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Opinions on these gyno studies

lilarnold

New member
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Apr 4, 2007
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230
- actually there are good studies showing reversal of existing gyno using SERMs - raloxifene best, nolvadex 2nd best.

also, Letrozole has anecdotal buzz for reversal, but last I searched (about a year ago), the only non-surgical agents that have studies showing reduction of EXISTING gynecomastia are the SERMs Nolvaldex and raloxifene. Ralox is more effective, but also more expensive and less available.

arimidex, which is an anti-a like Femera - letrozole - did nothing for reduction. great for prevention.

What may end up being shown is that because Femera - letrozole - is so much more effective at destroying or virtually eliminating Estrogen than arimidex , it would be effective at reducing existing gynecomastia even tho the studied anti-aromatse (arimidex) was not.


here's some of the SERM Gyno reversal studies:


1)
Prevention and management of bicalutamide-induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole.
Saltzstein D, Sieber P, Morris T, Gallo J.
Urology San Antonio Research PA, Pasteur Medical Plaza, San Antonio, Texas, USA.

A randomized, double-blind, placebo-controlled multicenter trial involving 107 men receiving bicalutamide ('Casodex') 150 mg/day therapy following radical therapy for prostate cancer assessed tamoxifen ('Nolvadex') 20 mg/day and anastrozole ('Arimidex') 1 mg/day for the prophylaxis and treatment of gynecomastia/breast pain. Tamoxifen, but not anastrozole, significantly reduced the incidence of gynecomastia/breast pain when used prophylactically and therapeutically. Serum testosterone levels increased with tamoxifen relative to placebo but prostate-specific antigen levels declined in all treatment groups. Further studies are needed to define the optimum tamoxifen dose and to assess any impact on cancer control. The use of tamoxifen in this setting remains to be investigated



2)
1: J Pediatr. 2004 Jul;145(1):71-6. Related Articles, Links

Comment in:

* J Pediatr. 2005 Apr;146(4):576; author reply 576-7.
* J Pediatr. 2005 Apr;146(4):576; author reply 576-7.

Beneficial effects of raloxifene and tamoxifen in the treatment of pubertal gynecomastia.
Lawrence SE, Faught KA, Vethamuthu J, Lawson ML.
Department of Pediatrics, University of Ottawa, Ontario, Canada.

[email protected]

OBJECTIVES: To assess the efficacy of the anti-estrogens tamoxifen and raloxifene in the medical management of persistent pubertal gynecomastia.

STUDY DESIGN: Retrospective chart review of 38 consecutive patients with persistent pubertal gynecomastia who presented to a pediatric endocrinology clinic. Patients received reassurance alone or a 3- to 9-month course of an estrogen receptor modifier (tamoxifen or raloxifene).

RESULTS: Mean (SD) age of treated subjects was 14.6 (1.5) years with gynecomastia duration of 28.3 (16.4) months. Mean reduction in breast nodule diameter was 2.1 cm (95% CI 1.7, 2.7, P <.0001) after treatment with tamoxifen and 2.5 cm (95% CI 1.7, 3.3, P <.0001) with raloxifene. Some improvement was seen in 86% of patients receiving tamoxifen and in 91% receiving raloxifene, but a greater proportion had a significant decrease (>50%) with raloxifene (86%) than tamoxifen (41%). No side effects were seen in any patients.

CONCLUSION: Inhibition of estrogen receptor action in the breast appears to be safe and effective in reducing persistent pubertal gynecomastia, with a better response to raloxifene than to tamoxifen. Further study is required to determine that this is truly a treatment effect.

PMID: 15238910 [PubMed - indexed for MEDLINE]

3)
Management of physiological gynaecomastia with tamoxifen.
Khan HN, Rampaul R, Blamey RW.
Professorial Unit of Surgery, Department of Surgery, Nottingham City Hospital, Nottingham NG5 1PB, UK.

AIMS: We aimed to confirm suggestions that tamoxifen therapy alone may resolve physiological gynaecomastia. METHODS: A prospective audit of the outcome of tamoxifen routinely given to men with physiological gynaecomastia was carried out at Nottingham. Men referred with gynaecomastia had clinical signs recorded, e.g., type (diffuse 'fatty' or retro-areolar 'lump'), size and possible aetiology. They were offered oral tamoxifen 20mg once daily for 6-12 weeks. On follow-up patients were assessed for complete resolution (CR), partial resolution where patient is satisfied with outcome (PR) or no resolution (NR). Success was either CR or PR. RESULTS: Thirty-six men accepted tamoxifen for physiological gynaecomastia. Median age was 31 (range 18-64). Tenderness was present in 25 (71%) cases. Sixteen men (45%) had 'fatty' gynaecomastia and 20 had 'lump' gynaecomastia. Tamoxifen resolved the mass in 30 patients (83.3%; CR=22, PR=8) and tenderness in 21 cases (84%; CR=0, PR=0). Lump gynaecomastia was more responsive to tamoxifen than the fatty type (100% vs. 62.5%; P=0.0041). CONCLUSIONS: Oral tamoxifen is an effective treatment for physiological gynaecomastia, especially for the lump type.

--

4) writeup:

Treatment of gynaecomastia with raloxifene.
Ariel S¨¢nchez (24 September 2003)
Centro de Endocrinolog¨ªa, San Lorenzo 876, (2000) Rosario, SF, Argentina



............We decided to evaluate the effect of raloxifene in a series of patients with gynaecomastia. Twelve patients aged 18-84 years were treated. Breast enlargement was unilateral in 5 cases; its duration ranged from a few weeks (7 cases) to several years (5 cases). Four patients were hypogonadal by clinical criteria, and had low serum testosterone. In two patients there was a possible drug effect (prasterone in one, ranitidine in the other). The size of breast tissue ranged between 1.5 and 6.0 cm. All patients had normal testes by palpation, and normal serum levels of estradiol, lh - leutenizing hormone - , FSH - follicle stimulating hormone - , prolactin, and alpha-HCG - human chorionic gonadotropin - . Liver function tests and serum creatinine also were normal. The dose of raloxifene was 60 mg every other day in 4 elderly patients (age 70 years or more), and 60 mg daily in the remaining; the medication was given for 2-12 months. Hypogonadal patients received, in addition, i.m. injections of testosterone enanthate, 100 mg twice a month.
Raloxifene was well tolerated; only one young patient reported a slight decrease in sexual potency. No subject complained of hot flushes; there were no episodes of thrombophlebitis during follow-up. The analgesic effect of treatment was fast (2-4 weeks) and sustained among 9 patients with pain and tenderness. The size of the gynaecomastia was evaluated monthly by means of a caliper (all patients), and ultrasonography (7 patients).

All patients responded: there was an average reduction in size of 61% (range: 34-100%); in 2 patients gynaecomastia disappeared. Six of 8 eugonadal patients (75%) had a reduction in the size of breast tissue of at least 50% (average, 73%). Among hypogonadal patients (all of them followed with ultrasonography) gynaecomastia disappeared in one, and size reduction in the remaining subjects ranged between 46 and 67% (this is particularly noteworthy, since testosterone replacement not infrequently causes or aggravates gynaecomastia due to local aromatization to oestrogens by mammary tissue). Maximal effect was observed during the first 2 months of treatment.

This open, observational study suggests that raloxifene may be a safe, well tolerated and effective therapeutic alternative for drug-induced or idiopathic gynaecomastia in men of all ages.



the ralox 60mg dose for reversal is from at least one study ( **broken link removed** ) and anecdotal info


- the nolva shorter-term 60mg for reversal is more bro-ology, based on many posts on many boards over many years by experienced vets --- the reversal studies are more conservative in the 30mg range over a longer period of time (example, Prevention and management of bicalutamide-induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole.
Saltzstein D, Sieber P, Morris T, Gallo J.
Urology San Antonio Research PA, Pasteur Medical Plaza, San Antonio, Texas, USA. )


some studies on safety and increased effectiveness of higher doses in stubborn cases:

-
1)
Idiopathic gynecomastia treated with tamoxifen: a preliminary report.Alagaratnam TT.
Department of Surgery, Queen Mary Hospital, University of Hong Kong.

Sixty-one Chinese men with idiopathic gynecomastia were treated with 40 mg of tamoxifen daily for one of four months (median, two months). Eighty percent had complete regression of their breast swelling. No long-term side effects of tamoxifen were observed over a median follow-up period of 36 months.
PMID: 3664552 [PubMed - indexed for MEDLINE]

2)
Tamoxifen treatment for pubertal gynecomastia.Derman O, Kanbur NO, Kutluk T.
Section of Adolescent Medicine, Department of Pediatrics, Hacettepe University Faculty of Medicine, 06100 Ankara-Turkey. [email protected]

We evaluated the efficacy of the tamoxifen treatment in 37 patients with pubertal gynecomastia. All had distinct, easily palpable breast swellings with a diameter of over three cm. Pain, tenderness, and swelling associated with gynecomastia were reported by six patients. Eight of the patients were obese. One patient also suffered from varicocele. Pain and size reduction was seen in all patients with tamoxifen treatment. No long-term side effects of tamoxifen were observed. The dose of tamoxifen was increased in three patients due to poor response. Two of the treatment group had recurrence problem at follow-up. We did not need to refer any patient to surgery. Tamoxifen treatment is relatively non-toxic, may be beneficial and we think it should be considered for pubertal gynecomastia.

PMID: 14719418 [PubMed - indexed for MEDLINE]

3)
Tamoxifen for flutamide/finasteride-induced gynecomastia.Staiman VR, Lowe FC.
Department of Urology, St. Luke's-Roosevelt Hospital Center, New York, NY 10019, USA.

OBJECTIVES: Current therapies for advanced prostate carcinoma lead to a marked decrease in serum testosterone levels, which renders patients impotent. In preliminary studies, combination therapy with flutamide and finasteride has been used as an alternative therapy for the treatment of prostate carcinoma because potency can be preserved. Both of these agents can cause gynecomastia and breast/nipple tenderness. METHODS: Six men being treated for advanced prostate carcinoma with flutamide/finasteride combination therapy developed painful gynecomastia, which was treated with tamoxifen 10 to 30 mg/day for 1 month. Clinical follow-up included breast measurements and determination of prostate-specific antigen (PSA), testosterone, and estradiol levels. RESULTS: While on this combination therapy for prostate carcinoma, 4 of 6 patients experienced a decrease in PSA level to less than 0.5 ng/mL. All patients remained potent. Serum testosterone increased in each patient who had a baseline level drawn. Estradiol levels were noted to be elevated in 4 of 6 patients at the time of evaluation for gynecomastia. After treatment with tamoxifen, circulating estradiol levels increased in 3 patients from 1.3 to 2.2 times the baseline level. Five patients experienced complete resolution of breast and nipple pain on tamoxifen 10 mg/day within the first month. The other patient had to be treated with 30 mg/day for 1 additional month, which subsequently resulted in pain resolution. CONCLUSIONS: These preliminary results suggest that low-dose tamoxifen is useful in treating painful gynecomastia for those patients on flutamide/finasteride combination therapy for advanced prostate carcinoma. [my note: ie drug induced gyno ]

PMID: 9426725 [PubMed - indexed for MEDLINE]
 

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