Talk:Dutasteride

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problems

On the forums of this site spamlink removed it shows some problems of dutasteride, such as the manboobs (gynecomastia) and that it doesn't lower the hairline as well as finasteride; and it does thickness of hair; it works faster but well after a while it stops working, something like that. I'm sure with some looking or some waiting there might be studies with better sources than forums--this article is stubby. Oh and supposedly it's not approved in the USA and some countries, so customs takes it and will destroy it. DyslexicEditor 03:18, 17 March 2006 (UTC)[reply]

Handling/Women

Can someone provide insight into why this chemical shouldn't even -handled- by pregnant women? Is it water soluble? Is it absorbed through the skin? And then, what effects does it cause? Alvis 04:44, 30 August 2007 (UTC)[reply]

Yeah, I read this and was trying to figure it out. I can't find much of anything online about it, other than it causes "A specific birth defect." Does anyone have anything even vaguely reliable on this?Trocisp 13:29, 30 October 2007 (UTC)[reply]
"Avodart can pass through the skin. Therefore, women who are pregnant or may be pregnant should not touch Avodart because it can pass through their skin and may cause a birth defect in their male baby. " (FDA Consumer Infor)
"The association of a lack of DHT and birth defects is that a woman who has a congenital severe deficiency of 5 alpha reductase can give birth to a male child with abnormalities of his urinary tract and present as a pseudohermaphrodite." (likely spamlink removed)
True, it's not exactly science. A search on PubMed reveals these (among others..):
Prostate visualization studies in males homozygous and heterozygous for 5 alpha-reductase deficiency. (PubMed)
Ambiguous Genitalia (lpch.org)
High dose androgen therapy in male pseudohermaphroditism due to 5 alpha-reductase deficiency and disorders of the androgen receptor. (PubMed) —Preceding unsigned comment added by 216.9.142.175 (talk) 03:18, 7 January 2008 (UTC)[reply]
DHT is part of a requirement to develop the sexual structures of a male child. Technically, there would be no problem if a woman pregnant with a girl touching it, however trying to explain those sorts of variations can lead to some women not heeding advice, so the instructions are simply "zomg, don't touch it!" So that mothers who are at risk for this particular teratogenic effect properly stay away from it. It just happens that some extra mothers end up avoiding the tablets unnecessarily. *shrug* not a bad thing in medicine. Basically, testosterone and DHT are both responsible for sexual differentiation and as stated above, there's a condition similar to 5-alpha-reductase deficiency issue for the fetus. --Puellanivis (talk) 17:58, 8 June 2008 (UTC)[reply]
The Wikipedia article on Finasteride (Proscar) states (Nov. 14, 2009):
Some users, in an effort to save money, buy Proscar instead of Propecia, and split the Proscar pills to approximate the Propecia dosage. Doing so is considered unadvisable if women of pregnancy age are in the household; this is because finasteride, even in small concentrations, can cause birth defects in a developing male fetus. The birth defects involve the development of male genitalia (no such effects have been noted in developing female fetuses). On most product inserts, it will be mentioned that the dust or crumbs from broken Proscar tablets should be kept away from pregnant women. —Preceding unsigned comment added by 66.167.61.123 (talk) 22:36, 14 November 2009 (UTC)[reply]
Emedicine states that
Use during pregnancy
'Propecia' is contra-indicated for use in women due to the risk in pregnancy.
Because of the ability of type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT) in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.
Exposure to finasteride: risk to male foetus
A small amount of finasteride, less than 0.001% of the 1 mg dose per ejaculation, has been detected in the seminal fluid of men taking 'Propecia'. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus (see Section 5.3).
During continual collection of adverse experiences, post-marketing reports of exposure to finasteride during pregnancy via semen of men taking 1 mg or higher doses have been received for eight live male births, and one retrospectively-reported case concerned an infant with simple hypospadias. Causality cannot be assessed on the basis of this single retrospective report and hypospadias is a relatively common congenital anomaly with an incidence ranging from 0.8 to 8 per 1000 live male births. In addition, a further nine live male births occurred during clinical trials following exposure to finasteride via semen, during pregnancy, and no congenital anomalies have been reported.
Crushed or broken tablets of 'Propecia' should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus. 'Propecia' tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. [emphasis added]

Dose for BPH treatment

What dosages are perscribed for BPH treatment? The article gives doeses for hair loss but not BPH. Genedial (talk) 04:20, 2 October 2008 (UTC)[reply]

There is no "official" dose for hair loss - this drug is not approved as a hair loss treatment. The dose for BPH is 0.5mg/day.Pondle (talk) 20:41, 2 October 2008 (UTC)[reply]

Body hair

Looking at the Electronic Medicines Compendium, neither Dutasteride nor Finasteride have reduction of body hair listed as a side effect. So I find the newly-inserted claim[1] very strange. Pondle (talk) 18:15, 23 August 2009 (UTC)[reply]

No "History" Section

Most Wikipedia articles have a "History" section. I went to Wikipedia instead of WebMD or other source because I expected it would talk more about when the drug was patented etc. 09:32, 22 January 2011 —Preceding unsigned comment added by 68.89.170.175 (talk)

Yes Wikipedia would love you to research and write this section. Remember we are all volunteers here :-) Doc James (talk · contribs · email) (if I write on your page reply on mine) 16:56, 12 September 2013 (UTC)[reply]

GSK Phase III Results "unknown"???

So they developed a superior hair loss treatment, spent 11 years in clinical trials, but the future of this drug for MBP is "unknown"??

They dropped it just like that?

Why is that??? Did the author of this article both to ***ASK*** why this is so?

It's "unknown"??? Why?

Are the results of FDA trials really ***SECRET*** and ***UNKNOWN***.

I don't think this is the case.

I smell snake oil.75.202.244.113 (talk) 16:26, 19 February 2013 (UTC)[reply]

Propose some edits and additional language in the Contraindications section

My name is Maitri Shah, PharmD, and I work for GlaxoSmithKline Pharmaceuticals (GSK) as a Medical Information Scientist. My intent is to provide information to the editors of Wikipedia for their use in dutasteride related articles to help ensure that healthcare professionals receive accurate and balanced scientific information.

Please visit my User Page for information regarding my intentions for engagement on Wikipedia in alignment with the Wikipedia Conflict of Interest Principle. Any potential side effects of Avodart (dutasteride) or other GSK prescription drugs should be reported to GSK at 1-888-825-5249 or to the FDA by visiting www.fda.gov/medwatch or call 1-800-FDA-1088. Complete Prescribing Information for all GSK products including Avodart (dutasteride) are available at www.gsk.com.

I would like to propose some edits and additional language in the Contraindications section (highlighted in green).

Contraindications

Dutasteride is for use in men only. Dutasteride is contraindicated for use in women of childbearing potential and during pregnancy including nursing women."Avodart Prescribing Information". Retrieved 2013-08-19.

May Ccauses birth defects in male embryos and fetuses, but not in female. Dutasteride has teratogenic effects in male fetuses. In animal studies, dutasteride inhibited development of male fetus external genitalia. It may causes abnormalities of physiological development if during gestation a pregnant woman is exposed to dutasteride. Women who are pregnant or may become pregnant should not take or handle the capsules since dutasteride is absorbed through the skin. If a woman comes in contact with leaking dutasteride capsules, she should wash the contact area immediately with soap and water.

A reference is not provided for this paragraph. If a reference is not available, suggest removing this paragraph. The adverse effects of dutasteride are identical to 5-alpha-reductase deficiency, where a developing male child is naturally deficient in 5-alpha reductase type II, and thus unable to synthesize it. As dutasteride inactivates 5-alpha reductase type II developing males would have the same adverse effects as a result of the drug as they would have with the deficiency.

Dutasteride is contraindicated for use in pediatric patients.

Dutasteride is contraindicated for use in patients with clinically significant hypersensitivity (eg, serious skin reactions, angioedema) to dutasteride or other 5-alpha-reductase inhibitors. Maitri Shah, PharmD, GSK (talk) 15:44, 20 August 2013 (UTC)[reply]

Wikipedia is not a source of medical advice. If you take a look at WP:MEDMOS you will notice that "should"s like you propose are not the sort of thing we put in articles.
 Not done -- [ UseTheCommandLine ~/talk ]# ▄ 05:48, 12 September 2013 (UTC)[reply]
I would suggest also that you not propose such complex edits. one at a time is much easier to manage. I count 8 additions in the previous proposal, and the more complex an edit is, the more difficult it is for an editor to make an assessment about whether it should be done. -- [ UseTheCommandLine ~/talk ]# ▄ 05:50, 12 September 2013 (UTC)[reply]
Thank you UseTheCommandLine for your guidance. I will definitely keep this in mind when proposing any future edits to the Wikipedia articles.Maitri Shah, PharmD, GSK (talk) 07:34, 16 September 2013 (UTC)[reply]
Hello Maitri. I have removed the unsourced safety claims and rewritten the "Contraindications" section (see Dutasteride#Contraindications). Your thoughts? --Anthonyhcole (talk · contribs · email) 06:45, 12 September 2013 (UTC)[reply]
Thank you Anthonyhcole for rewriting the “Contraindications” section. I agree with your suggestions.Maitri Shah, PharmD, GSK (talk) 07:34, 16 September 2013 (UTC)[reply]
Not happy with the source. It should be changed from the GSK website to the FDA at least. Doc James (talk · contribs · email) (if I write on your page reply on mine) 16:38, 12 September 2013 (UTC)[reply]
Done. --Anthonyhcole (talk · contribs · email) 16:48, 14 September 2013 (UTC)[reply]
Hi Doc James. Nice to engage with you again. Thank you for your advice. Moving forward I will keep my referencing to the FDA website. For this article, Anthonyhcole has already changed the reference. Maitri Shah, PharmD, GSK (talk) 07:34, 16 September 2013 (UTC)[reply]

Inconsistency

The information between these two Wikipedia entries is inconsistent.

"Dutasteride" article:

Dutasteride inhibits two of the three isoforms of 5-alpha reductase, I and II, whereas finasteride only inhibits type II, and has a much shorter half-life.

"5-alpha-reductase inhibitor" article:

Finasteride (Proscar or Propecia) inhibits the function of two of the isoenzymes (type II and III), whereas dutasteride inhibits all three — Preceding unsigned comment added by Sua429 (talk • contribs) 01:40, 21 August 2014 (UTC)[reply]

Adverse Drug Effects and Medication Safety

The first line of the Adverse Effects section is this: "Dutasteride has been found to be well-tolerated in clinical studies in both men and women, producing minimal side effects.[14]" The actual line appearing in the cited article, Hirshburg et al, is this: "Overall, 5- alpha reductase inhibitors were well-tolerated in both men and women, but not without risk, highlighting the importance of patient education prior to treatment." More importantly, this sentence, either the original version or the misquoted version, are of minor significance.

The essential sentence from Hirshburg is this: "Sexual effects including erectile dysfunction and decreased libido and ejaculate were reported in as many as 3.4 to 15.8 percent of men." — Preceding unsigned comment added by Sbelknap (talk • contribs) 23:27, 15 March 2017 (UTC)[reply]

See WP:NOTHOWTO about the advice giving you want to do in WP. As I already noted in the edit note. Jytdog (talk) 00:43, 16 March 2017 (UTC)[reply]

The actual line appearing in the cited article, Hirshburg et al, is this: "Overall, 5- alpha reductase inhibitors were well-tolerated in both men and women, but not without risk, highlighting the importance of patient education prior to treatment." The first line of the Adverse Effects section is this: "Dutasteride has been found to be well-tolerated in studies of both men and women, producing minimal side effects." This is a misquotation and disagrees with the other secondary high-quality source, which states, "Evidence from the randomized controlled trials suggested that 5ARIs were associated with increased adverse effects on sexual function in men with BPH compared with placebo. " — Preceding unsigned comment added by Sbelknap (talk • contribs) 02:41, 16 March 2017 (UTC)[reply]

You are missing the point of WP:NOTHOWTO. Please stop giving WP:UNDUE weight to the sexual side effects. The article discusses them with appropriate WEIGHT. You are apparently some kind of medical person and you must know that many drugs produce a huge range of side effects on the CNS, CV, metabolic, systems etc etc etc.. Outside of the sexual side effects, which are not that common, these drugs are relatively safe. Jytdog (talk) 03:07, 16 March 2017 (UTC)[reply]

Jytdog has reverted an edit that contains a high-quality review article about dutasteride written by Traish in the Korean Journal of Urology. No explanation was given. Please restore this edit and the citation. — Preceding unsigned comment added by Sbelknap (talk • contribs) 03:21, 16 March 2017 (UTC)[reply]

You have copied and pasted from the source. We paraphrase.
The KJU has an impact factor of less than one and has only existed since 2005[2] Doc James (talk · contribs · email) 03:53, 16 March 2017 (UTC)[reply]

The KJU began publishing in English 2010. The impact factor for the KJU for 2014 was 1.25, using the Thomson-Reuters 2 year impact factor metric. I expect the 2016 impact factor will be about 1.5, but this is not yet released, AFAIK. Here is a link: http://www.scimagojr.com/journalsearch.php?q=54538&tip=sid — Preceding unsigned comment added by Sbelknap (talk • contribs) 13:11, 16 March 2017 (UTC)[reply]

Traish's KJU review states that, "Considerable evidence exists from preclinical and clinical studies, which point to significant and serious adverse effects of 5α-RIs, finasteride and dutasteride, on sexual health, vascular health, psychological health and the overall quality of life." This statement by Traish accurately summarizes the consensus view of researchers who are studying the toxicity of finasteride and dutasteride. There are more than 100 primary source peer-reviewed scientific papers on this topic. The wikipedia articles cherry pick non-representative secondary sources and selectively and inaccurately quote from them. The wikipedia articles suppress high-quality secondary sources that summarize the toxicity literature on finasteride and dutasteride.Sbelknap (talk) 13:14, 16 March 2017 (UTC)[reply]

As (I assume) most editors know, the impact factor is (unavoidably) a lagging indicator of journal quality, given the nature of the impact factor metric(s). For KJU, I would suggest looking at the *slope* of the impact factor over time since 2010. Based on the high quality of articles published in KJU, and in comparison to the other urology journals, I would expect its impact factor to equilibrate at somewhere between 3 and 4 by 2020.Sbelknap (talk) 13:18, 16 March 2017 (UTC)[reply]

@Sbelknap:--Well,apparently it's 2016, not 2020.Cheers!Winged Blades Godric 13:39, 16 March 2017 (UTC)[reply]
Well, if you genuinely feel our articles are biased, you are welcome to improve them but citing from journals with such low impact factors and addition of some unsourced/self-cited stuff is hardly a step in the direction.Also take a kind look at the rank of urology journals.Winged Blades Godric 13:39, 16 March 2017 (UTC)[reply]
The impact factor for the KJU for 2014 was 1.25, using the Thomson-Reuters 2 year impact factor metric. That is the same or higher than several of the journals cited in the current dutasteride article on wikipedia. Notably, the Journal of Clinical and Aesthetic Dermatology has an impact factor similar to KJU: http://www.scimagojr.com/journalsearch.php?q=19700175129&tip=sid&clean=0 — Preceding unsigned comment added by Sbelknap (talk • contribs) 14:02, 16 March 2017 (UTC)[reply]

Jytdog had extended period of time to respond to comments on talk page while edits were blocked, but did not. Now jytdog reverts a summary of adverse effects from a high quality secondary source. The purpose of the wikipedia rules and guidelines is ultimately to present accurate content for readers. This goal is not being served here. The dutasteride article does not accurately give the current understanding of toxicity of these drugs. — Preceding unsigned comment added by Sbelknap (talk • contribs) 18:46, 19 March 2017 (UTC)[reply]

Orphaned references in Dutasteride

I check pages listed in Category:Pages with incorrect ref formatting to try to fix reference errors. One of the things I do is look for content for orphaned references in wikilinked articles. I have found content for some of Dutasteride's orphans, the problem is that I found more than one version. I can't determine which (if any) is correct for this article, so I am asking for a sentient editor to look it over and copy the correct ref content into this article.

Reference named "2014AArev":

I apologize if any of the above are effectively identical; I am just a simple computer program, so I can't determine whether minor differences are significant or not. AnomieBOT⚡ 06:50, 12 December 2017 (UTC)[reply]

Change to description of adverse sexual side effects

Hey,

I edited the adverse impacts section surrounding sexual side effects because the current section was deeply flawed. In case this starts an editing controversy, I wanted to defend this choice in detail.

"[...] but recent research data along with advances in medical science, specifically x-ray crystallogaphy, have allowed us to directly visualize how each molecule in a formula behaves inside the cell. It is now agreed and understood amongst biochemists that purified Dutasteride by itself is not associate with any side effect, but rather the other molecules in the manufactured formula, notably butylated hydroxyanisole (BHA), which is an alleged hormone axis disruptor, used in the formula for Avodart and Generic Dutasteride. [29]"


Has the following problems:

1) This reads like a sales pitch for the safety in a way that no wikipedia article should.

2) "It is now agreed and understood amongst biochemists that purified Dutasteride by itself is not associate with any side effect, but rather the other molecules in the manufactured formula" Large amounts of random extra molecules are not how commercially available pharmaceutical drugs work, and this "is now agreed" term is a profound claim about consensus that's just clearly trying to brush off concerns

3) The sole citation for these claims does not substantiate any claims made, nor does any that I'm aware of. It also says "There is no sufficient data available at the moment to draw a conclusion regarding the safety of BHA when referring to its endocrine disrupting effect." in the abstract...


Regarding "The latest research is confirmed by a literatiure review of all studies to date in 2017 by Dr. Totsti", only 1/3 citations listed after that have a Dr. Totsti as an author, none are from 2017, and none substantiate the claim made. This is clearly a false appeal to authority.

I edited it with more sources explaining the controversy over the existence of potential harm throughout the medical literature and the ongoing media coverage of this topic. — Preceding unsigned comment added by Haxxorz596 (talk • contribs) 16:57, 24 December 2021 (UTC)[reply]

Nocebo effect

71.38.208.131, what issues do you have with these edits? — Shibbolethink (♔ ♕) 04:48, 13 November 2022 (UTC)[reply]

@Saidmann - "There has never been a consensus concerning this unsourced statement" - I added a source [3]. you called it an opinion source. That is incorrect, by everything I see associated with the article. It's a Continuing Medical Education piece. Absolutely eligible for MEDRS. It is a secondary review source that has been peer reviewed, as evidenced by its different receipt and acceptance dates. What specifically do you see that makes you think this is an opinion piece? — Shibbolethink (♔ ♕) 23:25, 13 November 2022 (UTC)[reply]
Here's the choice quote regarding the nocebo effect:
Therefore, the current literature data are controversial, and it is not yet possible to establish a causal relationship between 5α-reductase inhibitors and the persistence of sexual symptoms. The studies that demonstrated a higher incidence of persistent side effects related to the use of finasteride have important biases and included limited samples, and are insufficient to confirm the existence of PFS. Likewise, they also do not allow distinguishing between a real adverse effect or a nocebo reaction to the medication. This nocebo effect was well documented in a study comparing patients who received counseling prior to finasteride treatment regarding the possibility of sexual side effects and those who had not; 43.6% of the patients who were informed presented symptoms, compared with 15.3% of the other group.14 The nocebo effect may also be related to the occurrence of persistent sexual complaints.
You can see clearly that this piece is secondary to the content itself from the way it's framed.
But if that isn't enough to get your rocks, here's a bunch of other sources which support the statement that the nocebo effect may play a role here:
Coskuner, Enis Rauf; Ozkan, Burak; Culha, Mehmet Gokhan (April 2019). "Sexual Problems of Men With Androgenic Alopecia Treated With 5-Alpha Reductase Inhibitors". Sexual Medicine Reviews. 7 (2): 277–282. doi:10.1016/j.sxmr.2018.07.003. ISSN 2050-0521. PMID 30301703.
In patients who are knowledgeable about the side effects of the drug, experiencing a higher rate of side effects is associated with the nocebo effect.20 Clearly, the sexual side effects observed based on the Male Sexual Function 4-item questionnaire in the blind arm of this study seem to be consistent with the 1-year outcomes of the treatment arm in randomized double-blind studies such as the PLESS study
Saengmearnuparp, Thiraphat; Lojanapiwat, Bannakij; Chattipakorn, Nipon; Chattipakorn, Siriporn (November 2021). "The connection of 5-alpha reductase inhibitors to the development of depression". Biomedicine & Pharmacotherapy. 143: 112100. doi:10.1016/j.biopha.2021.112100. ISSN 0753-3322. PMID 34479019.
The inconsistent findings among clinical studies can be due to the differences in study design and quality. Most of clinical studies were not a randomized-controlled trial or a well-designed large prospective observational study. Some of the limitations cited in the retrospective studies included the inbuilt selection and recall bias and in the cross-sectional studies cited the inference of a causal relationship. In clinical studies, the nocebo effect needs to be taken into account when discussing controversial findings, particularly relevant following the surge of evidence connected to depression in PFS being published in a post-marketing report in 2011
Than, Jeffrey K.; Rodriguez, Katherine; Khera, Mohit (24 July 2018). "Post-finasteride Syndrome: A Review of Current Literature". Current Sexual Health Reports. 10 (3): 152–157. doi:10.1007/s11930-018-0163-4. eISSN 1548-3592. ISSN 1548-3584.
Specifically, the patients who are aware of the sexual side effects had higher reported rates of erectile dysfunction and decreased libido, suggesting a clinically significant placebo effect. Future additional randomized trials may be needed to further investigate this effect.
Motofei, Ion G.; Rowland, David L.; Tampa, Mircea; Sarbu, Maria-Isabela; Mitran, Madalina-Irina; Mitran, Cristina-Iulia; Stoian, Anca Pantea; Diaconu, Camelia C.; Paunica, Stana; Georgescu, Simona R. (2 April 2019). "Finasteride and androgenic alopecia; from therapeutic options to medical implications". Journal of Dermatological Treatment. 31 (4): 415–421. doi:10.1080/09546634.2019.1595507. eISSN 1471-1753. ISSN 0954-6634. PMID 30897009.
Initial studies found that the adverse events were rare and in some cases were the result of the nocebo effect.
Diviccaro, Silvia; Melcangi, Roberto Cosimo; Giatti, Silvia (May 2020). "Post-finasteride syndrome: An emerging clinical problem". Neurobiology of Stress. 12: 100209. doi:10.1016/j.ynstr.2019.100209. ISSN 2352-2895. PMC 7231981. PMID 32435662.
Criticism about the existence of PFS has been also raised. In particular, subject selection in the study design, lack of adequate control groups, possible nocebo effect and the use of retrospective questionnaires may introduce important biases, leading to poor quality of the studies performed
Above are a lot of different sources, all of which are secondary reviews, which point this out. Unless there is an extremely good reason not to, I think it's clear this content belongs in the article. — Shibbolethink (♔ ♕) 00:40, 14 November 2022 (UTC)[reply]

Prevalence of sexual adverse events

The following source is currently used five times in the article:

Hirshburg JM, Kelsey PA, Therrien CA, Gavino AC, Reichenberg JS (July 2016). "Adverse Effects and Safety of 5-alpha Reductase Inhibitors (Finasteride, Dutasteride): A Systematic Review".

It seems mandatory - in the interest of readers - to use it one more time to report the current prevalence data of sexual adverse events. The paper reported them as follows:

"Sexual adverse events in patients treated with dutasteride have been found to be similar to finasteride. Roehrborn et al reported erectile dysfunction in 7.3 percent, decreased libido in 4.2 percent, and ejaculation disturbances in 2.2 percent, which are similar to reported rates for finasteride.47 Additionally, Andriole et al reported similar rates of sexual adverse events in a direct comparison between finasteride and dutasteride.17"

And:

"Sexual adverse effects are the most common category of complications from 5ARI use and have been documented to be anywhere from 0.9 to 38 percent.4,34 Of these, erectile dysfunction is the most common followed by ejaculatory dysfunction and loss of libido.34 Several studies have evaluated these parameters and found erectile dysfunction reported in 3.4 to 15.8 percent of patients treated with finasteride 5mg daily versus 1.7 to 6.3 percent treated with placebo, decreased libido in 2.36 to 10.0 percent of patient treated with finasteride versus 1.2 to 6.3 percent of patients treated with placebo, and affected ejaculation in 0.9 to 5.7 percent of patients treated with finasteride versus 0.5 to 1.7 percent treated with placebo.35-43"

And in both the ABSTRACT and the CONCLUSIONS:

"Sexual effects including erectile dysfunction and decreased libido and ejaculate were reported in as many as 3.4 to 15.8 percent of men."

--Saidmann (talk) 12:50, 15 November 2022 (UTC)[reply]

Just to be clear, what text do you want to add to the article? We should not be WP:UNDUE and report every single prevalence number you listed. Perhaps in the body, it would be appropriate to list out the top 3 such side effects, as I believe we do (without numbers). But I am not apposed to adding numbers. But I would agree it's important to report the prevalence of sexual side effects as a whole in the lead. But I do not think it is appropriate to report "15.8% of men experience sexual side effects". We should report the median of the estimates, as is customary. I also would rather that we bolster this with other secondary sources which back up these prevalence numbers, even if it's just narrative reviews. Because I recall several narrative reviews quote "4.8%" as that median number, but that appears inconsistent with this particular systematic review. — Shibbolethink (♔ ♕) 15:23, 15 November 2022 (UTC)[reply]
A median does not seem to be reported anywhere in the literature. The current ref 34 in its Table II list 4 dutasteride studies. This is not enough to calculate a meaningful median. On should therefore report the ranges: 5.4 to 9.0 for ED, 3.3 to 7.7 for libido, and 1.4 to 4.7 for EJD. I would agree with your suggestion to add the numbers to the three items and to add the ED-numbers - as an umbrella - to the lead. --Saidmann (talk) 16:03, 16 November 2022 (UTC)[reply]
@ User:Shibbolethink: What do you think should be done considering the current state of suggestions? --Saidmann (talk) 12:53, 19 November 2022 (UTC)[reply]
As I said above, this probably requires more than just one source, given how disputed the prevalence of these side effects is. — Shibbolethink (♔ ♕) 13:59, 19 November 2022 (UTC)[reply]
@ User:Shibbolethink: It is a review of four clinical dutasteride studies concerning this question (see Table 2). It is the most comprehensive review available in the literature on this particular issue. --Saidmann (talk) 13:16, 20 November 2022 (UTC)[reply]
Yes I know what a systematic review is. As I said above, it probably requires more than just one source. Different reviews have different inclusion criteria which make them more or less reliable. The most "comprehensive" =/= the most reliable. We should probably use 2 or more sources which differ in how they gathered this information to have the most verifiable assessment of prevalence. And I do not think we should report the overall range for each one, that would be UNDUE. Better to list the weighted median or mean of that range. as any good systematic review does. The fact that the systematic review you have linked does not do this makes me think we need another source which does. Its also quite old at 8 years ago in 2014, when many studies about sexual side effects that we cite were published much later. Its also not in a very reliable journal. The Korean Journal of Urology has an extremely low impact factor and SJR [4] which makes me question the reliability of this study. Normally, systematic reviews are published in higher impact journals than the studies they cite. The fact that this is not, the fact that it does not use Cochrane standards, the fact that it does not report any weighted means or medians, the fact that it is so old, makes me think this is not a very good citation for our purposes.
Another thing to consider is that many studies have examined the adverse effect rate in placebo preparations, which is an important aspect here given the many arguments about the "nocebo" effects of the drug on these subjective side effects. The review from Hirshburg et al in 2016 covers that well. This systematic review appears to be the most recent, and has the most included studies, though it focuses on depression. And there's also this review from 2017 which compares the different indications for 5aRIs and compares their sexual side effect profiles. So, given these other systematic reviews published in better journals with more included studies, why did you pick the one from 2016 and call it "the most comprehensive review available" ? When we have later reviews with more studies?
Is it because you wanted a dutasteride-specific review? Because the 2014 one also is not specific. The 2016 is also not specific. The best available studies, summarized in the 2017 review, also show that there is no significant difference between Finasteride and Dutasteride side effect profiles at most dosages. We can and should report sexual adverse effects as for all 5aRIs to be as accurate as possible.
And aside from ALL OF THIS, we should probably use a meta-analysis, given that is the type of study which is best equipped to answer this question. The Liu et al paper from 2016 is the only one I can find that does this. It is then referenced heavily and secondarily reviewed in the 2017 paper above. It concludes there is no impact of 5aRIs on sexual side effects in patients treated for AGA. But there is for patients treated for BPH (~1.5 fold risk). As the 2017 paper concludes, this may be because patients who are taking it for BPH are likely of older age and already have a high base rate of these effects before taking 5aRIs.
I think if we're going to use any of these studies for prevalence, it should be the 2017 review, and even then, I would suggest we do not report the overall range, but instead the prevalence reported in the single largest prospective randomized study (i.e. the highest quality study) which reports prevalence. The 2017 review lists this as the PROWESS study, which followed roughly 3,000 participants. It puts the sexual side effect prevalence at 4% (libido decrease), 2.1% (ED), and 6.6% (impotence). compared to 2.8, 0.6, and 4.7% for the control group. [5]. — Shibbolethink (♔ ♕) 13:19, 20 November 2022 (UTC)[reply]
I want to be even more clear: Ranges include massive outliers, studies with poor design, small sample sizes, poorly selected studies, etc. We do not typically report ranges of things like this on wikipedia, as it is 1) useless given how wide the range typically is from a systematic review like this, and 2) gives a poor impression to our readers of what the reality or accuracy of clinical trials is. — Shibbolethink (♔ ♕) 14:51, 20 November 2022 (UTC)[reply]
So your favorite is Fertig et al. (2017). But why did you not pick one of the dutasteride studies they listed? In Table 1 they listed five such studies. --Saidmann (talk) 18:41, 20 November 2022 (UTC)[reply]
yknow, didn't even think about it. But you're right, one of those would be best even if the two drugs are largely similar in numbers, we absolutely should not use a Finasteride study to report side effects for dutasteride. How about Andriole et al.the REDUCE trial: 0.5mg Dutasteride. 6,729 patients over 4 years. RCT. Extremely high quality study.
  • Dutasteride 0.5mg: Erectile dysfunction (9%), Decreased libido (3.3%), gynecomastria (1.9%), vs
  • Placebo group: Erectile dysfunction (5.7%), Decreased libido (1.6%), gynecomastria (1.0%)
  • adverse events related to sexual function... were observed in a minority... typically in the early months of therapy, with such events decreasing in the longer term.
  • The rate of discontinuation of the study drug owing to drug-related adverse events was less than 5%.
— Shibbolethink (♔ ♕) 18:52, 20 November 2022 (UTC)[reply]
Agree. So the best way appears to quote the Fertig et al. (2017) and the Andriole et al. (2010) in tandem. As you have edited more in this article than I, I would leave the implementation to you. --Saidmann (talk) 19:43, 20 November 2022 (UTC)[reply]
Added, let me know what you think — Shibbolethink (♔ ♕) 19:33, 22 November 2022 (UTC)[reply]
Well done. Thank you. I was also pleased to see you knocked out some pieces of jargon. Best wishes. --Saidmann (talk) 21:20, 22 November 2022 (UTC)[reply]

Clarify transgender use

The text re usage in transgender women is ambiguous. With respect, does it mean genetic males becoming women, or birth-gender women transitioning to men, or only those who have completed either transition and require maintenance? After checking the wikilink on hormone therapy, it was fairly obvious that women transitioning from male is intended, but Wikipedia should always be clear! I would simply make the edit, but I'm not sure how to word it appropriately -- and succinctly (unlike this post). D Anthony Patriarche (talk) 18:01, 9 March 2023 (UTC)[reply]

a "transgender woman" is someone who was born with XY chromosomes (usually) who presents as a woman. The language is identity-first. We describe trans people as the identity they present as. I think the current wording is appropriate, most of our readers know that (and if they don't a quick google of "trans woman" or a click through to the article would tell them as much). It's also in line with the standards in the wikipedia manual of style and the WikiProject LGBTQ recommendations. I think your confusion is true for a lot of people as well, not discounting it. I've added a wikilink to Trans woman since that might help some users, and it hasn't been wikilinked in that section anywhere. But I think over-explaining it further in the article text would be crude, unnecessary, and probably run afoul of those aforementioned guidelines. — Shibbolethink (♔ ♕) 19:23, 9 March 2023 (UTC)[reply]
“Transgender women” is not an ambiguous term at all and is always universally understood to mean people assigned male at birth. 99.108.224.199 (talk) 22:19, 11 March 2023 (UTC)[reply]
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