How can I help my fibromyalgia?

Answer: Ask your doctor about trialing low-dose naltrexone:

Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.

Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels.

Younger J, Noor N, McCue R, Mackey S.

Source

Stanford University School of Medicine, Palo Alto, California. jarred.younger@stanford.edu.

Abstract

OBJECTIVE:

To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.

METHODS:

Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.

RESULTS:

When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P = 0.039), but not improved fatigue or sleep. Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.

CONCLUSION:

The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.

Pain Med. 2009 May-Jun;10(4):663-72. doi: 10.1111/j.1526-4637.2009.00613.x. Epub 2009 Apr 22.

Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study.

Younger J, Mackey S.

Source

School of Medicine, Department of Anesthesia, Division of Pain Management, Stanford University, 780 Welch Road, Suite 208, Palo Alto, CA 94304-1573, USA. jarred.younger@stanford.edu

Abstract

OBJECTIVE:

Fibromyalgia is a chronic pain disorder that is characterized by diffuse musculoskeletal pain and sensitivity to mechanical stimulation. In this pilot clinical trial, we tested the effectiveness of low-dose naltrexone in treating the symptoms of fibromyalgia.

DESIGN:

Participants completed a single-blind, crossover trial with the following time line: baseline (2 weeks), placebo (2 weeks), drug (8 weeks), and washout (2 weeks).

PATIENTS:

Ten women meeting criteria for fibromyalgia and not taking an opioid medication.

INTERVENTIONS:

Naltrexone, in addition to antagonizing opioid receptors on neurons, also inhibits microglia activity in the central nervous system. At low doses (4.5 mg), naltrexone may inhibit the activity of microglia and reverse central and peripheral inflammation.

OUTCOME MEASURES:

Participants completed reports of symptom severity everyday, using a handheld computer. In addition, participants visited the lab every 2 weeks for tests of mechanical, heat, and cold pain sensitivity.

RESULTS:

Low-dose naltrexone reduced fibromyalgia symptoms in the entire cohort, with a greater than 30% reduction of symptoms over placebo. In addition, laboratory visits showed that mechanical and heat pain thresholds were improved by the drug. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient. Baseline erythrocyte sedimentation rate predicted over 80% of the variance in drug response. Individuals with higher sedimentation rates (indicating general inflammatory processes) had the greatest reduction of symptoms in response to low-dose naltrexone.

CONCLUSIONS:

We conclude that low-dose naltrexone may be an effective, highly tolerable, and inexpensive treatment for fibromyalgia.

How can I help my Crohn’s disease?

Answer: Ask your doctor about trialing low-dose naltrexone:

Dig Dis Sci. 2011 Jul;56(7):2088-97. doi: 10.1007/s10620-011-1653-7. Epub 2011 Mar 8.

Therapy with the opioid antagonist naltrexone promotes mucosal healing in active Crohn’s disease: a randomized placebo-controlled trial.

Smith JP, Bingaman SI, Ruggiero F, Mauger DT, Mukherjee A, McGovern CO, Zagon IS.

Abstract

BACKGROUND:

Endogenous opioid peptides have been shown to play a role in the development and/or perpetuation of inflammation. We hypothesize that the endogenous opioid system is involved in inflammatory bowel disease, and antagonism of the opioid-opioid receptor will lead to reversal of inflammation.

AIMS:

A randomized double-blind placebo-controlled study was designed to test the efficacy and safety of an opioid antagonist for 12 weeks in adults with active Crohn’s disease.

METHODS:

Forty subjects with active Crohn’s disease were enrolled in the study. Randomized patients received daily oral administration of 4.5-mg naltrexone or placebo. Providers and patients were masked to treatment assignment. The primary outcome was the proportion of subjects in each arm with a 70-point decline in Crohn’s Disease Activity Index score (CDAI). The secondary outcome included mucosal healing based upon colonoscopy appearance and histology.

RESULTS:

Eighty-eight percent of those treated with naltrexone had at least a 70-point decline in CDAI scores compared to 40% of placebo-treated patients (p = 0.009). After 12 weeks, 78% of subjects treated with naltrexone exhibited an endoscopic response as indicated by a 5-point decline in the Crohn’s disease endoscopy index severity score (CDEIS) from baseline compared to 28% response in placebo-treated controls (p = 0.008), and 33% achieved remission with a CDEIS score <6, whereas only 8% of those on placebo showed the same change. Fatigue was the only side effect reported that was significantly greater in subjects receiving placebo.

CONCLUSIONS:

Naltrexone improves clinical and inflammatory activity of subjects with moderate to severe Crohn’s disease compared to placebo-treated controls. Strategies to alter the endogenous opioid system provide promise for the treatment of Crohn’s disease.

Am J Gastroenterol. 2007 Apr;102(4):820-8. Epub 2007 Jan 11.

Low-dose naltrexone therapy improves active Crohn’s disease.

Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS.

Abstract

OBJECTIVES:

Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues. In an open-labeled pilot prospective trial, the safety and efficacy of low-dose naltrexone (LDN), an opioid antagonist, were tested in patients with active Crohn’s disease.

METHODS:

Eligible subjects with histologically and endoscopically confirmed active Crohn’s disease activity index (CDAI) score of 220-450 were enrolled in a study using 4.5 mg naltrexone/day. Infliximab was not allowed for a minimum of 8 wk prior to study initiation. Other therapy for Crohn’s disease that was at a stable dose for 4 wk prior to enrollment was continued at the same doses. Patients completed the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) quality of life surveys and CDAI scores were assessed pretreatment, every 4 wk on therapy and 4 wk after completion of the study drug. Drug was administered by mouth each evening for a 12-wk period.

RESULTS:

Seventeen patients with a mean CDAI score of 356 +/- 27 were enrolled. CDAI scores decreased significantly (P= 0.01) with LDN, and remained lower than baseline 4 wk after completing therapy. Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission (P < 0.001). Improvement was recorded in both quality of life surveys with LDN compared with baseline. No laboratory abnormalities were noted. The most common side effect was sleep disturbances, occurring in seven patients.

CONCLUSIONS:

LDN therapy appears effective and safe in subjects with active Crohn’s disease. Further studies are needed to explore the use of this compound.

How can I manage my rheumatoid arthritis better?

Answer: Try taking fish oil.

Br J Nutr. 2012 Jun;107 Suppl 2:S171-84.

Influence of marine n-3 polyunsaturated fatty acids on immune function and a systematic review of their effects on clinical outcomes in rheumatoid arthritis.

Miles EA, Calder PC.

Abstract

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease of the joints and bones. The n-6 polyunsaturated fatty acid (PUFA) arachidonic acid (ARA) is the precursor of inflammatory eicosanoids which are involved in RA. Some therapies used in RA target ARA metabolism.

Marine n-3 PUFAs (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) found in oily fish and fish oils decrease the ARA content of cells involved in immune responses and decrease the production of inflammatory eicosanoids from ARA. EPA gives rise to eicosanoid mediators that are less inflammatory than those produced from ARA and both EPA and DHA give rise to resolvins that are anti-inflammatory and inflammation resolving, although little is known about these latter mediators in RA.

Marine n-3 PUFAs can affect other aspects of immunity and inflammation relevant to RA, including dendritic cell and T cell function and production of inflammatory cytokines and reactive oxygen species, although findings for these outcomes are not consistent.

Fish oil has been shown to slow the development of arthritis in animal models and to reduce disease severity. A number of randomised controlled trials of marine n-3 PUFAs have been performed in patients with RA. A systematic review included 23 studies. Evidence is seen for a fairly consistent, but modest, benefit of marine n-3 PUFAs on joint swelling and pain, duration of morning stiffness, global assessments of pain and disease activity, and use of non-steroidal anti-inflammatory drugs.

How can I help my rheumatoid arthritic hands?

Answer: Try doing the hand exercises described in this study:

J Rehabil Med. 2009 Apr;41(5):338-42.

A six-week hand exercise programme improves strength and hand function in patients with rheumatoid arthritis.

Brorsson S, Hilliges M, Sollerman C, Nilsdotter A.

Abstract

OBJECTIVE:

To evaluate the effects of hand exercise in patients with rheumatoid arthritis, and to compare the results with healthy controls.

METHODS:

Forty women (20 patients with rheumatoid arthritis and 20 healthy controls) performed a hand exercise programme. The results were evaluated after 6 and 12 weeks with hand force measurements (with a finger extension force measurement device (EX-it) and finger flexion force measurement with Grippit). Hand function was evaluated with the Grip Ability Test (GAT) and with patient relevant questionnaires (Disability of the Arm, Shoulder, and Hand (DASH) and Short Form-36). Ultrasound measurements were performed on m. extensor digitorum communis for analysis of the muscle response to the exercise programme.

RESULTS:

The extension and flexion force improved in both groups after 6 weeks (p < 0.01). Hand function (GAT) also improved in both groups (p < 0.01). The rheumatoid arthritis group showed improvement in the results of the DASH questionnaire (p < 0.05). The cross-sectional area of the extensor digitorum communis increased significantly in both groups measured with ultrasound.

CONCLUSION:

A significant improvement in hand force and hand function in patients with rheumatoid arthritis was seen after 6 weeks of hand training; the improvement was even more pronounced after 12 weeks. Hand exercise is thus an effective intervention for rheumatoid arthritis patients, leading to better strength and function.

Here is the complete scientific paper that gives details of the hand exercises:

A six-week hand exercise programme improves strength and hand function in patients with rheumatoid arthritis.

——
Another study reporting the benefits of hand exercises for hand strength and function in people with rheumatoid arthritis:
Rheumatol Int. 2012 May 8.

Strengthening exercises to improve hand strength and functionality in rheumatoid arthritis with hand deformities: a randomized, controlled trial.

Cima SR, Barone A, Porto JM, de Abreu DC.

Source

Department of Biomechanics, Medicine and Rehabilitation of Locomotor System, Physiotherapy Course, School of Medicine of Ribeirão Preto FMRP-USP, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, CEP: 14049-900, Brazil.

Abstract

Rheumatoid arthritis (RA) is a systemic inflammatory and chronic disease of joints, which may result in irreversible deformities. To evaluate the effects of an exercise programme aimed at improving the hand strength in individuals with hand deformities resulting from RA and to analyse the impact these exercises have on functionality. Twenty women with RA hand deformities participated in the study. They were randomly divided into two groups as follows: Group 1 (n = 13) had women participating in the exercise programme aimed at improving handgrip (HS) and pinch strengths (PS) as well as the motor coordination of the hand; Group 2 (n = 7) had women with RA who received no treatment for their hands (control). The treatment programme for hands consisted of 20 sessions, twice a week and at-home exercises. Both groups were submitted to Health Assessment Questionnaire (HAQ) and evaluation of HS and PS by means of dynamometry. Re-evaluations were performed after 10 and 20 sessions in Group 1 and after 2 months in Group 2. After 20 sessions of physiotherapy, Group 1 had a significant gain in HS and PS (p < 0.05) in addition to the improvement of functionality as assessed by HAQ (p = 0.016). For Group 2, no difference was found between the variables analysed (p > 0.05). The strengthening exercises for individuals with RA hand deformity are beneficial to improve handgrip and pinch strengths as well as functionality.

——-

And more support:

Scand J Occup Ther. 2008 Sep;15(3):173-83.

Effect of an intensive hand exercise programme in patients with rheumatoid arthritis.

Rønningen A, Kjeken I.

Abstract

The aim of this study was to test the effect of an intensive hand exercise programme in patients with rheumatoid arthritis (RA). Designed as a clinical controlled trial, the first 30 participants received a conservative exercise programme (CEP), while the next 30 received an intensive exercise programme (IEP). Outcomes were assessed at baseline, and after 2 and 14 weeks. Hand strength, measured as grip strength and pinch strength, was the primary outcome variable. Secondary outcomes were joint mobility, hand pain, and functional ability. After two weeks, there were significant differences between the groups in favour of the IEP in pinch strength in the dominant hand (p = 0.01), as well as grip and pinch strength in the non-dominant hand (p = 0.04 and 0.05, respectively). After 14 weeks, there was a significant difference between the two groups in grip strength in the non-dominant hand (p = 0.04), again in favour of the IEP. There was a trend towards increased pain in the CEP group and towards decreased pain in the IEP group, with significant differences between the groups in several measures of pain after 2 and 14 weeks. However, there were few significant differences between the two groups regarding joint mobility and functional ability. The results indicate that, compared with a traditional programme, an intensive hand exercise programme is well tolerated and more effective in improving hand function in patients with RA.

How can I manage my fibromyalgia better?

Answer:  Watch these two lectures by experts in the field for some ideas:

How can I help my chronic fatigue condition?

Answer:  Listen to Dr Jose Montoya from Stanford University and Dr Daniel Peterson from Incline Village, Nevada, for current thinking and possible treatment ideas:

Dr Jose Montoya:

Visit the Standford University Chronic Fatigue website for all he latest news.

Dr Daniel Peterson:

http://www.youtube.com/watch?v=bptxtz6zbvg&list=UUxrPmgVwJ7-gLqZJK_qLeFg&index=6&feature=plcp

http://www.youtube.com/watch?v=9O2xpW2jzY8

For more interesting chronic fatigue interviews by Llewellyn King, go to:

http://www.youtube.com/user/MECFSAlert

How can I manage my multiple sclerosis condition better?

Answer: Make sure you get enough sun (within reason!), get your Vitamin D level checked, and ask your doctor about the possibility of taking a Vitamin D supplement.

Ther Adv Neurol Disord. 2012 Jul;5(4):187-98.

Relationship between 25-OH-D serum level and relapse rate in multiple sclerosis patients before and after vitamin D supplementation.

Pierrot-Deseilligny C, Rivaud-Péchoux S, Clerson P, de Paz R, Souberbielle JC.

Abstract

BACKGROUND:

Vitamin D could play a protective role in multiple sclerosis.

METHODS:

In an observational, uncontrolled study, vitamin D3 supplementation (3010 IU/day on average) was given to 156 consecutive patients with relapsing-remitting multiple sclerosis, under first-line immunomodulatory therapy and with initial 25-OH-D serum level lower than 100 nmol/l (40 ng/ml). Relapses were determined for 29.1 ± 8.4 months during vitamin D and 29.8 ± 10.1 months before supplementation. The 25-OH-D level was measured before supplementation and several times during supplementation. The incidence rate of relapses before and during supplementation was estimated using negative binomial regression models with follow-up durations as offset terms. The incidence rate and incidence rate ratio of relapses at various 25-OH-D levels were also calculated using negative binomial regression models.

RESULTS:

In 76 patients, immunomodulatory therapy preceded vitamin D supplementation (by 4.2 ± 2.7 years) and in 80 patients both treatments were started simultaneously. Under supplementation, the 25-OH-D level increased from 49 ± 22 nmol/l to 110 ± 26 nmol/l on average. Pooling data collected before and during supplementation, we found a significant strong inverse relationship between the relapse incidence rate and the 25-OH-D level (p < 0.0001), suggesting that vitamin D did indeed influence the relapse rate. Results of univariate, bivariate and multivariate analyses were analogous: in the multivariate model adjusted for age, disease duration and previous use of immunomodulatory therapy, every 10 nmol increase in 25-OH-D level was associated with a reduction in the relapse incidence rate of 13.7%. Dividing iteratively the population made up of pooled periods into two subgroups according to the 25-OH-D levels, the relapse incidence rate ratio decreased as the 25-OH-D level increased up to 110 nmol/l, but a plateau effect was observed beyond this limit.

CONCLUSION:

Further studies are warranted for accurate quantification of the vitamin D effect

Ann Neurol. 2010 Aug;68(2):193-203.

Higher 25-hydroxyvitamin D is associated with lower relapse risk in multiple sclerosis.

Simpson S Jr, Taylor B, Blizzard L, Ponsonby AL, Pittas F, Tremlett H, Dwyer T, Gies P, van der Mei I.

Abstract

OBJECTIVE:

A protective association between higher vitamin D levels and the onset of multiple sclerosis (MS) has been demonstrated; however, its role in modulating MS clinical course has been little studied. We investigated whether higher levels of serum 25-hydroxyvitamin D (25-OH-D) were associated with a lower risk of relapses in people with MS.

METHODS:

We conducted a prospective cohort study of 145 participants with relapsing-remitting MS from 2002 to 2005. Serum 25-OH-D levels were measured biannually, and the hazard of relapse was assessed using survival analysis.

RESULTS:

There was an inverse linear relationship between 25-OH-D levels and the hazard of relapse over the subsequent 6 months, with hazard ratio (HR) 0.91 (95% confidence interval [CI]: 0.85-0.97) per 10 nmol/l increase in 25-OH-D level (p = 0.006). When variation due to timing of blood collection was removed by estimating 25-OH-D at the start of each season, this association persisted, with HR 0.90 (95% CI, 0.83-0.98) per 10 nmol/l increase (p = 0.016). Taking into account the biological half-life of 25-OH-D, we estimated 25-OH-D at monthly intervals, resulting in a slightly enhanced association, with HR 0.88 (95% CI, 0.82-0.95) per 10 nmol/l increase (p = 0.001). Adjusting for potential confounders did not alter these findings.

INTERPRETATION:

In this prospective population-based cohort study, in a cohort largely on immunomodulatory therapy, higher 25-OH-D levels were associated with a reduced hazard of relapse. This occurred in a dose-dependent linear fashion, with each 10 nmol/l increase in 25-OH-D resulting in up to a 12% reduction in risk of relapse. Clinically, raising 25-OH-D levels by 50 nmol/l could halve the hazard of a relapse.

Mult Scler. 2009 Jan;15(1):9-15.

Higher levels of 25-hydroxyvitamin D are associated with a lower incidence of multiple sclerosis only in women.

Kragt J, van Amerongen B, Killestein J, Dijkstra C, Uitdehaag B, Polman Ch, Lips P.

Abstract

INTRODUCTION:

Multiple sclerosis (MS) is a chronic inflammatory disease with an as yet not fully understood etiological background. The geographical distribution of MS is striking with a prevalence that increases with latitude. For this reason, vitamin D deficiency is considered a possible pathogenic co-factor in MS.

MATERIALS AND METHODS:

To study the role of the vitamin D metabolism in MS, blood samples were taken twice (summer and winter) from 103 patients with MS and 110 healthy controls. Serum concentrations of 25-hydroxyvitamin D (25(OH) D) and 1,25-dihydroxyvitamin D (1,25(OH)(2)D) were measured, and detailed information on disease characteristics and environmental factors that might influence the vitamin D metabolite levels was collected.

RESULTS:

Mean serum 25(OH)D and 1,25(OH)(2)D concentrations were significantly higher in summer compared to winter in both patients and controls. Using logistic regression methods, we found that  in women for every 10 nmol/L increase of serum 25(OH)D level the odds of MS was reduced by 19% (odds ratio 0.81; 95% confidence interval: 0.69-0.95), suggesting a “protective” effect of higher 25(OH)D serum levels.  In addition, also restricted to women, a negative correlation was found between Expanded Disability Status Scale and 25(OH)D levels (r = -0.29, P = 0.020).

CONCLUSIONS:

Our data suggest that higher circulating levels of 25(OH)D are associated with a lower incidence of MS and MS-related disability in women. This may imply clues to the pathogenesis of the sex difference in risk and to the nature of the environmental factors involved in MS.

J Neurol Neurosurg Psychiatry. 2008 Feb;79(2):152-7. Epub 2007 Jun 19.

A longitudinal study of serum 25-hydroxyvitamin D and intact parathyroid hormone levels indicate the importance of vitamin D and calcium homeostasis regulation in multiple sclerosis.

Soilu-Hänninen M, Laaksonen M, Laitinen I, Erälinna JP, Lilius EM, Mononen I.

Abstract

BACKGROUND:

Past sun exposure and vitamin D3 supplementation have been associated with a reduced risk of multiple sclerosis (MS). There are no previous longitudinal studies of vitamin D in MS.

OBJECTIVES:

To compare regulation of vitamin D and calcium homeostasis between patients with MS and healthy controls. To study the correlation of parameters of vitamin D metabolism with MS activity.

METHODS:

We measured 25-hydroxyvitamin D (25(OH)D), parathyroid hormone (PTH), calcium, phosphate, magnesium, chloride, alkaline phosphatase, albumin and thyroid stimulating hormone in serum every 3 months and at the time of relapse over 1 year in 23 patients with MS and in 23 healthy controls. MRI burden of disease and T2 activity were assessed every 6 months.

RESULTS:

Vitamin D deficiency (S-25(OH)D < or = 37 nmol/l) was common, affecting half of the patients and controls at some time in the year. Seasonal variation of 25(OH)D was similar in patients and controls, but 25(OH)D serum levels were lower and intact PTH (iPTH) serum levels were higher during MS relapses than in remission. All 21 relapses during the study occurred at serum iPTH levels > 20 ng/l (2.2 pmol/l), whereas 38% of patients in remission had iPTH levels < or = 20 ng/l. Patients with MS had a relative hypocalcaemia and a blunted PTH response in the winter. There was no correlation between serum 25(OH)D and MRI parameters.

CONCLUSIONS:

The endocrine circuitry regulating serum calcium may be altered in MS. There is an inverse relationship between serum vitamin D level and MS clinical activity. The role of vitamin D in MS must be explored further.

Mult Scler. 2005 Jun;11(3):266-71.

25-Hydroxyvitamin D levels in serum at the onset of multiple sclerosis.

Soilu-Hänninen M, Airas L, Mononen I, Heikkilä A, Viljanen M, Hänninen A.

Abstract

Past sun exposure and vitamin D supplementation have been associated with a reduction in the risk of MS. We measured the serum concentration of 25-hydroxyvitamin D (25[OH]D) at the time of MS diagnosis in 40 MS patients and 40 controls. We found no difference in the serum levels of 25(OH)D between MS patients and controls when all samples or samples obtained during winter months were compared, but MS patients had significantly lower serum 25(OH)D concentrations in June to September than the controls. The vitamin D stores were adequate for bone metabolism (> 37 nmol/L) in 70% of MS patients throughout the year and within the hypovitaminosis level (< 37 nmol/L) in 30% of MS patients at some time of the year. During MS-relapses, 25(OH)D levels were lower than in remission, but mostly within the reference range observed in relation with normal bone metabolism. We conclude that the vitamin D stores in most MS patients are adequate for their normal bone metabolism. However, lower vitamin D levels during MS relapses than in remission suggest that vitamin D could be involved in the regulation of the clinical disease activity of MS. The optimal serum levels of vitamin D for the regulation of immune responses remain to be determined.

How can I manage my prostate cancer better?


Answer: Try drinking pomegranate juice.

Clin Cancer Res. 2006 Jul 1;12(13):4018-26.

Phase II study of pomegranate juice for men with rising prostate-specific antigen following surgery or radiation for prostate cancer.

Pantuck AJ, Leppert JT, Zomorodian N, Aronson W, Hong J, Barnard RJ, Seeram N, Liker H, Wang H, Elashoff R, Heber D, Aviram M, Ignarro L, Belldegrun A.

Abstract

PURPOSE:

Phytochemicals in plants may have cancer preventive benefits through antioxidation and via gene-nutrient interactions. We sought to determine the effects of pomegranate juice (a major source of antioxidants) consumption on prostate-specific antigen (PSA) progression in men with a rising PSA following primary therapy.

EXPERIMENTAL DESIGN:

A phase II, Simon two-stage clinical trial for men with rising PSA after surgery or radiotherapy was conducted. Eligible patients had a detectable PSA > 0.2 and < 5 ng/mL and Gleason score < or = 7. Patients were treated with 8 ounces of pomegranate juice daily (Wonderful variety, 570 mg total polyphenol gallic acid equivalents) until disease progression. Clinical end points included safety and effect on serum PSA, serum-induced proliferation and apoptosis of LNCaP cells, serum lipid peroxidation, and serum nitric oxide levels.

RESULTS:

The study was fully accrued after efficacy criteria were met. There were no serious adverse events reported and the treatment was well tolerated. Mean PSA doubling time significantly increased with treatment from a mean of 15 months at baseline to 54 months posttreatment (P < 0.001). In vitro assays comparing pretreatment and posttreatment patient serum on the growth of LNCaP showed a 12% decrease in cell proliferation and a 17% increase in apoptosis (P = 0.0048 and 0.0004, respectively), a 23% increase in serum nitric oxide (P = 0.0085), and significant (P < 0.02) reductions in oxidative state and sensitivity to oxidation of serum lipids after versus before pomegranate juice consumption.

CONCLUSIONS:

We report the first clinical trial of pomegranate juice in patients with prostate cancer. The statistically significant prolongation of PSA doubling time, coupled with corresponding laboratory effects on prostate cancer in vitro cell proliferation and apoptosis as well as oxidative stress, warrant further testing in a placebo-controlled study.

Read the complete scientific paper:

Phase II study of pomegranate juice for men with rising prostate-specific antigen following surgery or radiation for prostate cancer.


How can I manage my type-2 diabetic nephropathy condition better?


Answer: Discuss with your doctor about your taking curcumin. Curcumin is the active ingredient in turmeric:

Scand J Urol Nephrol. 2011 Nov;45(5):365-70. Epub 2011 May 31.

Oral supplementation of turmeric attenuates proteinuria, transforming growth factor-β and interleukin-8 levels in patients with overt type 2 diabetic nephropathy: a randomized, double-blind and placebo-controlled study.

Khajehdehi P, Pakfetrat M, Javidnia K, Azad F, Malekmakan L, Nasab MH, Dehghanzadeh G.

Abstract

OBJECTIVE:

End-stage renal disease (ESRD) due to type 2 diabetic nephropathy is a very common condition which is increasing in prevalence, and is associated with high global levels of mortality and morbidity. Both proteinuria and transforming growth factor-β (TGF-β) may contribute to the development of ESRD in patients with diabetic nephropathy. Experimental studies indicate that turmeric improves diabetic nephropathy by suppressing TGF-β. Therefore, this study investigated the effects of turmeric on serum and urinary TGF-β, interleukin-8 (IL-8) and tumour necrosis factor-α (TNF-α), as well as proteinuria, in patients with overt type 2 diabetic nephropathy.

MATERIAL AND METHODS:

A randomized, double-blind and placebo-controlled study was carried out in the Diabetes Clinic of the Outpatient Department of Shiraz University of Medical Sciences on 40 patients with overt type 2 diabetic nephropathy, randomized into a trial group (n = 20) and a control group (n = 20). Each patient in the trial group received one capsule with each meal containing 500 mg turmeric, of which 22.1 mg was the active ingredient curcumin (three capsules daily) for 2 months. The control group received three capsules identical in colour and size containing starch for the same 2 months.

RESULTS:

Serum levels of TGF-β and IL-8 and urinary protein excretion and IL-8 decreased significantly comparing the pre- and post-turmeric supplementation values. No adverse effects related to turmeric supplementation were observed during the trial.

CONCLUSION:

Short-term turmeric supplementation can attenuate proteinuria, TGF-β and IL-8 in patients with overt type 2 diabetic nephropathy and can be administered as a safe adjuvant therapy for these patients.

How can I manage my lupus nephritis better?

Answer: Discuss with your doctor about your taking curcumin. Curcumin is the active ingredient in turmeric:

J Ren Nutr. 2012 Jan;22(1):50-7. Epub 2011 Jul 13.

Oral Supplementation of Turmeric Decreases Proteinuria, Hematuria, and Systolic Blood Pressure in Patients Suffering From Relapsing or Refractory Lupus Nephritis: A Randomized and Placebo-controlled Study.

Khajehdehi P, Zanjaninejad B, Aflaki E, Nazarinia M, Azad F, Malekmakan L, Dehghanzadeh GR.

Abstract

OBJECTIVE:

Despite highly expensive treatments, lupus nephritis remains a major cause of morbidity and mortality in patients with relapsing or refractory lupus nephritis. Meanwhile, experimental studies indicate that curcumin attenuates both the binding of autoantibodies from systemic lupus erythematosus patients to their cognate antigens and also the inflammatory responses of tumor necrosis factor-alpha-stimulated human endothelial cells. Therefore, in this study we investigated effect(s) of oral curcumin supplementation on patients suffering from relapsing or refractory lupus nephritis.

DESIGN:

A randomized and placebo-controlled study was carried out.

SETTING:

The present study was conducted in Lupus clinic of Hafez Hospital, Out-Patient Department of Shiraz University of Medical Sciences.

PATIENTS:

A total of 24 patients with relapsing or refractory biopsy-proven lupus nephritis, who were randomized in 2 groups (trial [n = 12] and control [n = 12] groups) were included in this study.

INTERVENTION:

With each meal, each patient in the trial group received 1 capsule for 3 months, which contained 500 mg turmeric, of which 22.1 mg was the active ingredient curcumin (3 capsules daily). The control group received 3 capsules (1 with each meal) for the same period, which contained starch and were identical in color and size to capsules given to patients in the trial group. MAIN AUTOMATIC MEASURE: Data were analyzed using Statistical Package for the Social Sciences software version 15.0.

RESULTS:

A significant decrease in proteinuria was found when comparing pre- (954.2 ± 836.6) and 1, 2, and 3 months supplementation values (448.8 ± 633.5, 235.9 ± 290.1, and 260.9 ± 106.2, respectively) in the trial group. Also, systolic blood pressure and hematuria were found to decrease significantly when pre- and post-turmeric supplementation values were compared in the trial group. However, placebo capsules did not exert any statistically significant effect on measured variables in the control group over 3 months of the study. No adverse effect related to turmeric supplementation was observed during the trial.

CONCLUSION:

Short-term turmeric supplementation can decrease proteinuria, hematuria, and systolic blood pressure in patients suffering from relapsing or refractory lupus nephritis and can be used as an adjuvant safe therapy for such patients.