Docstoc

Does Tebonin® (Ginkgo biloba) provide relief in tinnitus

Document Sample
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus Powered By Docstoc
					                                Does Tebonin® (Ginkgo biloba)
                                provide relief in tinnitus?

Plain English Summary
The condition
Tinnitus (noise or ringing in the ears) is a common symptom of many diseases of the hearing
system. Patients with tinnitus are advised to see a doctor to exclude preventable conditions &/or
medication which might make tinnitus worse. While there is usually no cure for tinnitus there are
many techniques and self-help groups that can assist sufferers to manage their tinnitus to the point
where it is no longer a problem. There are also some products on the market that claim to offer
“relief”.

The promotion of Tebonin® (Ginkgo biloba)
In late April 2006, pharmacies in Australia received a fax alerting them to a major advertising
campaign to launch a “new” complementary medicine product, Tebonin® for the relief of tinnitus
and vertigo.
Tebonin® contains a proprietary extract of Ginkgo biloba leaves (EGb 761®) manufactured in
Germany by Dr. Willmar Schwabe GmbH & Co KG. It contains 120mg per tablet of EGb761®. For
adults, a dose of one to two tablets is recommended by the manufacturer.

Does Tebonin® work?
The authors of a number of recent scientific reviews have not been convinced that Ginkgo biloba
provides more relief for tinnitus than a pill without active ingredients (a placebo). The Australian
suppliers of Tebonin® were approached and asked to supply information about the efficacy of
Tebonin® with respect to tinnitus. A thorough search of the scientific literature was then conducted
by AusPharm Consumer Health Watch and the papers found were also reviewed. The Therapeutic
Goods Administration (TGA) was contacted to determine what claims for Tebonin® were listed on
the Australian Register of Therapeutic Goods and whether these claims had been submitted to
independent verification.
The Australian distributor provided two papers to support their claims that Tebonin® provided
“relief” &/or was “an effective treatment” for tinnitus. One paper was published in 1997 and in our
opinion was of poor quality. The other paper was published in 2000 and in our opinion provided an
uncritical review of earlier work. Both papers came to conclusions that differed from more recent
independent reviews.
Schwabe Pharma Asia Pacific Pty. Ltd. provided three additional papers published in 1997, 1999
and 2002. In our opinion, the statistical analysis of the 1997 paper was poorly performed and the
authors’ conclusion that Tebonin® provided greater relief than a placebo was not justified. The
1999 paper reported a trial that administered Tebonin® intravenously in hospital followed by oral
treatment. In our opinion, this research is not relevant to treatment of tinnitus with an “over-the-
counter” product. The 2002 paper was a review of earlier studies and concluded,
       “Overall, the results of these trials are favourable to ginkgo biloba as a treatment for tinnitus, but a
       firm conclusion about its efficacy is not possible. At present, the body of evidence is small. More
       trials are needed to test the therapeutic value of ginkgo biloba for relieving tinnitus.”




                                                                                                   Page 1 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
Our own review of the literature revealed two more recent, large, well designed, placebo controlled
trials that failed to show that Ginkgo biloba was more effective than a placebo in relieving the
symptoms of tinnitus. A 2005 New Zealand critical review summarised the present state of
knowledge as follows:
       “Some clinical trials have yielded positive results, however, these studies are few and have been
       limited either by design flaws, the small size of the significant effects, or else the results have not
       been published in peer-reviewed journals and therefore the quality of the research is not assured. By
       contrast, the two most systematic clinical trials, both double-blind and placebo controlled, and
       published in respected peer-reviewed journals, have yielded negative results and suggest that Ginkgo
       extracts are of little more use in the treatment of tinnitus than a placebo”.

Side effects, contraindications
The literature shows that Ginkgo biloba is generally well tolerated, with side effects being rare,
usually mild, and having a similar occurrence to placebo. Side effects reported include nausea,
vomiting, diarrhoea, headaches, dizziness, palpitations, restlessness, weakness, or skin rashes.
Ginkgo biloba may increase the risk of bleeding in patients taking other medicines that affect
coagulation, particularly warfarin, and it is recommended patients using both drugs be monitored by
their doctor. Safe use in pregnancy or lactation has not been established.

Value for money
Tebonin ® will cost consumers approximately AU$30-80 per month to use, although this will vary
depending on the dose and the place and time of purchase. In our opinion, a product that appears to
be no more effective than a placebo does not offer value for money.

The role of the Therapeutic Goods Administration (TGA)
Sponsors of complementary medicines regarded as “low-risk” by the TGA must “list” their product
with the TGA for entry onto the Australian Register of Therapeutic Goods (ARTG) prior to
marketing. If a sponsor wishes to make therapeutic claims about their product they are required to
hold appropriate scientific evidence to justify the claims made. However, the TGA does not
routinely ask to see (or evaluate) this evidence. In the case of Tebonin® the indication, “For the
symptomatic relief of tinnitus” (and many other claims) are “listed” on the ARTG; however the
TGA has yet to assess the scientific validity of these claims.

The advertising of therapeutic goods
The advertising of therapeutic goods in Australia is governed by the Therapeutic Goods Act 1989
and Regulations. All advertisements of “listed” products to consumers (such as Tebonin®) must
comply with the Therapeutic Goods Advertising Code 2005. In our opinion, the current
advertisements for Tebonin® do not comply with the Therapeutic Goods Advertising Code 2005.

Summary
AusPharm Consumer Health Watch is of the opinion that there is insufficient good quality scientific
evidence to support the promotion of Tebonin® for the relief of tinnitus at this point in time. People
with this symptom should consult their doctor. They can also inform themselves of various
management options by getting in touch with their local Tinnitus Association.




                                                                                                Page 2 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
Background
AusPharm Consumer Health Watch
We are a multi-disciplinary group (primarily pharmacists) who look critically at the claims made by
non-prescription health related products in the pharmacy marketplace, assess the therapeutic claims
they make against the existing research, look at product safety and value for money, engage in
dialogue with the product sponsor and then publish our findings. Our primary aim is to help
consumers make informed choices about these products.1

Tinnitus
Tinnitus is a physical condition, experienced as noises or ringing in the ears or head, when no such
external physical noise is present. Tinnitus is not a disease in itself. It is a symptom of a fault in the
auditory (hearing) system, which includes the ears and the brain.
Approximately 17 to 20 per cent of Australians suffer from some degree of tinnitus, varying from
mild to severe. The percentage of people who are severely affected is small but for these people
tinnitus can be disabling. Common causes of tinnitus are exposure to loud sounds, degeneration
(“wear and tear”) of the small bones in the middle ear and a number of prescription and non-
prescription drugs.
Patients with tinnitus are advised to see a doctor to exclude preventable conditions &/or medication
which might make tinnitus worse. In addition, although there is usually no cure for tinnitus there are
many techniques and self-help groups that can assist sufferers to manage their tinnitus to the point
where it is no longer a problem.2,3
There are also a number of products on the market offering “relief” from tinnitus, including some
complementary and alternative medicines. These are often used in the sincere hope they might
make a difference.4 It is important that the evidence for and against these products is available in the
public domain so that consumers can make an informed decision.

The promotion of Tebonin® (Ginkgo biloba)
Tebonin® contains a proprietary extract of ginkgo biloba leaves (EGb 761®) manufactured in
Germany by Dr. Willmar Schwabe GmbH & Co KG.5 It contains 120mg per tablet of EGb761®.
For adults, a dose of one to two tablets is recommended by the manufacturer.6
In late April, 2006 Australian pharmacies received a fax (Appendix I) from Pharmalink Marketing
Australia Pty. Ltd. alerting them to the fact that,
        “The companies behind the marketing and distribution of Remifemin® and Thirty Plus® are jointly
        launching a new product – Tebonin® (EGb761®) for the relief of Tinnitus and Vertigo”.
It described “major advertising” planned for Tebonin® included activity through May and June
2006 in national publications such as New Idea, Women’s Weekly and Reader’s Digest as well as a


1
  http://www.consumerhealthwatch.net.au/about.html (accessed 7/5/2006)
2
  http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Tinnitus_explained (accessed 7/5/2006)
3
  http://www.tinnitusvic.asn.au/index.htm
4
  http://www.tinnitus.org.uk/information/info%20sheets/front%20page/complementary_therapy.htm (accessed
7/5/2006)
5
  http://www.schwabepharma.com (accessed 9/5/2006)
6
  The pack (AUST L 125310) states, “Take 1 Tebonin 120 mg tablet daily…. For more intensive use, take 2 tablets
daily.”


                                                                                                     Page 3 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
half page editorial in all major newspapers across all states and a full page editorial in the Journal of
Complementary Medicine.
A search of the Australian Register of Therapeutic Goods (ARTG) showed the Australian sponsor
of Tebonin® to be Schwabe Pharma Australia Pty. Ltd. Telephoning the number listed on the
ARTG for Schwabe Pharma Australia Pty Ltd connected to a representative from Natural Health
Products Pty. Ltd. (the product’s distributor).
Pharmalink Marketing Australia Pty. Ltd., Schwabe Pharma Australia Pty Ltd. and Natural Health
Products Pty. Ltd. have the same telephone and fax number.
Currently, Natural Health Products Pty. Ltd. has a web site promoting this product for the relief of
tinnitus and vertigo7 (Appendix II). The web site claims8,
        “The modes of action in which Tebonin® functions to alleviate tinnitus and vertigo include:
        improvement of microcirculation, increasing suppleness and flexibility of red blood cells, improving
        blood vessel tone and permeability, increasing cell nutrient supply and waste product removal,
        improving efficiency of cellular energy conversion, protection of cell structure and integrity,
        scavenging of free radicals, cell membrane protection, mitochondrial stabilisation, neuroprotection.”
A brochure produced by the same company is also available (Appendix III). The brochure states
that,
        “Tebonin® (EGb 761®) has been shown through clinical research to be an effective treatment for a
        range of conditions relating to impaired micro-circulation.” It then lists, “Tinnitus, Vertigo,
        Peripheral Circulation, Cognitive Function, Memory and Mental Alertness.”
Two pharmacy websites reiterate,
        “Tebonin …has shown through clinical research to be an effective treatment for a range of
        conditions relating to microcirculation including Tinnitus, Vertigo, Peripheral Circulation and
        Cognitive Function.”9,10
The May 2006 issue of “Go Vita Good Health News”, the “Journal of Complementary Medicine”
and daily newspapers contained the advertisement shown in Appendix IV. The Tebonin® pack (and
packet insert) also uses the phrase, “an effective treatment” (Appendix V)

Our investigation
The Therapeutic Goods Administration (TGA) and the Complementary Healthcare Council (CHC)
were approached to clarify regulatory procedures for complementary and alternative medicines. In
particular, the TGA was asked for the contact details of the sponsor, what claims for Tebonin® were
listed on the Australian Register of Therapeutic Goods, whether those claims had been submitted to
independent verification.
On April 28, 2006 we telephoned the sponsor of Tebonin® and requested information about the
efficacy of Tebonin® with respect to tinnitus. The two (2) scientific papers provided were
compared with other papers obtained from a comprehensive search of the scientific literature.
On May 10, 2006 a draft report of our conclusions was sent to the product suppliers (as a courtesy).
In return, a series of letters were received including three (3) additional scientific papers. The
substantive issues raised by these letters were carefully considered and answered by the group.

7
  http://www.tebonin.com.au (accessed 7/5/06)
8
  http://www.tebonin.com.au/how_can_tebonin.asp (accessed 29/5/06)
9
  http://www.healthdepot.com.au/ssl/2-int/shopexd.asp?id=507 (accessed 9/5/06)
10
   http://pharmacydirect.com.au/PD_ProductOrderingInformation.asp?PID=19086&PLID=2 (accessed 9/5/06)


                                                                                                Page 4 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
At this time, the product suppliers requested, and the group agreed, to provide them seven (7) more
working days to provide additional scientific evidence that might change our opinion about the
efficacy of their product. No more scientific information was received from the product suppliers;
instead further letters arrived, this time from their legal representative requiring an undertaking not
to publish a report or otherwise engage in criticism of the product Tebonin®. This correspondence
also included an “expert opinion” from a senior medical advisor employed by Dr. Willmar Schwabe
GmbH & Co KG that raised various issues. After obtaining legal advice, this report was then
finalised.

Does Tebonin® work?
The Australian distributor (Natural Health Products Pty. Ltd.) provided two papers to support the
efficacy of Tebonin® in tinnitus. One paper was published in 1997;11 the other in 2000. 12 In our
opinion, the former was published in an obscure journal and was of poor quality; the latter provided
an uncritical review of earlier work. Both papers came to different conclusions than more recent
placebo controlled clinical trials and independent reviews.
Schwabe Pharma Asia Pacific Pty. Ltd. provided three additional papers published in 1997, 1999
and 2002. In our opinion, the statistical analysis of the 1997 paper13 was poorly performed and the
authors’ conclusion that Tebonin® provided greater relief than a placebo was not justified. The
1999 paper14 reported a trial that administered Tebonin® intravenously in hospital followed by oral
treatment. In our opinion, this research is not relevant to treatment of tinnitus with an “over-the-
counter” product. The 2002 paper15 was a review of earlier studies and concluded:
         “Overall, the results of these trials are favourable to ginkgo biloba as a treatment for tinnitus, but a
         firm conclusion about its efficacy is not possible. At present, the body of evidence is small. More
         trials are needed to test the therapeutic value of ginkgo biloba for relieving tinnitus.”
Our own review of the literature showed that in 2004, the same journal (Clin Otolaryngol.)
contained a more recent review of this subject that also presented the results of a new randomized
placebo-controlled double-blind trial.16 The authors concluded that Ginkgo biloba did not benefit
patients with tinnitus. This is the same conclusion reached by the authors of another large well
designed clinical trial17 and numerous recent reviews.18,19,20


11
   Gómez E. Multicentic study on the standardized Ginko biloba extract in the treatment of memory disorders, vertigo
and tinnitus. Investigación médica internacional (Mexico) 1997; 24: 31-39.
12
   Holstein N. Ginkgo special extract EGb 761 in tinnitus therapy. An overview of results of completed clinical trials.
Fortschr Med Orig. 2000;118: 157-64 [original article in German]
13
   Morgenstern, C. and E. Biermann. 1997. Ginkgo biloba special extract EGb 761 in the treatment of tinnitus aurium:
Results of a randomized, double-blind, placebo-controlled study. Fortschr Med 115: 7–11.
14
   Morgenstern C, Biermann E. The efficacy of Ginkgo special extract EGb 761 in patients with tinnitus. Int J Clin
Pharmacol Ther. 2002; 40: 188-97.
15
   Ernst E, Stevinson C. Ginkgo biloba for tinnitus: a review. Clin Otolaryngol 1999; 24: 164-167.
16
   Rejali D, Sivakumar A, Balaji N. Ginkgo biloba does not benefit patients with tinnitus: a randomized placebo-
controlled double-blind trial and meta-analysis of randomized trials. Clin. Otolaryngol. 2004; 29: 226–231.
http://www.blackwell-synergy.com/links/doi/10.1111%2Fj.1365-2273.2004.00814.x (accessed 7/5/06)
17
   Drew S, Davies E. Effectiveness of Ginkgo biloba in treating tinnitus: double blind, placebo controlled trial. BMJ
2001; 322: 1–6. http://bmj.bmjjournals.com/cgi/content/full/322/7278/73
18
   Lockwood AH, Salvi RI, Burkard RF. Tinnitus. New Eng J Med. 2002; 347 (12): 904–1011.
19
   Waddell A, and Canter R. Tinnitus. Clin Evid 2003; 10: 634–643. Available at:
http://www.aafp.org/afp/20040201/bmjx.pdf (accessed 7/5/06)
20
   Hilton M, Stuart E. Ginkgo biloba for tinnitus. The Cochrane Database of Systematic Reviews 2004, Issue 2. Art.
No.: CD003852. DOI: 10.1002/14651858.CD003852.pub2.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD003852/frame.html (accessed 7/5/06)


                                                                                                          Page 5 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
The most recent 2005 New Zealand review21 summarised the present state of knowledge as follows:
        “Some clinical trials have yielded positive results, however, these studies are few and have been
        limited either by design flaws, the small size of the significant effects, or else the results have not
        been published in peer-reviewed journals and therefore the quality of the research is not assured. By
        contrast, the two most systematic clinical trials, both double-blind and placebo controlled, and
        published in respected peer-reviewed journals, have yielded negative results and suggest that Ginkgo
        extracts are of little more use in the treatment of tinnitus than a placebo”.
The senior medical advisor employed by Dr. Willmar Schwabe GmbH & Co KG argued that trials
with negative outcomes do not necessarily indicate that the efficacy of a product is lacking. He also
implied that the listing of EGb761® in standard regulatory approved monographs (presumably in
Germany) should have been taken into account. Finally, he was concerned that we did not
distinguish studies performed with EGb761® from other preparations of Ginkgo biloba.
We agree that large-scale, well conducted clinical trials with negative outcomes do not necessarily
rule out that the product tested may be efficacious in a particular sub-group of patients. However,
we were unable to find good quality studies that confirmed EGb761® is “an effective treatment for
tinnitus relating to impaired micro-circulation” (nor are we aware of how such a sub-group of
patients can be practically identified clinically).
We note that drug registry information and product monograph information is often not up-to-date
with respect to the scientific literature and the association of a particular product with an indication
in such material is no proof of efficacy.
We dispute that Tebonin® (Schwabe extract EGb 761®) is sufficiently different from other
standardised extracts to invalidate the clinical trial evidence we have assessed. In Germany, we
understand that Ginkgo biloba extracts must meet the requirements of the 1994 German
Commission E monograph which specifies what the extract must contain. We are aware of negative
trials of German approved extracts of Ginkgo biloba with respect to their efficacy in tinnitus. Our
literature review of tinnitus treatment has failed to reveal good evidence from well conducted
scientific trial that EGb 761® is more efficacious than a placebo. We requested such literature from
Schwabe Pharma (Aust) Pty Ltd and they failed to provide it.
In conclusion, AusPharm Consumer Health Watch is of the opinion that there is insufficient good
quality evidence to justify the promotion of Tebonin® (or other products containing Ginkgo
biloba22) for the relief of tinnitus at this point in time. We accept that some relief has been
experienced by individuals with tinnitus using such products; however, in our opinion, this is most
likely due to a placebo effect. More (and better) evidence from controlled clinical trials (possibly in
subgroups of patients with different causes of tinnitus) is needed before this product can be
confidently recommended to tinnitus sufferers.

Side effects, contraindications
The literature shows that Ginkgo biloba is generally well tolerated, with side effects being rare,
usually mild, and having a similar occurrence to placebo. Side effects reported include nausea,

21
   Smith PF, Zheng Y, Darlington CL. Ginkgo biloba extracts for tinnitus: More hype than hope? J Ethnopharmacol.
2005; 100: 95-9.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15998570&quer
y_hl=4&itool=pubmed_docsum (abstract) (accessed 7/5/06)
22
    EGb761® contains 24% ginkgo flavone glycosides and 6% terpenoids while LI 1370 (which is used by Blackmores)
contains 25% ginkgo flavone glycosides and 6% terpenoids. Both extracts have been used in clinical trials.



                                                                                                  Page 6 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
vomiting, diarrhoea, headaches, dizziness, palpitations, restlessness, weakness, or skin rashes.23
Safe use in pregnancy or lactation has not been established. There are occasional reports of a
possible causal association between using ginkgo and bleeding events24 although studies of ginkgo
in small numbers of healthy people have not shown any coagulation abnormalities.25 A review of
this matter by the Australian Complementary Evaluation Committee in 1999 concluded that the risk
appeared low.26 However there remains concern that ginkgo may increase the risk of bleeding in
patients taking other medicines that interfere with coagulation, particularly warfarin.14 In 2005 the
Australian Adverse Reactions Advisory Committee warned practitioners about this and other
adverse reactions with complementary and alternative medicines and urged them to ask their
patients about such use and to report suspected adverse reactions.27

Value for money
Tebonin® will cost consumers approximately AU$30-80 per month to use, although this will vary
depending on the dose and the place and time of purchase.28 In our opinion, a product that appears
to be no more effective than a placebo does NOT offer value for money.

The role of the TGA
Sponsors of complementary medicines who wish to supply products in Australia must apply to the
Therapeutic Goods Administration (TGA) and have their product included on the Australian
Register of Therapeutic Goods (ARTG) as either a “Listed” or “Registered” medicine. All “Listed”
and “Registered” medicines must be manufactured in accordance with the principles of Good
Manufacturing Practice (GMP).
“Registered” medicines are assessed as having a higher level of risk, and are individually assessed
by the TGA for quality, safety and efficacy prior to market entry. “Listed” medicines are considered
to be of lower risk as they may only contain ingredients approved by the TGA as being of low risk
and may only make certain therapeutic claims. Most, but not all, complementary medicines are
“Listed” medicines (designated AUST-L on the packet).
Initially, the TGA did not require evidence to support manufacturers' claims for AUST-L products,
provided the products were not for the treatment of serious illnesses. A concern that multiple and at
times improbable claims were being made about such products led to the introduction in April 1999
of a requirement that sponsors of AUST-L products must hold evidence to substantiate their claims.
This evidence may be called for and evaluated by the TGA, should a concern or complaint arise at
any time during the life of a product. If the evidence is inadequate, the TGA may cancel the listing
for the product. A random sample of approximately 20% of new listings is assessed in detail each
year for compliance with the listing requirements. In 2003 an expert committee recommended that


23
   Sierpina VS, Wollschlaeger B, Blumenthal M. Am Fam Physician. 2003; 68: 923-6.
   http://www.aafp.org/afp/20030901/923.html (accessed 9/05/06)
24
   Bent S, Goldberg H, Padula A, Avins AL. Spontaneous bleeding associated with ginkgo biloba: a case report and
systematic review of the literature. J Gen Intern Med. 2005; 20: 657-61.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16050865&quer
y_hl=24&itool=pubmed_docsum (accessed 10/05/06)
25
   Jiang X, Williams KM, Winston S. Liauw WS, et al. Effect of ginkgo and ginger on the pharmacokinetics and
pharmacodynamics of warfarin in healthy subjects. British Journal of Clinical Pharmacology 2005; 59: 425–432.
http://www.blackwell-synergy.com/links/doi/10.1111/j.1365-2125.2005.02322.x (accessed 10/05/06)
26
   http://www.tga.gov.au/docs/pdf/cmec/cmecmi17.pdf Recommendation 17.3 (accessed 9/5/06)
27
   http://www.tga.gov.au/adr/aadrb/aadr0502.pdf
28
   http://www.healthdepot.com.au/ssl/2-int/shopexd.asp?id=507 (accessed 9/5/06)


                                                                                                  Page 7 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
sponsors of AUST L medicines should submit summaries of the evidence they hold to support the
efficacy of their products, and that the TGA should randomly audit this information.29
Tebonin® is categorised as a “Listed” product on the ARTG (No: 125310) and the indication, “For
the symptomatic relief of tinnitus” (and many other claims) are contained on the ARTG. However,
we understand that the TGA has yet to make any assessment of the scientific validity of these
claims.

The advertising of therapeutic goods
The advertising of therapeutic goods in Australia is governed by the Therapeutic Goods Act 1989
and Regulations. All advertisements of “Listed” products to consumers (such as Tebonin®) must
comply with the Therapeutic Goods Advertising Code 2005. The general principle of the Code is
that advertisements for therapeutic goods must contain correct and balanced statements; claims
must already be verified; and they should not mislead, or be likely to mislead, directly or indirectly.
In addition, advertisements must not state or imply that the product is effective in all cases of a
condition. Advertisements of complementary medicines placed in “specified media” such as
magazines, newspapers and broadcast media must be pre-cleared by the Advertising Services
Manager of the Complementary Healthcare Council of Australia.30
In our opinion, information on the Tebonin® pack, packet insert and the current advertisements for
that product, including those appearing in print media, do not comply with the above requirements
of the Therapeutic Goods Advertising Code 2005.

Conclusion
AusPharm Consumer Health Watch believes that there is insufficient good quality evidence to
support the promotion of Tebonin® for the relief of tinnitus at this point in time. People with this
symptom should consult their doctor. They can also inform themselves of various management
options by getting in touch with their local Tinnitus Association.31
AusPharm Consumer Health Watch has sent this report and our concerns about the current
Tebonin® advertising material to the Office of Complementary Medicines of the TGA, the
Complaints Resolution Panel of the Therapeutic Goods Advertising Code Advertising Code
Council (TGACC) and the Complaints Resolution Committee of the Complementary Healthcare
Council (CHC) so that they can consider the issues raised in this report.
                                                     On behalf of AusPharm Consumers Health Watch.
                                                                              Mark Dunn (Convenor)
                                                                                   62 McKenzies Rd
                                                                         Lesley Vale, Tasmania, 7054
                                                                                           Australia
                                                                               Mobile: 0427 981 517
                                                             Email: mark@consumerhealthwatch.net.au

                                                                                             June 6, 2006


29
   McEwen J. What does TGA approval of medicines mean? Aust Prescr 2004; 27: 156-8.
   http://www.australianprescriber.com/magazine/27/6/156/8/ (accessed 7/5/2006)
30
   http://www.chc.org.au/scripts/cgiip.exe/WService=ASP0012/ccms.r?Roxy=0x0005bba0&PageId=10047 (accessed
18/5/2006)
31
   http://www.tinnitusvic.asn.au/index.htm (accessed 7/5/2006)


                                                                                              Page 8 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
Appendix I




                                                     Page 9 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
Appendix II




                                                     Page 10 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?

Appendix III




                                                     Page 11 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?

Appendix IV




                                                     Page 12 of 13
AusPharm Consumer Health Watch Product Review:
Does Tebonin® (Ginkgo biloba) provide relief in tinnitus?
Appendix V




                                                     Page 13 of 13

				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:1907
posted:3/25/2010
language:English
pages:13
Description: Does Tebonin® (Ginkgo biloba) provide relief in tinnitus