Clinical Trial Registration For BZ-01-002: CTRI/2016/01/006481.

Case report: A novel case of paraneoplastic voltage gated calcium channel antibodies secondary to appendiceal adenocarcinoma.

Voltage gated calcium channels (VGCCs) play a critical role in neural transmission. Antibodies that target these ion channels can disrupt cellular signal transmission resulting in various clinical presentations. VGCC antibodies are most commonly associated with paraneoplastic syndromes such as Lambert-Eatons myasthenic syndrome. Here, we report a 47-year-old female with Stage IV appendiceal adenocarcinoma status post appendectomy and right hemicolectomy, who presented with progressive memory impairment, aphasia, ataxia, weakness, and headache. Neurologic exam was notable for right-sided parietal drift, decreased right arm swing, and ataxia of the bilateral upper extremities, more prominent on the right side. MRI of the brain with and without contrast was unremarkable. Cerebrospinal fluid (CSF) was notable for an elevated myelin basic protein (4.9 ng/mL, normal reference 0.0-3.7 ng/mL) with normal cell count, flow cytometry, and cytology. An extensive serum autoimmune neurology antibody evaluation revealed elevated VGCC autoantibodies (observed value: 96.1 pmol/L, normal range 0.0-30.0 pmol/L). A diagnosis of paraneoplastic voltage gated calcium channel antibodies secondary to appendiceal adenocarcinoma was made. The patient was treated with five exchanges with plasmapheresis over 10 days with significant clinical improvement in her symptoms. Upon literature review, this would be the first reported case of VGCC antibodies associated with appendiceal adenocarcinoma.

Duodenal Adenocarcinoma in a patient with Lynch Syndrome. A Case Report and Facts Related to Small Intestine Cancer.

Diagnosing small bowel cancer has been challenging due to its unusual presentation and inaccessibility on endoscopy. A 41-year-old male with a history of irritable bowel syndrome underwent esophagogastroduodenoscopy (EGD) for worsening fatigue and lightheadedness despite iron supplements therapy for low hemoglobin. Initial upper endoscopy showed esophagitis and non-bleeding duodenal bulb ulcer with exudate. Endoscopic ultrasound (EUS) with fine-needle aspiration was done due to persistent concern of malignancy and demonstrated moderately differentiated adenocarcinoma in the second portion of the duodenum. Endoscopic ultrasound with fine-needle aspiration may be a superior approach to diagnosing duodenal carcinoma than EGD alone. Small bowel cancer can be a part of the tumor spectrum of Lynch syndrome. Duodenal adenocarcinomas present at a late stage and portend a poor prognosis. We present a case of duodenal adenocarcinoma in an otherwise healthy individual emphasizing the importance of malignancy in the differential and genetic counseling in individuals with the family risk factor.

A newer approach in the treatment of seborrheic dermatitis with QR678® and QR678 Neo®-A prospective pilot study.

BACKGROUND: Seborrheic dermatitis is a common chronic inflammatory skin disorder that affects the scalp and is characterized by erythema and oily scales. It could perhaps be difficult to control and could seriously degrade one's quality of life. The study's objective is to assess the effectiveness of intradermal administrations of QR678 Neo® hair growth factor therapy for the treatment of scalp seborrheic dermatitis in both men and women. METHOD: Forty male and female patients with clinically diagnosed seborrheic dermatitis of the scalp in the age 18-45 years, not satisfactorily responding to standard therapy for at least 6 months, were included. 1 mL solution of QR678 Neo® was administered in the scalp skin of all patients at 3-week interval till eight sessions. Patients were advised to continue with antifungal shampoo and topical antifungal solution with steroid combination which they had been on during the treatment. Assessment of disease severity, dermoscopic evaluation, and self-assessment were done at baseline and at the end of the fourth and the eighth sessions. RESULTS: Improvement was observed in adherent scalp flaking score after eighth session (mean = 12) compared to baseline (mean = 60). The dermoscopic evaluation showed a noticeable difference from baseline (mean = 11) in erythema and scaling with the Seborrheic Dermatitis Scalp Severity Index tool at the end of treatment (mean = 2). A high satisfaction score was given for the efficiency in the self-assessment questionnaire. CONCLUSION: Our study proved that treatment with QR678 Neo® led to an improvement in the overall scalp condition by the resolution of flaking and inflammation.

Acquiring the Diagnosis of an Acquired Tracheoesophageal Fistula with EtCO2: A Case Discussion with Review of the Literature.

Acquired tracheoesophageal fistula (TEF) is a rare complication of esophageal or lung cancer. A 57-year-old male presented with complaints of vomiting, cough, 20 lb weight loss, and progressive dysphagia. Early laryngoscopy and CT chest showed a normal pharynx with an irregular thickness of the thoracic esophagus. The upper gastrointestinal endoscopy (UGIE) and upper endoscopic ultrasound (EUS) revealed a hypoechoic mass evolving as complete obstruction. During the procedure, minimal CO2 was used for insufflation; however, when attempts were made to traverse the obstruction, capnography revealed an end-tidal CO2 (EtCO2) estimating 90 mmHg indicating possible TEF. This case depicts the use of capnography during UGIE in diagnosing an acquired TEF.

Can Moxidectin Be an Anthelmintic Alternative for Trichuris trichiura and Strongyloides stercoralis: A Systematic Review.

Strongyloides stercoralis and Trichuris trichiura parasitic infections are two of the many neglected tropical diseases. These parasitic infections are of considerable public health relevance, particularly in resource-limited countries. Moxidectin, a well-established drug in veterinary medicine, is now a Food and Drug Administration (FDA) approved medication for human onchocerciasis. For the past five years, this medication has been under clinical trials to evaluate its efficacy and safetiness in other helminthic infections. Moxidectin might complement the already existing treatment and control of soil-transmitted helminthiasis (STH). Therefore, we systematically reviewed existing human interventional studies to evaluate the efficacy and safety of this medication when administered alone or in combination with other antiparasitic medications in order to achieve a cure.

Epidemiology, Burden, and Association of Substance Abuse Amongst Patients With Cardiovascular Disorders: National Cross-Sectional Survey Study.

BACKGROUND: Substance use disorders (SUDs) are considered to be a major risk factor for cardiovascular disorders (CVDs). In 2019, as per the National Drug Use and Health Survey (NSDUH), 20.4 million American adults suffered from a substance use disorder. The main purpose of this study is to determine the prevalence of several SUDs (cigarette smoking, cigar, smokeless tobacco, marijuana, cocaine/heroin/methamphetamine, and injectable illegal drug) amongst patients diagnosed with various CVDs (angina pectoris, myocardial infarction, and coronary heart disease). METHODS: This is a retrospective cross-sectional study carried out using the National Health and Nutrition Examination Survey (NHANES) database from 2013 to 2018, and respondents with CVDs were recognized using questionnaires. Different SUDs (active history) were identified amongst the adult population with a history of CVDs and without CVDs. Univariate analysis was performed using chi-square and unpaired t-test/Mann-Whitney test to identify characteristics of respondents with CVDs and mix effect multivariable logistic regression models were generated to find the prevalence of SUDs amongst the CVD population. Datasets were analyzed using Statistical Analysis System (SAS) software, and the p-value of < 0.05 was considered statistically significant. RESULTS: Of the 263465 respondents, 7.90% respondents were diagnosed with CVDs and were noted to be in older age group (median age: 69 years). CVDs were more prevalent amongst 66-years and above (19.36% vs. 45-64 years: 6.81% vs. 18-44 years: 1.17%), male (10.40% vs. female: 5.66%), Non-Hispanic White race (10.92%), and lower annual household income population (<$25000 vs. >$100,000:12.21% vs. 4.01%) (p<0.0001). When compared with respondents without a history of CVDs, respondents with a history of CVDs were noted to be more prevalent with a concurrent diagnosis of hypertension (85.98% vs. 79.53%), hypercholesterolemia (68.78% vs. 34.54%), diabetes (37.86% vs. 12.70%), stroke (17.4% vs. 2.71%), and congestive heart failure (28.80% vs. 1.31%) (p<0.0001). History of CVDs were more prevalent amongst the respondents using marijuana (overall 53.14%; CVD vs. no-CVD 65.42% vs. 52.81%; p<0.0001), cigarette smoking (60.47% vs. 40.41%; p<0.0001), cigar-smoking (47.05% vs. 35.58%; p<0.0001), methamphetamine/cocaine/heroin (23.82% vs. 16.71%; p<0.0001), smokeless tobacco use (18.53% vs. 14.59%; p<0.0001), and injectable illegal drug use (4.67% vs. 2.43%; p<0.0001). Additionally, prevalence of history of CVDs was almost double in respondents using cigarettes without filters (2.28% vs. 1.10%; p<0.0001) when compared with respondents using cigarettes with filters. CONCLUSION: Respondents who used marijuana or hashish, injectable illegal drugs, and e-cigars were at elevated risk for cardiovascular disorders. Providing situational awareness and offering a good support system can be a strategy to prevent the development of cardiovascular disorders among substance users.

Bioequivalence of a hybrid pegylated liposomal doxorubicin hydrochloride injection and Caelyx®: A single-dose, randomized, multicenter, open-label, two-period crossover study in patients with advanced ovarian cancer.

OBJECTIVE: To evaluate the bioequivalence of a hybrid pegylated liposomal doxorubicin (PLD) hydrochloride injection with reference product Caelyx®. METHODS: This multicenter, open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study was conducted in female patients aged ≥18 years and ≤75 years with ovarian cancer, whose disease progressed or recurred after platinum-based chemotherapy, and who were scheduled to start PLD therapy. Patients were intravenously infused drugs over 1 h at 50 mg/m2 dose two hours after breakfast on the first day of the chemotherapy cycle in period-I and crossed over to the other arm in period-II (day 29). Pharmacokinetic (PK) analyses were performed using two separate, validated liquid chromatography-mass spectrometry methods for encapsulated and unencapsulated doxorubicin. RESULTS: Both the test and reference formulations were well-tolerated and safe. The pharmacokinetic analysis for both encapsulated and unencapsulated doxorubicin was conducted in 50 patients and PK parameters were found to be comparable between test and reference products. The geometric mean ratios (90% confidence interval) of hybrid PLD/Caelyx® were; maximum measured plasma concentration (Cmax): 91.94-97.28%, area under the plasma concentration versus time from time 0 to t (AUC0-t): 95.19-103.67%, AUC from time 0 to ∞ (AUC0-∞): 95.13-103.66% for encapsulated doxorubicin and for unencapsulated doxorubicin Cmax: 92.08-116.46%, AUC0-t: 91.91-108.28%, AUC0-∞: 93.45-110.05%. CONCLUSION: The PLD formulation was found to be bioequivalent to Caelyx®.

Neuroimaging in the Rare Sleep Disorder of Kleine-Levin Syndrome: A Systematic Review.

Kleine-Levin syndrome (KLS) is characterized by episodes of hypersomnia. Additionally, these patients can present with hyperphagia, hypersexuality, abnormal behavior, and cognitive dysfunction. Functional neuroimaging studies such as fMRI-BOLD, Positron Emission Tomography (PET) or SPECT help us understand the neuropathological bases of different disorders. We conducted a systematic review to investigate the neuroimaging features of KLS patients and their clinical correlations. This systematic review was conducted by following the Meta-Analysis of Observational Studies in Epidemiology (MOOSE) and PRISMA protocol reporting guidelines. We aim to investigate the clinical correlation with neuroimaging among patients with KLS. We included only studies written in the English language in the last 20 years, conducted on humans; 10 studies were included. We excluded systematic reviews, metanalysis, and case reports. We found that there are changes in functional imaging studies during the symptomatic and asymptomatic periods as well as in between episodes in patients with K.L.S. The areas most reported as affected were the hypothalamic and thalamic regions, which showed hypoperfusion and, in a few cases, hyperperfusion; areas such as the frontal, parietal, occipital and the prefrontal cortex all showed alterations in cerebral perfusion. These changes in cerebral blood flow and regions vary according to the imaging (SPECT, PET SCAN, or fMRI) and the task performed while imaging was performed. We encountered conflicting data between studies. Hyper insomnia, the main feature of this disease during the symptomatic periods, was associated with decreased thalamic activity. Other features of K.L.S., such as apathy, hypersexuality, and depersonalization, were also correlated with functional imaging changes. There were also findings that correlated with working memory deficits seen in this stage during the asymptomatic periods. Hyperactivity of the thalamus and hypothalamus were the main features shown during the asymptomatic period. Additionally, functional imaging tends to improve with a longer course of the disease, which suggests that K.L.S. patients outgrow the disease. These findings should caution physicians when analyzing and correlating neuroimaging findings with the disease.

Pulvinar Sign, Stroke and Their Relationship with Fabry Disease: A Systematic Review and Metanalysis.

Background: Fabry disease (FD) is the second most common lysosomal storage disorder. This disorder affects multiple systems that include the cardiac, renal, and nervous system. The pulvinar sign (PS) is a relatively common sign seen in patients with FD. The PS is a bilateral, symmetrical pulvinar high signal relative to the signal intensity seen on unenhanced T1-weighted brain MR imaging. Methods: We conducted a systematic review with metanalysis to analyze the pool prevalence of the disorder. We used the Moose Guidelines and PRISMA Protocol for this systematic review and Robins 1 to access the BIAS of the study. To analyze the pool prevalence, we used "Open Meta-Analysis" software for analyzing the study. We used "Review Manager 5.4" to analyze the odds ratio between patients with and without the PS and patients with and without stroke among patients with FD. Results: We gather 12 studies from 2003 to 2021 for the analysis of this study. The pool prevalence of the study was 0.146 (0.076−0.217) (62/385 cases) with a 95% CI (0.0945−0.415) (p < 0.01). The prevalence was much higher in men (59 cases) than in women (3 cases). There was no relationship between the pulvinar sign and patients with stroke among patients with Fabry disease. Odds ratio 1.97 95% CI (0.35−11.21), p = 0.44; Tau2 = 0.77. There seems to be a correlation with renal failure (RF), but there were very few studies to conduct a metanalysis with RF. Conclusions: The prevalence of the PS among all studies was 23.9%; the prevalence of this sign is higher among males. We found that FD patients who had strokes did not have higher odds of presenting with the Pulvinar Sign than the FD patients who did not suffer a stroke. Patients with renal failure and FD seem to have a higher tendency to have the PS, but there were not enough studies to analyze that theory. Overall, we think the pulvinar sign has a poor prognostic value in patients with Fabry's disease.

Breast Cancer Secondary to Radiation Therapy in a Patient With Wilms Tumor.

Wilms tumor, one of the most common childhood malignancies, is typically treated with a combination of chemotherapy, radiation, and surgical resection. Wilms tumor survivors who received radiation therapy are, however, at a higher risk of secondary malignancies and need vigilant monitoring. We present the case of a 35-year-old female with history of Wilms tumor at age five, who received radiation therapy for pulmonary metastasis, and was found to have breast cancer at the age of 35. We discuss different protocols in treatment of Wilms tumor and current secondary malignancy screening recommendations. We also recognize the importance of screening guideline awareness among primary care physicians and its mortality and morbidity implications.

Gastric and Duodenal Neuroendocrine Tumor Incidentally Found on Endoscopy During the Evaluation of Iron-Deficiency Anemia.

Neuroendocrine tumors (NET) are a small fraction of overall gastrointestinal (GI) malignancies. Recently the incidence of NETs has increased due to advancements in diagnostic modality. While solid tumors are easily visible on routine endoscopy, identifying endocrine tumors can be difficult, and low incidence and non-specific presentation can be easily missed on upper gastrointestinal endoscopy (UGIE). The management differs based on the type of tumor and location, but the overall prognosis is good. We present a 59-year-old male with multiple NETs throughout the GI tract, diagnosed on repeat esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS) showing multiple gastric folds. A biopsy of multiple nodules was taken to diagnose type I NET with grade 2 differentiation finally. The mucosal nodules were resected with a band ligator, and surveillance endoscopy was recommended.

Effectiveness of QR678 and QR678 Neo® with intralesional corticosteroid vs. intralesional corticosteroid alone in the treatment of alopecia areata -A randomized, comparative, prospective study.

BACKGROUND: Alopecia areata (AA) is an inflammatory disorder, marked by chronic, persistent, and patchy loss of hair. At present intralesional/topical corticosteroids, Minoxidil solution, and topical immune-therapies are used for treatment. Though all these have side effects and high rate of relapse. As QR678 Neo® is proved to be effective in hair regrowth in male and female pattern hair loss, the aim of the study is to compare the efficacy of QR678 Neo® with intralesional steroid therapy vs. intralesional steroid alone in the treatment of AA of scalp in men and women. MATERIALS AND METHODS: A total of 20 participants in age group of 20-50 years with nonscarring patchy hair loss were chosen for the study. Patients were arbitrarily divided into two groups (Group A-intralesional steroid with placebo and Group B-intralesional steroid with QR678 Neo® ). All the participants were evaluated at baseline, 3 months and 6 months with standard global photography, dermoscopic assessment, and self-evaluation questionnaire at the end of study. RESULT: Marked improvement was seen in the global assessment score after 6 months (mean- 6.6 SALT) as compared to baseline (38.5 SALT score) in group B. There was significant reduction of black dots, yellow dots, broken hairs, and tapered hair at 6 months on video dermoscopic examination in group B. Also, higher satisfaction was experienced with the treatment in group B patients. CONCLUSION: QR678 Neo® in combination with intralesional steroids therapy proved to be significantly beneficial, efficient, and can be considered as safer treatment option for alopecia areata.

Evaluation of efficacy of intradermal injection therapy vs derma roller application for administration of QR678 Neo® hair regrowth formulation for the treatment of Androgenetic Alopecia-A prospective study.

BACKGROUND: Non-surgical hair restoration is one of the most exciting and innovative fields in cosmetic surgery today. The addition of latest technique like derma roller seeks to achieve better results for delivering pharmaceutical solution for hair growth in comparison with topical administration. AIM: We aim to compare intradermal injection vs. derma roller technique for administration of QR678Neo® hair regrowth therapy for the treatment of androgenetic alopecia (AGA) in male and female patients. METHOD: A sum of 50 patients in the age range of 20-70 years with AGA were included and divided into 2 groups; Group A (intradermal) and Group B (derma roller). Intradermal injection of QR678Neo® formulation and derma roller with superficial application of QR678Neo® was given in each group. Assessment was done using hair pull test, global photographic assessment, video-microscopic assessment, and patient subjective assessment at baseline, 6 months, and 1 year. RESULTS: Significant diminution in hair fall was seen in both the groups. All the video-microscopic assessment factors were better in intradermal injection group compared to the derma roller group, but not significant. Erythema and pain were high in derma roller group in compare to intradermal. CONCLUSION: Derma roller technique is more convenient and easy to perform, especially when the availability of a trained person to carry out intradermal injection is not feasible, it gives satisfactory results. It is also beneficial in needle phobic and apprehensive patients. Though the results are more efficacious with intradermal scalp injection technique, this study established satisfactory results with derma roller technique as well.

Evaluation of efficacy of QR678® and QR678® Neo hair growth factor formulation in the treatment of persistent chemotherapy-induced alopecia caused due to cytotoxic chemotherapy-A prospective pilot study.

BACKGROUND: Cancers are one of the main reasons of morbidity and mortality globally. Chemotherapy-induced alopecia (CIA) is one of the most alarming, terrifying, and traumatic adverse effects. A range of therapeutic measures has been suggested to alleviate CIA, but at present, there is no accepted pharmacological therapy that can assure prevention or management. AIM: The aim of the present study was to evaluate the efficacy of QR 678 Neo® therapy in the treatment of persistent chemotherapy-induced alopecia in women and men treated with cytotoxic chemotherapy for breast and lung cancers, respectively. METHODS: A total of 8 male patients with history of lung cancer and 12 female patients with history of breast cancer in the age range of 25-60 years, with WHO classification of grade I and II persistent alopecia who had undergone chemotherapy treatment, were selected for the study. At each visit, 1.5 mL solution of QR 678® was injected into the scalp skin of patients. A total of 8 sessions were performed at an interval of 3 weeks each. All the patients were evaluated with standard global photography, video microscopic assessment, and patient self-assessment questionnaire at baseline, 6 months, and 1 year. RESULTS: Marked improvement was seen in the global assessment score at 6 months (mean-8) which was maintained even after 1 year. Mean score increase in hair count at 6 months was 12.71 which further increased at 1 year. High satisfaction score was given by patients for slowing of hair loss (mean = 4.2) and also for overall hair growth. For appearance and growth of hair, the mean value was 3.4 and 3.8, respectively. CONCLUSION: The formulation of QR 678® and QR 678® Neo showed to be significantly safe and efficient for chemotherapy-induced alopecia in both men and women. Improvement in hair growth was maintained even at 1 year of follow-up. No patient had any severe adverse effects, and injections were also easily bearable by most of them.

Evaluation of efficacy of QR 678 and QR678 neo hair growth factor formulation for the treatment of female pattern alopecia in patients with PCOS-A prospective study.

BACKGROUND: Hair is an essential identity of women. Femininity, sexuality, attractiveness, and personality are symbolically linked to a woman's hair. Female pattern hair loss is found in 20%-30% of patients with polycystic ovary syndrome (PCOS). AIM: The aim of the present study was to evaluate the efficacy of QR678® and QR678 Neo® therapy in the treatment of female alopecia with PCOS. METHOD: A total of 20 females diagnosed with PCOS in the age 25-50 years, with complaints of female pattern alopecia with Ludwig, grades I, and II were selected for the study. At each visit, 1.5 ml solution of QR678® was injected in the scalp skin of patients. A total of eight sessions were performed at an interval of 3 week each. All the patients were evaluated with standard global photography at baseline, 4th and 8th session, and 2 months after 8th session. RESULT: Marked improvement was seen in the global photographic assessment score (mean = 8) which was maintained for over 1 year. In videomicroscopic assessment, after four sessions the patients had 8.07 fewer vellus hair, 6.07 more terminal hair, and average hair shaft diameter was 0.82 µm wider. After eight sessions, they had 11.66 fewer vellus hair, 13.77 more terminal hair, and hair shaft diameter was 2.86 µm wider than at baseline. CONCLUSION: Intra-dermal injections of QR 678® hair growth factor formulation is an effective option for female pattern alopecia with PCOS. This is the first of its kind study using QR678® and QR678 Neo® in PCOS patients.

Association of edentulousness and removable prosthesis rehabilitation with severity of signs and symptoms of temporomandibular disorders.

CONTEXT: There are very few studies concerning the role of denture status in temporomandibular disorders (TMDs) and those show conflicting results. AIM: To evaluate the association of edentulousness and removable prosthesis rehabilitation with severity of TMD signs and symptoms. SETTINGS AND DESIGN: Data were collected from 2000 subjects reporting for dental treatment, above 30 years of age. SUBJECTS AND METHODS: The subjects were interviewed with a questionnaire and clinically examined for TMD on basis of Helkimo's index. The number of existing teeth, wearing of removable dentures, need for denture repair, and age of dentures was recorded. STATISTICAL ANALYSIS: The association between the TMD findings and recorded variable outcomes was analyzed by means of Chi-square test. RESULTS: Completely edentulous individuals associated more with TMD related findings in incidence and intensity than partially/fully dentate subjects. Complete denture wearers were more associated with TMD symptoms, limited mandibular mobility, muscle tenderness, and pain on mandibular movement. Partial denture wearers were more associated with severely impaired temporomandibular joint function and joint pain. Signs and symptoms of TMD were more prevalent and severe in patients who needed to get their dentures repaired, those wearing dentures more than 5-year-old, and in patients who had not got their dentures repaired during the past 5 years. CONCLUSIONS: Edentulousness, complete/partial denture wearing and poor condition of the dentures associate with greater incidence and intensity of TMD associated signs and symptoms.

Maxcal-C (a polyherbal formulation) prevents ovariectomy-induced osteoporosis in rats.

OBJECTIVES: The aim of the present study was to investigate the anti-osteoporotic activity of Maxcal-C in ovariectomy (OVX)-induced osteoporosis in rats. MATERIALS AND METHODS: Sham-operated control rats were designated as Group I; Group II animals served as OVX control; Group III OVX control rats treated with Calcium Sandoz (50 mg/kg, p.o.); Group IV and V OVX control rats treated with Maxcal-C (250 and 500 mg/kg, p.o.), respectively. All the aforementioned treatments were given for four weeks after the development of osteoporosis. At the end of the treatment, serum biochemical parameters such as serum calcium and alkaline phosphate were measured. After sacrificing the animals, femoral bone parameters with histology, body weight, and bone breaking strength of 5(th) lumbar vertebra were measured. RESULTS: The treatment with Maxcal-C showed a significant improvement in serum biochemical, femoral bone parameters, and bone breaking strength of 5(th) lumbar vertebra with histopathological changes. CONCLUSION: The finding of the present study indicates that Maxcal-C showed a potential anti-osteoporotic activity. These results support the traditional use of Maxcal-C in the treatment of osteoporosis.

A study of the emotional effects of tooth loss in an edentulous Gujarati population and its association with depression.

CONTEXT: To fully estimate the burden of illness due to edentulism and establish valid treatment outcomes measures in this regard, it is equally important to study its psychosocial repercussions. AIMS: The aim was to conduct a study to explore the emotional reactions to tooth loss, screen for current depressive symptoms and test for association between the two; among an edentulous Gujarati population. SETTINGS AND DESIGN: A total of 147 edentulous people visiting the Prosthodontics Department were surveyed. SUBJECTS AND METHODS: A questionnaire (based on previous studies) to test the emotional reactions to tooth loss and Nine Item-Patient Health Questionnaire to test for depression were used. STATISTICAL ANALYSIS USED: The data were analyzed using the Chi-square (χ (2)) test with the help of SPSS v. 18.0 (IBM Corp., Armonk, NY, USA). RESULTS: Totally, 100 out of 147 edentulous people returned the questionnaire of which 58% experienced difficulties in accepting tooth loss and 37% felt unprepared for its effects. Those with difficulties accepting tooth loss had a greater effect on self esteem and social life, had more reservation about discussing tooth loss and was more likely to experience depression. Both groups were satisfied with dentures, had no problem meeting their friends or partners without dentures and leaving out dentures at night. CONCLUSION: About 58% of edentulous people had difficulties accepting tooth loss, which was unrelated to denture satisfaction. Respondents appeared to be restricted in social activities mainly due to functional limitations. Those with difficulties accepting tooth loss were more likely to experience depression.