Cannabis oil extracts for chronic pain: what else can be learned from another structured prospective cohort?

Introduction: The use of medicinal cannabis for managing pain expands, although its efficacy and safety have not been fully established through randomized controlled trials. Objectives: This structured, prospective questionnaire-based cohort was aimed to assess long-term effectiveness and safety of cannabis oil extracts in patients with chronic pain. Methods: Adult Israeli patients licensed to use cannabis oil extracts for chronic pain were followed prospectively for 6 months. The primary outcome measure was change from baseline in average weekly pain intensity, and secondary outcomes were changes in related symptoms and quality of life, recorded before treatment initiation and 1, 3, and 6 months thereafter. Generalized linear mixed model was used to analyze changes over time. In addition, "responders" (≥30% reduction in weekly pain at any time point) were identified. Results: The study included 218 patients at baseline, and 188, 154, and 131 at 1, 3, and 6 months, respectively. At 6 months, the mean daily doses of cannabidiol and Δ9-tetrahydrocannabinol were 22.4 ± 24.0 mg and 20.8 ± 30.1 mg, respectively. Pain decreased from 7.9 ± 1.7 at baseline to 6.6 ± 2.2 at 6 months (F(3,450) = 26.22, P < 0.0001). Most secondary parameters also significantly improved. Of the 218 participants, 24% were "responders" but could not be identified by baseline parameters. "Responders" exhibited higher improvement in secondary outcomes. Adverse events were common but mostly nonserious. Conclusion: This prospective cohort demonstrated a modest overall long-term improvement in chronic pain and related symptoms and a reasonable safety profile with the use of relatively low doses of individually titrated Δ9-tetrahydrocannabinol and cannabidiol.

Effect of intramuscular depot betamethasone injection in patients with fibromyalgia and elevated C-reactive protein levels.

Fibromyalgia is characterized by diffuse musculoskeletal pain and fatigue. There are limited data about systemic steroid treatment of patients with fibromyalgia in the English literature. Patients with fibromyalgia with ongoing diffuse musculoskeletal pain despite standard treatment, extreme fatigue and elevated C-reactive protein (CRP) levels without evidence of synovitis, or other source of inflammation, were asked to participate in our study. After consent, demographic, clinical and laboratory parameters in addition to body mass index were documented. These patients were interviewed and asked to answer the Revised Fibromyalgia Impact Questionnaire (FIQR) just prior, 1 and 4 weeks following 14 mg depot betamethasone intramuscular injection. Twenty-three patients were recruited and 21 completed the study. 19 patients were women with mean age of 42±10.12 and CRP level of 14.1±3.96 mg%, and all had negative rheumatoid factor and antinuclear antibodies. All patients had significant improvement in all of the FIQR parameters, at 1 and 4 weeks, except memory, anxiety and balance. It can be concluded that systemic intramuscular depot betamethasone injection seems to have a favorable effect in patients with fibromyalgia with elevated CRP levels for at least 4 weeks.

Global improvement in meibomian glands after chalazion surgery demonstrated by meibography.

PURPOSE: To evaluate the use of meibography as an objective measure of the effects of incision & curettage (I&C) chalazion surgery on meibomian gland loss and morphology as well as dry eye syndrome. METHODS: This prospective, interventional clinical study included adult patients with a primary chalazion which persisted despite conservative treatment. All patients underwent I&C surgery. The following parameters were compared both preoperatively and 21 days postoperatively: meibography, tear breakup time (TBUT), Schirmer test, meibum expression, tear meniscus height, meibomian gland dysfunction (MGD) grading, and the Ocular Surface Disease Index (OSDI). RESULTS: Thirty eyelids were enrolled in the study. The mean age ± SD was 40.56 ± 13.94 years. Meibography demonstrated a significant decrease in meibomian gland loss (P = 0.00) and improvement in morphology. The most common meibomian gland pathology preoperatively noted was morphological signs of atrophy that included fluffy areas and tortuous glands. Both of these findings improved postoperatively (P = 0.04 and P = 0.02, respectively). There were a significant change in MGD grading and a significant decrease in meibum expression score postoperatively (P = 0.00). TBUT and tear meniscus height also improved significantly (P = 0.00 and P = 0.003, respectively). The OSDI score improved significantly as well (P = 0.00). CONCLUSION: While incision and drainage surgery is a time-honored, standard treatment for chalazion, meibography now demonstrates a global improvement in the meibomian glands, not just the ones involved with the chalazion. In addition to the improvements in the clinical and dry eye syndrome parameters improvements, meibography findings demonstrate that early I&C surgery restores the meibomian glands architecture significantly.

Metabolic effects of medical cannabis treatment.

Cannabis has a wide range of favorable clinical effects on pain, sleep, mood, gastrointestinal symptom, appetite and physical activity, factors that may affect the metabolic profile of the consumer. In this study, we prospectively evaluated patients recently starting medical cannabis treatment. All patients from the rheumatology clinic, who were just approved for medical cannabis treatment for resistant chronic pain, were recruited. After consent, demographic and clinical parameters were documented, including indication for medical cannabis treatment, way of consumption, type of cannabis and monthly dose of medical cannabis. Fasting morning blood glucose, hemoglobin A1c, insulin, lipid profile, cortisol and uric acid levels, in addition to body weight, were obtained just prior to and 3 months following cannabis consumption. Wilcoxon' sign rank test was used to compare baseline levels to those obtained 3 months later. Twenty-eight patients completed the study. Mean age of the patients was 47.8±9.1 years and ~70% were female patients. 75% of all the patients had fibromyalgia. Mean monthly consumed cannabis amount was 22.21±3.6 g, and 21 (75%) patients used extracts (oil). There was no significant change in any parameter evaluated. The results of our study seem to indicate that medical cannabis, mainly extracts, have no significant effect on any parameter of the metabolic profile of patients with chronic pain syndrome, during 3 months of initial use.

The Effect of Medical Cannabis on Pain Level and Quality of Sleep among Rheumatology Clinic Outpatients.

Introduction: Medical cannabis (MC) is becoming increasingly popular for the treatment of chronic pain conditions. In this study, we evaluated the effect of MC treatment on pain level and quality of sleep of patients with different medical conditions at the rheumatology clinic. Methods: Patients licensed for the use of MC at the rheumatology clinics at different settings were located and contacted. Their demographic and clinical parameters were documented, including type of medical cannabis consumed, way of consumption, and current monthly consumed amount. These patients were contacted by phone and asked about the effect on pain level and quality of sleep. Results: A total of 351 patients were located, and 319 completed the questionnaire. Mean age was 46 ± 12 years, 76% were female, 82% had fibromyalgia, ∼9% had mechanical problems, ∼4% had inflammatory problems, ∼4% had neurological problems, and ∼1% had other problems. The average monthly consumed dose of MC was 31, 35, 36, and 32 g, with mean pain level reduction of 77%, 82%, 83%, and 57%, and mean sleep quality improvement of 78%, 71%, 87%, and 76% among patients with fibromyalgia, mechanical, neuropathic, and inflammatory problems, respectively. Mean THC and CBD contents were 18.38% ± 4.96 and 2.62% ± 4.87, respectively. The THC concentration, duration of MC consumption, and MC consumption dose had independent significant correlations with pain reduction while only the duration of MC consumption had an independent significant correlation with sleep quality improvement. Conclusions: MC had a favorable effect on pain level and quality of sleep among all spectrums of problems at the rheumatology clinic.

Initial Presentation of Pain in Patients with Fibromyalgia.

BACKGROUND: Fibromyalgia is characterized by diffuse musculoskeletal pain at the time of diagnosis, but many patients report their initial symptoms as being focal or local. OBJECTIVES: To evaluate, prospectively, the initial location of body pain in recently diagnosed patients with fibromyalgia. METHODS: Non-selected patients from the rheumatology clinic who were recently diagnosed with fibromyalgia (≤ 2 years) with symptoms of ≤ 4 years participated in our study. Demographic and clinical parameters were documented, as was the initial location of pain they had experienced. Sub-analysis of data according to gender and ethnicity was conducted using chi-squire test. RESULTS: The study comprised 155 patients. Mean age was 39.8 ± 11.7 years; 85% were female. Mean duration of symptoms was 2.11 years and of diagnosis was 0.78 years. Six patients (3.9%) reported initial symptoms of pain as being diffuse from the start, 10 (6.5%) could not remember the location of their initial symptoms, and 139 (90%) reported initial focal pain. Hands were reported as the initial area of pain for 25.2% of the patients, 19.4% reported the back, and 11% reported both trapezial areas as the initial area of pain. In 90% of the patients (excluding patients with back, abdominal, or chest pain) the initial symptoms were bilateral and symmetrical. No significant difference in initial presentation was found among different gender or ethnic groups. CONCLUSIONS: Pain in fibromyalgia patients usually presents as focal and symmetrical. Bilateral hand pain, followed by back pain, was the most common reported area of initial pain among fibromyalgia patients.

The impact of medical cannabis consumption on the oral flora and saliva.

OBJECTIVE: To evaluate the effect of medical cannabis consumption on oral flora and saliva. DESIGN: A clinical prospective study, at the rheumatology clinic of the Nazareth Hospital in Nazareth, recruiting consecutively patients approved for medical cannabis, evaluating their saliva flow, pH and microbial load of Streptococcus mutans and Lactobacillus, prior to and under medical cannabis treatment. METHODS: Patients recently licensed for medical cannabis treatment, were recruited just prior to starting medical cannabis consumption (week 0), 1 and 4 weeks later, patients provided 5-minute time saliva samples, which were measured for their volume and pH, and cultured on a special microbial kit, evaluating the growth of Streptococcus mutans and Lactobacillus. RESULTS: Out of 16 patients enrolled, 14 were female and had fibromyalgia. The mean age of the patients was 52.8±12.9 years. The mean saliva flow at week 0, week 1 and week 4 were 5.38±3.36 ml/5-minutes, 6 (p = 0.769) and 5.45 (p = 0.391), respectively, and for saliva pH were 6.28, 5.94 (p = 0.51) and 5.5 (p = 0.07) respectively also. The mean Streptococcus mutans growth score at weeks 0, 1 and 4 was1.8±0.75, 1.6±0.83 (p = 0.234), and 2.4±0.84 (p = 0.058), respectively. The mean Lactobacilli growth score at weeks 0, 1 and 4 was 2.59±0.88, 3.1±0.69 (p = 0.033) and 3.3±0.67 (p = 0.025), respectively. CONCLUSIONS: The results of this study show that medical cannabis consumption has no significant effect on saliva volume or pH, but it may be associated with changes in salivary levels of oral microbes such as Streptococcus mutans and Lactobacilli.

[CHARACTERISTICS OF MEDICAL CANNABIS USAGE AMONG PATIENTS WITH FIBROMYALGIA].

INTRODUCTION: Medical cannabis (MC) is becoming more and more popular among patients with chronic pain syndromes. In this study we evaluated the characteristics of MC use among patients with fibromyalgia. METHODS: All patients with fibromyalgia who were followed up at Laniado Hospital in Netanya and at the Nazareth Hospital in Nazareth, in addition to all patients followed at the different health service organizations by the first author were located and contacted regarding a large number of parameters. The data included demographic information, duration of fibromyalgia symptoms and diagnosis, duration of MC use, monthly consumption of MC, frequency of daily use, number of species of MC currently used, number of species previously used, types and features of MC supplied, methods of MC consumption, delay in MC supply, symptoms of cannabis withdrawal during delay in supply or shortage of MC, familiarity with the content of (-)- trans-Δ9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) of the current species used. Furthermore, information was retrieved on current medications for fibromyalgia and medications for fibromyalgia stopped after starting MC consumption, discontinuation of MC treatment, companies growing and supplying the currently consumed MC, names of current MC species, dominance of Sativa or Indica of the current MC species, and the impact of MC on clinical parameters such as pain, sleep, anxiety, depression, memory, concentration and weight. In addition, questions were presented regarding work, outdoor leisure time, driving, sharing their own MC with other people, opinion on the reform of MC in Israel and adverse effects of MC. RESULTS: One-hundred and one patients completed the study; 73% of the participants were female with a mean age of 45±11.8 years. The mean duration of fibromyalgia symptoms and diagnosis were 8.39±6 and 4.69±3.9 years, respectively. The mean duration of MC consumption was 15.3±12.6 months and the mean monthly consumption amount was 28.6±10.2 g. 54% smoked pure cannabis, 18% used vaporized cannabis only and 3 participants only used MC oil. The rest used a variety of combinations. The mean minimal daily frequency of MC consumption was 4.11±2.9 times and the mean maximal daily frequency was 7.9±5.6 times. The mean number of current daily MC species was 2.11±1 and the mean number of tried species was 6.7±5.2 for each participant; 47% of all the participants stopped any other treatment for fibromyalgia and 51% reduced the dose or the number of other medications for fibromyalgia. One patient only stopped MC treatment. Tikun Olam was the manufacturing company with the largest number of clients and its most popular species for daytime was "Alaska" and "Erez" for night-time. Mean improvement in sleep and pain was slightly more than 77% with less improvement in other parameters; 36% of the patients reported weight gain, while 16% reported weight loss; 51% reported having more leisure time outdoors. Nearly all patients refused sharing any amount of their MC with friends or family members, and all patients recommended MC treatment for their loved ones once they develop severe fibromyalgia; 61% of the participants were against the reform of MC and 11% were in favor of it. Nearly one quarter of the patients reported mild adverse effects and one patient developed a psychotic attack (was consuming 70 gram of MC monthly). CONCLUSIONS: MC is an effective treatment for fibromyalgia, with nearly zero % withdrawal from this treatment. The mean daily amount consumed was relatively low, less than 1 gram, and the main method of consumption was smoking with a huge variety in the frequency of smoking during the day and night among the participants. MC treatment enabled nearly half of the patients to discontinue any treatment for fibromyalgia and all participants recommended MC treatment for their loved ones in case they develop severe fibromyalgia. Most participants were against the reform of MC in Israel. Mild adverse effects were reported in nearly a quarter of the patients but did not result in discontinuing its consumption.

The Consumption of Cannabis by Fibromyalgia Patients in Israel.

OBJECTIVE: To report on the habits of cannabis consumption among fibromyalgia patients in Israel. PATIENTS AND METHODS: An Internet-based questionnaire was posted to three large fibromyalgia Facebook groups in our country. The questionnaire was anonymous and included demographic, clinical, and cannabis-related questions, including acquisition of a license for medical cannabis (MC) method and amount of cannabis consumption; need to buy cannabis beyond the medical allowance; effect of cannabis on pain, sleep, depression, and anxiety; adverse effects of cannabis; feelings of dependence on cannabis or other meds; the involvement of family members; tendency to drive after using cannabis; and employment and social disability status. RESULTS: Of 2,705 people, 383 (14%) responded to the questionnaire, with a mean age of 42.2±14.2 years. Of the responders, 84% reported consuming cannabis, and 44% were licensed for MC. The mean amount per month of cannabis consumed was 31.4±16.3g, and 80% of cannabis consumers (CC) smoked pure cannabis or cannabis mixed with tobacco. Pain relief was reported by 94% of CC, while 93% reported improved sleep quality, 87% reported improvement in depression, and 62% reported improvement in anxiety. Of MC-licensed CC, 55% bought cannabis beyond the medical allowance on the black market. Adverse effects were reported by 12% of CC. Only 8% reported dependence on cannabis. Most CC (64%) worked either full- or part-time jobs, and 74% reported driving "as usual" under cannabis use. CONCLUSIONS: Cannabis consumption among fibromyalgia patients in our country is very common and is mostly not licensed. Nearly all CC reported favorable effects on pain and sleep, and few reported adverse effects or feeling of dependence on cannabis.

Medical Cannabis for the Treatment of Fibromyalgia.

BACKGROUND: Fibromyalgia is a chronic pain syndrome, characterized by chronic musculoskeletal pain, fatigue, and mood disturbances. There are nearly no data on the effect of medical cannabis (MC) treatment on patients with fibromyalgia. METHODS: Data were obtained from the registries of 2 hospitals in Israel (Laniado Hospital and Nazareth Hospital) on patients with a diagnosis of fibromyalgia who were treated with MC. After obtaining patient consent, demographic, clinical, and laboratory parameters were documented. All the patients also completed the Revised Fibromyalgia Impact Questionnaire regarding the period before and after MC treatment. RESULTS: Thirty patients were identified, and 26 patients were included in the study. There were 19 female patients (73%), and the mean age of the study group was 37.8 ± 7.6 years. The mean dosage of MC was 26 ± 8.3 g per month, and the mean duration of MC use was 10.4 ± 11.3 months. After commencing MC treatment, all the patients reported a significant improvement in every parameter on the questionnaire, and 13 patients (50%) stopped taking any other medications for fibromyalgia. Eight patients (30%) experienced very mild adverse effects. CONCLUSIONS: Medical cannabis treatment had a significant favorable effect on patients with fibromyalgia, with few adverse effects.

Pre-injection of hyaluronic acid does not affect the systemic effects of intra-articular depot betamethasone injection at the knee joint.

Intra-articular injection (IAI) of both hyaluronic acid (HA) and depot-steroid preparations had the advantage of quick and prolonged favorable effects on pain relief among patients with symptomatic osteoarthritis of the knee (OAK). The effect of IAI of HA on the systemic effects of the intra-articular steroids had not been investigated. Non-selected patients attending the rheumatology clinic with symptomatic OAK who failed NSAIDS and physical therapy were offered an IAI of HA at the knee joint followed 20 min later by an IAI of 1 ml of Celestone Chronodose at the same joint (group 1). Morning serum levels of cortisol were obtained just prior to the IAI and 1, 2 and 8 days later. Demographic, clinical, and laboratory parameters were obtained also from all the patients. Age- and sex-matched group of patients from the same clinic were recruited as a control group (group 2). Mean baseline serum cortisol levels in group 1 was 381 ± 154 mmol/l vs. 376 ± 119 in group 2 (p = 0.954). Morning serum cortisol levels at day 1 and day 2 were 24 ± 6 and 22 ± 6 mmol/l, respectively, in group 1 patients vs. 27 ± 5.8 (p = 0.214) and 25 ± 5.6 mmol/l (p = 0.200), respectively, in group 2. These levels were significantly lower than baseline levels in each group. Morning serum cortisol levels at day 8 in group 1 and group 2 were 349 ± 128 and 314 ± 99 mmol/l, respectively (p = 0.419). Pre-injection of HA at the knee joint did not affect the systemic effect on the hypothalamic-pituitary-adrenal axis of IAI of Celestone Chronodose.

Testicular Ischemia Due to a Band Around the Spermatic Cord.

We present a case of an 18-year-old boy who was admitted to our hospital with a 2-day history of pain in the right scrotum. Ultrasound examination showed signs of ischemia, with dampened testicular arterial flow and bell-clapper deformity. Surgery revealed a constricting fibrous band around the distal spermatic cord resembling the bell-clapper deformity.

The association between Baker's cyst and medial meniscal tear in patients with symptomatic knee using ultrasonography.

INTRODUCTION: There are nearly no studies about the association between Baker's cyst (BC) and medial meniscal tear (MMT) using ultrasonography. PATIENTS AND METHODS: Nonselected patients who were referred for ultrasonography for the evaluation of knee pain were recruited. Demographic, clinical, and ultrasound parameters were documented. RESULTS: One-hundred and nineteen patients were included and 131 knees were evaluated. There were 59 (~50%) female patients and mean age of 46.4±17.7 years. BC was found in 31 knees (23%). BC was significantly associated with MMT (P=.029) and age (P=.002) after adjusting for other covariates. CONCLUSIONS: BC was strongly associated with MMT regardless of other intraarticular abnormalities.

Torsion of undescended third testis, as rare cause of painful inguinal mass.

Twenty years old young was referred to our department due to painful inguinal mass. The mass was diagnosed as torsion of third testis which was treated by orchiectomy. Polyorchidism is a rare entity with increased risk for malignancy and torsion.

Polyorchidism: two case reports and a review of the literature.

INTRODUCTION: Polyorchidism is a very rare anomaly that is defined by the presence of more than two testes. Although its presentation is primarily as triorchidism, cases of four testes have also been reported in the literature. CASE PRESENTATION: In this report, we describe color Doppler ultrasound findings in two cases. Patient 1 was a 37-year-old Arabic man with a scrotal mass and a double testicle in the right hemiscrotum visualized by ultrasound. Patient 2 was an 11-year-old Arabic boy with an inguinal mass resulted to be an additional testicle in the inguinal canal. The echogenic texture and vascular flow of supernumerary testicles in question were similar to those of the normal testicles; however, their size was smaller. After 3 years of follow-up, the tertiary testes in the two patients remained stable in both size and echogenicity. CONCLUSION: Ultrasound plays a crucial role in the evaluation of masses. Notably, inguinal or scrotal masses should not always be considered as lymph nodes or tumors. Indeed, a radiologist should always keep polyorchidism in mind when such masses are encountered.

The impact of Ramadan fast on patients with gout.

BACKGROUNDS: Ramadan fast is a religious custom in Islam. Increased serum uric acid level during this month had been reported in past studies of nongout patients. OBJECTIVES: The objective of this study was to assess the impact of Ramadan fast on patients with gout. METHODS: All Moslem patients with gout from the registry of Nazareth Hospital, who intended to fast during Ramadan, were asked to participate in our study (group 1). Data regarding age, gender, income, education, duration of gout, meds, adherence to low-purine diet, and gouty attacks were documented. Age- and gender matched Moslem patients from the same registry, but who did not intend to fast during Ramadan, were asked to participate as a control group (group 2). Just prior to and at the end of Ramadan, blood for uric acid, creatinine, and urea levels were obtained as well as body mass index, from all the patients. During Ramadan, patients were monitored for gouty arthritis or renal calculi attacks, as well as low-purine diet and medicine adherence. RESULTS: Twenty-one and 22 patients from groups 1 and 2, respectively, completed the study. Mean serum uric acid, urea, creatinine, and body mass index levels at the end of Ramadan fasts in group 1 patients were 8.11 mg/dL, 26.38 mmol/L, 0.87 mg/dL, and 31.0 kg/m, respectively, as compared with 7.92 mg/dL (P = 0.707), 24.54 mmol/L (P = 0.769), 0.84 mg/dL (P = 0.180), and 30.5 kg/m (P = 0.907) respectively, obtained just prior to the fast. No significant change in any parameter was seen also in group 2 patients. There also was no significant change between the 2 groups in arthritis or renal calculi attacks and also in medication and low-purine diet adherence, during Ramadan. CONCLUSIONS: There was no risk for a significant increase in gouty arthritic/renal calculi attacks or serum uric acid in patients with gout during Ramadan fast.