The study aims to investigate the effect of spa treatment on vascular endothelium and clinical symptoms of generalized osteoarthritis. Forty generalized osteoarthritis (GOA) patients referred to a government spa hospital, and 40 GOA patients followed on university hospital locomotor system disease ambulatory clinics were included as study and control groups, respectively. Study group received spa treatment including thermal water baths, physical therapy modalities, and exercises. Control group was followed with home exercises for 15 days. Plasma ADMA, L-arginine, L-arginine/ADMA ratio, routine blood analyses, 6-min walking test, including fingertip Osaturation, systolic/diastolic blood pressure, and pulse rate, were measured at the beginning and at the end of treatment. Groups were evaluated with VAS pain, patient, and physician global assessment; HAQ; and WOMAC at the beginning, at the end, and after 1 month of treatment. In study group, L-arginine and L-arginine/ADMA ratio showed statistically significant increase after treatment. PlasmaADMA levels did not change. There is no significant difference in intergroup comparison. Study group displayed statistically significant improvements in all clinical parameters. The study showed that spa treatment does not cause any harm to the vascular endothelium through ADMA. Significant increasein plasma L-arginine and L-arginine/ADMA ratio suggests that balneotherapy may play a preventive role on cardiovascular diseases. Balneotherapy provides meaningful improvements on clinical parameters of GOA.

Physical activity guidelines from around the world are typically expressed in terms of frequency, duration, and intensity parameters. Objective monitoring using pedometers and accelerometers offers a new opportunity to measure and communicate physical activity in terms of steps/day. Various step-based versions or translations of physical activity guidelines are emerging, reflecting public interest in such guidance. However, there appears to be a wide discrepancy in the exact values that are being communicated. It makes sense that step-based recommendations should be harmonious with existing evidence-based public health guidelines that recognize that"some physical activity is better than none"while maintaining a focus on time spent in moderate-to-vigorous physical activity (MVPA). Thus, the purpose of this review was to update our existing knowledge of"How many steps/day are enough?", and to inform step-based recommendations consistent with current physical activity guidelines. Normative data indicate that healthy adults typically take between 4,000 and 18,000 steps/day, and that 10,000 steps/day is reasonable for this population, although there are notable"low active populations."Interventions demonstrate incremental increases on the order of 2,000-2,500 steps/day. The results of seven different controlled studies demonstrate that there is a strong relationship between cadence and intensity. Further, despite some inter-individual variation, 100 steps/minute represents a reasonable floor value indicative of moderate intensity walking. Multiplying this cadence by 30 minutes (i.e., typical of a daily recommendation) produces a minimum of 3,000 steps that is best used as a heuristic (i.e., guiding) value, but these steps must be taken over and above habitual activity levels to be a true expression of free-living steps/day that also includes recommendations for minimal amounts of time in MVPA. Computed steps/day translations of time in MVPA that also include estimates of habitual activity levels equate to 7,100 to 11,000 steps/day. A direct estimate of minimal amounts of MVPA accumulated in the course of objectively monitored free-living behaviour is 7,000-8,000 steps/day. A scale that spans a wide range of incremental increases in steps/day and is congruent with public health recognition that"some physical activity is better than none,"yet still incorporates step-based translations of recommended amounts of time in MVPA may be useful in research and practice. The full range of users (researchers to practitioners to the general public) of objective monitoring instruments that provide step-based outputs require good reference data and evidence-based recommendations to be able to design effective health messages congruent with public health physical activity guidelines, guide behaviour change, and ultimately measure, track, and interpret steps/day.

AIM:To assess the ability of mammography and ultrasound individually and in combination to predict whether a breast abnormality is benign or malignant in patients with symptomatic breast disease.

MATERIALS AND METHODS:Patients included were those in whom histological confirmation of the abnormality following surgical excision was available. Mammographic and ultrasound appearances were prospectively classified using a four-point scale (1 = no significant lesion, 2 = benign lesion, 3 = possibly malignant, 4 = probably malignant).

RESULTS:Histological confirmation following surgical excision was available in 559 patients, of which 303 were benign and 256 were malignant. The imaging classification was correlated with histology in these 559 lesions. In predicting final histology, the sensitivity and specificity of mammography alone were 78.9 and 82.7%, respectively, of ultrasound alone were 88.9 and 77.9%, respectively, and of mammography and ultrasound in combination were 94.2 and 67.9%, respectively. Only one patient had both a mammogram and ultrasound reported as normal (category 1 for both tests) in whom subsequent histology revealed a carcinoma (0.4% of all carcinomas).

CONCLUSION:We found that the extensive use of ultrasound increases the cancer detection rate in this selected population by 14%.

Isolated cases and small series have described the development of complex regional pain syndrome, postural orthostatic tachycardia, and fibromyalgia after human papillomavirus (HPV) vaccination. These illnesses are difficult to diagnose and have overlapping clinical features. Small fiber neuropathy and dysautonomia may play a major role in the pathogenesis of these entities. We used the following validated questionnaires to appraise the chronic illness that might appear after HPV vaccination: The 2010 American College of Rheumatology Fibromyalgia Diagnostic Criteria, COMPASS 31 dysautonomia questionnaire, and S-LANSS neuropathic pain form. These questionnaires and a"present illness"survey were e-mailed to persons who had the onset of a chronic ailment soon after HPV vaccination. Forty-five filled questionnaires from individuals living in 13 different countries were collected in a month's period. Mean (±SD) age at vaccination time was 14 ± 5 years. Twenty-nine percent of the cases had immediate (within 24 h) post-vaccination illness onset. The most common presenting complaints were musculoskeletal pain (66%), fatigue (57%), headache (57%), dizziness/vertigo (43%), and paresthesias/allodynia(36%). Fifty-three percent of affected individuals fulfill the fibromyalgia criteria. COMPASS-31 score was 43 ± 21, implying advanced autonomic dysfunction. Eighty-three percent of the patients who had ongoing pain displayed S-LANSS values>12, suggesting a neuropathic component in their pain experience. After a mean period of 4.2 ± 2.5 years post-vaccination, 93% of patients continue to have incapacitating symptoms and remain unable to attend school or work. In conclusion, a disabling syndrome of chronic neuropathic pain, fatigue, and autonomic dysfunction may appear after HPV vaccination.

As part of an evaluation of the introductory campaign of human papilloma virus (HPV) vaccine in a Scottish health board, self-administered questionnaires were offered to all 5007 eligible girls in school following the third dose of HPV to identify side-effects, reasons for non-vaccination and future cervical screening intentions, and 2775 (56.2%) replied. In all, 630 (23.5%) of vaccinated girls reported side effects to the vaccination, about half of which were common injection-site reactions. Main reported reasons for non-vaccination related to perceived inadequate evidence for HPV safety and efficacy, and lack of perceived need or desire to be vaccinated. A total of 2430 (89.2%) of the girls expressed plans to take up cervical screening when older. Reasons for not planning to take up cervical smear were lack of knowledge about cervical screening, anticipated discomfort or embarrassment with the process and no perceived need for a cervical smear. Unvaccinated girls were less likely to report planning to attend for cervical smears in later life (Yates chi-square = 24.30, p<0.001). The findings emphasise the importance of information on safety and efficacy in future communications about HPV with schoolage girls. The relationship between vaccination and screening intention, and its implications for widening the gap in health inequalities, also requires careful attention in local implementation of the national HPV vaccination programme.

In recent years, a number of benign and malignant cervical glandular lesions exhibiting gastric differentiation have been described but premalignant gastric-type lesions have not been well characterized. We report a series of 9 cases of a rare form of cervical adenocarcinoma in situ (AIS) distinguished by gastric and sometimes intestinal differentiation and lack of association with human papillomavirus (HPV) infection. The lesions occurred in women aged 25 to 73 years (mean age 51 y). All cases were located at (or just proximal to) the cervical transformation zone and there was extension to the lower uterine segment in 3 cases, 2 of which also involved the endometrium. In all cases, the normal cervical glandular architecture was largely preserved but in 5 cases there was a mild degree of increased intraglandular architectural complexity. The glandular epithelium ranged from almost purely gastric in type (4 cases) to mixed gastric and intestinal (5 cases), with varying proportions of intermixed goblet cells. In contrast to the basophilic cytoplasm of normal endocervical glands, the gastric-type epithelium was typically predominantly composed of cells with eosinophilic or pale pink cytoplasm, but conspicuous foamy or clear cell cytoplasm was present in some cases. Nuclear atypia was present in all cases but was considered low-grade in 8. High-grade features such as marked nuclear pleomorphism and hyperchromasia were evident in only 1 case. Mitotic activity and apoptotic bodies were present but both were noted to be less frequent than in usual type (HPV-related) AIS. Immunohistochemically, there was usually positive staining with CK 7 (7/7 cases) and MUC 6 (7/8 cases) and some cases were positive with CK 20 (3/7), CDX2 (5/9), PAX 8 (5/9) and CEA (2/6). Estrogen receptor and progesterone receptor were usually negative, although Estrogen receptor was positive in 3 of 9 cases. p16 was negative or exhibited mosaic-type staining (nonblock staining) in all cases and there was mutation-type p53 staining in 2 of 9 cases. HPV molecular testing was negative in all 4 cases tested. We believe this unusual subtype of AIS, which we term"gastric-type AIS (gAIS),"represents a precursor to gastric-type adenocarcinoma of the cervix and suggest that gAIS and so-called"atypical lobular endocervical glandular hyperplasia"are related entities within a spectrum of premalignant gastric-type lesions for which we propose the umbrella term gAIS. The malignant potential and optimal management of gAIS are currently unknown but in one of our case a gastric-type adenocarcinoma developed 6 years after removal of a cervical polyp which contained gAIS. The introduction of HPV vaccination will result in a relative increase in incidence of premalignant and malignant cervical glandular lesions exhibiting gastric differentiation and these will not be detected by HPV-based screening programs.

OBJECTIVES:To examine the effect of early human milk (HM) feeding on the incidence of retinopathy of prematurity (ROP) among very low-birth-weight (VLBW) infants.

METHODS:Observational cohort research in a Level III neonatal intensive care unit. A total of 186 infants were enrolled in this pre-post cohort study (114 infants were included in the HM-fed group and 72 in the formula-fed group). ROP, type of feeding (early exclusive HM versus any formula), and potential confounding variables were measured. Differences between groups were explored.

RESULTS:The clinical characteristics of the neonates did not differ between the two groups. By bivariate analysis, HM feeding was associated with 75% lower odds of Stage 2 or 3 ROP (OR = 0.25, 95% CI: 0.091 to 0.705; p = 0.009) At multivariate logistic regression, type of milk feeding retained significance, exclusive HM being protective with p = 0.002.

CONCLUSIONS:This study found an association between early exposure to formula in VLBW infants and ROP. An initial HM diet, devoid of cow milk-containing products before achieving full enteral feeding, may help prevent ROP.

PURPOSE:To report a possible association between human papilloma virus (HPV) vaccination and uveitis.

METHODS:Spontaneous reports from the National Registry of Drug-Induced Ocular Side effects, World Health Organization and Food and Drug Administration were collected on uveitis associated with human papilloma virus vaccination. A MEDLINE search was performed using keywords"uveitis,""iritis,""iridocyclitis,""human papilloma virus,""Cervarix", and"Gardasil."

MAIN OUTCOME MEASURES:Data garnered from spontaneous reports included the age, gender, adverse drug reaction (ADR), date of administration, concomitant administration of other vaccinations, time until onset of ADR, other systemic reactions, and dechallenge and rechallenge data.

RESULTS:A total of 24 case reports of uveitis associated with human papilloma virus vaccination were identified, all cases were female, and the median age was 17. Median time from HPV vaccination to reported ADR was 30 days (range 0-476 days).

DISCUSSION:According to World Health Organization criteria, the relationship between human papilloma virus vaccination and uveitis is"possible."Causality assessments are based on the time relationship of drug administration, uveitis development and re-challenge data.

CONCLUSIONS:Clinicians should be aware of a possible bilateral uveitis and papillitis following HPV vaccination.

BACKGROUND:Whether human papillomavirus (HPV) vaccination could induce or trigger autoimmune diseases (AID) has been questioned, and potentially contributes to low immunization coverage in France. This study evaluated the association between HPV vaccination and the risk of AID using routinely collected data sources.

METHODS:All girls aged 13-16years between 2008 and 2012, covered by the general health insurance scheme and without history of HPV vaccination or AID, were included and followed using French nationwide databases. Fourteen neurological, rheumatological, haematological, gastrointestinal or endocrine AID, were identified from ICD-10 codes allocated to hospital stays and long-term illnesses or by marker drugs. Their incidence was compared between girls exposed and non-exposed to HPV vaccination, using a Cox model adjusted for inclusion year, geographic area, socio-economic indicators, healthcare use level and other immunizations.

RESULTS:Among 2,252,716 girls, 37% received HPV vaccine and 4,096 AID occurred during a mean follow-up time of 33months. The incidence of AID was not increased after exposure to HPV vaccination, except for Guillain-Barré syndrome (GBS) (incidence rate of 1.4 among exposed [20 cases] versus 0.4 per 100,000 PY among unexposed [23 cases]; adjusted HR: 3.78 [1.79-7.98]). This association persisted across numerous sensitivity analyses and was particularly marked in the first months following vaccination. Under the hypothesis of a causal relationship, this would result in 1-2 GBS cases attributable to HPV vaccine per 100,000 girls vaccinated.

CONCLUSIONS:Our study provides reassuring results regarding the risk of AID after HPV vaccination, but an apparently increased risk of GBS was detected. Further studies are warranted to confirm this finding.

INTRODUCTION:We carried out an active surveillance of common adverse events occurring among women (9 to 26 years old) receiving human papillomavirus vaccine (Gardasil® and Cervarix®) in 9 Italian Regions.

METHODS:Common adverse events occurring in the two weeks following each dose administration were collected using a structured diary.

RESULTS:From August 2008 to September 2011, 12,066 immunised women (9,084 receiving Cervarix® and 2,982 Gardasil®) were included in the surveillance for a total of 29,494 administered doses. 53% of women concluded the vaccination cycle (74% with Gardasil® and 47% with Cervarix®). 61% of women experienced an adverse event after the administration of the first dose. The high proportion of adverse events reported is mainly due to the design of the study, since women were requested to report all events occurring after the vaccination; however the majority of events were mild and transient.

DISCUSSION:As for all vaccines, and in particular for newly marketed ones, the surveillance of adverse events represents an essential step in the evaluation of a vaccination programme.

The potential anti-fatigue and performance benefits of hydrogen rich water (HRW) have resulted in increased research interest over the past 5 years. The aim of this study was to assess physiological and perceptual responses to an incremental exercise protocol after administration of 600 ml HRW within 30 min before exercise. This randomized, double blinded placebo-controlled cross over study included twelve healthy males aged 27.1±4.9 years. The exercise protocol consisted of a 10 min warm-up at 1.0 W.kg, followed by 8 min at 2.0, 3.0, and 4.0 W.kg, respectively. Cardio-respiratory variables, lactate and ratings of perceived exertion (RPE) were assessed in the last minute of each step. A significantly lower blood lactate was found with HRW (4.0±1.6 and 8.9±2.2 mmol.l) compared to Placebo (5.1±1.9 and 10.6±3.0 mmol.l) at 3.0, and 4.0 W.kg, respectively. Ventilatory equivalent for oxygen and RPE exhibited significantly lower values with HRW (32.3±7.2, and 17.8±1.2 points, respectively) compared to Placebo (35.0±8.4, and 18.5±0.8 points, respectively) at 4 W.kg. To conclude, acute pre-exercise supplementation with HRW reduced blood lactate at higher exercise intensities, improved exercise-induced perception of effort, and ventilatory efficiency.

Background. Multiple sclerosis (MS) is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-week treatment program. The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relaxation exercises in therapy room. Outcome variables were pain, disability, spasm, depression, fatigue, and autonomy, which were assessed before the intervention and immediately and at 4 and 10 weeks after the last treatment session. Results. The experimental group showed a significant (P<0.028) and clinically relevant decrease in pain intensity versus baseline, with an immediate posttreatment reduction in median visual analogue scale scores of 50% that was maintained for up to 10 weeks. Significant improvements were also observed in spasm, fatigue, disability, and autonomy. Conclusion. According to these findings, an Ai-Chi aquatic exercise program improves pain, spasms, disability, fatigue, depression, and autonomy in MS patients.

OBJECTIVE:To describe the outcomes of clinical evaluation, skin testing, and vaccine challenge in adolescent schoolgirls with suspected hypersensitivity to the quadrivalent human papillomavirus vaccine introduced in Australian schools in 2007.

DESIGN:Retrospective cohort study.

SETTING:Two tertiary paediatric allergy centres in Victoria and South Australia, Australia.

PARTICIPANTS:35 schoolgirls aged 12 to 18.9 years with suspected hypersensitivity reactions to the quadrivalent human papillomavirus vaccine.

MAIN OUTCOME MEASURES:Clinical review and skin prick and intradermal testing with the quadrivalent vaccine and subsequent challenge with the vaccine.

RESULTS:35 schoolgirls with suspected hypersensitivity to the quadrivalent human papillomavirus vaccine were notified to the specialised immunisation services in 2007, after more than 380 000 doses had been administered in schools. Of these 35 schoolgirls, 25 agreed to further evaluation. Twenty three (92%) experienced reactions after the first dose. Thirteen (52%) experienced urticaria or angio-oedema, and of these, two experienced anaphylaxis. Thirteen had generalised rash, one with angio-oedema. The median time to reaction was 90 minutes. Nineteen (76%) underwent skin testing with the quadrivalent vaccine: all were skin prick test negative and one was intradermal test positive. Eighteen (72%) were subsequently challenged with the quadrivalent vaccine and three (12%) elected to receive the bivalent vaccine. Seventeen tolerated the challenge and one reported limited urticaria four hours after the vaccine had been administered. Only three of the 25 schoolgirls were found to have probable hypersensitivity to the quadrivalent vaccine.

CONCLUSION:True hypersensitivity to the quadrivalent human papillomavirus vaccine in Australian schoolgirls was uncommon and most tolerated subsequent doses.

Low-fat diets, lipid-modifying nutraceuticals and a higher level of physical activity are often recommended to reduce dyslipidemia. A double-blind, randomized, crossover, controlled trial was designed to evaluate the independent and synergistic effects of()supplementation (4.5 g·day) with or without performing a physical exercise program (: aerobic exercise (3 days·week) + high-intensity interval training (2 days·week)) on blood lipids and BMI of 52 sedentary men with excess body weight. During six weeks, all participants were assigned to four intervention treatments (with PEP (SE), placebo with PEP (Ex),without PEP (Sm), placebo without PEP (C; control)) and plasma lipids were evaluated spectrophotometrically pre- vs. post intervention in stratified subgroups (overweight, obese and dyslipidemic subjects). Pre/post comparisons showed significant reductions in all plasma lipids in the SE group, particularly in those with dyslipidemia (≤ 0.043). Comparing the final vs. the initial values, BMI, total cholesterol, triglycerides and low-density lipoprotein cholesterol were decreased. High-density lipoprotein cholesterol increased in all treatment groups compared to C. Changes were observed mostly in SE interventions, particularly in dyslipidemic subjects (<0.05).supplementation enhances the hypolipidemic effect of a systematic PEP in men with excess body weight and dyslipidemia.

A CAUSAL ASSOCIATION BETWEEN MEASLES: mumps-rubella (MMR) vaccine and idiopathic thrombocytopenic purpura (ITP) was confirmed using immunisation/hospital admission record linkage. The absolute risk within six weeks of immunisation was 1 in 22 300 doses, with two of every three cases occurring in the six week post-immunisation period being caused by MMR. Children with ITP before MMR had no vaccine associated recurrences.

BACKGROUND:Classic Kaposi sarcoma usually remains on the skin and has a slow progression; thus, local treatment methods are preferable. Imiquimod is an immunomodulatory agent with antiviral, antitumoural, and antiangiogenic properties that is expedient against Kaposi sarcoma.

OBJECTIVES:We aimed to clarify whether imiquimod is effective on classic Kaposi sarcoma lesions by comparing imiquimod treatment with cryotherapy, which is the most-used treatment method in our department for this disease.

METHOD:Patients with classic Kaposi sarcoma were included. All lesions of each patient were evaluated and measured by the blinded investigator considering infiltration and surface diameters. Then, lesions were categorized into 2 groups by the other investigator (nonblinded), and imiquimod 5% cream was administered 3 times per week without occlusion in 1 group. Cryotherapy was performed every 3 weeks in the other group. All lesions were reevaluated and measured at the end of 12 weeks by the blinded investigator. Initial and last measurements were compared between the treatment methods.

RESULTS:Fifty lesions of 8 patients were included in this study. Imiquimod and cryotherapy were applied to 26 and 24 lesions, respectively. At the end of the study, statistically significant decreases were detected in all scores between weeks 0 and 12 with both treatment methods. Mean percentages of change in scores were not significantly different between the methods.

CONCLUSIONS:Based on a limited number of patients and lesions treated, we believe imiquimod may be a suitable option to use for the treatment of classic Kaposi sarcoma.

OBJECTIVE:To assess the immediate analgesic effect of wrist-ankle acupuncture on acute lumbago and the relationship between the analgesic effect and the expectation of patients.

METHODS:A randomized, single-blind, sham-controlled trial was designed. Sixty cases of acute lumbago were randomly divided into two groups, 30 cases in each one. In observation group, wrist-ankle acupuncture was adopted to the Lower 5 and Lower 6 bilaterally, no requirement of Deqi (arrival of qi). In control group, sham acupuncture was adopted. The treatment was applied once in either group, with the needles retained for 30 min. The Short-form McGill Pain Questionnaire (SF-MPQ) and the Modified-Modified Schober (MMS) test were used to assess the motion related pain and the situation of spinal flexion in 3 min before treatment and 5 min, 10 min, 15 min, during treatment and 30 min (needle removed), respectively. The Expectation and Treatment Credibility Scale (ETCS) was applied to analyze the relationship between the expectation of patients and the analgesic effect. The adverse reaction was recorded.

RESULTS:There were no statistically significant differences in SF-MPQ, MMS and ETCS before treatment between two groups (all P>0.05). In 5 min after needles insertion, the scores of the items in SF-MPQ in observation group were lower than those in control group (P<0.05, P<0.01). In 10 min after needles insertion, the scores of SF-MPQ in observation group were lower than those in control group and the scores of MMS were higher than those in control group (P<0.05). In 15 min after needles insertion, except the sensory pain rating index, the scores of the rest items in SF-MPQ in observation group were all lower than those in control group (P<0.05, P<0.01). In 30 min (needles removed), the scores of affective pain rating index of SF-MPQ and Visual Analogue Scale (VAS) in observation group were lower than those in control group (P<0.05, P<0.01). The expectation before treatment was negatively correlated with VAS scores in 5 min, 10 min, 15 min and 30 min after needle insertion separately in observation group (P<0.05), while the correlation was not found in control group (P>0.05). No adverse reaction was reported.

CONCLUSION:Wrist-ankle acupuncture can reduce acute lumbago immediately and significantly. The higher the expectation on the analgesic effect of wrist-ankle acupuncture the patients have, the better the analgesic effect will be. This therapy is highly safe in the treatment.

The purpose of this study was to evaluate the immediate and delayed effects of balneotherapy at the Dead Sea on patients with psoriatic arthritis (PsA). A total of 42 patients with PsA were treated at the Dead Sea for 4 weeks. Patients were randomly allocated into two groups: group 1 (23 patients) and group 2 (19 patients). Both groups received daily exposure to sun ultraviolet rays and regular bathing at the Dead Sea. Group 1 was also treated with mud packs and sulfur baths. Patients were assessed by a dermatologist and a rheumatologist 3 days before arrival, at the end of treatment, and at weeks 8, 16, and 28 from the start of treatment. The clinical indices assessed were morning stiffness, right and left hand grip, number of tender joints, number of swollen joints, Schober test, distance from finger to floor when bending forward, patient's self-assessment of disease severity, inflammatory neck and back pain and psoriasis area and severity index (PASI) score. Comparison between groups disclosed a similar statistically significant improvement for variables such as PASI, morning stiffness, patient self-assessment, right and left grip, Schober test and distance from finger to floor when bending forward. For variables such as tender and swollen joints, and inflammatory neck and back pain, improvement over time was statistically significant in group 1. Addition of mud packs and sulfur baths to sun ultraviolet exposure and Dead Sea baths seems to prolong beneficial effects and improves inflammatory back pain.

Aim:A very-low-calorie diet (VLCD) can reverse the underlying defects of type 2 diabetes mellitus (DM) in obese subjects. We determined the efficacy, safety, and durability of VLCD in Thai patients with DM and obesity.

Methods:Twenty Thai patients with DM and obesity were enrolled. After a 2-week trial, VLCD (600 kcal/day) was continued for 8 weeks, followed by a 4-week transition period. Data on diabetes remission (fasting plasma glucose level<126 mg/dl and HbA<6.5% without the use of glucose-lowering medications), glycemic control, metabolic parameters, and quality of life (QOL) were collected along with indices of insulin resistance (IR) and beta cell function. Glycemic control 12 months after discontinuation of VLCD was also examined.

Results:Among 19 patients (age 48 ± 2 years, BMI 27.7 kg/m) who completed the study, rapid improvement in glycemic control was observed in the first 2 weeks of VLCD. At both 8 and 12 weeks, diabetes remission was achieved in 79%. Significant weight loss was accompanied by a significant reduction in IR and an increase in beta cell function, starting at 4 weeks of VLCD. QOL also significantly increased. At 12 months after VLCD, however, DM remission was achieved in approximately 30%.

Conclusion:Very-low-calorie diet was effective and safe in inducing short-term diabetes remission in Thai subjects by ameliorating beta cell function and IR. Optimal long-term glycemic control was potentially durable as one-third of subjects remained without diabetes medication 12 months after VLCD.